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The Pharmaceutical "Business with Disease"

Up to date news and comment about the "Business with Disease".

December 31, 2004

Editor claims drug companies have a "parasitic" relationship with journals
The relationship between medical journals and the drug industry is "somewhere between symbiotic and parasitic," according to the editor of the Lancet, Richard Horton. But at the moment it has swung too much towards the parasitic, he told the House Commons select committee on health last month in his oral evidence on the role of the industry.
Read article at BMJ.com

Intimidation, Politics and Drug Industry Cripple U.S. Medicine
While the U.S. Food and Drug Administration (FDA) is supposed to safeguard the nation's medical products, drawing upon the substantive expertise of its drug scientists in vigilant dedication to the public's health, that is not the case today. Documentation, interviews and recent drug debacles depict a brutally different reality, with the Vioxx scandal alone estimated to have resulted in 30,000-55,000 U.S. deaths. "You have an agency in denial -- the FDA still maintains it made no mistake in the approval or regulation of Vioxx," says the agency's associate safety director, Dr David J Graham.
Read article at CommonDreams.org

Direct to consumer advertising is at the crossroads
of competing pressures from industry and health needs

Direct to consumer advertising increases the use of drugs and medical services and increases wealth for pharmaceutical, advertising, and media companies. It increases prescribers' workloads and increases expenditure by patients, taxpayers, insurers, and large employers.
Read article at BMJ.com

FDA to review "missing" drug company documents
The US Food and Drug Administration has agreed to review confidential drug company documents that went missing during a controversial product liability suit more than 10 years ago. The documents appear to suggest a link between the drug fluoxetine (Prozac), made by Eli Lilly, and suicide attempts and violence.
Read article at BMJ.com

December 30, 2004

FDA doctors defend agency's Vioxx moves
Two US regulators defended the Food and Drug Administration's handling of the withdrawn painkiller Vioxx, disputing the contention of heart researcher Dr. Eric Topol that the agency could have forced Merck & Co. to do more safety testing.
Read article at Boston.com

December 29, 2004

Has FDA become Big Pharma pawn?
After a year filled with stories of dangerous painkillers and questionable flu shots, critics say pro-industry forces have eroded the FDA's regulatory prowess. They charge the FDA yields to political pressure to speed drugs through the approval process, and is reluctant to yank a suspect medication off the market once approved.
Read article at CBS.MarketWatch.com

Lessons learned from troubles with COX-2 inhibitors
One of the nation's leading cardiovascular medical researchers has issued a call for less aggressive direct-to-consumer advertising and better safety assurances of medications in a special article posted online today by JAMA because of its relevance to the recent withdrawals and warning labels on the pain-relieving drugs known as COX-2 inhibitors.
Read article at MedicalNewsToday.com

Lawsuit Alleges Children's Motrin Causes Stevens-Johnson Syndrome
A lawsuit filed Tuesday against Johnson & Johnson alleges that Children's Motrin causes Stevens-Johnson Syndrome, a harmful reaction resulting in severe burning, blistering, blindness or death in some cases. The Plaintiff, Sabrina Brierton Johnson, age 7, claims that an allergic reaction to taking Children's Motrin (Stevens-Johnson Syndrome) caused her to become blind and photosensitive.
Read article at LegalNewsWatch.com

U.S. family files suit after woman dies during experimental AIDS drug regimen
The family of a pregnant woman who died while taking experimental AIDS drugs to protect her baby from getting the disease is suing the doctors, drug makers and hospitals involved in the study for $10 million US.
Read article at MedBroadcast.com

Gilmartin: Merck Says CEO May Testify In Vioxx Lawsuits
Merck Chief Executive Raymond V. Gilmartin may testify in some of the many lawsuits filed over the Vioxx recall, a company lawyer said.
Read article at Forbes.com

December 28, 2004

Chemotherapy lowers levels of antioxidants and micronutrients
Children undergoing chemotherapy for acute lymphoblastic leukemia (ALL) have significant changes in their antioxidant and micronutrient status which are related to their treatment outcomes, according to the results of a novel prospective study.
Read article at News-Medical.net

December 27, 2004

Over-the-counter cholesterol drug coming?
Merck next month will make its second try for approval to sell cholesterol drug Mevacor without a prescription. If the Food and Drug Administration approves, cholesterol drugs would become the third type of drug to switch from prescription to over-the counter status in the USA. Bristol-Myers Squibb said this month that it also intends to seek non-prescription status for cholesterol drug Pravachol.
Read article at USAToday.com

December 26, 2004

Big Pharma's Dirty Little Secret
The American healthcare system is the best in the world. Or so we are often told. But is it really true? It is certainly the best system for drug companies, which can charge the highest prices in the world to some U.S. consumers. The Congressional Budget Office has estimated that average prices for patented drugs in 25 other top industrialized nations were 35% to 55% lower than in the United States.
Read article at LATimes.com

December 24, 2004

FDA Statement on Iressa
The Food and Drug Administration (FDA) learned yesterday from AstraZeneca that a large clinical trial comparing Iressa (gefitinib) with placebo in patients with non-small cell lung cancer who had failed other courses of cancer therapy showed no survival benefit from taking Iressa.
Read article at ScienceDaily.com

December 23, 2004

FDA too dependent on drug money
The troubles surrounding a major class of painkillers may ultimately help cure what has long ailed the U.S. Food and Drug Administration. Despite research showing that high doses of Celebrex more than double the risk of heart attack, Pfizer has kept the medicine on the market, where it makes the company billions each year. The company has, however, pulled all advertising for the painkiller, which arguably helped create the problem in the first place.
Read article at Hamptonroads.com

Are Drug Makers Influencing Your Doctor?
When patients visit their doctor for medical care and advice, most believe they are getting unbiased medical attention that puts the patient's well-being first. But most patients are unaware that some doctors' advice might be affected by expensive gifts, lavish trips to luxury resorts, gourmet dinners and high-priced tickets to Broadway shows and sporting events.
Read article at ABCNews.com

FDA orders review of studies involving COX-2 pain drugs
The Food and Drug Administration on Thursday ordered a review of all prevention studies involving drugs such as Celebrex and Bextra, which have been associated with increased risk of heart problems. The agency also urged the public to limit use of over-the-counter pain medications.
Read article at SFGate.com

Drug risks raise doubt about ads
As the list of prescription drugs raising concern about possible harmful side effects grows, new questions are being asked about the wisdom of inundating consumers with a blizzard of ads for medicines whose safety or effectiveness may later be called into question.
Read article at CSMonitor.com

Substantial Bone Loss Seen With Depo-Provera Use
The results of a new study confirm that using the contraceptive Depo-Provera is associated with bone loss. Depo-Provera, also known as DMPA, is a long-lasting contraceptive hormone that is injected every three months.
Read article at Reuters.com

December 22, 2004

Rethinking over-the-counter drugs
A government finding that Aleve, the widely used pain reliever, appears to increase the risk for heart problems underscores how little is known about possible side effects of some common older medicines.
Read article at SFGate.com

F.D.A. Calls Ads for Cholesterol Pill Crestor 'False and Misleading'
AstraZeneca's recent full-page newspaper advertisements defending the safety of its cholesterol-lowering pill, Crestor, are "false and misleading," in part because serious concerns remain about the safety of the drug, federal drug regulators said Wednesday. The advertisements stated that "the F.D.A. has confidence in the safety and efficacy of Crestor" and that the agency "as recently as last Friday publicly confirmed that Crestor is safe and effective." Neither is true, said a letter from the Food and Drug Administration to AstraZeneca.
Read article at NYTimes.com

Good Pill, Bad Pill: Science Makes It Hard to Decipher
In one of the great examples of the mixed messages of science, the same study that killed the blockbuster arthritis drug Vioxx after showing that it had heart risks also found that the drug had a significant benefit: it prevented precancerous colon polyps in some patients, one of the study's principal researchers said.
Read article at NYTimes.com

The National Institutes of Health: Public Servant or Private Master?
For 15 million Americans, it is a daily ritual: gulping down a pill to reduce cholesterol. They do it because their doctors tell them to. Their doctors, in turn, rely on recommendations from the National Institutes of Health and its scientists, such as Dr. H. Bryan Brewer Jr. Brewer, as a leader at the NIH, was part of a team that gave the nation new cholesterol guidelines that were expected to prompt millions more people to take the daily pill. He also has written favorably of a specific brand of cholesterol medication, Crestor, which recently proved controversial. What doctors were not told for years is this: While making recommendations in the name of the NIH, Brewer was working for the companies that sell the drugs. Government and company records show that from 2001 to 2003, he accepted about $114,000 in consulting fees from four companies making or developing cholesterol medications, including $31,000 from the maker of Crestor.
Read article at LATimes.com

Doctors told to stop using painkiller
Doctors were yesterday advised to switch all patients taking the painkillers known as Cox-2 inhibitors on to other drugs following revelations that they increase the risk of heart attack. At least a million people are thought to have been on the drugs which were widely prescribed for arthritis before the first of the two market leaders, Vioxx, was withdrawn by the manufacturer Merck at the end of September. Four days ago Pfizer, which makes Celebrex, said it too had new data showing an increased heart attack risk.
Read article at TheGuardian.com

Safety Issue May Change Pill Culture
Safety questions about popular pain-killing medications may give people pause over the nation's pill-popping culture, analysts say, and that would give the beleaguered drug industry something else to worry about. The tendency to take prescription pills for everyday aches and pains, shyness, allergies, impotence, and other "lifestyle" concerns have helped prop up pharmaceutical company revenue. Now analysts say safety concerns may prompt a consumer backlash.
Read article ate WashingtonPost.com

AP Poll: Confidence in Drug Safety Remains
Consumers remain confident in the safety of prescription drugs sold in the USA at a time when some popular ones have been linked to health threats, an Associated Press poll found. They also expressed confidence in the Food and Drug Administration, the federal agency responsible for ensuring drug safety. But some indicated their confidence is limited.
Read article at RedNova.com

December 21, 2004

Bush Administration's Effective Denial of Drug Importation from Canada
Appears to be Due to Power of Drug Money

The findings released today by the Bush administration’s Drug Importation Task Force are highly suspect because of: 1) the task force’s makeup; 2) an intense lobbying campaign by the pharmaceutical industry, which included many former senior officials from the Bush administration; and 3) the industry’s financial support of Bush’s re-election, according to a report released today by Public Citizen.
Read article at Citizen.org

NHS Scotland launches Ritalin probe
The NHS Scotland health watchdog has launched an inquiry into the treatment of the childhood behavioural condition attention deficit hyperactivity disorder (ADHD) after new figures revealed a tenfold increase in the use of the psychoactive drug Ritalin.
Read article at NursingTimes.net

Potentially fatal toxicities occur with off label use of cancer drugs
Food and Drug Administration policies prevent pharmaceutical manufacturers from informing patients about potentially fatal toxicities that occur with some cancer drugs -- policies that should be revised immediately, according to Northwestern University researchers who have called for an immediate revision of these FDA policies, particularly because the drug thalidomide, which was approved by the FDA as an off-label cancer treatment in 1998, has been reported to have caused potentially fatal blood clots in the legs and the lungs in over 190 cancer patients.
Read article at MedicalNewsToday.com

A Fourth Painkiller Is Linked to Increases in Heart Problems
A new study has found that Aleve, a popular over-the-counter painkiller made by Bayer, could increase heart problems, and federal officials are warning patients not to exceed the recommended dose of two 200-milligram pills a day or continue therapy for more than 10 days without consulting a physician. It was the fourth big-selling pain medicine in recent months to be suspected of hurting the heart, and federal drug officials said that similar drugs, like Advil, might also increase heart risks.
Read article at NYTimes.com

Overdosed and Oversold
In the early 1960's, Congressional hearings on skyrocketing drug prices went nowhere. But the political logjam was broken when a eagle-eyed doctor at the Food and Drug Administration averted a potential disaster by advising the agency not to let thalidomide into the United States market. While the final legislation back then had little to do with prices or safety, the new law ushered in efficacy testing and led to the withdrawal of hundreds of drugs of no medical benefit from the market.
Read article at NYTimes.com

FDA Chief: Keeping Options Open on Naproxen
The head of the U.S. drug safety agency said on Tuesday the United States was keeping "all regulatory options open" as it studied data showing increased heart risks from some painkillers.
Read article at Reuters.com

December 19, 2004

White House official praises drug agency
The federal drug safety agency is doing a "spectacular job" of protecting the public, the White House chief of staff said Sunday. The assessment drew an immediate outcry from a Senate critic who charged that government oversight under the Bush administration has proved "a catastrophic failure."
Read article at SeattlePI.NWSource.com

Pfizer CEO Defends Celebrex, Won't Recall It
Pfizer Chief Executive Hank McKinnell said on Sunday doctors should be made aware of the health risks in prescribing Celebrex to their patients, but the company does not plan to recall its popular arthritis drug.
Read article at RedNova.com

Medicine Fuelled by Marketing Intensified Trouble for Pain Pills
In the mid-1990's, the medical community reached an inescapable conclusion. Researchers at the Stanford University Medical School and elsewhere who had long been monitoring arthritis and rheumatism patient records had found that thousands of patients, perhaps as many as 16,500, were dying annually from bleeding ulcers and other problems caused by widely used painkillers like ibuprofen. Within a few years, a new class of pain relievers, the so-called COX-2 inhibitors, burst onto the market with the promise they might reduce that toll.
Read article at NYTimes.com

December 18, 2004

American Consumers Suffer As More New Drugs Debut in U.S., Analysis Shows
Thousands of Americans are getting sick and many are dying each year from prescription drugs that were pushed onto the U.S. market ahead of the rest of the world. A Knight Ridder analysis shows that as the number of new drugs given first to Americans has increased, the reports of drug-induced ailments have soared. Yet, even as the deaths and damage have increased, the Food and Drug Administration has never instituted an aggressive system to track the safety of drugs once they're on the market.
Read article at RedNova.com

Bad news about Celebrex, Strattera, Iressa fuel criticisms of FDA
A string of negative reports about medications has the media buzzing with questions about the job FDA is doing and the public asking pharmacists and physicians questions about whether the drugs they are taking are really safe and effective.
Read article at MedicalNewsToday.com

December 17, 2004

Drug doubts
First Vioxx, now a new study alerts people to possible problems with fellow painkiller Celebrex. These are just one class of drugs. There have also been concerns raised recently about other prescription drugs, including the use of antidepressants for teenagers. Will this trigger a backlash?
Read article at CNN.com

US House panel asks Pfizer for Celebrex records
The U.S. House Energy and Commerce Committee said on Friday it requested documents from Pfizer Inc. related to painkillers Celebrex and Bextra, two drugs that have been linked to heart risks. The committee, in a letter to Pfizer Chief Executive Hank McKinnell, said it had concerns about Pfizer's statements in recent weeks about the safety of Celebrex.
Read article at Reuters.com

S. Africa Rips U.S. on AIDS Drug Debacle
President Thabo Mbeki's African National Congress party carried an article in its online journal Friday accusing top U.S. officials of treating Africans like guinea pigs and telling lies to promote the sales of a key AIDS drug. The article, published in ANC Today, was responding to Associated Press reports this week that U.S. health officials withheld concerns about a key nevirapine study before President Bush launched a 2002 plan to distribute the drug in Africa to protect newborns from catching HIV from their infected mothers.
Read article at APWire.com

Jesse Jackson calls for investigation into AIDS drug
The Reverend Jesse Jackson says the US government should immediately halt distribution in Africa of an AIDS drug that reportedly poses serious risks. The civil rights leader is calling for a congressional investigation into reports that US health officials withheld research from the White House that showed problems with the drug (nevirapine).
Read article at EyewitnessNewsTV.com

Pfizer Celebrex Trial Stopped After Heart Attacks
Pfizer Inc. on Friday said patients taking its blockbuster arthritis drug Celebrex in a long-term cancer-prevention trial had more than twice the number of fatal or non-fatal heart attacks as those taking a placebo.
Read article at Reuters.com

December 16, 2004

Woman Died During U.S. AIDS Drug Study; Family Never Told of Likely Cause
A pregnant Tennessee woman who enrolled in federally funded research in hopes of saving her soon-to-be-born son from getting AIDS died last year when doctors continued to give her an experimental drug regimen despite signs of liver failure, government memos say.
Read article at ABCNews.com

Bribes Alleged in Sales Policy for AIDS Drug
A New York sales representative for a Swiss biotechnology company was charged Tuesday by federal prosecutors with bribing doctors to write prescriptions for an expensive AIDS drug.
Read article at RedNova.com

Many FDA Scientists Had Drug Concerns, 2002 Survey Shows
Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite reservations about its safety, effectiveness or quality. The survey of almost 400 scientists also found that a majority had significant doubts about the adequacy of federal programs to monitor prescription drugs once they are on the market, and that more than a third were not particularly confident of the agency's ability to assess the safety of a drug.
Read article at WashingtonPost.com
Read also the article at UCSUSA.org
Read also the article at Peer.org

Busting Big Pharma
What happens when a slick sales force of 87,000 is set loose with billions of dollars to wine and dine, entertain and educate the US's 600,000 doctors? The short answer is that six years ago Americans spent $US89 billion on prescription drugs. Last year the amount exploded to $US149 billion. In the year to March 2004, Australia spent $5.8 billion on prescription drugs. The US accounts for half of all global profits for Big Pharma, as the pharmaceutical corporations are known.
Read article at TheAustralian.com

House's Author of Drug Benefit Joins Lobbyists
Representative Billy Tauzin, a principal author of the new Medicare drug law, will become president of the Pharmaceutical Research and Manufacturers of America, the chief lobby for brand-name drug companies, the trade group announced Wednesday.
Read article at NYTimes.com

December 15, 2004

Drug Induced Liver Injury Expected to Increase With Almost Half of All Americans Now Using Prescription Drugs
HepaLife Technologies, Inc, a development stage biotechnology company focused on the research, development and eventual commercialization of technologies and products for liver toxicity detection and the treatment of various forms of liver dysfunction and disease, today announces its expectations of increased drug induced liver injuries and adverse drug reactions due to a dramatic rise in prescription drug usage amongst Americans, with almost half of the population now taking at least one prescription drug and one person in every six taking three or more (Centers for Disease Control and Prevention, December 2, 2004).
Read article at RedNova.com
The CDC report can be found here

AIDS Research Chief Rewrote Safety Report
The government's chief AIDS researcher removed some negative safety conclusions from a subordinate's report on a U.S.-funded drug experiment, then ordered the research to resume over objections from his staff, memos show.
Read article at ABCNews.com

December 14, 2004

NIH Officials Warned of Nevirapine Risks But Did Not Inform White House, 2002
Although NIH officials were warned that a Ugandan clinical trial using the antiretroviral drug nevirapine was "flawed" months before President Bush announced an initiative to reduce mother-to-child HIV transmission in Africa and the Caribbean, they did not inform the White House of the risks associated with the drug's use in pregnant women.
Read article at MedicalNewsToday.com

Vioxx Lawsuits Swamp Merck
Merck Tuesday said that 475 personal injury lawsuits have been filed against the company relating to its withdrawal of Vioxx from the market on Sept. 30. Kenneth C. Frazier, senior vice president and general counsel, said the company will vigorously defend against the lawsuits, seeking to try the lawsuits on a case-by-case basis because each patient taking the drug has a different set of circumstances and medical conditions.
Read article at TheStreet.com

If Bush Needs a Cholesterol Drug, Do You?
If the county's top doctors say President Bush, an avid exerciser they describe as being in "excellent" health, needs a cholesterol-lowering statin drug, do you, too?
Read article at WebMD.com

Merck increases job cuts amid earnings decline
Merck & Co. Inc. whose earnings are being hurt by the withdrawal of its arthritis drug Vioxx, said on Tuesday it has increased the number of jobs it expects to cut by the end of this year to 5,100 from an original target of 4,400.
Read article at Reuters.com

Drug Czars
India's pharmaceutical tycoons are getting richer, thanks to growing international demand for their generic drugs. No surprise, then, that pharmaceuticals are the source of wealth for nine of India's richest people, who together have a collective net worth of $6.5 billion.
Read article at Forbes.com

Prescriptions to Combat Depression Raise Concern
A senior Government adviser on mental health has expressed concern that doctors are over-prescribing anti- depressants with little evidence of any public health benefit. Dr Dermot Walsh, the former Inspector of Mental Hospitals, told The Irish Times the increase in prescription of anti-depressants was also accompanied by a worrying rise in suicide rates. "There isn't any public health evidence that widespread increase in anti-depressants has resulted in a decrease in the incidence of depression," he said.
Read article at RedNova.com

This Is Your Country on Drugs
Don't steroids carry dangers? Of course they do. But so do the enhancement drugs we get from our doctors. Fen-Phen, the popular weight-loss drug that was linked to pulmonary hypertension and heart disease, has killed and harmed so many people that Wyeth, its manufacturer, has put aside more than $16 billion to compensate victims. Hormone replacement therapy, promoted in the 1960's as an anti-aging drug for women, has been linked to an increased risk of heart disease, strokes, pulmonary emboli and breast cancer. Antidepressants like Prozac, Paxil and Zoloft were described as "cosmetic psychopharmacology" a decade ago; today they are embroiled in a public controversy over their links to suicide and homicide.
Read article at NYTimes.com

Doctors link common chemotherapy drug to jawbone necrosis
Doctors at Long Island Jewish (LIJ) Medical Center recently discovered a link between a common chemotherapy drug and a serious bone disease called osteonecrosis of the jaw (ONJ).
Read article at MedicalNewsToday.com

Valdecoxib gets contraindication, boxed warning, USA
In addition to a contraindication for use of valdecoxib (Bextra-Pfizer) for the treatment of postoperative pain immediately following coronary artery bypass graft (CABG) surgery, FDA has added a boxed warning to the drug's labelling stating that serious, potentially fatal skin reactions-including Stevens-Johnson syndrome and toxic epidermal necrolysis-have been reported.
Read article at MedicalNewsToday.com

We Love Them. We Hate Them. We Take Them.
There were eight of us crowded into the exam room as an exasperated patient and I tried to figure out why he was feeling weak and tired and itchy and nauseated and almost fainted in the subway Thursday night. Two of us, the patient and I, were human beings. The rest had no voices, bodies or personalities in the ordinary sense of the word, but they played a role in the discussion that was just as vigorous and important as if they did. They were, of course, my patient's pills.
Read article at NYTimes.com

December 13, 2004

New study shows early ritalin may cause long-term effects on the brain
A new study conducted in rats by the National Institutes of Health (NIH) and McLean Hospital/Harvard Medical School suggests that the misdiagnosis of attention-deficit hyperactivity disorder (ADHD) combined with prescription drug use in children may lead to a higher risk of developing depressive symptoms in adulthood.
Read article at MedicalNewsToday.com
The DEA information about methylphenidate can be found here

December 10, 2004

US officials move toward drug safety independence
U.S. lawmakers and health officials are moving to give more independence to an office that reviews drug safety, but some experts say ensuring medicines are studied after they hit the market is more important than the bureaucratic pecking order. Health and Human Services Secretary Tommy Thompson is expected to announce changes as early as next week to give the U.S. Food and Drug Administration's Office of Drug Safety more autonomy from the Office of New Drugs, which approves new therapies. "I'm working on how I'm going to set that up," Thompson told reporters Wednesday, adding that a review group outside the FDA was a consideration.
Read article at Reuters.com

Rep. Stupak Calls on FDA to Assure Whistleblower Keeps his Job
The Food and Drug Administration asked a whistleblower, drug safety expert Dr. David Graham, to leave his position and move elsewhere in the agency, according to Congressman Bart Stupak. In a letter to the FDA Acting Commissioner Lester M. Crawford, Stupak and 21 congressional members have demanded assurance Dr. Graham will keep his job. The members also asked the Commissioner that he investigate the smear campaign conducted by some within the agency against Dr. Graham.
Read article at LegalNewsWatch.com
Read Rep. Stupak's press release on the subject here

Why doctors don't read research papers
I find the same when trying to read medical papers. Sometimes it is the austere formulaic style of the prose that seems a bit dishonest. The authors affect the scientific style of the disinterested observer when in truth they are advocates of their idea. I find myself wanting to say: "Hey! If you want to persuade me to your view that this is important—be honest about it. Tell me what you think and then, honestly, why you think it."
Read article at BritishMedicalJournal.com

Prozac is risky for children too
European drug regulators are concerned that Prozac, like its sister antidepressants, is unsafe for children, contrary to UK advice. The Committee for Medicinal Products for Human Use (CHMP) reviewed all of the available data. It said there was an increased risk of suicidal behaviour and thoughts with all antidepressants known as Selective Serotonin Reuptake Inhibitors (SSRIs). UK regulators say the benefits of Prozac in under-18s outweigh any risk.
Read article at BBCNews.co.uk

A Top Republican to Offer Drug Data Bill
A top Senate Republican on health care issues, Charles E. Grassley of Iowa, plans to introduce legislation early next year that would require pharmaceutical companies to register drug trials and report their results in a public database, an aide said yesterday. Several Democrats have introduced similar proposals in the Senate and the House. But the involvement of Mr. Grassley, who led recent hearings involving the drug industry and federal drug regulation, may be a significant advance because it signals some bipartisan support for such a bill.
Read article at NYTimes.com

December 9, 2004

Drug Maker Withheld Paxil Study Data
New documents uncovered by ABC News suggest GlaxoSmithKline, the maker of the popular antidepressant Paxil, failed to disclose important information about the possibility of an increased risk of suicidal behaviour in some children taking the drug, as well as serious withdrawal symptoms when some patients stop taking Paxil. The new documents obtained by the ABC News program "Primetime Live" have never before been made public. Earlier this year, the Food and Drug Administration ordered manufacturers to place a warning in bold print on antidepressants, alerting consumers that the drugs can cause suicidal tendencies in children and teenagers.
Read article at ABCNews.com
The previously covered-up GSK internal memo touting the "remarkable efficacy and safety in the treatment of adolescent depression" of Paxil can be found here

Bextra Found to Pose Risks After Heart Bypass Surgery
The government is warning of potential heart problems associated with the use of the painkiller Bextra in people who have recently had heart bypass surgery. The Food and Drug Administration said Thursday that it was adding the warning to the label of Bextra, as well as strengthening the label warnings on the possibility of severe skin reactions with the drug, which is made by Pfizer.
Read article at NYTimes.com

Baxter Ends Flu Vaccine Trial; Cites Side Effects
Baxter International Inc. on Thursday said it halted a late-stage European trial of a flu vaccine because of higher-than-expected rates of fever and other symptoms. The health-care products company said it has put further clinical studies for the vaccine, dubbed Preflucel, on hold while it analyzes data from the trial.
Read article at Reuters.com

CHMP meeting on Paroxetine and other SSRIs, European Medicines Agency
The European Medicines Agency scientific committee, the Committee for Medicinal Products for Human Use (CHMP), held an extraordinary meeting in London on 8 December 2004 and took two actions relating to paroxetine and to other SSRIs.
Read article at MedicalNewsToday.com
The EMEA press release can be found here

December 8, 2004

Lilly launches publicly available clinical trial registry
Eli Lilly and Company today will announce the launch of its publicly available clinical trial registry which will post the results from all Phase I through Phase IV clinical trials of Lilly's marketed products. Results that do not support the hypothesis being tested or that are contrary to the expected outcome will be disclosed.
Read article at NewsMedical.net
The Lilly clinical trials website can be found here

Medical Students Declare ‘Pharmfree Day' to Combat Biased Industry Temptations
The American Medical Student Association (AMSA), the nation's largest, independent medical student organization, with nearly 50,000 members, today announces National PharmFree Day, the first annual day of action where medical students, residents and physicians will speak out against the pharmaceutical industry's biased marketing practices.
Read article at MedicalNewsToday.com
Details of AMSA's PharmFree Campaign can be found here

How To Prevent Another Vioxx
In the U.S. drug industry, it often takes a disaster to bring change. Not until thousands of European babies were deformed by thalidomide in the late 1950s and early 1960s did Congress raise standards for approvals. Now the Food & Drug Administration and Congress are grappling with what FDA whistle-blower David Graham says "may be the single greatest drug-safety catastrophe in the history of this country" -- the use by millions of people of a painkiller, Vioxx, that raises the risk of heart attacks.
Read article at BusinessWeek.com

Doctors not influenced by pharmaceutical marketing tactics
Pharmaceutical drug companies spend upward of $25 billion per year in the USA on promoting new drugs and distributing free samples to doctors, but new research shows such marketing devices have little impact on physicians and their prescribing behavior.
Read article at MedicalNewsToday.com

Industry Distortion of the F.D.A.
Twelve years ago, the White House and Congress made an agreement with the pharmaceutical industry that seemed eminently reasonable at the time. The industry would supply substantial sums - reaching $200 million a year at latest count - to help the Food and Drug Administration hire more reviewers to speed the approval process for new drugs that might otherwise be held up solely by administrative logjams. The quid pro quo was that the government had to meet tight deadlines for reviewing drugs and had to keep steady its own financing for new-drug reviews, adjusted for inflation.
Read article at NYTimes.com

Merck's Board Appoints Panel to Investigate Handling of Vioxx
The directors of Merck, the giant drug maker, have opened an independent investigation into whether the company acted properly regarding Vioxx, the arthritis treatment that it withdrew from the market in September.
Read article at NYTimes.com

December 7, 2004

U.S. Imports 1.2 Million More Flu Shots
The United States has procured another 1.2 million foreign doses of influenza vaccine under an investigational new drug (IND) application. All of the doses are expected to be available this month. The new vaccine, Fluarix, was made by GlaxoSmithKline in its German plant. Under a protocol worked out with the U.S. Food and Drug Administration, Glaxo has agreed to make up to 4 million doses total available.
Read article at MedicalNewsToday.com
Details of Bush's campaign funding can be found here

Go East, Big Pharma
Drugmakers are expanding in China, but patents are still a worry
Read article at BusinessWeek.com

Vioxx three times as dangerous as Celebrex, study indicates
An independent study carried out at the University of Pennsylvania has shown that your risk of having a heart attack is three times greater with Vioxx than with Celebrex. Celebrex and Vioxx are both arthritis pain medications (prescription drugs).
Read article at MedicalNewsToday.com

Arava: the 'sixth drug' that may soon be under fire
At a recent hearing into the Vioxx affair, the FDA's Dr David Graham named five drugs that he considers too dangerous to be on the market. However, in his testimony, Dr Graham also cited Sanofi-Aventis' Arava as a drug he has recommended be withdrawn. Unlike the other five drugs, Arava has largely escaped the media spotlight, but there may yet be some tough questions asked about its safety.
Read article at BioPortfolio.com

A.M.A. Seeks More Openness in Drug Trials
The nation's largest group of doctors called yesterday for an end to restrictions in drug trial contracts that prevent academic and other researchers from freely discussing test data and results. In a unanimous vote, the policy-making board of the American Medical Association adopted a resolution yesterday that called for the development of guidelines to eliminate confidentiality clauses that can prevent researchers who have worked on a drug trial from discussing its results with other researchers and doctors.
Read article at NYTimes.com

December 6, 2004

FDA Mulls Easier Access to Cholesterol Drugs
Four years ago, advisory committees of the Food and Drug Administration rejected requests by several companies to turn their prescription cholesterol drugs into over-the-counter medications. Next month, at least one of the drugs will get another chance.
Read article at TheStreet.com

German lawmakers warns drug firms over price suits
Germany's ruling Social Democrats may oppose plans to cut a compulsory discount on patented drugs if drug companies go ahead with plans to sue over the main pricing system, a lawmaker was quoted in a German newspaper as saying on Sunday. The government has been locked in a battle with drug companies such as Pfizer Inc. and Altana AG over its drug pricing system, which the companies claim is unfair, but which Berlin says is needed to keep health-care costs under control.
Read article at ReutersHealth.com

Lipitor - Vioxx: Discovering the Statin - Painkiller Chain Reaction
Is there an obvious but overlooked connection between statin drugs, their side effects and the new-generation painkillers of the Vioxx class? An intriguing question for anyone interested in drug safety, one would think - except the FDA does not seem overly concerned.
Read article at NewMediaExplorer.org

Bayer to slash 560 jobs, with HQ hard hit
German drugmaker Bayer last week put an end to speculation that it is planning swingeing job cuts by confirming that it is planning to axe 560 positions in Germany and the US as part of restructuring its global pharmaceutical R&D operations.
Read article at InPharma.com

FDA Commissioner agrees to meet top Republican Charles Grassley
Lester Crawford, Acting Commissioner for the FDA, has agreed to meet Charles Grassley about the FDA's handling of safety concerns regarding Vioxx. Crawford wrote to Charles Grassley, Chairman of the Senate Finance Committee and said he took his concerns ‘very seriously'.
Read article at MedicalNewsToday.com

GPs get new anti-depressant rules
Doctors are to be issued with new guidelines on the prescription of anti-depressants, amid concerns too many people are taking them. The National Institute for Clinical Excellence guidelines cover drugs such as Prozac and Seroxat used by hundreds of thousands of people in the UK. The guidelines are set to say people with mild and moderate depression should seek alternative treatments.
Read article at BBC.co.uk

With or Without Vioxx, Drug Ads Proliferate
Just seven years after the Food and Drug Administration ended decades of restrictions by allowing drug makers to advertise prescription products directly to consumers, spending on such ads has reached $3.8 billion. To put that sum in perspective, it is more than companies like Coca-Cola, Pepsi-Cola and Cadbury Schweppes spend combined each year to sell their soft drinks. It even exceeds what one of the very largest marketers, Unilever, spends annually on global campaigns for all its brands, including Dove, Knorr, Lipton, Lux, Pond's, Slim-Fast and Wish-Bone.
Read article at NYTimes.com

At F.D.A., Strong Drug Ties and Less Monitoring
When federal drug officials suspected in 1992 that a popular allergy pill might cause heart problems, they turned to their own scientists. Their trial confirmed the danger, and the drug was pulled from the market. Eight years later, similar worries surrounded the arthritis pill Vioxx. But by then, the Food and Drug Administration had shifted gears, slashing its laboratories and network of independent drug safety experts in favor of hiring more people to approve drugs, changes that arose under an unusual agreement that has left the agency increasingly reliant on and bound by drug company money. Discovering Vioxx's dangers would take four more years.
Read article at NYTimes.com

December 5, 2004

Sleeping pills can kill, drug firm warns
A warning is to be issued about the widely used tranquilliser Ativan, which has been shown to have a rare but potentially fatal impact on patients' breathing. Ativan, one of the benzodiazepine-class drugs taken by more than one million Britons each year, is prescribed for people suffering from anxiety, panic attacks and resulting insomnia. Campaigners have accused the drugs companies for years of withholding information on the addictiveness of benzodiazepines, as well as their long-term side effects.
Read article at Guardian.co.uk

UN pricks pharma's conscience
The United Nations special rapporteur on the “right to health” says better policing is needed to ensure the pharmaceutical industry fulfils its social responsibilities.
Read article at NZZ.ch

December 4, 2004

Glaxo faces threat of UK class action over Seroxat
Lawyers acting for 1,700 people in the UK have issued a pre-action letter of claim against GlaxoSmithKline alleging serious side-effects have been suffered by their clients taking one of its best-selling drugs, the anti-depressant Seroxat.
Read article at TheIndependent.co.uk

December 3, 2004

Malpractice, Medicaid Shaping 2005 Congress Agenda
Republicans' long-sought curbs on medical malpractice awards are likely to top the congressional health care agenda when lawmakers return in January, even as Democrats prepare for a clash over potential cuts to Medicaid, aides said Friday. An aide to Senate Majority Leader Bill Frist of Tennessee told reporters Wednesday that capping doctors' liability in lawsuits will be at the top of his boss's list when the 109th Congress convenes in early 2005. The caps were a cornerstone of President Bush's domestic agenda in his re-election campaign, though the Senate has so far balked at passing them over strong opposition from Democrats.
Read article at Reuters.com

Politics, spin, and science
A US National Academy of Sciences panel made a remarkable recommendation last month, remarkable not for its content but that it had to be made at all. In the report the panel recommends: "When a federal advisory committee requires scientific or technical proficiency, persons nominated to provide that expertise should be selected on the basis of their scientific and technical knowledge and credentials. It is inappropriate to ask them to provide non-relevant information, such as voting record, political-party affiliation, or position on particular policies." The panel apparently felt compelled to make this recommendation after reports that scientists under consideration for advisory board appointments were being questioned about their political views by the Bush administration.
Read article at TheLancet.com

Crisis deepens at the US Food and Drug Administration
The US Food and Drug Administration, rocked by controversy in recent months, has now admitted that a senior management official secretly contacted a whistleblower group. That official attempted to discredit Dr David Graham, the FDA's scientist who criticised the agency during US Senate hearings, saying that the FDA failed to protect the public when it approved rofecoxib - despite evidence suggesting that the drug caused heart attacks and strokes.
Read article at BMJ.com

Tighter controls are needed to root out bogus patient groups
Patient organisations need to be more tightly regulated to protect the public from bogus groups and undue influence from the pharmaceutical industry and other funding bodies, UK MPs heard last week. Setting standards on transparency and accountability would help to distinguish legitimate patient groups from those set up by drug companies to promote awareness of a specific condition and drugs to treat it, said witnesses at the fourth public hearing of the health committee’s inquiry into the influence of the pharmaceutical industry.
Read article at BMJ.com

Two out of every three Americans know someone stricken by lung cancer
Two out of every three Americans know someone stricken by lung cancer, yet more than half of Americans don't realize that lung cancer is among the most lethal of cancers, according to a nationwide survey conducted on behalf of The Lung Cancer Online Foundation. The survey highlights the impact this deadly disease has on Americans.
Read article at News-Medical.net

New 20 year patients threaten to end AIDS drugs for developing countries
Efforts to bring antiretroviral treatment to AIDS patients in developing countries are threatened by the looming implementation of new World Trade Organisation’s patent rules, the charity Médecins Sans Frontières warned this week. The organisation’s TRIPS (trade related aspects of intellectual property rights) agreement comes into force for most signatories on 1 January 2005. It requires the organisation’s members to grant 20 year patents to new pharmaceutical products. Only the least developed countries can postpone implementation until 2016.
Read article at BMJ.com

US threatens Australia over plan to block exptensions to drug patients
The US government has warned Australia that legislative provisions seeking to ensure generic drugs are not blocked by frivolous patent extensions to branded drugs could trigger a trade dispute between the two countries. The warning comes as the Australian minister for trade, Mark Vaile, plans to push through what he describes as "minor changes" to legislation implementing the Australia-US Free Trade Agreement in the final parliamentary sitting for 2004.
Read article at BMJ.com

UK patients seek compensation after taking rofecoxib (Vioxx)
British lawyers are gearing up to launch a mass compensation claim in the British courts on behalf of hundreds of patients who had strokes or heart attacks after taking the arthritis drug rofecoxib (Vioxx). Two law firms, Leigh, Day & Co and Irwin Mitchell, investigated the possibility of suing the manufacturer, Merck, in the United States, but have decided to sue in the British courts instead under the Consumer Protection Act, which covers defective products.
Read article at BMJ.com

Americans Relying More on Prescription Drugs, Report Says
More than 40 percent of Americans take at least one prescription drug and 17 percent take three or more, the government said Thursday in a comprehensive report on the nation's health. The report documented the growing use of medications in the last decade, a trend that it attributed to the growth of insurance coverage for drugs, the discovery and marketing of new products, and clinical guidelines that recommend greater use of drugs to treat high cholesterol, high blood pressure, diabetes and other conditions.
Read article at NYTimes.com

December 2, 2004

'Female Viagra' fails to win FDA panel's approval
A Food and Drug Administration advisory committee voted Thursday not to recommend approving the first prescription treatment for female sexual dysfunction until more studies are done to determine the drug's risks. Procter & Gamble had urged approval of the testosterone patch, called Intrinsa, which has been nicknamed the "female Viagra." The company presented data to the panel that showed that women who tried the patch in clinical trials had improvements in sexual arousal and orgasms and had more satisfying sexual experiences. But the committee decided that Intrinsa should not be approved before researchers conduct additional studies to measure long-term health risks.
Read article at USAToday.com

December 1, 2004

Safety of American Drugs Is Questioned
In a sharp pivot, many medical authorities are questioning the fundamental safety guarantees for American drugs, threatening to dull the national appetite that has demanded and devoured pharmaceuticals at a faster clip for nearly a generation. In a challenge unthinkable even two months ago, Dr. Catherine DeAngelis, editor of the Journal of the American Medical Association, now compares the drug safety system to a dangerous building: "This building is on very shaky ground. Would I condemn it? No, but I would tell people, 'You go in at your own risk.'"
Read article at ABCNews.com

Britain backs HIV vaccine studies
Britain will work with other countries to speed up the development of an Aids vaccine, Chancellor Gordon Brown said on World Aids Day. He added Britain would buy up stocks to guarantee a market for vaccines being developed by researchers.
Read article at BBCNews.com

Celebrex safe, says Pfizer
The drug company that manufactures the anti-arthritic drug celecoxib has released evidence which it says proves its safety. Pfizer said this week that a review of studies involving nearly 40,000 patients shows that celecoxib, marketed under the trade name Celebrex,  was no more likely to cause heart problems than traditional painkillers.
Read article at NursingTimes.net

November 30, 2004

Brazil Plans to Break Patents on Foreign AIDS Drugs
Brazil will break the patents next year on between three and five foreign drugs used in the anti-AIDS cocktail central to its innovative program to fight the illness, the government said on Tuesday.
Read article at Reuters.com

Merck Demands Specific Proof in Vioxx Suits, Court Records Show
Keith Stubblefield took Merck & Co.'s Vioxx painkiller for six weeks before he had a fatal heart attack while washing his car. His widow sued Merck, saying that Vioxx killed him and that the company hid the drug's risks. Merck, which recalled Vioxx on Sept. 30 after a company study found it doubled heart attack and stroke risk after 18 months of daily use, denied the drug caused Stubblefield's death in March 2001. The No. 2 U.S. drugmaker argued in court papers that Stubblefield, 37, was an overweight smoker with high blood pressure and heart disease.
Read article at Bloomberg.com

FDA Responds to JAMA Studies on Cholesterol Drug Baycol, Reviews Records
FDA has launched a review of its records of the August 2001 withdrawal from the market of Bayer's statin Baycol in light of allegations made last week that the pharmaceutical company was aware of the risks associated with the drug but failed to inform FDA of its findings in a timely manner.
Read article at MedicalNewsToday.com

Free the Academic Drug Tests
Academic medical centers represent the top rung of medical research in this country and are widely thought to be impartial and independent. So it is disheartening to find them signing restrictive contracts with pharmaceutical companies that allow the companies to dictate what drug testing data can be openly discussed and published. The manufacturers of drugs and medical devices are already under increasing pressure to list all of their clinical trials and results in public databases. Now academic medical centers will need to clean up their own practices to help prevent suppression of information about the safety and efficacy of drugs.
Read article at NYTimes.com

Merck sued by New York Fund over Vioxx
The New York state comptroller sued Merck & Co., claiming the drug maker hid certain risks associated with the painkiller Vioxx. The company has been the subject of several investor lawsuits since it pulled Vioxx off the market, mostly because its stock has lost well over a third of its value since the recall. One of the losers has been New York state's pension fund, which has recorded $171 million in paper losses related to Merck, according to state Comptroller Alan G. Hevesi.
Read article at ABCNews.com

Pfizer outlines plan for combining cholesterol drugs
On Tuesday, Pfizer Inc., the world's largest drug-maker, outlined its plans to combine its best-selling Lipitor cholesterol-lowering drug with another drug that boosts the "good" type of cholesterol. In early trials, the combination pill significantly lowered bad cholesterol, known as LDL, while raising the desirable HDL that acts as a scavenger, scouring arteries of fatty deposits.
Read article at MenaFM.com

Warning over long-term HRT use
Hormone Replacement Therapy should only be used for the short-term relief of menopausal symptoms, say experts. The new guidance suggests that if a woman has taken HRT for around five years, she should consider if it is in her best interest to continue.
Read article at BBCNews.com

Merck Offering Top Executives Rich Way Out
With its stock plunging and its ability to thrive as an independent company uncertain, the drug giant Merck has adopted a plan that could give its top executives big bonuses if the company is taken over. Merck has been reeling since it withdrew its arthritis treatment Vioxx from the market on Sept. 30 after acknowledging that studies have found a higher incidence of heart problems in people taking the drug.
Read article at NYTimes.com

November 29, 2004

US FDA may reassign Vioxx whistleblower - lawyer
A U.S. Food and Drug Administration reviewer who criticized the agency's handling of Merck & Co. Inc.'s now-withdrawn Vioxx painkiller may be forced to another position at the agency, a lawyer for the scientist said on Monday. FDA efforts to move David Graham, the associate director for science in the Office of Drug Safety, have stepped up since he accused the agency at a Nov. 18 Senate hearing of failing to protect the public, said his lawyer, Thomas Devine.
Read article at Reuters.com

Uncle Pharma's Mischief in a Bottle
A major pharmaceutical CEO gets hauled up in front of Congress to do the congressional version of a perp walk. The executive's company stands accused of one of the worst drug screw-ups in recent history. Meantime, an FDA official, a scientist with an impeccable scientific track record who had managed to predict almost all of the major drug recalls, testifies that the drug should have been targeted for intense study and possible withdrawal up to three years earlier. The CEO is lauded on the business page for his affability and straightforwardness. The Food and Drug Administration is nailed on the front page for not doing its job. The scientist is profiled as a "devout Catholic," a "loner" and being against RU-486. To ask the obvious: What is that all about?
Read article at LATimes.com

Glaxo tells Blair to press G8 for patents reform
GlaxoSmithKline, the UK's largest pharmaceuticals company, has written to Tony Blair to demand new tax credits and patent concessions to encourage the development of medicines for the world's poorest countries. The company is also urging the Prime Minister to use Britain's presidency of the G8 group of industrialised nations to strengthen global agreements on intellectual property rights.
Read article at NetDoctor.co.uk

Contracts Keep Drug Research Out of Reach
Academic institutions and researchers are widely viewed as the impartial, independent heart of the system this country uses to test drugs and medical devices. But that independence often comes with strings attached, sometimes making those institutions and their researchers obstacles to the exchange and discussion of test results. The upshot is that doctors may not get all the information they need. In the wake of revelations about unpublished test data showing the potential risks of pediatric antidepressants, some doctors have stopped prescribing them. And even doctors who continue to prescribe the drugs question why they were kept in the dark.
Read article at NYTimes.org

Here, Kiddie, Here
How drug companies are pushing ADHD drugs for children by funding researchers and advocacy groups – and ignoring the studies which question their claims.
Read article at Alternet.org

November 28, 2004

GSK linked to trials forcing Aids drugs on deprived US children
GlaxoSmithKline will be accused this week of backing drug trials in the US in which underprivileged children were forced to test Aids treatments against their will. The trials have been taking place in New York under the auspices of the Administration for Children's Services, the body that looks after the welfare of children in New York City.
Read article at Independent.co.uk
The website of the Paediatric Aids Clinical Trials Group can be found here
The website of the New York city Administration for Children's Services can be found here

Big Brother in Your Medicine Cabinet
Have you ever heard of the “New Freedom Initiative”? No, it doesn't have anything to do with freedom, unless you count the freedom of the drug companies to sell more of their high-priced drugs to treat mental illness. For Americans on the home front, this is the scariest plan yet to come out of the Bush Administration.
Read article at InterventionMag.com
The website of the New Freedom Initiative can be found here

New cancer drugs to cost NHS £50m
The NHS faces a £50 million increase in its drugs bill next year to pay for a new generation of anti-cancer drugs that will allow millions more people to survive with the disease for many years. A special Observer investigation reveals that by 2010 there will be thousands more drug compounds to treat cancer, dramatically improving patients' survival rates.
Read article at Observer.Guardian.co.uk

November 27, 2004

Looking for Adverse Drug Effects
As the Food and Drug Administration continues to draw fire for its handling of various drugs and the flu vaccine crisis, one lesson is inescapably clear: the agency lacks enough power to ensure the safety of drugs after they are approved and on the market. That defect needs to be corrected before countless Americans are killed or hurt by dangerous side effects that did not show up in the original clinical trials and only became apparent when the drugs were in widespread use.
Read article at NYTimes.com

November 26, 2004

Pfizer pulls Celebrex in Turkey
Pfizer has temporarily stopped selling its COX-2 arthritis and pain drug Celebrex in Turkey due to disputes with health authorities, according to reports. The dispute is reported to be over restrictive language on cardiovascular issues to be used on the product's warning label.
Read article at Datamonitor.com

Feed your head
Monty Python had a phrase for it: "And now for something completely different." "That's what it's like for me addressing an education conference," says Alex Richardson. The Oxford University scientist gets plenty of practice at public speaking. Recently she has given the keynote speech at the York festival of food and drink, talked about fish at London's Royal Institution, and briefed Scottish MPs on autism.
Read article at TES.co.uk

When New Drugs Go Wrong: Role of the FDA Debated
Federal officials responsible for ensuring that medications are safe face a major limitation of drug research: Although a new drug is often tested on a few thousand patients, a serious side-effect may not be fully recognized until its users number in the hundreds of thousands. "To a real degree, the people who get the drug in the first few years after its approval are being experimented on," said Dr. Brian L. Strom, a professor of biostatistics and epidemiology at the University of Pennsylvania.
Read article at LATimes.com

Is drug regulation failing?
Something is rotten at the heart of the FDA. The United States Food and Drug Administration, mired in controversy over the last 12 months, now faces an extraordinary charge of attempting to discredit a whistleblower. As this week's issue reveals, David Graham, the FDA's associate director of drug safety, was so bothered about the difficulties of presenting his data on rofecoxib (Vioxx) in the Lancet that he took his case to the Government Accountability Group, a public interest group that protects whistleblowers.
Read article at BMJ.com

November 25, 2004

From bad to awful
However intense the pain, the troubles of the world’s big pharmaceutical companies has hardly seemed unusual. Half a dozen other industries in America have also been feeling the lash of energetic state regulators, a hostile business press, political scrutiny and the unwanted attentions of plaintiffs' lawyers. Rumours that Michael Moore plans to make a film about the drug industry (whose employees are under strict instructions to keep their mouths shut) had simply added one more item from what is fast becoming a standard list of business headaches in the new century. Yet, over the past week, the drug firms' crisis has appeared to morph into something uniquely dark and dangerous. Suddenly its American regulator, the Food and Drug Administration (FDA), finds itself under attack. And if public confidence in the regulator goes, worried industry executives and company shareholders are asking, what then?
Read article at Economist.com

Cholesterol drug faces review
Health Canada is reviewing the safety of Crestor, a popular drug used to lower cholesterol. Since early 2003, at least 14 Canadians who have taken the drug have developed serious muscle problems that can lead to kidney failure. Thursday's announcement comes on the heels of a warning from the U.S. Last week, a safety reviewer at the U.S. Food and Drug Administration called Crestor and four other drugs the most worrisome drugs on the market.
Read article at MSN.CBC.ca

Drug Firms Accused of Holding Back Addiction Information
Pharmaceutical giants deliberately suppressed information showing how addictive their drugs were, it was claimed today. Roche and John Wyeth and Brother were accused of withholding information showing their benzodiazepines were much more addictive than stated in prescription guidelines. The claims were made by Labour MP Phil Woolas. Mr Woolas, who is a trustee of the “Beat the Benzos” campaign, was giving evidence to the House of Commons health committee which is investigating the influence of the pharmaceutical industry.
Read article at News.Scotsman.com

Plan for first shelf antibiotic
The first antibiotic to be sold by pharmacies without a prescription may get the go-ahead under plans being considered by the (UK) drugs regulator. The Medicine and Healthcare products Regulatory Agency is consulting on whether to make chloramphenicol eye drops available over-the-counter.
Read article at BBCNews.com

AstraZeneca in big ads drive
Drugs giant AstraZeneca has launched a massive marketing offensive in the US to convince consumers its cholesterol-lowering drug, Crestor, is safe, as the pharmaceuticals industry finds itself in the firing line after the withdrawal of Merck's Vioxx painkiller. The company, headed by Sir Tom McKillop, is rolling out advertisements in newspapers across the nation with the headline: 'You can be assured that at AstraZeneca patient safety is our number one priority.'
Read article at ThisisMoney.com

Flu pandemic threatens billions
An influenza pandemic is likely to affect every country leaving millions dead and make more than a quarter of the world's population ill with no vaccines available until at least next March, the World Health Organisation says. An outbreak of bird flu that has killed 32 people in Thailand and Vietnam this year is the most likely cause of an inevitable pandemic but it was not clear if it would start in the "next week or the next years", said Dr. Klaus Stohr of the WHO global influenza programme.
Read article at SundayTimes.co.za

November 24, 2004

AstraZeneca to fight 'false promotion' lawsuit
AstraZeneca declared last night that it would vigorously contest a lawsuit accusing the Anglo-Swedish drug maker of falsely promoting its new ulcer drug as a more powerful medicine than an older version that is available at a cut-price rate.
Read article at TimesOnline.co.uk

You Want A Moral Issue? How About Drugs That Don't Kill?
As Democrats continue to search heaven and earth for a moral values issue they can call their own, I have just the prescription: Why not start with the immoral behavior of giant drug companies such as Merck that continue to sacrifice the health of the public on the altar of higher and higher profits?
Read article at AriannaOnline.com

How drug approval woes crept up on FDA
For many Americans, opening up the medicine cabinet may seem far more perilous than it did just a few months ago. Revelations about potentially deadly problems with government-approved drugs - from Merck's painkiller Vioxx to Bayer's cholesterol-fighter Baycol - have prompted even the conservative Journal of the American Medical Association (JAMA) to charge that the Food and Drug Administration's system for protecting consumers is broken.
Read article at CSMonitor.com

AstraZeneca Should End Crestor Ad Campaign, Group Tells FDA
AstraZeneca Plc, the U.K.'s second- largest drugmaker, is making misleading statements in the advertising campaign for its Crestor cholesterol-lowering medicine, the Public Citizen consumer group said in Washington. The ads, which appeared in newspapers including the Washington Post and the New York Times, contend that the U.S. Food and Drug Administration isn't concerned about Crestor's safety, Sidney Wolfe, director of Public Citizen's health research group, wrote today in a letter to FDA acting Commissioner Lester Crawford. That contradicts statements from FDA officials including David J. Graham.
Read article at Bloomberg.com

Senator calls for FDA probe
A U.S. lawmaker called Wednesday for a probe of reports that Food and Drug Administration officials tried to discredit a veteran scientist who testified over Merck & Co. Inc.'s withdrawal of Vioxx. In a letter to the Department of Health and Human Services, Senate Finance Committee Chairman Sen. Charles Grassley asked whether FDA managers contacted a whistle-blower protection group to file false charges in an attempt to tarnish the reputation of David Graham, the associate director for science in the Office of Drug Safety.
Read article at Money.CNN.com

Biogen gets the first FDA approval in 8 years for a multiple sclerosis drug
Today was a day of good news for multiple sclerosis patients: FDA granted approval to a new anti-multiple sclerosis drug Antegren developed by Biogen Idec Inc. after a priority review including one-year data from two Phase III studies. This is the first anti-MS drug approved by the FDA in eight years.
Read article at FinanceGates.com

CDC admits obesity stats flawed - pharmaceutical and weight loss industry at fault
A Wall Street Journal bombshell report that the U.S. Centers for Disease Control and Prevention (CDC) has admitted to serious statistical errors in calculating that obesity kills 400,000 Americans each year is only the tip of the iceberg of gross exaggerations and miscalculations, according to The Center for Consumer Freedom (CCF).
Read article at News-Medical.net

House Panel Joins Vioxx Inquiry
An influential House committee has joined in the congressional investigation of U.S. prescription drug safety, issuing extensive records requests Tuesday to the Food and Drug Administration and the drug manufacturer Merck & Co. The House Energy and Commerce Committee said it was seeking to understand how the heart risks of Merck's painkiller Vioxx were not addressed before the FDA approved the drug in 1999.
Read article LATimes.com

F.D.A. Employee Seeks Legal Help From Whistle Blowers' Group
Dr. David J. Graham, the drug safety reviewer who denounced his employer, the Food and Drug Administration, before a Congressional panel last week, said yesterday that he feared being fired and had sought legal help from a group that protects whistle-blowers. "My concern is retaliation from these people," Dr. Graham said in a telephone interview.
Read article at NYTimes.com

November 23, 2004

Glaxo says don't break up drug approval process
Splitting up the drug approval process by hiving off safety monitoring to a separate agency would be foolhardy, the research head of the world's second-largest drug maker, GlaxoSmithKline said on Tuesday. Tachi Yamada, chairman of research and development at Glaxo, urged caution before tampering with the existing system. "It would be very, very difficult and hazardous to consider the notion of separating out the review of efficacy from the review of safety, because all drug decisions are based upon the balance of risk to benefit," he told reporters during an R&D seminar.
Read article at Reuters.com

U.S. FDA Adds Restrictions to Acne Drug
Roche's acne drug Accutane and its generic versions will face tighter prescription controls to prevent harm to unborn children, U.S. health regulators said on Tuesday. The measures include a new joint database shared by all manufacturers of the drug to monitor patients, doctors and pharmacies, the Food and Drug Administration said.
Read article at NYTimes.com

Bayer says Baycol report 'unscientific'
Bayer on Tuesday rejected as "unscientific" a U.S. report alleging that it may have known its Baycol drug caused a high rate of a serious muscle condition more than a year before it warned of the risk. The authors of the report in the Journal of the American Medical Association (JAMA) were biased, Bayer said, highlighting that they were being paid to work with lawyers pursuing U.S. product liability claims over cholesterol-lowering Baycol.
Read article at Money.CNN.com

Millions still taking risky heart drug without warnings promised by FDA
A highly toxic heart drug continues to be prescribed to millions of patients nationwide without the detailed consumer warnings promised by the U.S. Food and Drug Administration more than a year ago. Each bottle of the drug, amiodarone, is supposed to include a new advisory that warns of its many risks and symptoms of fatal side effects and explains how the medication is supposed to be used. But the advisory, planned since October 2003, remains in draft form, bouncing back and forth between the FDA and the drug maker assigned to write it.
Read article at RealCities.com

AstraZeneca Faces U.S. Suit Over Nexium
A U.S. law firm has announced a class action lawsuit against AstraZeneca Plc accusing the Anglo-Swedish drugmaker of deception in its promotion of ulcer pill Nexium. Goodkind Labaton Rudoff & Sucharow said in a statement late Monday that AstraZeneca had falsely promoted Nexium as a more powerful and more effictive drug than its previous ulcer pill Prilosec, which is now subject to cheap generic competition. The law firm said that as of 2003, Prilosec was on sale at 46 U.S. cents a pill compared to $4 a pill for Nexium.
Read article at Reuters.com

Possible conflits of interest to influence look at suspected adverse drug reactions
A review of the published literature and of internal company documents from the manufacturer of cerivastatin (Baycol) a cholesterol lowering drug removed from the market in 2001, suggests that information about serious adverse effects of this medication was known to the company within months after this drug was launched, and that company analyses showing substantially increased risk of rhabdomyolysis were apparently not published or disseminated to physicians and patients.
Read article at MedicalNewsToday.com

Medical Journal Calls for a New Drug Watchdog
The United States needs a better system to detect harmful effects of drugs already on the market, and it should be independent of the Food and Drug Administration and the drug industry, medical researchers and journal editors said yesterday. Arguing that it was unreasonable to expect the same agency that approves drugs to "also be committed to actively seek evidence to prove itself wrong," the editors of The Journal of the American Medical Association (JAMA) recommended that the nation consider establishing an "independent drug safety board" to track the safety of drugs and medical devices after they were approved and in widespread use.
Read article at NYTimes.com

November 22, 2004

Arthritis Pills Little Use in Beating Cancer
Painkillers taken by millions of arthritis sufferers worldwide are actually of limited use in relieving symptoms, Norwegian scientists said on Tuesday. Researchers from the University of Bergen said their findings suggested the drugs should be used only on a short-term basis and be prescribed much more critically in future.
Read article at Reuters.com

Antidepressants May Increase Risk of Abnormal Bleeding
New users of selective serotonin reuptake inhibitors (SSRIs, a type of antidepressant) have an increased risk of being admitted to the hospital for abnormal bleeding. Case reports and observational studies have shown a relationship between SSRI use and abnormal bleeding. It is believed that serotonin plays a role in blood clotting, and because SSRIs affect serotonin levels, they may be associated with an increased risk of bleeding.
Read article at DocGuide.com

Report Faults Bayer on Baycol Withdrawal
New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the federal Food and Drug Administration to protect the public from such risks. This time it's Baycol, a cholesterol-lowering statin that Bayer AG withdrew in 2001 after some who took it developed a severe and sometimes fatal muscle disorder. A new study found that the risks were far greater than had been believed.
Read article at Yahoo.com

Roche consumer health sale cleared by EU
Bayer’s acquisition of the Roche consumer health business, a major player in the vitamin supplements market, has been approved by the European antitrust authorities, giving way to the creation of the region’s biggest consumer health business.
Read article at inPharma.com

November 21, 2004

Business View: Big pharma haunted by the spectre of Pinto
Remember the Ford Pinto? It was a small car with a poorly located fuel tank, which happened to explode if someone went into the back of it. Ford had lobbied US regulators against making changes to the car, producing a cost/benefit analysis that said "only" 180 people were likely to be killed by the Pinto's faults. And that was not worth the $137m (about £330m in today's money) that would have been needed to sort out the problem. The regulators were not impressed. Nor were the courts. Nor were the public. Ford's reputation went through the floor. Is the same thing happening in pharmaceuticals?
Read article at Independent.co.uk

Merck Steps Up PR Campaign After Recall
Merck & Co.'s campaign to defend itself in the wake of the recall of the pain reliever Vioxx intensified as it placed a package of three full-page ads in seven prominent newspapers beginning last Friday. That follows several television appearances as well as testimony before Congress by the company's chief executive. But public relations experts are calling the campaign predictable and said it lacks a crucial element necessary to bolster Merck's claims that it acted responsibly and timely in removing Vioxx from the market: Parties with no self interest or financial ties to the company coming to its defense.
Read article at ABCNews.go.com

Shades of the Vioxx Case for Another Drug
At a hearing Thursday on Capitol Hill, senators excoriated top federal drug regulators for failing to realize three years ago that Vioxx, a pain pill that Merck withdrew in September, was dangerous. But the Food and Drug Administration today faces almost exactly the same situation with another arthritis drug, Bextra, that it did with Vioxx three years ago. And just as with Vioxx, it is far from clear what the agency should do. In a sign that they believe they acted appropriately in the Vioxx case, top agency officials are handling the Bextra situation exactly the same way.
Read article at NYTimes.com

November 20, 2004

AIDS, Industry, Congress Put FDA on a Fast Track
In the 1990s, after decades of taking a slow, skeptical approach to approving new medicines, the Food and Drug Administration responded to pressures from patient advocacy groups, private industry and Congress by streamlining the way it did its job. Instead of acting as a suspicious cop, the FDA began to embrace a philosophy of working with the pharmaceutical industry as a trusted partner. It is that sea change, critics say, that has led to the controversy over Vioxx and to charges that in recent years the agency has too often allowed unsafe drugs to reach the market — with sometimes catastrophic results.
Read article at LATimes.com

Survey shows need for conservative, drug-free options
A new survey showing that nearly half of all Americans are concerned about the safety of the medical care they receive should send a strong signal to the health and insurance industries that safer non-drug, non-surgical treatments should be considered whenever possible, according to the American Chiropractic Association (ACA).
Read article at News-Medical.net

UK drug firms deny safety doubts
British drug firms have defended the safety of two products which were deemed unsafe by an American expert - Crestor, a cholesterol-lowering drug from AstraZeneca, and GlaxoSmithKline's Serevent, used by asthma patients.
Read article at BBCNews.com

November 19, 2004

Mutual medicine
From developing strategy for a product at the earliest pre-launch phase to promoting older, established products the pharma industry has always worked closely with clinical advocates. These experts, who are often referred to as key opinion leaders (KOLs) provide valuable input and feedback to the pharma industry to support the marketing process. In fact, the industry could not supply the right products, information or educational materials to the medical profession and patients without a close working relationship with them.
Read article at inPharm.com

US fears knock £3bn off AstraZeneca value 
Nearly £3bn (€4.2bn) was wiped off the value of pharmaceuticals giant AstraZeneca today after a US safety official raised concern over one of its key drugs. David Graham, of the US Food and Drugs Administration (FDA), told the US Senate Finance Committee that a closer review of anti-cholesterol drug Crestor was needed amid fears that it causes acute kidney failure.
Read article at IrishExaminer.com

FDA Vioxx fiasco raises questions about AIDS drug approvals for developing world
AIDS Healthcare Foundation today noted that the current "FDA fiasco" involving the agency's initial approval and subsequent recall of Merck's troubled arthritis drug, Vioxx, raises serious questions about the FDA's ongoing parallel role in the approval of generic AIDS drugs for widespread use in Africa and the developing world. At present, the President's Emergency Plan for AIDS Relief (PEPFAR) which pays for, or provides AIDS drug treatments for patients in developing world countries stipulates that if cheaper generic drugs are to be used, they must be approved for 'bio-equivalency' to their branded drug counterpart by the FDA.
Read article at NewsMedical.net
The AHF website can be found here

Two Vioxx Critics Allege Pressure
Two leading scientists said in Senate testimony yesterday that they were pressured to back off criticism of the painkiller Vioxx after warning that it might cause heart attacks and strokes in some patients. Gurkirpal Singh, a professor at Stanford University's medical school, said a senior executive of Merck & Co. Inc., the maker of Vioxx, contacted his superiors and suggested that Singh would have career problems if he continued to raise concerns. "I was warned that if I persisted in this fashion, there would be serious consequences for me," Singh said.
Read article at PhiladelphiaEnquirer.com

FDA will increase postmarketing surveillance of drugs
After controversies about the possible increased risk of suicide in children taking antidepressants and the increase in heart attacks and strokes in patients taking rofecoxib (Vioxx), the US Food and Drug Administration has announced plans to strengthen its surveillance of drugs on the market. The agency's Center for Drug Evaluation and Research will hire the Institute of Medicine to assemble a committee to review the effectiveness of the US drug safety system with emphasis on the FDA's postmarketing surveillance. Steven Galson, acting director of the centre, said, "Our current drug approval system has demonstrated that we don't always understand the full magnitude of drug risks prior to approval of drug products."
Read article at BMJJournals.com

November 18, 2004

Anti-Cholesterol Drug Launched
A new drug, Lipitor, formulated to checkmate coronary heart disease and other associated ailments, was launched in Lagos last week by the multi-national pharmaceutical company, Pfizer Specialties Limited. Speaking at the launch ceremony, Dr. Bimbola Ogunkelu, former minister of cooperation and integration in Africa, who was chairman of the occasion, stated that coronary heart disease was a major killer in Nigeria.
Read article at AllAfrica.com

Study Suggests How COX Drugs Cause Heart Disease
Painkillers suspected of causing fatal heart disease may act by starting the process of hardening the arteries, researchers proposed on Thursday. The drugs, known as COX-2 inhibitors, include Merck and Co.'s Vioxx, which earned the company $2.55 billion a year but was pulled off the market on Sept. 30 after a study showed it doubled the risk of heart attack and stroke. Tests on mice suggest COX-2 inhibitors might be especially dangerous to younger women, who are normally protected by biology from heart disease.
Read article at Reuters.com
An abstract of the study can be found here

Grassley Calls for Independent Review of Drugs on Market
U.S. Senate Finance Committee Chairman Charles Grassley called for independent reviews of drugs on the market at a hearing in which he called the recall of Merck & Co.'s Vioxx painkiller a ``disaster.'' The U.S. Food and Drug Administration's relationship with drugmakers is ``too cozy,'' Grassley, an Iowa Republican, said as he opened the hearing on Capitol Hill. He said the FDA failed to heed its own scientist's warning about Vioxx, which Merck withdrew Sept. 30 after the drug was linked to heart attacks and strokes.
Read article at Bloomberg.com

F.D.A. Failing in Drug Safety, Official Asserts
Federal drug regulators are "virtually incapable of protecting America" from unsafe drugs, a federal drug safety reviewer told a Congressional panel on Thursday, and he named five drugs now on the market whose safety needs "to be seriously looked at." In testimony before the Senate Finance Committee, Dr. David Graham, the reviewer in the Food and Drug Administration's Office of Drug Safety, used fiery language to denounce his agency as feckless and far too likely to surrender to demands of drug makers.
Read article at NYTimes.com

FDA Is Flexing Less Muscle - Some Question Its Relationship With Drugmakers
In the past four years, the Food and Drug Administration has taken a noticeably less aggressive approach toward policing drugs that cause harmful side effects, records show, leading some lawmakers, academics and consumer advocates to complain that the agency is focusing more on bolstering the pharmaceutical industry than protecting public health. From 2001 to 2004, three important drugs were taken off the market, compared with 10 that were recalled from 1996 to 2001.
Read article at WashingtonPost.com

‘FDA Has Been Asleep at the Switch'
Over the past few months, Americans have been bombarded with bad news about popular medicines. While the pharmaceutical companies have borne the brunt of the blame, the FDA has also come under fire for its oversight of the drug industry.
Read article at Newsweek.com

Earlier Merck Study Indicated Risks of Vioxx
Nearly a year before Merck received results from the clinical trial that prompted the company to withdraw its painkiller Vioxx from the market, the company received preliminary results from a separate study of patient records that also apparently indicated that the drug posed cardiovascular risks. Merck has not publicly disclosed that separate study's results or referred to it in any of its statements about Vioxx's safety record since announcing in late September that it would stop selling the drug.
Read article at NYTimes.com

Child antidepressant use 'rising'
The UK has seen the fastest rise in the prescribing of antidepressants and other mind-altering drugs to children, a study of nine countries shows. University of London researchers compared prescribing rates between 2000 and 2002 in countries in Europe, South America and North America. During that period, the UK saw a 68% rise in children being prescribed drugs to stimulate or calm the brain.
Read article at BBC.co.uk
The study can be found here

November 17, 2004

Pfizer's Contraceptive Can Weaken Bones
The U.S. Food and Drug Administration on Wednesday ordered a strong, new warning for Pfizer Inc.'s injectable contraceptive called Depo-Provera, saying it could permanently weaken bones. The agency called for the strongest warning possible -- a so-called "black box" -- for the drug's packaging, saying that long-term use of the drug can lead to a loss of bone density. But the FDA also said the drug is still safe and effective.
Read article at WashingtonPost.com

Spin Doctors
GlaxoSmithKline's Michael Szap is on the lecture circuit. "People complain about the cost of their medications," the senior district sales manager says, his voice rising. "But the money goes back into research and development."
It's a point Szap repeats eight times in a 45-minute presentation to 12 pharmacy students and staffers at Woodhull Medical Center in Brooklyn, N.Y. And it's a message he and more than 9,000 GSK foot soldiers will deliver this year to as many as 500,000 prescription drug customers--professionals and patients--in intimate and informal gatherings across the country. "Medicines save lives," Szap also says repeatedly to these same groups.
Read article at Forbes.com

Heartburn Medication May Reduce Tumor Resistance to Cytotoxic Drugs
Proton pump inhibitors--a type of heartburn medication--may be able to reverse tumor resistance to cytotoxic drugs such as cisplatin or 5-fluorouracil, according to a new study.
Read article at MedicalNewsToday.com
An abstract of the study can be found here

Say No To Prescription Drugs
The pharmaceutical industry, despite a golden age of biology that has unravelled mysteries of the genetic code and yielded miracle drugs that save thousands of lives, may be on the brink of getting hit by a backlash. Millions of us are popping prescription pills for innocuous ills, when simple lifestyle changes of diet and exercise - harped on by physicians for decades - are more effective and a lot cheaper.
Read article at Forbes.com

Drug Dispute Snags U.S.-Australia Pact
Nine months ago, the United States and Australia completed negotiations on a landmark trade agreement that won unusually broad bipartisan support in Congress. But a dispute over drugs, both prescription and generic, is threatening to delay the effective date of Jan. 1.
Read article at NYTimes.com

Limiting Medical Malpractice Jury Awards Top Health Priority for Bush
Supporters of President Bush maintain that with an expanded Republican majority in the Senate, "there could be enough momentum to overcome Democratic-led resistance" to the president's medical liability reform proposal in 2005, the AP/Las Vegas Sun reports.
Read article at MedicalNewsToday.com

November 16, 2004

Rheumatoid Arthritis Drug Linked to Cancer
For people with rheumatoid arthritis, methotrexate is the treatment of choice in reducing pain and inflammation. But there's evidence the drug can activate a virus that can increase the risk of lymphoma and similar cancers in some patients. The study appears in this month's issue of the Journal of the National Cancer Institute .
Read article at WebMD.com
An abstract of the study can be found here

Acetaminophen shows positive cardio protective effects In heart attack, arrhythmia
Long an under-studied yet widely-used over-the-counter medication, acetaminophen over the last few years is becoming recognized for a range of potential therapeutic uses beyond headache and pain. One promising area is cardiology, where researchers decided to test the “common wisdom” that acetaminophen had no potential in treating heart disease. This position has been popular in the medical community despite that fact that “there are no in vivo reports on acetaminophen efficacy during myocardial infarction,” a team from Rutgers University notes in the November issue of the American Journal of Physiology-Heart and Circulatory Physiology.
Read article at NewsMedical.net

FDA Adds New Warning Label for Abortion Pill
U.S. Food and Drug Administration announced today important safety changes to the labeling of the abortion pill Mifeprex, also known as RU-486, after receiving reports linking the drug to serious bacterial infection. Mifeprex, made by Danco Laboratories, was approved in 2000 for the termination of early pregnancy, defined as 49 days or less.
Read article at LegalNewsWatch.com
The FDA press release can be found here

November 15, 2004

High-Dose Steroids Up Heart Disease Risk Greatly
Treatment with high doses of medicinal steroids (glucocorticoids) more than doubles the risk of cardiovascular disease, new research suggests.
Read article at Reuters.com
An abstract of this study can be found here

Merck's Gilmartin Rejects Claims Vioxx Risk Ignored
Merck & Co. Chief Executive Officer Raymond Gilmartin said his first indication that the painkiller Vioxx carried a heart risk came on Sept. 23, and the company withdrew the medicine a week later. Gilmartin laid out Merck's defense against mounting criticism from lawmakers, trial lawyers and doctors who say Merck should have known as early as 2000 that Vioxx was dangerous.
Read article at Bloomberg.com

Prescription Drugs to Get Electronic IDs
The U.S. Food and Drug Administration on Monday announced an anti-counterfeiting initiative that would provide prescription drugs with an electronic fingerprint by outfitting them with tiny chips and antennas.
The announcement was closely timed with moves by several pharmaceutical giants to place radio frequency identification (RFID) tags on certain products susceptible to counterfeiting.
Read article at HealthScout.com

Ranbaxy, Other Drugmakers, Face 94.5 Million Pound Claim in U.K.
Ranbaxy Laboratories Ltd., Germany's Merck KGaA and other three drugmakers may have to pay a 94.5 million pound ($175 million) claim from a U.K. probe of alleged anti-competitive behavior regarding the generic version of ulcer medicine Zantac.
The National Health Service's Counter Fraud and Security Management Service filed a lawsuit in June alleging the companies restricted the supply of the ranitidine, causing the NHS to spend more than needed. The government said today it is asking for about 69.3 million pounds and interest of 25.2 million pounds, the agency said in an e-mailed statement.
Read article at Bloomberg.com
The NHS Counter Fraud and Security Management Service website can be found here

Parents demand acne drug inquiry
The family of a north Devon student are calling for a worldwide inquiry into a drug they say caused the depression which led him to kill himself. Medical student Jon Medland, 22, had been taking Roaccutane for mild acne for just three-and-a-half weeks. An inquest ruled his death in Manchester in January was suicide.
Roaccutane's manufacturers, Roche Pharmaceuticals, said no causal link had been established between the drug and either depression or suicide.
Read article at BBC.co.uk
The Accutane/Roaccutane Action Group website can be found here

November 14, 2004

Prescription For Trouble
When the pharmaceutical giant Merck pulled its blockbuster pain medication Vioxx off the market in late September, it became the largest prescription drug recall in history. The company says it took immediate action after a new study showed that Vioxx doubled the risk of heart attacks and strokes in some patients. However, according to internal Merck documents 60 Minutes has seen, and interviews with outside scientists, Merck had concerns that Vioxx could possibly cause cardiovascular risks long before it was pulled off the market.
Read article at NYTimes.com

November 13, 2004

Scientist Who Cited Drug's Risks Is Barred From F.D.A. Panel
The Food and Drug Administration has told a researcher that he cannot be part of an advisory panel that will meet early next year to review the safety of a class of drugs, COX-2 inhibitors, used to treat arthritis and pain. The reason, the agency said, is he publicly stated that he thought one of these drugs caused heart problems and that Pfizer, its maker, knew that and was covering it up.
Read article at MedicalNewsToday.com

November 12, 2004

Common antidepressant may affect youth's bone development
A common class of drugs prescribed to children with depression may have an adverse effect on bone growth, according to a study published online in the journal Endocrinology by researchers at the Indiana University School of Medicine.
Read article at MedicalNewsToday.com
The study can be found here

November 11, 2004

Sharper teeth for medicines watchdog
The government yesterday announced sweeping changes to the medicines watchdog body after years of criticism and pressure, banning those who sit on its central licensing committee from having any personal or financial interests in pharmaceutical companies.
Read article at Guardian.co.uk

ERISA Class Action Filed Against Makers of Vioxx, Merck & Company
A class action lawsuit was filed against Merck & Company on behalf of participants and beneficiaries of the Merck & Co., Inc. Savings and Security Plan and the Employee Stock Purchase and Security Plan, the law firm Scott + Scott, LLC said in a press release on Wednesday.
Read article at LegalNewsWatch.com

Who can cure the pharmaceuticals?
The industry's influence has seeped into the fabric of medical life. It has tapped the worst of human motives - money, power and glory. A mega-billion-dollar global business, it has a Big Brother potency outstripping that of governments, at which it has been known to snap its fingers as it breaks safety rules to suit its own commercial ends.
Read article at NewsStatesman.com

Drug shipments to US may be halted, says top Canadian official
As more and more Americans buy their drugs from Canadian pharmacies, authorities in Canada are becoming so concerned about domestic supplies that a top official said the Canadian government may halt shipments to the US if the trade continues to grow.
Canadian Health Minister, Ujjal Dosanjh, said ‘'We certainly cannot be the drugstore for the United States of America.'
Read article at MedicalNewsToday.com

Hopes thin for future of Astra's blood drug
The future of AstraZeneca's blood-thinning medicine, Exanta, was thrown into fresh doubt last night after France's leading drugs regulator confirmed that it was reviewing the medicine's approval status.
Jean-Ugo Trouvin, director for evaluation of medicine products at the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), told The Times that the watchdog was specifically reviewing differences in the way safety data was presented to the regulator and to the US Food and Drug Administration (FDA).
Read article at TimesOnline.co.uk

Drug firms warned to publish trial data after safety fears
Drug companies have been warned by the Government's drug regulator to publish the results of all clinical trials of new medicines following allegations that vital safety data has been withheld putting patients at risk.
This follows allegations that drug companies have selectively published trial data to get new products on to the market and has concealed alarming findings about existing products.
Read article at Independent.co.uk
The Senate Finance Committee press release listing the witnesses can be found here (PDF)

Merck Chief Is Asked to Testify
A top Republican lawmaker called Wednesday for Merck & Company to answer questions about its withdrawn drug Vioxx on Nov. 18 at the first Congressional hearing to address the drug's safety problems.
Senator Charles E. Grassley, chairman of the Senate Finance Committee, which will hold the hearing, requested testimony from Raymond V. Gilmartin, chief executive of Merck, and Lester M. Crawford Jr., acting commissioner of the Food and Drug Administration, to discuss whether they had made mistakes in notifying the public about the drug's heart risks.
Read article at NYTimes.com
The Senate Finance Committee press release listing the witnesses can be found here (PDF)

November 10, 2004

Inquiry to centre on Pfizer drug development
Eliot Spitzer's inquiry into Pfizer, the giant American drugs maker, is to focus on the development and marketing of Zoloft, a strong anti-depressant, it has emerged.
The New York attorney-general, together with Richard Blumenthal, attorney-general for Connecticut, has written to Pfizer asking for the results of unpublished clinical trials into the drug, as well as for information on the way the treatment has been marketed. It has been suggested that Zoloft might trigger suicidal thoughts among children prescribed the drug to ease the symptoms of manic depression.
Read article at TimesOnline.co.uk

Pharmaceutical Watchdog under Fire from MPs
The chairman of the House of Commons science and technology select committee today called for an independent inquiry into the pharmaceutical industry's regulatory agency.
Labour's Dr Ian Gibson said it was difficult to engender trust in the Medicines and Healthcare products Regulatory Agency (MHRA) when it was funded by the industry.
Read article at Scotsman.com

New Study Links Pfizer's Bextra, Similar to Vioxx, to Heart Attacks
The incidence of heart attacks and strokes among patients given Pfizer's painkiller Bextra was more than double that of those given placebos, according to preliminary results of a study presented yesterday at the American Heart Association meeting in New Orleans.
The study, which pooled data from 5,930 patients taking part in 12 trials, found 2.19 times the number of heart attacks or strokes among patients given Bextra, compared with those given placebos.
Read article at NYTimes.com

'Normal' Blood Pressure May Still Be Too High
A new study of heart disease patients finds that "normal" blood pressure may not be low enough. By reducing their pressure well below the levels suggested by national guidelines, patients had fewer heart attacks, strokes, cardiac arrests, hospitalizations for chest pain, procedures to open blocked coronary arteries, and deaths.
Read article at NYTimes.com
The full study can be found here

November 9, 2004

Bristol-Myers discloses SEC probe
Bristol-Myers said it received notice from the SEC on Oct. 25 of the probe, which it believes is geared toward an existing investigation by German officials on "potential violations of the Foreign Corrupt Practices Act and/or German law."
Read article at CBS.com

Merck, Schering Launch Huge Heart-Drug Test
Merck and Schering-Plough enter the cholesterol wars in earnest with a huge clinical trial announced today. The study will be called “Improve It,” short for “Improved Reduction of Outcomes: Vytorin Efficacy International Trial.” It will enrol 10,000 people who already have heart trouble, such as past heart attacks or chest pain. These people are at incredibly high risk for additional heart problems. Patients will either receive 40 milligrams of Zocor, the second-highest dose, or a dose of Vytorin that combines 40 mg of Zocor with 10 mg of Zetia. Patients will be followed for two years, and the number of heart attacks, deaths, re-hospitalizations for heart problems and heart surgeries will be counted.
Read article at Forbes.com
The Schering-Plough press release can be found here

27% are predisposed to heart disease in US
Middle-aged adults who do not yet have heart disease but have a spectrum of symptoms called metabolic syndrome are very likely to also have clogged arteries, researchers said on Monday.
The findings suggest primary care doctors should be screening patients for the signs of heart disease early and often, the researchers told a meeting of the American Heart Association.
Read article at IndependentOnline.co.za

Status quo keeps US pharma happy
The news that US President George Bush will be residing at the White House for a further four years has been greeted with some measure of relief by the pharmaceutical industry, which had been worried about drug price curbs in the event of a John Kerry victory.
Read article at inPharma.com

Spitzer turns spotlight on Pfizer
Investigations into the ethical behaviour of the drugs industry widened yesterday when it emerged that New York attorney general Eliot Spitzer has opened an inquiry into Pfizer.
The pharmaceutical firm said Mr Spitzer's office has requested information relating to the testing and possible promotion of drugs for uses that have not been approved by regulators.
Read article at Guardian.co.uk

Justice Dept. and S.E.C. Investigating Merck Drug
Federal prosecutors and the Securities and Exchange Commission are investigating Merck & Company in connection with Vioxx, the painkiller that was withdrawn from the market in late September because it increased the risk of heart attacks in long-term users.
Merck said yesterday that it had received a subpoena from the Justice Department "requesting information related to the company's research, marketing and selling activities with respect to Vioxx." It said the request related to a "federal health care investigation under criminal statutes."
Read article at NYTimes.com

November 8, 2004

Pfizer Likely to Add Warning to Bextra
Pfizer Inc.said Friday it's likely that a so-called "black box" warning will be added to the label of its pain killer Bextra, which is similar to the recently pulled Vioxx, because it sometimes leads to a serious skin reaction.
Pfizer made the announcement in its most recent quarterly report, filed with the Securities and Exchange Commission Friday. A black-box warning is the strongest warning available for prescription drugs.
The drug has in a few cases caused Stevens Johnson syndrome, which occurs when the immune system turns on itself to rid itself of a drug, in effect burning the patient from the inside out.
Read article at AP.com

Big business to cash in?
As hundreds of lawyers pack their bags for Las Vegas to plot their legal assault on Merck, they might want to throw in some protective gear too. A hailstorm is about to hit.
President Bush, fresh off his re-election and gains in Congress by his Republican allies, singled out medical malpractice reform as a top legislative priority. Proponents are trying to rein in multimillion jury awards that they say hurt businesses -- and shareholders.
Read article at CNN.com

Hundreds used as 'drug guinea pigs'
The health of hundreds of UK patients is at risk because their GPs are secretly being paid to use them as guinea pigs in drug trials, an investigator has told the BBC.
Read article at BBC.co.uk

Drug Ads -- Without Harmful Side Effects
In the years that arthritis pain drug Vioxx was on the market, starting in 1998, Merck spent $100 million annually on ads that appeared on TV and in newspapers and magazines. The drug's rise was so spectacular, in part, because of the highly effective consumer marketing that built it into a $2.5 billion dollar revenue source for Merck before its withdrawal on Sept. 29.
Read article at BusinessWeek.com

Drug reaction breakthrough
New research to reduce the incidence of adverse drug reactions in the community is being pioneered by the University of Ballarat (Australia).
The ‘data mining' research maximises the information extracted from existing drug safety data by cross-referencing much of the existing information on adverse drug reactions.
Read article at News-Medical.Net

November 7, 2004

Ties to industry cloud doctors' credibility
They led influential medical groups, starred at prestigious meetings, published in top journals and were undisputed giants in their field.
But when these famous doctors advised the government recently on new cholesterol guidelines for the public, something else they had in common wasn't revealed.
Eight of the nine were making money from the very companies whose cholesterol-lowering drugs they were urging upon millions more Americans. Two own stock in them. Two others went to work for drug companies shortly after working on the guidelines. Another was a senior government scientist who moonlights for 10 companies and serves on the board of one of them.
Consumer groups and others are questioning not only the advice these doctors gave, but also their fundamental ability to act in the public's best interest.
Read article at AJC.com

Merck faces threat of £10bn actions
Merck, the beleaguered US pharmaceuticals group, could be forced to pay out as much as $18bn (£9.7bn) over 10 years as a result of lawsuits linked to Vioxx, its controversial arthritis drug.
Read article at Telegraph.co.uk

November 6, 2004

Why Vioxx, but not Other Drugs in Its Class, May Increase Cardiovascular Risk
Researchers have discovered additional evidence -- now at the molecular level -- that point to important differences between Vioxx and other COX-2 inhibitors. In a new study, it was observed that Vioxx caused biochemical changes that contribute to the development of heart disease. Celebrex, another widely prescribed COX-2 inhibitor, did not.
Read article at MedicalNewsToday.com

Pfizer Discloses 2 State Probes
Pfizer Inc., the world's largest drug maker, said New York Atty. Gen. Eliot Spitzer requested information about the promotion of some of its drugs for unapproved uses. Pfizer said Connecticut Atty. Gen. Richard Blumenthal also requested materials on so-called off-label promotion of its Zoloft antidepressant. The company disclosed the probes in a regulatory filing. Doctors sometimes prescribe medications for applications that haven't been approved by regulators. Although such use is legal, promotion of drugs for off-label use isn't. Shares of Pfizer declined 27 cents to $28.79 on the NYSE.
Read article at LATimes.com

Vioxx Populi? Withdrawal raises questions about drug approval in Canada
On September 30th 2004, Canadians learned that Vioxx was being voluntarily withdrawn from the market by its producer, Merck & Co. Inc. A COX-2 selective non-steroidal anti-inflammatory drug (NSAID), Vioxx had been approved in Canada since October 1999 for the treatment of acute and chronic symptoms of osteoarthritis, rheumatoid arthritis, acute pain and menstrual pain. At the time, Vioxx was the tenth most commonly prescribed drug in Canada, with three million prescriptions for it written in the last year alone.
Read article at DominionPaper.ca

November 5, 2004

Vetting the watchdog
The Committee on Safety of Medicines advises the Medicines and Healthcare Products Regulatory Agency - the MHRA - and they issue licenses for all drugs available in the UK. From now on, Channel 4 News has been told, all members - from the chairman to lay experts - will no longer be able to hold any personal interest in the pharmaceutical industry.
Read article at Channel4.com

Purdue Pharma to pay $10M over Oxycontin
Purdue Pharma LP has agreed to pay $10 million to the state to settle a lawsuit that accused the company of dishonestly marketing the painkiller OxyContin in West Virginia.
Read article at Boston.com

Pfizer faces Canadian suit over drug Celebrex
A Canadian class-action lawsuit has been launched against Pfizer Inc. alleging that its arthritis drug Celebrex caused cardiovascular side effects, the law firm launching the suit said on Friday. The Saskatchewan-based Merchant Law Group included Pfizer's Bextra in its suit and also named Boehringer Ingelheim, Germany's largest pharmaceutical firm, for its Mobicox, in the same class of drugs. The head of the law firm, Tony Merchant, told Reuters the Pfizer suit was launched in early October, soon after it had started a similar suit against Merck & Co. Inc. for its pain drug Vioxx.
Read article at ReutersHealth.com

FDA to Review Post-Market Safety Checks
The U.S. Food and Drug Administration will ask the Institute of Medicine to study the agency's safety monitoring of medicines already on the market, Acting FDA Commissioner Lester Crawford said on Friday. Crawford said the study was one of a group of measures following criticism of the FDA's handling of safety problems with Merck & Co. Inc.'s now withdrawn Vioxx arthritis drug and antidepressant drug use in children.
Read article at Reuters.com

J&J Workers May Testify on Marketing
Drug maker Johnson & Johnson disclosed in a regulatory filing that the U.S. attorney in Boston wanted to talk to some present and former employees about the marketing of its Topamax epilepsy treatment. The probe started in December 2003 and is looking at how Johnson & Johnson's Ortho-McNeil Pharmaceutical unit marketed the drug, including alleged "off-label" marketing, the New Brunswick, N.J., company said in a Securities and Exchange Commission filing. Drug makers can't promote their products for non-approved uses.
Read article at LATimes.com

Doubts over blood pressure drug
A drug commonly prescribed to lower blood pressure is not effective in reducing cardiovascular deaths and heart attacks, research suggests. A team from Umea University Hospital in Sweden reviewed studies comparing the beta blocker atenolol with dummy pills, and other anti-hypertensives. It was no better than placebos, and less effective than other drugs at cutting heart attacks and deaths.
Read article at BBCNews.com

Arthritis drug warnings 'ignored'
An arthritis drug should have been taken off the market years before it was finally withdrawn, say researchers. Manufacturer Merck withdrew Vioxx in September after evidence linking it to heart problems. Bur an analysis by the University of Berne in Switzerland found serious question marks over the safety of the drug dating back to 2000. The research, which suggests patients were needlessly put at risk, is published in The Lancet.
Read article at BBCNews.com

Lawyers Organizing for Mass Suits Over Vioxx
Hundreds of plaintiffs' lawyers who claim that people were injured or killed by the painkiller Vioxx plan to meet next week to lay the groundwork for a nationwide legal assault against the drug's maker, Merck. The lawyers expect the discussions to begin informally on Tuesday in Pasadena, Calif., in the hallways of a conference on Vioxx litigation that will also be open to defence lawyers. On Thursday, at a meeting in Las Vegas for plaintiffs' lawyers only, those who are suing Merck, or plan to, expect to discuss specific strategies.
Read article at NYTimes.com

November 4, 2004

Pfizer shares fall on report of Celebrex deaths
Pfizer Inc.'s shares fell as much as 6.2 percent on Thursday after a report in a Canadian newspaper said the company's arthritis drug Celebrex was linked to 14 deaths. The paper cited the country's health officials. Officials from Pfizer were not immediately available for comment.
Read article at Reuters.com

China's Pharmaceutical Market Growing 15% Annually
China's pharmaceutical market is growing at an annual rate of fifteen percent with the ethical drug market valued at over $6 billion. China's over-the-counter drug market is currently valued at over $1.2 billion and is estimated to reach $5 billion by 2010.
Read article at MedicalNewsToday.com

Drug Safety Reviewer Says F.D.A. Delayed Vioxx Study
In a series of testy e-mail exchanges with his bosses, a federal drug-safety reviewer contends that an effort to publish his study demonstrating the dangers of Vioxx was delayed and demeaned by top officials at the Food and Drug Administration. The e-mail and meeting notes also show that Dr. David Graham, an official in the F.D.A.'s Office of Drug Safety, is seeking to launch a study of the safety of Bextra and Mobic, two arthritis pills that are similar to Vioxx. Merck withdrew Vioxx in September after finding that it caused an increase in the risk of heart attacks.
Read article at NYTimes.com

November 3, 2004

Pfizer Statement on U.S. Presidential Election
Pfizer today congratulates President Bush on his re-election and salutes Senator Kerry for waging an important debate about the future of the United States. As President Bush prepares for his second term, Pfizer offers our best wishes and highest hopes for the future. The coming days are sure to be full of challenges and, for the sake of all Americans, we wish the President nothing but success.
Read article at PharmaLive.com

Drug stocks rally on expected Bush victory
Shares in U.S. and European drug groups rallied on Wednesday as investors banked on President George W. Bush winning the U.S. presidential election, reducing the threat of government-imposed price cuts.
Read article at Reuters.com

Mothers to be warned to stay off painkillers
Children exposed to painkillers such as aspirin and paracetamol while in the womb are four times more likely to develop schizophrenia as adults, a study of Danish patients has found.
Read article at Health.Telegraph.co.uk

Two HIV drug ads misleading, says FDA
Two Abbott Laboratories Inc. promotions for HIV-fighting drug Kaletra exaggerated benefits and left out information about life-threatening safety risks, U.S. regulators charged in a letter made public Tuesday. The Food and Drug Administration ordered the company to stop circulating the advertisements immediately. One ran in POZ, a magazine aimed at people with the HIV virus, and another was posted in restrooms, the FDA said.
Read article at MSNBC.com

F.D.A. Releases Memo on Vioxx
Providing details from a report it had described broadly in August, the Food and Drug Administration published a memorandum yesterday that indicated Merck's Vioxx painkiller might have contributed to 27,785 heart attacks and deaths from 1999 through 2003.
Read article at NYTimes.com

November 2, 2004

Cholesterol Pills and Grapefruit Don't Mix
Taking certain cholesterol-lowering drugs at the same time as grapefruit juice can increase the risk of potentially life-threatening muscle toxicity, British regulators warned on Tuesday. The Medicines and Healthcare Products Regulatory Agency said the risk was greatest with Merck & Co Inc's Zocor, or simvastatin, which recently went on sale without prescription in Britain, and Pfizer Inc's Lipitor.
Read article at Reuters.com

Drug firm criticised over girl's death
One of the world's largest drugs manufacturers was heavily criticised at a fatal accident inquiry yesterday for "exaggerating the relative safety" of a controversial asthma drug. The inquiry into the death of five-year-old Emma Frame, from Strathaven, Lanarkshire, who died after being prescribed Flixotide in extremely high doses, also heard that doctors failed to properly monitor treatment and her death could have been avoided. Flixotide is manufactured by GSK.
Read article at TheHerald.co.uk

Senate Investigators Interview Lawyer Who Has Sued Merck
Senate investigators examining Merck's recall of its Vioxx painkiller have interviewed an Alabama lawyer whose firm has filed 58 lawsuits against the company on behalf of people claiming injuries. The lawyer, Andrew Birchfield, said he met for more than three hours in Washington on Monday with staff members of the Senate Finance Committee, which is led by Senator Charles E. Grassley, an Iowa Republican. Mr. Birchfield said he handed over company documents and statements of Merck executives and scientists obtained during the litigation.
Read article at NYTimes.com

November 1, 2004

New vaccines to counter biological agents such as anthrax
Scientists at Imperial College London and Hammersmith Hospital are to help develop new vaccines in case of a terrorist release of biological agents such as anthrax. The team has been awarded $4.5 million by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institute of Health (NIH) to develop new vaccines against a possible bio-terrorist attack, and new emerging infectious diseases.
Read article at News-Medical.net

Court Won't Hear Appeal in Fen-Phen Case
The Supreme Court declined Monday to hear an appeal from a drug manufacturer that sought to limit evidence that fen-phen users want to present in their lawsuits claiming heart valve damage. In a defeat for drug maker Wyeth, the court let stand a lower ruling that a federal judge went too far when he issued an order restricting the evidence. The Philadelphia judge reasoned that the diet drug users had violated a $3.75 billion settlement agreement with the Madison, N.J.-based company.
Read article at WashingtonPost.com

U.S. stocks down as Merck, election jitters weigh
Shares of Merck fell more than 6 percent after the Wall Street Journal reported the company tried to bury concerns over its drug Vioxx for years.
Read article at Reuters.com

Merck Tried to Bury Vioxx Concerns for Years
Internal e-mails and other documents from Merck & Co. show the company fought for years to keep safety concerns from undermining the drug's commercial prospects, the Wall Street Journal reported on Monday.
Read article at Reuters.com

October 30, 2004

U.S. Asks Merck for Added Data
The Food and Drug Administration told Merck & Company that it required further safety and efficacy data before it would approve the drug Arcoxia, the company's successor to the pain reliever Vioxx, the pharmaceutical maker announced yesterday.Most analysts and doctors had expected the F.D.A. to seek additional information before approving Arcoxia. Merck withdrew Vioxx from the market last month, after a study showed it doubled patients' risk of heart attack and stroke. The two medications are in the class of drugs known as COX-2 inhibitors.
Read article at NYTimes.com

Doctors and drug companies are locked in "vicios circle"
A radical new approach to paying drug companies should be introduced—rewarding them for improving health rather than maximising sales, the UK parliamentary health committee has been told. The proposal, by Healthy Skepticism, an international watchdog group based in Australia that is concerned with misleading drug marketing, was put to committee members during a week long visit to Australia that ended last week.
Read article at BMJ.com

October 29, 2004

Patients taking Crestor Have Higher Rate of Kidney Damage
Patients taking the cholesterol drug Crestor have a higher rate of kidney failure or damage than patients taking all other statin drugs (Lipitor, Zocor, Lescol, Pravachol and Mevachor), according to a Public Citizen analysis of government data.In a press release, Public Citizen, a consumer advocacy group, said that it sent the information on Friday to the U.S. Food and Drug Administration and renewed its call for the drug to be taken off the market.
Read article at LegalNewsWatch.com

October 28, 2004

Financial Conflicts of Interest in Physician's Relationship with the Pharmaceutical Industry—Self Regulation in the Shadow of Federal Prosecution
The past two years have witnessed extraordinary regulatory ferment in the area of conflicts of interest involving physicians, especially conflicts arising in relationships with the pharmaceutical industry. Professional regulatory bodies, the pharmaceutical industry, and the government have all decided that physicians and drug manufacturers need stronger advice about appropriate relationships.
Read article at NEJM.org

October 27, 2004

Drug firms still promote HRT
Drug companies slashed promotional spending on hormone replacement therapy by more than a third after a widely publicized report released in 2002 warned of health risks for menopausal women taking the hormones, a new study says. But while the companies stopped all advertising in the United States aimed directly at consumers, they still spent millions of dollars on promotions to doctors and gradually increased promotional spending on lower-dose forms of the medication, says the study co-authored by a University of Alberta doctor and published today in the Journal of the American Medical Association.
Read articla at Canada.com

October 26, 2004

Lax rules let supplements lurk as health threats
"Drug therapies are replacing a lot of medicines as we used to know it," said George W. Bush during the 2000 presidential debates with then-presidential hopeful Al Gore. Although it was one of what would become many "Bushisms" to follow, the future president had a point: What exactly is a drug?
Read article at USAToday.com

Acid Suppressing Drugs May Raise Pneumonia Risk
People who take medication to reduce stomach acid seem to be at increased risk of developing pneumonia, the results of a population-based study suggest. The findings apply to both proton pump inhibitors (PPIs) such as Nexium or Prevacid, for example, and to H2-receptor antagonists, which include popular products such as Pepcid and Zantac.
Read article at Yahoo.com

Newborn mice given Prozac grow up depressed
Mice treated with the antidepressant Prozac early in life grow into adults with emotional problems, a new report concludes. Whether the drug has the same effect on people is unknown. But the result will add to the growing debate over what risks Prozac (fluoxetine) and similar SSRI drugs (selective serotonin reuptake inhibitors) pose for young children and unborn babies. "If they really need these drugs, people should take them. They can be life savers," says Jay Gingrich, a psychiatrist at Columbia University in New York City, US, who led the research. "But it is a little bit alarming to find they might carry risks that aren't apparent until later in life."
Read article at NewScientist.com

October 25, 2004

The Health of Nations
For years the people in Washington have offered one plan after another that they said would provide health care for all Americans and rein in costs. Each plan has failed. Today more people than ever have inadequate coverage or no insurance at all. And still costs continue to spin out of control. Notably absent from the rhetoric has been any mention of the existing system's inherent flaw - the inability of market-based, for-profit medicine to deliver on the political promises.
Read article at NYTimes.com

Vioxx Class Action Lawsuit Filed Against Merck in Kentucky
Kentucky law firm Getty & Mayo filed a consumer fraud class action lawsuit against Merck & Company, alleging that the company deceived consumers by promoting the popular arthritis drug Vioxx in its advertising as a safe and reliable painkiller, when it knew there were safety risks associated with the use of the drug, the law firm said in a press release today.
Read article at LegalNewsWatch.com

Breast Cancer Chemo May Increase Stroke Risk
In general, chemotherapy appears to increase the risk of stroke in patients with breast cancer, researchers report in the October 20th issue of the Journal of the National Cancer Institute. Chemotherapy -- but not a specific chemotherapeutic regimen -- more than doubled the risk of stroke.
Read article at Reuters.com

October 22, 2004

Australia may bow to drug firms' demands
Prime Minister John Howard may bow to pressure from United States drug companies to ensure the operation of the America-Australia free trade agreement (FTA). Mr Howard on Friday held out the possibility of changing Australian laws, passed with government support earlier this year, aimed at protecting generic drugs and keeping a lid on pharmaceutical prices. It follows a concerted campaign by American drug companies against the amendments that the government was forced into accepting after pressure from the Labor Party.
Read article at SMH.com.au

I'm backing Bush, says chief of drug firm
Pharmaceutical company Astrazeneca hopes George W Bush will win the US presidential election because his rival, John Kerry, would try to cut the cost of medicine. The London-based company yesterday claimed a Democrat administration would seek to reduce the price the government pays for drugs under America's Medicare programme, reducing profit margins of companies such as Astrazeneca.
Read article at Money.Telegraph.co.uk

Safety review ordered into popular painkillers
A European medicines regulator will today order a safety review of four powerful painkilling drugs taken by more than 750,000 people in Britain amid fears that they could increase the risk of heart attacks and strokes. The European Medicines Evaluation Agency (EMEA) will announce a review of the Cox-2 inhibitors class of drugs, used to treat pain caused by arthritis and other conditions.
Read article at Independent.co.uk

October 21, 2004

Statins: A Risky Step?
Those "miracle" pills that lower your cholesterol may, in fact, be doing more harm than good. At least one researcher is out to determine if statins pose more risks than benefits.Beatrice Golomb, M.D., Ph.D., from the University of California, San Diego, is involved in an NIH-funded study of 1,000 subjects who have been randomized to receive statins or placebo. The study will look at the effect these drugs have on cognitive function. Another study she's involved in will examine all adverse events caused by the drugs.
Read article at Ivanhoe.com

Failing the Public Health — Rofecoxib, Merck, and the FDA
On May 21, 1999, Merck was granted approval by the Food and Drug Administration (FDA) to market rofecoxib (Vioxx). On September 30, 2004, after more than 80 million patients had taken this medicine and annual sales had topped $2.5 billion, the company withdrew the drug because of an excess risk of myocardial infarctions and strokes. This represents the largest prescription-drug withdrawal in history, but had the many warning signs along the way been heeded, such a debacle could have been prevented.
Read article at NEJM.org

Antipsychotic drugs linked to insulin resistance in children
Researchers from the Johns Hopkins Children's Centre say a group of drugs known as "atypical antipsychotics" that are commonly used to treat children with aggression, bipolar disorder, and schizophrenia may trigger insulin resistance, a condition that increases the risk of developing Type 2 diabetes and heart disease later in life.
Read article at MedicalNewsToday.com

October 20, 2004

Critics See Drug Industry Behind Mental Health Plan
Bush Plans to Screen Whole U.S. Population for Mental Illness', read the headline in the 'British Medical Journal' (BMJ) and the project, with increasingly controversial drug treatment at its core, is underway as you read this. Structures to put the scheme in place have been developed under a so-called "Federal Action Agenda," announced in Washington on Jun. 9, and include mandatory mental health screening, which the plan recommends be linked with "treatment and supports". The plan's full details have yet to emerge as the Action Agenda still "has not been publicly released," according to A Kathryn Power, director of the Centre for Mental Health Services (CMHS), the Bush administration body spearheading the effort.
Read article at CommonDreams.org

Death of a Drug: The Aftermath of Merck's Recall
Wharton management professor Michael Useem, director of the school's Center for Leadership and Change Management, notes that one of the key mantras in corporate crisis management is: "Hide nothing, tell all." Less than a week after Merck & Co.'s voluntary withdrawal of its blockbuster arthritis pain medication Vioxx, following an extended clinical trial that linked the drug to heart attacks and strokes, the jury is still out on whether the pharmaceutical giant followed this cardinal rule.
Read article at Wharton.UPenn.edu

Nevirapine effect on 'good' cholesterol outranks Efavirenz or statins, 2NN study reports
Participants in the 2NN study who received either nevirapine (Viramune) or efavirenz (Sustiva) experienced increases in high density lipoprotein (HDL) cholesterol over and above the degree that would be expected from a protease inhibitor-containing regimen, according to findings published this week in the new online journal Public Library of Science Medicine.
Read article at AidsMap.com

Wyeth sees possible fen-phen charges within months
Wyeth on Wednesday warned it may need to set aside additional financial reserves "in the next few months" to cover liability to former users of its two recalled "fen-phen" diet drugs. The drugmaker has already taken more than $16 billion in fen-phen charges since the two medicines were recalled in 1997 after being linked to heart valve damage among some of the 6 million Americans that had taken them. Company officials said Wyeth was still facing more than 50,000 lawsuits filed by former fen-phen users who claim they were harmed by the drugs.
Read article at Reuters.com

Novel approach to treat high lipid levels in the blood
Roche and Japan Tobacco Inc today announced a licensing agreement for the late-stage development and commercialization of JTT-705, JT's innovative cholesteryl ester transfer protein (CETP) inhibitor, for the treatment of dyslipidemia. Dyslipidemia is a blood lipid dysfunction that results in abnormal lipid and lipoproteins levels in the blood stream, leading to a significantly increased risk of cardiovascular disease. The compound JTT-705, which is currently in phase II clinical development, regulates lipids by increasing the levels of high-density lipoproteins (HDL), so called “good” cholesterol in the blood.
Read article at MedicalNewsToday.com

Drug (Money) Traffic
In order to elect politicians friendly to the pharmaceutical industry, its trade group has quietly funneled millions of dollars to non-profits – in violation of the law, says a watchdog group.
Read article at Alternet.org

Uganda Opens Africa's Biggest AIDS Training Center
The biggest HIV/AIDS training centre in sub-Saharan Africa opened in Uganda Wednesday with officials hopeful it will significantly boost the continent's ability to fight the deadly pandemic. The Infectious Diseases Institute, largely funded by drug giant Pfizer, aims to teach hundreds of health care workers advanced techniques in fighting a disease the United Nations estimates has infected 26 million people in Africa.
Read article at Reuters.com

Hospitals get tough with drug firm reps
The several dozen drug company reps gathered yesterday at a Hospital of the University of Pennsylvania auditorium weren't there to pitch drugs. They were trying to persuade the Penn system not to pitch them out. Like other health-system leaders unhappy with practices of drug representatives, Penn officials are considering banning them from talking to doctors at their three hospitals. Drug company freebies such as pens, notepads and the pink cookies marking breast cancer awareness month might be outlawed. "Even token items," said P.J. Brennan, patient safety chief for the University of Pennsylvania Health System, "can create the impression of a quid pro quo" between doctors and drug sellers.
Read article at Philly.com

Canadians File Vioxx Class Action Lawsuit
Lawyers representing Canadians who used the popular arthritis drug Vioxx filed a national class action lawsuit against Merck & Company on behalf of all patients who suffered from cardiovascular complications including heart attack and stroke. Toronto law firm Rochon Genova LLP filed the lawsuit in Ontario Superior Court of Justice. Four other class actions have been commenced in Quebec, together with claims in British Columbia, Ontario and Saskatchewan.
Read article at LegalNewsWatch.com

October 19, 2004

Bush vs. the Laureates: How Science Became a Partisan Issue
Why is science seemingly at war with President Bush? For nearly four years, and with rising intensity, scientists in and out of government have criticized the Bush administration, saying it has selected or suppressed research findings to suit preset policies, skewed advisory panels or ignored unwelcome advice, and quashed discussion within federal research agencies.
Read article at NYTimes.com

EU regulator demands more openness from drug firms
Europe's top drug regulator said on Tuesday that pharmaceutical companies were failing to share key clinical data with doctors and sometimes worried more about the stock market than about patients. Thomas Lonngren, executive director of the European Medicines Agency, said last month's worldwide withdrawal of Merck & Co Inc.'s arthritis drug Vioxx had highlighted the need for a better flow of information.
Read article at Reuters.com

Group Sue AstraZeneca on Ulcer Drug
The AFL-CIO and two California consumer groups Monday sued AstraZeneca, accusing the company of misleading patients into switching to its expensive new ulcer drug just as the patent on its nearly identical but older Prilosec pill was set to expire. The suit was filed in Los Angeles County Superior Court by the labor union, the Congress of California Seniors and the California Alliance for Retired Americans on behalf of consumers nationwide who purchased the newer pill, called Nexium.
Read article at LATimes.com

Combination hormone therapy doubles breast density
and quadruples risk of abnormal mammograms

Postmenopausal women who take combination estrogen-plus-progestin hormone-replacement therapy for one year experience a twofold increase in breast density - a known risk factor for breast cancer - and a quadrupled risk of having an abnormal mammogram, according to new findings from a sub-study of the Women's Health Initiative, or WHI.
Read article at MedicalNewsToday.com

A New Trial of Celebrex, and Questions on Its Timing
Less than three weeks after Merck withdrew its arthritis painkiller Vioxx from the market because it increased the risk of heart attacks, Pfizer announced plans yesterday to test if its best-selling painkiller Celebrex, which is in the same class of drugs as Vioxx, can do the opposite - help prevent heart attacks. But Pfizer's announcement is raising questions. For one, Pfizer warned only last Friday that Bextra, another of its drugs in the same class as Vioxx and Celebrex, increased the risks of heart attack and stroke in patients undergoing coronary-bypass surgery. So the timing of the announcement of the new Celebrex trial could divert attention from the warning about Bextra.
Read article at NYTimes.com

October 18, 2004

Consumers File Nexium Class Action Lawsuit Against AstraZeneca
Europe's second-largest drugmaker AstraZeneca is being sued by a coalition of consumer activists who claim its blockbuster heartburn drug, Nexium, the Purple Pill, is no more effective than its over-the-counter drug Prilosec. The coalition on Monday filed a class action lawsuit against AstraZeneca, alleging that the company sought to reserve its market share and profits as the patent on Prilosec was set to expire, by initiating a massive and misleading advertising and promotional campaign to deceive consumers into purchasing Nexium, a nearly identical new drug.
Read article at LegalNewsWatch.com

Painful Withdrawal for Makers of Vioxx
The two Merck & Co. executives were sombre as the company plane pitched and rolled through the remnants of Hurricane Jeanne on the night of Sept. 28. The turbulence outside the aircraft was an echo of the corporate tempest leading up to their trip. For five days Merck had been struggling with what to do with frightening new data that showed that long-term use of their $2.5 billion arthritis drug Vioxx doubled the risk of heart attacks and strokes, confirming concerns raised by earlier studies. Now research lab director Peter S. Kim and general counsel Kenneth Frazier were flying to Boston to tell one of the men most responsible for Vioxx's success that Merck would be pulling the drug in two days.
Read article at WashingtonPost.com

October 17, 2004

The Side Effects Of Asthma Medication
Latest research shows that a common class of drugs used for acute asthma attacks might be causing the very thing it aims to treat.
Read article at MedIndia.net

Kerry Ad says Flu Vaccine Fiasco is President's Fault
The Kerry electoral campaign is attempting to place the blame for the flu vaccine fiasco directly on Mr Bush's shoulders. Many politicians are saying that the Bush administration ignored reports from the General Accounting Office warning about vaccine supplies. The Bush campaign says the accusation is ‘another deplorable political move.' The Kerry ad basically says that the Bush administration has just stood around doing nothing ever since 2001 when warning signs about vaccine production problems that could affect millions of people were staring them in the face.
Read article at MedicalNewsToday.com

October 16, 2004

Cholesterol guidelines become a morality play
They led influential medical groups, starred at prestigious meetings, published in top journals and were undisputed giants in their field. But when these famous doctors advised the government recently on new cholesterol guidelines for the public, something else they had in common wasn't revealed. Eight of the nine were making money from the very companies whose cholesterol-lowering drugs they were urging upon millions more Americans. Two own stock in them. Two others went to work for drug companies shortly after working on the guidelines. Another was a senior government scientist who moonlights for 10 companies and even serves on one of their boards.
Read article at USAToday.com

Revised labeling issued for Infliximab
The Warnings and Adverse Reactions sections of the prescribing information for infliximab (Remicade-Centocor) have been revised to warn patients and prescribers of the possibility of lymphoma with use of the tumor necrosis factor (TNF) alpha blocker.
Read article at MedicalNewsToday.com

FDA Orders Strong Warnings on Antidepressants Used by Adolescents
All antidepressants must carry a "black box" warning to describe the risk and emphasize the need for close monitoring of children and adolescents being treated with antidepressant medications, the U.S. Food and Drug administration said Friday. The Public Health Advisory is part of a multi-pronged strategy to warn the pubic about the increased risk of suicidal thoughts and behavior in children and teens being treated with antidepressant drugs. "Today's actions represent FDA's conclusions about the increased risk of suicidal thoughts and the necessary actions for physicians prescribing these antidepressant drugs and for the children and adolescents taking them," said Dr. Lester M. Crawford, acting FDA Commissioner.
Read article at LegalNewsWatch.com

October 15, 2004

The Lawyers Next Target?
Since Merck pulled its arthritis blockbuster Vioxx from the market, trial lawyers have been flooded with thousands of phone calls from angry patients looking to sue. But Vioxx is just the tip of the iceberg. Emboldened litigators are likely to see the drug industry as a big, juicy target, stepping up their efforts against a host of medicines ranging from schizophrenia medicines to acne pills. The Food and Drug Administration's decision to put a severe warning related to adolescent suicide on antidepressants could make those medicines a target, too.
Read article at Forbes.com

Did FDA tell Merck of drug studies before their release?
In the wake of the recall of Merck's arthritis drug and painkiller Vioxx, Sen. Charles Grassley, R-Iowa, is looking into whether the Food and Drug Administration had a prior pact with Merck to notify the firm before publishing negative drug studies. Grassley on Friday sent a letter to Merck Chief Executive Raymond Gilmartin asking what type of agreement the company sought or obtained from regulators about getting information on FDA studies of Merck drugs prior to publication. The senator also queried Gilmartin on how much advance notice Merck wanted."The issue for doctors and their patients is, did the government agency that's supposed to regulate pharmaceuticals have an inappropriate agreement with Merck? And did a cozy relationship between the FDA and a pharmaceutical company allow a drug with known safety risks to stay on the market much longer than it should have?"
Read article at MarketWatch.com

Forbes Magazine Special About The Vioxx Debacle
Merck's recall of its popular painkiller Vioxx after a big study found it increased the risk of heart attacks and strokes could set off the next big class-action feeding frenzy.
more...

U.S. Orders New Warning on Antidepressants for Kids
All antidepressants must come with tough warnings explaining that the drugs increase the chances of suicidal behavior in some children and teens, U.S. health officials said on Friday. In an order to drug makers, the Food and Drug Administration said the information to be highlighted in a black box must also state whether the drug has, or has not been, cleared for use by children. Only Eli Lilly and Co.'s Prozac is FDA-approved for treating pediatric depression.
Read article at Reuters.com

Chiron faces potential class action
Lawyers have filed the first lawsuit in a potential class action against biotechnology firm Chiron, alleging that it intentionally hid problems at its Liverpool flu vaccine manufacturing plant which ended with British regulators closing it down. The plant's closure has led to a 50% shortfall in vaccines in the US at the onset of winter. Law firm Milberg Weiss Bershad & Schulman said Chiron violated securities law by touting its 'impressive revenue growth' in 2003, boosted by Fluvirin vaccine sales, at a time when the firm had some serious hidden problems.
Read article at ThisIsLondon.com

Pfizer Hikes Warning on Bextra Skin Risk
Pfizer Inc. said on Friday it is sending additional information to healthcare professionals about its arthritis drug Bextra, a COX-2 product in the same class as the withdrawn drug Vioxx. The company said it is working with regulatory authorities around the world to update the Bextra product label to warn of a rare but serious skin reaction that exists with Bextra, mainly within the first two weeks of therapy.
Read article at Reuters.com

Lessons from the withdrawal of rofecoxib
Patients would be safer if drug companies disclosed adverse events before licensing
The history of the development and marketing of non-steroidal anti-inflammatory drugs is both fascinating and frightening. It offers a strange combination of stunning commercial successes and dramatic calamities, the latest concerning the recently withdrawn drug rofecoxib (Vioxx). In the 1960s research showed that salicylates were good for pain relief in rheumatoid arthritis, but as with steroids, their use was limited by toxicity. So the major pharmaceutical companies developed non-salicylate, non-steroidal anti-inflammatory drugs (NSAIDs). Over the subsequent 40 years we have seen a procession of new agents come and go, each one being heralded as either more efficacious or less toxic than its competitors. As new NSAIDs appeared, the indications steadily broadened from inflammatory diseases to almost any painful condition. Each time a new drug was launched the market expanded, resulting in annual estimated sales of more than $20bn (£11.1bn; {euro}16.1bn) worldwide.
Read article at BMJ.com

By 2020, 50% of over 50s At Risk For Fractures From Osteoporosis Or Low Bone Mass, USA
US Surgeon General Dr Richard H Carmona, warned today in a new report that by 2020, half of all American citizens older than 50 will be at risk for fractures from osteoporosis and low bone mass if no immediate action is taken by individuals at risk, doctors, health systems, and policymakers. This new report, "Bone Health and Osteoporosis: A Report of the Surgeon General" says that 10 million Americans over the age of 50 have osteoporosis, the most common bone disease, while another 34 million are at risk for developing osteoporosis. And each year, roughly 1.5 million people suffer a bone fracture related to osteoporosis.
Read article at MedicalNewsToday.com

Second drug firm found guilty of "switching" patients to new drugs
A second drug company has been forced to abandon a programme of switching patients on GPs' lists to a new drug, after a ruling from the drug industry's regulatory body. GlaxoSmithKline was found to be in breach of a clause of the code of conduct of the Association of British Pharmaceutical Industry for paying for a third party or practice staff to switch asthma patients who used both salmeterol (Serevent) and beclomethasone (Becotide-100) to Seretide, a dual action inhaler containing salmeterol and fluticasone (Seretide). Beclomethasone is available in generic form, while the other two products are available in the United Kingdom only as branded drugs.
Read article at BMJ.com

Herbal, nutritional supplements linked to ocular side effects
An estimated 42 percent of Americans use herbal medicines or nutritional supplements. Many people taking these products and their physicians are unaware of the adverse reactions they can cause. An Oregon Health & Science University researcher reviewed reported cases of ocular side effects associated with these products. His findings are published in the American Journal of Ophthalmology this month.
Read article at MedicalNewsToday.com

Drug companies accused of putting patients' lives at risk
Patients' lives are being put at risk by the practices used by some drug companies to promote their products, medical experts warned MPs yesterday. Many papers on new drugs published in respected journals such as the British Medical Journal and The Lancet were ghost written by drug company advisers, MPs on the Commons Health Select Committee were told. Drug companies also bombarded doctors with gifts. The pharmaceutical industry's code of practice on free gifts was broken "on a daily basis" but neither doctors nor drug companies admitted it. One doctor revealed he had been offered a bribe of two years' salary not to publish research on the side effects of a new heart drug which ran "counter to the interests" of the company producing it.
Read article at Independent.co.uk

Legal blow prompts Bayer warning on settlements
Bayer, the German chemicals to healthcare giant, last night admitted that it may need to set aside extra provisions as it said it would consider settling lawsuits from US claimants who suffered strokes after taking cold remedies containing one of its chemicals. A spokesman for the company told The Times that Bayer might have to compensate as many as 1,200 Americans who suffered severe strokes after taking phenylpropanolamine (PPA).
Read article at TimesOnline.com

October 14, 2004

Bayer loses $400,000 in medical lawsuit
A Texas jury awarded $400,000 to a man who claims he had a stroke after taking Bayer AG's Alka-Seltzer Plus cold medicine. A state court jury in El Paso, Texas, found that Bayer made a defective and dangerous product when a safer alternative was available, said Peter Kraus, the man's lawyer. An Alka-Seltzer Plus ingredient, PPA, or phenylpropanolamine, is a decongestant that Kraus said is associated with increased risks of strokes. Bayer says the product is safe.
Read article at PittsburghLive.com

After the Recall, Merck Talks About a Successor to Vioxx
Merck & Company, the drug maker that recalled its painkiller Vioxx because of a link to heart disease, said yesterday that short-term studies had shown its planned successor, Arcoxia, to be safer. Merck will present safety findings on Arcoxia next week at the American College of Rheumatology's annual meeting in San Antonio, Peter S. Kim, president of Merck's research laboratories in Whitehouse Station, N.J., said at a news conference. The company is seeking United States regulatory approval to sell the new medication, which is the same class of drug, COX-2 inhibitor, as Vioxx.
Read article at NYTimes.com

Epilepsy drug 'lowers baby IQs'
A drug given to pregnant women to combat epilepsy can significantly lower their child's IQ, researchers say. Scientists studied 375 children born to epileptic mothers in the Liverpool and Manchester areas. They found children of mothers who took sodium valproate were more likely to have lower IQs and more likely to have anatomical abnormalities.
Read article at BBCNews.com

State Files Class Action Suit Against Vioxx
A class action lawsuit has been filed in Albuquerque against the makers of Vioxx. The suit was filed late Thursday afternoon against Merck. The pharmaceutical giant pulled the arthritis drug off the shelf last month.This is the first lawsuit of the kind that Dr. Rath predicted in the Chemnitz speech, June 21, 1997!
Read article at TheNewMexicoChannel.com

October 13, 2004

Congress, SEC Look at Chiron Flu Suspension
The U.S. Congress began investigating on Wednesday whether the U.S. Food and Drug Administration overlooked problems at a British plant that led to the withdrawal of half the country's flu vaccine supply. And the Securities and Exchange Commission joined federal prosecutors in looking at whether U.S-based Chiron Corp. tried to cover up problems at its influenza vaccine plant in Liverpool, England. Earlier this month Britain's Medicines and Healthcare Products Regulatory Agency suspended Chiron's license to ship influenza vaccine from its Liverpool plant, saying it had found systemic problems that led to some bacterial contamination.
Read article at Reuters.com

Drug groups 'may quit UK if forced to slash prices'
Richard Barker, the new director general of the Association for the British Pharmaceutical Industry, warned yesterday that companies may pull out of the UK if the Government forces them to reduce drug prices. "If the pharmaceutical industry does consent to price reductions imposed by the Government, then that is a statement about the attractiveness of this country as a place to invest," he said. "Companies have a choice about where they do things. It is not an empty threat."
Read article at Netdoctor.co.uk

Glaxo opens new wing in Cape Town
International pharmaceutical company GlaxoSmithKline opened an R18 million manufacturing facility in Cape Town this week, from which no profits will be realised. The facility will be dedicated to the production of albendazole for a global donation programme to eradicate lymphatic filariasis, or elephantiasis. The programme is based on a once-a-year dose of two drugs: albendazole plus either DEC or Mectizan. The treatment must be carried out for four to six years.
Read article at BusRep.co.za

October 12, 2004

Polypharmacy now the norm
Diseases are untreated and under treated among many older individuals in residential care and assisted-living facilities, according to an analysis of prescribing patterns in 2,014 residents aged 65 years and older.
Read article at Pharmacist.com

Pfizer sued over Celebrex complications
A Floral Park man is suing Pfizer, claiming the pharmaceutical manufacturer's anti-inflammatory drug Celebrex caused him to suffer an irregular heartbeat. The lawsuit, filed Friday in Nassau Supreme Court by Robert Roesler, 61, a disabled carpenter, comes in the wake of health warnings that the arthritis drug Vioxx causes heart problems. Drug maker Merck & Co. pulled Vioxx from the market last month after finding it increased the risk of heart attack and stroke. Lawsuits quickly followed. But attorney Robert Sullivan, who represents Roesler, said his client's suit is the first of its kind to be filed in New York State against Celebrex.
Read article at BillingsGazette.com

Drugs firms accused of spending more on own shares than R&D
The priorities of the drugs industry were yesterday called into question by research that shows many of the biggest companies spent more in the past 18 months on share buybacks and dividends for shareholders than on product research and development. According to the note from Banc of America analyst David Peterson, the nine biggest drug manufacturers spent some $56bn (£31bn) over the past 18 months on dividends and buybacks.
Read article at Guardian.co.uk

Slightly increased risk of Ischemic stroke found with Tamoxifen
Researchers at Duke University Medical Center have found a slightly elevated risk of "ischemic" stroke due to a blood clot in the brain in patients treated with tamoxifen - a drug commonly prescribed both for preventing breast cancer and treating women with the disease. The researchers emphasize that this slight increase in risk does not mean that use of tamoxifen should be reduced, given the drug's considerable benefits.
Read article at MedicalNewsToday.com

Questions on the $3.8 Billion Drug Ad Business
The issue of drug advertising directly aimed at consumers was thrust into the news recently when Merck withdrew its arthritis painkiller Vioxx from the market, citing studies indicating a risk of heart attacks or strokes. Critics noted the role that advertising and marketing played in the drug's being widely prescribed to patients who might have done just as well with ibuprofen or other inexpensive over-the-counter remedies.
Read article at NYTimes.com

October 11, 2004

Merck plans to select new CEO by Dec. 2005
Drugmaker Merck acknowledged Monday that it has hired an executive search firm to look for a successor to Chairman and CEO Raymond Gilmartin, but said it did so before its decision last month to pull painkiller Vioxx from the market. Some Wall Street analysts have said the Vioxx problem may cause Gilmartin, 63, to leave the company before his mandatory, age-65 retirement in March 2006.
Read article at USAToday.com

Reducing the potential for terrorist misuse of life science research
Can terrorists utilise the findings of life science research to engineer deadly viruses that could be unleashed on the world? Can valuable new cures for deadly diseases be turned into more sinister applications? Recent incidents involving anthrax and ricin have been relatively low-tech, but scientists recognise that one day the results of cutting-edge research in the life sciences may be utilised in more harmful ways.
Read article at MedicalNewsToday.com

FDA had found problems in flu vaccine plant in 2003 but did nothing
In 2003 the FDA had found problems at the Chiron, Liverpool, UK flu vaccine plant - however, they did not order a full inspection or suggest the plant be closed down. The FDA inspection only took place last weekend after the British authorities suspended the company's licence in that plant. 50% of the USA's flu vaccine supply was to have come from the Liverpool plant. The FDA says they carry inspections every two years. They say they did not know about more serious problems until August 25th this year when Chiron told them 6 to 8 vaccines were contaminated.
Read article at MedicalNewsToday.com

October 10, 2004

British Vioxx patients to target Merck in US
British patients taking the arthritis treatment Vioxx are preparing the sue its manufacturer, Merck, the US pharmaceuticals group, in courts in the US after it emerged 10 days ago that the drug can cause heart attacks and strokes.
Read article at Telegraph.co.uk

Money's corrupting influence on medicine
Fears that money has an undue influence on the practice of medicine are not new. In the 12th century, the Jewish philosopher Maimonides wrote an oath for physicians that included this admonition: ''Do not allow thirst for profit, ambition for renown and admiration to interfere with my profession." Nine centuries later, the situation has not improved. Money -- mainly drug company money -- flows into every nook and cranny of the medical world. It pays for clinical trials, medical education, and academic research. It gets handed out to doctors as gifts, free meals, consulting fees, and payments for speaking.
Read article at Boston.com

October 9, 2004

Women sue over epilepsy drug risks
Families whose children were born with fetal anti-convulsant syndrome are suing the makers of anti-convulsant drugs taken by mothers during pregnancy, in what could become a substantial group action. Three claims have been lodged at the High Court in London on behalf of four children, and nearly 30 more claims, one involving a mother who works as a general practitioner, are being prepared.
Read article at BMJ.com

October8, 2004

Codex is coming and the pharma cartel starts to spin the news:
Vitamins Raise Deaths Risk From Cancer?

On Friday, October 1, 2004 The Guardian newspaper (UK) along with many other venerable newspapers and media sources throughout the world prominently featured reports of a study to be published the following day in the well known medical journal The Lancet. The Guardian report carried the disturbing headline.
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Arthritis Drug Has Blood Cancer Risk
Johnson & Johnson is warning doctors that patients taking its rheumatoid arthritis drug Remicade may have a higher risk of lymphoma, a blood cancer, the company said on Friday. The warning will be added to the drug's package insert and means the drug's safety profile will more closely match that of rival drugs in the same class. The label will warn of a three-fold increase in the risk for rheumatoid arthritis patients taking the drug compared with the normal population, said Michael Parks, a spokesman for Centocor, the J&J unit that markets Remicade.
Read article at Reuters.com

Time for a 'regime change' in attitude about medicine
Poof! Half of our flu vaccine is gone, because the British government suspended the license of a major manufacturer, Chiron, over a contamination problem. Is this a public health nightmare, as the "authorities" are crying, or an opportunity to stop and think?
Read article at SFgate.com

Drug giants 'ignored dangers of painkiller in pursuit of profits'
The multibillion-pound global pharmaceutical industry was accused yesterday of ignoring safety risks in pursuit of profits after the largest withdrawal of a prescription drug in history. Doctors on both sides of the Atlantic said the removal from sale of Vioxx, a painkiller for arthritis, demonstrated the failure of the industry and drug regulators to protect people. They warned of a public health emergency over other painkillers in the same class, known as Cox 2 inhibitors, which could also pose a risk. Articles in The Lancet and the New England Journal of Medicine said the companies making the painkillers knew of the potential risk for five years but failed to run the necessary trials to check whether the drugs posed a real danger.
Read article at Netdoctor.co.uk

Bill Aims to Force Drug Makers to Register Trials of Products
Democratic lawmakers in Congress introduced legislation yesterday that would require makers of drugs and medical devices to register clinical trials of their products in a public database when they start and report the test results on it. The legislation would require trial registration before a clinical trial involving patients could be conducted at an academic institution or a private clinic.
Read article at NYTimes.com

October 7, 2004

Head injury drug increases deaths
A head injury treatment used for the past 30 years could be killing rather than saving patients, experts warn. A Medical Research Council (MRC) study of more than 10,000 patients found giving anti-inflammatory drugs to reduce brain swelling increased the risk of death. The anti-inflammatory drugs, called corticosteroids, increased the risk of death by about 20% within two weeks of patients with head injuries being admitted to hospital and the trial was stopped early as a result.
Read article at News.BBC.co.uk

Vioxx News
Kenneth B. Moll & Associates, a Chicago law firm, on Tuesday said it filed the first worldwide Vioxx class action lawsuit against Merck & Co., on behalf of all patients who were prescribed the drug.
Read article at LegalNewsWatch.com

Diabetes 'catastrophe' means twice as many will suffer from it by 2010
Britain is facing a huge increase in diabetes in what doctors are calling one of the greatest health catastrophes the developed world has seen. In the UK, 1.8 million people live with the condition, which reduces life expectancy by 10 years, is the leading cause of blindness and increases by 15 times the risk of amputation of the legs, according to a report published yesterday.
Read article at Netdoctor.co.uk

October 6, 2004

AstraZeneca Executive Confident Of Getting Iressa Europen OK
AstraZeneca PLC executive Alex Holden told analysts Wednesday the company is confident of gaining European approval for its lung cancer drug Iressa. The drug is approved in 32 countries, including Japan and the U.S. Discussions with regulatory authorities in Europe are ongoing.
Read article at Money.Iwon.com

New analysis of HRT risks
Taking combined HRT can sharply increase the risk of developing a blood clot for some women, according to new research, that adds to the other risks associated with the therapy. HRT has also been connected in recent research to an elevated risk of breast cancer and heart attack, prompting many women to seek herbal or other alternatives to ease menopausal symptoms.
Read article at NutraIngredients.com

Kerry camp shifts focus to 'imploding' US health system
A study released by the Kaiser Family Foundation finds insurance premiums in the United States have soared by 59 per cent since 2000. On average, a family health plan costs workers and their employers $10,000 (£6,000) a year. Moreover, those without any health coverage increased by 3.2 per cent in 2003 compared to the year before to reach no less than 45 million Americans. Both John Kerry and his running mate, John Edwards, are seizing on those figures and other health care-related statistics - notably the soaring cost of prescription drugs - to indict the Bush administration for failing to take action.
Read article at Independent.co.uk

FDA Study Estimates Vioxx Linked to 27,000 Heart Attacks
A study led by a Food and Drug Administration safety official projects that the widespread use of Vioxx may have led to more than 27,000 heart attacks and sudden cardiac deaths before the drug's abrupt withdrawal last week by Merck & Co., Wednesday's Wall Street Journal reported. The number is in comparison to how many similar incidents would have occurred had the same patients been taking Celebrex, the Pfizer Inc. drug that competed with Merck's blockbuster arthritis treatment. The analysis specifically found that from Vioxx's approval in 1999, through 2003, an estimated 27,785 heart attacks and sudden cardiac deaths "would have been avoided" had Celebrex been used instead of Vioxx.
Read article at Nadaq.com

October 5, 2004

Parkinson's trial halted
One of the most promising experimental therapies for Parkinson's disease could be shelved after scientists revealed today that a clinical trial has been stopped because of safety concerns.
Read article at Nature.com

Merck Faces Class-Action Complaint in Illinois Over Vioxx
Illinois residents have joined a growing line of plaintiffs suing the maker of arthritis drug Vioxx, after Merck & Co.'s shock announcement last week that it decided to withdraw its product from the worldwide market for safety reasons. Attorneys filed a class action complaint Monday in Cook County Circuit Court that covers the estimated 300,000 people in Illinois who took Vioxx.
Read article at Money.IWON.com

October 4, 2004

Are there problems with FDA safety review process?
Vioxx was the first prescription drug since 2001 to be taken off the market for safety reasons. The problems with Vioxx raise questions about the FDA’s safety review process and the length of time it took Merck to pull the drug, observers say. The FDA has come under intense pressure from the industry and elsewhere to approve drugs more quickly, despite clinical trials that some say enrol too few patients and for too short a time for worrisome side effects to surface.
Read article at MSNBC.MSN.com

Why Medicare Wants More Drug Studies
The medical profession has a costly, little-known secret: Many treatments don't work all that well for many -- even most -- people. And doctors often don't know what are the best therapies for any given disease, especially when faced with competing classes of drugs for, say, high blood pressure. As a result, many people aren't getting the best possible treatment -- and the resulting costs to the health-care system are estimated to be in the billions.
Read article at BusinessWeek.com

October 3, 2004

Vioxx pulled from market: But is this reason to celebrate?
The cable news channel I was watching today proclaimed the startling news that Merck had withdrawn its multi-billion-dollar arthritis drug, Vioxx, from shelves worldwide because the medication had been linked to severe and even fatal heart complications. The report advised anyone taking Vioxx to contact their physicians about prescribing alternative medications. The station then broke immediately to a commercial for Celebrex. As a physician who has been cautioning patients about the ills of both medications, I did not feel the urge to dance like the stars of so many commercials for arthritis remedies. Both Celebrex and Vioxx are known as COX-2 inhibitors, a sub-class of non-steroidal anti-inflammatory drugs, or NSAIDS. Older NSAIDS include ibuprofen, naproxen, indomethacin, and many others, including the prototype aspirin. In 1998, fatalities due to NSAIDS among arthritis sufferers rivalled deaths from AIDS.
Read article at PRWeb.com

New Epidemiologic Study Showed Vitamin D Inadequacy Is Highly Prevalent Among Women Treated for Osteoporosis in North America
More than half of women currently treated for osteoporosis have suboptimal levels of vitamin D, according to new research presented today at the American Society for Bone and Mineral Research (ASBMR) meeting in Seattle. More than 10 million people in the United States are estimated to have osteoporosis and 80 percent are women. Vitamin D, an essential component of osteoporosis therapy, helps to ensure that the body absorbs and retains calcium and phosphorus, both critical for building bone.
Read article at PRNewswire.com

October 2, 2004

Merck The Subject Of Purported Class Action Suit
Lawyers filed a purported class-action lawsuit against Merck & Co. (MRK), which Thursday recalled its blockbuster arthritis medication Vioxx, which increases risk of a heart attack or stroke.
Read article at DowJonesNews.com

Good Riddance to a Bad Drug
After three years of denying that the arthritis drug Vioxx could induce heart attacks and strokes, this week Merck bowed to reality: it withdrew Vioxx from the market. The impact of this decision is far-reaching, and not only because tens of millions of people have tried Vioxx. It also highlights the absence of Food and Drug Administration oversight of the pharmaceutical industry as well as the lack of comprehensive long-term studies of not only Vioxx but its entire class of arthritis drugs.
Read article at NYTimes.com

October 1, 2004

Under Construction
Follow up to media report 041176. A fascinating history of Kos Pharmaceuticals, the company that makes Niaspan, and also a combined niacin/statin product called Advicor, which it markets in partnership with Merck (who make the statin – Mevacor).
The article also indicates that Kos is developing a further niacin/statin product, this time using simvastatin, in the guise of another Merck product, Zocor – the second highest selling statin worldwide. Read article at PharmaExec.com

US consumer body calls for review of cholesterol guidelines
Cholesterol lowering guidelines issued in July by the US National Institutes of Health (NIH) are being challenged by a consumer organisation that is petitioning the NIH to appoint an independent panel to review them. The petition, organised by the Center for Science in the Public Interest, a consumer advocacy organisation funded by subscribers to its newsletter and by individual donors, has asked the NIH to "create an independent review panel free of conflicts of interest to review all the data in the five studies that led to [the July] update... If warranted, [the NIH] should issue revised conclusions."
Read article at BMJ.com

Protecting profits
With several successful drugs due to come off-patent soon, pharmaceutical companies are starting to worry about future revenues. But changes in EU legislation could offer respite for these firms by granting tighter controls over generic drugs makers. Pharmaceuticals are big business. It is the world's most profitable industry: In 2002, (according to author and former New England Journal of Medicine editor Marcia Angell) the combined profits of the top ten drugs companies in the Fortune 500 list were greater than the profits of the 490 other companies in the list combined, at US$56 billion. But the sources of future earnings are looking increasingly uncertain.
Read article at Lancet.com

September 30, 2004

Merck Announces Withdrawal of Vioxx Painkiller
Merck & Company announced today that it was immediately pulling its arthritis and acute pain medication Vioxx from the worldwide market after data from a clinical trial showed that the drug produced an increased risk for heart attacks and strokes. Worldwide sales of Vioxx in 2003 amounted to $2.5 billion, the company statement said and Merck's shares plunged by more than $12 — reducing the company's market capitalization by about $26 billion.
Read article at NYTimes.com

September 29, 2004

European Commission proposes regulation aimed at promoting medicines for children
The European Commission has adopted a proposal for a regulation on medicines for children that aims to improve the health of the children of Europe by ensuring the authorisation of medicines, specifically researched and developed to meet their therapeutic needs.
Read article at MedicalNewsToday.com

Sales reps told not to divulge Paxil data
In a memo last September, GlaxoSmithKline (GSK) provided an update on concerns over its Paxil medicine, including study results showing a high incidence of suicide and hostility, but instructed its sales representatives in bold letters not to "discuss the contents" with doctors. A Glaxo spokeswoman denied any attempt to conceal information from doctors but ethics experts questioned the drug maker's intentions.
Read article at NJ.com

Side effects limit Tamoxifen use
Researchers at the University of North Carolina say it's unlikely that the breast cancer drug tamoxifen will ever be given widely to women as a preventive medication because the drug would avert only a maximum of 6% to 8.3% of breast tumors in eligible women. Tamoxifen's possibly harmful side effects, including blood clots and stroke, would rule out some 90 percent of women who might benefit from taking it.
Read article at SouthBendTribune.com

September 27, 2004

NIH seeks consulting ban
Under a proposal announced last week, all employees of the National Institutes of Health (NIH), including intramural scientists, would be barred from engaging in paid consulting activities with drug and biotech companies for at least 1 year while the agency reviews its procedures and develops more effective oversight systems. The proposed ban, disclosed to employees in an E-mail message last Friday (September 24), will affect more than 5000 scientists, including several hundred who have existing consulting arrangements in place. Those scientists will be instructed to cease those collaborations once the ban is implemented, NIH officials said.
Read article at BioMedCentral.com

September 25, 2004

Move to switch statins to non-prescription in US
US medical authorities should follow the lead of Britain and allow the sale of cholesterol lowering agents without a prescription, said a US professor of medicine in an editorial published in the American Journal of Cardiology (2004;94:753-6). British medical authorities switched simvastatin (Zocor) to over the counter status in July, making it the first statin to be available without prescription. Dr Antonio Gotto, professor of medicine at Weill Cornell Medical College, New York, applauded the move, saying that the "proven effectiveness and good safety record of statin medications argues for a similar move in the US."
Read article at BMJ.com

September 24, 2004

Insider Challenges Drug Industry on Imports
A dissident executive from Pfizer, the world's largest drug maker, denounced the pharmaceutical industry on Thursday for resisting legislation that would allow imports of low-cost prescription drugs from Canada and other countries. His comments gave new life to a flagging effort by members of Congress from both parties and both houses to pass such legislation this year.
Read article at NYTimes.com

September 20, 2004

The Raid on Medicare
The real cost of the Medicare prescription drug bill is finally emerging: The drug industry gets more than $100 billion in profits, while seniors and taxpayers get the tab.
Read article at Alternet.org

August 20, 2004

Antidepressant Study Seen to Back Expert
A top government scientist who concluded last year that most antidepressants are too dangerous for children because of a suicide risk wrote in a memo this week that a new study confirms his findings.
Read article at NYTimes.com

August 16, 2004

Seniors getting risky drugs
Medicines deemed hazardous to the elderly are still too often prescribed, researchers have found.
Read article at latimes.com

August 14, 2004

Heart Ailment Warning on Cancer Drug
The government and Genentech are warning doctors that Avastin, which is used to treat colorectal cancer, increases patients' risk of chest pain, strokes, ministrokes, heart attacks and potentially lethal heart ailments. A Genentech spokeswoman, Colleen Sweeney, said Friday that heart ailments had killed some patients who took the drug, but she could not say how many.
Read article at NYTimes.com

August 11, 2004

Wyeth to Appeal $1 Billion Diet Drug Judgment
Drugmaker Wyeth will appeal a $1 billion judgment against it over a drug used in the so-called fen-phen diet drug combination, after a Texas court denied its motion for a new trial, a securities filing shows.
Read article at Reuters.com

August 10, 2004

Starting Young in Treating High Blood Pressure
As blood pressure levels rise among America's youth, doctors are increasingly prescribing antihypertensive medications to children and teenagers. They hope that by catching and treating hypertension early, they will save lives.
Read article at NYTimes.com

August 9, 2004

Some Elderly Are Given Inappropriate Drugs, Study Says
One in five elderly Americans filled prescriptions for drugs deemed inappropriate for older patients, a study of 1999 insurance claims said on Monday.
Read article at Reuters.com

August 8, 2004

Prozac 'found in drinking water'
Traces of the antidepressant Prozac can be found in the nation's drinking water, it has been revealed.
Read article at BBCNews.com

City Sues Drug Companies, Claiming Medicaid Fraud
New York City has filed a lawsuit against the nation's leading pharmaceutical companies, accusing them of deceptively inflating the cost of their drugs and defrauding taxpayers out of tens of millions of dollars. The complaint, filed late Wednesday in Federal District Court in Manhattan, charges that 44 pharmaceutical companies and their subsidiaries - nearly every major drug maker in the nation - have violated federal and state Medicaid laws by committing fraud, engaging in unfair and deceptive trade practices and seeking unjust enrichment.
Read article at NYTimes.com

August 6, 2004

Parkinson's Drug Linked to Heart Valve Damage
Parkinson's Drug Linked to Heart Valve Damage
Read article at Reuters.com

Pfizer Says Named In Suit Involving Zoloft Marketing
Pfizer Inc. says that it has been named in a lawsuit alleging the company violated California law in marketing its antidepressant drug Zoloft. The purported class-action suit was filed last month in Los Angeles Superior Court. The suit, on behalf of all California residents, seeks unspecified damages and injunctive relief, Pfizer said in its quarterly report filed with the Securities and Exchange Commission.
Read article at DowJonesNewswires.com

Facts & Statistics from the pharmaceutical industry
Some fascinating facts & statistics from the Association of the British Pharmaceutical Industry showing the extent of big pharma's financial activities.
Read article at ABPI.org.uk

August 5, 2004

Autoimmune Drugs Linked to Tuberculosis Cases
Drugs to treat rheumatoid arthritis and other autoimmune diseases have been linked to tuberculosis cases in California , U.S. health officials say.
Read article at Reuters.com

New York City Files Lawsuit Against 44 Drug Makers
New York City officials filed a lawsuit in federal court late Wednesday against 44 drug makers, claiming they overcharged Medicaid for prescription drugs. The suit filed in the Southern District of New York names some of the largest makers of prescription medications, including Aventis Pharmaceuticals Inc., Bristol-Myers Squibb Co., Eli Lilly and Co., Johnson & Johnson, Merck & Co. Inc., Schering-Plough Corp. and Wyeth.
Read article at Forbes.com

August 4, 2004

Spitzer Asks Drug Maker for Off-Label Use Material
Johnson & Johnson said yesterday that the New York attorney general, Eliot Spitzer, had asked for information about six of its drugs, including marketing materials, the results of clinical trials and data on prescriptions for so-called off-label use. Johnson & Johnson is the third drug company to come under scrutiny from Mr. Spitzer in recent months over its handling of clinical trial data and drug marketing practices.
Read article at NYTimes.com

Bristol-Myers Squibb to Pay $150 Million in Settlement
Drug giant Bristol-Myers Squibb Co. is paying $150 million to settle federal regulators' charges that it manipulated its inventory of medicines in a fraudulent scheme to inflate its earnings and meet Wall Street targets, the Securities and Exchange Commission announced Wednesday. The company agreed to pay a $100 million civil fine and an additional $50 million to go to a fund for shareholders in its settlement with the SEC.
Read article at Forbes.com

August 3, 2004

New York to Sue Pharmacy Benefit Company
New York 's Attorney General Eliot Spitzer is set to announce a lawsuit against one of the biggest pharmacy benefit managers in the United States.
Read article at Reuters.com

AIDS Medicines Are Approved
Federal regulators said on Monday that they had approved two AIDS drug combinations designed to simplify treatment for patients in the United States and in poor countries - and no doubt to maximize the marketing opportunities.
Read article at NYTimes.com

Crestor Side Effect Report Delayed
A drug company illegally delayed reporting side effects linked to its anti-cholesterol drug Crestor, a consumer advocate contended Tuesday in urging a Food and Drug Administration investigation. It's the latest attack on Crestor by the private group Public Citizen, which argues that Crestor is riskier than its competitors and should be banned.
Read article at APNews.MyWay.com

August 2, 2004

Hazards of Modern Medicine
Iatrogenic illness -- disease produced as a result of medical treatment -- is now recognised as a health hazard of global proportions. MEDLINE (the computerised medical research database of the United States National Library of Medicine) includes over 7,000 articles, reports, and scientific research papers since 1966 that show a substantial number of patients suffer treatment-caused disorders and adverse drug reactions. These harmful effects, which can be serious and even lethal, are associated with every facet of modern medicine including drugs, other medical therapies, diagnostic procedures, and surgery.
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July 31, 2004

Scandals have eroded US public's confidence in drug industry
Only 13% of Americans believe that pharmaceutical companies are "generally honest and trustworthy," putting the industry on a par with tobacco, oil, and managed care companies, a recent Harris Poll survey has found. Public confidence in drug companies has plunged harder and faster than for any other industry, the survey indicates.
Read article at BMJ.com

July 29, 2004

First OTC Cholesterol Drug Launched in Britain
In a clear move designed to increase the earning potential of these drugs, Britain has become the first country in the world to sell a cholesterol-lowering drug over the counter, without a prescription.
Read article at Reuters.com

July 24, 2004

In a Shift, Bush Moves to Block Medical Suits
The Bush administration has been going to court to block lawsuits by consumers who say they have been injured by prescription drugs and medical devices. The administration contends that consumers cannot recover damages for such injuries if the products have been approved by the Food and Drug Administration. The administration said its position, holding that individual consumers have no right to sue, actually benefited consumers. The threat of lawsuits, it said, "can harm the public health".
Read article at NYTimes.com

July 8, 2004

Pfizer Reports China Has Lifted Its Viagra Patent
Regulators in China took away Pfizer's patent there on Viagra, the drug company said yesterday, in a case that the Bush administration considers an important test of China's commitment to international trade agreements.
Read article at NYTimes.com

June 16, 2004

Glaxo, Pressured by Spitzer, Publishes Paxil Data
GlaxoSmithKline Plc, responding to a lawsuit claiming it suppressed negative data about its antidepressant Paxil, published results of trials showing the drug is broadly ineffective in children and adolescents and could increase risks of suicidal behaviour.
Read article at Reuters.co.uk

A Large Medicine Maker But Not Competitive
China has become the world's second largest producer of raw medicine, with an annual output of some 800,000 tones.
Read article at China.Org.cn

June 15, 2004

President Bush Proposes Spending $15 Million To Begin New G8 HIV Vaccine Initiative
President Bush proposed that the United States contribute $15 million to start a new global consortium to collaborate and share research to develop an HIV/AIDS vaccine. Group of Eight leaders from the United States, Japan, Germany, France, Britain, Italy, Canada and Russia on Tuesday at a summit in Sea Island, Ga., announced the formation of the Global HIV Vaccine Enterprise to speed the development of an HIV/AIDS vaccine and streamline research and development efforts.
Read article at MedicalNewsToday.com

Over half of COX-2 patients take aspirin, possibly negating the COX-2 GI benefits
Findings reported in a study published today in the Archives of Internal Medicine found that over half of patients within a predominantly retiree population taking COX-2 anti-inflammatory drugs on a long-term basis were also taking aspirin therapy for its cardio-protective benefit. Previously published clinical research has shown that using aspirin along with COX-2 therapies can negate the gastrointestinal (GI) benefit of using COX-2's, one of the primary reasons for using these more costly medications.
Read article at MedicalNewsToday.com

June 12, 2004

GlaxoSmithKline faces US lawsuit over concealment of trial results
The British pharmaceutical giant GlaxoSmithKline (GSK) is facing a major lawsuit in the United States over alleged concealment>of negative trial results involving its antidepressant paroxetine(marketed there as Paxil and in Britain as Seroxat
Read article at BMJ.com

Greek authorities probe illegal clinical studies on elderly people
Prosecutors in Greece are investigating claims that elderly people have been used for clinical studies without their knowledge. According to a leaked report by health inspectors, residents of an old people’s home in Athens were allegedly used in a clinical study on their cholesterol and triglyceride concentrations without their written consent.
Read article at BMJ.com

June 11, 2004

Experts Urge Integrated AIDS Strategy
Mistakes made by industrialized nations in dealing with the AIDS epidemic could be repeated in developing countries unless HIV prevention efforts are expanded along with treatment, experts warned. In a report published ahead of the International AIDS Conference in Bangkok next month, scientists cited an unprecedented opportunity to integrate HIV prevention with treatment programs in poor countries, where most of the infections now are.
Read article at ABCNews.com

Glaxo climbdown over Seroxat trials
Battered by accusations of a cover up of clinical data, GlaxoSmithKline has agreed to release summaries of studies examining the safety and efficacy of a key anti-depression drug.
Read article at ThisIsMoney.com

GlaxoSmithKline warned by FDA over TV ads for Paxil CR drug
GlaxoSmithKline PLC late Thursday was warned by the US Food and Drug Administration that TV ads for its anxiety drug Paxil CR are too broad.
Read article at III.co.uk

June 2, 2004

US Health Corps Prepare to Swoop on NHS
The UK government has issued a report which shows that a US health maintenance organization, Kaiser Permanente, can offer the same level of service as the NHS, but at cheaper prices. There's only one problem. The report is wrong.
Read article at CorporateWatch.org

May 24, 2004

Drug firm threatened us, say MMR families
Families who claim the MMR vaccine has caused illnesses in their children have accused one of the three drug companies involved in the case of trying to intimidate them into dropping legal action.
Read article at Guardian.co.uk

May 15, 2004

Whistleblower removed from job for talking to the press
A whistleblower who uncovered evidence that major drug companies sought to influence government officials has been removed from his job and placed on administrative leave. His findings showed that the pharmaceutical company Janssen had paid honorariums to key state officials who held influence over the drugs prescribed in state-run prisons and mental hospitals.
Read article at BMJ.com

Two more medicines advertisements blocked by regulator
Promotional material for two anti-hypertensive agents has been withdrawn after complaints to the UK’s Medicines and Healthcare products Regulatory Agency. The complaints were made in March, shortly before the MHRA issued advice to companies not to make claims that imply that medicines have no side effects when their summaries of product characteristics made clear that they do.
Read article at PharmJ.com

May 14, 2004

Pfizer guilty, to pay $430M
Pfizer Inc. will plead guilty to criminal charges and pay $430 million in fines to settle charges that a company it bought illegally promoted non-approved uses for a drug. The settlement with the world's largest pharmaceutical company over Warner-Lambert, which Pfizer bought in 2000, includes a $240 million criminal fine -- the second-largest ever imposed in a health-care fraud prosecution.
Read article at CincyPost.com

April 16, 2004

FDA Move On Antidepressant Study Scrutinized
The Food and Drug Administration is coming under scrutiny for its handling of a staffer's conclusion that there were likely links between some antidepressant drugs and suicidal tendencies among young people
Read article at DownJonesNews.com

Cholesterol Drugs Tied to Birth Defects
Researchers from the U.S. National Institutes of Health found that statin use during the first trimester of pregnancy is associated with severe central nervous system defects and limb deformities
Read article at HealthDay.com

April 8, 2004

Doctors Without Borders: Why You Can't Trust Medical Journals Anymore
Should research scientists who have financial stakes in the products they are writing about be forced to disclose those ties? To which the average person might reasonably respond, of course they should. But the more pertinent question is why scientists with financial stakes in the outcome of scientific studies are allowed anywhere near those studies, much less reviewing them in elite journals.
Read article at WashingtonMonthly.com

April 7, 2004

Nominal Benefits Seen in Drugs for Alzheimer's Disease
The drugs now available to treat the memory and thinking problems of Alzheimer's disease have not lived up to the public's high expectations for them and offer such modest benefits on average that many doctors are unsure about whether to prescribe them.
Read article at NYTimes.com

April 6, 2004

Eli Lilly Gives Research Foundation $6 Million
Eli Lilly settle out of court with Oklahoma Medical Research Foundation in patent infringement case. The lawsuit contended that work by two of the foundation's doctors helped in the development of the Lilly drug Xigris to treat blood infections. The foundation wanted an up-front payment for the development plus a share of Lilly's sales.
Read article at WLFI.com

FDA kept suicide findings secret
Ten months ago, when concerns arose about a possible link between children taking antidepressant drugs and suicide attempts, senior officials at the Food and Drug Administration ordered their leading expert to head up an examination of the evidence. When the government scientist filed his report last winter, however, his bosses decided to keep it secret — even though it found that children who took the drugs were twice as likely to be involved in serious suicide-related behaviour as those who did not
Read article at AJC.com

April 4, 2004

UK firm tried HIV drug on orphans
GlaxoSmithKline embroiled in scandal in which babies and children were allegedly used as 'laboratory animals'
Read article at Guardian.co.uk

March 23, 2004

Supplement, drug reactions may not pose serious risk
The growing use of dietary supplements has caused alarm in recent months among the medical community who fear dangerous interactions with prescription medicines. But a new study concludes that most potential drug-supplement interactions are not serious
Read article at Nutraingredients.com

March 19, 2004

U.S. FDA looks at anemia drugs, cancer risks
U.S. regulators are considering whether two anemia-fighting drugs, often given to cancer patients, may in some cases stimulate tumor growth, a question raised by studies of similar products sold in Europe . The Food and Drug Administration has scheduled a meeting of outside experts for May 4 to gather input on safety issues surrounding the medicines, Amgen Inc.'s Aranesp and Johnson & Johnson's Procrit
Read article at Forbes.com

March 15, 2004

Antibiotic use linked to breast cancer risk
A new study has found evidence that antibiotics use is associated with an increased risk of breast cancer in women. According to the latest findings by US researchers, women who take antibiotics are at a higher risk of being diagnosed with breast cancer, and the risk rises depending on the number of prescriptions taken
Read article at DiscoveryHealth.co.uk

March 04, 2004

U.S. Lawmakers Push for Drug Monitoring Systems
U.S. lawmakers on Thursday called for better government oversight of legal but potentially addictive prescription drugs, including painkillers, stimulants and sedatives. Democrats and Republicans said more monitoring programs are needed to track sought-after drugs that are easily obtained through prescription forgery, corrupt physicians, and patients switching from one doctor to another collecting prescriptions.
Read article at Reuters.com

Consumer Group Says Ban Cholesterol Drug
A consumer group has asked the U.S. government to ban an AstraZeneca cholesterol drug approved only months ago, citing reports of dangerous reactions and one death. The prescription drug, Crestor, hit the U.S. market last September. Since the drug's launch, seven patients who took it developed life-threatening muscle deterioration, and nine experienced kidney failure or damage. One 39-year-old U.S. woman died from kidney damage and muscle breakdown, a known side effect of the statin drugs such as Crestor
Read article at Reuters.com

February 27, 2004

FDA considers tighter restrictions on drug
Recent restrictions have failed to reduce the number of pregnancies among women using Accutane , an acne drug that causes serious birth defects — prompting critics to call Thursday for major government curbs on who can get a prescription and how. The Food and Drug Administration is asking its scientific advisers what additional safeguards are needed to battle the birth-defect problem that Accutane has posed since it first hit the market in 1982
Read article at Redding.com

HRT risks 'were known years ago'
Women could have been told about the risks of taking hormone replacement therapy years ago. Researchers say studies showing HRT may increase the risk of heart disease were published as early as 1997. But most were done by drug companies and were not publicly available. The risk was only formally acknowledged in 2002 when a large US trial was halted
Read article at BBCNews.com

February 25, 2004

More negative effects from HRT
Diminished hearing may be a further side effect of hormone-replacement therapy (HRT), according to a small pilot study funded by the US National Institutes of Health. Depending on the measure, HRT recipients on average did anywhere from 10 to 30 per cent worse on hearing tests than women who had not received HRT
Read article at Nutraingredients.com

February 24, 2004

A Debate on Radiation in Breast Cancer
Radiation treatment is being prescribed for more and more breast cancer patients, including women who would have been told just a few years ago that they could skip it. The added therapy mostly affects those women who are treated with mastectomy and chemotherapy, and have fairly good prognoses at what is called Stage 2 cancer. But cancer experts and doctors are divided over whether these women really need radiation to improve their chances of survival
Read article at NYTimes.com

February 20, 2004

The human right to health and medicine
The public needs to know the truth about the healthcare system, said Ismail Sukkariyyah , a medical doctor and former member of Parliament. One area that has been lacking in particular, says Sukkariyyah , speaking a day after a lecture on “Public Health as a Human Right” by health and human rights activist Aida Seif El- Dawla at the American University of Beirut , is the dissemination of facts about corruption surrounding the sales of pharmaceuticals in Lebanon . “ Lebanon had a $600 million pharmaceutical bill last year,” he said, sitting in his Hamra clinic. That bill, he noted, includes monies from drugs being sold at inflated prices, the sales of mislabelled and ineffectual drugs, as well as profits from drugs that are available here that have been banned from the world market.
Read article at Terra.net.lb

February 17, 2004

Pharmaceutical industry to lose out
More than R2 billion will be lost in the pharmaceutical industry if the draft regulations on the Medicine Control Act are implemented. This is according to some delegates meeting today at a Pharmaceutical Society of South Africa (PSSA) seminar
Read article at SABCNews.com

February 16, 2004

Bush's AIDS Initiative
In his State of the Union address a year ago, President Bush announced an ambitious new program to combat AIDS overseas. He pledged to spend $15 billion over five years to prevent new AIDS infections, provide antiretroviral treatment and care for the sick and orphans.
Read article at NYTimes.com

Germany Launches HIV/AIDS Vaccine Trial
Scientists in Germany on Monday launched the country's first test of an HIV vaccine, a yearlong program that will involve up to 50 volunteers and is backed by the New York-based International AIDS Vaccine Initiative. The trial will be conducted at university clinics in Bonn and Hamburg , and also at Belgian hospitals in Brussels and Antwerp
Read article at ABCnews.com

February 14, 2004

Controversial disease dropped from Prozac product information
The drug manufacturer Lilly has been forced to drop one of the disorders it had previously listed for its antidepressant drug fluoxetine (Prozac), following a finding by the European drug regulator that the condition was not a well-established disease entity. Some health researchers welcomed the regulator's decision, saying premenstrual dysphoric disorder (PMDD), which was only recently described, was an invented illness and a strong example of the medicalisation of ordinary life
Read article at BMJ.com

February 5, 2004

Schering-Plough Halts Lung Cancer Study
Schering-Plough ends study of new cancer drug. The company said its drug Sarasar, one of the most important products in its pipeline of experimental medicines, was not adequately effective against non-small-cell lung cancer to justify continuation of the study
Read article at Reuters.com

February 3, 2004

Single Drug for Cholesterol, Blood Pressure Approved
The U.S. Food and Drug Administration has approved the Pfizer drug Caduet for simultaneous treatment of both high cholesterol and high blood pressure, the company says. The single pill contains ingredients from both the cholesterol drug Lipitor (atorvastatin calcium) and the blood pressure medication Norvasc (amlodipine besylate)
Read article at Healthday.com

HRT raises risk of breast cancer recurrence, alternatives needed
A Swedish study established to assess the effect of hormone replacement therapy (HRT) for women with a history of breast cancer has been stopped early after preliminary results show 'unacceptably high' risks of breast cancer recurrence for HRT users
Read article at Nutraingredients.com

February 2, 2004

Inquiry Sought in House Vote on Drug Plan for Medicare
A leading House Democrat has called on Speaker J. Dennis Hastert to initiate an ethics investigation into accusations of bribery during last November's vote on the new Medicare drug plan, warning that Democrats will conduct their own inquiry if the House leader does not act. In a Jan. 20 letter to the speaker, Representative Steny H. Hoyer of Maryland, the Democratic whip, said an investigation by the House ethics committee was needed to protect the reputation of the House after Representative Nick Smith, Republican of Michigan, said groups and lawmakers had offered support for his son's Congressional campaign if Mr. Smith backed the measure, which passed 220 to 215
Read article at NYTimes.com

February 1, 2004

Making Drugs, Shaping the Rules
Since the mid-1990's, a group of drug companies, led by Johnson & Johnson, has campaigned to convince state officials that a new generation of drugs - with names like Risperdal, Zyprexa and Seroquel - is superior to older and much cheaper antipsychotics like Haldol. The campaign has led a dozen states to adopt guidelines for treating schizophrenia that make it hard for doctors to prescribe anything but the new drugs
Read article at NYTimes.com

January 30, 2004

Vatican accuses drug companies of genocide
The Vatican has become embroiled in the battle to reduce the cost of anti-HIV medications, after a Vatican spokesman yesterday accused drug companies of “genocide” by refusing to lower their antiretroviral prices in Africa.
Read article at Aidsmap.com

Trying to Police Misleading Drug Ads
"The F.D.A. is in a semi-lawless mode with respect to enforcing drug advertising rules," said Sidney M. Wolfe, director of the Health Research Group at Public Citizen in Washington, an advocacy group. "It began in the Clinton administration, but it's gotten much worse. The amount of enforcement has gone down when the amount of advertising has gone significantly up."
Read article at NYTimes.com

January 20, 2004

FDA Set to Step Up Its Scrutiny of Effects of Herbal Supplements
In the wake of its decision to ban the weight-loss treatment ephedra, the Food and Drug Administration is planning to step up its scrutiny of the health effects of a number of other herbal supplements. In a speech Tuesday, FDA Commissioner Mark McClellan is expected to highlight herbal products that the agency wants to examine more closely
Read article at WSJ.com

Drug Companies Get Too Close for Med School's Comfort
A report from Harvard School of Public Health in The New England Journal of Medicine indicates that the pharmaceutical industry spends roughly $15.7 billion annually marketing medications, with $4.8 billion dedicated to detailing individual physicians, or roughly $6,000 to $11,000 a doctor a year. Studies indicate that most physicians meet with pharmaceutical representatives four times a month. Studies also reveal that most physicians erroneously believe the representatives do not influence prescribing habits
Read article at NYTimes.com

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