Dr. Rath Health Foundation

Dr. Rath Health Foundation

Responsibility for a healthy world Dr. Rath Research Institute 100+ Studies Published In PubMed

The Pharmaceutical "Business with Disease"

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

December 3, 2006

Deaths Prompt Pfizer to End Cholesterol Drug Trials
Pfizer Inc. announced Saturday that it has cut off all clinical trials and development work for a cholesterol drug that was supposed to be a star product because of an unexpected number of deaths and cardiovascular problems among patients who used it.
Read article at WashingtonPost.com

May 25, 2006

Regulators slam drug trial firm
UK drug regulators have heavily criticised the firm which carried out the drug trial which left six men seriously ill. Parexel failed to follow several trial procedures including keeping proper patient records, ensuring 24-hour medical cover, and checking insurance.
Read article at BBCNews.com

May 24, 2006

Researchers Say Attention Deficit Drugs Likely Send Thousands of Children, Adults to ERs
Accidental overdoses and side effects from attention deficit drugs likely send thousands of children and adults to emergency rooms, according to the first national estimates of the problem. Scientists at the U.S. Centers for Disease Control and Prevention estimated problems with the stimulant drugs drive nearly 3,100 people to ERs each year.
Read article at ABCNews.com

May 12, 2006

Doctors Challenge Merck Study, Say Data Shows Vioxx Remained Dangerous at Least 1 Year After Use
People who took the painkiller Vioxx were at increased risk of heart attack and stroke for at least a year after they stopped taking the drug, several doctors said Friday, challenging claims the drug's maker had made the day before. The doctors refuted the interpretation of a study by Merck & Co. Company officials had contended Thursday that users of Vioxx weren't at increased risk of heart attack or stroke in the year after quitting the drug.
Read article at ABCNews.com

May 11, 2006

Drug reactions 'must be reported'
Some 250,000 patients yearly are admitted to hospital in the UK with adverse reactions to drugs at a cost of 466 million, a report suggests. Serious reactions to medicines can include sudden death, respiratory failure and heart attacks.
Read article at BBCNews.com

May 11, 2006

Cancer drug Glivec may harm bones
Glivec (imatinib), which has dramatically improved survival prospects for some cancer patients, can interfere with bone development, according to U.S. researchers. Results of a study published this week in The New England Journal of Medicine indicated that the drug inhibits bone formation and resorption – a process known as bone remodelling.
Read article at ASCO.org

May 09, 2006

Many Docs Prescribe Drugs 'Off-Label' With Little Scientific Rationale
Doctors wrote more than 100 million prescriptions in the United States in 2001 for reasons that had "little or no scientific support," according to a just-published study on the prevalence of so-called "off-label" drug use. In all, the study estimated that 1 in 7 prescriptions were written without good medical evidence that they would work. The estimate was derived from prescriptions written by doctors in office-based medical practices.
Read article at DailyNewsCentral.com

May 08, 2006

Long-term HRT 'ups cancer risk'
Long-term use of oestrogen-only hormone replacement therapy (HRT) does increase the risk of breast cancer, a major study suggests. The US study comes just weeks after research appeared to rule out any connection in the short to medium term.
Read article at BBCNews.com

May 08, 2006

CDC Wants AIDS Virus Testing to Be Part of Routine Physical Exams for Adults and Teens
Testing for the AIDS virus could become part of routine physical exams for adults and teens if doctors follow new U.S. guidelines expected to be issued by this summer. Federal health officials say they'd like HIV testing to be as common as a cholesterol check. The guidelines for voluntary testing would apply to every American aged 13 to 64, according to the proposed plan by the U.S. Centers for Disease control and Prevention.
Read article at ABCNews.com

May 07, 2006

Nigerian Panel Reportedly Finds That Pfizer Violated International Law With Drug Testing
Nigerian medical experts have concluded that Pfizer Inc. violated international law during a 1996 epidemic when the company tested an unapproved drug on children with brain infections, The Washington Post reported. A Nigerian government report on the panel findings that was never released was recently obtained by the Post. The report was provided by a source who asked to remain anonymous because of personal safety concerns, the newspaper reported Sunday.
Read article at ABCNews.com

May 04, 2006

US Federal Government Awards Contracts to 5 Companies to Speed Up Flu Vaccine Production
The government on Thursday awarded more than $1 billion to five drug manufacturers that are developing technology for speedier mass production of vaccines in case of a pandemic. The money comes from the $3.8 billion that Congress approved last year. The goal is to be able to distribute vaccine to every American within six months of a pandemic striking.
Read article at ABCNews.com

April 28, 2006

Pfizer Boldly Advertising Celebrex Again
The ads feature a man holding a boy's hand as they walk up a stadium staircase. "52 steps won't keep you from taking him out to the ball game," they say. But a heart attack would.
Read article at NYTimes.com

April 27, 2006

Roche Profits Spike On Flu Scare Sales
Roche, the Basel , Switzerland drug giant, saw its first quarter sales jump 22% to $7.7 billion, more than many analysts expected. The sales beat may be due mostly to sales of Tamiflu, a pill to treat influenza infections that many nations are stockpiling in fear of a bird flu pandemic, said Timothy Anderson, an analyst at Prudential Securities, in a note to investors.
Read article at Forbes.com

April 20, 2006

Study Finds a Link of Drug Makers to Psychiatrists
More than half the psychiatrists who took part in developing a widely used diagnostic manual for mental disorders had financial ties to drug companies before or after the manual was published, public health researchers reported yesterday. The researchers found that 95 — or 56 percent — of 170 experts who worked on the 1994 edition of the manual, called the Diagnostic and Statistical Manual, or D.S.M, had at least one monetary relationship with a drug maker in the years from 1989 to 2004.
Read article at NYTimes.com

April 12, 2006

Lawsuit Alleges Merck Negligent in Promoting Osteoporosis Drug Fosamax
Merck & Co, which is already facing a raft of cases over its pain reliever Vioxx, may need to hire additional attorneys to fight a recently filed lawsuit alleging the company was negligent in promoting its osteoporosis drug Fosamax. According to a lawsuit filed Monday in U.S. District Court in Fort Myers, Fla., Fosamax is a defective product because it can cause osteonecrosis of the jaw, or a rotting of the jaw bone. The suit, which seeks class action status, alleges that Merck concealed and continues to hide Fosamax's potentially dangerous side effects from patients and doctors.
Read article at ABCNews.com

Expert Says Bird Flu No Imminent Threat
Even if bird flu does arrive on U.S. shores on the wings of a migratory bird, the virus is unlikely to makes the inroads in poultry or in people that it has in less developed countries, the nation's top avian influenza expert says.
Read article at ABCNews.com

April 11, 2006

Vioxx Plaintiff Gets $9M Punitive Damages
A New Jersey man was awarded $13.5 million from Vioxx maker Merck & Co., including $9 million in punitive damages on Tuesday after a jury found that the company knowingly withheld data about the pain drug's risks from federal regulators. The state court jury had given John McDarby, 77, of Park Ridge, and his wife, Irma, $4.5 million last Wednesday, saying Merck's conduct showed a "wanton and willful disregard of another's rights."
Read article at ABCNews.com

April 11, 2006

Drug firms 'inventing diseases'
Pharmaceutical firms are inventing diseases to sell more drugs, researchers have warned. Disease-mongering promotes non-existent diseases and exaggerates mild problems to boost profits, the Public Library of Science Medicine reported.
Read article at BBCNews.com

April 5, 2006

Charges for NHS fraud allegations
Nine people and five companies will be charged with conspiracy to defraud the UK ’s National Health Service (NHS) over drug prices and supply, the Serious Fraud Office (SFO) has said. The criminal case involves warfarin and several penicillin-based antibiotics. The SFO said the nine individuals would be charged when they surrendered to bail during the next three days.
Read article at BBCNews.com

Heart Disease, Stroke Are Biggest Third World Plagues, Killing More Than AIDS, TB and Malaria
Each year cardiovascular disease kills 13 million people in developing countries, almost triple the number who die from AIDS, tuberculosis and malaria combined, researchers said Wednesday. Cardiovascular disease including heart disease, heart failure and stroke is the world's biggest killer.
Read article at ABCNews.com

February 22, 2006

U.S. Health Care Bill by 2015: $4 Trillion
Health care — which now consumes about one in every six dollars spent in the United States — will eat up one of every five dollars by 2015, according to a new government analysis.  Government and private spending for health care will average about $12,320 per person in 2015, almost double the 2005 figure of $6,683. Or, put another way, the nation's health care bill could total more than $4 trillion.
Read article at ABCNews.com

February 13, 2006

Drug Companies Stop Recruiting for Test
Biotechnology company Genentech Inc. and its majority stockholder Roche Holding AG said Monday they temporarily halted recruiting volunteers for a large human test of the blockbuster cancer drug Avastin after more patients than expected died.
Read article at Yahoo News (USA)

February 10, 2006

Feds Recommend Warnings on ADHD Drugs
Concerned about the risk of sudden death or serious injury associated with Ritalin and other stimulants used to treat attention deficit hyperactivity disorder, a federal advisory panel says the drugs should carry the most serious type of warning label. The proposed "black box" warning would inform doctors, patients and parents of the uncertainty regarding the risk the drugs may pose to the cardiovascular system.
Read article at ABCNews.com

February 10, 2006

FDA: Merck Had Time to Warn About Vioxx
Merck & Co. could have warned that its popular painkiller Vioxx might increase the risk of heart attacks as soon as the first evidence showed up, rather than waiting two years for federal approval, a former Food and Drug Administration official testified Friday.
Read article at ABCNews.com

February 09, 2006

Medical Research Must Put Public Interests Before Commercial Decisions, Warns UK Faculty
Doctors employed by pharmaceutical companies must always put the best interests of patients before their medical research, even if it brings them into conflict with their employers, according to new practical advice from the Faculty of Pharmaceutical Medicine published in the February issue of IJCP
Read article at Medical News Today (UK)

February 07, 2006

Divided Loyalties?
Diabetes patients anxious to weigh the pros and cons of an experimental diabetes drug called muraglitazar might expect some help from the American Diabetes Association (ADA). But they won't find much on the ADA Web site. For example, there is no information about research linking the drug to possible increased risk of fatal heart problems. Also, the Web site has yet to report that the Food and Drug Administration (FDA) approved the drug only on the condition that its maker, Bristol-Meyers Squibb -- which last year donated more than $1 million to the ADA -- produce additional safety data first. The diabetes group acknowledges financial support from the drug maker in its annual report and on a Web page called "Corporate Health Ambassador Case Study," but not the precise amount of the donation.
Read article at Washington Post (USA)

February 07, 2006

Exposed: the secret corporate funding behind health research
Academics and the media have failed dismally to ask the crucial question of scientists' claims: who is paying you?
Read article at The Guardian (UK)

February 05, 2006

Journal Article a Wild Card in Vioxx Trial
A top medical journal's criticism of a study cited in Vioxx lawsuits is expected to play a part in the retrial of the first federal Vioxx lawsuit but it's not clear if it will be a legal hand grenade or a nuclear warhead. The disclosure that some negative data was omitted from the study could make manufacturer Merck & Co. look as if it's hiding something, legal experts say.
Read article at ABCNews.com

February 03, 2006

Pharmas May Rake In Extra Billions with Medicare Drug Plan
The new Medicare drug benefit will give drug companies up to $2 billion in extra profits this year because they're no longer required to pay rebates on drugs bought by the government for the elderly poor. The hefty windfall raises new concerns that the Bush administration won't fully realize its promises of lower drug prices in the troubled new program.
Read article at Daily News Central (USA)

February 01, 2006

Drug side effects can mimic early dementia: study
Common drugs used to treat depression, Parkinson's disease and allergies can produce side effects that can be mistaken for early dementia, scientists said on Wednesday. They added that doctors should be aware the drugs, known as anticholinergics, can cause confusion, memory loss and disorientation and question patients about medication they are taking before prescribing drugs for early dementia.
Read article at Reuters.com (USA)

January 30, 2006

UK Government Warned Over Pharmaceutical Industry Investment
The announcement by a major Japanese-based pharmaceutical company of a multi-million pound investment in the UK was welcomed by the Association of the British Pharmaceutical Industry (ABPI) - but it also warned that the country has to compete harder than ever to win future investment.
Read article at Medical News Today (UK)

January 29, 2006

EMEA Statement On The Safety Of Ketek (telithromycin), Europe
The European Medicines Agency (EMEA) has reviewed cases of serious liver injury associated with the use of Ketek (telithromycin). Following this preliminary review the Agency's Committee for Medicinal Products for Human Use (CHMP) has asked the marketing authorisation holder (Aventis Pharma S.A.) to change the product information of Ketek to include stronger warnings concerning liver disorders. Cases of serious acute hepatitis, including liver failure, some of which were fatal, have been reported to and assessed by the EMEA in the context of the continuous monitoring of the safety of Ketek.
Read article at Medical News Today (UK)

January 28, 2006

US agency wants to limit lawsuits against drug manufacturers
The US Food and Drug Administration has issued a policy statement that will make it harder for people to sue drug manufacturers. The statement, supporting an arrangement known as "pre-emption," was inserted into the agency?s new guidelines on drug labelling. It asserts that complying with the FDA?s labelling requirements should pre-empt or supersede individual states? liability statutes.
Read article at BMJ (UK)

January 25, 2006

Study Questions Safety of Heart Drug
A drug commonly used to prevent excessive bleeding in heart surgery patients greatly increased the risk of kidney failure, a new international study found. The drug aprotinin marketed under the brand name Trasylol is the second clotting medication in two weeks linked to serious complications.
Read article at ABCNews.com

January 25, 2006

Millions more to get heart drugs
An extra 3.3 million people (in the UK) will become eligible for cholesterol-busting drugs, thanks to new NHS guidelines. GPs will be urged to prescribe statins to those with a 20% risk of developing cardiovascular disease within 10 years, as well as those who have it.
Read article at BBC News (UK)

January 25, 2006

Ban urged on industry gifts to doctors
The gifts, drugs and classes that makers of pharmaceuticals and medical devices routinely give doctors undermine medical care, hurt patients and should be banned, a group of influential doctors says in an article published Wednesday in The Journal of the American Medical Association.
Read article at International Herald Tribune (USA)

January 24, 2006

Warfarin Increases Risk Of Bone Fracture
Elderly patients taking the commonly prescribed blood thinner warfarin experience an increased risk for osteoporosis-linked bone fractures, according to a study at Washington University School of Medicine in St. Louis. The results suggest physicians should carefully monitor the bone health of patients placed on the medication and that their patients should take steps to decrease the risk of osteoporosis.
Read article at Medical News Today (UK)

January 23, 2006

Popular Antidepressants May Also Affect Human Immune System
Drugs that treat depression by manipulating the neurotransmitter serotonin in the brain may also affect the user's immune system in ways that are not yet understood, say scientists from Georgetown University Medical Center and a Canadian research institute.
Read article at Medical News Today (UK)

January 23, 2006

An expensive free lunch
I arrived late to the pediatrics conference and snuck in around the side to grab some food. "Wow! Chinese chicken salad with sesame dressing," I thought to myself. "Just what I need." I was exhausted from my day in the neonatal intensive care unit, and the fresh food could not have looked tastier - especially in light of the dry cafeteria garden burgers I had been eating for weeks. As we left, I commented to a friend how delicious the lunch had been. "Thanks to the drug company," he said.
Read article at LA Times (USA)

January 23, 2006

Bristol-Myers Near to Settling Failed-Drug Suit
Bristol-Myers Squibb Co. is close to settling a shareholder lawsuit over its failed experimental blood-pressure drug, Vanlev, for more than $150 million, people familiar with the agreement said. The settlement, which could be announced as early as this week, pertains to a suit that alleges Bristol-Myers hailed Vanlev as a potential blockbuster even after a dangerous side effect surfaced. The agreement would bring to nearly $1 billion the amount of money the New York drug maker has agreed to return to shareholders in the past two years.
Read article at Wall Street Journal (USA)

January 20, 2006

Death Reported From Novel Antibiotic
Researchers reported Friday three cases of severe liver problems, including one death, in patients at a North Carolina hospital after they began taking a novel antibiotic. Federal regulators said they were reviewing an unknown number of U.S. cases involving the drug, telithromycin, and were consulting with their counterparts overseas.
Read article at ABCNews.com

January 20, 2006

Rice Explains Aid Restructuring to USAID Employees
Secretary of State Condoleezza Rice faced a barrage of pointed questions yesterday from employees at the U.S. Agency for International Development, who expressed concerns that an administration move to centralize the management of foreign assistance will weaken the agency and place short-term political goals ahead of long-term development aims.
Read article at Washington Post (USA)

January 17, 2006

FDA Says Haemophilia Drug Linked to Deaths, Strokes, Heart Attacks in Some Patients
A hemophilia drug has been linked to deaths, strokes, heart attacks and other complications in patients given the medicine for other types of out-of-control bleeding, such as cerebral hemorrhages, according to FDA researchers. The medicine, NovoSeven, is a clotting drug that was introduced in 1999 after being approved by the Food and Drug Administration to stop bleeding in hemophiliacs.
Read article at ABCNews.com

January 14, 2006

Doctors outraged at Patriot Act's potential to seize medical records
US doctors across the political spectrum are protesting at a provision in the Patriot Act that allows the government to seize patients' medical records without a probable cause or a warrant. The act prohibits doctors from telling anyone, including the patient, that their sensitive medical records have been seized. Doctors who violate the gagging order can be fined and prosecuted for obstruction of justice.
Read article at BMJ (UK)

January 13, 2006

Next Vioxx Cases Scheduled for Spr
The next two federal lawsuits claiming that the painkiller Vioxx caused heart attacks or other cardiovascular problems are scheduled for trial this spring. The case that ended last month in a mistrial and will be retried in February looks at whether very short-term use could cause a heart attack. The next two cases will involve increasingly longer periods on the drug.
Read article at ABCNews.com

January 13, 2006

20% Patients On Commonly Prescribed Diuretics Have Abnormal Sodium And Potassium Levels
One in five patients taking diuretics commonly prescribed for high blood pressure or heart conditions end up with reduced sodium and potassium levels, according to a study published in the January issue of the British Journal of Clinical Pharmacology
Read article at MedicalNewsToday.com

January 11, 2006

Drug Makers Scrutinized Over Grants
A Congressional investigation of the money that drug companies give as supposed educational grants has found that the payments are growing rapidly and are sometimes steered by marketing executives to doctors and groups who push unapproved uses of drugs. Twenty-three drug makers spent a total of $1.47 billion in 2004 on educational grants, or an average of $64 million per company, according to the Senate Finance Committee. That number was a 20 percent increase from the total in 2003, which was $1.23 billion.
Read article at New York Times (USA)

January 06, 2006

FDA Asks Advisory Committee To Examine Cardiovascular Risks Of ADHD Medications
FDA has asked the agency Drug Safety and Risk Management advisory committee to examine the potential cardiovascular risks of attention deficit hyperactivity disorder medications in response to reports of deaths and other serious adverse events in individuals who have taken the treatments
Read article at MedicalNewsToday.com

January 05, 2006

Patients Treated With Popular Diabetes Drug Report Blurry Vision, Swollen Legs
Patients taking two widely used diabetes drugs have reported blurry vision and swelling of the legs and feet, the Food and Drug Administration and manufacturer GlaxoSmithKline said Thursday. The company said it has received "very rare" reports of new or worsening diabetic macular edema in diabetic patients who have taken Avandia or Avandamet. The swelling of the portion of the retina most important for sight can cause blurry or distorted vision.
Read article at ABCNews.com

January 03, 2006

Heart Failure Drug Maker Reports Additional Deaths in Patients in Study Done 3 Years Ago
The manufacturer of the heart failure drug Natrecor reported two additional deaths in patients involved in a study carried out three years ago but said it was confident the cases don't mean an increased risk. The deaths had not been previously reported to Natrecor's manufacturer, Scios Inc., a Johnson & Johnson subsidiary, company spokesman Mark Wolfe said Tuesday.
Read article at ABCNews.com

December 17, 2005

Journal criticises Vioxx study for omitting three heart attacks
The New England Journal of Medicine has issued an editorial "statement of concern" about the omission of data in a paper it published. It said that three heart attacks were omitted from a study comparing rofecoxib (Vioxx) with naproxen, under-stating the risks of rofecoxib.
Read article at BMJ (UK)

December 12, 2005

Vioxx court case ends in mistrial
A US judge has declared a mistrial in the first federal lawsuit against drugs giant Merck and its Vioxx painkiller. The move came after a jury in Houston was unable to agree on whether the drug had caused a man's fatal heart attack.
Read article at BBC News (UK)

December 10, 2005

Doctor Suggests Merck Trial May Have Led to Demotion
Less than a week after his videotaped lambasting of Merck was played in a Houston federal courthouse, Dr. Eric Topol, a prominent cardiologist, has lost his title as chief academic officer of the Cleveland Clinic's medical college.
Read article at New York Times (USA)

New funding to make UK "a world class environment for medical research"
The English government has announced a raft of initiatives to boost medical research in the NHS. The chancellor of the exchequer, Gordon Brown announced a series of measures which he said would make "the UK a world class environment for medical research, development and innovation, through a programme of investment and reforms that enable high quality and cost-effective medical advances to be discovered and developed quickly, cheaply, and reliably."
Read article at BMJ (UK)

November 24, 2005

Ruling May Hurt Merck in Federal Trial
U.S. District Judge Eldon Fallon ruled Nov. 16 that plaintiff lawyers in the trial starting Tuesday in Houston may present evidence that brief Vioxx use can trigger heart attacks and strokes, rejecting Merck's motion to throw out the case for insufficient evidence. The case involves a 53-year-old St. Augustine, Fla. seafood distribution manager, Richard Irvin, who had a fatal 2001 heart attack after just a month on the former blockbuster arthritis pill.
Read article at ABCNews.com

November 14, 2005

U.S. drug industry's credibility gap hurting
The image problems of the U.S. drug industry are beginning to hurt pharmaceutical companies where it matters most - at the bottom line. A year after Merck's withdrawal of its arthritis medicine Vioxx led to an industrywide credibility crisis, the U.S. Food and Drug Administration is blocking new medicines that might previously have passed muster. Doctors are writing fewer prescriptions for antidepressants and other drugs whose safety has been challenged, like hormone replacement therapies for women in menopause.
Read article at International Herald Tribune (USA)

November 05, 2005

Professors speak out against advertising directly to consumers
The drug industry's "onslaught of advertising to promote prescription drugs... does not promote public health" and "increases costs and unnecessary prescriptions," more than 200 US medical school professors said last week. In the United States the industry spends $4bn (£2.3bn; €3.3bn) a year on direct to consumer advertising.
Read article at BMJ (UK)

Merck Facing First Federal Vioxx Trial
With Merck & Co. now 1-and-1 in state lawsuits over its Vioxx painkiller, the nation's No. 5 drug maker may face higher stakes later this month in the first federal trial of charges that it knowingly rushed a potentially lethal drug to market to pocket billions in profits. The federal Vioxx trial is scheduled to begin Nov. 29 in Houston, just 40 miles north of the state court where Texas jurors last August slapped Merck with a $253 million verdict in the first Vioxx trial in the nation.
Read article at ABCNews.com

October 24, 2005

FDA Withdraws Approval for ADD Drug
The FDA has withdrawn approval for a drug used to treat attention deficit hyperactivity disorder because it has been associated with liver problems, including death, agency officials said Monday.
Read article at ABCNews.com

October 18, 2005

Dementia Drugs Can Increase Death Risks
Drugs often used to treat elderly patients with dementia-related aggression and delusions can raise their risk of death, according to a study that reinforces new warning labels required on the medications. The researchers pooled results of 15 previous studies on drugs known as atypical anti-psychotics and sold under the brand names Zyprexa, Risperdal, Seroquel and Abilify.
Read article at ABCNews.com

October 17, 2005

Merck Doc Testifies That Company Considered Adding Compound to Vioxx to Lower Heart-Attack Risk
Merck & Co. executives privately discussed adding an aspirin-like compound to Vioxx to lower the painkiller's chances of causing heart attacks, a company researcher said Monday during the fifth week of a product-liability trial over the now-withdrawn drug. The lawyer for a man who blames Vioxx for his heart attack continued to cross examine Merck researcher Dr. Alise Reicin about the company's actions after an internal study showed people using the drug had five times as many heart attacks as those using naproxen, an older, cheaper pain reliever.
Read article at ABCNews.com

AIDS Drug Maker to Pay $704M in Settlement
The Swiss manufacturer of the AIDS treatment drug Serostim agreed Monday to pay $704 million and plead guilty to scheming to boost sagging sales by, among other things, offering kickbacks to doctors to write prescriptions.
Read article at ABCNews.com

October 12, 2005

Germany's Schering stops testing of uterus drug
Germany's Schering will stop giving uterine fibroid drug asoprisnil to patients in an extension to a late-stage trial due to adverse effects, it said on Wednesday, sending its stock down nearly 5 percent. Schering had originally planned to file for regulatory approval in Europe this year, later amended to 2006, and launch the drug in 2007.
Read article at Reuters.com

October 11, 2005

Merck scientist says profits did not trump safety
A Merck & Co. Inc. scientist on Tuesday vehemently denied a Vietnam War veteran's claims the company put profits ahead of safety in marketing its popular pain killer Vioxx. "I chose a career in research to try to save human life," Alise Reicin, vice president of clinical research at Merck Research Laboratories, testified in the second Vioxx civil case to go to trial. "To suggest that I would put profit before human safety is really completely outrageous."
Read article at ABCNews.com

Merck scientist says profits did not trump safety
A Merck & Co. Inc. scientist on Tuesday vehemently denied a Vietnam War veteran's claims the company put profits ahead of safety in marketing its popular pain killer Vioxx. "I chose a career in research to try to save human life," Alise Reicin, vice president of clinical research at Merck Research Laboratories, testified in the second Vioxx civil case to go to trial. "To suggest that I would put profit before human safety is really completely outrageous."
Read article at ABCNews.com

Wyeth smallpox vaccine to carry heart warning
Wyeth's smallpox vaccine will come with a new "black-box warning" about cardiac problems that have occurred after immunization, the U.S. Food and Drug Administration said on Tuesday. A black-box warning is the strongest type of warning for prescription drugs and vaccines in the United States.
Read article at Reuters.com

October 10, 2005

Merck defense in second Vioxx case has rough start
Merck & Co. Inc. has only started presenting its defense in the second Vioxx trial, but one thing seems clear: The company's lawyers have gotten off to a shaky start. Already reeling from a big loss in the first Vioxx trial -- and harsh criticism of how its legal team handled that case -- Merck has a lot riding on the product liability trial under way in its home state of New Jersey. But experts say the drug company's lawyers may be struggling to regroup after New Jersey Superior Court Judge Carol Higbee on Friday threw out the testimony of Merck's first witness, research executive Briggs Morrison, prompting an unusual shouting match between the judge and a Merck lawyer.
Read article at ReutersHealth.com

October 8, 2005

Medicines regulation and the pharmaceutical industry
How does an agency funded by user fees make impartial decisions about the safety of new and licensed drugs? A critical look at drug regulation by the BMJ
Read article at BMJ.com

October 4, 2005

Bush Considers Military Role in Flu Fight
President Bush, increasingly concerned about a possible avian flu pandemic, revealed Tuesday that any part of the country where the virus breaks out could likely be quarantined and that he is considering using the military to enforce it.
Read article at ABCNews.com

Paxil May Increase Risk of Birth Defects
Paxil, an antidepressant drug, may increase the risk of birth defects for pregnant women taking it during the first trimester, the Food and Drug Administration warned last week.
Read article at LegalNewsWatch.com

September 28, 2005

Class Action Filed Against Pfizer Over Marketing of Lipitor
A nationwide class action lawsuit was filed today against Pfizer Inc., alleging the world's largest drug company devised a promotional scheme to boost sales of its anti-cholesterol drug Lipitor by misleading women and seniors about the link between the drug and heart disease.
Read article at LegalNewsWatch.com

Study Hints at Paxil Tie to Birth Defects
The Food and Drug Administration is warning that a study has suggested that the antidepressant Paxil may be associated with birth defects. Paxil's manufacturer, GlaxoSmithKline, said it will include the results of the study in the drug's list of precautions.
Read article at ABCNews.com

Merck Asks for Mistrial in Vioxx Case
Two weeks into its second product-liability trial over withdrawn painkiller Vioxx, Merck & Co. asked a judge to declare a mistrial, citing testimony from a plaintiff's witness the company said unfairly inflamed the jury.
Read article at ABCNews.com

September 27, 2005

Ex-Merck Scientist: Some Data Not Disclosed
Alzheimer's disease patients who took Vioxx in two studies had higher death rates than those on a placebo, but Merck & Co. never notified physicians or its sales representatives, its former chief scientist conceded in testimony played in court Tuesday.
Read article at ABCNews.com

September 23, 2005

Genentech Stops Enrolling Patients in Study
The maker of a promising ovarian cancer drug said Friday it stopped enrolling patients in a study because of gastrointestinal perforations.
Read article at ABCNews.com

September 22, 2005

Medical Statistics Expert Says Short-Term Use of Vioxx
Can Double Risk of Heart Attack and Death
Even short-term use of the painkiller Vioxx can double the risk of heart attack and death, a medical statistics expert testified Thursday in a product liability trial, a finding that manufacturer Merck & Co. misrepresented.
Read article at ABCNews.com

September 21, 2005

Former Merck Scientist Had Vioxx Concerns
A former chief scientist of Merck & Co. had concerns about the cardiovascular safety of painkiller Vioxx years before the company pulled it off the market, according to a videotaped deposition played in court Wednesday in a Vioxx product liability trial.
Read article at ABCNews.com

September 20, 2005

Merck Rebuked for Touting Vioxx Safety
Three years before it pulled Vioxx off the market, Merck & Co. publicly touted the safety of its arthritis drug in promotional campaigns and a news release, prompting a rebuke by federal regulators, according to documents shown to jurors Tuesday in a product liability trial over the drug.
Read article at ABCNews.com

September 9, 2005

FDA Lets Scientists With Drug Company Ties Evaluate New Insulin Product
The Food and Drug Administration (FDA) is under fire again today for allowing scientists with direct financial ties to a drug manufacturer to serve on an advisory committee charged with evaluating that company's product. At a meeting today of the Endocrinologic and Metabolic Drugs Advisory Committee that considered the safety and efficacy of Pfizer's proposed insulin inhaler, at least three of the committee's nine members had direct ties to Pfizer, the product's manufacturer, or its technological partner, Nektar Therapeutics. One other member-the acting chairman-holds stock in Pfizer.
Read article at CSPInet.org

September 2, 2005

Ministers order drug ad crackdown
Pharmaceutical industry advertising is to be policed following concerns raised by MPs, the UK government says. But ministers stopped short of a fundamental overhaul of the drugs regulator after April's Health Select Committee questioned its independence.
Read article at BBCNews.com

August 26, 2005

Merck to Mull Settling Some Vioxx Suits
Merck & Co. will consider settling a limited number of lawsuits over its withdrawn painkiller Vioxx, a spokesman said Friday. The drug's link to heart attacks and strokes has spawned thousands of lawsuits and last week's $253 million jury verdict in Texas.
Read article at ABCNews.com

August 20, 2005

Merck Faces More Challenges in Next Round
Drug-maker Merck & Co.'s blistering defeat in the nation's first Vioxx trial was only round one in a series of expected court battles in the coming months, many of them involving plaintiffs who have some major advantages.
Read article at ABCNews.com

August 19, 2005

Jury Awards Widow $253.4 M in Vioxx Trial
A Texas jury found pharmaceutical giant Merck & Co. liable Friday for the death of a man who took the once-popular painkiller Vioxx, awarding his widow $253.4 million in damages in the first of thousands of lawsuits pending across the country.
Read article at ABCNews.com

August 16, 2005

Study Links Painkillers, Blood Pressure
Women taking daily amounts of non-aspirin painkillers such as extra-strength Tylenol should monitor their blood pressure, doctors say following a new study suggesting a link between the drugs and hypertension. While many popular over-the-counter painkillers have been linked before to high blood pressure, acetaminophen, sold as Tylenol, has generally been considered relatively free of such risk.
Read article at ABCNews.com

August 13, 2005

Nazi Medicine and the Nuremberg Trials:
From Medical War Crimes to Informed Consent
Paul Weindling is a renowned expert on medicine in Nazi Germany. His new book is the third in "an informal trilogy on German medical atrocities." The preceding two were Health, Race and German Politics between National Unification and Nazism 1870-1945 (published in 1989) and Epidemics and Genocide in Eastern Europe (published in 2000).
Read article at BMJ.com

August 12, 2005

Research Scientist Gives $105 Million to N.Y.U.
A scientist who hid from the Nazis as a child, escaped a Communist regime, did pioneering medical research and made a fortune on a blockbuster drug will give $105 million to the New York University School of Medicine, his professional home for four decades, university officials said yesterday.
Read article at NYTimes.com

Lilly Subpoenaed for Documents Relating to Sales of Zyprexa
In June 2005, Eli Lilly and company received a subpoena from Florida attorney general’s office seeking documents on Medicaid-related sales of the company’s Zyprexa and its marketing and promotional practices with respect to the schizophrenia drug. The subpoena came from the Medicaid Fraud Control unit of the state attorney general’s office, the company said in regulatory filing on August 3, 2005.
Read article at LegalNewsWatch.com

New FDA Restrictions on Accutane, Acne Drug Known to Cause Birth Defects,
Include Registry
The thousands of Americans who take the acne drug Accutane and people who prescribe and dispense it must enroll in a national registry, part of a major government program to tighten access to the medicine that causes birth defects. The Food and Drug Administration enacted unprecedented curbs Friday in trying to keep Accutane and its generic competitors on the market while ensuring that women who use the risky pills don't get pregnant. Critics see it as the drug's last chance, after two decades of safety warnings and other restrictions failed to end Accutane-damaged pregnancies.
Read article at ABCNews.com

August 11, 2005

Cancer link with hormone therapy known since 1930s, say researchers
The cancer causing potential of the sex hormones used in hormone therapy has been known since the 1930s, say researchers and women's health advocates in the Journal of Epidemiology and Community Health. And questions about adverse effects on cardiovascular health have been raised since the 1970s, they add.
Read article at MedicalNewsToday.com

August 9, 2005

Today's Insider Trading Suspect May Wear a Lab Coat
The process of approving drugs, with the huge bets placed on their outcome, has always been a fertile ground for potential insider trading. A hint of success in a clinical trial can send shares of a biotechnology company surging. The Securities and Exchange Commission is now taking a closer look at whether doctors, participating in clinical trials with drug companies, are accepting money to talk to analysts and investors about the confidential results of a trial.
Read article at NYTimes.com

August 6, 2005

FDA's New Conservatism Draws More Fire
The US Food and Drug Administration is issuing twice as many advisories about potential risks posed by drugs and five times as many black-box warnings -- its highest alert -- as it did a year ago. And approval times for new drugs are nearly twice as slow, The New York Times reported Saturday.
Read article at DailyNewsCentral.com

August 3, 2005

FDA To Review Drug Companies' Marketing Tactics
FDA as early as Tuesday plans to announce a review of direct-to-consumer prescription drug advertisements, the Wall Street Journal reports. FDA and the pharmaceutical industry are facing pressure to alter advertising practices for drugs, with agency research showing that many physicians and consumers think drug ads exaggerate benefits and do not adequately disclose risks.
Read article at MedicalNewsToday.com

August 1, 2005

Pfizer's Celebrex arthritis drug to add warnings
Pfizer Inc. on Monday said the label of its Celebrex arthritis drug has been changed to add a prominent warning of possible cardiovascular risks, such as an increased chance of heart attacks, in line with new warnings on other arthritis and pain drugs. The label will also carry a new warning that Celebrex, like older painkillers, can cause serious ulcers and gastrointestinal bleeding.
Read article at Reuters.com

July 29, 2005

U.N. Cancer Agency Adds Hormone Pills to List of Substances That Can Cause Cancer
The U.N.'s cancer research agency added hormone pills Friday to the list of substances that can cause cancer. The International Agency for Research on Cancer said that based on consistent evidence from studies in recent years, it was reclassifying hormonal menopause therapy from "possibly carcinogenic" to "carcinogenic."
Read article at ABCNews.com

July 28, 2005

Science community must find way to investigate questionable research
The British Medical Journal is calling on the international scientific community to find a means of investigating previous studies by any researchers alleged to have submitted unsubstantiated work for publication.
Read article at MedBroadcast.com

July 26, 2005

Mars unveils chocolate drug
MARS, famous for chocolate bars, has unveiled plans to develop medicine that uses cocoa to help treat diabetes, strokes and vascular disease. The privately held US company that produces M&Ms and Mars bars said overnight it hoped to make medications based on flavanols - plant chemicals or antioxidants with health benefits found in cocoa, as well as red wine and green tea. Mars is now in talks with several large pharmaceutical companies in the US for a licensing or joint venture agreement to develop medicinal products based on its research.
Read article at News.com

July 21, 2005

In Training Video, Merck Said Vioxx Did Not Increase Risk of Heart Attack
Merck told its sales representatives that its painkiller Vioxx did not increase the risk of heart attacks, according to a Merck training video played on Wednesday for jurors in the first Vioxx lawsuit to reach trial. The video, which had never before been publicly shown, also depicts actors playing Merck representatives avoiding a question about Vioxx's potential to increase blood pressure -- a documented side effect.
Read article at NYTimes.com

July 18, 2005

Merck used 'dodge ball' on Vioxx questions-lawyer
Merck & Co. used a game called "dodge ball" to teach its sales force how to avoid questions about safety problems with Vioxx, a lawyer for plaintiffs suing the pharmaceutical giant told a jury on Monday.
Read article at Reuters.com

July 17, 2005

Ethics Problems Rock NIH
Forty-four government scientists who also worked as consultants for drug companies violated agency regulations designed to prevent conflicts of interest, a review by the National Institutes of Health shows.
Read article at DailyNewsCentral.com

July 16, 2005

Drug Companies Contracting With Doctors To Lead Information Sessions
The Wall Street Journal on Friday examined how drug manufacturers have "seized upon" doctors as an "effective tool for getting their message across" to other doctors. According to the Journal, "thousands" of physicians serve as part-time lecturers for drug companies, talking to other doctors at lunch or dinner meetings about diseases and the drugs with which to treat them.
Read article at MedicalNewsToday.com

July 15, 2005

U.S. Warns Fentanyl Patients About Drug
After 120 Deaths Among Users of Narcotic Patches
The government is investigating 120 deaths among users of patches that emit the painkiller fentanyl and warned patients Friday to be sure to use the powerful narcotic properly to avoid accidental overdose. The Food and Drug Administration is probing whether any of the deaths are related to inappropriate use of the painkiller or factors related to the product's quality.
Read article at ABCNews.com

July 13, 2005

FDA Asks Purdue Pharma to Withdraw Palladone for Safety Reasons
After acquiring new information that serious and potentially fatal adverse reactions can occur when Palladone (hydromorphone hydrochloride) extended release capsules are taken together with alcohol, the U.S. Food and Drug Administration has asked Purdue Pharma L.P., the makers of the drug, to withdraw it from the market.
Read article at FDA.gov

Cholesterol-reducing statins may cause serious muscle damage in some patients
Some patients with underlying health conditions could be at risk of serious side-effects from widely prescribed cholesterol-lowering drugs known as statins, Health Canada warned Tuesday. The medications, which include Lipitor (atorvastatin), Zocor (simvastatin), Mevacor (lovastatin), Lescol and Lescol XL (fluvastatin), Pravachol (pravastatin) and Crestor (rosuvastatin), put some patients with pre-existing medical conditions at greater risk of muscle-related problems.
Read article at MedBroadcast.com

Glaxo asthma drugs face safety review
Drugs giant GlaxoSmithKline has been put on notice that US regulators are to review the safety of its asthma drugs Serevent and Advair. The Food and Drug Administration will ask a panel to review the Glaxo drugs, and Novartis' Foradil, to see if more can be done to minimise potential side effects. The panel will review data on small numbers of severe asthma flare-ups with salmeterol - the active ingredient of the Glaxo drugs - and will vote on whether the drugs should continue to be sold.
Read article at ThisIsMoney.co.uk

Drug firms arming for battle at ballot box $43 million in past month alone
given to fight stringent prescription discounts
In the past month, drug companies from across the nation have raised more than $43 million to challenge a union-backed initiative on the Nov. 8 special election ballot that would cut prescription drug prices for a wide range of California residents.
Read article at SFGate.com

July 12, 2005

FDA says drug maker altered data on pills
Able Laboratories Inc., a maker of generic drugs that recalled all of its products in May, gave the government fabricated data so its drugs would appear to meet federal standards when they did not, according a Food and Drug Administration report.
Read article at Boston.com

Cancer Drugs Offer Hope, but at a Huge Expense
Ten thousand dollars once seemed a lot to pay for a few months' supply of a drug. No more. Avastin. Erbitux. Gleevec. Herceptin. Rituxan. Tarceva. These are among the first in a wave of new drugs giving hope to millions of cancer patients by treating the disease in new ways, like blocking the blood vessels that feed tumors. But they are all highly expensive, up to $100,000 for a course of treatment that lasts a few months.
Read article at NYTimes.com

EU court backs health supplements ban
A European court today backed controversial legislation that will outlaw the sale of thousands of vitamin and mineral supplements across the EU. The European court of justice decided to uphold the controversial food supplements directive, which will restrict the sale of natural remedies, vitamin supplements and mineral plant extracts.
Read article at Guardian.co.uk

July 11, 2005

Parkinson's drugs tied to compulsive behaviors
Dopamine agonist drugs, which are used to control movement problems caused by Parkinson's disease, may lead to pathological gambling and other compulsive behaviors, yet another study has shown. Discontinuing or reducing the dose of the drug appears to curb the compulsions.
Read article at Reuters.com

UN commission adopts safety guidelines for vitamin and food supplements
Labelling to stop consumers overdosing on vitamin and mineral food supplements and guidelines to minimize the emergence of potentially deadly drug-resistant microbes were among some 20 new and amended standards announced today by a United Nations commission that is the highest international body on food standards.
Read article at UN.org

July 10, 2005

Allegations of Fake Research Hit New Hight
Allegations of misconduct by U.S. researchers reached record highs last year as the Department of Health and Human Services received 274 complaints 50 percent higher than 2003 and the most since 1989 when the federal government established a program to deal with scientific misconduct.
Read article at ABCNews.com

July 9, 2005

FDA Orders Warning Labels on Viagra
The government on Friday ordered warnings onto the labels of Viagra and two other impotence drugs after some users developed a form of blindness while cautioning that it's impossible to know if the pills are to blame. The Food and Drug Administration's move comes as the agency is under intense pressure to investigate more aggressively and warn the public about drug side effects.
Read article at ABCNews.com

July 7, 2005

Drug Makers Top Lobbying Presence
The pharmaceutical industry's run of success on Capitol Hill has benefited from the more than $800 million spent since 1998 on lobbyists and political campaigns, a political watchdog group said Wednesday. The trade group representing drug makers said the money helped patients.
Read article at ABCNews.com

July 6, 2005

Senators Ask Drug Giant to Explain Grants to Doctors
The Senate Finance Committee yesterday began an inquiry into whether Johnson & Johnson used educational grants to promote the pediatric use of its former heartburn medication, Propulsid, even as internal company concerns mounted during the 1990's about the drug's safety in some children. The inquiry follows a June 10 article in The New York Times describing how, despite growing evidence linking the drug to heart problems and deaths, the company helped pay for a physician's book recommending Propulsid's use in children and gave grants to pediatric gastroenterology organizations that favored such use.
Read article at NYTimes.com

July 4, 2005

Merck Seeks Postponement in Vioxx Trial
Merck & Co. is asking a judge to delay the first wrongful death trial over its pain reliever Vioxx, saying it cannot receive a fair trial if the Texas case begins next week as scheduled. The company wants the trial postponed for at least 60 days, citing recent publicity about the drug.
Read article at ABCNews.com

July 3, 2005

Frist Asks for Moratorium On Prescription-Drug Ads
Senate Majority Leader Bill Frist today called on pharmaceutical companies to stop advertising drugs directly to consumers for the first two years they're on the market, but the industry is unlikely to make such a sweeping move. The drug industry is under increasing political pressure over direct-to-consumer ads because of the rising cost of medications and safety questions that arose last year over drugs that had been widely promoted in high-profile television ads.
Read article at WSJ.com (Subscribers only)

July 2, 2005

Drug Lobby Got a Victory in Trade Pact Vote
The sidewalk between the drug industry's headquarters in Washington and the United States trade representative's office has been taking a pounding from the wingtips of industry lobbyists. The work of these drug industry courtiers, who represent what is arguably Washington's biggest and wealthiest lobby, appears to have succeeded in the Central American Free Trade Agreement. The agreement would extend the monopolies of drug makers and, critics say, lead to higher drug prices for the mostly impoverished people of the six Latin American countries it covers.
Read article at NYTimes.com

Drug safety and regulation
In the past few months, medical journals have published numerous editorials and news items relating to drug safety and regulation. The withdrawal of rofecoxib (Vioxx) has been the single biggest issue, but the cardiovascular safety of other cyclo-oxygenase-2 (COX 2) inhibitors and possible suicidal tendencies associated with selective serotonin reuptake inhibitor (SSRI) antidepressants have also raised considerable concerns. These high profile cases have resulted in the regulatory bodies responsible for drug safety coming under fire.
Read article at BMJ.com

July 1, 2005

European Medicines Agency concludes action on COX-2 inhibitors
Concluding its review of the class of COX-2 inhibitors, the European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Bextra (valdecoxib) and recommended new contraindications and warnings for other COX-2 inhibitors that continue to be available in the European Union (EU).
Read article at MedicalNewsToday.com

June 30, 2005

Americans Endure 4 Million Drug Reactions a Year
Adverse reactions to medications forced an estimated 4.3 million Americans to see doctors in 2001, federal researchers report, in what they call the first national survey of its kind. That represents a significant increase from 2.7 million such visits in 1995, according to results of the review.
Read article at MedicineNet.com

Drug firm makes £12m settlement
The Department of Health has won £12 million compensation from a generic drug maker, marking a breakthrough in a long-running civil action against copycat drug suppliers. Generic UK, a subsidiary of Merck, the German pharmaceutical company, has agreed to pay the money in respect of generic drugs covering antibiotics and Zantac, the anti-ulcer pill. The company, which did not admit liability, said that it would co-operate with an ongoing investigation into alleged price-fixing arrangements. The Department of Health took civil action against Generics UK for alleged anti-competitive cartel conduct in connection with the supply of generic drugs to the NHS.
Read article at TimesOnline.co.uk

June 23, 2005

Pharmaceuticals in Waterways Raise Concern
Academics, state officials and environmental advocates are starting to question whether massive amounts of discarded pharmaceuticals, which are often flushed down the drain, pose a threat to the nation's aquatic life and possibly to people.In waterways from the Potomac to the Brazos River in Texas, researchers have found fish laden with estrogen and antidepressants, and many show evidence of major neurological or physiological changes.
Read article at WashingtonPost.com

June 15, 2005

Lilly Agrees to Pay $690M to Settle Zyprexa Class Action Lawsuits
Eli Lilly & Co. said it has agreed to pay $690 million to settle about 8,000 Zyprexa lawsuits pending in the United States, over its alleged failure to provide adequate warning that the drug could increase a patients' risk for developing diabetes.
Read article at LegalNewsWatch.com

Bristol-Myers to Pay $300 Mln to End Fraud Probe
Bristol-Myers Squibb Co. will pay $300 million to avoid prosecution for inflated sales, and two former company executives were indicted. The company, the fifth-biggest U.S. drug maker, settled a three-year probe by U.S. prosecutors in Newark, New Jersey, into selling excess inventory to wholesalers to meet sales goals, a practice called ``channel stuffing.'' Bristol-Myers, which gave wholesalers incentives to discourage returns of the products, was charged with conspiracy to commit securities fraud and won't be prosecuted if it makes required reforms in the next two years.
Read article at Bloomberg.com

EU says AstraZeneca profits exceeded fine
AstraZeneca Plc made far more in profits by illegally delaying the entry of generic rivals to ulcer drug Losec than the fine the European Commission set on Wednesday, a Commission spokesman said.
Read article at Reuters.com

June 14, 2005

FDA Backs Plan to Monitor Drug Safety Through Medicare Program
The Food and Drug Administration on Monday endorsed an idea that experts said could greatly improve the nation's drug safety system: using information from the forthcoming Medicare prescription benefit to spot problems with new medications. The "FDA strongly supports the use of data from Medicare … to identify safety risks for recently approved medications and to learn more about the real-world outcomes of medication use," Dr. Janet Woodcock, the FDA's acting deputy commissioner for operations, said in a statement.
Read article at LATimes.com

June 12, 2005

US regulator suppresses vital data on prescription drugs on sale in Britain
Vital data on prescription medicines found in millions of British homes has been suppressed by the powerful US drug regulators, even though the information could potentially save lives. An investigation by The Independent on Sunday shows that, under pressure from the pharmaceutical industry, the American Food and Drug Administration routinely conceals information it considers commercially sensitive, leaving medical specialists unable to assess the true risks.
Read article at Independent.co.uk

June 11, 2005

Drug firms driven by profit not safety
Recent scandals involving drug safety suggest companies are motivated more by profit than the welfare of patients. That subtle shift in motivation is undermining the basic notion of right and wrong. Moral ambivalence might well sum up the current situation.
Read article at IrishExaminer.com

June 10, 2005

2 Senators Studying Ties Between Drug Makers and Purchasers for Federal Programs
Two senators sent letters to 18 major drug makers Thursday asking for information about grants they have given in recent years to state officials and other organizations that may have influenced drug purchases by federal Medicaid and Medicare programs. Senators Charles E. Grassley, chairman of the Senate Finance Committee, and Max Baucus, the panel's ranking Democrat, said they wanted to ensure that the grants are used for allowable educational purposes - not for influence peddling.
Read article at NYTimes.com

Lucrative Drug, Danger Signals and the F.D.A.
Dozens had died and more than 100 patients had suffered serious heart problems by March 1998 after taking Propulsid, a popular medicine for heartburn. Infants, given the drug to treat acid reflux, seemed particularly at risk. Federal officials told Propulsid's manufacturer, Johnson & Johnson, that the drug might have to be banned for children, or even withdrawn altogether. Instead, the government and the company negotiated new warnings for the drug's label - though not nearly as tough as regulators had wanted.
Read article at NYTimes.com

June 9, 2005

Many scientists confess to sin of misconduct
Scientific misconduct may be far more extensive than the occasional high-profile cases of fabricated research or plagiarism, according to survey results published in today's issue of the journal Nature. The researchers found that 33 percent of the scientists surveyed admitted to engaging in at least one of 10 research misbehaviours in the previous three years. The results were even more striking for mid-career scientists, some 38 percent of whom acknowledged such misbehaviour.
Read article at BaltimoreSun.com

June 8, 2005

When doctors learn, drug firms often pay the tab
The 75 psychiatrists gathered at the Hilton Philadelphia City Avenue had hardly a clue that the professional courses they were taking had anything to do with pharmaceutical companies like GlaxoSmithKline, Cephalon or Wyeth. There were no free drug samples, no pharma reps schmoozing doctors in the halls, no invitations to free steak dinners. If any pharmaceutical company staff had shown up with their ID badges on, said event coordinator Harry Smeenk, "they'd be walked out." But while nearly invisible at the event, pharma companies were indeed big players: They paid for it.
Read article at Philly.com

Public 'misled' over heart drug
A government agency has admitted it misled the public over support to allow a heart drug to be sold by high street chemists without a prescription. The Medicines and Healthcare products Regulatory Agency said last year that two-thirds of those consulted were in favour of such a move. But after a criticism from consumer press Drug and Therapeutics Bulletin, it conceded the figures were wrong. Only a third agreed statins should be sold over-the-counter.
Read article at BBCNews.com

Drug Safety Panel Is Critized
The new drug safety board established by the Food and Drug Administration to restore confidence in the nation's drug supply will actually set back efforts to improve the safety of the medications Americans take and will not make it any easier to take dangerous drugs off the market, an FDA whistle-blower and a key senator said. FDA safety officer David Graham said that after reviewing the makeup and structure of the Drug Safety Oversight Board, he concluded that the panel is "severely biased in favor of industry" and that "the FDA cannot be trusted to protect the public or reform itself."
Read article at WashingtonPost.com

June 7, 2005

Cases, Fines Soar In Fraud Probes Of Drug Pricing
Months before a new law kicks in that will dramatically escalate government spending on drugs, state and federal prosecutors are investigating 150 cases that involve alleged pricing fraud by some of the world's largest drug makers and could produce more than $1 billion in criminal fines and civil penalties this year.
Read article at WSJ.com

June 3, 2005

Florida Appeals Court Rules Pharmacists Can Be Liable for Failing to Warn About Drug Risks
A Florida appeals court has ruled for the first time that pharmacists can be held liable for failing to warn about risks associated with use of drugs repeatedly or in harmful combinations, even if they are filling a doctor's prescriptions.
Read article at ABCNews.com

June 2, 2005

Commission outlines new strategy for pharmaceutical industry
EU Industry and Enterprise Commissioner Guenter Verheugen has outlined a strategy to improve the pharmaceutical industry's competitiveness within the EU. The strategy, based on three central features, includes financial incentives to support small to medium-sized enterprises (SMEs) and start-ups, which constitute a major component of the European biopharmaceutical sector.
Read article at EUBusiness.com

U.N. Official Says It's Not Realistic to Stop Spread of HIV/Aids by 2015 Target Date
The United Nations' top HIV/AIDS official acknowledged at a conference Thursday that it was no longer realistic to hope that the world will meet its goal of halting and reversing the spread of the pandemic by 2015. Peter Piot, head of the U.N. campaign to combat AIDS, told reporters that it was still "possible" to reach that goal and some countries would get control of the disease. But HIV/AIDS is spreading much faster than efforts to rein it in crucial regions including Eastern Europe and Central America, and stopping the spread isn't realistic, he said.
Read article at ABCNews.com

June 1, 2005

Doubt Is Their Product
Uncertainty is an inherent problem of science, but manufactured uncertainty is another matter entirely. Over the past three decades, industry groups have frequently become involved in the investigative process when their interests are threatened. If, for example, studies show that a company is exposing its workers to dangerous levels of a certain chemical, the business typically responds by hiring its own researchers to cast doubt on the studies. Or if a pharmaceutical firm faces questions about the safety of one of its drugs, its executives trumpet company-sponsored trials that show no significant health risks while ignoring or hiding other studies that are much less reassuring.
Read article at Sciam.com

Hiding the Data on Drug Trials
Any Americans gullible enough to believe that the drug industry can be trusted to report fully on what clinical trials it is sponsoring or what results were found must be sorely disappointed by recent developments. A government survey determined that three of the largest drug companies have effectively reneged on their pledges to list trials in a federal database.
Read article at NYTimes.com

Pharmaceutical Companies Submit Ghost written Articles, Medical Journal Editors Say
USA Today on Tuesday examined how some editors of medical journals say they have received submissions for publication that appear to have been ghostwritten by pharmaceutical companies intending to promote a particular product.
Read article at MedialNewsToday.com

May 31, 2005

Despite Vow, Drug Makers Still Withhold Clinical Information
When the drug industry came under fire last summer for failing to disclose poor results from studies of antidepressants, major drug makers promised to provide more information about their research on new medicines. But nearly a year later, crucial facts about many clinical trials remain hidden, scientists independent of the companies say.
Read article at NYTimes.com

The Big Pill Pitch
Pharmaceutical companies spent more than $4 billion in 2004 on direct-to-consumer advertising, a 23 percent increase over the previous year, according to IMS Health. Since 1997, when the Food and Drug Administration changed guidelines on prescription drug advertising, opening the door to television ads, the industry has been increasingly bypassing the physician and pitching more and more drugs directly to the public. Today, it's hard to make it through a prime-time TV show without seeing a drug commercial.
Read article at USNews.com

May 30, 2005

Ibuprofen use is associated with an increased risk of breast cancer
Ibuprofen use is associated with an increased risk of breast cancer, and long-term daily use of aspirin is associated with an increased risk of estrogen receptor/progesterone receptor (ER/PR)-negative breast cancer, according to a new study in the June 1 issue of the Journal of the National Cancer Institute.
Read article at News-Medical.net

May 28, 2005

Medical whistleblowers speak out
The US Food and Drug Administration (FDA) was "the single greatest obstacle to doing anything effective" about Vioxx, said FDA drug safety officer David Graham at an unprecedented roundtable of medical whistleblowers sponsored by the Public Library of Science (PLoS) and the Government Accountability Project.
Read article at ScienceBlog.com

May 25, 2005

Doctors selling medical records
Doctors are secretly selling confidential medical records to a marketing firm with links to the pharmaceutical industry. GPs are being paid in gift vouchers or as little as $150 to hand over drug records of their patients.
Read article at News.com.au

Drug Companies Influence Medical Research
Many U.S. medical schools are willing to give companies that sponsor studies of new drugs and treatments considerable control over the results, according to survey results that some doctors found troubling. Half of the schools said they would let pharmaceutical companies and makers of medical devices draft articles that appear in medical journals, and a quarter would allow them to supply the actual results.
Read article at ABCNews.com

May 24, 2005

Will cholesterol lowering drugs be OTC?
Industry experts believe the popular cholesterol-lowering statins will be the next class of drugs to go over the counter [in the United States] according to a study by Cutting Edge Information.
Read article at Mydna.com

Crestor Side Effects Deemed Worse
New research seems to challenge a Food and Drug Administration decision not to pull the cholesterol-lowering drug Crestor off the market, with data showing it causes more kidney and muscle problems than rival medications.
Read article at ABCNews.com

May 23, 2005

Tens of Thousands of Cases Seen Over Vioxx
A federal judge told dozens of lawyers crowded into a courtroom here Monday that there could ultimately be up to 100,000 cases filed against Merck & Co. over its now withdrawn pain reliever Vioxx, and that he could hear a case as early as the fall.
Read article at ABCNews.com

Drug Firms Don't Disclose Enough
The editor-in-chief of the New England Journal of Medicine accused three of the largest drug companies of "making a mockery" of efforts to create transparency in clinical trials, saying that could lead some important medical publications to avoid publishing their studies. Dr. Jeffrey M. Drazen, the editor, said that Pfizer Inc., GlaxoSmithKline PLC and Merck & Co. are not providing enough useful information on clinical trials they register with the government.
Read article at ABCNews.com

Drugs firms in the dock over trial reliability
Pharmaceutical firms were accused recently of rigging clinical trials before publishing them in medical journals. Last week Richard Smith, former editor of the British Medical Journal, told The Scotsman that despite the process of peer review, companies are able to publish the results they want by asking the 'right' kind of questions.
Read article at Scotsman.com

May 19, 2005

Preserving the Global AIDS Fund
The world has two big programs that fight AIDS in poor countries. One, created by President Bush, will spend more than a billion dollars in 15 hard-hit nations this year. It is a very important lifesaving initiative, but it could do even more. The pharmaceutical industry has kept it from buying cheap generic versions of AIDS medicines. And the religious right has pushed it toward abstinence-only programs and away from the people most likely to become infected: prostitutes, gays and intravenous-drug users. Fortunately, there is also the Global Fund to Fight AIDS, Tuberculosis and Malaria, which has been free to do the work America shuns. But its ability to continue to do so is at risk.
Read article at NYTimes.com

May 17, 2005

GSK Promotes Trizivir in Naive Patients, Despite Negative Findings, Says AHF
In reaction to an announcement today by GlaxoSmithKline (GSK) that the FDA has granted traditional approval for the company's fixed-dose AIDS drug Trizivir, AIDS Healthcare Foundation (AHF), the largest AIDS organization in the US which operates free AIDS treatment clinics in the US, Africa, Central America and Asia, decried GSK's continued promotion of its all-in-one AIDS treatment despite the drug's demonstrated failure in a 2003 NIH trial.
Read article at Investors.com

Medical journals 'too close to firms'
Medical journals are an extension of the marketing arms of drug firms, says an ex-British Medical Journal editor. Dr Richard Smith, who edited the BMJ for 13 years, criticised the journals' reliance on drug company advertising.
Read article at BBCNews.com

Breast Cancer Study Halted After Deaths
A study in which women with breast cancer were given two chemotherapy drugs simultaneously was cut short after the combination contributed to the deaths of two patients and caused life-threatening complications in an alarming number of others.
Read article at ABCNews.com

May 13, 2005

New law aims to distance the FDA from the drug industry
Legislation aimed at ending the close relationship between the US Food and Drug Administration and the drug industry was introduced last week in the House of Representatives by Congressman Maurice Hinchey (Democrat) of New York. The Food and Drug Administration Improvement Act 2005 has been endorsed by the Center for Science in the Public Interest in Washington, DC, a non-profit education and advocacy organisation. Merrill Goozner, director of the centre's integrity in science project, said it was "exactly what is needed to restore public confidence in the FDA."
Read article at BMJ.com

May 11, 2005

Prescription Drugs Linked to Sudden Heart Attacks
Certain gastric, anti-psychotic and antibiotic drugs increase people's risk of dying from a sudden heart attack, Dutch researchers said. The study by the Erasmus Medical Center in Rotterdam concluded the drugs interfere with the heart's electrical activity and cause an estimated 15,000 sudden cardiac deaths a year in Europe and the United States.
Read article at Health.DailyNewsCentral.com

Common drugs linked to sudden deaths
A range of common drugs prescribed for ailments from sore throats to indigestion may increase people's risk of dying from a sudden heart attack, researchers have warned. The study in Netherlands concluded the drugs interfere with the heart's electrical activity controlling heartbeat and they were associated with a three-fold increased risk of sudden death due to cardiac arrest.
Read article at Xinhuanet.com

May 10, 2005

Drug industry admits it has been its own worst enemy
The new head of the drug industry's main lobbying arm yesterday admitted that its recent image problems have been self-inflicted. ''Look, we've made some mistakes. We're not perfect. But we do an amazing job," said Billy Tauzin, president of Pharmaceutical Research and Manufacturers of America.
Read article at Boston.com

FDA Releases Details for Proposed Prescription Drug Watch Web Site
FDA officials on Friday issued guidelines for its Drug Watch Web site -- expected to be launched later this year -- that will contain safety information on drugs currently under review. FDA said the Web site "is intended to identify drugs for which FDA is actively evaluating early safety signals."
Read article at MedicalNewsToday.com

First Vioxx Trial Likely to Start July 11
The first wrongful death trial over Merck & Co.'s now withdrawn pain reliever Vioxx is likely to be scheduled for July 11 in Texas, officials in the case said. Plaintiff lawyer Mark Lanier filed a request on Tuesday with the district court of Brazoria County, Texas, asking that his case begin the week of July 11. He said he chose the timing based on instructions from the court and expected the request to be granted. A senior court officer who requested anonymity also said the trial would most likely have a July 11 start date.
Read article at ABCNews.com

Drug makers working on U.S. advertising guidelines
Drug makers are developing voluntary guidelines aimed at improving television and other advertisements as part an effort to rebuild public trust, the industry's top lobbyist said on Monday. Companies have been criticized for creating television commercials and magazine ads that glorify a drug's benefits while minimizing the risks of side effects.
Read article at Reuters.com

May 9, 2005

Marketing a Disease, and Also a Drug to Treat It
Neurodex - is it a drug in search of a disease?
Read article at NYTimes.com

May 8, 2005

Monitoring Program Finds Serious, Unreported Adverse Drug Reactions
A monitoring program developed by a Northwestern University researcher has successfully identified a large number of previously unknown, serious and often-fatal drug reactions associated with 15 commonly used drugs, including Plavix®, thalidomide and drug-coated cardiac stents.
Read article at ScienceDaily.com

Drug sales calls wear on doctors
By the time Dr. Jeffrey Kopin finally closed his office doors to visits from drug industry sales representatives last fall, he was getting up to five visits a week from multiple salespeople working for the same company, encouraging him to prescribe the same drug.
Read article at ChicagoTribune.com

Under New Medicare Prescription Drug Plan, Food Stamps May Be Reduced
Elderly people with low incomes may lose some of their food stamps if they sign up for the new Medicare prescription drug benefit, the Bush administration said Saturday. When Medicare begins covering drugs in January, older Americans will spend less of their own money on drugs and will therefore have more to spend on food, reducing their need for food stamps, officials said.
Read article at NYTimes.com

Drug Makers Reap Benefits of Tax Break
A new tax break for corporations is allowing the biggest American drug makers to return as much as $75 billion in profits from international havens to the United States while paying a fraction of the normal tax rate.
Read article at NYTimes.com

May 6, 2005

Documents Show Vioxx Sales Tactics
What Merck & Co. calls good salesmanship emphasizing the positive in selling the painkiller Vioxx a Democratic congressman says is disinformation designed to deflect safety concerns. The public got an extraordinary glimpse Thursday into the world of drug marketing, as lawmakers released confidential Merck documents that detail how a sales army of 3,000 aggressively pushed the multibillion-dollar drug before it was pulled from the market last fall because of heart attack risks.
Read article at ABCNews.com

A Serious Drug Problem
There was a brief flurry of outrage when Congress passed the 2003 Medicare bill. The news media reported on the scandalous vote in the House of Representatives: Republican leaders violated parliamentary procedure, twisted arms and perhaps engaged in bribery to persuade skeptical lawmakers to change their votes in a session literally held in the dead of night. Later, the media reported on another scandal: it turned out that the administration had deceived Congress about the bill's likely cost. But the real scandal is what's in the legislation. It's an object lesson in how special interests hold America's health care system hostage.
Read article at NYTimes.com

May 5, 2005

Merck's marketing of Vioxx called misleading
Drugmaker Merck misled doctors for years about the safety of its blockbuster painkiller, Vioxx, Rep. Henry Waxman said Thursday at a congressional hearing on the drug maker's sales tactics. "Health risks were viewed as 'obstacles' the sales force was instructed to surmount," said Waxman.
Read article at USAToday.com

'Miracle heart pill would work'
A 'miracle pill' that combines different heart drugs would save thousands of lives, research suggests. A Nottingham University study of over 13,000 patients found a pill bringing together three drugs extended life in people with a history of heart disease.
Read article at BBCNews.com

Merck Announces Resignation of Chief and Names Replacement
Merck & Co. said Thursday that Raymond V. Gilmartin is stepping down effective immediately from the top leadership spots at the drugmaker which has been under pressure since recalling its blockbuster painkiller Vioxx last fall. Merck named Richard T. Clark as chief executive officer, president and a director in Gilmartin's place. Gilmartin is also stepping down as chairman although no successor was named.
Read article at NYTimes.com

Foster Kids Used to Test AIDS Drugs
To gain access to hundreds of HIV-infected foster children, federally funded researchers promised in writing to provide an independent advocate to safeguard the kids' well-being as they tested potent AIDS drugs. But most of the time, that special protection never materialized, an Associated Press review has found. The research funded by the National Institutes of Health spanned the country. It was most widespread in the 1990s as foster care agencies sought treatments for their HIV-infected children that weren't yet available in the marketplace.
Read article at ABCNews.Go.com

May 4, 2005

Legislation Would Bar Industry-Connected Scientists From Reviewing Drugs
Scientists with financial ties to drug makers or other medical companies would be prohibited from serving on federal advisory committees charged with reviewing the safety of drugs, if reform legislation offered by Representative Maurice Hinchey (D-NY) becomes law.
Read article at CSpinet.org

May 3, 2005

Pharma's Ghosts
A Georgetown University doctor is alleging that an education firm working with drug giant AstraZeneca tried to ghost write an article in a medical journal. Adriane Fugh-Berman, an associate professor of alternative medicine at Georgetown, charges that she was approached by a medical education firm, Mold, United Kingdom-based Rx Communications, to write an article on the potential of medicinal herbs and dietary supplements to interact with a commonly used blood thinner, Coumadin. "They sent me a completed manuscript with my name on it," Fugh-Berman says, "and I hadn't actually agreed to write anything."
Read article at Forbes.com

May 1, 2005

Hard Sell - How Marketing Drives the Pharmaceutical Industry
Rick Crone was the rock in his family. The Marine veteran -- and father of two -- handled much of the care of his disabled wife, Nicolette, for the more than two decades they were together. But in 2001, Rick's spirits plummeted, an ominous change Nicolette said she first noticed after he started taking a new prescription for back pain. His upbeat personality faded over the next months, and late one night in April 2002 as his family slept, the 49-year-old father walked into the garage and hanged himself.
Read article at SFGate.com

April 30, 2005

Drug companies only perpetuate pharmaceutical myths
Drug companies want us to believe that soaring prices for prescription drugs are necessary to cover their research and development (R&D) costs -- a claim that implies that they spend most of their money on R&D, and that after they pay for it, they have only modest profits left over. Curtailing prices, they say, would choke off R&D and stifle innovation. But the real story is very different. Big drug companies actually spend relatively little on R&D -- far less than they spend on marketing and administration, and even less than what they have left over in profits. In 2002, for example, the top 10 US drug companies had sales of US$217 billion. According to their own figures, they spent 14 percent of sales revenues on R&D. But they spent over twice as much, a whopping 31 percent, on marketing and administration. And they had 17 percent left over as profits.
Read article at Taipeitimes.com

Drug company is censured for offering perks to prescribing nurses
The drug company AstraZeneca has been censured by the UK drug industry’s watchdog for offering nurses excessive hospitality at educational meetings located in luxury hotels. The watchdog, the Prescription Medicines Code of Practice Authority, ruled that one of the meetings had breached clause 2 of the code of practice, which says that methods of promotion must never bring discredit on or reduce confidence in the pharmaceutical industry. The meeting, which AstraZeneca cancelled after a complaint from a local GP, was due to be held at the Cameron House Hotel in Loch Lomond. Nurses who were due to attend the meeting were scheduled to have three hours of talks on asthma during a stay of nearly 24 hours at the hotel, which included dinner, bed and breakfast, and lunch.
Read article at BMJ.com

April 29, 2005

HRT alternative linked to cancer
An alternative steroid treatment to conventional HRT may increase the risk of womb cancer, say UK researchers. The Cancer Research study of more than a million women found those on tibolone were more likely to get endometrial cancer than those on combined HRT.
Read article at News.BBC.co.uk

Data for evaluating drugs is often poor, say experts
Evidence based medicine is moving from relatively simple questions about a drug’s safety and effectiveness to thornier questions of relative clinical effectiveness and cost effectiveness, international experts agreed at a meeting last week. The experts, from the United States, Canada, the United Kingdom, and Germany, had assembled to discuss these issues with congressional and policy staff in Washington, DC. "While there is a lot of data out there, unfortunately it is often very poor," said Dr Peter Littlejohns, director of the UK’s National Institute for Health and Clinical Excellence. This leads to an evaluation that is based more on cost than on effectiveness, within a framework of ethical values, he said.
Read article at BMJ.com

April 27, 2005

Doctors Influenced By Mention Of Drug Ads
Actors pretending to be patients with symptoms of stress and fatigue were five times as likely to walk out of doctors' offices with a prescription when they mentioned seeing an ad for the heavily promoted antidepressant Paxil, according an unusual study being published today. The study employed an elaborate ruse -- sending actors with fake symptoms into 152 doctors' offices to see whether they would get prescriptions. Most who did not report symptoms of depression were not given medications, but when they asked for Paxil, 55 percent were given prescriptions, and 50 percent received diagnoses of depression.
Read article at WashingtonPost.com

April 26, 2005

Letting the Dogs Out
The U.S. drug industry spent $4.1 billion hawking pharmaceuticals to consumers last year, a 28% jump from 2003. In the next decade, U.S. taxpayers will shell out at least $800 billion to buy them under the new Medicare drug benefit. With so much at stake, who are the federal watchdogs standing guard for consumers? Unfortunately, they are more Chihuahua than Rottweiler.
Read article at LATimes.com

April 25, 2005

Drugmakers go furthest to sway Congress
When Sen. Bill Frist needed help in November for a quick tour celebrating the victories of newly elected Republican senators, he didn't have to look far. A Gulfstream corporate jet owned by drugmaker Schering-Plough was ready to zip the Senate majority leader to stops in Florida, Georgia and the Carolinas.
Read article at USAToday.com

Baxter, other drug firms hit with AIDS-related lawsuit
Baxter International Inc. and other drug companies sold blood-clotting medicine for hemophiliacs that carried a high risk of transmitting AIDS to markets in Europe more than a year after switching to newer, safer products in the United States, according to a lawsuit filed here Friday.
Read article at SunTimes.com

J&J Adds Mortality Risk to Heart Drug Label
Johnson & Johnson has revised the label of its Natrecor heart failure medicine to include data that suggest it may increase the risk of death, following two widely publicized medical journal articles that questioned its safety.
Read article at Reuters.com

April 24, 2005

Newly disclosed e-mails add Vioxx wrinkle
In 2000, amid rising concerns that its painkiller Vioxx posed heart risks, Merck overruled one of its own scientists after he suggested that a patient in a clinical trial had probably died of a heart attack. In an e-mail exchange about Vioxx, the company's most important new drug at the time, a senior Merck scientist repeatedly encouraged the researcher to change his views about the death "so that we don't raise concerns." In subsequent reports to the Food and Drug Administration and in a paper published in 2003, Merck designated the cause of death as "unknown" for the patient, a 73-year-old woman.
Read article at ChicagoTribune.com

April 23, 2005

Serono Sets Aside Big Sum as U.S. Inquiries Continue
The setting aside of $725 million by Serono, Europe's biggest biotechnology company, to settle investigations involving its AIDS drug Serostim seems to suggest that the company is preparing to pay one of the largest settlements ever in a government pharmaceutical inquiry. But the lack of specifics from Serono executives left financial analysts bewildered yesterday. The company had previously disclosed that it had complied with government subpoenas for information about the marketing and pricing of Serostim, which prevents a wasting syndrome frequently seen in AIDS patients. Serono had played down the significance of the subpoenas, saying that they were similar to requests received by other drug companies.
Read article at NYTimes.com

Probe looks at Foster Kids in Drug Trials
A city agency that put more than 400 HIV-positive foster children into clinical trials for AIDS drugs has asked for an independent review of the program after children's rights advocates said it amounted to exploitation. John Mattingly, commissioner of the Administration for Children's Services, said the inquiry would investigate whether the agency had the necessary permission from parents or guardians to include the children in the research from the late 1980s to 2001.
Read article at ABCNews.Go.com

April 22, 2005

Lawyers Donated to Vioxx Judge's Campaign
The judge handling the first scheduled wrongful death trial over the pain reliever Vioxx received $60,000 in campaign contributions last year from political action committees funded by the law firm that filed the suit.
Read article at LATimes.com

Merck under investigation over Vioxx
British health regulators are investigating the American drugs company Merck to find out whether it correctly reported side-effects from the arthritis painkilling drug Vioxx to the authorities. The drug was withdrawn from the market by Merck last September due to data that showed it caused heart attacks and strokes in some patients. The regulator, the Medicines and Healthcare products Regulatory Agency, would not comment on the investigation.
Read article at Guardian.co.uk

New arrangements for the Medicines and Healthcare products Regulatory Agency
Major changes are occurring at the Medicines and Healthcare products Regulatory Agency (MHRA) and these hold promise for real advance. The events of the last weeks and months give important insights into the changes now underway. On 5 April the House of Commons health select committee in its report on the influence of the pharmaceutical industry found that the agency was complacent, lacking the competence to act as a licensing authority. It recommended that the agency be subject to an independent review. On 7 April, government laid before parliament the Medicines (Advisory Bodies) Regulations, presaging the abolition of the agency's two key advisory bodies—the Medicines Commission and the Committee on the Safety of Medicines—both essentially unchanged since the early 1970s. On 13 April the national press carried advertisements inviting senior professionals and representatives of patients and consumers to fill posts in the new system.
Read article at BMJ.com

April 21, 2005

Not in my name
Recently, the House of Commons health select committee looked at the submission of ghost-written articles to medical journals. Witnesses from two pharmaceutical groups, GlaxoSmithKline and AstraZeneca, "strongly denied that ghost-writing was practised in their respective companies". But such work can be hired out. Last summer, I was asked by RxComms, a British medical communication company, to author a review of interactions between herbs and warfarin (a generic anticoagulant prescribed to prevent strokes or blood clots). Well, not "author", exactly. The usual practice is for a complete article to be supplied; all I would have to do was review it and sign it off.
Read article at Guardian.co.uk

April 20, 2005

Drug companies pile on perks for doctors
Dr. Arnold Kassanoff says the best gift he ever got from a drug company was a trip to Monaco for him and his wife in 1982. "We were told in advance that there would be, you know, everything was covered except gambling,” says Kassanoff. “All your meals. No tipping allowed. Nothing. And just enjoy yourself.” What did he think they wanted from him in exchange for the trip?
Read article at MSNBC.MSN.com

Novartis warns of skin issues with epilepsy drug
Novartis AG’s epilepsy drug Trileptal has a new warning about life-threatening skin reactions reported by patients who took the medicine, the company and the Food and Drug Administration said.  “Such serious skin reactions may be life-threatening, and some patients have required hospitalization with very rare reports of fatal outcome,” Novartis said in a letter to physicians that was posted on the FDA Web site.
Read article at MSNBC.MSN.com

April 19, 2005

Rheumatoid Arthritis Drugs May Up Lymphoma Risk
Taking "TNF blockers," such as Remicade and Enbrel, to treat rheumatoid arthritis does not increase the overall cancer risk, but the drugs may heighten the risk of lymphoma, according to a new report. Still, because only a few patients in the study developed lymphoma, further research is needed to confirm these findings. Previous reports have linked rheumatoid arthritis with an elevated risk of lymphoma, a cancer of the body's lymph node system.
Read article at Reuters.com

Study Questions Heart Failure Drug
A genetically engineered drug that was hailed as a breakthrough in the treatment of heart failure when it was approved in 2001 might actually raise patients' risk of dying soon after treatment, researchers say. Pooling results from three studies, the researchers found that hospitalized patients given nesiritide appeared much more likely to die in the first month after treatment than those given traditional medication such as nitroglycerin or dummy pills. The intravenous drug has been given to more than 600,000 patients nationwide.
Read article at ABCNews.Go.com

Drug Firms' Influence Over Doctors Criticised
The influence of the pharmaceutical industry has led to inappropriate prescribing by doctors, it has been claimed. In addition, steps must be taken to restore appropriate boundaries between the pharmaceutical industry and the medical profession, according to Dr Amy Brodkey, associate professor of psychiatry at the University of Pennsylvania School of Medicine. Prof Brodkey told a joint meeting of the Irish College of Psychiatrists and the Scottish, Welsh and Northern Ireland Divisions of the Royal College of Psychiatrists that the influence of pharmaceutical companies led to "demonstrable harms, including less effective, wasteful and sometimes harmful prescribing practices".
Read articles at RedNova.com

April 18, 2005

McKillop bemoans state of 'Big Pharma'
It is a rare event when a top executive strongly attacks his own industry, but Sir Tom McKillop has done just that. McKillop, chief executive of AstraZeneca, Europe's third-largest drug manufacturer, said recently that pharmaceutical companies have a poor reputation around the world. He also said Big Pharma, as the industry is known, faces uncertain prospects because of low profit margins and regulatory pressures.
Read article at TheHerald.co.uk

Seeking a cure for legal headaches
The world’s leading drug makers face a growing threat from generic-drug manufacturers, a faltering pipeline of future blockbuster medications and a poor public image. Several court cases are highlighting their battles to stay healthy in the long term.
Read article at Economist.com

National Cancer Institute Halts Drug Trial
The National Cancer Institute said on Monday it halted a trial it was sponsoring of AstraZeneca PLC cancer drug Iressa because the medicine was not increasing patients' survival. The interim results of the NCI study mirror findings of another trial disclosed in December which also found Iressa did not improve survival rates of lung cancer patients. The NCI was testing Iressa in lung cancer patients who had completed chemotherapy to see if the drug would prolong their lives. But in a statement, the NCI said interim analysis failed to show improved survival rates.
Read article at ABCNews.Go.com

April 16, 2005

Americans Buy More Medicine Than Others;
Experts Say Trend Threatens U.S. Health, Wealth

About 130 million Americans swallow, inject, inhale, infuse, spray, and pat on prescribed medication every month, the U.S. Centers for Disease Control and Prevention indicates. Americans buy much more medicine per person than any other country. The number of prescriptions has swelled by two-thirds over the past decade to 3.5 billion yearly, according to IMS Health, a pharmaceutical consulting company. Americans devour even more nonprescription drugs, polling suggests.
Read article at ABCNews.Go.com

April 15, 2005

FDA Warns Pfizer, Bayer on Drug Ads
U.S. regulators said on Friday they have issued warnings about misleading advertisements for Pfizer Inc.'s allergy drug Zyrtec and Bayer AG's impotence pill Levitra. The Food and Drug Administration sent letters to both companies telling them to immediately stop using the promotional materials.
Read article at WashingtonPost.com

Say no to the free lunch
Are you a pig or a weasel? Or do you consider yourself above all that? When the BMJ published a special issue on the links between doctors and drug companies in 2003, the cover showed pigs in white coats lunching and golfing with weasel drug reps. At the time this seemed strong stuff even to those involved in editing the issue. But little has happened since to suggest that the image was wrong. In fact, every day new revelations suggest that the reality is worse.

Read article at BMJ.com
The influence of big pharma
Read article at BMJ.com
Drugs for Alzheimer's disease and related dementias

Read article at BMJ.com
News in brief
Read article at BMJ.com

New rules drive off NIH researchers
Read article at BMJ.com
Confessions of a drug rep
Read article at BMJ.com

April 14, 2005

Ex-Drug Company Execs Accused in Kickbacks
Four former executives of drug maker Serono Laboratories were charged Thursday with offering doctors kickbacks for writing prescriptions for an AIDS treatment drug with sagging sales. A federal indictment accuses two former vice presidents with getting two regional sales directors to use illegal methods to persuade doctors to write more prescriptions for the drug Serostim.
Read article at ABCNews.Go.com

Drugmakers Likely To Step Up Analysis Of Side Effects
With the recent discovery that some long-available drugs have potentially serious side effects, pharmaceutical company IT managers foresee a growing emphasis on monitoring and analyzing drug-usage data in an effort to spot problems earlier. Stepped-up efforts to collect and analyze information about commercially available drugs were a common topic of discussion at this week's SAS Users Group International conference in Philadelphia. SAS Institute Inc. sells analysis software used by a number of major pharmaceutical companies in the drug-development process.
Read article at InformationWeek.com

GlaxoSmithKline investors bring Paxil lawsuit
GlaxoSmithKline (GSK) is facing a class action lawsuit in the US from investors who allege it concealed problems with its anti-depressant drug Paxil. They allege the firm violated securities laws by issuing "false or misleading public statements". It comes after studies found Paxil could increase the risk of suicidal behaviour in adolescents. GSK, which is also facing patient lawsuits over Paxil, said the allegations were "without merit".
Read article at BBCNews.com

April 13, 2005

The Drug Approval Pendulum
Most of the time, when we use the word "fashion," we are talking about hemlines, or footwear, or shades of nail polish. But there are also intellectual fashions, literary fashions, political fashions. In fact, almost any sphere of human activity is subject to abrupt shifts in conventional wisdom: Even the arcane world of pharmaceutical regulation is afflicted by highly emotional mood swings.
Read article at WashingtonPost.com

Tough Warning Labels, Weak Results
The FDA can require tough language on drugs, but that's no guarantee patients or even doctors are getting the message. Because of the public nature of the controversy surrounding the Cox 2 drugs, many patients and doctors are likely to be aware of the tough language on the drug's label. But in too many cases, the warnings get overlooked, or even ignored, by physicians and the public. "The FDA puts a lot of stock into what they allow in the labeling," says Dr. Barry Massie, chief of cardiology at the San Francisco Veterans Affairs Medical Center. "But [a lot of] that [information] in fact it doesn't get to the physician."
Read article at BusinessWeek.com

April 12, 2005

Activists Attack Ethics of Pfizer AIDS Drug Trial
A clinical study into an experimental AIDS pill made by Pfizer Inc, the world's biggest drugmaker, should be halted because it offers patients no safety net, activists said Tuesday. The European AIDS Treatment Group (EATG) said the design of the trial for Pfizer's so-called CCR5 inhibitor drug maraviroc, previously known as UK-427,857, was putting people with HIV at unnecessary risk of developing full-blown AIDS.
Read article at Reuters.com

Drug companies 'stay silent about fakes to protect profits'
Pharmaceutical companies in Britain are covering up the discovery of fake versions of their products and contributing to thousands of deaths across the world, an investigation into counterfeit drugs has found. Fake versions of antibiotics, antimalarials and lifestyle drugs such as slimming and sex aids are flooding the market in some countries but manufacturers of the genuine medicines are reluctant to publicise the problem for fear of harming sales of their branded products, doctors say.
Read article at News.Independent.co.uk

April 11, 2005

New England Journal of Medicine Perspective Pieces Examine OTC Status for Statins,
the Future of Speciality Hospitals

"Statins and Over-the-Counter Availability," New England Journal of Medicine: It is "relatively easy to see why an FDA advisory committee ... recently recommended against" granting statins over-the-counter status because the medications "fail to meet many of the ... criteria for a switch to over-the-counter status," Brian Strom, a professor of biostatistics and epidemiology at the University of Pennsylvania School of Medicine, writes in a perspective piece.
Read article at MedicalNewsToday.com

April 9, 2005

House Dems want to repeal Michigan law that protects drug makers
State House Democrats want to allow residents hurt by a prescription medication to be able to sue drug makers for damages, something severely limited in Michigan. Democrats are expected to announce Monday a three-bill package of legislation that would repeal the state's 1996 law that shields drug makers from liability if their product was approved by the Food and Drug Administration. The legislation is retroactive, which would allow residents harmed by an FDA-approved drug since the old law took effect to file a lawsuit.
Read article at Freep.com

April 8, 2005

Pfizer faces a barrage of lawsuits
Pfizer today finds itself the focus of a growing, multifront legal threat similar to the one faced by Merck, the manufacturer of Vioxx. A series of securities lawsuits accuse Pfizer executives of damaging investors by making false and misleading statements about the safety of Celebrex and Bextra. Several consumer lawsuits and product liability cases charge that the company deceived consumers who bought Bextra and caused serious health injuries to patients who took the drug.
Read article at USAToday.com

Drug company rebuked
A pharmaceutical company was yesterday found to have undermined an urgent safety restriction on its antidepressant drug and misquoted official guidance on the treatment of depression so as to favour its product. Wyeth has been forced to withdraw an information pack about the drug Effexor, which is now only allowed to be prescribed by specialists in mental health since it has been associated with more deaths and other side effects than others in its class.
Read article at Netdoctor.co.uk

Plant-based dietary supplements - Scientists to study
Wake Forest University School of Medicine has received a $7,500,000 grant from the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Dietary Supplements (ODS) to open a research center to study dietary supplements. The school of medicine, part of Wake Forest University Baptist Medical Center, is one of five centers nationwide selected for funding. Research conducted by the funded centers will explore the safety, effectiveness, and mechanisms of botanicals, which are plant-based dietary supplements.
Read article at MedicalNewsToday.com

EU to fund research in medicine
The European Union is aiming to help finance research into medicines for treating diseases like Alzheimer's, cancer and diabetes as part of its bid to convince drug makers to stop moving such work to the United States.
Read article at IHT.com

April 7, 2005

Merck looks to FDA talks over Vioxx
An FDA decision Thursday to allow Celebrex to remain on the market despite a suspected link to cardiac problems fanned some investors' hopes that Merck & Co.'s Vioxx might also soon return to the market, albeit with prescribing restrictions. In a statement released by the Food and Drug Administration earlier in the day, the agency said it will "carefully review any proposal from Merck for resumption of marketing of Vioxx." The statement marked the first time since a February hearing on the issue that the agency has mentioned the possibility of Vioxx coming back on the marketplace.
Read article at MarketWatch.com

Pfizer Takes Painkiller Bextra Off Market
A common family of drugs used to treat rheumatoid arthritis have been linked with skin problems. Up to a quarter of people taking anti-TNF drugs get skin infections, rashes or eczema, a Dutch study in Arthritis Research and Therapy reveals.
Read article at ABCNews.com

April 5, 2005

MPs slam slack pharmaceutical regulation
Regulation of the pharmaceutical industry is inadequate, leaving powerful drug companies free to promote "a pill for every ill", an influential parliamentary committee has said. Recent scandals, notably the worldwide withdrawal of arthritis drug Vioxx, highlighted significant failings in the system, according to the Health Select Committee on Tuesday. "Like any industry, drug companies need effective discipline and regulation, and these have been lacking," said committee chairman David Hinchliffe.
Read article at Reuters.co.uk

April 4, 2005

UK at heart of the great statin experiment, warns Drug and Therapeutics Bulletin
The reclassification of the cholesterol-lowering drug simvastatin as the over-the counter product Zocor Heart-Pro for preventing heart attacks, was not based on robust evidence of clinical benefit, warns Drug and Therapeutics Bulletin (DTB).  DTB has also uncovered evidence that the medicines regulator (the Medicines and Healthcare products Regulatory Agency - MHRA) inaccurately reported the consultation which preceded the reclassification.
Read article at MedicalNewsToday.com

April 3, 2005

Arthritis drug linked to infections
A common family of drugs used to treat rheumatoid arthritis have been linked with skin problems. Up to a quarter of people taking anti-TNF drugs get skin infections, rashes or eczema, a Dutch study in Arthritis Research and Therapy reveals.
Read article at BBCNews.com

Drugs firms 'creating ills for every pill'
The power of Britain's multi-billion-pound drugs industry has turned this country into an over-medicalised society that believes in a pill for every ill, a Commons inquiry will claim this week. The report will say that the billions of pounds poured into researching and promoting new drugs have fuelled an over-emphasis on medicinal cures at the expense of cheaper and better therapies, or simple prevention.
Read article at Observer.Guardian.co.uk

Some Vioxx Patients Denied Right to Sue
Dr. David Cox is a stay-at-home dad, but not by choice. Cox is recovering from a stroke — a condition he blames on Vioxx. "They found a blood clot in one of my arteries of my brain and I subsequently suffered a stroke to my brain stem," said Cox, who now must shade his eyes with dark glasses. "The light sensitivity causes intense migraines."
Read article at FoxNews.com

March 31, 2005

M.S. Drug Tied to a Death
Biogen Idec and the Elan Corporation said that a third patient had developed a fatal nervous system disorder linked to the multiple sclerosis drug Tysabri, which the companies stopped selling last month. The patient, who died in 2003, had Crohn's disease and took Tysabri in a clinical trial, said Amy Brockelman, a spokeswoman for Biogen
Read article at NYTimes.com

March 30, 2005

Drug access boost for poor plan
Plans to increase access to essential medicines for the world's poorest countries have been unveiled by the UK Government. New guidelines on how to tackle the problem have been approved by the British pharmaceutical industry.
Read article at BBCNews.com

March 29, 2005

Cancer Drug Costs Skyrocket, Not Benefits
In the two weeks since Genentech's expensive new drug Avastin was found to help the sickest lung cancer patients live a few months longer than expected, investors have pumped nearly $17 billion into the company. But what's good for the patients, the company and its investors is also heavily stressing the ailing U.S. health care system, raising uncomfortable questions about the cost of end-of-life care.
Read article at ABCNews.com

March 28, 2005

Miracle Malpractice
Medical technologies are a main driver for escalating drug costs, helping put health coverage out of reach for millions of Americans. In a new book, Hope or Hype: The Obsession with Medical Advances and the High Cost of False Promises, two medical professionals explore disturbing practices and trends that lure consumers into thinking that "new" drugs and technologies are equivalent to or better than old ones.
Read article at Alternet.org

March 27, 2005

FDA Issues Guidelines for Pharmaceutical Companies
for Warnings, Restrictions on Use of Prescription Drugs

FDA on Thursday issued new guidelines detailing "when and how drug makers should go beyond label warnings and incorporate other restrictions on the use of a drug.”
Read article at MedicalNewsToday.com

March 25, 2005

Brazil's Bold Move
Bolstering its reputation as a world leader in price wars over AIDS medications, Brazil is threatening to break antiretroviral drug patents unless drug companies allow it to manufacture generic versions of four major AIDS drugs.
Read article at Alternet.org

March 24, 2005

FDA: A lot more drugs on the way
The Food and Drug Administration sped up its drug review process last year, approving a record number of generic drugs and doubling its approval rate for name-brand prescription drugs, as the FDA tries to repair its reputation from the Vioxx crisis.
Read article at Money.CNN.com

Lesser-Than-Evil Patent Law Pleases Drug Firms
Boxed in by pressures from its communist allies on one side and the ultra-nationalist opposition on the other, the ruling Congress party-led United Progressive Alliance has managed to pass a patent law in the Indian parliament that broadly conforms to World Trade Organisation rules while protecting national interests.
Read article at IPSNews.net

Production Problems Turn Into Money Problems at GlaxoSmithKline
GlaxoSmithKline's factory troubles are turning into a big financial problem. Three weeks after government regulators seized undelivered supplies of GlaxoSmithKline's popular antidepressant Paxil CR and ordered its manufacturing line to be shut, the company remains uncertain about when it can fix its production problems and resume shipments. At least one analyst predicts that the drug, which had been forecast to have sales of more than $800 million, will not return to the market this year.
Read article at NYTimes.com

March 23, 2005

Patents Bill drives a wedge between health, pharma segments
Has India played into the hands of companies who see the country as no more than a market of 50-odd million "paying public"? Or with the passing of the Patents (Amendment) Bill in both Houses of Parliament, has the country truly taken its initials steps in a long international journey?
Read article at TheHinduBusinessline.com

March 22, 2005

U.S. health care 'system' driven by embedded vested interests
Medical sociologists examine how American social, cultural, and political-economic contexts govern the structure, efficiency, and operational nature of U.S. health care delivery in a special issue of the Journal of Health and Social Behavior (JHSB), a scholarly publication of the American Sociological Association (ASA).
Read article at MedicalNewsToday.com

Death by Regulation
Consumers are being defrauded out of their health and money by a regulatory system that is a proven failure.
Read article at Lef.org

March 21, 2005

Study Raises Concerns About J&J Drug
A study and an editorial published in Circulation, the medical journal of the American Heart Association, raise concerns about whether Natrecor, an intravenous heart failure drug sold by Johnson & Johnson, is safe for the kidneys.
Read article at Forbes.com

Health Advocates Call for Reform of FDA Advisory Committees
Stop placing scientists with direct financial conflicts of interest" on Food and Drug Administration advisory committees, health advocates wrote in a letter to Acting FDA Commissioner Lester Crawford. In the letter dated March 10, 2005, the groups said the agency failed to comply with the Federal Advisory Committee Act (FACA) when it assigned scientists with ties to manufacturers of arthritis pain drugs known as Cox-2 inhibitors, including Vioxx and Celebrex, to serve on a panel charged with evaluating those drugs.
Read article at LegalNewsWatch.com

March 18, 2005

Biogen puts warning on an MS drug for liver risk
Biogen Idec's multiple sclerosis drug Avonex might cause severe liver damage in rare cases, according to the company and the Food and Drug Administration. The warning, which came on Wednesday, was another blow, though probably only a glancing one, to Biogen, already reeling from the halt in sales of its other multiple sclerosis drug, Tysabri, which was linked to a rare brain infection.
Read article at IHT.com

March 17, 2005

Panellists Tied to Study They're Probing
Six of the nine scientists serving on an expert medical panel investigating a U.S.-funded AIDS study are receiving grant money from the agency at the center of the probe, according to documents and interviews. The Institute of Medicine said it was aware of the financial ties but approved the members' participation because they have special expertise, receive only a minority of their overall dollars from the National Institutes of Health and won their grants competitively. The six panel members are receiving from $120,000 to nearly $2 million a year from the NIH, according to agency records and interviews by The Associated Press.
Read article at RedNova.com

Bush FDA Choice Rattles Advocacy Groups
President Bush's nominee to oversee the Food and Drug Administration rejected claims by Senate Democrats Thursday that the agency has failed to adequately monitor prescription drug safety, but promised to create an independent board to help the agency track drugs once they're approved. "I don't think we've been tarnished," said Lester Crawford, who has been acting or deputy FDA commissioner for the past three years. "... (But) I promise to you to do everything in my power to stem the tide and do the right thing."
Read article at SFGate.com

March 16, 2005

Drug giant forced to end trials
Drugs giant GlaxoSmithKline have been ordered to suspend trials of an MS and Crohn's disease drug over its links to another withdrawn treatment. It is in the same class of drugs as the MS medication Tysabri, withdrawn after two patients developed brain infections last month.
Read article at BBCNews.com

Drug companies intensify cancer treatment push
The war on cancer has some fortified soldiers. Some of the nation's biggest drug companies are investing an increasing amount of resources toward finding treatments for the disease. Cancer research has been a hallmark of companies such as Bristol-Myers Squibb Co. and AstraZeneca PLC. But over the last few years, others including Wyeth, Schering-Plough Corp., GlaxoSmithKline PLC and most notably Merck & Co. have been intensifying their work on cancer medicines. They've purchased smaller, cancer-focused drug makers; formed licensing arrangements; added staff and created specialized research centers.
Read article at RedNova.com

March 15, 2005

Brazil Takes Step Toward Breaking AIDS Patents
Brazil has moved a step closer to breaking AIDS drugs patents by asking U.S. companies for the right to copy four products so the country can slash health costs, the government said on Tuesday. Brazil requested Merck & Co. Inc., Abbot Laboratories Inc. and Gilead Sciences Inc. to grant "voluntary licensing" of drug technology so it can keep its much-copied AIDS program afloat, the health ministry said.
Read article at Reuters.com

Putting Profits Ahead Of Patients
It must be cold comfort for the nation's leukaemia patients that the transformation of Novartis--the European drug maker that recently announced its $8.4 billion acquisition of two generic drug companies--did not occur in the early 1990s.
Read article at Forbes.com

Drug makers to profit from Bush scheme to label kids mentally ill
Citing recommendations by the New Freedom Commission on Mental Health (NFC), George W. Bush wants to launch a nationwide mental illness screening program in government institutions, including the public school system, for all students from kindergarten up to the 12th grade. The New Freedom Commission was established by an executive order Bush issued on April 29, 2002.
Read article at OnlineJournal.com

March 14, 2005

Post-market surveillance of drugs inadequate, study suggests
A study of drugs withdrawn from the Canadian market over the last four decades uncovers some worrisome facts - and some surprising gaps in regulatory information, a commentary published Tuesday in the Canadian Medical Association Journal suggests. Health Canada doesn't keep a list of drugs removed from the market for safety reasons, nor is there clear information on what should trigger a safety withdrawal, said author Dr. Joel Lexchin, a long-term critic of the pharmaceutical industry.
Read article at MedBroadcast.com

FDA Refuses to Ban AstraZeneca Cholesterol Drug
The prevalence of neural tube defects in Europe has not declined substantially in the past decade, despite national policies of folic acid supplementation in half the countries, finds a study in this week's BMJ.
Read article at Yahoo.com

March 11, 2005

EU Chief Calls for Closer Focus on Drug Safety
Europe must do more to ensure the safety of medicines following recent product scandals, European Commission Vice President Guenter Verheugen said on Friday. He told a meeting of the European Medicines Agency (EMEA) that new monitoring mechanisms -- some of which will be introduced this year -- were needed to track adverse side effects of medicines after launch.
Read article at Reuters.com

Merck in arbitration with insurers
Merck is in arbitration with some of its insurers over whether they will be required to cover legal settlements stemming from the company's recalled drug Vioxx.
Read article at Marketwatch.com

March 10, 2005

Eczema drugs linked to cancer risk, says FDA
Two eczema creams — Novartis AG’s Elidel and Fujisawa Healthcare, Inc.’s Protopic, must carry a strong warning of cancer risk, the Food and Drug Administration said Thursday.
Read article MSN.com

Film exposes pharmaceutical secrets
Hailed as a blockbuster drug, Vivexx is an antidepressant that its maker claims is so effective it will make standard bearer Prozac seem like "penny candy." There's one hitch: Vivexx has been linked to liver problems that can cause death. But its manufacturer believes that pesky detail can be circumvented by stifling doctors who know about the problem and forbidding its sales representatives to raise the issue with physicians. Sounds like real life, right?
Read article at Boston.com

Consumer Drug Ads Facing Their Moment of Truth
The landscape of prescription drug advertising to consumers will definitely change in the wake of recent government hearings on the popular painkillers Celebrex, Vioxx and Bextra. Exactly what the new panorama will look like is still unclear, but both industry and government officials predict consumers will be more educated and less entertained in the future.
Read article at Yahoo.com

U.S. Group: AstraZeneca Drug Risk Higher Than Others
The rate of serious muscle damage reported in patients who took AstraZeneca Plc's cholesterol drug Crestor was six times higher than with similar medicines, a consumer group said on Thursday. The findings by consumer group Public Citizen contradicted a statement by the U.S. Food and Drug Administration last week that the risks of muscle injury from Crestor were similar to those of related drugs.
Read article at Reuters.com

Senator Says FDA Needs Independent Safety Office
The Food and Drug Administration needs an independent drug safety office with the power to order pharmaceutical companies to add warning labels to dangerous medicines, a top U.S. Senate Republican said on Thursday. Senate Finance Committee Chairman Charles Grassley said he was preparing legislation to establish such an office in response to controversies surrounding Merck & Co. Inc's withdrawn arthritis pill Vioxx and other drugs.
Read article at Reuters.com

March 9, 2005

Glaxo says U.S. Justice Dept probes drug pricing
GlaxoSmithKline Plc Europe's biggest drugmaker, said the U.S. Department of Justice was investigating whether certain of its pricing policies violated Medicaid rules. The company, which disclosed the probe in a filing with the Securities and Exchange Commission late on Tuesday, said it was cooperating in the investigation by government attorneys.
Read article at Reuters.com

March 7, 2005

Safety Vs. Efficacy
Last week, investors in biotech Biogen Idec got a taste of the biggest risk in the pharmaceutical business: unexpected side effects. After one death due to an apparent side effect, Biogen and partner Elan pulled their multiple sclerosis drug Tysabri, which had been approved with rapid speed by the Food and Drug Administration only four months before. It was the most recent of several drug safety dilemmas.
Read article at Forbes.com

Pfizer Stirs Concern With Plans to Sell Heart Drugs Only as Pair
A drug that could be one of the most promising new heart treatments in a decade is generating controversy even before it is approved, because its maker, Pfizer, plans to sell it only in combination with the company's best-selling cholesterol treatment, Lipitor. At a cardiology conference in Orlando, today, researchers sponsored by Pfizer are expected to present positive new results about the drug, which has been shown in preliminary studies to substantially raise levels of what is known as good cholesterol, a novel approach to preventing heart disease.
Read article at NYTimes.com

March 5, 2005

F.D.A. Panel Weighs Fate of a Drug for Cancer?
A federal advisory panel began wrestling yesterday with whether to remove from the market a lung cancer drug that was rapidly approved for use by desperate patients but has now failed to prolong lives in a large clinical trial. The advisory panel to the Food and Drug Administration was not asked to vote on the fate of the drug, Iressa, which is made by AstraZeneca. Agency officials said they would await more data before making any decision.
Read article at NYTims.com

March 4, 2005

Pfizer launches freezer pops for cough relief
The taste of liquid remedies or the sight of pills often send children burrowing beneath their covers and can be messy or difficult for children to take. Children's PediaCare Medicated Freezer Pops, however, provide parents with an easy new way to give their children cough relief, lasting up to eight hours.
Read article at Pharmaceutical-Business-Review.com

Experts and the Drug Industry
When a government advisory panel concluded that the painkillers Celebrex, Bextra and Vioxx could all be safely marketed despite evidence of cardiac risks, the decisive votes were cast by experts who had financial ties to the drugs' manufacturers. That disturbing fact was revealed last week in a Times article, based on data compiled by the Center for Science in the Public Interest, an advocacy group.
Read article at NYTimes.com

Boy's Cancer Prompts FDA to Halt Gene Therapy
The Food and Drug Administration has suspended several U.S. gene therapy experiments after learning that a third child who underwent treatment in France has developed cancer as a result, a development that has cast a pall over the struggling research field.  Adding to the gloom, researchers are due to report today that a monkey has died of cancer caused by a gene therapy experiment six years ago. That suggests the treatments may carry long-term as well as near-term risks, said scientists who will be discussing the issue at an FDA meeting.
Read article at WashingtonPost.com

March 3, 2005

Crestor May Pose Risk of Muscle Damage
The popular new cholesterol-lowering drug Crestor may cause an increased risk of potentially life-threatening muscle damage, especially in people of Asian ancestry, the Food and Drug Administration said yesterday. In a formal advisory, the agency said the risk is small and was largely identified and understood when the drug was approved in 2003. But because of new post-market studies that underscored the concerns, the agency concluded that the public should be informed and that warnings on the product label should be strengthened.
Read article at WashingtonPost.com

Senate bill takes away power from states and shields drug companies
from accountability for vaccine injuries

They are at it again. Those determined federalists and lobbyists for big Pharma, who view informed consent advocates and vaccine victims as an impediment to exercising more control over and making more money off of America's forced vaccination system. This time, they are using the public's memory of September 11, 2001 to push a Senate bill (S.3) deceptively entitled "Protecting America in the War on Terror Act of 2005."
Read article at RedFlagsWeekly.com

March 2, 2005

Tamoxifen Raises Endometrial Cancer Risk
Doctors often prescribe the drug tamoxifen to breast cancer patients over the long term, to help reduce the chances of cancer recurrence. But a new study confirms tamoxifen can also boost the risk of endometrial cancer in both pre-menopausal and postmenopausal women, with that risk increasing the longer a woman takes the drug.
Read article at RedNova.com

Securities Lawsuit Filed Against AstraZeneca Over Exanta
A class action lawsuit was filed on behalf of all persons who purchased American Depository Receipts ("ADRS") of AstraZeneca, PLC between April 2, 2003 and October 11, 2004. The lawsuit alleges that the drug maker AstraZeneca and certain of its officers and directors issued materially false statements concerning the results of clinical trials of the Company's investigational oral anticoagulant Exanta, and the status and likelihood of the approval of the New Drug Application for Exanta.
Read article at LegalNewsWatch.com

F.D.A. Official Admits 'Lapses' on Vioxx
After the Food and Drug Administration insisted for months that it did nothing wrong in its oversight of the withdrawn pain pill Vioxx, a top agency official acknowledged "lapses" in the agency's actions before a Senate panel onTuesday. Dr. Kweder said the agency took too long to get information about Vioxx's heart risks into the prescribing label that is provided to physicians. More than a year passed between an advisory panel's conclusion that those risks should be highlighted and the label changes, she said.
Read article at NYTimes.com

March 1, 2005

AIDS Drugs Might Combat Bird Flu - Reuters
The anti-HIV drugs known as protease inhibitors may be effective against the bird flu virus, according to an Italian researcher.
Read article at Reuters.com

FDA Seeks Drug-Warning-Label Authority
The Food and Drug Administration asked Congress on Tuesday for authority to dictate label changes for drugs to end the type of haggling with pharmaceutical companies that delayed warnings to Vioxx users about potential heart problems.
Read article at InteliHealth.com

February 28, 2005

FDA drug approval times likely to grow
The withdrawal of a multiple sclerosis treatment is likely to lead to even longer product approval times for pharmaceutical companies as pressure mounts on the Food and Drug Administration to improve drug safety, experts say. The news Monday that one patient died and another developed a serious disease while taking the MS treatment Tysabri, made by Biogen Idec Inc. and its Irish partner Elan Corp., is the latest in a series of negative revelations about drugs' safety and effectiveness.
Read article at SeattlePI.NWSource.com

February 27, 2005

Hard sell: how marketing drives the pharmaceutical industry
The painkillers Vioxx, Celebrex and Bextra may go down in history as a classic example of the danger posed by aggressive industry promotion of prescription drugs to both patients and doctors.
Read article at SFGate.com

February 26, 2005

Senator Questions FDA Panellists' Ties to Industry
An advisory panel's recommendation that the Food and Drug Administration allow two painkillers to stay on the market despite cardiac risks was marred by its members' ties to drug makers, a senior lawmaker said Friday. But two doctors who served on the panel suggested another explanation for close votes on the painkillers Bextra and Vioxx: a difference of perspective between physicians on the committee.
Read article at LATimes.com

FDA's safety reform is greeted with scepticism
The US consumer watchdog group Public Citizen has described the creation of a new safety body at the Food and Drug Administration as a "desperate" and "cynical" attempt to respond to public alarm about the harms of prescription drugs.
Read article at BMJ.com

February 25, 2005

U.S. health spending is expected to double in decade
The Bush administration has predicted that government will account for nearly half of all U.S. health care spending by 2014. Further, the administration said on Wednesday, total health spending will double in a decade, to $3.6 trillion in 2014 from $1.8 trillion last year, while gross domestic product, the total output of goods and services, will grow more slowly.
Read article at IHT.com

FDA panellists with ties to industry vital in getting Cox-2 drugs back on market
Ten members of the U.S. Food and Drug Administration advisory panel who voted that a group of powerful pain killers should continue to be sold had ties to the drugs makers, a new analysis shows. Their votes were crucial in keeping two of the three drugs in question on the market. A study by the Center for Science in the Public Interest indicates that 10 of the 32 panel members had ties to either Pfizer Inc., or Merck & Co., ranging from consulting fees and speaking honoraria to receiving research support from the companies.
Read article at MedBroadcast.com

Influenza Vaccination Programmes For Children
in USA and Canada Based on Little Evidence

Children in the USA and Canada are being vaccinated against influenza without adequate proof that it will work, concludes a study published in this week's issue of The Lancet. Most immunisation campaigns target people aged 65 years or older. The USA and Canada have recently started vaccinating children, including those aged 6 to 24 months, in the hope of reducing disease spread, admissions and visits to hospitals, deaths of elderly relatives, complications (such as ear infections and pneumonia), absences from school, and parental loss of workdays and over-prescribing of antibiotics. However, there is no evidence that vaccinating children can achieve these goals.
Read article at MedicalNewsToday.com

Poll Shows Americans Value Drugs, But Say Drug Makers Put Profits First
Americans believe prescription drugs are improving their lives, but most also say that the drug industry cares more about profits than people, according to the latest Kaiser Health Poll Report issued by Kaiser.
Read article at KFF.org

February 24, 2005

Heart Attack Risk with HIV Drugs a Concern
The risk of having a heart attack for HIV-positive people increases the longer they're on anti-HIV drug therapy, according to the latest results of a large multi-center study. However, the overall absolute risk of a heart attack is still "modest," Dr. Jens Lundgren of the University of Copenhagen told an audience at the 12th Annual Retroviral Conference on Wednesday.
Read article at Reuters.com

February 22, 2005

Pharmaceutical and biotechnology industry in the new EU countries
presents considerable potential

In contrast to subdued growth in the pharmaceutical markets of the former 15-state European Union (EU), pharmaceutical markets in the 'new' EU accession markets are expanding vibrantly. While the former has been increasing at eight per cent annually, the latter has been growing at the rate of 16.5 per cent over the past five years, offering exciting growth opportunities to pharmaceutical and biotechnology companies.
Read article at News-Medical.net

Clampdown on misleading drug ads
Companies who use misleading advertising to promote drugs and other medical products will be "named and shamed" the (UK drug) regulator has announced. The Medicines and Healthcare products Regulatory Agency (MHRA) plans to clampdown on poor advertising. It will target inflated claims about a product's effectiveness, and the use of confusing information. As well as pursuing legal action where appropriate, the MHRA will publish advert reviews on its website.
Read article at BBCNews.com

February 21, 2005

Novartis to become world's biggest generic drugs maker
The Swiss drugs firm Novartis today agreed to buy German firm Hexal and most of US company Eon Labs in deals worth €5.6bn (£3.8bn). The acquisitions will make it the world's largest generic drugs manufacturer. Novartis will gain a leading position in the major markets for generic drugs, which are chemically identical to more expensive branded rivals, in Germany and the US. It is buying 100% of Hexal and 67.7% of Eon Labs from the Struengmann family, of Germany.
Read article at Guardian.co.uk

FDA Policy Adviser Says More Agency Collaboration With Pharmaceutical Industry
Would Help Restore Confidence in Medication Safety

Amit Sachdev, deputy commissioner for policy at FDA, on Wednesday said that increased collaboration with the pharmaceutical industry would help restore public confidence in the agency's prescription drug approval process and the safety of medications on the market.
Read article at MedicalNewsToday.com

February 20, 2005

FDA Safety Official Testifies COX-2 Inhibitors
Have Cardiovascular Risks Similar to Smoking

COX-2 inhibitors increase risk for cardiovascular events at about the same rate as cigarette smoking, hypertension and diabetes, FDA Office of Drug Safety Officer David Graham told an agency advisory committee on Thursday.
Read article at MedicalNewsToday.com

February 19, 2005

AIDS Case in N.Y. May Not Be a Harbinger of Supervirus
The virulent and highly drug-resistant case of AIDS recently found in a New York City man is similar in some ways to two Canadian cases that appeared in 2001 and did not lead to the spread of a "supervirus," as some fear may happen in New York.
Read article at WashingtonPost.com

A Reminder That No Drug Is Risk-Free
When a federal panel of doctors and scientists recommended allowing the sale of arthritis medicines from Pfizer and Merck despite acknowledging their heart risks, it did more than just give new life for Celebrex, Bextra and possibly Vioxx - three drugs some analysts had viewed as doomed. The panel's recommendations backed the pharmaceutical industry's stance that no medicine is risk-free and that patients should sometimes be allowed to choose medicines that have serious risks even for conditions that are not life-threatening.
Read article at NYTimes.com

Activists sue Merck and Pfizer
Healthcare activists in Massachusetts sued Merck & Co. Inc. and Pfizer Inc. in separate lawsuits over marketing campaigns for their arthritis pain medications, alleging the companies misled consumers by advertising benefits of the drugs while not disclosing the full range of risks and shortcomings.
Read article at Boston.com

FDA panel supports return of Vioxx drug
A Food and Drug Administration advisory panel yesterday recommended that Merck & Co. could resume selling the painkiller Vioxx, but must include stringent warnings of the heart problems it can cause and restrictions on its use. The panel also decided that, like Vioxx, the drugs Celebrex and Bextra pose cardiovascular risks but offer enough benefits that they should remain available -- with warnings and limits similar to those for Vioxx.
Read article at Boston.com

February 18, 2005

Bush Signs Landmark Bill On Class-Action Lawsuits
President Bush on Friday signed a bill that he says will curtail class-action lawsuits against companies and "marks a critical step toward ending the lawsuit culture in our country." The legislation aims to discourage multimillion-dollar class-action lawsuits by having federal judges take them away from state courts, a victory for conservatives who hope it will lead to other lawsuit limits. The president has described class-action suits as often frivolous, and businesses complain that state judges and juries have been too generous to plaintiffs.
Read article at WSJ.com (Subscription needed)

Alzheimer's Drug Fears
A drug prescribed to treat dementia in elderly patients actually accelerates their mental decline, a shocking new study of Alzheimer's sufferers in the North of England claims today. More than eight million people have used Seroquel since 1997 and it is given to about 45pc of dementia patients in care homes to control agitation.
Read article at RedNova.com

European warning on Cox-2 painkillers as fears grow
European watchdogs issued a warning yesterday about the use of Cox-2 type painkillers amid growing concerns about their health risks. The European Medicines Agency said doctors should be cautious about giving the drugs to patients with risk factors for heart disease, and should not prescribe them to people who have heart disease or have had strokes. It also advised that the lowest dose and shortest course should in any case be prescribed.
Read article at Netdoctor.co.uk

SSRIs and suicide: evidence supports the association
People taking selective serotonin reuptake inhibitors (SSRIs) are more likely to attempt suicide than people taking placebo or a non-SSRI drug.
Read article at BMJ.com

America approves bill to limit class action lawsuits
Landmark legislation aimed at curbing class action lawsuits against big business in America overcame Democratic opposition yesterday to win approval in Washington. The measure transfers most class action suits from state to federal courts. The US house of representatives approved the bill by 279 votes to 149. It now needs only the president's signature.
Read article at Guardian.co.uk

February 17, 2005

Merck May Consider Selling Vioxx Again
Merck will consider selling its arthritis pill Vioxx again if the U.S. Food and Drug Administration decides the cardiovascular risks are similar to those of related prescription pain relievers, a company official said on Thursday. New information on competing pain drugs presented to a U.S. advisory committee over two days at a public hearing has changed the company's evaluation of Vioxx, Merck Research Labs President Peter Kim told an FDA advisory panel.
Read article at Boston.com

Hormone therapy controversy raises drug safety issues
"The hormone therapy debate is one more example of a larger issue: are the medications that doctors prescribe safe, and do the benefits outweigh any risks?" said Michelle Naughton, Ph.D., lead author of an article in the current issue of Journal of Social Issues.
Read article at MedicalNewsToday.com

February 16, 2005

Party may be over for Big Pharma
Reynold Panettieri Jr. is sitting pretty, flush with drug-company money for his research on asthma at the University of Pennsylvania. Edward Garvey, on the other hand, is miffed, having lost his pharmaceutical marketing job in New Jersey because of corporate cost cutting. These are the clashing realities of the global pharmaceutical business today, with the Philadelphia region one of its hubs. Companies are gambling ever bigger sums of money on blockbuster products, with painful consequences when they falter.
Read article at Philly.com

Merck Says Heart Risk Not Limited To Vioxx
Researchers at Merck now say that the cardiovascular effects that caused Vioxx to be pulled from the market were part of a "class effect," which may extend at least two other similar medicines.
Read article at Forbes.com

February 15, 2005

Drug sales in the US head for stagnation
The rate of growth in America’s massive drugs market is set to grind to a halt over the next three years amid mounting safety fears, a leading consultant has revealed. In a forecast that is closely watched by the pharmaceuticals industry, IMS Health, the industry research firm, is predicting that US sales growth in prescription medicines will flatten out at just 7.5 to 8.5 per cent a year for each of the next three years.
Read article at TimesOnline.co.uk

FDA to Create New Drug Safety Board
The U.S. Food and Drug Administration said on Tuesday it was creating a new drug safety board to improve the monitoring of medicines already in the marketplace, a response to charges the agency has failed to protect the public from dangerous side effects. The announcement comes on the eve of a three-day FDA meeting called to discuss the safety of painkillers like Merck & Co. Inc.'s now-withdrawn Vioxx that have been linked to an increased risk of heart disease and stroke.
Read article at Reuters.com

Drug Industry's Longtime Critic Says 'I Told You So'
Dr. Wolfe, a director at Public Citizen, a consumer advocacy group, has been angry with the Food and Drug Administration and talking himself hoarse about it for nearly 34 years. He has condemned dozens of high-priced medicines and denounced their makers. He has castigated state medical boards and railed about rates for Caesarean sections. He has sought to ban unpasteurized milk and some herbal supplements.
Read article at NYTimes.com

Truth in Advertising
Investigators reviewed pharmaceutical ads in American medical journals and found that nearly one-third contained no references for medical claims; while the majority of references to published material were available, only a minority of company data-on-file documents were provided upon request; and the majority of original research cited in the ads was funded by or had authors affiliated with the product's manufacturer.
Read article at MedicalNewsToday.com

More Pain For Pfizer
One the eve of a crucial Food and Drug Administration hearing, the New England Journal of Medicine is releasing damning new details from studies indicating that the Pfizer painkillers Celebrex and Bextra may cause the same sorts of heart problems that led to the recall of Merck's Vioxx last fall. The top-line results of the studies were announced last fall, but this is the first publication of the full details. In one study of Bextra and its injected cousin parecoxib, heart bypass patients treated for as little as ten days with the drugs had nearly quadruple the risk of having a heart attack or other cardiovascular-adverse events in the next month.
Read article at Forbes.com

February 12, 2005

Health Agency Chief Seeks Conflict Summit
The head of the U.S. National Institutes of Health said he wants government and academic leaders to meet to address conflicts of interest in medical research, the Los Angeles Times reported on Saturday. "We need to have a summit discussion to say, 'Look, what is the interest of the public?' The interest of the public is to make sure the science that's done is not tainted," the Times quoted NIH Director Dr. Elias Zerhouni as saying.
Read article at Reuters.com

Rare and Aggressive H.I.V. Reported in New York
A rare strain of H.I.V. that is highly resistant to virtually all anti-retroviral drugs and appears to lead to the rapid onset of AIDS was detected in a New York City man last week, city health officials announced on Friday. It was the first time a strain of H.I.V. had been found that both showed resistance to multiple drugs and led to AIDS so quickly, the officials said. While the extent of the disease's spread is unknown, officials called a news conference to say that the situation is alarming.
Read article at NYTimes.com

A Dismal Class-Action Finale
Senator Joseph Biden, the Delaware Democrat, got it exactly right when he pronounced the limits on class-action lawsuits approved on Thursday by the Senate a bad idea whose time has come.
Read article at NYTimes.com

Wyeth rheumatoid arthritis drug causes fatal side effects in 134 users
Rheumatoid arthritis drug Rheumatrex Capsule caused fatal side effects in 134 people between March 1999 and November 2004, according to a manufacturer's report. Wyeth K.K., the Japanese subsidiary of U.S. drug manufacturer Wyeth, said in its annual survey that the side effects were caused by methotrexate. An estimated 100,000 people nationwide are taking the drug.
Read article at Japantimes.co.jp

Novartis to Pay $49.2 Million in Civil, Criminal Penalties
A unit of Novartis agreed to pay $49.2 million in civil and criminal fines and be excluded from federal healthcare contracts to resolve a probe into its marketing of nutritional products to Medicare and Medicaid.
Read article at LATimes.com

February 11, 2005

Bush vows veto of any tampering with Medicare plan
President George W. Bush warned Congress on Friday he would veto any legislation that would take away prescription drug coverage for senior citizens, a new Medicare benefit whose rising costs are causing heartburn in Washington.
Read article at ReutersHealth.com

Drug regulators are trying to quash study, senator says
The tension and intrigue surrounding a crucial federal drug advisory committee meeting next week, already high, reached a boil on Friday when Senator Charles E. Grassley charged that top federal drug regulators intended to suppress an important study. The panel has been convened to discuss whether Celebrex and Bextra, heavily selling arthritis pills from Pfizer, hurt the heart and are worth their potential risks. But top officials of the Food and Drug Administration have forbidden Dr. David Graham, a drug-safety officer at the agency, to discuss before the panel a large study of that very question, said Dr. Gurkirpal Singh of Stanford University School of Medicine, Dr. Graham's co-author.
Read article at NYTimes.com

Amgen Says Trial Halted on Safety Concern
Amgen Inc. confirmed Friday that it halted a clinical trial of an experimental treatment for Parkinson's disease because the drug could cause permanent brain damage.
Read article at WashingtonPost.com

FDA had concerns about Vioxx for years
U.S. drug regulators had serious concerns about Vioxx more than two years before Merck & Co. pulled the popular painkiller over safety concerns. The Food and Drug Administration knew Alzheimer's studies showed older people taking the drug were more likely to die than those in a placebo group but did not order Merck to warn doctors about such concerns.
Read article at BigNewsNetwork.com

Marketing of Vioxx: How Merck Played Game of Catch-Up
At times, it is necessary to "neutralize" the opposition, or at least Merck & Company executives seemed to think so. In 1999, the company's new pain drug, Vioxx, was beaten to pharmacy shelves by a competing drug, Celebrex. Merck apparently hoped that nationally known rheumatologists like Dr. Roy Altman could help it catch up.
Read article at NYTimes.com

February 10, 2005

Regulator sought curbs on high dose of cholesterol drug
Experts at the UK's medicine regulator expressed serious worries over high doses of controversial cholesterol-lowering drug Crestor just two months before it went on the market, confidential documents seen by the Guardian reveal. Their concerns were overruled by a European-wide decision to allow the high dose, 40mg, on the market.
Read article at Guardian.co.uk

Medicare Prescription Drug Benefit To Cost $720 Billion Over First 10 Years, CMS Says
The new Medicare prescription drug benefit will cost more than $720 billion over its first 10 years, with costs reaching $100 billion annually by 2015, according to new estimates released Tuesday by CMS Administrator Mark McClellan.
Read article at MedicalNewsToday.com

February 9, 2005

Bioterror Bill Would Increase Drug Costs
The Generic Pharmaceutical Association (GPhA) today issued a strong warning to the Senate that biodefense legislation (S. 3) in its current form would effectively extend patents for marketed drugs and delay access to more affordable generic medicines - unnecessarily increasing prescription drug costs to consumers, businesses, and government purchasers by tens of billions of dollars a year.
Read article at MedicalNewsToday.com

Savings in US President's Budget Undercut
By Reductions in Disease Prevention And Health Promotion

The American Public Health Association (APHA) says that proposed savings as outlined today in President Bush's budget are severely undercut by the administration's failure to adequately invest in disease prevention and health promotion activities. "While controlling federal spending is critical, the administration's failure to adequately invest in prevention means that any perceived short-term savings will result in greater health and medical expenditures in the long-term," says Georges C. Benjamin, MD, FACP, executive director of APHA. "It's like owning a car, but never taking it in for service. Without prevention, catastrophic failure is imminent."
Read article at MedicalNewsToday.com

February 8, 2005

Illinois Joins Other States Suing Drug Makers
The Illinois attorney general accused 48 major drug makers of fraud for overcharging government health care programs, joining several other U.S. states filing similar suits, authorities said on Tuesday. The lawsuit filed in Cook County Circuit Court in Chicago by state Attorney General Lisa Madigan "alleges that the people of Illinois overpaid hundreds of millions of dollars over the last decade or so," said her spokeswoman, Melissa Merz.
Read article at Reuters.com

Merck Cancelled an Early Study of Vioxx
Merck & Company executives have long insisted that they never pursued a clinical trial to directly study the heart risks of the pain drug Vioxx because other tests they were conducting would supply those answers just as quickly. But previously undisclosed company documents show that the drug maker was poised to begin a major cardiovascular study of the drug in 2002, and abruptly dropped the project just before it was set to start. The trial was scheduled to produce data by March 2004 but may have provided answers about Vioxx's risks even earlier if patients had shown ill effects.
Read article at NYTimes.com

Vaccine maker's '91 memo suggests mercury-level risk
A memo from Merck & Co. shows that, nearly a decade before the first public disclosure, senior executives were concerned that infants were getting an elevated dose of mercury in vaccinations containing a widely used sterilizing agent. The March 1991 memo, obtained by the Los Angeles Times, said 6-month-old children who received their shots on schedule would get a mercury dose as much as 87 times higher than guidelines for the maximum daily consumption of mercury from fish.
Read article at SanFransiscoChronicle.com

Will your vitamins be banned from the shelves after August?
If you are among the 43 per cent of the population who take vitamins, minerals or other food supplements, you may well be feeling a little alarmed and confused. On August 1, the European Food Supplements Directive takes effect. From then, the only vitamins and minerals that can be sold in Britain will be those on a list of permitted substances, or those for which an application to be added to this "positive" list has been made.
Read article at Telegraph.co.uk

February 6, 2005

Guiding a company in the midst of a crisis
Merck & Co. Inc. has been in crisis since Sept. 30, when the company pulled its prescription painkiller Vioxx off the market after a study confirmed the drug increased the risk of heart attack and stroke. Merck chief Raymond Gilmartin is grappling with multiple product-liability and shareholder lawsuits. Scheduled to retire in April 2006 under a plan in place before the Vioxx disaster, Gilmartin spoke with Globe reporter Christopher Rowland during a visit to Boston last week.
Read article at Boston.com

Lilly's Boss Says American Health System is Unhealthy to the Core -
Offers Principles for Reform

America's health care system is hurting, and fixing it requires the urgent attention of elected officials, Eli Lilly and Company's Chairman, President and Chief Executive Officer Sidney Taurel said today.
Read article at MedicalNewsToday.com

February 4, 2005

Merck CEO Rejects Bankruptcy, Merger Talk
There is no way Merck & Co. will have to declare bankruptcy over pending Vioxx litigation, nor is it considering a major merger, the company's chief declared Thursday. In an interview with MarketWatch, Chairman and Chief Executive Raymond Gilmartin contended the strength of Merck's cash flow, coupled with conservative management, will keep the pharmaceutical giant financially sound.
Read article at SmartMoney.com

Novartis drug risk seen similar to Vioxx
A clinical trial for Novartis AG's experimental painkiller Prexige showed the risk of heart attack, stroke and death was "similar" to Merck & Co. Inc.'s now withdrawn Vioxx, U.S. regulatory staff said in documents released on Friday.
Read article at Alternet.org

FDA staff questions heart risks of Merck's Arcoxia
Merck & Co. Inc.'s painkiller Arcoxia offers a "marginal" advantage in gastrointestinal safety but seems "worse than" other pain drugs in terms of deaths and serious cardiovascular problems, U.S. regulatory staff said in documents released on Friday. Merck conducted studies on Arcoxia comparing it to a placebo, naproxen and other medicines known as nonsteroidal anti-inflammatory drugs.
Read article at Alertnet.org

Glaxo demands China, India, Brazil respect patents
GlaxoSmithKline, Europe's biggest drug maker, is calling for Britain to use its presidency of the G7 to ensure the world's emerging economic powerhouses respect patents and clamp down on counterfeiting. "Globally, the UK must work to deliver a level playing field by demanding respect for intellectual property rights in the countries that benefit the most from globalisation -- India, China, Brazil," GSK Chief Executive Jean-Pierre Garnier said on Friday.
Read article at Reuters.co.uk

Newborns at Risk of Antidepressant Withdrawal
Newborn babies could be at risk of suffering withdrawal symptoms if their mothers are prescribed antidepressants during pregnancy, researchers said on Friday. The drugs known as selective reuptake inhibitors (SSRIs) can cause convulsions, irritability, abnormal crying and tremors.
Read article at Reuters.com

February 3, 2005

Bush's Calls for Tort Overhaul Face Action in Congress
With President Bush pressing Congress for a swift overhaul of the nation's civil liability system, action in the Senate Judiciary Committee this week is quickly turning into the political laboratory for what will be doable and what will be difficult. In his State of the Union address on Wednesday evening, Mr. Bush once again urged lawmakers to rewrite the tort law rules to do away with what he has called frivolous and costly lawsuits, which he has repeatedly said have become a significant drag on the economy.
Read article at NYTimes.com

FDA Warns Glaxo on Hypertension Drug Marketing
The U.S. Food and Drug Administration warned GlaxoSmithKline Plc on Thursday about misleading advertisements touting its hypertension drug called Coreg. The company presented the marketing information at a conference last June, using posters that omitted risk information and overstated how well the drug worked, the FDA said in a letter posted on its Web site.
Read article at Reuters.com

NIH Workers Angered by New Ethics Rules
National Institutes of Health Director Elias A. Zerhouni stood before hundreds of NIH employees yesterday to explain why it had become necessary for him to impose, in his words, "drastic" restrictions on stock ownership and other forms of outside income, which take effect today for all agency employees.
Read article at WashingtonPost.com

Gift for drug industry?
As anyone who watches Sunday's Super Bowl will note, the demand for erectile-dysfunction drugs has not emerged in a vacuum. The manufacturers of Viagra, Levitra and Cialis have been bombarding sporting-event telecasts with advertising for their highly profitable drugs.
Read article at SFGate.com

Liver alert on hyperactivity drug
A drug used to treat behaviour problems in children has been linked to liver damage, say experts. Strattera was licensed for the treatment of attention deficit hyperactivity disorder (ADHD) last year.
Read article at BBCNews.com

AstraZeneca facing class action suits over Iressa
AstraZeneca’s Japanese subsidiary is facing the threat of a class action lawsuit over the fatal side-effects of Iressa, its lung cancer treatment. The 29 Japanese lawyers representing the families of Iressa victims are also mulling cases against the London-based parent company and are planning a fact-finding trip to the UK.
Read article at TimesOnline.co.uk

February 2, 2005

Pushing Risky Drugs
Even as expert advisers to the Food and Drug Administration prepare to take a closer look at a potentially risky class of painkillers, the COX-2 inhibitors, disturbing new evidence has emerged that these drugs have been prescribed primarily to patients who do not need them. If an analysis just published in The Archives of Internal Medicine holds up under further scrutiny, it will provide a telling example of how an avalanche of marketing can propel the use of new drugs far beyond reason, posing needless risks to patients they are unlikely to help.
Read article at RedNova.com

Jobs not a priority as companies repatriate foreign profits
When the U.S. Congress passed a one-time tax break on corporate foreign profits last year, lawmakers said their main purpose was to encourage American companies to build new operations and hire more workers at home. But as corporations are gearing up to bring tens of billions of dollars back to the United States this year, adding jobs is far from their highest priority. Some, in fact, say they might end up cutting their work forces.
Read article at IHT.com

Half of Bankruptcy Due to Medical Bills
Half of all U.S. bankruptcies are caused by soaring medical bills and most people sent into debt by illness are middle-class workers with health insurance, researchers said on Wednesday. The study, published in the journal Health Affairs, estimated that medical bankruptcies affect about 2 million Americans every year, if both debtors and their dependents, including about 700,000 children, are counted.
Read article at Reuters.com

Class-Action Lawsuits
Tort reform is in the eye of the beholder. In the name of reforming the nation's civil justice system, and with scant public debate, President Bush and Congressional Republicans are racing to reward wealthy business supporters by changing the rules for class-action lawsuits. Their real objective is to dilute the impact of strong state laws protecting consumers and the environment and to make it harder for Americans to win redress in court when they are harmed by bad corporate behavior.
Read article at NYTimes.com

UK should help build African drug industry
The country’s national academy of science is calling for the government to help build a drug industry in Sub-Sahara Africa by providing long-term investment.
Read article at BlackBritain.co.uk

February 1, 2005

4 Networks Reject Ad Opposing Bush on Lawsuits
An advocacy group, USAction, said on Monday that four television networks had turned down its request to run an advertisement opposing President Bush's effort to clamp down on medical malpractice lawsuits.  The group wanted to run the spots just before Mr. Bush's State of the Union address on Wednesday. But networks said the advertisement violated their standards for advertising on controversial issues.
Read article at NYTimes.com

NIH to Ban Deals With Drug Firms
Under a far-reaching reform to be announced today, all staff scientists at the National Institutes of Health will be banned from accepting any consulting fees or other income from drug companies, and the employees must also divest industry stock holdings, officials said.
Read article at LATimes.com

Pfizer Says 1999 Trials Revealed Risks With Celebrex
Celebrex, the popular arthritis and pain medicine from Pfizer, sustained another blow yesterday when the company acknowledged that a 1999 clinical trial found that elderly patients taking the drug were far more likely to suffer heart problems than patients taking a placebo.
Read article at NYTimes.com

Popular painkiller to be withdrawn
Twenty years after doctors were warned that a painkiller taken by 1.7m people a year was linked to suicides and accidental deaths, the government announced yesterday it was to be withdrawn. Co-proxamol, also known by the trade names Distalgesic, Cosalgesic and Dolgesic, is involved in between 300 and 400 deaths every year. About a fifth of those are accidental, sometimes involving alcohol.
Read article at Netdoctor.co.uk

US government list of cancer-causing agents grows
The Department of Health and Human Services released its Eleventh Edition of the Report on Carcinogens today, adding seventeen substances to the growing list of cancer-causing agents, bringing the total to 246.
Read article at MedicalNewsToday.com

January 31, 2005

FDA Reinstates Military Anthrax Vaccination Program
The Food and Drug Administration has invoked the Project BioShield Act of 2004 for the first time to partly overturn a judge’s ruling that anthrax vaccine adsorbed (AVA) was approved in violation of FDA regulations and could not be administered to troops against their will.
Read article at Mealeys.com

January 30, 2005

Class-action lawsuit claims antipsychotic drug led to diabetes
A B.C. man has launched a class-action lawsuit against drug maker Eli Lilly over its medication Zyprexa, claiming the company "minimized" the heath risks of taking the anti-psychotic drug. The suit filed in the B.C. Supreme Court alleges Vancouver's Marc Estrin developed diabetes as a result of taking the drug to treat schizophrena.
Read article at MedBroadcast.com

January 28, 2005

Merck Slumps On SEC Vioxx Investigation
The pharmaceutical giant said Friday that the U.S. Securities and Exchange Commission has started a formal inquiry into the company's handling of the withdrawal of Vioxx. Previously, Merck said the SEC was conducting an informal investigation.
Read article at Forbes.com

January 26, 2005

Merck sets aside $675m to pay for arthritis drug lawyers
The US drugs company Merck is to spend at least $675 million on lawyers and other legal fees to defend itself against writs from patients who suffered side-effects from the arthritis drug Vioxx. The district attorney in Munich, Germany, has started a criminal inquiry into the company over the drug, Merck admitted yesterday.
Read article at Netdoctor.co.uk

January 25, 2005

Novartis chief admits pharmaceutical industry has lost public trust
Daniel Vasella, chief executive of Novartis, has warned his peers that ‘big pharma’ has lost the trust of consumers and regulators in the midst of product recalls and clinical data controversies.
Read article at EthicalCorp.com

Doctor cuts Wall Street, drug maker ties
A prominent Cleveland Clinic researcher has stopped working as a paid consultant for a Wall Street fund and has broken ties to many drug companies to avoid any potential conflicts of interest.
Read article at Boston.com

Medical journal prints controversial study of Vioxx; had withheld the report
A medical journal published a study Tuesday of coronary disease related to the anti-inflammatory drug Vioxx after withholding the report because the researcher said he had been threatened by superiors at the U.S. Food and Drug Administration. The Lancet, which originally planned to publish the paper on Nov. 17, released the study online.
Read article at MedBroadcast.com

January 24, 2005

Group Calls on FDA to Pull Pfizer Pain Drugs
U.S. regulators should pull Pfizer Inc.'s arthritis drugs Celebrex and Bextra from the market because they are too risky, U.S. consumer watchdog group Public Citizen said in a letter on Monday. In a formal petition to the U.S. Food and Drug Administration, Public Citizen said the two drugs' potential to cause heart attacks and strokes outweighed any possible benefit.
Read article at Reuters.com

Avoiding Another Vioxx
"Too cozy" is how Senator Charles Grassley of Iowa referred to the relationship between the U.S. Food and Drug Administration and pharmaceutical companies in the aftermath of the Vioxx debacle. Although the FDA admits no substantive lapse in vigilance, congressional pressure and consumer outrage are forcing officials to rethink the agency's role and perhaps even the drug approval process itself.
Read article at SciAm.com

January 23, 2005

Vioxx, Celebrex overprescribed?
Millions of Americans who were prescribed Vioxx or Celebrex in the drugs' first few years on the market could have safely taken older, cheaper painkillers such as ibuprofen, a new study says. The drugs' main selling point was that, theoretically at least, they were less likely to cause bleeding and other serious stomach complications than older nonsteroidal anti-inflammatory drugs, or NSAIDs. But patients at low risk for such problems accounted for two-thirds of the growth in Vioxx and Celebrex use from 1999 — when the drugs came on the market — to 2002, researchers report today in the Archives of Internal Medicine.
Read article at USAToday.com

January 22, 2005

UK Drug Regulator Planning to Get Tough on Sales Pushes
The UK drugs regulator is considering plans to "name and shame" pharmaceuticals companies that engage in aggressive or misleading marketing. The organisation is also looking at tightening rules on company- sponsored entertainment and hospitality for doctors, and on "disease awareness" campaigns that implicitly promote a particular drug to people. It may also step up prosecutions for the most serious breaches by drug companies.
The Medicines and Healthcare Products Regulation Agency (MHRA) is to ask for public comments on possible "get tough" policies, after taking private soundings from the drug industry over the past weeks.
Read article at RedNova.com

Safety Concerns Reported on J & J. Alzheimer's Drug
Regulators are reviewing the safety of the Alzheimer's disease drug Reminyl after data from two clinical trials indicated that people taking the drug had a much higher death rate than those taking a placebo. The review was announced yesterday by Johnson & Johnson, which said it was in discussions with the Food and Drug Administration and regulators in Europe and Canada.
Read article at NYTimes.com

January 21, 2005

AstraZeneca cancer drug could be banned in Japan
Japan’s Ministry of Health and Welfare is considering banning Iressa, AstraZeneca’s controversial lung cancer drug, after accepting a report that linked the medicine to 588 deaths in the country — more than four times the number previously thought. An official spokesman for the ministry told The Times last night that the findings would raise the “possibility” that Iressa would be now be withdrawn. The report, compiled by a panel of scientists, concludes that 1,473 patients suffered side effects after taking Iressa and that the drug was linked to 588 deaths.
Read article at TimesOnline.co.uk

Novartis sucked into Serious Fraud Office inquiry
The Serious Fraud Office is investigating a division of Novartis, one of the world's largest pharmaceutical firms, for alleged criminal marketing practices as part of its investigation into alleged price-fixing by drugs companies. Novartis's generic drug division, Sandoz, is being investigated to find out if it broke criminal or competition law while selling its products. Sandoz makes a wide range of drugs in the UK, from the breast cancer treatment tamoxifen to diazepam and ibuprofen.
Read article at Guardian.co.uk

January 20, 2005

WHO backs AIDS drug despite FDA warning
The World Health Organisation (WHO) said it would continue recommending use of the Viramune drug in AIDS patients despite a U.S. regulatory warning, as the benefits were greater than toxicity problems. "We don't think at the moment to change our policy ...," Charles Gilks, director of WHO's AIDS treatment and prevention scale-up team, told Reuters on Thursday. "We are aware of the toxicity profile, but at the moment we believe the benefits outweigh any problems," he said.
Read article at Alertnet.org

Lawyers Plan Attack on Merck Over Vioxx
Most of the roughly 250 lawyers assembled in the Wyndham Philadelphia hotel ballroom listened intently Thursday as fellow attorney Barry Hill showed off an extensive collection of trinkets and product samples emblazoned with the logo of the now-withdrawn drug Vioxx. "Maybe you can use them (the samples) as evidence," joked Hill, a Wheeling, W.V., trial lawyer who bears a resemblance to the actor William Holden.
Read article at Forbes.com

Study Shows Plavix Has Higher Ulcer Risk
Plavix, a heart drug recommended by medical groups as an easy-on-the-stomach substitute for aspirin, instead showed a much higher risk of recurrent ulcers in a small but provocative study. The study could upend the treatment guidelines for tens of thousands of Americans who must take anti-clotting drugs for their hearts but are prone to gastrointestinal problems.
Read article at Philly.com

January 19, 2005

Cancer Now the Leading Killer of Americans
Cancer has displaced heart disease as the leading killer of Americans under the age of 85, according to the American Cancer Society's latest projections released Wednesday. Even though the mortality rates are higher relative to heart disease, according to the latest report, the mortality from many types of cancer is actually declining. Cancer now accounts for about 23 percent of all deaths among Americans regardless of age, the annual report found.
Read article at HealthScout.com

U.S. Warns of Safety Risks of Boehringer AIDS Drug
An important AIDS drug can cause sometimes deadly liver damage but remains a key option for many patients, U.S. health officials warned on Wednesday. The Food and Drug Administration said doctors should weigh benefits and risks before prescribing the drug, Boehringer Ingelheim's Viramune, also known by the generic name nevirapine.
Read article at Reuters.com

Pfizer's Celebrex Risk Gets Worse
In an earnings statement issued by Pfizer recently it revealed, for the first time, that there may have been other, inconclusive data that could be used to argue that Celebrex poses a heart risk.
Read article at Forbes.com

NIH Halts Use of COX-2 Inhibitor in Large Cancer Prevention Trial
The National Institutes of Health (NIH) announced today that it has suspended the use of COX-2 inhibitor celecoxib (Celebrex) for all participants in a large colorectal cancer prevention clinical trial conducted by the National Cancer Institute. The study, called the Adenoma Prevention with Celecoxib (APC) trial, was stopped because analysis by an independent Data Safety and Monitoring Board showed a 2.5-fold increased risk of major fatal and non-fatal cardiovascular events for participants taking the drug compared to those on a placebo.
Read article at MedicalNewsToday.com

January 18, 2005

More Evidence of Heart Risks from Bextra
Combining aspirin with the painkiller Bextra may magnify the heart-related risks associated with Bextra and similar drugs. Two new studies offer new clues about the role of Bextra in heart disease. They suggest that combining Bextra with aspirin may increase the risk of blood clots that could trigger a heart attack or stroke.
Read article at WebMD.com

January 17, 2005

Public to view drug side effects
Patients will be able to examine data on the safety of different medicines, the UK government has announced. Anonymised data on suspected adverse drug reactions will be published on the Medicines and Healthcare products Regulatory Agency website. Researchers will be able to access more detailed information.
Read article at BBCNews.co.uk

Lilly Launches Public Outreach Initiative to "Correct" Allegations About Company and Prozac
Eli Lilly and Company today announced its plans to correct “inaccurate statements” circulating in the news media based on a collection of random papers anonymously sent to the British Medical Journal (BMJ). Lilly has posted a detailed explanation of those papers in question on its website and has published an open letter to patients in leading U.S. newspapers to state its case.
Read article at MedicalNewsToday.com

Drug advertising: FDA warning may return to haunt Pfizer
Pfizer has withdrawn advertising of its COX-2 products in view of the FDA's concerns and the wider controversy surrounding the safety of COX-2s. Whether intentional or not, the 'misleading' advertisements will have benefited sales as the general public will mostly be unaware of the violations against the FDA's rulings. The immediate future does not look good for either the COX-2 class or Pfizer.
Read article at CommentWire.com

Protests over US bill to shield drug firms from court
Patients in the US who suffered severe side-effects from revolutionary new drugs may be denied recourse to the courts under a new law being drawn up by President Bush's second administration. The move would shield the world's major drug companies from waves of expensive litigation, in effect capping the costs associated with controversial drugs such as Vioxx, Merck's arthritis painkiller which the manufacturer withdrew after several users suffered heart attacks or strokes.
Read article at Guardian.co.uk

January 16, 2005

Another cholesterol drug seeks OTC status
Although a Food and Drug Administration advisory panel has recommended against selling one cholesterol-lowering statin drug over-the-counter (OTC), the maker of another is moving forward with plans to seek the agency's permission to make the switch.
Read article at USAToday.com

January 15, 2005

Insurers cut cover to drug firms amid fear of lawsuits
Insurance companies are cutting the amount of cover they are prepared to offer big drug manufacturers against litigation amid fears of a surge in new lawsuits from patients.
Read article at TimesOnline.co.uk

Amgen Issues Warning on Drug
Amgen Inc. sent a letter to doctors warning that high doses of anemia drugs, including the company's Aranesp, might be dangerous for cancer patients. Amgen said it issued the letter after studies of similar drugs sold by Roche Holding and Johnson & Johnson showed a higher death rate in patients whose red-blood cell levels exceeded targets.
Read article at LATimes.com

FDA Announces Dates for Public Meeting on Non-Steroidal Anti-Inflammatory Drugs
The Food and Drug Administration (FDA) has announced a joint public meeting of the agency's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to be held February 16, 17 and 18, 2005. The committees will discuss the overall benefit-to-risk considerations (including cardiovascular and gastrointestinal concerns) for COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) and related medicines.
Read article at MedicalNewsToday.com

FDA Panel says 'No' to making Mevacor an OTC drug
An FDA advisory panel said ‘no' to Merck's request that its statin, Mevacor, become an OTC (over-the-counter) drug. The panel voted 20 against and 3 in favour of the request. What the advisory panel recommends is usually accepted by the FDA.
Read article at MedicalNewsToday.com

January 14, 2005

Europe's Officials Grill Drug Firms on Painkillers
Officials from Pfizer Inc, Merck & Co Inc and Novartis AG will appear next week before a panel of European drug experts, who are meeting to consider curbs on the use of COX-2 painkillers.
Read article at Reuters.com

Drugs early-warning system 'not working'
The UK's biggest pharmaceutical companies have called on the Government to do more to ensure that doctors report side effects from new drugs, in an attempt to head off growing public concern about the side effects of blockbuster drugs.
Read article at NetDoctor.co.uk

A Push in States to Curb Malpractice Costs
As state legislative sessions open across the country this week, Republican governors and lawmakers in many states are mounting major campaigns to control medical malpractice insurance premiums by limiting civil litigation. In Georgia, Missouri, Washington and more than a dozen other states, Republican legislators have made malpractice premiums a priority this year, groups that track such legislation said. In Kentucky, Maryland and Mississippi, Republican governors have already waded into the fray.
Read article at NYTimes.com

A Gift for Drug Makers
With all the problems and the bad publicity that drug companies have been facing recently, you might think that this would not be a good time for the Bush administration to toss yet another bonanza their way. But the administration is like an ardent lover in its zeal to shower the rich and powerful with every imaginable benefit. So tucked like a gleaming diamond in proposed legislation to curb malpractice lawsuits is a provision that would give an unconscionable degree of protection to firms responsible for drugs or medical devices that turn out to be harmful.
Read article at NYTimes.com

Exporting Cures, Importing Misery
In the heavily polluted region of Patancheru, the production of pharmaceuticals to save lives in the West may be cutting lives short in India.
Read article at Alternet.org

January 13, 2005

FDA Warns Pfizer About 2 Drugs' Ads
The Food and Drug Administration has warned Pfizer Inc. that television and print advertisements for its painkillers Celebrex and Bextra misled consumers, according to a letter made public Wednesday. Five advertisements did not disclose side effects and other risk information and made "unsubstantiated effectiveness claims," the F.D.A. said in a letter dated Jan. 10 that was posted on its Web site.
Read article at NYTimes.com

FDA Considers Sales for Cholesterol Drug
The US government is considering whether a drug for a serious chronic condition, high cholesterol, should sit on drugstore shelves alongside medicines for headaches, allergies and athlete's foot.
Read article at ABCNews.com

January 12, 2005

Watchdog Group: Avoid 181 Prescription Drugs
There are 181 popular prescription drugs on a "Do Not Use" list issued by the watchdog group Public Citizen on Wednesday. The drugs, including the cholesterol-lowering drug Crestor, the birth control pill Yasmin, and controversial pain relievers Celebrex and Bextra, are condemned by the group because their potentially dangerous side effects far outweigh their benefits or because there are safer alternatives that work just as well
Read article at WebMD.com

Statins: A risk to your baby?
Some birth-defects specialists say they are concerned about the possibility of a cholesterol-lowering statin drug going over the counter, a move to be considered today and Friday by a Food and Drug Administration advisory committee.
Read article at USAToday.com

January 10, 2005

Pfizer to Pull Its Ads for Arthritis Painkiller
Pfizer has said that it will immediately stop advertising Celebrex, an arthritis pain reliever, to consumers after a study showed that high doses were associated with an increased risk of heart attacks. Pfizer appears to have had little choice in deciding to end the advertising campaigns. The U.S. Food and Drug Administration said Friday that it was considering regulatory measures that could include severe label warnings or even requiring that the drug be withdrawn in the United States.
Read article at RedNova.com

AstraZeneca Reports Death of Crestor Drug Patient
AstraZeneca Plc's cholesterol-lowering drug Crestor has been linked to the death of a patient, Europe's third largest drugmaker said on Monday. The death, possibly due to the severe muscle-wasting condition rhabdomyolysis, has been reported to regulators worldwide, company spokesman Steve Brown said.
Read article at Reuters.com

January 8, 2005

Equality in the 1990s would have saved 900,000 black Americans
Eliminating racial inequality in health care in the United States would have saved the lives of almost 900 000 black people from 1991 to 2000, says a report published in the American Journal of Public Health. Equality of care would have saved five times the number of lives saved by new technologies and treatments, the investigators say.
Read article at BMJ.com

Rejecting political correctness
Known for his outspoken views on NHS reform and private medicine, Karol Sikora, professor of cancer medicine and honorary consultant oncologist at Imperial College London's School of Medicine, is now grappling with medical education. After being approached by Buckingham University's vice chancellor, Terence Kealey, himself a doctor, Professor Sikora was appointed dean elect of Britain's first private medical school at Buckingham University, the only UK university not directly funded by the government. He finds the challenge of implementing a new medical course appealing.
Read article at BMJ.com

January 6, 2005

Drug tests: too speedy - or safe enough?
Prescription drugs pulled from the market. Drug ads voluntarily yanked from TV and print. "Black box" warning labels placed on some medicines, and safety doubts raised about others. As Americans try to figure out how suspect drugs got into their medicine cabinets - and who is to blame - two startling facts are coming to the fore: 1) The consumption of all medications involves some risk and 2) The bar for establishing their safety is set much lower than many people think.
Read article at CSMonitor.com

Gefitinib (Iressa™) Marketing Authorisation Application Withdrawn In EU
AstraZeneca today announced that it is withdrawing the European Marketing Authorisation Application (MAA) for IRESSA™ (gefitinib) in treating patients with non-small cell lung cancer (NSCLC) from the European Medicines Agency (EMEA).
Read article at MedicalNewsToday.com

Drug research openness promised
The world's leading drug companies have promised to publish more data about clinical trials into new medicines to reassure the public about their safety. Results of all industry clinical trials will be published on the internet later this year under plans drawn up by pharmaceutical trade associations.
Read article at BBCNews.com

January 5, 2005

Malpractice Bill Shields Drugmakers
The medical malpractice bill backed by President Bush would prevent consumers from seeking punitive damages from the makers of Vioxx and Celebrex, two popular pain medications recently linked to increased risks of heart attacks and strokes, according to legal experts on both sides of the issue. While Bush often touts the medical malpractice proposals as a prudent way to stop frivolous lawsuits against doctors, the bill's less-discussed liability protections for pharmaceutical companies such as Merck & Co., the manufacturer of Vioxx, is generating controversy this week.
Read article at WashingtonPost.com

Bush promotes plan to limit medical liabilityl lawsuits
President George W. Bush said Wednesday in Collinsville that he wanted Congress to pass medical malpractice reform, and do it this year. Speaking before a backdrop of about 125 doctors in white lab coats, Bush said that trial lawyers are filing frivolous lawsuits that add billions of dollars to health care costs while forcing doctors to curtail vital care. "What I'm here to do is say as clearly as I can - the United States Congress needs to pass real medical liability reform this year," Bush said. The cornerstone of that reform plan is a $250,000 cap on "pain and suffering" damages.
Read article at Kentucky.com

January 4, 2005

Statin Use May Slightly Impair Brain Function
The results of a new study suggest that treatment with a cholesterol-lowering statin called simvastatin (Zocor) may have small negative effects on brain function. The effects on cognitive function were "too small" to have any immediate implications for the way the statin is prescribed, but they do suggest the possibility that the drug may harm the brain
Read article at Reuters.com

Lilly and Novartis schizophrenia drugs may increase diabetes risk
Researchers have found that patients treated with the anti-psychotic agents clozapine and olanzapine, marketed as Novartis's Clozaril and Eli Lilly's Zyprexa respectively, may be at an increased risk for insulin resistance, a major risk factor for diabetes.
Read article at Pharmaceutical-Business-Review.com

NIH whistleblower says government bungled AIDS study in Uganda
Federal officials involved in a U.S.-funded study in Uganda endangered the lives of hundreds of patients testing an AIDS drug because of careless and negligent research practices, a government whistleblower said Tuesday. Dr. Jonathan Fishbein said officials at the National Institutes of Health overlooked safety problems with the drug, which was being used to protect babies in Africa from HIV infection during birth.
Read article at MedBroadcast.com

Bush Administration pressures Canada to eliminate drug importation
Canadian mail-order drug importation may become illegal soon due to new regulations proposed by the Liberal Government. After quietly supporting the practice for four years, the Liberals made a conspicuous about face after President Bush's November visit to Canada. Health Minister Ujjal Dosanjh confirmed that the president conferred with Canadian Prime Minister Paul Martin on the matter.
Read article at News-Medical.net

Michigan law makes drug suits difficult
Michigan is the only state in the country with a law that shields drug makers from liability if the drug was approved by the Food and Drug Administration, according to the Michigan Trial Lawyers Association. Plaintiffs can win damages only if they prove a company withheld or misrepresented information about a drug that would cause the FDA to not give or withdraw its approval.
Read article at freep.com

January 3, 2005

Long-Term Use of Non-Steroidal Anti-Inflammatory Drugs
May Cause Severe Intestinal Damage
According to a study published today chronic users of non-steroidal anti-inflammatory drugs (NSAIDs) have an increased risk of bleeding and visible damage to their small intestine. "We have always known that NSAIDs can cause potentially deadly stomach complications, but the extent of the impact on the small intestine was largely unknown until now," said David Graham, MD, lead study author. "The introduction of video capsule endoscopy gave us an opportunity to examine the small intestine and learn that NSAIDs can cause severe damage to this organ."
Read article at DocGuide.com

Drug firms under fire over secrecy on 1,096 trials
More than 1,000 drug trials have taken place in Ireland over the last seven years, with little or no public knowledge. Although the Irish Medicines Board (IMB) authorises all trials, it does not provide any public information on drugs being tested, the number of patients involved in trials, the drug firms concerned or the results of such studies.
Read article at IOL.ie

January 1, 2005

Indicting Big Pharma
Is the pharmaceutical industry a dangerous and crooked business that federal and state authorities need to bring to heel? Should those who develop market or prescribe drugs hang their heads in shame when faced with the stark reality of what they do to earn a living? Is Big Pharma in fact the moral equivalent of the tobacco industry?
Read article at AmericanScientist.org

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