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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 f