De meeste medische studies zijn misleidend.*
Bijna alle wetenschappelijke onderzoeken van de farmaceutische industrie zijn misleidend. Iedereen die in het onderzoeksproces betrokken is waaronder onderzoekers, doktoren, controleurs, uitgevers enz. hebben financiële relaties met de opdracht gevende
farmaceutische industrie. Een belangrijk wapen in de misleiding is het gebruik maken van ghostwriting waarbij bekende wetenschappers een positief verhaal vertellen alsof ze zelf het onderzoek gedaan hebben. Een bekend voorbeeld hiervan zijn de Vioxx studies, waarvan later gebleken is dat al die mooie verhalen niet juist waren.
Misleading medical research common: journal editor
Misleading research is often published in major medical journals and doctors are lending their names to it, the editor of the Journal of the American Medical Association said on Tuesday.
Doctors, regulators, publishers and others are all taking money, information and small presents from pharmaceutical companies and being influenced in the process, said Dr. Catherine DeAngelis.
"It goes for all of us," DeAngelis, whose journal is influential nationally and globally, said in a telephone interview.
Her journal, commonly known as JAMA, published a paper accusing Merck and Co. of suppressing data that showed its now-withdrawn pain drug Vioxx was harming patients, and saying that academic researchers had lent credibility to the company's allegedly manipulated research by putting their names on the work.
Merck and the independent researchers have denied this and say the journal is mistaken in this case.
But DeAngelis said there is a "gigantic" problem of drug companies influencing doctors and patients. Her journal presents the Merck case as a specific example of one facet of the problem.
"We have given away our profession and we have got to take it back," she said.
Drug companies spend millions of dollars on promotional materials, from pens to prescription pads. They pay for doctors to travel to seminars, often in exotic places, to learn about drugs.
They set up elaborate booths at medical meetings and send articulate drug representatives and "detailers" to pay personal visits to doctors.
CAREFUL WATCHDOGS
"Physicians in private practice shouldn't even take a pen from anybody, let alone pizza lunches or whatever," DeAngelis said.
In addition, the companies fund many medical studies. Government funds are usually only used for the first stages of research -- the rest is left to companies who conduct studies to seek licensing for various drugs. DeAngelis said there is no way around this.
But, she added, "The editors (of medical journals) have to be very, very careful watchdogs over what we publish."
The influence does not usually amount to outright bribery, DeAngelis added. "We just have to be more careful, all of us, and insist that we are not going to be hoodwinked by them, fooled by them," she said.
"The physician should learn from other physicians, not from some detail person," DeAngelis said.
The Consumers Union agreed.
"Pharmaceutical companies need to get out of the business of 'ghostwriting' articles for medical journals," Dr. John Santa, a medical consultant to Consumers Union, said in a statement.
One of the studies in the journal shows that Merck researchers mostly wrote one of the studies alleged to have shown the higher risk of deaths but later added the names of Alzheimer's experts Dr. Leon Thal of the University of California, San Diego, and Steven Ferris of New York University.
Ferris denies his name was simply pasted onto the study and said he was involved in both the research and in writing the article. "I am livid about it," he said in a telephone interview.
Thal died in a plane crash in 2007 but was a prominent Alzheimer's expert who would have been able to catch any errant data showing a risk of deaths or stroke, Ferris added.
"We did participate in the study and we did participate in the process of producing the final manuscript," Ferris said.
Vioxx studies often used "ghost authors"
A review of industry documents from the litigation surrounding Vioxx, the arthritis pain reliever that was withdrawn from the market by Merck, Inc. in 2004, reveals that clinical trials and review articles published about the drug were often written by company employees or other unacknowledged authors, while an academically affiliated investigator, who may have had little involvement with the study or who did not always disclose sponsor-related financial support, was listed as the primary author.
Vioxx, also known generically as rofecoxib, is a pain reliever and anti-inflammatory drug approved by the U.S. Food and Drug Administration in 1999. The drug was considered particularly useful because it provided the effects of non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen, without causing the gastrointestinal side effects also seen with NSAID.
By 2004, enough reports associating the drug with a significant increase in heart attacks and strokes were received that it was withdrawn from the market. Since then, there has been considerable controversy and along with the lawsuits, questioning how long Merck had been aware of these potentially fatal side effects and how the drug was able to received FDA approval.
"This case-study review of industry documents related to Vioxx demonstrates that Merck used a systematic strategy to facilitate the publication of guest-authored and ghost-written medical literature," lead investigator Dr. Joseph S. Ross, from the Mount Sinai School of Medicine, and colleagues report in the Journal of the American Medical Association.
Ross' team evaluated the guest authorship and ghostwriting related to Vioxx by reviewing court documents and medical literature. The court documents were generated primarily between 1996 and 2004. Roughly 250 documents were included in their review.
For the clinical trials, their findings indicate that Merck researchers often prepared the manuscripts and then sought out academically affiliated investigators to collaborate as guest authors. These recruited authors were then frequently listed as either the first or second author, indicating that they lead or provide guidance for the study.
For scientific review articles, Ross' team found that Merck marketing employees would develop manuscript plans, contract a medical publishing firm to ghostwrite the manuscripts, and then recruit external, academically affiliated researchers to be the authors.
The results indicate that 92 percent (22 of 24) of clinical trial articles published disclosed financial support from Merck. By contrast, just 50 percent (36 of 72) of the review articles published disclosed sponsorship from Merck or financial compensation to the author from Merck.
In a related study of litigation documents, Dr. Bruce M. Pasty and Dr. Richard A. Kron mal, from the University of Washington in Seattle, found evidence that Merck may have misrepresented the risk-benefit profile of the Vioxx in trials of patients with Alzheimer's disease or cognitive impairment. In particular, the drug's mortality risk may have been minimized.
"Primum non nocere does not only hold true for physicians directly treating patients, but also holds true for all involved in medical research, biomedical publication, and medical education," Drs. Catherine D. DeAngelis and Phil B. Fontanarosa, editors with JAMA, write in a related commentary.
"When integrity in medical science or practice is impugned or threatened -- such as by the influence of industry -- patients, clinicians, and researchers are all at risk for harm, and public trust in research is jeopardized."
SOURCE: Journal of the American Medical Association, (Juni
2008)
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