Critics of the pharmaceutical industry have long complained that drug companies resort to unscrupulous tactics to market their wares, handpicking friendly researchers (to whom they pay handsome consulting fees) for clinical trials, ghost-writing the results, and running studies for the express purpose of encouraging the adoption of new drugs. Such studies are known as "seeding" trials, and a new report in the current issue of the Annals of Internal Medicine reveals in disturbing detail how one company -- Merck -- paid for, ran and published such a seeding trial without bothering to tell the so-called authors of the study its true purpose: to encourage the use of Vioxx among primary care physicians. Indeed, as the editorial accompanying the report notes, "...deception is the key to a successful seeding trial. Institutional review boards, whose purpose is to protect humans who participate in research, would probably not likely approve an action that places patients in harms' way in order to influence physicians' prescribing habits."
As the Annals report notes, the seeding trial itself had little scientific merit. At the same time the it was launched, Merck was also starting the VIGOR trial to be the "definitive study of gastrointestinal toxicity." Interestingly enough, both the seeding trial, known as ADVANTAGE, and the VIGOR trial, uncovered the increased cardiac risk for Vioxx compared to naproxen, although as the world now knows, that risk was underestimated when the VIGOR study was first published in the New England Journal of Medicine in 2000.
The true purpose of the ADVANTAGE trial only became apparent because the extensive litigation around Vioxx unearthed internal Merck documents that showed the extent to which its marketing department had planned and run the whole shebang. As this and other cases illustrate, it is very difficult to get an inside view of drug company tactics short of a subpoena or official law enforcement request. Indeed, it took both to pry out of GlaxoSmithKline internal documents that showed the extent to which the pharmaceutical giant had tried to suppress negative results about the safety and effectiveness of its blockbuster antidepressant, Paxil.
As I reveal in Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial, GlaxoSmithKline only gave up these damaging corporate documents after an official request from the New York Attorney General's office and a subpoena from lawyers representing the families of teenagers who killed themselves on Paxil or tried to. The resulting New York AG lawsuit essentially forced GlaxoSmithKline to post the results of all its clinical trials, negative as well as positive, on a publicly available website and led to other reforms as well. Yet such valuable "windows" into the drug industry could be closed if the US Supreme Court allows federal agencies to "pre-empt" state lawsuits against the drug industry. That is something none of us should wish for.
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The nine Merck documents cited in the Hill paper, and others, can be viewed at the University of California's Drug Industry Document Archive (http://dida.library.ucsf.edu) by entering "cs:humeston" without the quotations in the query box.
Kim Klausner
Digital Libary Manager
The Injury Of Objectivity
If I were to rate the corruptive tactics performed by big pharmaceutical companies, the intentional corruption of implementing fabricated and unreliable results of clinical trials would be at the top of the list. Pharmaceutical companies manipulate the trials they sponsor because of their power to control others involved in the process largely absent of regulation. This is a matter of requiring authenticity and, more importantly, assuring the safety of the public health.
Decades ago,
clinical trials were conducted in academic settings that focused on the acquisition of knowledge and the completely objective discovery of novel medicine. Then, in 1980, the Bayh-Dole Act was created, which allowed for such places to profit off of their discoveries that were performed for pharmaceutical companies in the past. This resulted in the creation of for-profit sites, called Contract Research Organizations (CROs), which are composed of community research sites with questionable investigators void of necessary experience or quality regarding their research purpose and ability. Since they are for-profit, the trials conducted at CROs are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner has been transformed into a method of marketing, which includes altered results of the trial to favor the sponsor’s medication. Their activities are absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit the collusive relationship between the site and the sponsor.
Further disturbing is that once the trials are completed, the medical articles are then written by ghostwriters, who are not identified and acknowledged by the sponsor, and are not trained in clinical research overall, as they are simply freelance writers. How often ghostwriters are utilized by pharmaceutical companies remains a mystery. This activity removes accountability and authenticity of the fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring an author to be placed on the trial that likely had no involvement with the trial, and, along with others, was paid by the sponsor. To have the trial published, the sponsor pays a journal, along with the promise of purchasing thousands of reprints of the study from the journal. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers and research sites to support the industry. So benefits of medicine studied in such a malicious way can potentially harm patients and their treatment options. The purchased reprints are distributed to the sponsor’s sales force to share the content with prescribers — your doctor.
Such misconduct impedes research and the scientific method with frightening ethical and harmful concerns. Our health care treatment with medications is now undetermined in large part in such situations, as well as the objectivity that has been intentionally eliminated regarding the trust in the scientific method in this type of activity illustrated in this article. More now than ever, meds that are removed from the market are given black box warnings. Now I understand why this is occurring.
The pharmaceutical industry needs transparency and disclosure in order to correct what we have historically relied upon for conclusive proof — the scientific method. More importantly, research should not be conducted in a manner that the sponsor can interfere in the ways I described in this article. We should call for independent sites with absolutely no involvement with the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion. Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course. We can no longer be dependent on others for our optimal health. Knowledge is power, and is also possibly a lifesaver.
Ethics and Science need to shake hands.
– Richard Cabot
Dan Abshear (published on www.brainblogger.com)
Author’s note- Similar claims validate the above on www.plos.org
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