Vioxx Study Ghostwriters

A New York Times article from yesterday details the gross practice of giant pharmaceutical companies using ghostwriters to draft research studies on their own drugs, and then finding “prestigious doctors” who are well recognized in the medical community to lend their names as authors of the piece. The NY Times article was actually reporting early on the finding of an academic journal article that is to be released today by JAMA (Journal of the American Medical Association).

In this case, the big pharma culprit was Merck. Evidence of the practice was discovered through litigation procedures over Vioxx, a hugely popular arthritis drug that GAP client (and FDA Safety Officer) David Graham exposed as causing at least 40,000 fatal heart attacks to Americans by 2004, when it was removed from shelves.

Besides numerous other pieces of evidence, one ‘smoking gun’ was:

The article cited one draft of a Vioxx research study that was still in want of a big-name researcher, identifying the lead writer only as “External author?”

Nice. The lead author of the JAMA article put this latest revelation in perspective pretty well:

“It almost calls into question all legitimate research that’s been conducted by the pharmaceutical industry with the academic physician.”

This isn’t just a few select research papers, either:

For example, in 16 of 20 papers that reported on clinical trials, a Merck employee was designated as the author of the first draft of the manuscript. But an outside academic scientist was listed as the lead author when the study was published.

Finally, the article details a JAMA editorial that calls for changes to be made to correct this situation:

In an editorial on Wednesday, the journal said the analysis showed that Merck had apparently manipulated dozens of publications to promote Vioxx.

“It is clear that at least some of the authors played little direct roles in the study of review, yet still allowed themselves to be named as authors,” the editorial said.

The editorial called for immediate changes in the practice, calling upon medical journal editors to require each author to report his or her specific contributions to articles.

That’s exactly what should happen. Transparency is absolutely essential when dealing with drug studies. Deceptions of study authorship undermine American public health and consumer confidence of the FDA’s ability to protect patients. Of course, that confidence is pretty low nowadays anyway.

-- Dylan Blaylock

Comments

[Dan Abshear]

The Human Injury of Lost 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
Author's note: What has been written was based upon information and belief.