Tuesday, August 5, 2008

Saving the Medical Literature from Sponsorship Bias

Doucet and Sismondo, of the Philosophy Department of Queen's University in Ontario, recently wrote about the problem of sponsorship bias in the medical literature (http://jme.bmj.com/cgi/search?andorexactfulltext=and&resourcetype=1&disp_type=&sortspec=relevance&author1=doucet&fulltext=&volume=34&firstpage=; access requires subscription)

Doucet and Sismondo cite their fellow Canadian philosopher, Arthur Schafer, who wrote about his "sequestration thesis" in the same journal. In turn, I relied on Schafer's work to develop my own "divestment strategy" in HOOKED.

In summary, the present authors review the extensive evidence showing undue sponsorship bias, and the specific ways that medical journal reports of pharmaceutical trials may introduce inappropriate commercial bias. They then look at three commonly proposed solutions--increased financial disclosure; the CONSORT standards; and trial registries--and show precisely how each is able to address only a small portion of the different causes of inappropriate bias. They conclude that only radical changes, removing industry financing largely from drug trials, will be effective in the end (while acknowledging the political difficulty of implementing the radical changes).

Doucet M, Sismondo S. Evaluating solutions to sponsorship bias. J Med Ethics 34:627-30, 2008.

1 comment:

Anonymous said...

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 is based upon information and belief.