I noticed something strange about a couple of posters I covered at a recent conference. Both reported clinical trials on the same drug, and both acknowledged that the studies were supported by GlaxoSmithKline, the drug's manufacturer.
That wasn't strange. Pharmaceutical companies sponsor clinical trials all the time, and they frequently report the results of the trials (at least the favorable ones) at medical conferences.
What was strange was the authorship of those studies. In one study the first author was a physician at an obscure hospital in an obscure town in Ohio, and the other five authors were GlaxoSmithKline employees. In the other study four of the six authors were physicians at a private specialty practice in Southern California, and the other two authors were GlaxoSmithKline employees.
I suspect that the physician in Ohio and the physicians in Southern California were not truly the investigators who carried out the study or analyzed the results, and they almost certainly didn't write the poster presentations. They were "beards," enticed by GlaxoSmithKline to add the appearance of independence to studies that were designed and analyzed by company scientists, with the results written up in-house by a ghost writer.
This is an unfortunately common practice in the pharmaceutical industry, and GlaxoSmithKline is certainly not the only offender. One of the most highly publicized cases of ghostwriting by pharmaceutical companies involved Procter & Gamble, their osteoporosis drug Actonel, and a scientist named Aubrey Blumsohn, a pathologist, bone specialist, and formerly a professor at Sheffield Teaching Hospitals, Sheffield, UK.
Dr. Blumsohn relates this complex--and still evolving--story on his blog, and it's been covered fairly extensively in the press, including in a detailed article that appeared in Slate at the end of 2005. Briefly, after giving a $252,000 research contract to Sheffield Teaching Hospitals for a study on Actonel, Procter and Gamble employees analyzed the data and had a ghost writer prepare abstracts for several medical conferences, listing the Sheffield scientists as senior authors. Dr. Blumsohn suspected that the analyses may not have been kosher, and he requested access to the randomization codes that would allow him to conduct independent analyses. Incredibly, Procter & Gamble repeatedly denied the senior author of the study full access to the data that he himself had generated.
You'll have to read Dr. Blumsohn's blog for all the ins and outs of this astounding story. He ended up losing his job for daring to discuss that story with journalists. He finally did get access to some, but not all, of the raw data. He has reanalyzed this data and has begun publishing these re-analyses, which to no one's surprise are somewhat less favorable to Actonel than the original analyses.
In his latest blog post, Dr. Blumsohn describes how Procter & Gamble continues to act very strangely. He submitted an abstract of his reanalysis to be presented at an upcoming meeting of the International Bone and Mineral Society. As he is required to do by the society's disclosure rules, he acknowledged that the original research was supported by Procter & Gamble. Somehow, a mysterious Procter & Gamble scientist named Dr. Purple got a hold of this abstract in advance of publication and demanded that the society remove the funding disclosure. The society agreed at first, but when it became apparent after Dr. Blumsohn's complaints that he had not authorized the disclosure's removal, they put it back in. Dr. Blumsohn includes documentary evidence of his allegations on his blog, including the orginal abstract as well as email correspondence between the society and Dr. Purple (who may well have stepped out of a game of Clue, holding a candlestick in the conservatory).
I'm a writer myself, and I know honorable writers who ghostwrite scientific articles for pharmaceutical companies. I don’t believe that this, in itself, is unethical, as long as all the study's authors are aware that this is being done, as long as they have all had full access to the data, and as long as they endorse all of the study’s results and interpretations. Some medical journals have begun insisting that all co-authors of a paper describe their roles in the study and formally state that they endorse its results and conclusions. Perhaps the organizers of medical meetings should take similar steps.
Thursday, March 15, 2007
Ghost Writers on the Sly
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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 by pharmaceutical companies by hired third parties who manipulate these trials they sponsor because of their power to control others involved in such trials that is largely absent of regulation would be at the top of the list, and likely the most damaging to the requirement of authenticity and, more importantly, assuring the safety of the public health, as I understand that this does in fact occur.
Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of meds. 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 research trial sites, called Contract Research Organizations, which is often composed of community research sites with questionable investigators possibly void of necessary research experience or quality regarding their research purpose and ability. Since they are for- profit, with some CROs making billions of dollars a year. The trials conducted at such places are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their med being studied in 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 med. Their activities are absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit what may be a collusive relationship between the site and the sponsor.
Further disturbing is that once the creation of the trials is completed, they are then written by ghostwriters often, although no one seems to know how often. These people are not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers, as one does not need research training or certification in order to perform this function. Rarely do trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the sponsor. Also, these hired mystery writers are known to make about 100 grand a year. This activity removes accountability and authenticity of the possibly 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 for doing this deceptive act.
To have the trial published, the sponsor pays a journal to do this in various ways, I understand, such as purchasing thousands of reprints of their 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 pharmaceutical industry. So benefits of meds studied in such a malicious way potentially can harm patients and their treatment options and safety risks. The purchased reprints are distributed to the sponsor’s sales force to share the content with prescribers which may lack validity.
Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns, if in fact true based on reports by others. If so, our health care treatment with meds is now undetermined in large part with such corruptive situations, as well as the possible absence of objectivity that has been intentionally eliminated. Trust in the scientific method in this type of activity illustrated in this article is absent. More now than ever, meds are removed from the market are given black box warnings. Now I understand why this may be occurring.
Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method. More importantly, research should not be conducted in a way that the sponsor can interfere in such ways described in this article, requiring independent sites with no involvement with the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters. 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
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