Tuesday, April 08, 2008

The Scientific Misconduct Wiki (Procter and Gamble)

Unlike static websites, the blogging paradigm allows a great deal of collaboration and interchange between people (witness the rallying of support for Bob Fiddaman over the legal threats he received from GSK). Investigative journalism through Blogs has becoming increasingly important. It is fair to say that the majority of concerns raised about the ENHANCE trial of Vytorin have been brought to light by investigative bloggers, Forbes magazine and the Wall Street Journal. The immediacy of blogs (and news reports) makes it hard to develop a body of systematic evidence, or to get keep historical perspecive. A Wiki provides a different model which allows both collaboration and systematic collection of information.

I have therefore started the Scientific Misconduct Wiki to run in parallel with this blog. Hopefully this will form the seed of a peer reviewed online journal devoted to Scientific Integrity. For the moment, it will serve as a non-collaborative repository for reports and academic analysis of the integrity scandal involving Procter and Gamble and the drug Actonel (including the serious implications of the failed but rather sad attempts at coverup and delay by "regulators"). I will add to the collection in parallel with the blog postings. Currently, the Wiki contains all of the Collated News Reports about the Actonel story to set a framework and timescale for discussion of the science and principles.

Most recent in the news listings is this paper by Professor Martin Bland on the statistical re-analysis and attempted reconstruction of the first of the three implicated P&G publications. (Bland, M. 2007. "Risedronate, the BBC and me". Significance - Royal Statistical Society:@ 4:4:175-178). The reanalysis of the second of the three publications is here.

Here is the raw data eventually provided by Procter and Gamble in April 2006 [Link] that formed the supposed basis of three P&G publications (two only in draft) as well as many scientific meeting abstracts. Under the circumstances, P&G should have allowed an open statistical analysis, but they have refused to allow such open scrutiny. The data is therefore encrypted (see "Procter & Gamble - Let's take the high road"). Nevertheless, please join the people who downloaded it previously.

This refusal of openness is unexpected, because P&G no longer have much to hide. P&G and "authors" (of publication 1) have of course admitted to all of the key "errors" in the first publication. The problems in the second and third publications were similar, but even more overt. Authors have also admitted to having been less than truthful over access to data - the central problem. Of ongoing concern is the refusal by P&G to provide confounding variables to authors, and more perversely the refusal to provide the wording of consent forms that patients would have signed.

If anyone would like to assist as editor of a peer-reviewed Wiki-based Scientific Integrity Journal, please let me know.

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1 comment:

Anonymous said...

From www.brainblogger.com:

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 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.

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, as the 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, along with the promise of 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.

Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns. 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 is 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