We posted first here in 2005, then here, here, here, here, here, here, here and here about the story of Dr Aubrey Blumsohn's dispute with Procter and Gamble (P&G) and the University of Sheffield in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Some of the analyses done by P&G seemed biased in favor of the drug. Despite repeated attempts, P&G would not give Blumsohn access to the raw data of the project. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him. As far as I can tell, he eventually lost his academic position at the university, and has not been rehired. Also as far as I can tell, these events have never been the subject of open hearings at the university, or of investigations by any outside body.
This week, Dr Blumsohn, who now has quite a following (currently #53 on the Healthcare100 hit parade) for his Scientific Misconduct Blog, posted about the lack of response to a letter he wrote in 2005 to the UK Association of University Teachers (AUT), which later merged with another organization to form the University and Colleges Union (UCU). He also noted that the UCU has failed to respond for an even longer time to the case of a faculty member at another university who was dismissed apparently after her research (about the politically controversial topic of the characteristics of people seeking asylum in the UK) was found to be "incompatible" with that university. It is unclear why the UCU has ignored two cases in which universities sacrificed their faculty members' academic freedom to avoid offending the powerful. It is disgraceful that the case of Dr Blumsohn has never been publicly revisited at the University of Sheffield, and never been investigated by any academic or medical organization.
What befell Dr Blumsohn has been a continuing motivation for us to at Health Care Renewal. Sadly, it is hardly the only case of medical and health care academics who suffered because because what they said or wrote, no matter how true, offended those in power. Credible medical and clinical science will not long survive when scientists cannot draw conclusions that threaten vested interests. Academic medicine's credibility will not long survive in the absence of academic freedom.
Well-said, and I agree whole-heartedly. With the zealousness in which some academics protect encroachment on the privileges of tenure, it is surprising to me that so little ink has been spilled in tracing what happened to Dr. Blumsohn.
ReplyDeleteWhen will authorities respond?
ReplyDeletePublished on www.brainblogger.com
The Human Injury of Lost Objectivity
If I were to rate the corruptive tactics performed by big pharmaceutical companies during my intimate experience with them , the intentional strategy of implementing fabricated and unreliable results of clinical trials performed by others possibly top the list, as they often were sponsored by a pharmaceutical company. By this atrophy of the scientific method absent of authenticity, harm and damage is possibly done to the health of the public. Most would agree that the science of research should be sound and as sterile and aseptic as possible- completely free of interference. However, it appears, money and increased profits can be a catalyst for reckless disregard for human health that is largely unregulated. This is particularly a factor on post-marketing studies of various pharmaceutical companies because others seem to be deliberately ignorant.
Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of meds and devices to benefit mankind. Then, in 1980, the Bayh-Dole Act was created, which allowed for such places with their researchers to profit off of their discoveries that were performed for pharmaceutical companies and others in the past. This resulted in the creation of for-profit research trial sites, called Contract Research Organizations that are often composed of primarily community patient care clinics absent of any research training compared with the former. Because of this structure, investigators of these pharmaceutical sponsored trials are likely void by sponsor design of necessary research experience or quality regarding their research purpose and ability to ensure its sterility, yet benefit it’s supporter. These quite numerous CROS are in fact for- profit, with some CROs making billions of dollars a year.
The trials conducted at such places again are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their particular med being studied in the trial. Etiology for their deception regarding this manipulation is because the pharmaceutical company that sponsors such a trial is basically creating a marketing tool for this studied drug of theirs. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner ensures favorable results of the sponsor’s medication after the trial is complete. Their activities are again believed to be 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, as such sites are largely unregulated.
Further disturbing is that once the creation of the trials is completed, the research paper is often composed with specific directions by the sponsor to writers known as ghostwriters. 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 have their name be placed on the trial, while this hired author likely had absolutely no involvement with the trial, or even reviewing the trial is not asked by the hired author.
To have the trial published, the sponsor has been known to pay a journal, and the sponsor bribes the journal in a few ways, such as the sponsor purchasing from a selected journal thousands of reprints of their study from the journal, for example. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers mentioned earlier and progressively growing research sites to receive the support the pharmaceutical industry. So benefits of meds studied in such a malicious way potentially can harm patients and their treatment options along with clear safety risks. The purchased reprints bought by the sponsor of the study are distributed to the sponsor’s sales force to share the content with prescribers, with the sales force completely unaware about this manipulation. As a bonus, the sponsor may pay this journal to advertise their products to be placed in this journal as well.
Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns, as stated previously. If so, our health care treatment options with meds are now undetermined in large part due to such corruptive situations, as well as the absence of objectivity that has been intentionally eliminated with trials produced in this way. Trust in the scientific method in this type of activity illustrated in this article is absent and replaced with what could be harmful to others.
More now than ever, meds are removed from the market or are given black box warnings, which is basically eliminating future growth of the black box drug. 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 cannot in any way interfere in such ways described in this article, which would require independent clinical trial sites with no involvement of 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
Author’s note: What has been written was based upon information and belief.
The post and the latter response to it leaves me crestfallen. I tend to be on the idealist side of the moral spectrum but even the least rigid in this regard must be moved by these revelations.
ReplyDeleteThe depths to which profiteering has infiltrated the lattice of objective inquiry and applied science is amazing. Pharma seems to have "it" covered: funding of Universities on the one hand and control of extramural research on the other. And by nefarious means to say the least.
Sadly, given the dollar-is-king culture we now live in, in this flat-world of ours, regulation and windows of exposure will likely just spread around the muck instead of mop it up.
EA