This entry is courtesy our friends over at the Integrity in Science Watch, http://www.cspinet.org/integrity/. Their Sept. 8 press release features a rundown of sweetheart deals recently concluded between big drug firms and major universities, headlined by a 5-year, $25M deal between Harvard and GlaxoSmithKline giving GSK first rights to any patents generated by Harvard scientists around stem cell research. Equal numbers of GSK and Harvard reps sit on the steering committee to oversee this process. Similar deals listed by Integrity include UC-Santa Barbara, Cal Tech, MIT, U Mass, and Columbia all joining forces with AstraZeneca, and I previously blogged about UNC pretty much selling its school of public health to a commercial CRO (http://brodyhooked.blogspot.com/2008/09/cros-how-independent-really.html).
Perhaps the most intriguing part of the Integrity post is this comment: The drug industry is increasingly turning to campus-based researchers to supplement its own lagging research and development efforts, which have fallen on hard times. The number of new drugs coming out of industry labs and approved by the Food and Drug Administration is at record-low levels.
This analysis tends to confirm a trend that I suggested in HOOKED. It is really interesting that the assembly-line, merger-mania model of industrial research that the industry has favored heavily for the past 15-20 years has been such a bust. The industry thought that they could pretty much crank out useful and safe new molecules on demand if they just used a highly industrial system in which business efficiency and close links between R&D and marketing were the operative principles. Turns out, not so. So now the industry is coming back to the academic investigators, whose "inefficient" habits condemned them under the old regime. (Could it be that being really curious about how things work is actually a pretty good way to generate new scientific knowledge? Or that you really ought to try to understand basic mechanisms before you rush off to develop a new drug?)
This is of course good news for a University president frustrated with dropping NIH research budgets and the loss of tax revenues for higher ed., and who is looking to industry as the sugar daddy du jour. It is bad news for those of us concerned about the integrity of science and the huge conflicts of interest that arise when industry takes over the academic enterprise. The sad point is that there are, generally, pretty good ways to get the research done but also to maintain the integrity and separateness of the academic institution. To negotiate such a contract those on the U. side need a backbone, and a couple of other pieces of anatomical equipment best left unspecified in a family blog. In today's race to the pay window, too few universities seem to have the requisite anatomical parts. Even Harvard.
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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 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
(published on www.brainblogger.com)
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