Thursday, January 3, 2008

Guinea-Pig Ethics

Carl Elliott’s excellent article on “Guinea-Pigging” in the forthcoming January 7 New Yorker (only the abstract is available on-line) educated me about a topic I should have known about already – the inner workings of pharmaceutical contract research organizations.

Over the past decade, pharmaceutical companies have increasingly outsourced the conduct of clinical trials to contract research organizations. CROs are big business. Revenues are estimated at close to $18 billion. The largest 10 firms enrolled more then 640,000 subjects in trials in 2004.

“Guinea-Pigging” is the insider term for the job of research subject in a CRO project. This isn’t volunteering from altruistic motives as patients of mine with HIV and cancer have done to contribute to scientific progress in an area they care about. It is a job, and not an elevated one. A guinea pig for a sleep study described the work as a form of prostitution – “I would sell my body not to slobbering johns who assail the street whore with their unkempt organs, but to slick, white coated neuropsychologists who use thrice sterilized catheters, electrodes…and invasive thermometers to get what they want.”

Readers who, like me, do not yet know in any detail about the recruitment of healthy subjects for CRO studies can visit Guinea Pig Zero, defined as a "jobzine for people who are used as medical or pharmaceutical research subjects." And, as well, websites for large CROs, such as Pharmaceutical Product Development, Charles River Laboratories, and Covance.

CROs are at the heart of the development of new treatments, but they have largely been under the radar in terms of recognizing just how important they have become. Subject recruitment is becoming a worldwide industry. I look forward to learning more about the area in the next few months. We owe Carl Elliott thanks for bringing questions about the ethics of the role -- safety, compensation, and non-exploitation, to the fore.


Anonymous said...

Thanks for the post. There's also a book about guinea pigging by Robert Helms (who was quoted in The New Yorker article). It's called Guinea Pig Zero.

Jim Sabin said...

Hi Darby -

Thanks for the link to the Helms book. Have you read it? His website is informative, well-written and engaging.



Anonymous said...

Published on

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