Trial by Coercion?
'Coercion' is a word sponsors of clinical trials never want used to describe their treatment of participants. Why? I can think of at least three reasons. It runs counter to federal regulations governing clinical research. It certainly isn't good for public relations. And it makes it difficult to recruit volunteers for future studies.
Coercive situations range from the merely questionable to the outright illegal, bordering on evil. Some ethicists would argue that any payment for participation in a clinical trial (other than simply reimbursing for expenses such as transportation to and from a clinic) may induce someone to volunteer for a study, possibly putting themselves at risk, when they would not ordinarily do so. If the individual would not normally take the risk, then the payment could be considered coercive. On the other end of the spectrum is the nursing home resident who is told her family wants her to participate and, if she doesn't, family members will be angry with her and may stop visiting.
Take the recently-reported allegations against a large for-profit clinical testing center, SFBC International, Inc. Bloomberg.com reported in November that research participants complained that they were threatened with deportation (the volunteer participants were immigrants living in Florida) if they did not sign statements retracting their initial responses to questions from journalists about their clinical trial experiences. Whether or not officials of SFBC did, in fact, make such threats is irrelevant. SFBC has reportedly agreed to meet with staff of Senate Finance Committee Chairman Charles Grassley concerning clinical trial practices in general. In any case, if such threats were made or even implied, they would constitute a coercive behavior.
Think about it. If research participants are 'volunteering' because they are being threatened, then their participation is not really voluntary at all. And if their responses to questions concerning their clinical trial experience are being shaped by the circumstances under which they are being questioned, then the science goes completely out the window because their answers are not freely given.
Coercion in clinical research is poor policy and lousy science. Such practices are not common, thankfully. But, if you are a clinical trial participant and feel you are being coerced, either bring your concern to the attention of the research team or the Institutional Review Board (IRB) overseeing the study... or withdraw from the study.
-Joe
Related Topics: Ethics and Medical Research Can Go Hand in Hand, Clinical Trials: Are they safe?
Coercive situations range from the merely questionable to the outright illegal, bordering on evil. Some ethicists would argue that any payment for participation in a clinical trial (other than simply reimbursing for expenses such as transportation to and from a clinic) may induce someone to volunteer for a study, possibly putting themselves at risk, when they would not ordinarily do so. If the individual would not normally take the risk, then the payment could be considered coercive. On the other end of the spectrum is the nursing home resident who is told her family wants her to participate and, if she doesn't, family members will be angry with her and may stop visiting.
Take the recently-reported allegations against a large for-profit clinical testing center, SFBC International, Inc. Bloomberg.com reported in November that research participants complained that they were threatened with deportation (the volunteer participants were immigrants living in Florida) if they did not sign statements retracting their initial responses to questions from journalists about their clinical trial experiences. Whether or not officials of SFBC did, in fact, make such threats is irrelevant. SFBC has reportedly agreed to meet with staff of Senate Finance Committee Chairman Charles Grassley concerning clinical trial practices in general. In any case, if such threats were made or even implied, they would constitute a coercive behavior.
Think about it. If research participants are 'volunteering' because they are being threatened, then their participation is not really voluntary at all. And if their responses to questions concerning their clinical trial experience are being shaped by the circumstances under which they are being questioned, then the science goes completely out the window because their answers are not freely given.
Coercion in clinical research is poor policy and lousy science. Such practices are not common, thankfully. But, if you are a clinical trial participant and feel you are being coerced, either bring your concern to the attention of the research team or the Institutional Review Board (IRB) overseeing the study... or withdraw from the study.
-Joe
Related Topics: Ethics and Medical Research Can Go Hand in Hand, Clinical Trials: Are they safe?
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Dear Doctor, What did you think about the new movie "The Constant Gardener"? Do large drug companies actually perform dangerous clinical trials in other countries where poverty and greed trump ethics?
Yes, it is possible, especially in developing countries, for unethical clinical research to be conducted. And yes, it has been done. That said, it is in the best interest of major pharmaceutical firms not to exploit participants. The world is taking note of where and how clinical research that is used to win FDA approval of a new drug is done. No, it's not ethically defensible. And soon, with the world watching, it won't be practical as a business strategy.
Recently published on 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 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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