|P.Mean: Sneaking ineligible patients into a clinical trial (created 2009-10-30).|
There was an interesting article in the New York Times:
- Chen PW. Bending the Rules of Clinical Trials. The New York Times. October 29, 2009. [Accessed October 29, 2009] Available at: www.nytimes.com/2009/10/29/health/29chen.html.
that described a terminal cancer patient and the doctor's goal to get them access to a new experimental drug, even though the patient was not eligible for the clinical trial that was studying this drug. It's a difficult situation for doctors. Do you do what's best for the patient in front of you, knowing that the data collected from this patient might corrupt the findings of the clinical trial?
Apparently a large number of doctors think it is okay to use fraudulent methods to enroll an otherwise ineligible patient into a clinical trial if that is the only way to get access to a new experimental drug. The results of a survey on this appear in
- Charles W. Lidz, Paul S. Appelbaum, Steven Joffe, Karen Albert, Jill Rosenbaum, and Lorna Simon, "Competing Commitments in Clinical Trials," IRB: Ethics & Human Research 31, no. 5 (2009):1-6. Abstract available at www.thehastingscenter.org/Publications/IRB/Detail.aspx?id=3890
The New York Times article pointed out some of the problems with enrolling an ineligible subject, including having the drug falsely tainted with adverse events because patients who were prone to certain adverse events were not excluded from the trial. A weblog about the article invited individual responses:
Here's what I submitted.
Let's be honest with terminology. Misrepresenting your patient's status is fraud. Obtaining free care and access to new treatments for your patient through the use of fraud is theft.
Is it okay to use fraud and theft to benefit your patient? Even if no other party is suffering through your use of fraud and theft, this conduct conflicts with the basic ethical principle that the ends never justify the means.
But there are other victims of this fraud and theft: the drug company who ends up subsidizing the care of a patient who will, at best, provide no useful information to the company. The other volunteers in the study, who are doing this, not for their own benefit, but for the benefit of others who have the same disease are also harmed when someone joins their ranks for a fraudulent goal. And the future patients who have to live with a distorted evidence base are probably the greatest victims.
We do need more humane rules for the availability of experimental drugs for patients with an otherwise hopeless prognosis. I can understand why a patient with a terminal diagnosis might be interested in this course of action, but what excuse do the doctors themselves have? They are willing to lie and steal in this setting, not because their own life is at stake, but because they want to please the paying patient in front of them at the expense of other doctors' patients. It frightens me to think what they are probably doing with their tax returns.
A bit harsh perhaps. What do you think?
This work is licensed under a Creative Commons Attribution 3.0 United States License. This page was written by Steve Simon and was last modified on 2010-04-12. Need more information? I have a page with general help resources. You can also browse for pages similar to this one at Category: Exclusions in research.