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Before you join a clinical trial: Read this first

Michael Kirsch, MD
Physician
April 11, 2017
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From time to time, friends, patients, and relatives ask my advice on participating in a medical experiment.  My response has been no.  More accurately, once I explain to them the realities of research, they don’t need to be persuaded.  They back away.

Here’s the key point.   When an individual volunteers to join a research project, the medical study is not designed to benefit the individual patient.  This point is sorely misunderstood by patients and their families who understandably will pursue any opportunity to achieve some measure of healing for an ailing individual.  I get this.

In addition, I believe that these research proposals are often slanted in a way to suggest that there may direct benefit that the patient will receive.  I am not accusing the medical establishment of uttering outright falsehoods to prospective study patients, but there are two powerful forces that may incentivize investigators to recruit patients with undue influence.

The Medical Research Industrial Complex is a voracious beast that needs a steady diet of new recruits.  In other words, the beast must be fed.

Investigators have bias favoring their research and truly believe that the new drug has a real chance of helping study patients.

The truth is this:  In general, research projects are designed to generate new knowledge that will be used to help patients down the road, not those in the study.  Of course, I cannot state with absolute certainty that a study patient won’t realize a favorable result, but this serendipitous outcome is not the study’s planned yield. It should be viewed as a happy accident.  This is why the study is properly called a research experiment.

Beware of the packaging.  If your mom or dad has Alzheimer’s disease, of course, you would be susceptible to the following hypothetical pitch:

Is someone you love struggling with Alzheimer’s disease?  Our Neurological Institute is fighting hard against this disease and is now testing a new drug to help conserve memory.  Call for confidential information.

Recently, in France, 90 volunteers took a study medicine testing the safety of a psychiatric medication.  One volunteer is now dead, and others have suffered irreversible brain damage.  We don’t know the underlying facts yet.  While a horrible outcome is not tantamount to guilt, this is a terribly troubling event that must be sorted out. We will find out soon enough if the French study subjects were given all the information they were entitled to, and if the investigators and others behaved properly.  The investigation that must be full and fair.  A conclusion of c’est la vie won’t be enough.

If you want to join a medical study to serve humanity — and not yourself — then you are free to make an informed choice.  Be mindful of the risks including those that are not known.

Helping others is a praiseworthy act.  So is telling the truth.

Michael Kirsch is a gastroenterologist who blogs at MD Whistleblower.

Image credit: Shutterstock.com

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