Blog | Wednesday, March 30, 2016

Protecting human subjects in medical research

There was a tragedy in France recently that did not involve offensive cartoons, radicalized jihadists or terrorists masquerading as refugees. Innocent French citizens were taken down by a profession whose mission is to heal and comfort. A medical clinical trial careened off the rails and crashed. Ninety volunteers were in a study testing the safety of a psychiatric medication. One is dead and others have suffered irreversible brain damage. While a horrible outcome is not tantamount to guilt, this is a deeply disturbing event that must be investigated.

Were these volunteer study patients properly informed? Are medical study patients here in the U.S. truly making a free choice?

From time to time, friends, patients and relatives ask my advice if they should participate in a medical experiment. While I am a doctor, I usually say no. And, once I explain to them the realities of medical research, they usually say no also.

While my colleagues may chastise me for not encouraging my patients to join clinical trials, my primary obligation is to advocate for the patient before me, not for society. If physicians contemplate changing this ethical construct to consider the greater good when we advise patients, then we need to engage the public in a serious conversation on this issue.

When an individual joins 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 help an ailing relative. I get this. I wonder, however, how many of them would sign up if they knew that they would be unlikely to personally benefit.

There are 3 powerful conspiring forces that may exert undue influence on prospective study patients:
• Medical research needs a steady diet of new study recruits. In other words, the beast must be fed.
• Medical investigators often have biases favoring their research and truly believe that the new drug or treatment has a real chance of helping study patients. Phrasing such as “preliminary results are quite promising” may be well intentioned, but may be beyond the facts.
• Patients, particularly those who are not responding to conventional treatment, are vulnerable.

Here's the truth. Medical research projects and clinical trials 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 assert that a study patient won't realize a favorable result, but this serendipitous outcome is not the study's planned yield.

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

Is someone you love struggling against Alzheimer's disease? Our Neurological Institute has been fighting hard against Alzheimer's disease and is now testing a new drug to help conserve memory. Call for confidential information. Doesn't this wording suggest direct benefit toward volunteers? Are study participants, in fact, facing risks without benefit?

I strongly support medical research which is our source of future cures and treatments. The medicines and treatments that we use today are the result of years of research done years ago. We need to generously fund our respected research institutions. But, we must ensure that the research community adheres to the highest ethical standards, and that any breaches are exposed and remedied. There's a reason that the term informed consent contains the word informed. Uninformed or misinformed consent can't be tolerated.

We will find out soon enough if the French study subjects were given all the information they were entitled to, and if investigators and others behaved properly. Even if no lapses are discovered, it will underscore that experimental treatment has unknown risks, which may be devastating. In other words, investigators may be unaware of the full extent of a study's risks. Hence, patients aren't fully aware either.

If you want to join a medical study to serve humanity and not yourself, then you are free to make this informed choice, and I applaud your decision. Helping others is a praiseworthy act. So is telling the truth.

This post by Michael Kirsch, MD, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.