Blog | Monday, June 25, 2018

Are clinical trials safe? The risks of medical research


The day before I wrote this, I read about a research fiasco where 3 individual were blinded after receiving stem cell injections into their eyes. This research was done in a physician's office and cost each patient $5,000. What a tragic outcome. At least two of these patients discovered that this treatment was available by clicking on ClinicalTrials.gov, a name that suggests government approval, which is not true. Clearly, the name of this website is deceptive. Neither the Food and Drug Administration or the National Institutes of Health had any endorsement or sponsorship role here. Moreover, press reporting indicates that these patients had scant medical evaluation prior to and following the medical procedure.

Note to readers:
• Legitimate clinical trials generally do not charge patients for participation.
• Legitimate clinical trials have intensive evaluation to screen patients for eligibility. Many or most patients may be excluded because of specific requirements of the study. Adhering to these requirements is what helps to make a medical study valid.
• Legitimate clinical trials have a rigorous informed consent procedure.
• Legitimate clinical trials have aggressive follow-up after the experimental procedure so that results and adverse reactions can be measured and recorded.
• Legitimate clinical trials aim to publish their results in peer reviewed journals.

Ophthalmologists have commented that injecting both eyes with an experimental treatment on the same day is an obvious deviation from acceptable research practice. Think about it. Wouldn't you want to inject only one eye at a time for reasons that need not be explained?

Like every doctor, I prescribe medications and treatments that are not approved by the FDA, a practice that the FDA supports. Much of my advice is based upon my knowledge and experience, and may not be supported by sound medical evidence. This is not because I am a quack, but because we don't always have medical evidence for a patient's particular medical issue. Should we tell such a patient to return in a decade or two when the supportive evidence is available, or should we use our medical knowledge and judgment as best we can to address the current issue?

However, if I am prescribing a medicine to you off label, meaning for a purpose not officially approved by the FDA, I won't call it “research” or refer to it as a “clinical trial.” It's simply an ordinary day in the practice of medicine.

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.