I read an Op-Ed piece in the New York Times this week that discussed “Seeding Trials” and potentially dangerous effects of these types of trials. According to the article, a seeding trial appears to be a clinical trial, however it is more of a marketing device aimed to familiarize doctors with new drugs. In fact, doctors who are apart of the study are often paid for each test subject they recruit. By having such an integral role in the trial, doctors are more likely to prescribe the drug after the study.
The FDA does not view seeding trials as illegal because the drugs have already been approved. The primary purpose of these trials is to promote the use of the drug amongst doctors with pseudo studies. What’s more alarming is that patients within these studies have died or suffered adverse consequences as a result. They are often unaware of exactly what they are signing up for; they enter these studies with hope that their condition will be helped.
The research trials are approved by Institutional Review Boards, or IRB’s, unfortunately the IRB’s are for profit organizations that often paid by the sponsors of the studies they evaluate. Last week, the FDA announced it would re-examine its rules governing the interest and protection of human subjects. Perhaps the next steps will be to establish an independent review board that will be financially and administratively separate from the research it evaluates.
The author’s point is one that should be considered in any type of research; patients volunteer for research with the hopes that the knowledge generated will benefit others. They should not be deceived in participating. An editorial published in the Annuls of Internal Medicine by Dr. Harold C. Sox states that a seeding trial appears to have, “[an] apparent purpose is to test a hypothesis…the true purpose is to get physicians in the habit of prescribing a new drug.” Any practicing Physician should agree that a medication, supplement or treatment only be prescribed for the health benefit of the patient. Prescriptions and treatments should not be given for the financial gain or other benefit of any other person or entity. Primum non nocere.