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 (FDA) 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?
The Human Eye - Handle with Care!
Like every doctor, I prescribe medications and treatments that are not approved by the FDA, a practice which 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.
When you say “may not be supported by sound medical evidence“, you are a bit misleading and unnecessarily disparaging to yourself and the rest of us. Evidence may be anecdotal and still sound. Evidence may be from well appearing research and still be completely wrong.ReplyDelete
However, I was struck in “The Emperor of all Maladies”, how cavalier and deceitful some researchers can be.
There's a dictum taught to practitioners, don't be the first or the last to use something new.ReplyDelete
Some things become common practice, not because there is the formality that goes with FDA approval but because it is in widespread use. While there is technically only one betablocker specifically approved for hyperthyroidism, any one will ablate the symptoms so the choice becomes sometimes its pulmonary advantages or once a day use rather than the fda approval. Many drugs are like that in all specialties, and economically in this day of cost concern help maintain a competitive market. We are not experimenting on patients in the office without their consent and are generally in accordance with community standards of care.
the error may be in too loose a criteria to be part of a clinical trials list. in the .gov imprint is to provide protection to citizens, which is pretty much why government exists at all, it needs to screen those studies that want to be listed so that the world of medical research stays somewhat above the caveat emptor level