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!
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.
ReplyDeleteHowever, 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.
ReplyDeleteSome 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