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.