MD Whistleblower

Yes, with an explanation.  Of course, if your doctor is prescribing a medicine, it must be approved by the Food and Drug Administration (FDA). But, it may not be approved for your specific condition.  Let me explain. The FDA is charged with determining when a drug is considered safe and effective and can be brought to the marketplace.  Bringing a drug from the research bench to the pharmacy is a complex and arduous process that takes many years, even when it’s running smoothly and on schedule.  As you might expect, there are often unforeseen obstacles that will extend the timeline to approval when the FDA requires more studies to address their concerns.  Often, the drug must be abandoned at some point in the process, after millions of dollars of R & D investment.  We should consider this reality before we demonize PhRMA reflexively, which has become sport today.  Guardians of Safety When a drug is ultimately approved, this approval...

Some time ago, a patient arrived to my office prepared to enjoy the joy of colonoscopy.  Many of the patients on my endoscopy schedule are scheduled by other physicians and gastroenterologists.   In other words, I meet many of them for the first time on their special day.   My task is simply to perform the procedure and to then refer them back to their medical professionals.   In general, the system works well as we have many checks to assure that there are no safety barriers to performing the requested procedure in an out-patient setting.   Even when I schedule a procedure on one of my own patients, my patient’s medical record will be reviewed in advance by another medical professional. While the system works well on the safety front, it is less effective on the medical necessity front.   When an endoscopy schedule is open to referring medical professionals, there will be instances when the medical necessity of the procedure is questionable.   T...

With some regularity, patients contact me requesting antibiotics.   Many patients regard this as a casual and routine request, but I don’t.  When I hit the ‘Send’ button authorizing an antibiotic – or any medication refill – I am declaring that I personally agree that the medicine is medically necessary.  In general, I sign off on most routine medication refill requests without issue, unless the patient hasn’t seen me in the past year or so.  I would hesitate to refill if patient communicates that his heartburn is worse and requests that I double the dose of his reflux medicine.  This patient will be asked to see me in the office. There are times that I will prescribe antibiotics without an office visit.   This assumes that there is an existing professional relationship between me and the patient and that the medical facts support sending in a prescription.   There also needs to be a reservoir of trust such that the patient would contact me if h...

Have you ever heard of a drug called Ozempic?   Just kidding.  As we all know, this medicine and numerous related drugs are the rage.  It is classified as a GLP-1 drug.  The percentage of my patients who are taking these drugs is steadily rising.  Of course, initially Ozempic’s purpose was in diabetic management.  Once it was discovered that weight loss was a ‘side-effect’, a new therapeutic mission was discovered.  Indeed, public demand to use this medicine off-label for weight loss has risen sharply.  Currently, there are two GLP-1 agonist medicines that the FDA (Food and Drug Administration) has approved for obesity treatment.  I can promise you that pharmaceutical R & D on similar and next-generation weight loss pharmaceuticals is supercharged.  Why the interest? There is an obesity epidemic in America. The medical, financial and societal consequences of obesity are staggering. Diet and exercise options are insufficiently ...