"Safe and Effective?"

Does FDA Approval Guarantee Safety?

It’s hard to watch your favorite show or the news without being bombarded with pharmaceutical commercials promoting their latest “safe and effective” drug or medical treatment. Even the mass global COVID vaccination program touted the Emergency Use Authorized vaccines as “safe and effective” and parroted by everyone from the POTUS, celebrities, sports figures, local and state politicians, church leaders, and our doctors.

Most people assume “safe and effective” means the product has been properly reviewed and the data analyzed by the FDA. I know that’s what I used to think until my husband’s tragic death from Zoloft-induced suicide which was advertised and prescribed by doctors as “safe and effective.” Just because a drug or device is FDA-approved, it does not mean the product is guaranteed to be safe.

Unfortunately, what we didn’t know is the FDA’s approval process favors drug companies over consumers like Woody, and FDA approval does NOT necessarily guarantee safety. In fact, Big Pharma actually pays for the majority of drug safety reviews through their application process ; provides the data for the FDA review, and trending towards using some sort of fast tracking regulatory pathway (like Breakthrough Therapy Designation, Accelerated Approval or even Emergency Use Authorization) which greatly speeds up approval with fewer clinical trials.

“FDA approval is based on evidence — provided by the company that makes the medical product — that the benefits of the product outweigh the risks for most patients for a specific use. It doesn’t necessarily mean the product is safe.”

Diana Zuckerman, president of the National Center for Health Research

Over the years, I have participated in several trainings in Washington DC about the FDA approval process. It is eye-opening and would recommend everyone have a general understanding of the FDA approval process. The MISPLACED TRUST article above from Drug Watch gives a good, easy to understand overview of the FDA approval process.

Today, I am a voting member on the FDA Psychopharmacologic Drugs Advisory Committee reviewing drug company provided data and making recommendations to the FDA regarding new products. This has given me even further insight into the FDA process. Safety will always be my priority as a committee member. Drugs often get approved and put on the market, assuming that the FDA has REMS (Risk Evaluation and Mitigation Strategies) guardrails in place to catch safety signals.

Unfortunately, I have witnessed too many times where the advisory committee members voted to approve the product despite raising safety concerns. Take Nuplazid for example. Our FDA Advisory Committee voted 12-2 for the Parkinson psychosis drug using Breakthrough Therapy designation. The news media touted it as “break through” treatment despite only being tested in a 6-week study of less than 200 total patients (split between placebo and treatment group). Of course, “break through” means something different to desperate families looking for treatments. They want hope.

The only two NO votes were from myself and the patient representative who lives with Parkinson’s disease. At the time of the FDA Advisory Committee I remember thinking the marginal benefits do not outweigh the potential risks including death. In good conscience I couldn’t vote to approve this new treatment.

Sure enough, two years later there were many reports of deaths and CNN started to investigate.

“Physicians, medical researchers and other experts told CNN that they worried that the drug had been approved too quickly, based on too little evidence that it was safe or effective. And given these mounting reports of deaths, they say that more needs to be done to assess Nuplazid’s true risks.”

What I have come to learn is clinical trials present the best case scenarios with ideal conditions in a controlled setting. However, that’s not how the real world works when given to millions and mixed with person’s lifestyle, co-morbidities and other medications.

We should always have a health dose of skepticism when we hear “safe and effective.” It just might save your life.