Why David Healy Is Wrong About the Safety of New Medicines
For the record, I am someone who believes that drugs should only be used when other modes of treatment fail. If you are newly diagnosed with high blood pressure, or you are found to be pre-diabetic, you shouldn’t immediately resort to medicines. Instead, you should go the route of diet and exercise. Over the years I have seen this work for many people. In addition, I am of the view that EVERY DRUG has side effects. This doesn’t apply just to prescription medications but even to over-the-counter medicines like acetaminophen or ibuprofen. When taking a drug, the benefit-risk profile must be considered. Only when the benefit outweighs the risk should the drug be taken.
However, I take exception to some recent comments of Dr. David Healy which are flat-out wrong. Healy is a psychiatrist and author who has written extensively on the side-effects of psychiatric medications. I certainly agree that drugs to treat CNS disorders like schizophrenia and depression are not benign. While they can provide great comfort for patients suffering from these diseases, these drugs are known to cause adverse events like weight gain and sexual dysfunction. The physician-patient interaction is critical in successfully managing the progress made in treating these diseases and determining which medication is most appropriate.
But Healy is off-base in recent comments he has made on Twitter and on his blog with reference to medicines in general. Two Tweets are particularly concerning:
“Any drug released since 1990, esp the biologic gp of drugs, should be considered a poss candidate for late side effects”
“Osteoporosis treatments are a good example of a case where drugs cause problems that may take months/years to appear”
On the latter point, Healy is referring to the findings of rare but serious adverse events associated with bisphosphonates. These compounds are used to treat osteoporosis and are the mainstay for the treatment of this disease. They act by decreasing bone resorption, thus slowing bone loss and protecting against bone fractures – a problem for post-menopausal women. Despite the fact that these drugs have been on the market for more than two decades, like any class of drugs that are prescribed for chronic use, their effects over decades of use are unknown. However, post-marketing reports of atypical femur fractures and necrosis of the jaw led the FDA to convene the Reproductive Health and Drug Safety/Risk Management Advisory Committees to review studies where bisphosphonates were used in osteoporotic patients for 6 – 10 years.
The bottom-line from the FDA analysis of these studies is that bisphosphonates are important drugs for skeletal health, but that the benefits of these drugs in preventing bone fractures may peak after 5 years. The FDA advised the following:
“The available data do suggest that bisphosphonates may be safely discontinued in some patients without compromising therapeutic gains, but no adequate clinical trials have yet delineated how long the drugs’ benefits are maintained after cessation.”
From all of this, Healy ascertains that any drug approved since 1990 should be considered a possible candidate for late side-effects. Where does he get this? What makes 1990 special? His implication is that the studies done in support of new drug applications (NDAs) prior to 1990 were more thorough and vigorous. This is absurd. Furthermore, his singling out of biologic drugs makes no sense at all. The fact of the matter is that the pre-approval testing of drugs in the 1980s was far less vigorous than what now happens. Back then, a new drug to treat the pain of arthritis would only need to complete 90 days of continuous testing before approval. Similarly, lipid lowering drugs were approved with only LDL lowering properties and a year of patient exposure. This same paradigm held for novel anti-diabetic agents where simple blood glucose lowering and 12 months of testing in patients were the norm. Today, for drugs such as these that are to be used chronically, sponsors are required to show that their new medicine actually improves the long-term health of a patient. Thus, pre-approval testing to show the reduction of heart attacks and strokes for drugs to treat obesity, diabetes or heart disease are needed – studies that generally involve tens of thousands of patients to be dosed for 3 – 5 years. Such studies are needed not just for FDA approval but also for convincing payers to reimburse patients for these new drugs.
The hurdles that must be overcome to get a new drug approved are higher than they have been in the history of medicine. Does this mean that new drugs are totally safe? Absolutely not. But to say that newer drugs are less safe than older ones is incorrect.