Side Effects

The number of ads on tv for prescription drugs is mind-numbing. I wonder if anyone pays attention to the listing of possible side effects. I don't, but I do marvel at the pleasant scenes that are shown as the list is read. It turns out that the FDA does not expend much effort on side effects either. In 2015, the Government Accountability Office reported that the “FDA lacks reliable, readily accessible data” needed for systematic oversight and to ensure that drug companies comply with agreements to track safety after a drug comes to market.

The main way the FDA uses to tell us of possible side effects is with the label on the bottle. STAT has an interesting article about this with regard to a popular drug for rheumatoid arthritis, Actemra. It is used by more than 760,000 patients globally and generated sales of $1.7 billion last year, making it Roche’s fifth highest-grossing drug. Studies have shown that Actemra patients experienced an unusually large number of serious side effects that don’t appear on the drug’s warning label.

Actemra is not alone when it comes to warning labels.  As Dr. Vinay Prasad, an oncologist and medical ethicist at the Oregon Health and Science University, says,. “We’ve done a very good job of making it easier to approve drugs, often based on very preliminary evidence. But we haven’t ramped up the standards of post-marketing surveillance to make sure that what’s been out there for several years is safe and effective. The system is broken, and all the financial incentives are lined up to keep it broken.”