Money and Medicine - Device Approval and Herbal Smoking Remedies

In Europe, one of the most popular smoking cessation medications is actually a plant derived substance called cytisine. This inexpensive herb has been found, in a recent study, to be more 30% effective than nicotine patches or gum. Why is this product not used more in this country? Perhaps checking the profits and sales of the nicotine replacement therapy would be a clue.

You may have recently read that the FDA withdrew recommendations for a procedure known as morcellation which was a technique used to remove fibroids. It involved an expensive new machine. In its initial approval the FDA relied on a report from a physician on its panel who said the adverse effects were not as bad as reported. This doctor had received over $150,000 in speaker fees from the manufacturer.

Indeed, the Wall Street Journal reported that of 122 FDA advisers who evaluated cardiologic, orthopedic, and gynecologic devices from 2012–2014, one third had received compensation (e.g., money, research grants, food, or travel) from device companies, and nearly 10% overall had been compensated by companies whose device they were assessing. The FDA disclosed almost none of these relationships.

I rarely recommend new treatments or devices unless they are a dramatic improvement or have been in use for a significant time. I have seen too many of these adverse events being reported long after approval; perhaps this again is part of the reason.