Nesitiride was a new drug rapidly approved by the FDA in 2001 for acute heart failure based on studies showing that it reduced pressure in the lungs and reduced symptoms after a few hours of treatment. However, after several more studies were conducted, higher risks were noted. In a study published in the NEJM in July, 2011, nesitiride was no better than placebo and had a much greater risk of hypotension (low blood pressure).
COMMENT: On the surface, this study proved that this drug was ineffective, as well as leading to excess risk. The major point, however, is that the drug was not thoroughly tested on patient outcomes before being approved by the FDA. As I discuss in Chapter 6 of my BOOM or BUST book, there is a huge push by pharmaceutical companies to get quicker approval for drugs from the FDA. As I also discuss, the majority of drugs that have had rapid approval have been taken off the market, have proven not as effective and/or have caused side effects that were not substantially identified before approval. Although patients suffering from various diseases would like to benefit from new drugs, it is not wise to rush approval until the benefits and side effects are well established.
Posted on
Mon, September 19, 2011
by Larry Altshuler, M.D.
filed under