Wednesday, February 16, 2005

Safety Issues Exist Beyond Vioxx and Celebrex

Check out the article on Forbes.com about our work on the relative risks of nesiritide, a medicine for the treatment of heart failure marketed by Scios/J&J. It is pretty impressive that somehow J&J has escaped the attention that this drug should be receiving. Although it is nowhere near the magical level of $1 billion in sales, nesiritide is used for about 10% of the one million heart failure hospitalizations annually.

I know why nesiritide was approved by the FDA; the drug does improve symptoms more quickly than other medicines that were already available. What I don't understand is why Medicare agreed to pay for it to be used in an unapproved setting, doctors' offices, when there was a lack of safety and effectiveness data in this setting.

Perhaps this press will help open people's eyes and minds. Merely because there is no evidence of danger associated with a medicine does not mean a medicine is safe, when, as is the case for nesiritide, no one has bothered to look.