Dr. Goldberg –
Our JAMA piece was not even about comparative effectiveness research, or about paying for treatments. We agreed in it that orphan drugs for cancer may sometimes need to be approved with less valid data than is usually required, and called for better understanding how well these drugs work by studying their outcomes once they are on the market. But cancer patients do not benefit – and may well suffer more -- if a drug that does not work is approved and then given to them. We undertook this analysis to help understand how patients with rare diseases could be provided with drugs that actually are going to help them; we certainly did not publish it because of some secret agenda to delay or deny treatment to people. Your making such a wild charge just makes you look silly.
I also do not recall ever having said that BiDil should not be approved because we don’t know its mechanism of action. In any case, since it was just a combination of two widely available generic drugs, the treatment would be readily available whatever FDA did with the application for its approval as a patentable combination.
Reasonable people can (and do) differ about the best way to evaluate new medications, but this statement is so wild that it just looks weird. A flaming, inaccurate diatribe like this reflects badly on its author. Most others on the right have reassessed the wisdom of depicting those with whom they disagree as “malignant presence[s]” who want sick children to “drop dead,” and calling for someone to “pull the plug” on them. Such hate speech just makes those who use it look like they are flailing around in ill-founded rage.
