Drugs

Manifesto

No, not that kind. There are two "controversial" drug topics being discussed in the press today, which I don't consider to be controversial at all.

It turns out, although Merck was saying the cardiovascular problems with Vioxx were not a major concern until the 2004 study that led to the drug's recall, the company was looking to reformulate the drug to improve its safety. I hate to rain on the "let's crap on big pharma" parade, because it's kind of fun, but companies do this all the time. They take a good drug, and they make it better. It's called life-cycle management, and you are always trying to improve on product characteristics to boost sales and product perception.

It's like saying, "Coca-Cola has a new version of Coke that is only one calorie. So they admit that Coke is high in calories!" There was certainly data that said Vioxx did not have a great cardiovascular profile, like for instance Aspirin, and Merck was trying to improve on that. I don't think that's a crime.

The second "controversy" is that the FDA has approved a drug, BiDil, for use in African-American patients specifically. I am sure people will freak out about this, as it has already been a source of debate, and it's a worthwhile debate. But it is not as if this drug was designed for African-Americans, suggesting that there is some sort of discriminatory drug development program.

Consider this sequence of events. A drug seems like it will work for chronic heart failure. Doctors test it in a huge trial, and when they look at the data, there is little difference between the drug and placebo. The doctors look closer, and discover that if you only consider the African-American patients in the trial, the drug appears to have a significant benefit. So, they design a trial only with African-American payments to investigate this finding. The result is so good that, ethically, they have to stop the trial early, because patients on placebo are dying at a much faster rate than patients on the drug (note: patients on both sides were also receiving standard of care, it's not as if they were withholding medicine from sick patients).

So while people debate the morals and ethics of having a drug just for black patients, they need to really be considering what would be the ethical implications of NOT approving this drug for black patients. Slippery slope arguments can easily be shouted down with Kaplan-Meier separation curves - people are given a chance to live longer.