Vioxx
We know that the FDA or NICE have institutional incentives to ban drugs that may be beneficial, as to them false positive is far worse for their careers than a false negative.
I.e. consider the following two mistakes for a regulator to make:
- Approving a drug that unexpectedly kills people it wasn’t supposed to. This one ends your career.
- Not approving a drug that could improve people’s lives. This one hardly anyone, if anyone, ever finds out about.
The second mistake is the one you’re going to want to make, so you’re not going to approve drugs even when there are people who it might help.
On the other hand Merck has the opposite incentive:to try to retail drugs even when they are more unsafe than the regulators approve of.
So we have two competing institutions and patients need for useful drugs is caught in the middle.
If we had a regulatory situation where adults were allowed to make up their own minds about the risks and benefits of a drug, then Vioxx would be legal for sale but with clear instructions as to the risks taken. Some would still take it, some would not, and it would be their (and their doctors) choice based on the facts.
In such a situation the incentive for pharmaceutical firms to massage the data would be much reduced. It would still exist as better data will make more people accept the apparent risk, but the massive incentive that exists to bring the drug just below the arbitrary risk line that FDA/NICE might require would be gone.
So it’s hard to get worked up about this “evil” corporation out to make money. Everybody’s out to make money, including the regulators - who never want to be scapegoats. We should be asking for an adult regulatory regime, not demonising the businessmen.