Pharmaceuticals really are marvelous things. They're responsible for most of the increases in life expectancy that took place in the 20th century, and believe it or not, even with rising drug costs they save us money by replacing more expensive treatments like surgery. Saving money is nice, of course, and so is the extra economic growth we have from keeping more productive people around. But the really great thing is the number of active life years it adds to the world--active life expectancy is actually increasing faster than ordinary life expectancy in the US.
Unfortunately, no cloud is without its silver lining. In the case of pharmaceuticals, it's the fact that some small number of the people who take them will thereby be made worse off. The regulatory and liability systems try to control that, but as Derek Lowe points out, they can't fix everything:
This illustrates why either extreme of that argument is untenable. On the make-‘em-pay side, you have trial lawyers arguing that if companies just wouldn’t put defective products on the market, well, they wouldn’t have anything to worry about, would they? Test your drugs correctly and things will be fine! But Exubera’s pre-approval life was as long and detailed as could be. The testing went on and on – and after all, insulin itself has been on the market for more than half a century. What more would a company need to say something is safe?
Then there’s the other side – total pre-emption, which says that the FDA is there to regulate and sign off on safety and efficacy, and by gosh we should have them do it. Once this mighty agency gives its stamp of approval, that settles it. But again, the FDA put Exubera through all kinds of paces. If every drug took that long and cost that much to develop, we’d be in even worse shape than we are now, believe me. So what’s the agency to do?
The truth, as far as I can see, is that no one can guarantee the safety of a new drug. If you want to take that further, guaranteeing the safety of an existing drug isn’t possible, either. Every known drug is capable of causing trouble at some dose, and every known drug is capable of causing trouble at its normal dose in some people. Every new drug has the possibility of doing things no one ever anticipated, once it gets into enough patients for enough time. Every single one.
Complete safety doesn’t exist, and never has. You can have more safety, if you’re willing to take enough time and spend enough money. But you can take all the time we have on earth, and spend all the money available, and you still won’t be able to promise that nothing bad will ever happen. Pretending that either the drug companies or the regulatory agencies can make that fact go away is a position for fools and demagogues.
Libertarians tend to chafe at the notion that companies should be liable for something they couldn't predict. On the other hand, neither could the person who took the drug--why should they bear all the costs? Liability, in theory, pretty effectively socializes the risk of something that has great public benefits.
The problem, of course, is that juries aren't particularly well equipped to handle scientific arguments. Liability as a solution for medical disasters errs both ways--it often fails to punish the guilty, and does snare the innocent (see Breast Implants, class actions against). The liability system evolved during an era in which most problems were basically comprehensible to the average juror. Now with things like environmental pollutants, construction safety standards, medical malpractice, pharmaceutical liability, and securities law, jurors are dealing with things that take advanced degrees (or the work experience equivalent) to understand.
I don't know what the solution is; perhaps we should push the VICAP model more widely for pharma risk in cases where the side effects were simply unpredictable. But that has its own problems.
Another acronym I had to look up. According to Wikipedia, VICAP stands for the following:
"Vi-CAP (Violent Criminal Apprehension Program) is a nationwide computerized system implemented in 1985 by the FBI out of Quantico, Virginia."
Thank you, Emily Litella.
Posted by Lady Lucy | April 11, 2008 11:42 AM