This article at Stat by Rebecca Robbins really caught me eye. It describes clinical trials where the participants are being asked to pay thousands of dollars just to join the trial. There seems to have been an increase in this sort of thing lately, and I’ll be completely clear: I think that’s a terrible idea that needs to be dealt with quickly.
FDA regulations permit such charges in “extraordinary circumstances”, such as when a drug is so expensive that it would never otherwise be tested. But the people trying this – small outfits doing rejuvenation-through-young-blood-donors or stem cell therapy trials in Panama, that sort of thing – are bending that clause out of recognition. The idea isn’t that you announce a trial when you have no money and therefore claim that it won’t be run unless people pony up.
I have objections on principle, and objections in practice. The principles are these: we drug companies are asking people to be our experimental test subjects, and we can’t do without them. We’re asking them to take risks in order to advance our drug programs and medical science in general. So you’re going to ask people to pay for that? We should be paying them – in fact, we do. This is reminiscent of Jim MacDonald’s law of publishing, that “Money flows towards the writer”. If your publisher starts asking you for money to do editing and production, etc., you are probably being scammed (that link to John Scalzi updates the idea for the age of self-publishing). And if you are being asked to pay thousands of dollars just to get in the door of a clinical trial, I fear the same.
My objections in practice are that this idea is perfectly designed to take advantage of desperate patients and their families. I have the same problem with this that I have with eliminating the requirement to show clinical efficacy. Here, I’ll go get a consciencectomy operation so I have a free hand; they’ll surgically remove any shred of ethical behavior in me that they can find. (I figure this operation must exist, based on what some people get up to). Now I’m ready to enroll people in my clinical trial for Alzheimer’s, testing my proprietary blend of bioflavanoids and antioxidants. The pills may look like raisins with an enteric coating sprayed on them, but that’s because that’s exactly what they are. They’re just full of all-natural goodness, though, and for only $5,000 a head, you can get your elderly relative in a *Real Clinical Trial* for what just might be a *Cure For Alzheimer’s*! Wow! You know, I’m charging too little. I’ll bet I could fill the place up at $10,000/grandma instead, so why the hell don’t I do just that? I’m absolutely in the clear on bad side effects – there won’t be any, unless there’s some raisin allergy lurking out there in the population that I haven’t heard about. Primum non nocere, you losers – here, chew on a raisin, it’ll make you feel better. Maybe. Hey, maybe they’re also a preventative for Alzheimer’s. Register another trial! They’ll be lined up around the block for that one!
OK, if you think that there aren’t people who would do this, all I can do is advise you to look around you. Finally, consider how this looks. People are already up in arms about the amount that they have to pay for approved drugs that have been through trials and FDA review. How does it look to shake people down just for the chance to take an investigational one? No, no one needs this. It’s bad news in every direction. The FDA has the authority to do something about this, and they’d better.