Kerry’s outstanding piece on access to experimental drugs from the August/September issue of Reason is now available online. I think the thing that sets this article apart from typical libertarian FDA hit pieces is the way it so evenhandedly explains the rationale for excluding some dying patients from clinical trials. There is no ideological table pounding. I really understand why the system works the way it does in a way I never did before. It is moving without being sentimental. And, overall, completely devastating.
Will Wilkinson
The Sweet Release of Reason
Wow, that was a really good article.
Wow, that was a really good article.
The problem is the efficacy requirement itself. The article never explains why efficacy (as opposed to basic safety) should be a concern of the FDA at all. That a $10B clinical testing industry and its regulatory enforcers think so is not a good enough reason. This is particularly so as evidence rolls in that personal biology influences drug response, meaning that widespread use of new drugs may be important to identifying the subgroup of patients for which it is effective. Treatments to which even large numbers of patients do not respond are not necessarily “snake oil.”
The problem is the efficacy requirement itself. The article never explains why efficacy (as opposed to basic safety) should be a concern of the FDA at all. That a $10B clinical testing industry and its regulatory enforcers think so is not a good enough reason. This is particularly so as evidence rolls in that personal biology influences drug response, meaning that widespread use of new drugs may be important to identifying the subgroup of patients for which it is effective. Treatments to which even large numbers of patients do not respond are not necessarily “snake oil.”
It is heartbreaking, but not any more heartbreaking than when insurance companies deny coverage for treatments because they are considered “experimental” by the company even though already FDA approved. People regularly die as a result of that as well.
It is heartbreaking, but not any more heartbreaking than when insurance companies deny coverage for treatments because they are considered “experimental” by the company even though already FDA approved. People regularly die as a result of that as well.
Jen, I think the important difference is that in the case of FDA-approved drugs not covered by insurance, it is not against the law to take them. That may be a moot point if you can’t otherwise afford them, yes. But at least they are not forbidden.
Jen, I think the important difference is that in the case of FDA-approved drugs not covered by insurance, it is not against the law to take them. That may be a moot point if you can’t otherwise afford them, yes. But at least they are not forbidden.
Yes, it is a moot point if you can’t otherwise afford them. Also, something the article doesn’t mention is that if terminally ill people are eventually allowed to take the experimental drugs, it is likely that they would have to pay for those as well. It’s unlikely that anyone not in a clinical trial would get them for free. Then they have the same problem that the insured but denied have- if you can afford to pay for it out of pocket, you might live. If not, well then that’s too bad.
The constitutional argument has got to be troubling for insurance companies because if there is a constitutional right to experimental but potentially life saving treatments, then some subscribers would no doubt challenge the legality of the clauses that let insurers of the hook for what they deem to be experimental treatment.
Interesting article!
Yes, it is a moot point if you can’t otherwise afford them. Also, something the article doesn’t mention is that if terminally ill people are eventually allowed to take the experimental drugs, it is likely that they would have to pay for those as well. It’s unlikely that anyone not in a clinical trial would get them for free. Then they have the same problem that the insured but denied have- if you can afford to pay for it out of pocket, you might live. If not, well then that’s too bad.
The constitutional argument has got to be troubling for insurance companies because if there is a constitutional right to experimental but potentially life saving treatments, then some subscribers would no doubt challenge the legality of the clauses that let insurers of the hook for what they deem to be experimental treatment.
Interesting article!
Someone could write a story about suicide bombings of FDA offices by terminal patients. This thought is shared for entertainment purposes only, of course.
Someone could write a story about suicide bombings of FDA offices by terminal patients. This thought is shared for entertainment purposes only, of course.
When I read stories like this, I can’t understand why everyone isn’t a libertarian at least in ideology. I can see for example why a public school administrator isn’t a libertarian, but if he read something like this, I think the selfishness of his protectionist position whould hit home. They always claim the are protecting the patient, or the student, or the public as a whole, but what they don’t tell you about is the pain and suffering the protection is causing others.
When I read stories like this, I can’t understand why everyone isn’t a libertarian at least in ideology. I can see for example why a public school administrator isn’t a libertarian, but if he read something like this, I think the selfishness of his protectionist position whould hit home. They always claim the are protecting the patient, or the student, or the public as a whole, but what they don’t tell you about is the pain and suffering the protection is causing others.