These companies could start producing Ebola vaccine/treatments tomorrow — except that the Food and Drug Administration’s insistence on randomized studies and endless demands for more data means firms have to spend millions on paperwork instead of producing medicines.
Try to imagine a randomized study for an ebola vaccine conducted on human beings. “We’re going to expose hundreds of people to ebola, half of whom will have been given the vaccine and half of whom will have been given a placebo.”
One idea I have is a separate agency that uses principles-based regulation instead of rules-based regulation. Companies could elect to abide by this alternative regulator and bypass he FDA.
Having said that, I am generally not in favor of taking the latest media-inflated crisis and saying that it confirms one’s political outlook. And I am not suggesting that the ebola story should be used to confirm mine.
The FDA blocks all drugs, the only difference is there are highly visible victims. It is valid criticism.
Unfortunately, this criticism isn’t very well grounded.
First, your criticism of placebo controlled trials for deadly diseases has already been resolved. We already have active controls in clinical trials. So the clinical trial will not be experimental treatment versus placebo. It would be current best treatment with experimental therapy versus current best treatment. Alternatively, FDA also allows for use of historical controls in certain situations like this one where mortality is a clear endpoint. Because mortality is a clear endpoint getting good data to show that your product decreases mortality should not be difficult. .
Second, anyone that says we have cures for Ebola already but that FDA is holding up the cures through bureaucracy does not understand the situation. FDA is willing to bend over backwards to help drugs that save lives. They just don’t want snake oil or drug products with poor data to be rolled out as a cure-all. But even assuming that FDA blocked the drug’s legality in the United States. It wouldn’t matter because the FDA does not regulate drugs in Liberia. So any new found cure could be rolled out in Africa without the need for FDA approval.
Third, the article merely assumes that all of the products and devices used are efficacious and the requirement for “randomized studies” is somehow outdated science. I don’t know how the author thinks that you can prove something works without randomized clinical trials. But regardless, randomized clinical trials are not outdated science. They are the best tool we have.
Lastly, if you create another agency that has a lower threshold for approval of a drug product, no one will ever go through the FDA to get approval. This will allow more medication onto the market that does not have good clinical data to back it up. So you will be increasing bad medicine, not necessarily increasing the rate of good medicine.
“People would be eating dirt and chairs!” is one hypothesis.
Should it be rigorously tested by comparing legally-enforced FDA rules against a control group and/or alternative regulatory schemes?
If the answer is “no, we can enforce decisions affecting millions of lives without such testing”, then we can certainly also allow such decisions, and we don’t need the FDA. If the answer is “yes, we need such testing to make sure that our decisions will work out the way we expect”, then at least in the short run we need alternatives to the FDA.
“Lastly, if you create another agency that has a lower threshold for approval of a drug product, no one will ever go through the FDA to get approval.”
I just don’t buy this statement at all. Assuming that the FDA has a good track record of indeed proving treatments safe and effective then many companies would want their drug to be certified under the new standards as a strong signal of quality. Treatments certified under the FDA should enjoy a premium in the marketplace.
On the other hand, if the FDA is not effective or if its standards are higher than necessary, then no one would, as you say, go through their process. And in that case, no one should.
Having different, competing standards for safety and efficient of medical treatments could be a very good thing indeed.
No company would be willing to produce it for fear of liability and may need that suppressed before doing so.