There is one thing that I want to discuss related to the FDA approval of new drugs. It is an idea that I have have had for several years, but it has become more relevant recently. A recent headline has given me a renewed interest in this and made me realize that it is an idea that could have a significant impact on how we look at new drugs.
Back in November 2021, a headline popped up in my news feeds saying that the FDA wanted 55 years to process a public records request for COVID-19 vaccine data. Here is one link to one such article.
Like many people, my initial reaction was shock. Were all the conspiracy theories concerning the COVID-19 vaccine correct? Was the government trying to hide something?
After a moments pause to gather my thoughts, I remembered that I don’t actually believe things that show up on the internet, and I delved a bit further into this, and based on my research, I came up with three conclusions.
1) Whoever wrote this headline needs to be fired. Journalism should be at least somewhat unbiased an impartial at presenting all sides of the story. Whoever penned this headline obviously had an agenda and wrote the headline in a way to promote it rather than attempt in any way to present a fair summary of the issue. 2) My idea (which I promise I’m getting to) would have been a tremendous way to avoid this problem. 3) The COVID-19 vaccine was absolutely not a minimally tested, quick fix to a problem.
So, back to the article. What is actually going on.
The FDA is required, by law, to release data when a request is made. That is perfectly acceptable. And it appears that it tries to meet those requests in a timely fashion.
The problem is that many of the FDA records contain data that is not public. For example, medical records of specific people are not public data. It is perfectly fine to release a record that says that patient #12345 was given a trial version of the COVID-19 vaccine. It is NOT fine to release a record that says that patient ‘John Smith of Miami, Florida’ was given the vaccine.
So, when the FDA gets a public record request, they have to look at every single page and redact (i.e. hide) the non-public information. The request made to the FDA was to release essentially all of the information concerning the COVID-19 vaccines, which amounts to around 329,000 pages of information. Such an enormous request cannot be handled quickly. For someone to read (and edit) every one of those pages will take an enormous amount of time and manpower (and it’s not like this is the only request the FDA has for public records). The FDA has proposed that it can release about 500 pages per month, which will indeed take 55 years to complete the entire request.
Now, I don’t know anything about FDA procedures. I don’t know how many requests for public records they receive, or how large those requests are. I’m not sure how many FDA employees are devoted to handling these requests, or how many pages per day each employee can redact. It is quite possible that 500 pages per month is unreasonably on the low side… but I suspect it is no more unreasonable than the requester’s proposal that the FDA produce 80,000 pages per month. A truly reasonable number is probably somewhere in the middle. But even if a reasonable number is 10,000 pages per month (and I suspect that this is still higher than reasonable), it will still take almost 3 years to fulfill the request.
And before I go any further… let me mention again my third conclusion that I gained. The vaccine companies produced 329,000 pages of data about their vaccines. I have no idea how many pages of data are produced in developing most new drugs, but I cannot imagine that it exceeds that by a huge amount. As a matter of fact, I suspect that this number is higher than average considering the fact that new technologies were employed to develop these vaccines. However, that is a supposition on my part and may be incorrect. But even so, it is clear that an enormous amount of research has gone into producing these vaccines.
So now, my idea.
The FDA is responsible for determining if a drug is safe to use as a treatment. It clearly needs access to the raw data from the drug company to determine this. But in general, it doesn’t need to know that ‘John Smith’ was treated. It’s sufficient to know that patient 12345 was treated. So, what if all of that data were given to the FDA in a redacted form, rather than a raw form. The company would have a database that contained the information that patient #12345 was ‘John Smith’, but that data would be completely separate from the redacted data. It might not even be necessary to supply that information to the FDA (though I’m fine either way provided it is kept separated and heavily protected by both the drug company and the FDA).
Then, as part of the FDA approval process, the redacted data is made available on a public web site where anyone and everyone can download the data, analyze it, and post comments and criticisms about the results.
What would be the results of this? First, there would basically be no need for anyone to make a public information request because all of the data would already be available. It wouldn’t take 55 years, or even 3 years to access all of the COVID-19 data. It might take hours (or even days) to download that much data… but still very reasonable. It would also allow the FDA to devote it’s resources to analyzing data instead of responding to public record requests.
Watchdog organizations would then be free to analyze the data and discover problems, including those that might have been ‘conveniently overlooked’ by the drug company, or even the FDA. These organizations would then be able to draw their own conclusions about the safety and effectiveness of these new drugs. This would give you, the potential drug user, a number of sources of information that could be used to help make an informed decision about whether or not you should take a certain drug.
There would be some legal ramifications to this change. First, it would obviously be an absolute requirement that all of the data be provided (in a redacted form). I suspect (hope) that this requirement already exists, but I am not familiar with FDA rules. If it is not currently a requirement, it should be. I would also make patent protection contingent on this requirement being met. If it were proven that a drug company had withheld data, patent protection would be immediately withdrawn. In addition, other penalties would apply (such as fines or limits on what types of drugs the company would be allowed to develop).
Another ramification would be that the data, along with results produced by other agencies, would need to be public and could not be withheld from people.
That is enough about health care for now. I certainly have not exhausted the subject, but for the time being, that’s enough to get some ideas out there.