FDA Drug Approval and a Lack of Long-Term Studies

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Edgy Labs interviews Kira Mills, a McNair Scholar with a focus on Organic Chemistry from Texas A&M University of Commerce, to discuss the FDA and their perceived lack of long-term studies.

Edgy Labs interviewed Texas A&M McNair Scholar about FDA drug approval.Click To Tweet

EL: As a scientific scholar that’s worked in drug discovery and synthesis–the first step of any drug approval process–do you have any comment on the recent press on the lack of long-term studies?

Mills: Interestingly enough, the only things I’ve heard about the testing process are slight complaints that it takes too long. Although, most everyone still agrees why the current benchmarks are important.

Think of it from the scientist’s perspective: you’re part of a team that discovers and develops this brand new, super awesome drug and then just have to sit on it for 5 years. That kinda sucks, ya know?

EL: I think I can empathize with that. I read that drug approval time usually lasts around 11 years.

Mills: Yeah, it also usually depends on what kind of drug it is. I personally don’t think there’s a detrimental lack of long-term studies, but obviously, new side effects will be discovered once a product has been on the market for a while.

For one, that’s a much larger sample size than anything you can get during clinical trials.

And two, if said side effect takes 25 years to show up, of course, no clinical trial is going to take that long – the pharmaceutical companies can’t afford it, the FDA can’t afford it and no person will volunteer that much of their time on an “experimental” drug.

Even if all of the institutions involved were able to put forth the time, money and effort, it could be nearly three decades before life-saving medicines are able to be administered to the people that need them now.

EL: I suppose that’s true, but what about all of those late night commercials? Are those drug approval concerns just the result of hungry advertisers/lawyers?

Mills: Late night commercials about side effects?

EL: You know–this type of thing:

Mills: The biggest critique I have is that a lot of them are for “outdated” medicines (I could be wrong as I don’t watch a lot of commercials these days). But, from the ones I’ve seen it’s mostly for either medicines and surgeries dating back decades, or for the first versions of certain things (like the ring birth controls).

That stems from the fact that when these products were released they were less regulated – either because the time period allowed them to be or because they were such new technologies there were loopholes and things around their safety testing.

Because of that, I do think that our methods of testing all things health related need to be standardized across the board.

Instead of saying “pain medicines need extensive testing but this birth control that women will be inserting into themselves long-term is probably fine,” we could potentially ensure a more democratic testing process to the overall benefit of the population.

As it stands, I can’t recall if the current regulations are standard or categorized, but I know that is a place where problems have occurred in the past.

EL: What about side effects that result in death? Do you think we’re doing enough to ensure people’s lives aren’t in jeopardy?

Mills: Honestly, any drug will cause death in the right person at the right dosage. It sucks, but it’s going to happen. This is because there’s currently no way to test every drug for every possible pre-existing condition.

I think to some extent “enough” is being done because they try to test for the most likely interactions, both in animals and people. But there’s only so much we can do until tech reaches a level where we can have completely synthetic organs that can be put through that much to simulate all the possible conditions and interactions

EL: Do you think that the problem here has more to do with doctors being so quick to accept current drug approval standards?

Mills: So, I think the biggest thing here that most people don’t realize is that yeah, we could increase all of the safety measures we take before approving a drug.

We could double the required sample sizes for clinical trials and make them do 20-year studies to look for any long-term effects. We could try to get people with various pre-existing conditions that might cause severe side effects. We do technically have the capabilities for that. But if we did, the cost of drugs would skyrocket.

Everybody wants the best of both worlds: having super safe, perfect medicines to fix every ailment there is. But they also want to be able to get these things super cheap. Getting both of those is just impossible until we can get synthetic organs in the lab to do all of our testing on.

There’s currently a lot of talk about the heads of pharmaceutical companies just charging ridiculous prices to make a bigger profit, and while it’s not nearly to the extent people who are against “Big Pharma” want it to be, we have to acknowledge that these are businesses: fraud still exists.

But, by and large, the biggest reason for drug cost is the cost of materials (which is always high considering drugs are organic molecules and organic solvents and reagents are crazy expensive) and resources.

The people behind the creation of these drugs are scientists from various fields with PhDs and years and years of experience. They are valuable, and they deserve the salaries they get.

EL: So, moving forward, how do we solve (or minimize) the current problem of long-term pharmaceutical side effects until we can get to a point where we can use synthetic organs?

Mills: Honestly, as ridiculously optimistic and cliche as it sounds, all we can do is continue to support and fund these fields.

Adding more regulations will fix some problems while creating new ones. The only way to truly improve the medicines people are taking and reduce side effects is to create new and better drugs.

While there are severe side effects, including death, the things we’re being prescribed now are still insanely better than the previous common medicines. And I personally think the current level of regulation is a good midway between safety and efficiency.

Ultimately, our primary goal should be to give scientists the ability to improve our healthcare by allowing them to discover and create new things.

Is the US doing enough to fund pharmaceutical research? How long do you think it will be before routine artificial human organ testing will be possible in order to shorten drug approval times?  

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