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This podcast uses government documents to illuminate the workings of the American government, and offer context around the effects of government agencies in your everyday life.
Welcome to Civil Discourse. This podcast will use government documents to illuminate the workings of the American Government and offer contexts around the effects of government agencies in your everyday life. Now your hosts, Nia Rodgers, Public Affairs Librarian and Dr. John Aughenbaugh, Political Science Professor.
N. Rodgers: Hey, Aughie.
J. Aughenbaugh: Hello, Nia, How are you?
N. Rodgers: I'm good. How are you?
J. Aughenbaugh: I'm lovely. Thank you.
N. Rodgers: I know that we're going to talk about controversies of the Food and Drug. Administration is the third and wrap-up this series.
J. Aughenbaugh: Yes.
N. Rodgers: But I figured this episode is going to be super short because there aren't any. No controversies. Everything they do is completely right. They give you right the first time and we're done. Listeners, that's it. That's the end of our episode. We'll see you next week.
J. Aughenbaugh: But yes, we're going to start a new series.
N. Rodgers: He lives in fantasy world. Is that?
J. Aughenbaugh: Yes, exactly
N. Rodgers: You got to break my heart and told me that that's not true.
J. Aughenbaugh: I'm sorry, Nia, once again.
N. Rodgers: Heartbreaker.
J. Aughenbaugh: Yes, I am breaking your heart. Rain on your parade. Whatever metaphor you choose to use for once again, are your hopes and dreams being squashed? There have been, okay, spoiler alert, a few controversies.
N. Rodgers: Is it a few really?
J. Aughenbaugh: Yeah. There have been a few.
N. Rodgers: Can I say something that you mentioned to me off podcasts that we didn't tell people?
J. Aughenbaugh: What's that?
N. Rodgers: That there's actually legislation that says that the Food and Drug Administration that is not medical advice.
J. Aughenbaugh: Correct?
N. Rodgers: They are not in the business of being doctors directly to people?
J. Aughenbaugh: That's correct.
N. Rodgers: So when they okay something, that's not medical advice that they're giving you, you should be talking directly with your physician.
J. Aughenbaugh: That's correct.
N. Rodgers: About whether this drug will in fact help you, harm you?
J. Aughenbaugh: Correct.
N. Rodgers: Can be taken with other drugs. All they're saying is, "This is as far as we know, safe and as far as we know for off-label use will not cause in most cases," although I think they do have an acceptable level of death. But in most cases will not cause catastrophic events. But they never say, "Sure, just go ahead and take" like that's not what they mean
J. Aughenbaugh: That's correct because this goes back to the original reason why the Food and Drug Administration was created. The Food and Drug Administration was created in the early decades of industrialization because we were getting food and drugs substances on the market in the United States that were harming people. So people were turning to the government and saying, can you make sure that food and drugs, substances that are being sold are not harmful to consumers, to the American public.
N. Rodgers: Because back in the day, a guy would show up with a truck in your neighborhood and he would say, I have this remedy for rheumatism and it would be made of who knows what, you had no idea what was in that stuff. And sometimes they got lucky and something worked. Most of the time it didn't, but that guy was long gone by the time.
J. Aughenbaugh: You actually use the pejorative term, either in the second episode of the series or the first.
N. Rodgers: The snake oil salesmen?
J. Aughenbaugh: That is correct. That's the origin of that word because, you know, typically a guy would show up into a community and say, I got this magic elixir. That will not only go ahead and cure you of your stomach problems, but you could also go ahead and use it to clean up your fine China.
N. Rodgers: Anything that cleans your fine China, you probably should not be swallowing. I'm just saying.
J. Aughenbaugh: It can also be used to go ahead and wash down your your horses after a hard day's of labor.
N. Rodgers: There were tinctures and there were just bottles of random stuff with only use one drop so that it would theoretically last a long time except one drop of anything is probably not going to help you.
J. Aughenbaugh: Yes.
N. Rodgers: Yeah, there was all that mess. So that's why we get the FDA. But even so, even when we get the FDA, we get the FDA saying now, we're not saying we're doctors. A bunch of them are doctors.
J. Aughenbaugh: Even though the FDA has a bunch of doctors who review the clinical test results of those who are going through the approval process. But they're not telling us to go ahead and use these drugs. These drugs should be prescribed by your family doctor.
N. Rodgers: Who knows you and has met you and knows
J. Aughenbaugh: That's right.
N. Rodgers: Knows all the other things you may be taking knows your history, knows all that stuff, but isn't one of the controversies with the FDA that they have regular review and like priority review. You can get moved up in the list.
J. Aughenbaugh: Yes. In 1992, Congress passed the Prescription Drug User Fee Act, PDUFA.
N. Rodgers: That one doesn't read as well as some of the others.
J. Aughenbaugh: I love government acronyms.
N. Rodgers: PDUFA.
J. Aughenbaugh: PDUFA.
N. Rodgers: What are you going to PDUFA me? Anyway, sorry.
J. Aughenbaugh: This law basically allows the FDA to collect fees from companies to expedite the drug approval process.
N. Rodgers: That seems bad.
J. Aughenbaugh: Yes it does.
N. Rodgers: The reason I think that seems bad is so the [inaudible]
J. Aughenbaugh: anti-sarcasim
N. Rodgers: Anti-sarc.
J. Aughenbaugh: Yes
N. Rodgers: If we're trying to get approval for that. One of the big pharma who I will not name big Pharma because I don't want to get sued. But one of the big pharma companies is also pursuing something like that. They can pay to play. They could get moved up in priority before us.
J. Aughenbaugh: Correct.
N. Rodgers: Then we're out getting that approval or we don't get that approval as soon as they do.
J. Aughenbaugh: Yes.
N. Rodgers: That seems unfair.
J. Aughenbaugh: Yeah.
N. Rodgers: Rather it seems biased in favor of big pharma.
J. Aughenbaugh: Yeah, those with the resources to pay for what they call priority review. Basically the law, this law, PDUFA, created, if you will, to separate review paths. You had the Standard Review which we discussed in the first episode. Then we have the priority review. Now, standard review basically takes about 10 months. Let's say Nia. You and I have done the animal and human trials. We go to the FDA for the standard review. It generally takes the FDA about ten months to review, all the documents, all the test data, et cetera. That we shovel their way.
N. Rodgers: I would be willing to bet that we hear nothing in those ten months because this is the federal government?
J. Aughenbaugh: Yes.
N. Rodgers: It's like it falls into a hole and you're not even sure that the guy who got who is supposed to read it. Got it. But anyway.
J. Aughenbaugh: Yes. But then you've got priority review. Now, technically the FDA is opposed to reserve that just for drugs that offer major advances and treatments or they provide treatment where none existed. Priority review typically only takes six months, half a year. It takes four months off the process.
N. Rodgers: Which can be millions.
J. Aughenbaugh: Oh, yes. I mean, because if you can get it to the market. You can put it Into the hands of patients being prescribed this drug by doctors. You're talking about a lot of potential revenue here right
N. Rodgers: I don't like that though.
J. Aughenbaugh: I don't like it either, on the other hand.
N. Rodgers: Because I can see a lawyer saying, this provides better treatment and therefore it should be moved up even though it's not a new trick. You know what I mean, when they say advancement in treatment, that's vague. That's government speak for bringing me a lawyer and make an argument in front of me. You know what I mean? There are people who could make an argument that aspirin is an advancement in treatment for some whatever thing. I have I have feelings about that.
J. Aughenbaugh: Well, unlike most of the issues or government processes and government documents that we discussed, I have mixed feelings because on one hand, I agree with you. This seems to be priority review, seems to be the thing that a big drug company with a lot of money and with a lot of attorneys, could use to their advantage. On the other hand, again, one of the criticisms of the FDA throughout its entire history, and Nia, I came across this from books and articles that were written about the FDA in the 1940s and '50s when I was doing research for these episodes, was that the FDA takes too darn long to approve, again, needed drugs. You and I talked off recording about the latest controversy in regards to Alzheimer's drugs. Where you have families of Alzheimer's patients who were just like, why is it taking so long for the FDA to approve drugs that might go ahead and help my husband, my wife, my mom or dad, my grandparents
N. Rodgers: From the FDA's point of view, that is also a mixed bag because if you go too fast, you end up with vioxx, you end up with thalidomide, you end up with fen-phen. You end up with drugs that get approved and then start killing people left and right or damaging people left and right.
J. Aughenbaugh: That's right.
N. Rodgers: Vioxx was a painkiller. They thought this is great until they suddenly realized it was giving heart attacks to four out of every thousand people who've taken it. By the way, those are not good odds with a drug. It's this weird mix of, I want it faster but I also want it to be really safe and for us to understand what's happening. You can't always have both of those at the same time. It's again, part of that push pull that the FDA experiences with, we want to release drugs as soon as we can safely release them by the same token. One of the things we know is that we don't study anything long enough to know what the true long term effects are.
J. Aughenbaugh: Yeah. Because with many drugs, we may not be aware.
N. Rodgers: For months or years.
J. Aughenbaugh: Yes.
N. Rodgers: The NFL is only just recognizing concussions as a problem even though we've been hitting people in the head playing football for 100 years now.
J. Aughenbaugh: Yeah.
N. Rodgers: But we're now starting to understand what that does to the human brain over a regular consistent set of injuries separate from the FDA.
J. Aughenbaugh: We've mentioned two controversies. At the end of the last episode, we talked about pay for delay. We've just talked about the pay for priority. Third controversy, let's say Nia we take antisac to the FDA. Ten months later, they send us an email and say, we're denying your approval.
N. Rodgers: Do they have to tell us why?
J. Aughenbaugh: Yes, they do.
N. Rodgers: They can't just say because we liked Bill Neuman better.
J. Aughenbaugh: Yes.
N. Rodgers: Even though that may be true, considering Bill versus us. That may be true that people like him better.
J. Aughenbaugh: That's right. For listeners if you were like, who's this Bill Neuman. In the previous episode, we said our colleague Bill Neuman was producing a generic version.
N. Rodgers: We used him in our generic discussion.
J. Aughenbaugh: Yes.
N. Rodgers: Though he is not a generic individual.
J. Aughenbaugh: No.
N. Rodgers: He's an outstanding individual but we used him as the bad guy because if you knew him, you would know that it's like picking a kitten as the bad guy. He's just totally not.
J. Aughenbaugh: Yeah. That's 180 degrees different with Bill Neuman's personality.
N. Rodgers: Yeah. That's why we picked him because other people we might name might be a little too close to bad guy for comfort but not Bill Neuman. Anyway, they have to tell us why they're doing it. They can't just say because we picked a different person.
J. Aughenbaugh: Here's where the controversy arises. They outline the reasons in a response letter but then the agency has created over time an opportunity for the drug company to meet with FDA officials to discuss the issues. If that discussion does not clear things up, the company then can ask for a hearing, correct any issues, submit new information, or withdraw the application. One of the criticisms here is that a company that gets denied in that official response letter, that's not the end of the, shall we say interaction or negotiation.
N. Rodgers: Again, mixed feelings because they get a second chance.
J. Aughenbaugh: Yes.
N. Rodgers: But because that's likely to be Big Pharma they are cutting out people who may not have the resources to go after a second chance.
J. Aughenbaugh: Yes.
N. Rodgers: Because in order to do a second chance, you probably have to have in-house counsel, you probably have to have a lot of scientists who can rework the data and do all that other stuff. You would need to throw resources at that in order to be able to rework that. If you were a small company, that option might not be open to you.
J. Aughenbaugh: That option may not be open.
N. Rodgers: No doesn't technically mean no.
J. Aughenbaugh: Yes.
N. Rodgers: No means convince me.
J. Aughenbaugh: Yes.
N. Rodgers: Goodness, that would be terrible in some instances.
J. Aughenbaugh: Again, I have mixed feelings about this because I understand why the FDA or any government agency that denies somebody something that they want from the government gives an appeal.
N. Rodgers: That's your court guy and that's what we do.
J. Aughenbaugh: That's hardwired into American constitutional values, due process of law. But like you, I'm just like but the post letter meeting and then the appeal seems to be just set up, designed for those who have the resources to basically just wear the FDA down.
N. Rodgers: I was going to say to pressure the institution to give them what they want.
J. Aughenbaugh: Again, for our listeners, if you've been following along in any of the major newspapers over the last roughly 2-3 months, there's been a lot of criticism about the fact that the FDA has recently approved a new Alzheimer's drug which interestingly enough, the company who made it got the denial letter. But then when they met with the FDA to figure out why they were being denied, the FDA went ahead and said, well, maybe we should go ahead and bring this to market anyways.
N. Rodgers: Let's talk mixed message.
J. Aughenbaugh: Congress is thinking about having some hearings about this because the company is going to charge like, I think, and correct me if I'm wrong because you and I both read the article by others. This was going to be like $5,000 per treatment or something. It was just bizarre, just utterly bizarre.
N. Rodgers: A newly approved drug with a steep price tag of $26,500 a year.
J. Aughenbaugh: Yes.
N. Rodgers: Roughly $2,500 a month, give or take. I know 2,250 a month.
J. Aughenbaugh: Yeah.
N. Rodgers: That would be for most people one or one and a half of their paychecks?
J. Aughenbaugh: Yes.
N. Rodgers: That's a heck of a price to pay for. We can't even get into prices of drugs though because the FDA does not control the price of a drug.
J. Aughenbaugh: That's right.
N. Rodgers: That's the market. There have been some people out there who've done some pretty evil things with pricing drugs. The guy who changed the price of the Hep C drug because he said he was making money for his shareholders and embraced it to $700 a dose. Then that was unaffordable for most people with hepatitis. Like, what are you doing? Then there's all the problems with insulin and how much insulin costs and people having to take half doses.
J. Aughenbaugh: Then EpiPens.
N. Rodgers: EpiPens, and that'll be $800 for an EpiPen. I'm sorry, excuse me, what? What did you say? The FDA has no control over that. That's the market.
J. Aughenbaugh: Yes.
N. Rodgers: The FDA doesn't approve, we approve but you have to make it an affordable drug. There are other parts of the government.
J. Aughenbaugh: But yeah. Now you're talking about the Federal Trade Commission.
N. Rodgers: Can regulate the costs.
J. Aughenbaugh: Or the Anti-trust Division of the US Justice Department.
N. Rodgers: Or even if Medicaid and Medicare are purchased by the government in blocks, they can force prices because of the amount that they buy.
J. Aughenbaugh: That's right.
N. Rodgers: If I'm going to buy this drug that I'm going to get to every Medicaid patient or close to every Medicaid patient, I can usually force Big Pharma to give me a decent price for it.
J. Aughenbaugh: Yes. But the FDA is not involved with that.
N. Rodgers: No.
J. Aughenbaugh: That's a third controversy. A fourth controversy is medical devices.
N. Rodgers: The FDA has the statutory authority to review medical devices. Medical devices are supposed to go through roughly the same review process as do drugs. Devices have to go through laboratory and animal testing to answer basic questions about safety. Then they're tested on people to make sure that they're safe and effective. All right. Sounds good?
J. Aughenbaugh: All good.
N. Rodgers: Sounds good.
J. Aughenbaugh: We would prefer that this oxygen mask does not set fire to your house.
N. Rodgers: Yes. Okay. The FDA has come up with a classification system to rank medical devices based on the risk that they may pose. Okay.
J. Aughenbaugh: Oh, see this sounds dangerously like an actuarial table.
N. Rodgers: Okay.
J. Aughenbaugh: Hang in which people's body parts are measured by some accountants somewhere.
N. Rodgers: Okay. So Class 1 devices are "least risky" whereas Class 3 devices support or sustain life. An example of a Class 1 device is an oxygen mask. Class 3 are things implanted in a body; pacemakers, breast implants, HIV diagnostic tests. I'm reading this as I'm doing my research and I'm like, Oh say, Class 3 devices include breast implants. I know those can be dangerous, particularly if they rupture. But those are considered riskier than oxygen mass, which I've known a fair number of older people in my family with oxygen masks, and without them, they don't live. But nevertheless, according to the FDA. Some of this just strikes me as so arbitrary.
J. Aughenbaugh: Right.
N. Rodgers: Okay.
J. Aughenbaugh: Right. Well, it's the same as classifications of drugs. Right?
N. Rodgers: Yes.
J. Aughenbaugh: I'm not entirely certain that marijuana and heroin should be on the same classification of drugs. They do very different things to the human body.
N. Rodgers: But according to the FDA and the DEA, which are the two agencies who have to agree on whether or not a drug is a Class 1 drug for the Controlled Substances Act, marijuana is on the same list as heroin, cocaine.
J. Aughenbaugh: Which an organ are not suggesting that heroin is not without its dangers and detriments. But we are saying that heroin and marijuana is not without its detriments, but he does vastly different things to the human body than cocaine does. That's just a physical fact.
N. Rodgers: Yes.
J. Aughenbaugh: Anyway, so that's interesting controversy is what falls into what category in terms of whether it's a Level 1 device, Level 2 device, or Level 3 device. I'll let your oxygen mask slide, but I'm going to need to see more tests on these breast implants. That's fascinating. Yet by the same token, I can totally understand why pacemakers are Level 3.
N. Rodgers: Sure.
J. Aughenbaugh: Because that's acting as your heart. Not for all intents and purposes.
N. Rodgers: But based on the classification of your device, you have to go through a different review. Low to moderate risk devices go through what's known as a pre-market notification, a PMN. Okay?
J. Aughenbaugh: Okay.
N. Rodgers: All you basically got to do is let the FDA know 90 days before you start selling your device. Then it's up to the FDA.
J. Aughenbaugh: To stop you.
N. Rodgers: To stop you.
J. Aughenbaugh: That it seems fraught with problems.
N. Rodgers: But high risk.
J. Aughenbaugh: Especially if it's only 90 days.
N. Rodgers: 90 days.
J. Aughenbaugh: I don't even know if they didn't get around to, bringing your application in that time.
N. Rodgers: Well, particularly because the FDA, like most government agencies, is chronically understaffed.
J. Aughenbaugh: Right. Give it to him in the summer when nobody is around and see how long that takes.
N. Rodgers: Yeah, right.
J. Aughenbaugh: Oh my goodness.
N. Rodgers: But high-risk devices, your Class 3, they basically have to go through your standard approval process, just like drugs do.
J. Aughenbaugh: They have to show clinical trials they had.
N. Rodgers: Oh, yes. The whole shooting match. Right.
J. Aughenbaugh: What falls into what category is the controversy there? It's not that you don't want stringent controls over what we would think of as Class 3. It's that you want to be sure that the right things fall into Class 3 versus Classes 1 and 2.
N. Rodgers: That's where the big debates are between the medical device companies and the FDA. Because you fight long and hard as a medical device company to get your devices either into Class 1 or Class 2 but not Class 3.
J. Aughenbaugh: My pacemaker doesn't really take the place of your heart. Well, whoa. Yes, it does. Okay. Yeah, I could see where that would be controversial and I can see again where money helps you with that. Lawyers and money and the ability to present that to the FDA in a certain way.
N. Rodgers: Because if you have a really good team of scientists who can sit down with FDA reviewers and go ahead and say, you know, really, this is not a life-sustaining device.
J. Aughenbaugh: Except that then when it comes on the market, the first thing it's going to be called is life-sustaining.
N. Rodgers: The late night TV ads are going to talk about how you can live another 15 years.
J. Aughenbaugh: Right.
N. Rodgers: If you get this particular device. Right? Again, that's up to a different federal agency to go ahead and review those claims. That's the Federal Trade Commission.
J. Aughenbaugh: But that brings up another heart of that controversy, which is, okay, pacemakers. Let's just say you're going to test pacemakers. You're not going to test pacemakers on people whose hearts are perfectly fine.
N. Rodgers: That is correct.
J. Aughenbaugh: Because that will make them need a pacemaker when they didn't need one before. We're going to stop your heart and replace it with this pacemaker. Or stop your heart's natural rhythm and replace it with, I should say, your natural rhythm. By that standard, it is not randomized. It's not like the theory of general. Correct me if I'm wrong because I'm not great with methodology. But the theory behind any tests like that of any subject, let's say probably say you're interviewing voters. You need a randomized sample of the voters in order to get a broader view, a representative view.
N. Rodgers: Representative sample. Yeah.
J. Aughenbaugh: If you only chose college students between the ages of 18 and 21 to interview about a particular candidate, you are likely depending on the institution that you're at to get a very biased sample.
N. Rodgers: Yeah.
J. Aughenbaugh: Right? How do they make sure that device is, did they just say, oh, well, that's part of the device world, is that we can only test it on the people who actually need the device?
N. Rodgers: You raise one of the critiques of the FDA's medical device review process. That it's really difficult with medical devices to do the control experiments that you are looking for. I mean, because you can do that with drugs. We discussed that in the first episode.
J. Aughenbaugh: Exactly where you said some people got the drug and some people got the.
N. Rodgers: Placebo.
J. Aughenbaugh: Placebo and that helps you randomize.
N. Rodgers: Yes, so you can control for it and you can get a more representative sample. But with medical devices, particularly with.
J. Aughenbaugh: Some people randomly got a pacemaker, some people didn't. That's not going to end well, and it's going to end quickly.
N. Rodgers: Yeah, I'm worried if we think about oxygen mass.
J. Aughenbaugh: Right.
N. Rodgers: Some of the people in our trial didn't get oxygen.
J. Aughenbaugh: Didn't get good oxygen.
N. Rodgers: But the end result of that after, oh, I don't know, four or five minutes it's going to be bad.
J. Aughenbaugh: We're laughing listeners, but I mean, this is some pretty serious.
N. Rodgers: But that's serious.
J. Aughenbaugh: This is some serious stuff. The other thing about medical devices is that the FDA gets criticized for not staying current in regards to evolving technology. You're seeing this. A lot of medical devices now, much like automobiles, have sophisticated computer systems.
N. Rodgers: Oh, heck, yeah.
J. Aughenbaugh: Okay.
N. Rodgers: It used to be that a blood pressure monitor, you had the squeezy thing?
J. Aughenbaugh: Yes.
N. Rodgers: You did the squeezy thing on your arms up to a certain point, and then you listened for when your blood started flowing through your vein again and then you're like aha, that's your blood pressure. Now, you hook it up to your phone and it does a whole thing. It's part of NASA's mission control. It has a bunch of buttons on it.
J. Aughenbaugh: Bells and whistles are going off and you're getting digital readouts.
N. Rodgers: It can be sent to your doctor and all kinds of stuff without you.
J. Aughenbaugh: Yes.
N. Rodgers: Anyway, I'm just saying. The other thing I would imagine is devices out in the wild are probably pretty hard to keep up with. Like once a device goes out into the market, sorry, listeners, I'm going to tell you a brief story you don't care about, but it is illustrative. Yours truly has been looking for a humidifier. There are approximately 456,000 humidifiers on the market. Me picking between them has turned out to be an existential crisis. Like it's worse than me picking a house or any other major life decision. It's turned into this whole thing because there's all these choices. I can't tell the difference one from another. I imagine that that becomes problematic with the FDA keeping up with whether the devices are working or they're working the way they're supposed to be working, are they still effective? I don't know. That seems like to me that once it gets out into the market it's really hard to pull back.
J. Aughenbaugh: It's hard to pull back, and you're also pointing too, and I think maybe you did not intend this. But one of the big issues is the secondary or used markets for medical devices.
N. Rodgers: I didn't intend that, but you're right. That's me going to Goodwill and looking for a humidifier there.
J. Aughenbaugh: Okay. But I mean, think about pacemakers.
N. Rodgers: Does that thing still work?
J. Aughenbaugh: Think about pacemakers.
N. Rodgers: Do you think there's a used market for pacemakers?
J. Aughenbaugh: Yeah, because if you can go ahead and change out the batteries, you could take a pacemaker from one person.
N. Rodgers: Who no longer needs it and we hope they rest in peace.
J. Aughenbaugh: Yes, and insert it in somebody else.
N. Rodgers: That is so gross.
J. Aughenbaugh: Okay.
N. Rodgers: Sorry. That's my reaction. Wait, that's been where? No, thank you, I'll get my own.
J. Aughenbaugh: But the used market for medical devices, the medical devices are cheaper. People who are on lower incomes-
N. Rodgers: That's true.
J. Aughenbaugh: Can afford this.
N. Rodgers: I have the financial wherewithal to be grossed out by that. But there are some people who would not. You're right. Thank you for calling me on that, because you're right. It's a financial issue for some folks. They use whatever is available to them.
J. Aughenbaugh: Yeah. The last controversy I want to mention, and we've already talked about this with our colleague, Judy Twigg, who for our listeners, if you want to go in and get a short course on everything COVID-19, you got to type her name in the Google machine. She's given a lot of great interviews.
N. Rodgers: That's true, and she talked to us at the beginning of the vaccine dispersal.
J. Aughenbaugh: Yes.
N. Rodgers: Once there were vaccines she talked to us about how they were going around the world or not.
J. Aughenbaugh: Yes.
N. Rodgers: That's the case.
J. Aughenbaugh: The politics of all of that. But the COVID-19 pandemic gave the United States and the world of crash course on drug development.
N. Rodgers: That's true. A lot of people who didn't have any idea how drugs developed before this, couldn't help, but I must say hid away from the news. They couldn't help but know how at least the vaccines were doing. Because it was being reported every day.
J. Aughenbaugh: Yes. Nia, you touched on this in our previous episode. A lot of Americans when COVID hit were just like, why isn't there a vaccine? Then they were like, well, what's the government doing about this? We talked about it in the last episode about how first the Trump administration and then continuing on with the Biden administration, used the US federal government's vast resources to incentivize drug companies to produce vaccines, to produce masks, to produce tests, right?
N. Rodgers: Right.
J. Aughenbaugh: But all of that happened much quicker than the standard drug approval. But there were even delays with COVID-19, so that the FDA could go ahead and do their safety review. Again, that's going to be part of the tension. It's one of the reasons why listeners Nia and I wanted to go ahead and do a multi-episode dive into the drug approval process. Because at least for me, I don't know about you Nia, but at least for me, part of my interest in all of this was based on what we as Americans experienced with the production of COVID-19 vaccines. I was just utterly fascinated by how we could go from when the virus hit the United States to a few short months later, not a few short months later.
N. Rodgers: It was about a year.
J. Aughenbaugh: It was about a year.
N. Rodgers: But that's an inordinately short amount of time when you consider that the normal length of time is 10-15 years. However, they had been working on the base of a drug for quite awhile. The base of a corona style drug that would help with a lot of these diseases. Because we've had similar diseases, SARS and other diseases that have come out that they're like, dang, we need to be able to have something that we can. That's how we ended up with something as quickly as we did, was because they were all ready three-quarters of the way there in terms of a virus that would deal with a respiratory illness of this nature.
J. Aughenbaugh: But there were plenty of Americans who were very skeptical about the safety of the vaccines in part because the approval process by the FDA.
N. Rodgers: Felt short-circuited.
J. Aughenbaugh: Yes.
N. Rodgers: Yeah.
J. Aughenbaugh: Again this is the downside of the FDA having a well-established approval process which typically means a drug from development to approval and marketing usually takes much longer. Many Americans were just like, "What's going on here? Are we not concerned about the safety and effectiveness of these vaccines? I'm not putting that stuff in my body."
N. Rodgers: We tested them on doctors and nurses.
J. Aughenbaugh: Yes, we did.
N. Rodgers: Which, in retrospect, seems like a bad idea. For the most part, worked out in our favor. While we're talking about COVID-19 and COVID-19 vaccines, couple of things we should mention. First of all, there are some people who had adverse reactions to the vaccine. There are people who have adverse reactions to the flu vaccine, to all kinds of vaccines. You're going to wherever and you need a vaccine for yellow fever, and they take the vaccine, and then they get sick. It does happen with a certain amount of the population. I think the pharma companies were pretty clear on that. There was going to be a certain percentage of people that this will harm. What you have to do is value that against the number of people it will protect and where do you make that split. The other thing that's coming out now is this disinformation or anecdotal information. My friend got the COVID vaccine and then they died a month later. People regularly in the world, Neil deGrasse Tyson has a big volume treatise about this, don't understand statistics, and they don't understand probability, and they also don't understand correlation and causation.
J. Aughenbaugh: That's right.
N. Rodgers: Just because two things happen at the same time does not mean they cause each other. It is a known fact in criminology that murder rates go up in the summer. It is also a known fact in the world that ice cream eating rates go up in the summer. But people eating ice cream does not make them murderous. Maybe if you had really bad ice cream it happens once in a while that there's a connection, but those are not causally related.
J. Aughenbaugh: That's correlation.
N. Rodgers: Right. What you're having is both things are happening in the heat of the summer and both things are happening when people are outside more so they have more opportunity to hurt each other. There's all these other factors. We would encourage people to when you hear anecdotal connections like that, just stop and think, is that a rare event or is that a common event? If you're hearing that and it's 80% of the people that it happened to, well, now we might have a real problem on our hands.
J. Aughenbaugh: We might have causality here. But just because two events happen does not necessarily mean that.
N. Rodgers: That they made each other happen.
J. Aughenbaugh: They're causally connected. Instead, what you might have going on is correlation.
N. Rodgers: It's really hard for humans because we like to make order from the chaos. We want the chaos of the universe to make sense and so we tend to say things like,"W ell, they got that and three days later they died. That thing must have caused it." Maybe. Maybe it did, but maybe it didn't. You have to ask yourself those questions.
J. Aughenbaugh: I mean, an example I use with my students, Nia, is I drink coffee every day, a whole bunch. I'm also grumpy a lot of days.
N. Rodgers: Coffee does not make you grumpy.
J. Aughenbaugh: Yes. In fact, if anything it may make me less grumpy. But if you look at the number of days that I drink coffee and the number of days that I'm also grumpy, you could go ahead and argue that there's some causality but really all it is is correlation, right?
N. Rodgers: Right.
J. Aughenbaugh: I drink coffee and I'm frequently grumpy.
N. Rodgers: Also, we would encourage anybody when you are caught up in a new story to ask yourself, who is telling me this news and why are they telling it to me? Do they have a dog in this fight? Are they going to earn money from it? Are they going to earn eyeballs from it? Are they going to get clicks or views? Keep that in mind when somebody is telling you something. That doesn't mean it's not true but it is something to keep in mind. Also, the flip of that is people were screaming for that vaccination. They wanted to be vaccinated. The pressure on the government was enormous. I feel certain, don't you think that probably President Trump called Big Pharma every day? Do you have it yet?
J. Aughenbaugh: Right. Well and again you make a really good point there, Nia. When we're recording this is a few days after the terrible earthquake in Turkey and Syria, and the number of people in those countries who are begging their government to respond.
N. Rodgers: The pressure is enormous.
J. Aughenbaugh: Yes. You see that with public health crisis. You see that with natural disasters.
N. Rodgers: Katrina. People sitting on top of houses saying, "I could use a ride out of here."
J. Aughenbaugh: At that point, they're so desperate that they don't care if you follow your established procedures. They want a solution. They want help. But the FDA has been tasked with making sure that whatever help is afforded through drugs, medical devices. Heck we didn't even talk about food. That's a completely different set of what we're saying.
N. Rodgers: Oh no. We're going to talk about food another time because we have to talk about nutrition in this country too anyway. But you're right. The FDA is swimming upstream against public pressure all the time. "I want that new drug," and the FDA has to say, "Whoa. Slow your roll there, buddy, because we need to make sure that it's at least relatively safe. But we need to have some clue that we're not just going to kill mass amounts of people by releasing this drug out into the market." Because as soon as a drug is released into the market somebody starts working on a generic side eye bill, name it.
J. Aughenbaugh: We may go ahead and cure sarcasm but if we then end up creating a whole bunch of insomniacs, that's not good.
N. Rodgers: You're not sarcastic anymore but you haven't slept in a month. Well, that's bad. That's just bad for the human body. The FDA also has to balance the idea of what harm the drug will do versus what health benefit it will create which is why you get those labels. Aughie and I would like to end these episodes by encouraging you to find an over-the-counter medication if you don't take a medication or if you take a medication to read the hundred folded piece of paper, because it's been folded 400 times to fit in your box.
J. Aughenbaugh: With really small print.
N. Rodgers: With really small print so you may have to get out a magnifying glass. Read the chemical interactions, read the possible side effects, read all that stuff, and then think about the fact that the FDA has said yes but the benefit outweighs those side effects.
J. Aughenbaugh: After you get done reading that-
N. Rodgers: Don't ever read another one because it'll just make you sad. Just read the one.
J. Aughenbaugh: This is the public service announcement feature of these episodes. If you still have your mind and you still have questions, please contact your physician or your pharmacist with those questions and get those answers.
N. Rodgers: Exactly. Please do not email me or Aughie because neither one of us has a medical degree and we're not in good enough shape that you want our medical advice, either one of us. Because Aughie will tell you to drink eight pots of coffee and take a lap and I will tell you to teach your body weight in chocolate. Neither one of us is good advice medically. Go to your physician if there's any question.
J. Aughenbaugh: We're not medical doctors and we don't play one.
N. Rodgers: On TV ever.
J. Aughenbaugh: No, never.
N. Rodgers: Or on a podcast.
J. Aughenbaugh: No. All right, Nia.
N. Rodgers: Thank you, Aughie.
J. Aughenbaugh: Thank you, Nia
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