So in this second lecture video for the week, I want to focus on over-the-counter medication, and we'll also cover a little bit of the controversy over herbal supplements, especially in the United States. So one, I guess, time point I want to highlight here is 1962, when, as you can see on the screen, the Kefauver-Harris Amendment was passed. Now, this particular amendment was in response to... the FDA's inability to react appropriately to the thalidomide event.
If you haven't heard of that, thalidomide was a drug that was, when taken by women who were pregnant, resulted in birth defects around the rest of the world. And even though people in the United States, physicians in the United States, knew of this problem, the FDA didn't have the legal power to stop the company who manufactured it from selling it. For whatever reason, they just didn't have the oversight for that, which is obviously a problem. So this particular amendment gave the FDA the oversight that they needed. And in particular, we kind of read off a few of the features of the law.
First, the manufacturers had to prove that the drug was effective before they could market it. and they also had to publish any side effects. So you can credit this amendment for the huge list, the litany of side effects that usually are read out if you're watching a commercial for a drug. And the evidence that manufacturers use to support this claim that their drug works has to be based on controlled clinical trials, not by the company, but by experts, which of course would have hopefully prevented the thalidomide.
issue from happening. And then one final thing is that the FDA has to approve any drug before the drug can be marketed and sold to the American public. So that was a huge switch in how drugs were marketed and how they were vetted before being sold. And from the former FDA commissioner, Margaret Hamburger, excuse me, Hamburg, with the passage of the amendments, The FDA was no longer a helpless bystander while unproven drugs were streaming into pharmacies and onto patients'bedside tables.
Now, a lot of you might be thinking, well, what about supplements? We'll get to that. We'll get to why supplements don't appear to fall under this amendment.
So I'm just going to show you a kind of a staggering long list of over-the-counter medication types. A lot of drugs are sold over-the-counter, and I don't expect you necessarily to be able to rattle off this whole list, but just to give you an idea of the scope, and I'm sure you've seen this when you go to a pharmacy, there's aisles and aisles of drugs of different types that you can just pick up without a prescription. Antacids, antidiarrheal, so for just gastrointestinal issues. Sunscreens, technically it's a drug if it's blocking UV rays.
Dandruff medication, special shampoos, bronchodilators, usually for inhalers. asthma medication, stimulants, caffeine pills, things like that, cold remedies, NyQuil, DayQuil, skin preparations to respond to maybe acne, things like that, laxatives, of course, again, could help with gastrointestinal distress, anti-emetic, that's kind of a fancy word, that basically is any drug that's used to prevent or reduce the risk of vomiting. vitamin or mineral products, oral hygiene products, toothpaste, things like that, analgesics, pain relievers, Tylenol, antitussives, that's cough medication that's helping with reducing coughing, eye products, so, you know, Visine tears to help with eye dryness, things like that, dental products, again, back with kind of toothpaste, etc.
Emetics, just the opposite of anti-emetics. Emetics are drugs that... assist with vomiting.
Antiperspirants, antimicrobials, these are things like antibacterial soap. Antibacterial soap largely nowadays anti-excuse me trying to think of the name off the top of my head. Antibacterial drugs that you would typically need to prevent any kind of bacterial infection internally can't be sold over the counter.
But if it's a topical application, then they're still technically okay. hemorrhoidal medication, sedatives and sleep aids. I think NyQuil, the company that makes NyQuil now makes a sleep aid that's exclusively the part of the drug that assists you with sleeping.
Allergy medication like Claritin, Zyrtex, things like that, contraceptives, and then weight control medication. So there's a whole bunch of different medications that aren't, I guess, risky enough. or as prone enough to abuse for there to be a need for oversight. But let's talk more specifically about a few, use the word specific multiple times, a few over-the-counter drug classes. Analgesics, and again, if you haven't written this down yet, these are any medication that provides pain relief.
Over-the-counter analgesics, you've probably heard it before. For instance, aspirin, which is a substance that you may have even made in chemistry lab. It's fairly straightforward to make. Aspirin was synthesized a while ago by Bayer, a very famous pharmaceutical company. But now that it's been in kind of marketing for so long, there's a lot of generic medication that is basically aspirin.
You might have heard, let me just write down a few of the other names for aspirin. Anacin, I haven't heard this one before, but that's one of them. Bufferin.
And then one component of Excedrin is aspirin. Excedrin I have heard of before. So aspirin is really, really useful for pain relief. Much more so, though, for dull, aching pain. So if you have like a really, um, like you cut yourself pretty deeply and that's really, really painful for you.
Aspirin is, is much better at dulling, you know, headache pain, maybe kind of cramping pain, things like that. Um, but doesn't really cover up sharp pain as well. Um, how does it work?
It works to block a substance known as prostaglandins. Prostaglandins are typically released, um, in the body, uh, at peripheral sites of pain. released at peripheral sites of pain.
And honestly, a lot of the detail we're talking about here, we're going to get to next week and the week after that, when we start talking about what's happening at the synapse when a drug is doing what it's doing. And another interesting thing, even though aspirin is really helpful for dull, aching pain, it doesn't seem to be as helpful if the pain is related to your stomach for whatever reason. What are some side effects of taking aspirin?
You've probably heard of this before. If you take it too frequently over too long a period of time, there's a risk of stomach bleeding. And this is pretty much true for a whole bunch of over-the-counter analgesic medication. If you take Tylenol too long, if you take ibuprofen too long, there are some organ-related risks.
to taking each of these kinds of drugs. So probably not something to take every day, just in case you might experience pain. You may have heard that aspirin is useful to respond to heart attacks.
If you're experiencing symptoms of a heart attack, take an aspirin. Why? Well, because it's also something known as an anticoagulant. which basically means it thins the blood, right? And it makes it less likely that the blood is going to, I can't think of the word, form scabs, things like that.
It also will slow the growth of any blood clot that might be the cause of the heart attack. So it's a good kind of temporary intervention while that individual gets to the hospital for further treatment. Acetaminophen, Tylenol, which we talked about in the previous lecture a little bit, is useful for, again, that same kind of dull, aching pain.
It's also useful if someone has a fever, so it can be used to counteract, let me write this out instead of just saying it, counteract dull pain and fever. and you'll usually see this listed on the bottle when you purchase this particular product. I mentioned each of these has an organ failure or organ risk related to it. For acetaminophen, it's your liver.
If you take acetamin for too long, there's a risk of developing liver problems. In fact, some people, if they take high doses for a longer period of time, some people have actually died because of overdosing. Ibuprofen, another drug you've probably heard of before, also marketed as Motrin. Similar idea, I think, for... Ibuprofen is not so much the liver as the kidneys that are implicated in the risk of taking ibuprofen for too long.
And then another analgesic you may have heard of is naproxen as well. So there's a lot of different versions of over-the-counter analgesics, but always remember there are potential side effects. There are potential downstream consequences, physically speaking. One thing I want to highlight here too is that the same exact substance can be strategically marketed to a particular demographic.
And for instance, if you look at, you know, in the pharmacy, you see a bottle of Motrin, you see a bottle of ibuprofen, they're the same drug, right? Technically speaking, you're getting the same exact substance in that pill, but they're targeted to very different groups of people. So I just didn't, this is not a very scientific thing, but I just went to the... the marketing websites for each of these companies.
If you look at Motrin's marketing, these are the kinds of images you see, right? You see largely women and children in these marketing campaigns. But if you look at, and by the way, this was August of 2020, if you look at marketing for Newprint, which is another brand name for this, the same underlying drug, you see images like this, right? Older men.
It's kind of interesting. And then same drug, Advil, Advil's ibuprofen, and you see kind of active people, but they're not in a particular demographic necessarily. So it seems like Motrin, they're trying to sell that brand to women.
They're trying to sell Nuprin to older men, and Advil is kind of like everybody's drug, even though it's the same drug. So next time you go and you see Advil costs more or Nuprin costs more than Motrin, just get the Motrin, probably. going to help you just the same. So that's analgesics.
Let's talk about another category of over-the-counter medication, cold and allergy medication. What's interesting about some cold and allergy medication, which is going to connect to our later discussion of opioids, some cold medication that you can buy with a prescription has codeine in it, which is an opiate, right? It actually, it's not as potent, obviously, as morphine, but it does the same kinds of things, physiologically speaking, as morphine does.
But if it's over the counter, probably won't have more codeine in it. Cold and allergy medication will typically consist of a few types of drugs. So in any given bottle, for instance, of DayQuil, you'll probably have some kind of decongestant. And it's kind of small type, but you can see down here, it tells you what exactly, what kinds of drugs are in a dose of DayQuil. Acetaminophen, pain relief.
So if you take some DayQuil, you'll probably have help with the aches and the pains that usually go along with a cold. Phenylephrine, that's a fun word, is sometimes used in some of this medication as a decongestant to help with all of the built-up phlegm that's in your system. Pseudoephedrine used to be in NyQuil and DayQuil. Pseudoephedrine.
was a decongestant, but it has been removed since. And you'll probably not be able to find any over-the-counter cold medication that has pseudoephedrine in it, I believe because of the potential for abuse. So that's been since removed. You can see this one, this is an older picture because it still has pseudoephedrine in it, but that was replaced with phenylephrine. as the primary decongestant.
You'll also usually see some kind of expectorant, some kind of expectorant which essentially helps you to cough up anything that isn't particularly helpful. Antitussives helps to do the opposite, stop you from coughing too much. That's usually dextromethorphan, and you can see that one in this example called Belson on the screen there, dextromethorphan. which is listed as a cough suppressant. And then usually you'll see some kind of antihistamine, which can try to slow down your body's histamine reaction, an allergic reaction to some of the foreign objects in the body.
There's a whole bunch of different antihistamines you'll probably see, though, including one we've already talked about, loratadine, also known as claritin, diphenhydramine, which is also sold as Benadryl, and chlorpheniramine maliate, that's a fun long name, all different options for an antihistamine response. All right, a few more. things to highlight here.
So if you're looking for an over-the-counter version of a stimulant or a sedative, there's a few options. Caffeine pills are legal, not just legal, can be gotten without a prescription. Usually it's not much more caffeine than you could get in a few cups of coffee. And then diphenhydramine, which is also used in cold medication, you can see on the previous slide, also used as an antihistamine, knocks a lot of people out, right?
Makes people really sleepy. My husband's one of them. When he takes diaphenhydramine, he has to kind of cut the dosage a little bit. Otherwise, he's just asleep all day.
And then let's start talking about the herbal supplement category and why that is not regulated in the same way as these other over-the-counter drugs are. So there are a few things that herbal medication companies that create herbal medications have to assure the public. The manufacturer who creates any herbal supplement has to ensure that the supplement is safe, which is helpful. The Food and Drug Administration, excuse me, though, doesn't have the same kind of preventative oversight that they do when we're talking about over-the-counter medication like analgesics, etc. for whatever reason, the way drug law is right now, the FDA can only move against a company after it has been sold and enough people have experienced negative effects of the herbal supplement.
So after the drug reaches the market, people start complaining, then the FDA can step in and take action. And what also is really interesting is that those companies that sell herbal supplements, fish oil, St. John's wort, things like that. They don't even have to register with the FDA to get approval before selling the drug. So whereas with over-the-counter medication, there has to be clinical trials. They have to demonstrate using external experts.
This is safe. This is effective. With herbal products, that is not nearly as stringent, which is why I guarantee you will read this on any herbal supplement that is sold in the United States.
there's usually a disclaimer, right? This is required by law. Any statements they make, right, improves memory or helps you stay awake, has to have this disclaimer, which is basically, like, we don't really know that this is the case, right?
These statements have not been evaluated by the FDA. This product is not intended to diagnose you, to treat you, to cure you, or to prevent any disease, which begs the question, why are we taking the drug? If that's, if that's all true, why are we taking the drug, right?
So here's just a couple examples of how this can be used for kind of nefarious purposes. You'll see a lot of this in online marketing especially where there'll be a lot of claims made about a particular drug, there'll be a picture of the drug, and then they'll allow you to purchase the drug online. Let me highlight a few things.
So this is just one I found at random called Pectosol. It's saying it's made with real citrus pectin, the kind of substance that you use to make jam. I'm not sure why we're supposed to be impressed by that.
It can help you restore your immune balance and your health. Do you want to enhance your immune system? Sure, I do.
Do you want to remove toxic radioactive metals in your body? Sure, that sounds good. Do you want to slow down the doubling time of your prostate?
Okay. A lot of things that don't seem to be really related to each other are claimed to be addressed by this particular supplement. And then they, you know, ask you, will you pay us $30? for 90 capsules.
The FDA cannot do anything about this unless it hurts people after the fact. And there you go, there's your disclaimer statement. These statements have not been evaluated.
This drug is not intended to diagnose, treat, cure, or prevent any disease, etc. It's not just kind of shady websites that fall prey to this though, right? If you walk into any big box store, any pharmacy, you're going to see an aisle with a whole bunch of herbal supplements, all of which have this asterisk disclaimer statement.
So here's an example from CVS or Nationwide Pharmacy, really, really well-known company. um, they're on their website, they're still selling this, the supplement called Prevagen, which is currently under investigation for the flaws in some of the claims that they're making. Um, so you can, you could go and buy this right now.
I don't recommend it, but you can go and buy this right now. And these are the claims, the claims that they're making. Prevagen improves memory, asterisk, which points down to the FDA disclaimer. Prevagen is safe and effective. It's safe and effective, but we haven't evaluated whether that claim is true, right?
the FDA has not evaluated these claims. Number one, pharmacist recommended memory support brand pay us $42 or $1.40 per pill. That's pretty pricey for something like this. So let me give you just a sense for, at least in this case, how the FDA is trying to work against the sale of Prevagen. So in 2017, the FTC, the Federal Trade Commission, actually sued.
the company who produces Prevagen. And just to give you a sense for the progress that was made, they just pulled a whole bunch of claims that were made like, as we age, mild memory problems result in more difficulty remembering. They also lead to an inability to focus, pay attention, or stay on task.
With advanced age comes increasing stress that can affect the brain. If you've taken brain and behavior, you know that in terms of memory loss over time, Yes, we lose our reaction time over time. We get a little bit slower to respond to things, right, over time.
We also lose certain types of memory. But most kinds of memory, we actually improve until our, like, 50s or 60s, and then we decline to where we were when we were in our 20s or 30s. So a lot of these companies are taking advantage of this lay theory that as we get older, oh, no, we're going to lose our mind, we're going to lose our memory, which is not really borne out by the research. So they're kind of... playing on fears that we all have as we age, which is a little bit disruptive, to put it mildly.
But the FTC is still in the process of pursuing this lawsuit. They're pulling up, for instance, this claim that Prevagen has been clinically tested. When they actually went and probed the data behind this study, the data didn't look like this. the company is essentially misrepresenting the research that they claim they did to support this idea that Prevagen improves memory.
On the graph on the back of the product, it says 90 days, bigger improvement on memory than 30 days after using, than eight days after using. But the actual results, there were no differences between those three time points. They, one kind of random side. thing.
They say that they found the protein that's used in this drug in jellyfish, and they kind of use that in their marketing too, right? It's used in jellyfish. That must mean it's good, right?
They also really, really target those fears, as I mentioned. So here's just a couple examples. They have some customer testimonies.
Mary remembers names better. I probably noticed a difference within a month of taking Prevagen. I was able to remember things better.
I wasn't as frustrated with myself, which was great. The issue is, this could just be a placebo effect. If you haven't actually done a clinical trial and you compared a control group who's taking a placebo, a sugar pill, to a group which is taking Prevagen, the drug, and demonstrate that there's a difference in memory advantage, then this is probably just the person thinking that the drug is working and noticing things more that provide evidence for the drug working.
It's not actually... evidence that it works. Here's just a couple more examples.
This is the most insidious of all. This was part of an advertisement sent out to largely older adults. How often do these occur? And this sentence especially, you may want to ask a loved one to help you answer the questions. Essentially priming the person, the older adult, to think, I am not capable of taking this test on my own.
I need someone else to help me. And then the questions that are asked seem to be assessing memory. They seem to be, oh, this is like a, you know, a test to make sure that I'm, you know, I'm capable in terms of my memory. But none of these have been validated.
None of them are reliable. They're not a published, validated scale. They're just, you know, the company execs made these up, and they're trying to use them to make people think that they're really assessing their memory. So a lot of shady, underhanded. manipulation of facts type of tactics used at least for this particular example to sell this particular substance.
So if you're interested, I'll put these slides up on Moodle. There's a lot more detail here that I'm kind of skipping through because I don't want to spend too much time on it. But this is the you can argue that this is the result of the FDA's lack of oversight over herbal supplements.
If supplement companies don't have to produce clinical evidence that their herbal supplement works, they're not going to do it. Right. There's no incentive for them to do it.
And that. that court case is ongoing. It's still not completely resolved, which kind of brings up this big question. Why? Why does the FDA have oversight over the kind of drugs, but not over herbal supplements?
One argument might be, well, you know, St. John's Wort and ginkgo biloba, right, those aren't drugs. Those are like a separate class of things. But why would you consider them different from drugs? Herbal supplements create side effects, just like drugs do. Herbal supplements have...
actual effects, right? They have drug effects on you. They can calm people down. They can help people with their digestive systems.
They're not just inert things. If they were inert things, that would be a problem because you're just taking something that's not doing anything for you, right? So there's no reason to argue that they're not drugs.
They have drug-like effects. Here's just another example, GHB or gamma hydroxybutyrate. is a depressant.
It serves to calm people down. St. John's wort, which I've mentioned before, is used often as an antidepressant. It has a couple active compounds in it, hypericin and pseudohypericin.
Ephedra, also known as ma huang, is an herbal supplement that has stimulant properties, very similar to caffeine, things like that. And melatonin is used as an herbal supplement to help with people who experience jet lag or people who work on shift work. And there's evidence that it works, that it does these things.
So why call it a supplement instead of a drug if it's got the same kinds of effects as drugs do? I already mentioned that side effects can happen taking herbal supplements. So, for instance, I've brought up ephedra already. Ephedra had kind of controversy when it was sold.
The FDA had to remove ephedra-containing substances because they were harming people. You can see 16,000 reports of injuries, 62,000 consumer complaints, at least 155 people died because of taking herbal supplements. So there's this halo around herbal supplements. People look at herbal supplements and think, oh, these aren't drugs.
They must be safer than drugs. And that can be very misleading. And a lot of people can get hurt because of the marketing tactics and because of this this halo of safety that goes around them. In fact, you could argue in some ways they're less safe than over-the-counter drugs because they don't have as much oversight and you don't have as much evidence what might happen if you take this drug, this supplement, etc.
So it's just something to be careful of, to be aware of when you're considering whether to purchase one of these. Alright, I guess I'll pause there and the next video we'll get into drug use statistics.