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May 9, 2023

Sorell Schwartz, PhD - What you must know about the meds you are taking

Dr. Schwartz explains the confusion between the FDA and CDC and their roles, the importance in taking our medications as directed, the interaction among our mutiple medications, the difference between side effects and adverse effects, the efforts toward deprescribing, the proper way to stop a medication and the current thinking about Mifepristone and Misoprostol.

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Sorell Schwartz, PhD is Professor Emeritus of Pharmacology at Georgetown University Medical Center, Senior Pharmacology Advisor at the U.S. Food and Drug Administration and has had advisory appointments at the National Library of Medicine, the FDA, the EPA, the National Institute on Drug Abuse, the FTC, the U.S. House of Representatives, OSHA, the Department of Defense, the FBI and WHO.

Dr. Schwartz explains the confusion between the FDA and CDC and their roles, the importance in taking our medications as directed, the interaction among our mutiple medications, the difference between side effects and adverse effects, the efforts toward deprescribing, the proper way to stop a medication and the current thinking about Mifepristone and Misoprostol.

This is a podcast you cannot miss. Your life could literally depend on it.

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Disclaimer: Unedited AI Transcript


Announcer (00:06):

You are connected and you are listening to specifically for seniors, the podcast for those in the Remember When Generation. Today's podcast is available everywhere you listen to podcasts and with video at specifically for senior's YouTube channel. Now, here's your host, Dr. Larry Barsh.

Larry (00:39):

My guest today on specifically for seniors is Sorl Schwartz. Dr. Schwartz is Professor Emeritus of Pharmacology at Georgetown University Medical Center. He has served as professor of Pharmacology at Georgetown University School of Medicine, senior Pharmacology Advisor at the US Food and Drug Administration, the head of Pharmacology Division at the US Naval Medical Research Institute, and has had advisory appointments at the National Library of Medicine, the F D A, the epa A, the National Institute on Drug Abuse, the ftc, the US House of Representatives, osha, the Department of Defense, the F B I and W H O. Welcome to specifically for Senior Sorl.

Sorell Schwartz (01:41):

My pleasure, Larry. Thank you.

Larry (01:43):

During the Pandemic two US agencies were mentioned continuously, and some listeners to the podcast mentioned that they were confused about the difference between the C D C and the F D A and the interrelationship between the two. Can you clarify that for us?

Sorell Schwartz (02:06):

Well, both agencies are agencies of the department of Health and Human Services. The FDA is a regulatory agency and it regulates food, drugs, and cosmetics. Now food is, it doesn't approve a Grade A steak, but it approves any additive added to that stake. So the, so the safety of foods is, has mostly to do with food additives. Also if you have a paper in which you're wrapping food for a freezer or something like that, and there's some chemical component of that paper that also needs approval of the fda the but is regulatory, meaning that it sets the rules for what drugs can be on the market, whether they're prescription drugs or whether they're over the counter drugs. They also approve devices such as you know, anything for the heart or anything that's generally indwelling doesn't have to be indwelling, but all devices have to be approved by the by the fda.

Sorell Schwartz (03:30):

The C D C on the other hand, is not a regulatory agency but it is an agency which actually sets sometimes advisories and sometimes requirements. For example, we go back to the COVID 19. The FDA had to approve the EF safety and efficacy of a vaccine, but the C D C established who gets the vaccine, somebody over 65 not children under five and so forth like that. The f and the C D C has some authority advisory and some of it le statutory that allows them to make certain decisions regarding something affecting public health. So again, in drugs, for example, it can if there is a reason to restrict the use of a drug, in this case, a vaccine, which is a, comes under the fda they can set those requirements, but they can't set whether or not it is safety or efficacious that's required by by the food and Drug Administration.

Sorell Schwartz (04:57):

So they're both agencies that, and by the way, there was the question you ask and you say that people were confused. That's interesting because I think even the governor itself was confused because they have a memorandum, memorandum of understanding between the FDA and the C D C not from 1980 or 1990, but from June of 2022. So there, there is an actual memorandum understanding that shows where they have separate responsibilities and where they have overlap in responsibilities. And the c D C is the major contact or the liaison between the US Health System and the World Health Organization.

Larry (05:52):

This podcast is directed mostly at older adults. What are the specific issues with medication use in seniors, in older adults

Sorell Schwartz (06:03):

With seniors in particular? We have a a number of a number of issues that, that are that are specific to to older ucs, older adults. First of all, appropriateness where you say, well, is appropriateness an issue with, with everybody? Yes. But unfortunately, when clinical trials are done to establish safety and efficacy of a drug the elderly generally, frequently, usually are not included in these clinical trials, especially people over 80. So it, it may be for example, that a a woman in her late eighties has a breast tumor removed. There's not a great deal of data on what type of chemotherapy is safety and efficacious for someone of that age. You know, that would be a follow up, let's say, to having that tumor removed. So that's the, the problem.

Sorell Schwartz (07:27):

Also, the problem of the elderly is that people over 65, and especially over 80, if I make it that far, are, are generally suffering from multiple medical issues. And multiple medical issues mean generally multiple physicians and multiple physicians generally mean multiple drugs, and that's what we call polypharmacy. Polypharmacy is the use of multiple drugs for the purpose of treating. It could be treating one condition, but generally it comes about because are you treating the high blood pressure you're treating, you're, you're, you're treating metabolic syndrome or, or pre-diabetic or diabetic arthritis. And a whole line of ailments, not impossible in the younger generation, but quite common in the in the older generation. There is also a problem of what we call compliance. And compliance means following the directions. And the, the older person who has, let's say five, five drugs a day or more and that's fairly common for people over the age of 80.

Sorell Schwartz (09:06):

They, as you know, you have these little dis, these dispenses where you divide your drugs up over a a week period, and you open a, you know, Monday, Tuesday, Wednesday, and Thursday, et cetera section that, that is part of compliance. Making sure that the drug is used properly and used properly again, means taking it on time. It's almost impossible to maintain a drug regimen where there is a requirement, let's say, to take a particular drug three times a day. That's why there is a, a major, major pharmaceutical effort to develop and place these drugs within a sustained release. I'm gonna have to take it once a day about the about the only drug that you don't have to hint a person to push them to take it is a narcotic analgesic. When they're suffering severe pain, you don't have to remind them to take the drug. But the the compliance is is a major issue. Of course, cost is an issue. And

Larry (10:35):

Let's well, let's get back to cost a little later, but, okay. In, in regard to compliance. So taking drugs in the prescribed dose at the prescribed time of day there's, there's an issue with food or taking it on an empty stomach.

Sorell Schwartz (10:58):

Well, there's there are two primary concerns with with drugs that unfortunately are not well understood by a wide variety of the practitioner population because it requires really a knowledge with a separate a separate literature, literature. One is drug drug interaction, and the other is drug food interaction. Drug food interactions are very common, and you commonly hear grapefruit juice as being a as interfering with drug efficacy or safety. And actually, it's a, it's an, it's an appropriate label to consider grapefruit juice a potential harmful agent when it comes to taking drugs, especially if you're taking multiple drugs. The major effect of grapefruit juice and a lot of other, a lot of other foods R two one decrease the absorption of a drug from the gastrointestinal tract and to to increase the absorption of drug from the gastrointestinal tract.

Sorell Schwartz (12:30):

You say, well, how can you do both? Well it can do both. One, by there is what we call a pre systemic metabolism, which drug that occurs inside the intestinal. And so what can happen is, like grapefruit tooth can inhibit the first metabolic actions of the, of the body on the drug which allow actually more drug to be absorbed than is planned for from the clinical trials, because less of it is destroyed before it gets taken up. And then that same type of action can occur that it is not as broken down as readily and as fast as normal, which means that the blood levels can go higher and and, and it can be harmful, and there are many demonstrations of it. The opposite can happen where the, the, the drug can interfere or enhance the metabolism of the drug to make it, to, to make it less effective because the blood level becomes less than it should be.

Sorell Schwartz (13:49):

But grapefruit juice is not the, the only the only issue at hand. For example you milk and milk products with antibiotics is a is, is, is a, is a, is a caution that physicians readily know about. And, and there are a lot of drug preparations, or over the counter preparations like the Mylanta tubs and so forth that have a lot of calcium salts in them for the anac effect. And those calcium the calcium in those drugs excuse me, in those foods or over the counter drugs, can result in inactivating antibiotics while they're in the in the gut. So there's that, you know, that type of interaction. Even green leafy vegetables, which are supposed to be which are supposed to be very helpful, which of course they are but they contain a, generally contain a high level of what called vitamin K. And vitamin K is a vitamin that is important in blood clotting. And if you are taking a blood thinner such as aspirin or the prescription blood thinners that it is possible that a very heavy diet of green leafy vegetables can interfere with their efficacy because of the vitamin K, which affects the blood product. And we, on and on, by the way, by the way, we can have an entire two credit course in a medical school. It's just on drug food interactions,

Larry (15:52):

<Laugh> and alcohol with antibiotics.

Sorell Schwartz (15:57):

Well, anti alcohol has a number of interaction problems. One is, is, is just the additive effect of alcohol with anything at the president central nervous system like antihistamines like sedatives like tranquilizers like anti-depressants. Alcohol can add to the action of all of those. But there is another major problem with alcohol where a, a drug as non-toxic as we think as Tylenol can become not only toxic, can become deadly because Tylenol is the active ingredient of Tylenol. Acetaminophen is broken down in the body. And it, and what is one of the metabolites, one of the products of the breakdown of the acetaminophen is a very toxic metabolite, a very toxic substance that is significantly toxic to the liver. Well, how can we then take Tylenol? Well, because there is a a certain class of enzymes and enzyme assistance in the body that immediately inactivate that metabolite.

Sorell Schwartz (17:28):

So we don't have to worry about it, except for one thing is that alcohol is also metabolized by that same that same group of enzymes and co-factors. And the problem is that if someone is drinking a lot of alcohol they can use up all of those factors that protect them against that metabolite. And it's not like, you know, not having a Tylenol right after you drink it can be having a Tylenol after you've had a couple of martinis before dinner every day for a week. It's, it's not a really close time relationship. You can't avoid that type of toxicity by just not having the two alcohol and Tylenol together. They can be apart, but what's left in the body with excess, with not excess, but having drinking a lot of alcohol is that loss of protection against that metabolite.

Sorell Schwartz (18:33):

And I have seen, and both from a clinical point of view and from a forensic point of view kids as as young as six year old dying from dying from that, you say, well, how can a six year old die from having too much alcohol? Well, you'd be surprised. And but there is it is responsible for a number of deaths of from, of liver failure in, in adults of of any age, anybody who drinks alcohol consistently, not as an alcoholic, which of course would put you in trouble. But, but just as a two martinis before dinner every night is enough to put you in a position where the use of Tylenol in high consistent could be very toxic to your liver.

Larry (19:44):

You mentioned polypharmacy before. Yes. Can we clarify it a little bit?

Sorell Schwartz (19:52):

It's just taking two medicines independently. And they may each have side effects that in their regular, in the ordinary dose is not is not a significant threat to the health of the individual. But another drug having the same side effect, of course, they can be additive or just like in the foods where one drug affects the metabolism of another, and therefore the blood level of the, of the drug that that that can be a serious result. Now, there are certain, what we call effect checkers, that you can put in two drugs and determine whether they have an incompatibility for adverse effects from all the research that's been done. But the problem in polypharmacy where you have five, even 10 or 12 drugs being taken at one time, where each drug in and of itself is completely safe the combination could be unsafe. The problem is we don't have research data that will say, okay, if you combine these 12 drugs this is what you have to worry about with adverse effects. You can look at the adverse effects of either one of them, yeah, of any of them. But together, how they interact with each other can be a, an entirely different scene.

Larry (21:41):

One of the problems that comes up in a dental practice since I'm a dentist or was a dentist, is the use of psychotropic drugs in dementia patients, and then needing a sedative in a dental office and not having that much experience with psychotropic drugs. How do we handle that?

Sorell Schwartz (22:06):

Well, you handle the same way as you would handle automobile mechanic working at an airport, trying to take care of shed engines. You don't let 'em do it. The, the fact is, is that every practitioner dental every specialty of medicine, veterinarian podiatry, everybody who has a particular license to prescribe a drug has the responsibility to know enough that in that prescribing, they're not doing harm. Unfortunately, there's a couple of reasons that, that doesn't always hold true. One is because the practitioner's ill-informed or uninformed or misinformed which is not necessarily a blame on him or her but just because the valuable, the the information is valuable, or two, there is no information really to help them. There's, there's, there's no alert. It's it's interesting that one, we think that once a drug is approved by the fda, well, that's their job.

Sorell Schwartz (23:31):

It's now safe and efficacious. But 20% of drugs eventually end up with what we call a black box horn. And where on the on the inserts, the, the, on the other information that FDA particularly approves to be said about the drug from the manufacturer to the practitioner it's required to be bounded in a black box to make sure that they don't miss it. And 4% of the drugs end up being actually taken off the market after being approved because of adverse effects. And you say, how can that happen? Why didn't, why didn't they know about that during the clinical trial? And the fact is, is that if you have a serious adverse effect that occurs in one out of 10,000 people your clinical trials aren't gonna pick it up unless you're lucky.

Larry (24:29):

We, you keep talking about adverse drug effects. What are adverse drug effects? How do you classify, categorize?

Sorell Schwartz (24:38):

Yeah, you can say, well, we have side effects and we have adverse effects. A side effect is an effect which you, you expect you expect to occur and you put up with it because imbalance against the therapeutic effect you need the drug. But when that side effect becomes either becomes actually harmful to the patient, like a patient driving driving or operating machinery while being on the influence of a drug that has a side effect of suppressing their their ability to stay away or some other effect that actually is, is not just a side effect, but there's a there's a significantly threatening health actually threatens a health disturbance. So if you have a drug like an antihistamine which could make you tired and or sleepy that sleepiness is, is a side effect. But if you get in a car and you fall asleep at the wheel and get into an accident, that side effect is become an adverse effect. Or you can have a drug that has an effect on various blood cells which is in and of itself an adverse effect, meaning, adverse meaning that it can or does cause a health disturbance, or more or worse, can be deadly too.

Larry (26:39):

Okay. As seniors, you talked about multiple drugs, five, 10 medications. Suppose as an individual, we feel, Hey, we we're just taking too many drugs. What can we do about that? Is there a way to minimize this?

Sorell Schwartz (27:01):

That is a very important question because there is now a practice afoot in called de-prescribing. And de-prescribing is an organized response to polypharmacy. And that means that a person is a, a person goes to their primary care provider, and that primary care provider provides is prescribes a drug. They go to the cardiologist, and the cardiologist prescribes a drug, then they go to their rheumatologist who prescribes a drug for their arthritis, and so on and so on. The psychiatrist prescribes an antidepressant, and these things just added, and all of a sudden you have polypharmacy, and now you think, are all of these drugs really necessary? And so there comes now where we look over this patient's particular role of drugs that they're taking, and you say, is this necessary or is that necessary? That is a current, a relatively recent effort.

Sorell Schwartz (28:19):

I mean, not, not in the past five months, but you know, in this millennium that to, to look at patient's medication list and do the prescribing of, of working out what drugs they can do without. So that's a, that's a very important question. And it's a question that in particular, every primary care provider should be asking about their patients who they know are not only seeing them, but are seeing a wide variety of other specialists for just the health disturber set results, because they've been lucky enough to get to be 75 or 80, or 85 or 90 and so forth.

Larry (29:13):

But we, we shouldn't just stop medications on our own.

Sorell Schwartz (29:18):

Well, no stopping medications on your own can can have serious consequences. For example antidepressant drugs, antidepressant drugs don't work because you take the drug and all of a sudden you get a reaction. Antidepressant drugs work by changing the essentially the chemistry in, in, in the brain altering what we call neurotransmitters chemicals that carry signals from one part of the brain to the other. But it, it doesn't occur with a snap of a finger. It takes a while for the brain to adjust to this new process. If all of a sudden you stop taking the drug it holds a danger because essentially you you get beca caught between a rock and a hard place. You stop taking this drug because you feel you don't need it, or you don't like the side effects or whatever it is.

Sorell Schwartz (30:28):

But the brain's gotta have a chance to come back to normal or what it was before the drug. And therefore for example, in stopping in, in, in, in stopping antidepressant drugs the the patient has to be withdrawn gradually. The same thing is true steroid drugs. As someone who has been taking what we call corticosteroids, cortisone like drugs over a prolonged period at a certain dosage level their body says well, since we have all this cortisone like material coming in from the other side, we don't have to produce it anymore. Well, if you suddenly stop the, the steroids, stop the cortisone like drug that you've been taking, and suddenly stop it, the body doesn't quite just really pick up the pick up and, and go back to what it was.

Sorell Schwartz (31:33):

It takes a while for it to recover. And during that time, since those hormones are so important for handling stress one, one could easily have a stress event that the body can't handle. And it could be deadly. And it is deadly. So when someone is most people who have been on, let's say steroids for a couple of weeks because of some acute situation they're, they'll, they'll be instructed. Now, we want you to go from five tablets per day to four tablets per day, to three tablets per day, to, and give your body a chance to come back. And equilibriate

Larry (32:16):

Is the same true for anticoagulants.

Sorell Schwartz (32:20):

The same is true for anticoag coags, not to the same extent not to the same extent as cortisone like drugs or we call, or corticosteroid drugs. But yes. Again if you have a if you're taking anticoagulant there is a the, the, the sequence for chemical changes that occurs. It's sort of like a is sort of like a, an automobile production line, that there are so many, so many different factors in it, and they change depending on where the anticoagulant or blood thinner is, is working. If all of a sudden you stop that blood thinner you upset that whole process and you could end up you could end up with what's called a coagulopathy that is that your blood your blood coagulates too fast and that can be, that can be very deadly

Larry (33:38):

On a pragmatic basis. The cost of medications for some seniors is out of hand in this country. Is there anything that the individual can do if they can't afford their prescribed medications?

Sorell Schwartz (33:57):

Well that's I guess I, I, I guess that I can only advise that there are people who are a lot more clever than I am in those regards to how to get around it. But there is, of course there are some in some drugs that are very, very expensive. So you can have a course of chemotherapy for an individual with cancer could cost on the just on, on an open la on, on an open market could cost $35,000 a month. That is generally recognized by insurance companies. First of all, they don't pay what the insurance companies don't pay, what the drug companies want to charge to on a, on a public basis. They have a, they come to an agreement with the insurance company, with the pharmaceutical company as to what they will pay for the particular drug.

Sorell Schwartz (35:11):

That what that is, is is pretty much of a secret too often that you don't, you, you may get you may pick up a prescription of pharmacy and pay a $5 copay, and then you see that the retail price of what you just picked up is $250. But there, so there is that the medical, the, the medical insurance under, under Medicare Part D can be with recent legislation can be negotiated even much further. Also, companies who that have a non-cancer cancer drugs generally fall in a little different category. But in, in, in, in non-cancer drugs, they may have a drug that's used for some type of neurological condition that is you know, may maybe cost five, $10,000 a month. And most, most of the major companies have particular programs where the patient can receive the drug, either free or at a very at a very reduced cost. And that's, that's, that's that's done primarily at the initiation of the pharmaceutical company. It's not a government program.

Larry (36:43):

Just one other question, and this really isn't related to seniors, except as we may have a daughter or a granddaughter in the news lately, the Supreme Court has kept Meone and Misa Prosol available for now, but a lower court has challenged the FDA's safety, even though it's been on the market for what 20 years or so. If, if somebody listening has a daughter or a granddaughter who is now questioning whether these drugs are safe, what's your feeling?

Sorell Schwartz (37:29):

Well let's go back to just covering the point from I, I dealt with a lot of forensic issues and such. In 1993 the Supreme Court came up with a, a, a very important decision. It used to be that we used to say that kids will fly in a courtroom if an expert says so. So there was a challenge to a particular drug effect alleged, alleged birth defects from a, from an anti-aging drug. And the point was brought out that the the witnesses for the plaintiff, the expert witnesses for the plaintiffs it's not that they are hired guns because everybody gets paid as, as an expert witness for their time. They're not being paid for their testimony, they're being paid for their time. But there, there are unfortunately, a number of so-called experts who, like I say, will make pigs fly in a courtroom.

Sorell Schwartz (38:54):

So there was a decision in in 1993 called the Dalbert decision in which the Supreme Court ruled that the judge is a gatekeeper that is, the judge can decide whether an expert's testimony is or is not a valid comes from a, a, a valid basis. But the interesting thing is, is that this Supreme Court decision didn't give the judge the right, the right to decide whether something was safe. It gave the judge to decide whether an expert giving testimony was in fact qualified to give that testimony. So or, and, and, and, and could determine the weight to, to that expert's testimony. So the, the problem that appear that, that occurred here is that you had a judge making a decision, but on data that was already known which was the so-called psychosocial effects of, of the drug.

Sorell Schwartz (40:08):

One thing that was claimed, well, you know, as drugs have been on the market for 23 years everybody knows it's safe. Yes, everybody does know it's safe, but it should be kept clear. As I, as I pointed out before, every once in a while, you get a situation where we don't, we don't, that a drug effect is adverse effect is so rare that it may take 20 minute, 20 20 years before it just show up. I mean, that's, that's not impossible. It's probably implausible, but it's not impossible. But that's not the issue. The issue with the NiFi, pone and misoprostol is the fact that these both of these drugs and the NiFi briones was, was the target drug the effects that the judge was ruling on, and that the plaintiffs were claiming were effects that had already been considered.

Sorell Schwartz (41:13):

They weren't new effect, they weren't new discoveries. There's nothing new. And the fda had Dawn had given it the appropriate safety and efficacy review that that was necessary. So there is, I can say this, I, I, you know, whether a drug is safe or is not, you know, its safety is everybody's own decision, but there is nothing on which that, that judge based his decision that has not already been considered in the in the safety and efficacy of the drug on that basis. There's no difference in, in safety before or after that decision.

Larry (42:07):

Wow. We covered an awful lot in this discussion. Is there anything we forgot or that you'd like to mention in relation to drugs and seniors?

Sorell Schwartz (42:19):

Well, I think actually the, the, the, the point that you brought up in question about what can we do about it that if things are going fine, you know, if they ain't broke, you know, don't fix it, type of thing. But if they're not doing fine if there are drug interaction problems and someone is taking a dozen drugs, and, and it's not uncommon for people over 80 to be taken a dozen drugs, and that, what, what is called now deprescribing not based on the patient's choice, but based on consideration by the, the physician's who are treating them. I think that's an important thing to consider and to ask to ask your doctor about. And may be that the, the doctor hasn't caught up, but they, they will, as, as we get more and more into this whole realm of targeted therapy and so forth,

Larry (43:33):

This has been enlightening, informative, and I'm sure the listeners are gonna find this podcast extremely valuable. Thanks for coming on Sorl. It's been a pleasure.

Sorell Schwartz (43:48):

Well, thank you, Larry, for the opportunity, because I, I think it's important to get this information across.

Larry (43:54):

Thanks again.

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Sorell L. Schwartz, PhDProfile Photo

Sorell L. Schwartz, PhD

Emeritus Faculty
Sorell Schwartz is Professor Emeritus of Pharmacology. His areas of concentration include quantitative systems pharnacology and pharmacometrics; adverse drug reactions, human subject and clinical trial ethics, and causal assessment methods for drug and chemical injury. Research approaches are primarily through computer simulation of biological processes to aid understanding of those processes. His has focused on physiologically-based pharmacokinetic and pharmacodynamic modeling and its application to such areas as exposure assessment, target-tissue concentration estimation for risk assessment, and the design of dosing regimens for experimental drugs. His most recent work concerns bio-mathematical approaches to understanding and modeling nonlinear dynamical behavior in cancer immunotherapy and other systems. He serves as a primary resource for clinical trial pharmacokinetics. He has extensive experience in the assessment of adverse drug reactions in the clinical, regulatory and forensic settings, and continues to have responsibilities for such assessments at Georgetown.