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🎙Facts Are Only Half the Picture: Navigating Historical Trauma in Clinical Trials Ep 217

• Dr. Michael Koren, Ken Amaro • Episode 217

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How does one navigate the complexities of clinical trials while honoring historical contexts? Join us on MedEvidence as we sit down with Councilman Ken Amaro, who shares his experience participating in a clinical trial for cholesterol management. Motivated by the heart-wrenching loss of two close friends, Ken's story is a powerful tale of taking charge of one's health despite legitimate concerns. We discuss his initial hesitations, deeply rooted in the historical trauma of the Tuskegee syphilis study, and explore how weighing the benefits and risks can lead to informed health decisions that transcend generational mistrust.

We also discuss generic drugs, focusing on the FDA's role in ensuring their quality and safety. Specifically, we examine the journey of Rosuvastatin from a brand-name drug to a generic option, addressing common consumer worries and the significance of making well-informed healthcare choices. Tune in for a thought-provoking discussion that promises to enlighten and inspire.

Talking Topics:
🎙Tuskegee Syphilis Study
🎙Participation in Medical Research Trials
🎙Generic Drugs

Part 1 Facts Are Only Half the Picture - Release Date July 17, 2024

Part 2 Navigating Historical Trauma in Clinical Trials - Release Date July 24, 2024

Recording Date: May 24, 2024

Be a part of advancing science by participating in clinical research.

Have a question for Dr. Koren? Email him at askDrKoren@MedEvidence.com

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Music: Storyblocks - Corporate Inspired

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Announcer:

Welcome to MedEvidence, where we help you navigate the truth behind medical research with unbiased, evidence-proven facts, powered ENCORE Research Group and hosted by cardiologist and top medical researcher, Dr. Michael Koren.

Dr. Michael Koren:

Hello, I'm Dr. Michael Koren, the executive editor for MedEvidence, and I am very privileged to have Ken Amaro here. Councilman, Ken Amaro here.

Ken Amaro:

Thank you, sir.

Dr. Michael Koren:

And he's a local celebrity, a long history of a media career in TV here in Jacksonville, Florida, and we've been having this great conversation about the truth behind the data, and at the end of our last session, you disclosed the fact that you're involved in a clinical trial. And that's what I do for a living. So, wow, what a coincidence and really not a coincidence, of course, which is the reason we invited him here is because of that in part, but let's talk about that. How did you get involved in this clinical trial? What attracted you to the clinical trial? And I also want to talk a little bit about as an African-American person were there any barriers that you had to consider before you got involved?

Ken Amaro:

Very, valid point because, first off, I've followed ENCORE Research and what you guys have done, and so I got on the newsletter and you send me information as to upcoming studies, and this particular study that I'm participating in has to do with my cholesterols, and I've historically have had a problem of ebb and flow, if you will, with the numbers, and I had recently two of my good friends very good friends passed away. One had cardiovascular issues and he experienced a stroke and he never recovered.

Ken Amaro:

And the other was diagnosed with Lewy body dementia disease and that got progressively worse, if you will, and so in my mind I see the connection between these two and we're in the same age group, and when the opportunity presented itself, I decided well, maybe as a preventative measure, I would participate in this study. I wanted to be sure that I'm being taken an ounce of prevention, if you will. But there was some reluctance to be honest and I think, like within the African-American community, when you speak about research ,there's always some hesitancy because of the history of the Tuskegee trials, if you will and so we tend to stigmatize and think that everything is horrific when we don't measure. There might be tremendous benefits to participating.

Dr. Michael Koren:

sure.

Ken Amaro:

And I had to have a conversation with myself. If you will, is this something that I really want to do? And you know I respect what you do, to be honest. So I'm not trying to be offensive when I say guinea pigs or anything like that, but do I want to present myself as such , and when I started thinking about the merits of it, it outweighed whatever reluctancy I may have had.

Dr. Michael Koren:

Sure.

Ken Amaro:

And so that's why I'm participating and I'm looking forward to the outcome.

Dr. Michael Koren:

Well, thank you for participating and that's really insightful. So, for every patient that decides to do a clinical research project, there's a driver, there's some value proposition and, in your case, you wanted to be proactive about your health and deal with the lipid issue, which, of course, is one of the areas where we could prevent heart disease and stroke.

Dr. Michael Koren:

So clearly we have lots of data. So the truth is that treating cholesterol issues improves your prognosis, but there's also the truth that when you're in a clinical trial, there's certain unknowns, and by doing a structured program where we're looking at you very carefully, looking for safety at every visit and analyzing how this could possibly help you get, hopefully, the benefits of being part of it and you minimize the risks, and that's kind of what we do. But you brought up a lot of really, really good points. I'm going to unpack those a little bit, okay, so let's talk a little bit about Tuskegee. We talked about that when we train our investigators and it was a horrible episode in US history which is to be very clear, but there's some details that are actually pretty interesting that most people don't know.

Dr. Michael Koren:

So the Tuskegee syphilis study was supposed to be a six-month observational trial of what was happening in the South for men who were exposed to syphilis and what the outcomes were for them. And at that time we were just in the infancy of treatment. And there was some initial funding actually that came from the chairman of Sears Roebuck, a very wealthy man who actually donated some money for African-American institutes, particularly in the South, to help with the health of African-American people. That funding wasn't enough to keep a study going on for an extended period of time. Then the US government got involved relatively early on in the 1930s and they became fascinated with the science, the natural history of syphilis, without telling the participants what was going on, which was horrible.

Dr. Michael Koren:

And unfortunately during the course of time the information about syphilis and the treatments for syphilis that became available were not disclosed to the participants, and so there were originally about 400 active African-American men who were not educated, that were sharecroppers. Basically, the researchers often went out to the field so that these people wouldn't come to the medical center and learn about things that were available for them, and there was also 200 control patients who were African-Americans that didn't have the disease, so they could see the difference at the time. Just to show you how the government used its power in ways that disadvantaged the people. When those people were drafted for World War II and the recruits were getting penicillin shots, the US government said, oh, don't give these people penicillin shots because we want to study them. And that happened behind the scenes, without even the participants knowing about it, and this went on, unfortunately, really sadly, for 40 years until the Washington Post did an expose. So a lot of bad things happened there.

Dr. Michael Koren:

But, some good things came out of that.

Ken Amaro:

And I think, generationally, that lack of transparency is what has created questions of doubt in participating in trials and research, which is unfortunate because there's a great health disparity among the African-American community and I think, with revelation of truth is what we're speaking about. Perhaps we can get more like myself engaged in some of these studies, that again, looking at merits more so than anything else.

Dr. Michael Koren:

And again, if you want to deep dive into the truth, a couple other points I'll make is that there was as much of a socioeconomic element to this as a racial element to this. So remember, this was performed at Tuskegee University, which is a historically black university. The physicians and nurses and others were largely African-American that were involved in it and they had knowledge of it, and so this wasn't purely racial. There was a big socioeconomic component to this. So uneducated people got taken advantage of. The other thing that's really important is that, fortunately, there was a very dramatic response to this horrible episode in US history.

Dr. Michael Koren:

So immediately upon the discovery of this, the expose, the government went into their analysis mode and they passed something eventually in 1974 called the National Research Act, which led to a lot of fundamental changes in the way we do business and ultimately led to what was called the Belmont Report that came out in 1979, which stated what the ethical framework was for all research in the United States. So things that changed based on that and these are very profound, important changes is one every study that we did had informed consent written if possible. Every study had an institutional review board or an ethics committee to make sure that the research was vetted by an independent party before any research could be done. And then we created this regulatory apparatus where we developed professional research sites to make sure that these ethical standards were always met. And the autonomy of the patient was considered the first element of the ethics that people had the free will to decide if they're going to do a study. They had the opportunity to ask questions about the study and if they changed their mind, that was okay.

Dr. Michael Koren:

We also made sure that all the studies were set up so that there was a net benefit. We call that beneficence that when we looked at the science that the studies were set up, where we constantly analyzed the data, if it became very clear that the intervention was either really really good or not so good, we would tell the patients and change the protocol based on that information. And then, finally, we did something called distributive justice. We should make sure that there was not one party that was responsible for the risk. So back in the old days it was common to put prisoners in studies without their consent or without their ability to ask questions. That went away. Vulnerable populations were protected. So there's some profound changes that occurred in the 1970s that are part of our ethos now and I just want to make sure everybody knows that.

Ken Amaro:

That's awesome and I didn't know that, but I did know that.

Ken Amaro:

pointing to what you said, once I made the decision to participate, I was walked through the consent process and it was explained and I was given opportunities to proceed or not to proceed, and so I felt comfortable with that. That the decision was made in a very objective atmosphere where I was provided as much information as possible about the trial and what's expected and I had the option of moving forward or not, and that made me gave me a great deal of confidence to proceed.

Dr. Michael Koren:

Yeah, and again, thank you for participating and thank you for your due diligence. Yeah, and again, thank you for participating and thank you for your due diligence.

Dr. Michael Koren:

So let's talk a little bit about the science, which is fun for me and maybe an area that you have an opportunity to ask me questions, but so cholesterol issues are very prevalent. Cholesterol issues are a place where cardiologists and other physicians can make a big difference for people, so we've been doing cholesterol studies for many, many years. The statins were a breakthrough class of cholesterol drugs and we have dozens of statin studies and I like to tell my patients that the number one side effect of statins is that you live longer.

Ken Amaro:

Which is not a bad side effect.

Announcer:

Exactly.

Dr. Michael Koren:

And that is something that we reinforce. It's interesting statins are now generic, so pharmaceutical companies are not promoting them, so you don't hear as much about the good part of the statins, but people like to talk about the muscle aches and the other side effects, and that's had, unfortunately, a bit of a negative public health impact is that statins are not used as much as they used to be and we're seeing more and more people having their cholesterol levels drift up because they're not taking the proven therapies. But in the case that you're involved with, we're looking at patients that have elevated cholesterol levels, either on statins or people that just can't tolerate statins, and there are classes of drugs that we're looking at, and one of the classes that we're looking at that you're involved with is called the CETP class, which stands for Cholesterol Ester Transfer Protein inhibitor. Okay, very jargony, but that class of drugs is unique in that it raises HDL more than anything else we have and it can lower LDL.

Dr. Michael Koren:

And what's interesting is that there's been a number of studies of these type of medications that have shown mostly a neutral to maybe a slightly positive effect. There was one study of a drug that actually resulted in elevated blood pressure and that was stopped relatively quickly once we identified that there was an off-target effect of that particular member of that class. But with the molecule that you're involved with, it's called Obicetrapib. I happen to know quite well the two cardiologists who were involved in developing that drug. They actually purchased the rights to that drug from another pharmaceutical company and started their own company because they were so excited about it, and the data to date are just fabulous. And so so far, so good. But this is you're part of a process now that works with the FDA, where literally thousands of people from around the world are participating in the same study at the same time to show that the effects of this product are as positive as we think they will be.

Ken Amaro:

And I'm looking forward to the end result. It's interesting. As you speak of statins, I can share my personal experience. You know, a few years ago I was diagnosed with type 2 diabetes and that became a change factor, if you will, affecting blood pressure and cholesterol and just about every darn thing, if you pardon, my plain English. B ut then I started taking Crestor.

Announcer:

Rusatin, I think Rosuvastatin, yeah, Rosuvastatin.

Ken Amaro:

And, in the back of my mind, I had not been diligent, even though my attending physicians would say listen, take it. I take it. Sure, I didn't. I'd go a week and then I'd go without a week.

Ken Amaro:

Yeah, it's hard to comply, yeah you know I've had these moments and I'm listening to you and now I have a little bit more clarity as to the merits of doing it consistently. Yes, and I have not been that diligent. S ince I started this trial I've tried to be extremely diligent in doing my day-to-day use of of it. A nd something you said that caught my attention as well since it's now in these drugs are now in the generic stages, that they're not promoted as much, even though the merits are there. The merits haven't changed.

Dr. Michael Koren:

That is correct,

Ken Amaro:

The fact that they're generic hasn't changed the benefits of it. No, but because it sounds like correct me if I'm wrong because it sounds like there's no tremendous financial benefit

Dr. Michael Koren:

To promote them

Dr. Michael Koren:

Yeah, that's right. Exactly,

Ken Amaro:

Which is tragic!

Dr. Michael Koren:

Yeah, but you make a fabulous point. Yeah, but you make a fabulous point. That's an amazing point. So Rosuvastatin was developed by a company called AstraZeneca. We actually helped in the development work back in the late 1990s, in the early aughts, and it was on the market for its period of time and the patent runs out at a certain point, becomes generic. But Rosuvastatin is a drug that's been proven to improve outcomes in people at high risk for cardiovascular events and that doesn't change when it becomes generic. But what happens is that it becomes multisourced. There are a lot of different manufacturers that can make the product and the price comes way down. The profit margin becomes very narrow and no one has the budget to promote it and tell people how good it is.

Ken Amaro:

What about the quality of it, since there are so many manufacturers now of this particular drug?

Dr. Michael Koren:

Sure, yeah, the FDA oversees that. They actually even go overseas because a lot of generic drugs are made outside the United States or outside of Western Europe and they'll go to China, they'll go to India, they'll go to places where generic drugs are made to assure the quality. There's actually a little political debate about that. Is the FDA giving away knowledge when they go inspect these factories elsewhere? But you make a point and if you really want to dig in, you can see who manufactured the generic version and make sure it's one of the reputable generic drug manufacturers. Where would you get that information? It'll be on the pill bottle.

Ken Amaro:

Okay, yeah, and as far as can you go to the FDA's website for example, and see if there have been inspections or quality assurance or anything of that nature.

Dr. Michael Koren:

I'm sure there is some place to get that information, but I haven't accessed that myself so I can't answer that with direct knowledge. But I do know that the FDA does inspect foreign factories, and whether or not any particular factory was inspected is something I'm sure is in the government record somewhere, I'm just not sure where to put my finger on it.

Ken Amaro:

Because in the vein, I remember I was taking irbesartan family of drugs when I received a family notice of a recall and I went to the pharmacist and they looked at the pill bottle and the n inspected bottle saying its not that one it's made in

Ken Amaro:

Puerto Rico or.

Ken Amaro:

China or somewhere, wherever it was.

Ken Amaro:

And so, from a consumer or user end perspective, you don't know where it's manufactured and you don't know what the quality control is. You don't know if it's as effective as over here Exactly. That's right, but, if I'm hearing you correctly, there is an effort to make sure that quality is consistent wherever it's made. There is. a regulatory process, so a generic manufacturer has to show that they're making a pill that's chemically almost identical. It doesn't have to be perfectly identical, but really pretty darn close, and the FDA does inspect things. So the incident you're talking about was a raw ingredient that came from a Chinese factory and they tracked that to the other generic manufacturers that were using it as a raw ingredient. It was actually just a trace impurity that had carcinogenic potential and again there was not any high risk to any people and it freaked a lot of people out. But because of the abundance of caution in the system that was identified in, those, generic manufacturers that were sourcing that product were not allowed to sell their product in the United States for a period of time

Ken Amaro:

Well, this conversation has restored my confidence, at least in the generic product that I use and, as consumers, we're always watching our pocketbooks and sometimes we're driven by cost before benefits, and there has to be a shift in our thinking.

Ken Amaro:

I think

Dr. Michael Koren:

Well, again, it's information, so the truth behind the data. People have to have the information, the information has to be put in the proper context and then you need to have people that help you understand it. So conversations like we have help people really understand how the whole system works and, at the end of the day, there are lots of consumer protections. We've learned a lot from our mistakes. We're much better at doing things than we were years ago, and people can benefit from all this knowledge. By participating in clinical trials, as you have with the knowledge that you're not a prisoner when you're in a clinical trial, we will educate you throughout. There'll be people looking out for the beneficence or the potential benefit for the whole population. At the end of the day, it's also a fun process, so maybe we'd close by. Has it been enjoyable for you?

Ken Amaro:

So far the experience has been tremendously comforting, reassuring, easy. I have no negative experiences at all, which speaks a lot.

Dr. Michael Koren:

Well and I'll leave you with one of my favorite data points to share.

Dr. Michael Koren:

When you ask people in the United States or in Europe that have not been exposed to clinical research whether or not you're interested in a clinical trial, only about 40% say yes. But if you ask people who are graduates of a clinical trial program and you say, would you be open to doing a second clinical trial, 97% to 99% of people say yes. So there are very few products that I could think of where there's sort of skepticism before you've been exposed to it, but once you do, there's almost universal acceptance. So, Ken, thank you for this interview.

Ken Amaro:

Well, thank you for having me.

Dr. Michael Koren:

Yeah, this has been fabulous. I enjoyed learning more about you. I've always been a fan, but now I'm even a bigger fan.

Ken Amaro:

Well, thank you.

Dr. Michael Koren:

And thank you for the work you do for the city council and your work for policy. You're very clear to say that your work is not in politics but it's in policy, and that's much appreciated. I guess you have a big vote coming up on the

Announcer:

But I'm sure maybe you'll have a podcast at some point. MedEvidence.

Dr. Michael Koren:

But I'll be following you to see what your thinking is about that and again, thank you for being part of MedEvidence.

Announcer:

Thank you for having me. Thanks for joining the MedEvidence podcast. To learn more, head over to MedEvidence. com or subscribe to our podcast on your favorite podcast platform.

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