Su Robotti, Founder of MedShadow, and Jonathan Block, Content Manager, discuss a new study that reveals overdiagnosis of asthma. Is it possible you’ve been misdiagnosed? How would you know? Watch to learn more.
In honor of Valentine’s Day, Su Robotti, Founder of MedShadow, and Jonathan Block, Content Manager, discuss how certain foods can increase sexual drive, while others can be a wet blanket. Before planning a romantic dinner, you need to watch this video.
Su Robotti: Hello. I’m Su Robotti, and I’m the founder of MedShadow.
Jonathan Block: I’m Jonathan Block. I’m the content manager here at MedShadow.
SR: Today, Jonathan and I are in the mood for love, but sorry, not for each other. It’s Valentine’s Day approaching rapidly. We had one of our wonderful authors, Tory Rodriguez, research and had done an article for us. You’ll find in our website, but we wanted to talk about it today. What’s the name of the article?
JB: The article is “Six Foods That Can Either Boost or Suppress Your Libido.”
SR: That makes it easy, so now I know what to order for a Valentine’s Day dinner.
SR: But the first thing on my list should be chocolate.
JB: And that would actually be one of the items that actually does increase your libido, and it’s obviously something very, very much associated with the holiday. But another item that’s associated with Valentine’s Day that actually isn’t so great for you is alcohol, because obviously, a lot of couples like to go out have a nice dinner. I’m sure when you go out to dinner for dessert, you get something with chocolate, but then you might want some wine or even some champagne. Alcohol is one of the worst things, according to the research that Tory Rodriguez did, in boosting your libido and actually do just the opposite, so you probably want to, if not — I know a lot of people will not avoid alcohol entirely on Valentine’s Day — keep it to a minimum.
SR: Well, I guess no nightcap for me then. I never ever, ever eat pomegranates. I’m one of those — well, I’m not even sure how to eat a pomegranate, but I may have to learn for Valentine’s Day.
JB: You should, because as the advertising says, it’s palm wonderful. It’s one of those super foods. It also happens to be a super food for you in the bedroom as well, very good for increasing the libido. And another item that might be surprising to boost your libido and you’ll find out why it’s surprising, and the second is garlic. And you might think garlic can give you bad breath; it does. But on the other hand, it’s going to make things really spicy in the bedroom according to Tory’s research.
SR: Well, one that — and she also turned up the study that showed that women who were sleeping with men who had eaten garlic that day actually found that their body scented more attractive.
JB: That doesn’t mean that you should go around wearing a thing of garlic around your neck unless you want to ward off vampires.
SR: Now, I married an Italian, so garlic is kind of a daily occurrence in our household, but we also eat a lot of lasagna, and I’ll be skipping that at Valentine’s Day.
JB: Absolutely. Carbs and heavily processed foods, killer for libido, avoid it like the plague.
SR: Killer, well, if it makes you lethargic and sleepy.
SR: Apparently, anything with white rice or heavy carbs — not the thing to have. She didn’t mention turkey, but the tryptophan in turkey, well, that’s a story for another day; it’s that actually does make you sleepy. What’s the last thing? Soy — soy milk, soy products, tofu — none of that is good for you, because it boosts the natural estrogen in your body which is not always a bad thing; it’s actually a good thing. But when it comes to being in the mood for love, testosterone rules. Occasionally, you do find soy in odd things you wouldn’t expect to find it in. Canned tuna — check the contents; it sometimes it’s used as preservative. Power bars will often have it in there, and Tory says — but I had yet to see this — in frozen desserts, so read the labels. And I think that that does wrap it up, so please do look for the article by Tory Rodriguez.
JB: On our website at medshadow.org, and thank you very much for watching.
SR: And happy Valentine’s Day.
This week, Su Robotti, founder of MedShadow Foundation, and Jonathan Block, the Content Manager of MedShadow.org, discuss the pros and cons of vaping. There are claims that vaping will help people quit smoking, but statistics don’t back that up at this point. On the other hand, there are fewer toxic ingredients in e-cigarette smoke. And teenagers are turning to vaping in bigger numbers than ever.
Su Robotti: Hi my name is Sue Robotti, and I’m the founder of MedShadow.
Jonathan Block: Hi, I’m Jonathan Block and I’m the content manager here at MedShadow.
SR: Today, we’re going to talk about e-cigarettes and vaping. They recently came to my attention because I have a relative who is a lifelong smoker. And, for the last holiday, I gave her a vape as a gift. Now, I really don’t believe that it’s healthy in any case to inhale anything in your lungs other than oxygen, than the air we breathe. However, I’m convinced that vaping is at least less damaging to you than our cigarettes. But Jonathan, what do you think?
JB: I think that they are as dangerous as cigarette smoke. Right now, there was a study that just came out in the major medical journal that found that e-cigarettes actually don’t discourage the use or the picking up of smoking by teens. It has been thought that perhaps E-cigarettes would be a substitute for smoking, but actually just the opposite has been found in this new study, not only does it not, as I’ve just mentioned, discouraged them, they may actually encourage them to pick up the tobacco habit as well.
SR: It does seem that that studies says more kids are vaping than were anticipated to be smoking.
SR: So that is the sad side effect, but, I’m looking at a person who does have had the ability to give up cigarette smoking and it is causing health issues. So downgrading, so that she’s not smoking a tobacco product, she’s getting only the nicotine and not the tar, cuts out a lot of the health issue. The EU is recommending vaping and e-cigarettes as substantially safer than cigarette smoking.
JB: Right, obviously compared to standard tobacco smoking, it does appear that vaping is not as dangerous, it doesn’t mean it’s completely harm-free. There are plenty of dangers associated with vaping itself. Some of them have to do with the fact that the flavorings that are used in Lula V, of the tar that you would find in cigarette smoking, you really don’t know what’s in those flavorings. Another issue that I have with the flavorings is that the manufacturers have created a number of them that are specifically geared toward children flavor, such as bubble gum or cotton candy, that to me is an obvious ploy to get young kids to start to use vaping devices.
SR: It’s Joe Camel all over again.
SR: For cigarettes, that is the problem, and I will admit, that my relative’s son who is not a smoker, was easily able to teach you how to vape because he has vaped, not a regular vaper, but like all of his friends, he vapes from time to time.
JB: Just wanted to bring up one other thing that is potentially dangerous, that why vaping is particularly dangerous people and teenagers is that the study that I refer to in the beginning of this episode, it’s also found that the young people who engaged in vaping also tend to engage in more risky behavior such as multi-sex partners, marijuana usage, and abuse of opioid painkillers.
SR: Yeah, but that’s one of those old questions, is correlation, causation, I mean–
SR: How do you really say you vape and all of a sudden you want to throw your clothes off and have sex?
JB: Right, well I think we could better agree that young people shouldn’t be smoking or vaping, you’re making the point that for a lot of people who had been smoking for some time, vaping maybe the lesser of two evils.
SR: That is the only point that I can make in support of vaping. Once again, I circle back to try not to put anything into your lungs except for nice, clean air. But if you do smoke and you can’t quit or you can’t bring yourself to quit, maybe they can use an alternative.
JB: Also, if our watchers have any further questions about vaping, we have a number of resources about vaping on our website at www.medshadow.org, go there and search for vaping.
SR: And please, sign up for our e-newsletter so you get the latest information from medShadow.org.
JB: Thank you.
This week, Su Robotti, Founder of MedShadow Foundation, and Jonathan Block, Content Manager, talk about the importance of ensuring that clinical trials for medicines are conducted with a diverse population. Did you know that African-Americans need a higher dose of warfarin than other groups do? That’s what makes this kind of testing so important.
Su Robotti: Hello and welcome to MedShadow TV. My name is Su Robotti and I’m the founder of MedShadow.
Jonathan Block: I’m Jonathan Block, and I’m the content manager for MedShadow.
SR: Very recently, the FDA came out with new guidelines on increasing the diversity in clinical trials for drugs. We find this to be very important, and we’re delighted that the FDA has done this.
There are three phases of clinical trials that a drug has to go through before it can be approved or disapproved by the FDA. The first phase is usually animal testing, and much, much, research and testing goes on before you can get through a phase one trial. Should it pass the phase one trial, then it goes onto human trials at levels two and three. The second trial level is simply test for safety. They give to healthy people and they just make sure that they’re no unexpected adverse events, which generally means a significant lead bad side of that, sometimes death.
But by the time it’s gone through all the animal trials, we can be pretty sure it’s not going to cause death, but they’re looking for adverse events. Phase three is – they’re all important, but really the most important and the final step, and that is testing the drug usually gets to placebo, in a population of people who have whatever the disease or issue is that the drug is designed to work on.
And this is where they can test both efficacy, which is does it work, and safety in a population where it actually has some sort compromised health because they’re taking the drug. As I said, some people will get a placebo, which means no drug, no active ingredients for it, and some people will get the actual drug. There are risks—being in the clinical trial, but there are also benefits.
JB: Can I just add something — just to talk to bringing up a point as to what eh FDA is doing that is new here, and that’s the emphasizing and having more diverse patient populations in clinical trial, now you’re probably saying to yourself–
SR: Why do we care about that?
JB: Why do you care? Because you probably think for all humans, which is true, but the thing is, is that first of all, there are certain populations that are more susceptible to some diseases such as diabetes and heart disease and others. Also there are, we know as a fact, that there are certain drugs from prior testing of drugs that were given to women rather than men to that those things have to be adjusted. A good example of that is Ambien. Another thing is that there are certain groups of people that really don’t participate in clinical trials especially those who are 75 years and older, African Americans and females. The good news is that–
SR: Don’t forget, pregnant women were deliberately left out of clinical trials for many, many years, which meant that a pregnant woman who needed to take a drug, the doctors simply had to guess it what it might be on the woman who’s entice to exchange because of pregnancy and on the fetus.
JB: The good news, especially about the fact that there’s not that many women, is that as part of this new initiative that Su was talking about is that they are going to emphasize getting more women into a clinical drug trial.
SR: And older people, I hope. Many trials take place overseas, because a lot of American citizens don’t like to be in clinical trials, and that’s another problem, because ethic background can have a significant difference. Do you have any examples of an ethnic background?
JB: Absolutely, one of the best examples is a blood thinner known as Coumadin, the generic name is warfarin, and research has discovered that African Americans require higher doses in order to achieve the same therapeutic effect that you would see in western European and Asian populations.
SR: So it seems to work the same, or the same efficacy at the same dosage level for western Europeans and for Asians, but when African Americans–
JB: They need more, they need more Coumadin in order to get the same therapeutic effect. Another good example which is another drug that our audience maybe familiar with is the cholesterol lowering medication known as Crestor or rosuvastatin. That’s a group of cholesterol lowering drugs known as statins, and again through additional research, it was discovered that in Asian populations, there should be a lower starting dose in order to minimize the possibility of side effects.
SR: The FDA is putting out a call, asking Americans to volunteer for clinical trials and trying to make it easier to find clinical trials. Now, there are some issues of clinical trials, so it can be some unexpected side effects or adverse events could happen, but you can be assured that your rights as a patient are protected both by law and by an ethics bureau called the Institutional Review Board. So before any clinical trial is set up with humans, it has to pass the ethnics board.
In addition, particularly if you’re in a phase 3 trial, where you maybe taking this drug because you were looking for a new cutting edge drug, which this might be, you will be getting excellent healthcare. Even if you get a placebo, you will end up getting excellent healthcare. So all in all, you’re doing something good for yourself, you’re doing something good for the medical community and helping thousands and thousands of people get access to a drug that could be very helpful or approving that a drug is not helpful, which is just as important. Keeping drugs that aren’t effective, or whose side effects are so strong that they negate the value of the drug — to know that before it goes to the market is a wonderful savings in healthcare.
SR: Good. Well thank you, I hope you will look for the opportunity to participate in clinical trials so Jonathan, are you going to look for clinical trial to participate in? You could do a phase 2, you’re perfectly healthy?
JB: You never know, I guess I have to go online and start seeing if there are actually any trials in the New York area that I can take part of.
SR: Good, and thank you for not asking me. Please come back soon and check out our website.
JB: Thank you.
This week, Su and Jonathan look back on the biggest stories of 2016, including the exposive growth of opioid addiciton and the pros and cons of the 21st Century Cures Act. And a little shout-out to our favorite health-related website (ahem).
Su Robotti: Hi, I’m Su Robotti, and I’m the Founder of MedShadow, and this is–
Jonathan Block: Jonathan Block, I’m the Content Manager for MedShadow.
SR: Today, we’re going to talk about what were the three big news stories of 2016. It’s hard to imagine we’re done with 2016 already, but, before we sweep it out the door, let’s reviews as we found the fascinating, appalling and interesting about the year. First up is opioid.
JB: Yes, opioids kind of dominated sadly the news throughout the year because as many of our viewers know, we’re in a massive opioid epidemic and trying to get some sort of policies in order to turn that around, and unfortunately, nothing seems to be changing even though there was some legislation that was passed earlier this year that will increase funding for opioid addiction and treatment. They still have a, they still have a long way to go before that epidemic is going to be appropriately tackled unfortunately.
SR: Too little is known about what the bases of addictions are, about how to help people get rid of their addictions. And we’re getting too many drugs on the market too quickly—Fentanyl is the latest deadly drug, and you know, I’ve been told that you cannot take Fentanyl with any regularity and survive.
JB: Well, the thing is, also, is that even now, a lot of these manufacturers are coming out with so called abused deterrent versions of it, there’s still ways that you can get around, still abusing it. The other thing is that these drugs are still heavily marketed by these companies through doctors. Even now the pharma companies know the inherent dangers of opioids and what can happen when you take them over the long term–
SR: Oh I got to say, I got to say–
JB: Go right ahead.
SR: Any doctor who is unaware of the addictive problems of opioids at this point, you just hand in medical licenses.
JB: Well, maybe they do understand but they’re getting kickbacks from the pharma companies.
SR: No, we need, we need everyone on the same team here.
JB: Oh I agree.
SR: The pharmaceutical companies need to match that, yes, but the doctors need to be able to say no, and the patients need to understand that sometimes life hurts–
SR: And you can’t always take a pill, opioids don’t even work in many of the cases that they’re given to the people.
JB: Well that’s the thing that you just touch upon, and is that patient education is really what’s going to turn the tide with this epidemic.
SR: I don’t know what will, but hopefully–
JB: Well it can and cannot–
SR: Maybe 2017 will be able to figure out the opioid problem–
JB: Fingers cross–
SR: Yes. Next: 21st Century Cures. This is a classic example of “don’t believe headlines.” Don’t believe in name of acts. 21st Century does want to help cures, and they’re pretty a lot of money towards the Cancer Moonshot. But there are many, many aspects of the 21st century cures that could end up being 21st Century Hurts. One of the major problems I have with the 21st Century Cure is that it continues to rush the trials of drugs through the vetting process. It pushes the FDA to approve drugs faster than the FDA’s ever been comfortable with–
JB: And with less concrete data supporting it, that’s the crucial thing. You could do it faster, that’s one thing, but if you do it faster with less concrete evidence, that’s double whammy.
SR: Right. So, we would very much, we very much want more money for research, but we also want a thoughtful method approach, because drugs that are pushed on to the marketplace can have devastating consequences for those who take them. Which now leads us to a very, what I consider, a sad example of a drug called–
JB: Exondys 51, also known as Eteplirsen. This was a drug that was approved in the fourth quarter of 2016 for a condition known as Duchenne muscular dystrophy. Why is this, why are we discussing this? Because this was a drug that was approved with a trial of just 12 young boys, there was no placebo arm, because usually, not usually almost every other drugs that is approved, they have to have a placebo arm to make sure that there isn’t a placebo effect going on. This drug, Exondys 51, did not have a placebo. The other thing is that the actual efficacy of the drug was kind of, iffy at best.
SR: Without a placebo, it’s hard to know what the efficacy is. This is a horrible disease, obviously, it’s muscular dystrophy based, it only affects boys, and most of these boys affected with it don’t live passed their mid-teen years.
SR: So the drug hasn’t been really tested long enough to show that it has a longevity aspect to it. It has brought some numbers that are markers into better alignment, and I’m all forward letting people in dire circumstances use any drug that they want to. There is a process and place for that to happen.
JB: There already is–
SR: You apply to the FDA, the FDA has virtually never said no to this process, and the pharmaceutical company, when possible, will go along when the get enough drug to give out to. So why should this drug do the process? It doesn’t make sense to me. The worse aspect of it though is that it’s — first of all since it’s not proven to extend the lives of these children, but there’s so few people affected with it in the USA and in the world, that the other two drug companies that were developing drugs for this specifically, for this specific problem, will probably not pursue it because the market’s just not big enough to support more than one drug.
JB: It’s an orphan drug which is a drug that serves a very small market usually under 10,000 people worldwide.
SR: Which is–
JB: The other thing that I want to touch upon with you is the fact that these kids, the young boys mostly who have Duchenne and their families false hope — so, the other thing is that what this process showed was how the FDA will approve drugs without concrete evidence when they succumb to public pressure, and a lot of that is because of patient advocacy groups, and many of them, if not most of them, do have good intent, but a lot of patient advocacy groups are actually funded by the very drug companies that are trying to get these drugs approved.
SR: That’s true.
JB: So they have a major conflict of interest.
SR: Yes, it does seem that anybody testifying from the FDA who is a member of a drug advocacy group should have to also reveal where the funding for the drug advocacy group comes from.
JB: Patient advocacy group–
SR: Thank you — patient advocacy group—anyway, so that is our wrap of the year–
JB: And in a sense and many senses, they are drug advocacy because they are advocating from drug company.
SR: It’s true.
JB: True, so are we going?
SR: So Jonathan, is there any good news this year?
JB: Yes, and that involves the growth of MedShadow which has benefited our audience. The amount and number of resources that are available to the public have just grown immensely in 2016. A good example of that is the Need to Know feature which many of our loyal audience is probably familiar. So we’re growing by leaps and bounds and we intend to further do so in 2017 and beyond.
SR: Yes, MedShadow has grown substantially this year. We have more than 150,000 unduplicated website visitors every month. I believe the people are coming to the website because just like Jonathan and I believe, most people want to know, is this drug going to help me a lot of a little, and are the side effects worth the risk of the drug. So please, keep coming back to MedShadow and we will keep trying to answer that question.
JB: Thank you.
Put down the Xanax. This week, MedShadow Founder Su Robotti and Content Manager Jonathan Block talk about using easy forms of meditation to manage stress during the holidays.
Su Robotti: Hello and welcome to MedShatowTV. My name is Sue Robotti, and I’m the founder of MedShadow.
Jonathan Block: And I’m Jonathan Block. I’m the content manager for MedShadow.
SR: Today, we’re going to talk to you about stress. We’ve been feeling a lot of stress. The holidays are coming, and stress is caused by too much food, too many relatives, too much pressure, too much gift shopping, too much drinking.
The key here is too much. Today, we want to help you take it down a notch, calm down, and we want to help you do that through meditation.
First of all, what is stress? The physical response to a stressful situation is adrenalin and cortisol enter your bloodstream. It increases your blood pressure, and your heart rate starts to go stronger. And if this isn’t dealt with easily or quickly, and it continues for a period of time, it can lead to gastrointestinal problems. It can lead to heart disease. It can lead to brain dysfunction like I’m having now. It can lead to a lot of long-term issues with heart disease and gastrointestinal problems among other things.
But Jonathan, what do you suggest we do? Should we pop a pill? That would be very quick.
JB: Absolutely, don’t. You’ve actually alluded to it, and that was through meditation, which is the main part of an idea known as mindfulness, which is defined as being aware of the present. I mean, I know what a lot of people are thinking — the same thing that I was thinking when I heard the word mindfulness. That just sounds like a whole bunch of new age hooey.
JB: I’m going old school. I can tell you from a personal experience as somebody who’s dealt with stress, and anxiety, and depression. Meditation associated with mindfulness actually does work. It works well.
And why don’t you take a pill? Because pills have side effects.
Mindfulness meditation — and we’ll be discussing this in a little bit — there are clinical studies that have demonstrated that mindfulness meditation can be used for a number of different conditions avoiding these sort of drugs, which as our MedShadow audience knows, most of which — if not all — are associated with side effects, drug interactions, or other nasty effects.
SR: In fact, is meditation as effective as antidepressants?
JB: Yes, it is. There’s been, I want to say, 40 to 50 clinical studies done just on comparing mindfulness and meditation with antidepressants. They’ve all come to the same conclusion. Mindfulness meditation is as effective as antidepressants.
So why — I know what you’re going to say. I’m going to read your thoughts. But why not just take a pill, right?
SR: Why not?
JB: I know that’s the easy way to go out. The thing is is that as I just mentioned, antidepressants and other antianxiety pills like the Xanax or the Valium that some people in our audience may be taking, have taken, or thinking about taking.
Mindfulness meditation is something that you can teach your brain how to think. It helps you relax without the use of drugs, and therefore you can learn how to deal with stress and anxiety over the long term. It’s actually much better for you, because you’ll actually train your brain how to better handle stress and anxiety but without the nasty side effects of a pill which means it is harder work.
But in the long term, the long-term efficacy of it has been demonstrated whereas with antidepressants, we know that people develop problems, and they lose their efficacy. And for some people taking antidepressants and anti-anxiolytic drugs, they just aren’t even effective anymore.
SR: So let’s take a breath.
SR: And how do you meditate? Do you have to sit cross legged? Do you have to hold your fingers in the air? Do you have to say, “Ohmm”?
JB: No, you’re thinking of some of the Buddhist meditation. But this type of meditation like the meditation that pretty much busy people or people that don’t want to go, “Ohmm,” want to do — can take as little as 10 minutes.
That’s what I do a day. I only do 10 minutes. I do some breathing exercises. There are also ways which if you learn more about mindfulness and we’ll provide you with some information about that in a second — the mindfulness, actually, you train your brain to relax. I know this sounds weird, because I didn’t believe it until I started doing it. And then in the words of a great Monkees song, “I’m a Believer,” and I’m a believer now about how effective mindfulness is and how effective mindfulness meditation is as well.
SR: So do you take classes? How do you learn to do this?
JB: I do a combination of things. I have read some books. There’s an excellent website that is operated by the fine people at UCLA known as the UCLA Mindfulness Awareness Research Center. That address is http://marc.ucla.edu. They actually have free relatively short meditations that you can download and listen to, and you can start on your own.
There’s another resource that I use a lot. This is a paid resource. It’s an app, and you can also do on your computer called Headspace. But I pay — I find it particularly effective. I looked at a lot of them, and I find Headspace — just to let the audience know, neither Headspace nor UCLA has asked us to mention them. This is just from my own personal experience.
SR: And then I’ll add one that’s free that I use; it’s called Breathe. But there are many, and you’ll find the one that you like if you just Google guided meditations, and you’ll find it.
I started meditating by simply becoming quiet and not using guided meditation — just setting a timer and trying to still my thoughts calmly for 3 minutes at a time. I got up to 5 minutes. And honestly, guided meditation is much easier.
JB: Oh, yes.
SR: And I would like to graduate to regular quiet meditation. But for now, I’m finding that I become more calm and happy using the guided meditation.
JB: And if you’re a novice — I still consider myself a novice — I find that the guided meditation works a lot better.
Just one other point because I know we’re talking a lot about this. It’s that mindfulness meditation is actually good not only for — works well, I should say — works not only well for depression, anxiety, and stress, but it’s been shown that people that want to lose weight through practice of mindfulness meditation, they can actually teach themselves to eat less.
SR: Eat less during meditation?
JB: No, afterwards, because they train their brain.
SR: You mean through their mindfulness.
JB: Right, because they think — like they ‘think before.’ You’ve heard the term, “Think before you act.”
JB: You teach yourself how to think before you eat, and you’re more careful at what you eat. But just by taking a few — by doing 10 minutes of meditation every day and then when you go and decide to have your meal, people who have done meditation and mindfulness, they train their brain to think, “Maybe I don’t need that side of French fries. Maybe I should get a side of quinoa or something of that nature, something of a more healthy starch.”
SR: Yes. My downfall is more of when I’m in a family situation, and there’s cheese, and crackers, and nuts, and all these good stuff in front of me, and I find I’m eating without thinking. I think you’re going to tell me that that’s not mindful.
JB: It’s not mindful, but everybody is allowed during the holidays to cheat a little bit. The thing is not to make it a regular part of your life. And even if you just have a few — if you — let’s say you cut out — maybe you only eat nuts, but instead of reaching for the Ferrero Rocher chocolate, maybe in parties you might have had 3. Now, maybe you’ll only have 1. That’s even mindfulness just like making even a slight change. And then as you get better and better at mindfulness and meditation, you’ll learn to control yourself better.
SR: Okay. So instead of taking a pill, instead of eating chocolate, instead of taking a long hot soak in the tub, what we’re going to do is try meditating to de-stress.
JB: Actually, taking a long hot soak in the tub is actually very good.
SR: Soak in the tub — we’re saying yes to this.
JB: We are saying yes to that.
SR: What about taking a walk or a jog?
JB: Also excellent.
JB: Just lose the medications and go easy on the chocolate.
SR: Okay. Do that and have a great holiday.
JB: Yes. From all of us here at MedShadow, thank you for making MedShadowTV, which just premiered this year, such a wonderful success, and a happy holidays to you and your family. Take care.
Su Robotti: Hi, I’m Su Robotti, and I founded medshadow.org.
Jonathan Block: And I’m Jonathan Block, MedShadow’s content manager.
SR: Today, Jonathan and I are going to talk to you about the 21st Century Cures Act. This Act has a lot of good aspects to it. The 2 primary benefits to it are that it would send millions of dollars to the National Institute of Health for drug development and testing. The other good aspect is that it will lead to faster approval for drugs, so they get to the marketplace and to saving lives more quickly. Presently, it takes a lot of time and money for a drug to get to marketplace. It has 3 levels of clinical trials. It can take years, and millions, and millions of dollars.
Jonathan, are we asking too much of the drug companies with this?
JB: Absolutely not. In the effort to rush new drugs to market, pharmaceutical companies under this legislation will have to skimp on clinical trials. What do I mean by this? It means that the trial durations would be shorter, and the number of people enrolled in the trials would be shorter. My fear is that by doing this you may not be able to find out certain side effects, because you’re using smaller patient population for much less time. And as we’ve seen in the past in this country, even drugs that have gone through extensive testing, you discovered issues with them later on. The most notorious example would be the pain drug, Vioxx, which led to heart problems and was ultimately withdrawn from the market.
SR: The other problem with having shorter clinical trials with fewer people involved in them is that it doesn’t allow enough patients in the trial to discover, to include subgroups — subgroups like women, or elderly, or teens, children, subgroups like pregnant women, or Hispanic, Latino, African-American, or African. And the problem with that is that drugs often synthesize differently in different people.
A great example is Ambien, the sleeping drug. It was tested primarily on men; it tested very well. And when they woke up in the morning, they were refreshed and felt great. But when it went out into the marketplace approved for everybody to use, women used the drug and woke up not refreshed; they woke up groggy. It led to a lot of car accidents, a lot of confusion, a lot of lawsuits until ultimately Ambien’s directions had to be changed and the dosage lowered for women.
If the clinical trials had been set up to include different subgroups of people and identify within those subgroups how it acted differently, we could have avoided many deaths and a lot of lawsuits. So how long does it take for our drugs to get to the market today? Is it too long?
JB: It actually isn’t too long. I have some statistics here that kind of indicate that it’s not as slow to approve many drugs as it has in the past. Sixty percent of the drugs that were approved in 2015 were approved — what’s known as in an expedited review through terms known as fast track priority and accelerated approval. That means that they came to market much faster compared to the normal drug approval process. Also, about half of those drugs that were approved were for drugs to treat rare or orphan diseases. Those are diseases that relatively few people suffer from. So there a lot of new drugs that are coming out on the market. For example, last year, there were 45 of them, and that’s actually a pretty good number for the FDA.
SR: One last thought – post-approval. When the drug is finally approved and goes to marketplace, under any circumstances, we believe that there needs to be a much more rigorous and well-financed post-approval study process. It takes too long for the FDA to find out through population trials that a drug is causing harm or isn’t acting effectively.
JB: I just want to add one thing to that and that becomes even more important when the initial clinical trials if this legislation passes are going to be even shorter and skimpier than they are in the past. That just makes post-marketing trials that much more important and why they need to be funded much better.
SR: So for these many reasons, we’re hoping that the 21st Century Cures Act gets looked at very, very closely. For more information about 21st Century Cures Act and the side effects of the medicines that we all take every day, please go to medshadow.org. Thank you.