Archives

Episode 20: Acupuncture & Traditional Medicine Working Together

This week, Su and Jonathan discuss using acupuncture in conjunction with traditional medicine. And Su reveals a surprising positive side effect from an acupuncture session.

Su Robotti: Hello, my name is Suzanne Robotti, and I’m the founder of MedShadow. And–

Jonathan Block: I’m Jonathan Block. I’m the content manager here at MedShadow.

SR: Today, Jonathan and I want to talk to you about acupuncture. The whole concept of someone sticking needles in me is not something I look forward to, but I’ve tried it. Have you tried it?

JB: I have not tried it, so I’d be interested to know a little bit about your experience. But before we get into that, a lot of people, when they think about acupuncture, they have that reaction like, you’re going to have needles put into you, and I think it’s actually going to be painful, but from some of the medical literature, that’s actually the opposite point of view.

We had a wonderful piece written in MedShadow recently by someone you know very well, your own acupuncturist, Dr. Noah Rubenstein, when he talks about how acupuncture can not only be used in a complimentary fashion to traditional medicine, but can also potentially replace drugs, you know, do the acupuncture in place of the drugs. But the fact is that acupuncture and traditional medicine don’t have to have to be mutually exclusive. They should actually be used in combination together, and I know this is something that’s very near and dear to you, since you do acupuncture. So, why don’t you show the audience what your experience has been.

SR: That’s exactly what my experience was. My shoulder became sore when I moved it in certain ways, and it didn’t seem to be getting any better with time, so I went to my acupuncturist, Dr. Noah, and he put some needles in it, and it felt somewhat better, and I spoke to a physical therapist who gave me a few exercises, and it felt a little better and I went back to see Dr. Noah again, and I worked both on a little acupuncture, a little physical therapy, and in time, and it’s substantially better. It’s not quite perfect, but it’s substantially better. So, you know, the acupuncture and the physical therapy was — I don’t know, but I felt very much that it was helpful.

JB: Right. One of the things we like to mention here at MedShadow is that many of the drugs that people take have side effects. One of the advantages of acupuncture, which Dr. Noah talks about, is that when you have acupuncture, there are really aren’t very many side effects associated with it. Another point that he makes is that, in traditional medicine, when you have side effects, sometimes, additional medications are added just to deal with those side effects, while in acupuncture, if there are side effects, either from drugs or from some other form of treatment that you are receiving, the goal of acupuncture is to eliminate any side effects right away. So that, I feel, is another benefit of acupuncture as well.

SR: Yes, actually, Dr. Noah talks a lot about people who are under care and taking medicines that they have to take, for say, chemotherapy, and he will often work with those patients to alleviate the side effects to lower the amount of drugs that they have to take in order to get better.

JB: True. I mean one of the things that Dr. Noah mentions is that there are some leading medical institutions that are actually using acupuncture as part of treatment. The one that he mentions is right here in New York City, at the Memorial Sloan Kettering Cancer Center. They’re actually using not only acupuncture, but also some elements of Chinese medicine to deal with cancer treatment and also with the side effects that is often associated with chemotherapy.

SR: Well, I’ll tell you, as I started off saying, I was very wary of acupuncture and had very little interest, but what convinced me to go was a good friend of mine, a radiologist, and if Western medicine can take care of it, he wants you to have that shot, have that operation, take that. He is totally a believer in medicine working, but, when he had hurt his shoulder, he went to an acupuncturist, and you know, found that really did heal it completely, which is exactly why it is well, my good friend a radiologist, who totally believes in Western medicine, found a lot of success with an acupuncturist. I should certainly be open minded to it.

JB: Absolutely. And I think one of the important things about what we’re discussing today, is that acupuncture can be an option for you, of course, to something that you want to discuss not only with your medical physician, but also if you choose to try acupuncture, to have your acupuncturist and your medical doctor work hand in hand, and most likely, you’ll achieve the best results that way.

SR: Yes. I make sure my regular internist knows exactly what my acupuncturist is doing. There is one story I will tell, here again, and that is, the first time I went to my acupuncturist, I gave my life story and I mentioned in there that I’ve always suffered badly from motion sickness, and he said, maybe we can do something about that, as an aside, and it was not the reason I went to go see him. I was there for my shoulder. And the next thing I knew, I was on an airplane a few weeks later and realized I had not taken my motion sickness pill, we were in a cloud, it was bouncing and I was not sick. He cured my motion sickness. It was the strangest thing, and I’ve been back a few times for touch-ups and to keep it strong, but it’s been a wonderful side benefit, is that my motion sickness is almost gone. Yay. Thank you Dr. Noah.

JB: Great, well thanks very much Sue for sharing your stories with acupuncture with us, and thank you everybody out there for joining us today.

SR: Please go to our website, www.medshadow.org.

JB: Thank you.

Episode 19: On the Inside When the FDA Assesses an Opioid Delivery Method

In this episode, MedShadow founder Su Robotti discusses her first experience as an appointee to the FDA Drug Safety and Risk Management Advisory Committee. The Committee discussed the delivery system of a strong opioid called Opana.

Su Robotti: Hello my name is Suzanne Robotti and I’m the founder of MedShadow. And today, I’m with —

Jonathan Block: Jonathan Block and I’m the content manager here at MedShadow.

SR: I recently was appointed to the FDA’s Advisory Committee on Drug Safety and Risk Management, and Jonathan is full of questions about it.

JB: Absolutely, first of all, to start off, what was the purpose of your first meeting with the committee that you just were at in Washington, DC?

SR: Sure. The question about the drug in front of the committee was Opana and that is a hydromorphone drug, used for pain management. It was two committees, actually, sat together. The Drug Safety and Risk Management Committee, which I’m on, and also the Analgesics Committee which is the committee on pain management. Their panel, let’s see, there are 27 of us, all together there that is combined panels, and most of the people sitting there were epidemiologists, who are doctors that focused on how diseases go through an entire society that brought concepts of disease, and also analgesics specialist, pain specialist. I, represented, I’m a consumer representative on the Drug Safety and Risk Management Committee. So my responsibility is to bring the consumer’s point of view to the table.

JB: Great. Now, our audience may not be aware that Opana is an opioid type pain killer, which has its own set of issues. More specifically, what was the purpose of this meeting in terms of what about Opana was under debate?

SR: Well, Opana was reformulated about 4 years ago, 5 years ago to add a new coating on it that would it much more difficult to crush, or to crush or press it to inject it, in an attempt to make it abuse deterrent or AD. So initially, they thought that if they put this coating on it, they would be able to add “Opana ER,” that’s extended-release, and add AD to it for its deterrent. But the post-marketing studies, of the how the drug was accepted into society, how it was used by doctors and by patients, showed that it wasn’t actually abused deterrent, but it shifted to the style of abuse, the type of abuse to the drug.

JB: Can you explain how it shifted?
SR: Sure. The abuse method of choice with Opana, but before its extended-release, but before it had this coating on it, was to crush it and to either chew it and swallow it or to crush it and snort it, or abuse it nasally, as they would say. After this hard coating went on it, it was very difficult to crush, impossible to just, I think impossible to chew and crush it, and when it did crush, it turned into a gel-like substance which theoretically is more difficult to ingest. Unfortunately, what happened was that it did deter snorting Opana, but addicts quickly shifted over to working with the gel, watering into a more liquidly substance and shooting it intravenously.

JB: Wow, that sounds very dangerous. Were there any additional problems besides your still addicting drug shooting it your arm? What sort of additional problems popped up?

SR: What they did find was that Opana, and again, I should say, that the entire hearing is available on the FDA website to watch and listen to the expert testimony and the doctors’ comments on it. So, my comments here are really what my impressions, my recollections and mu understanding was on, not on a medical expert. So having sat on this committee, I think I can say with clarity that the difference between snorting a drug and injecting a drug is the needle stick into the skin because Opana tends to be a quick-acting drug when broken in the extended release method and crush it and liquidated it. It’s a quick high that it goes down fast. So that those who are truly addicted to it, and that having to inject themselves or feeling that they have to inject themselves 3 or 4 times a day, with other skin pricks, veins start to collapse, infections starts, sepsis can set in which is very dangerous, and the transmission because of shared needles, and another reason, Hep C and HIV becomes common among these type of abuse.

JB: So what did you end up voting on, what’s the question or questions of what was the vote?

SR: The bottom question that was put in — there were several discussions questions that lead into the final vote, and the final vote was the question — does the risk of Opana ER still outweigh the benefits? Obviously, when it was first approved, the decision was, yes, the benefits outweigh to this, but I voted, at this point, it doesn’t. I, based on the information that was presented and the comments of the doctors at the table, that the risk of an intravenously abused drugs far outweighs the risks of a nasally abused drug and what one hopes, when you have an addict in the family, one hopes to keep the addict alive until somewhat rehab or program can help that addict and bring them back to a healthful lifestyle. With nasal drug abuse, that’s only going to hurt your own sinus cavity. With an intravenous drug, you get into sepsis and HIV and Hep C which just makes your company so much more difficult.

JB: So what happens at this point now that your committee and with the joint committee, now that this has happened, what happens to Opana ER? Does it get removed from the market, does the labeling have to be changed, is there some change to the labeling that the manufacturer wanted but now it won’t get? What happens now with that drug?

SR: Well, you have to go to the FDA for bringing Opana back into the table to discuss not just the AD labeling which is, you know, not something that it was ever going to happen on this case based on the studies done. But the FDA went back to discuss, really how can we move this profile from high risk to less risk. And it’s up to the FDA staff, at this point. What will ultimately happen, we are an advisory committee, the vote on the advisory committee were 18 people who agreed, who voted in the same way that I did, that the benefits no longer outweigh to the risks There are 8 people who thought that the benefits do start, and 1 person just felt that the scientific research is not strong enough to make a clear a vote on anything.

The committee chair, who is a great chair, has written up the entire proceedings and will be submitting it to the head of the FDA, for the final decision that the FDA can’t actually demand of have it be removed from the market, because they don’t have that power. However, they can change the labeling, they — to add a “black box” warning — they can recommend stronger risk management procedures, more education for doctors, pushing registration for doctors when they prescribe the drug that should be registered in a national list that other doctors know, that this patient potentially is getting multiple prescriptions for that.

So that there are things that the FDA can do, but what I think many people in the committee hope, and what I hope, was that Opana would go back to the drawing board — Endo is the company that makes it — and find a way to make this drug more safe for everybody to use because pain management is a big issue, the world is changing in pain management. It has gone way beyond just opioids, but integrating multiple [approaches] — biofeedback, physical therapy, acupuncture, other ways — so that they can be made part of the pain management profile, which is not be dependent on them alone, and be a stronger and better drug.

JB: Great, Sue. That was at least to me, a very interesting description and accounts of your meeting, thank you so much for sharing it with me, and of course with our MedShadow audience.

SR: I did write a blog on this experience, if you like to look at it, it’s at our website, www.medshadow.org.

JB: Great, thanks very much.

SR: Thank you.

Episode 18: Adult-Onset Asthma

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.

Su Robotti: Hello my name is Su Robotti and I’m the founder of MedShadow.

Jonathan Block: I’m Jonathan Block and I’m the content manager here at MedShadow.

SR: Thanks for joining us. Jonathan and I wanted to bring to your attention a study on adult onset asthma. It seems as perhaps not all the adults who have been diagnosed with asthma, may have asthma or maybe there seems to be a remission rate, and this is important, because right now, asthma is considered a chronic disease. Once diagnosed with asthma, you’ll probably be on medicines for it, or it would be on your medical record for life. Why is that probably, Jonathan?

JB: Well, I’m going to blame it though, first of all, back to these studies that you were talking about that was published in the journal of American Medical Association that found that one in three people that have been diagnosed with asthma actually don’t even have asthma. They’ve been misdiagnosed. Now why is this a problem? Because over diagnoses can lead to unnecessary medical treatment, and as the watchers of MedShadow TV know, all medicines have side effects and you don’t want to take a medicine unless you absolutely have to.

SR: There are two issues at hand here. There could be the issue of over diagnoses and there could be the issue of remission. So first, talk about over diagnoses. There is no definitive tests that says, yes, you have asthma or no you don’t. It’s a nuance disease, a doctor needs to use some judgment on this. There are a couple of standardized testing that can be used. Spirometry…

JB: Spirometry–

SR: Spirometry, and the Vincula challenge or two of them, but the doctor will also consider most importantly your symptoms, your personal history, and your family history, and come to a decision. Quite often, if a patient presents or comes in with wheezing, long-term coughing, chest tightness, the doctor will hand the patient an inhaler, and if that inhaler helps to clear up the wheezing or discomfort immediately, that can end up being the diagnosis. And that is a rushed diagnosis.

JB: About 20 percent of the people that do have asthma, they end up going to remission with asthma, unfortunately, what also happens that even under in remission, they still may continue to take their oral corticosteroid medication.

SR: So our suggestion is that every so often you go back to your doctor, or go to a new doctor, and ask for a re-diagnosis, just to check, do you really have asthma or has it cleared up or maybe you never really had it, new underlying issue is going away on its own. The doctor will probably work with you on a plan on how to figure that. I will say don’t just stop taking medicine, you need to talk to your doctor about this. There were some limits to this study–

JB: Yes, there were. First limit was that the patients that were included were only followed for 50 months, which is anybody that knows anyone that has asthma has a very short period of time to be looked at for asthma. People who have been taking oral corticosteroids for a long period of time were excluded from the study which is key and only about 45 percent of the people included in this trial and the study that involved the trial were actually on an active medication.

SR: If you want more information on asthma or on the corticosteroids, please go to our website at www.medshadow.org where you should find a lot of more information, right Jonathan?

JB: Exactly.

SR: Thank you.

Episode 17: 6 Foods that Help – and Hurt – Libido

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.

MedShadowTVEpisode17libido

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.

JB: Correct.

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.

JB: Exactly.

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.

Episode 16: The Pros and Cons of Vaping

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.

JB: Correct.

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.

JB: Correct.

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–

JB: Agree.

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.

Episode 15: The Importance of Diversity in Clinical Trials

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.

MedShadowTVepisode15
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.

JB: Exactly.

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.

Episode 14: The Top Stories of 2016

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–

JB: Exactly–

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.

JB: Correct.

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.