Full Transcript Available

Subscribe now on: iTunes | Google Play | Stitcher | Soundcloud | Spotify | RSS | or search "Ashes Ashes" on your favorite podcast app.

Chapters

  • 01:51 Drug prices out of control
  • 08:08 Case story: Inhalers
  • 10:38 The process of drug approval
  • 14:41 American drug patent system and the games companies play
  • 20:23 Behind the scenes: clinical trial results manipulation
  • 22:06 Behind the scenes: clinical trial human guinea pigs
  • 27:58 Behind the scenes: clinical trial oversight
  • 31:21 Are drugmakers even making the medicines we need?
  • 36:24 The evils of socialized medicine
  • 38:10 Going forward: alternative systems

(We know this automated transcript sucks, we'll try and fix it up soon!)


David Torcivia:

I'm David Torcivia.

Daniel Forkner:

[0:00] I'm Daniel Forkner.

David Torcivia:

[0:03] And this is Ashes Ashes, a show about systemic issues, cracks in civilization, collapse of the environment, and if we're unlucky, the end of the world.

Daniel Forkner:

[0:12] But if we learn from all of this maybe we can stop that the world might be broken but it doesn't have to be.

This week we're continuing our series on the American health-care system this is part 2 but all three parts stand on their own so if you haven't heard the first part feel free to stay with us and catch one tomorrow. Last week of course we covered the American Health System and how it has derailed itself from the tracks of social good to one of prophet. And this perverse incentive of profit has affected so many parts of it whether that's the hospital system and other providers, whether it's the way the Physicians and other doctors practice their trade, or the way the insurance companies compete on private markets in ways that end up driving up prices and premiums and deductibles for all of us. And of course we heard three personal stories from you the audience and of this part 2 we're going to be discussing the cost of drugs. That's right David we are single-handedly going to tear down the pharmaceutical industry so buckle up.

David Torcivia:

[1:16] That's right Daniel the pharmaceutical industry is maybe the big bad wolf out of everything that is the incredibly expensive American Healthcare System, weird news stories constantly coming in about a drug that might be originally a few hundred dollars raised to tens of thousands of people bankrupted trying to buy prescriptions that they need to survive. But who would have ever guessed an industry. Began with con men selling questionable tonics would have become such an exploitative system concerning itself primarily with profit.

Daniel Forkner:

[1:52] What do I think most people understand that the companies that Supply are drugs aren't always the most ethical.

Drug Prices Out Of Control [1:58] Because I feel it in the bills they receive I mean you mentioned last week how the primary cause of bankruptcy in America comes from medical bills, and it doesn't matter if these are individual drugs that someone's taking for a specific illness or a whole class of drugs to treat a much broader disease. I'm in the same drugs that were costing $10,000 per year to treat multiple sclerosis in the 90s. Will those same drugs Rose to around $60,000, my 2015 and what's so maddening to a lot of people is that drugs that have been around for centuries are not immune to price hikes and increases like this. There's one particular medicine that treats gout. It has been used for hundreds of years and today in Canada this pill the sold for about $0.09 that same pill in the United States branded Colcrys will that will run you over $7 Davis.

David Torcivia:

[2:53] And typically with markets at technology increases and a scale of production grows ever larger cost are supposed to decrease but in some reason with Pharmaceuticals the opposite often occur, almost 10% of the entire US population as diabetes, probably of course for many other reasons we've covered in the show things like air pollution sugar the topics are endless. And all these people need insulin we have figured out at this point how to make insulin really well and for surprisingly affordable amount. But still the prices climbed and unfortunately for the many people that absolutely required in order to survive.

Daniel Forkner:

[3:31] In fact an estimated 25% of those 30 million people cannot take insulin the way they need to because of the cost which puts them at risk for serious health risks and even death as we mentioned last week.

David Torcivia:

[3:44] The number one prescription drug in the world Amara is taking my patience for a number of things in its price has increased dramatically in the United States from 12000 a year in 2012 to us $60,000 today. In Europe though the cost of this drug has been much lower between 10 and $22,000 and it's about to get even lower than that because the drugs European patents have just expired a few days ago, but the United States although the main patent for Humira expired in 2016 the company that produces it managed to acquire more than 100 patents on the drug, and this means it'll extend its Monopoly light at least into the 2030s some of these patent have nothing to do with the drug itself but involved process he's like Manufacturing, so while Europeans we could do enjoy this drug Americans we spending $60,000 a course for the next decade because this us drug patent system is truly one-of-a-kind and we'll dive into this, more detail shortly in this episode.

Daniel Forkner:

[4:45] But David you mentioned companies that raise prices on drugs, and a good example of this comes from the Investment Company valeant pharmaceutical which in 2015 came under Fire for its explicit business model which was to purchase established and essential drugs and then Spike their prices that's what their business existed to do it took the price of glumetza an important diabetes drug from $896 to above $10,000 basically overnight. In addition and important medication for regulating heartbeats was increased by this company from $4,500 to $37,000 they did in an instant.

David Torcivia:

[5:27] CEO of valeant Martin shkreli also had another investment company that bought up an important generic antiparasite drug and then raise the price from just $13 to 750. Show me these high prices and price manipulation are not exclusive to only brand-name drugs, companies have been monopolizing markets for generic medicines which don't hold any patents and then raising their prices this much as the market will bear.

Daniel Forkner:

[5:56] And before you say we'll hold up David and Daniel Martin shkreli went to jail.

David Torcivia:

[6:00] Or unrelated charges.

Daniel Forkner:

[6:02] Yes for misleading investors not increasing the price of this drug but you still might say this is an isolated thing this was a small hedge fund company not many people are doing this but in fact this type of activity is so rampant. But just this year these price hikes and frequent drug shortages have prompted over 300 hospitals across the country and climbing as well as the US Department of Veteran Affairs to come together to form a new nonprofit dedicated to reliably supplying hospitals around the country with essential generic drugs, so the hospitals themselves are looking to get into the drug Market in order to avoid this type of price and Supply manipulation by big Pharma.

David Torcivia:

[6:44] Now we hope this turns out to be good news for the bottom line of many hospitals and especially that this savings trickles down not just the hospitals but to the patients that they serve. What the pharmaceutical industry is going to change even more dramatically with upcoming mergers that are under review right now. CVS and Aetna the major insurance company and local pharmacy are talking about when the allergist's mergers in business history. Similarly Cigna and express another insurance company in pharmaceutical provider are also trying to merge in order to provide what they claim is a. More unified health care experience combining the healthcare information you get at your doctor or your hospital with the pharmacies that ultimately Supply the drugs are prescribed. But traditionally these type of murders in the healthcare industry have not saved consumers money but rather raise prices and streamline The Profit taking ability of these company.

Daniel Forkner:

[7:37] But David once again I feel like these standard counter to all of this you know we're talking about the prophet that pharmaceutical companies rake in at the expense of the American Health bill and the prices that we pay.

[7:50] A lot of companies say hey we charge high prices because, we have to recoup the high development cost and because we need to Spur additional investment into research to create new drugs. And that's something we're going to be talking about in more detail later on in this episode, but I think there's one example that really challenges this notion that companies raise prices simply for research and development.

Case Story: Inhalers [8:16] And this this example begins in the 1970s when scientists bring the alarm that chlorofluorocarbon chemicals and various aerosol products were ripping a hole in the ozone layer threatening to end life on Earth. Countries took this seriously they came together and they said we need to ban all products that use the CFC pellets now asthma inhalers at the time they used CFC propellants, and the active ingredient albuterol was a generic drug meaning anybody can make it so the price of an inhaler was around $5 a pop at this time, not despite the fact that these inhalers had CFCs in them these countries that came together to form the Montreal protocol they said we need to exempt medical inhalers because of their necessity and because they have a negligible effect on the atmosphere anyway. So that sounds like it worked out for the pharmaceutical companies right David they don't have to replace their inhaler.

David Torcivia:

[9:13] Yeah it certainly sounds like they won the the good end of the deal on that one.

Daniel Forkner:

[9:17] What store is not over so hold on many of the big pharmaceutical companies that came together and they created a new inhaler anyway with a different propeller system. One that would be free at these CFCs and in the process they applied for new patents on these devices, but here's where the story gets crazy then they used their trade group The International pharmaceutical aerosol Consortium which is a mouthful to Lobby Congress and to lobby with in other countries to have those old CFC inhalers banned from the markets, so just to clarify they spent hundreds of millions of dollars to get Congress to ban their own product. And this resulted in a new Monopoly where the only inhalers available were brand name with this new patent-protected propellant system and as you would expect prices went through the roof where they say to this day. So David those inhalers that people rely on to save their life that cost $5 back in the day how much do you think they cost today.

David Torcivia:

[10:18] Well if I've learned anything from the healthcare industry it's probably hundreds of dollars.

Daniel Forkner:

[10:23] That's right the average price for a brand-name inhaler today is between 200 and $500. And although new generics have hit the market since 2015 even these are between 80 and $300 and we're going to see you in a little bit why that might be.

Drug Approval

David Torcivia:

[10:39] I want to get Daniel I think we've gotten ahead of ourselves a little bit and to really understand the dollars involved in this process and I mean we all know that making a new drug is expensive, it's a lot of money to put in a research, by the money into testing and then it will definitely marketing and and appointees drugs and so maybe we need to understand exactly why that process is so expensive him why that process exist in the first place, and of course this process really get started with drug approval. The idea that we need to approve our drugs to make sure that they're safe is surprisingly at least in the United States relatively recent it wasn't until 1962 that these companies actually had to run clinical testing, the FDA use then to approve postpone or reject the new drugs. Like all things is well intention legislation has a lot of problems with it and these problems have magnified as time went on, to explore with some of these problems with the legislation actually work.

Daniel Forkner:

[11:36] First new drug applications simply had to show that these drugs being tested were safe. We never asked whether new drug for better than those already available for the same treatment which is something that a lot of countries outside of the United States do, we simply said oh you want to bring this new drug onto the market will prove that it does something more than if we just gave someone a sugar pill and also that it doesn't kill them, so very loose loose standards here and II missing from our evaluation of new drugs was whether they would be cost-effective or affordable this is something to every other country looks at in the process of bringing a new drug to Market and in addition to this lack of price control the American system for patenting drug gained a lot of complexity that ended up hurting us as the consumers, today at pharmaceutical companies can hold more than a dozen patents for a single drug which really gets away from the one patent One Drug ideal, and there are multiple avenues for extending those patents which makes it very expensive and time-consuming for other drugmakers to bring generics and other alternative to the market they had to do a lot of litigation they have to wait a long time in all this gets really expensive which could explain why even those generic inhalers that we have today are still super expensive.

David Torcivia:

[12:55] Obviously this create an environment that is right for profiteering and unfortunately Slim in terms of social good, to this day BFD has to approve a new drugs so long as it is more effective than just a placebo. Go to the studies that look at 1 drugs Effectiveness first another which means that companies are spending Millions to test produce and Market drugs at like we should have never been made in the first place so that they can create new pageants on them and hike up their price is right, Windows would be generics would start to hit market and began to take hold.

Daniel Forkner:

[13:28] If that wasn't bad enough David, that these drugs are evaluated on their effectiveness relative to other similar drugs the HIV aids crisis in the 1980s caused the FDA to relax the rules even further. Manufacturers can get their drugs approved through an accelerated process in which their drugs are evaluated based on what's called surrogate measures, so using a surrogate measure the FDA will approve drugs that impact symptoms that correlate with an illness, without any evidence that the drugs impact the underlying illness itself drugmakers are usually supposed to follow up these new medicines with studies to measure their long-term Effectiveness but often this never happens, patent means tons of an effect of drugs come out onto the market between 2004 and 2014 a study found that a full 74% of all Cancer drugs, did not add a single day to a cancer patient's life but they were approved because they showed to have some impact on a random thing that correlates with cancer, and keep in mind that will not effectively extending life expectancy at all many of these Cancer drugs can cost well over $100,000 per year.

The Patent Game

David Torcivia:

[14:42] To really understand this game we need to understand the patent system that drives it in the US drug patents are for 20 years, but some of these regulatory processes can take up to eight years to be completed, meaning a drug company as about 12 years in order to profit off the drug that they've created worst case scenario. And their Isis is far far too short of a Time, any need or would prefer much much longer periods for their drugs and we spoken about intellectual property patent this drugs a little bit in the past and episode 33 All rights reserved and in order to better exploit the system they've created a lot of little clever loopholes and ways of playing these patent game. There are a number of strategies that they employed to maintain his monopolies and there is no reason that they employ them except to maintain the Monopoly and further extend their profit extraction. First and most obvious in the system is litigation under current US regulation any objection to a new patent or claim a patent-infringement sets off an automatic 30-month halt to the introduction of a new. It's two and a half years pharmaceutical companies either apply for new week patent so sue would be generic makers right before their own pads are about to expire to get that guaranteed 30 month extension this requires expensive litigation on the part of generic makers to defend themselves and that drives the prices of both the original drug as well as he's cheaper alternatives.

Daniel Forkner:

[16:07] And it gets a lot worse from there the ones that pharmaceutical company gets its 30 month extension it often employed something they like to call in the business as product hopping, so manufacturers cannot bring a generic onto the market unless there is a brand-name version out there already because the generic makers do not have to run new clinical trial so long as they can show that the drug formula is the same as the brand name and creates the same level of medicine in the body called bioequivalence, now David if you're the Savvy list or you might see where it's going if there's no brand-name drug on the market there can be no generic introduced. So what these companies will do is they redesigned the drug in some way usually in the delivery system so instead of swallowing it you chew it, or instead of one sugar coating it has a different sugarcoating but ultimately it's the same chemical formula will then they file patents on this quote new and improved drug and then pull the old product from the Shelf. Hospitals and doctors then have no choice but to sign new long-term contracts for the new drug and the would be generic manufacturers cannot bring their alternative to Market because of, there is no brand name version so then the Monopoly continues for several more years until they do it again and again.

David Torcivia:

[17:27] But of course it doesn't end just there you often get situations where generics that have been available for a long time just suddenly disappear, it was a case several years ago word generic drug that cost only $2 and was widespread in treating nausea in cancer patients and those in post-surgery suddenly disappeared. The only available drug no friend made by glaxo was 75 times more expensive. Not only was glaxo pain generic makers to Halt production I had convinced PFD that the Giants were dangerous despite having the exact same side effects as though friend in fact these dangers only appeared at levels 100 times higher the most traditionally prescribed in the generic by the time the dust settle and Zofran pens expired original generic makers out of business and hospitals at long-term contracts for the four more expensive Zofran.

Daniel Forkner:

[18:19] And David you mentioned episode 33 All Rights Reserved I think everyone should listen to this if they want to understand why these patents and intellectual property on drugs is so problematic, we start looking at the history of intellectual property. We get a different narrative than the one that tells us that this is what's necessary for Innovation I mean speaking of pharmaceuticals itself some of the biggest and most successful pharmaceutical companies in the world come from Switzerland, and the foundations of these companies were built mainly by French entrepreneurs gymnast, and others in the field that were fleeing the French Patton system into Switzerland in the late 19th century for the express purpose of setting up shop in a country that at that time did not have an established patent system, but doubt with the chemical and pharmaceutical Industries. The absence of intellectual properties that literally what led to the Bedrock of Switzerland International pharmaceutical presents. And it's that patent system that is now starving Innovation for life-saving medications and driving cost rapidly up.

David Torcivia:

[19:28] So what ultimately does this boils down to what is the meaning of these pharmaceutical patent games. Will know that pharmaceutical companies want to make money but I think we need to take a step back for just a second and ask. What is the fundamental mechanism that allows a pharmaceutical company to make profit, I'm sure they have tails what's going on that enables those sales simply put that mechanism is about restricting access, a company makes profit on life-saving drugs like insulin or devices like inhalers or epipens, only by restricting the ability for people to access that drug without that restriction no one would agree to pay the exorbitant prices. These are all themes will explore later on in this episode. For the moment let's continue examining exactly what it takes to bring a drug to Market especially the clinical trials and Publications and it takes to produce a brand new drug.

Daniel Forkner:

[20:23] There's some crazy things that go on behind the scenes with these clinical trials but real quick it's important to just touch on how this data is published from these trials,

Manipulation [20:33] so before the FDA will approve a drug the pharmaceutical company has to test it in clinical trials on human beings.

[20:41] When it conducts these trials the companies are not required to publish the results and so the public including your doctor that's eventually going to prescribe this drug to you, does not have access to much of the data pharmaceutical companies intentionally withhold negative results of their studies often conducting multiple clinical trials until they get the results they want. Researchers in one case found that about 40% of all clinical trials are never published in the story gets worse from here of the studies that Pharmaceuticals do published. Data is often left out meaning that the results have been cherry-picked to include only the data that makes the product look good, for example the pharmaceutical company that owns the antidepressant Prozac, published the results from a clinical trial in which out of 245 study participants the company had omitted data on 218 of them, bisque you the results to make Prozac look 5 times more effective than it actually is. Similarly additional data manipulation is possible when these drug companies conduct multicenter trials in which one study is carried out in multiple locations this allows them to publish multiple papers with different authors all showing positive results giving it the illusion that these drugs are more effective than they actually are when in fact the underlying data is the same for all of these studies.

Guinea Pigs

David Torcivia:

[22:07] Now manipulating results of these trials so at the publishing all of this is totally insane and it's mind-boggling that this is even legal, let's dive deeper one more time and look at the humans, are involved in the state of because in addition to the problems associated with this publication bias there is a very long history of abuse when it comes to testing drugs and studying medically related phenomena in human beings tear the United States in 1932 the US government recruited 600 poor black men for studying what's the participants were promised free treatment for what they called quote, Bad Blood. In reality government wanted to monitor the spread of syphilis 399 men from the study had syphilis the researchers did that information from them, I made it a point to deny then treatment despite the availability. Penicillin for treating syphilis as early as 1945 the study which was supposed to run for 6 months went on for 40 years as these men was syphilis or simply studied until they die.

Daniel Forkner:

[23:12] And that story broke a long time ago people were understandably outraged. But while the study was going on one of the men who was involved in conducting the study was sent to Guatemala Again by the US government to conduct a similar and even more tragic study there. This took place between 1946 and 1948 and we didn't learn about this study until 2010 what they did is they took 1500 Guatemalan soldiers prisoners and mentally ill patients and then deliberately infected them with syphilis. I guess just to see what would happen.

David Torcivia:

[23:49] There's a very long list of unethical research in women's health as well as doctors chose to test early designs of the birth control pill on for women in Puerto Rico heralded quote father of modern Gynecology J Marion Smith Advanced his practice by using the bodies of women slaves, performance 30 surgeries without any anesthesia on one woman alone. And when it comes to the pharmaceutical industry one spin-off of this pressure to bring drugs to Market as quickly as possible is a degrading and exploitative nature of phase 1 clinical trial.

Daniel Forkner:

[24:26] This brings us up to the modern-day and there are many examples of clinical trial abuse, in 1996 a company was discovered recruiting homeless alcoholic from shelters with a little bit of cash in order to test drugs on them and a 1999, a man died from gene therapy trial in which researchers at the University of Pennsylvania cut corners and safety and disclosure in order to complete the study on time but perhaps one of the biggest recent scandals wasn't covered in 2005, in Miami the company sfbc International had for years been running the largest clinical trial Center in North America in an old Holiday Inn Motel in the subject it was recruiting were largely undocumented immigrants and poor Latinos and African-Americans the medical director was unlicensed up to eight participants were house per room, and shortly after the story broke the county ordered the building demolished because of multiple fire and safety code violations.

David Torcivia:

[25:26] As crazy and it as improbable as this event sounds it is not an outlier nothing has really changed and that story broke in 2005, clinical trials are still almost entirely conducted by for-profit companies known as contract research organizations Lebanon sent it to complete these studies as quickly and as cheaply as possible with virtually no oversight from review boards participants sign contracts in which they will be paid under the condition that they make it to the end of the particular study, then they are administered experimental drugs sometimes kept in the facility for weeks at a time, and here's the insane part as per a majority of these contracts if a participant gets injured as a result of the test being done to them they are denied reimbursement for the cost of treatment. If they are injured as a result of the test being done to them causing them to drop out of the study they are denied compensation for their participation, these companies prey on the poor and vulnerable classes of our society offering a little bit of cash to become a human guinea pig and then if anything goes wrong these mostly uninsured individuals are stuck with the bill. This is part of how many of our expensive drugs ultimately make it to Market not to mention the countless multitude of drugs that fail and is clinical trials, and never reach us.

Daniel Forkner:

[26:46] Yeah this is this whole process is just pretty disturbing to think about it and I mean if you think about how many people in this country. Don't have a lot of money in savings don't have a job find themselves in a situation where maybe they don't have housing the idea that you can go to a facility and participate in a study for 3 weeks and in make a few thousand dollars that is hard to turn down if you have the opportunity to do that, and many people make this their full-time profession methods the average guinea pig if this is what they do just jumping study to study can make around 17 to even $20,000 a year but it would cost.

[27:25] Many of these clinical trials they only accept healthy patient at least on paper and that's because you don't want to give an experimental drug to someone who might be receiving treatment for something else, at which could then interfere with that treatment and causes or symptoms to get worse but a lot of these people, they understand that this is a business transaction the drug companies understand that, the people participating in the study understand that and so they often will I will say yes I'm healthy no nobody in my family has a history of disease because of they say otherwise they won't get to participate and that's locked in, but David someone like you want to go hold up these companies don't just conduct,

Oversight [28:03] studies on their own right these things have to be approved I mean the government is involved in approving these drugs that have to look at these clinical trials how is it that something can go so horribly wrong to a company can be operating a large clinical trial Center in a in a run-down holiday in churning these undocumented immigrants and poor people in and out, how is that possible when we should have regulatory bodies in place to ensure that these studies are safe.

David Torcivia:

[28:30] Okay well let's talk just for one moment about these review boards because there's so much we can go on on this clinical trials and could really be its own episode it's really heinous there's additional reading available on our website I encourage you to check it out but additionally there's a lot that we can say, I mean this is from the mentally ill homeless people in Philadelphia that Recruiters in tights with cash to participate in studies involving experimental psychiatric drugs to the ethical pitfalls of conducting research clinical trials in prisons all around the country but I mean everyone is wondering like where's the oversight in this and of course clinical trials to do have to be approved and monitored before they can go forward.

Daniel Forkner:

[29:08] I would think so David.

David Torcivia:

[29:10] Well yes and no. So institutional review boards do exist to protect subjects in these trials but they were designed with the idea that these studies will be conducted an academic study. Pharmaceutical companies use to recruit academic institutions to design and execute drug trials and he's review boards were made up of volunteer faculty members would approve or recommend changes to studies their colleagues were conducting in their own the cilities but all that changed, in the same way hospitals have chosen to save costs by selling departments like dialysis care to private companies as we saw last week pharmaceutical companies have chosen to save time and money by hiring private companies the conducting studies with an conduct them in weird places like old Holiday Inn motels review board still have to approve the studies but all they are is a proving a piece of paper, you don't actually see the studies being conducted and to make this worse review board some cells are now semi privatized they are paid a fee to review these studies any companies that conduct the studies are free to shop around until they find a review board willing to take their money, and as far as the FDA is concerned when they were view clinical trials they are primarily looking at the Integrity of data not the rights of the participants no one monitors the safety of these trials.

[30:28] And what's really interesting is how, Nate wrote this idea of a human guinea pig has become, we see the media all the time there's a Simpsons episode where Homer sells out and becomes a human guinea pig does the new TV series out right now on Netflix about experimental clinical drug trials in the dramatic effects can have on the participants, this is a punchline in jokes what's the same way that rape has become what it involves prisons, in reality these are people suffering in these situations people who are pushed to the brink will have no choice and have to make money somehow. Ultimately do that by selling their bodies to these for-profit companies that exist, solely to test experimental drugs on people who very much do not need them. This is a for-profit industry directly profiting off the health of some of the most vulnerable populations within the United States and abroad.

Medicine We Need

Daniel Forkner:

[31:21] I think for the cynical listeners out there who might be saying look, I feel bad for his clinical trial participants I don't like the fact that pharmaceutical companies are manipulating data to make their trucks look more effective than they are but at the end of the day if they're developing the drugs that we need, then in some way the system is working, and you know maybe we can encourage some nonprofits out there some ngos to clean up some of these abuse is going on along the margins. But are these companies actually doing fundamentally what we want, medicine to do which is to create the drugs we need not just to survive but to prevent and cure are most terrible diseases and illnesses and, Andres Torres to a healthy body one that is free of illnesses it turns out that this system might not even be doing that. According to dr. Michael Brownlee quote if the March of Dimes was operating according to today's Foundation models we'd have iron lungs and five different colors controlled by iPhone app. But we wouldn't have a cheap polio vaccine in quote. It so that's the fundamental question and it may be the most serious flaw in this profit motivated pharmaceutical system. In a consumer economy such as ours what happens David to a market when there are no customer.

David Torcivia:

[32:44] Well there is no Market.

Daniel Forkner:

[32:46] Exactly and if the customers of drug companies are sick people will how much you get rid of them.

David Torcivia:

[32:52] Well you could let them die.

Daniel Forkner:

[32:55] David you cure them.

David Torcivia:

[33:01] Oh wait what.

Daniel Forkner:

[33:03] If you cure the people who rely on your drug than the market for your drug dies. This is what the ultimate purpose of medicine should be to eliminate the market for diseases that we don't want.

David Torcivia:

[33:15] Eliminate in a good way.

Daniel Forkner:

[33:17] Exactly eliminated from the population but when the process of creating that medicine is run by companies seeking growth and profit you get some, very serious conflict of interest. A report delivered by Goldman Sachs was leaked earlier this year and it's really highlights this very conflict. In report directed at biotech companies the question was asked is curing patients a sustainable business model. A biotech vice president rights to her clients quotes. The potential to deliver one shot cures is one of the most attractive aspects of gene therapy however such treatments offer a very different Outlook with regard to recurring Revenue versus chronic therapy. And she goes on to provide an example quote the company Gilead Sciences is a case in point where the success of its hepatitis C franchise has gradually exhausted the available pool at readable patience, in the case of infectious diseases such as hepatitis C during existing patient also decreases the number of carriers able to transmit the virus to new patients does the incident pool also declined. Where an incident pool remain stable like in cancer the potential for a cure poses less risk to the sustainability of a franchise.

[34:39] Yeah David noticed how she refers to treatments as a franchise like you would a video game or movie franchise that you hope to keep churning out more and more sequels. It's a what is her ultimate recommendation what she tells her clients that if they want to remain profitable. They need to ignore illnesses that disappear from the general population once treated instead they should focus on illnesses that can be treated but continue to supply a pool of patients. Or better known as customers.

David Torcivia:

[35:09] And that's ultimately what this profit model of medicine comes down to yes there are conspiracy theories that the drug makers are also the ones spreading disease, and you get a lot of crazy ideas like that which I mean may or may not be that crazy which will talk about next week but really what this model means is that the companies we have entrusted our help to aren't, all interested in pursuing cures for things that they cannot make money from.

Daniel Forkner:

[35:37] David has damning as this leaks report is because of how explicit and directed is. It away pharmaceutical companies have admitted to this type of thinking for a while, you know we've all heard the billion-dollar development argument on the one hand drugmakers say that their high prices are Justified because it cost so much money to develop drugs. But as it turns out a lot of times up to half of the reported costs are opportunity cost meaning the money they could have made by investing the different type of drug. So when they say it's going to cost a ton of money to develop a drug for some rare disease. What they might be saying in reality is that they can make a lot more money developing another commercial drug like another sleep aid pill.

Evils Of Socialized Medicine

David Torcivia:

[36:24] But this is not the only model that drugs have to be produced on every talked about in that same intellectual property episode episode 33 All rights reserved, there are some drugs made without a patent, most famously the polio vaccine which was funded in large part by public dollars as well as money from Charities like March of Dimes, they thought their drug would not be patentable and under the law of the day that would very much be the case but is that same drug where manufactured now. If it was manufactured at all and odds are made Might instead be a world where we had multiple choices of iron lung to take from rather than the drug that cured this disease is Daniel just mention what if it was created it would certainly be patented and that drug that life-saving drug that quite literally changed the world will be locked up behind expensive cost, and I think if there are any objections to this socialization of drug research and ownership excluding those with financial interest in maintaining the status quo of course along the lines of well we don't want the government involved and something people assume it's best left the markets. But it's important to point out the government still to this day is already involved in bonding a ton of our drug research the only difference is that we the people who pay for this research do not then get ownership over the drugs that we fund.

[37:45] Under the bay Dole Act of 1980 companies can completely under research with our federal money which again is the people's money, and then patent their inventions take control of them and sell them back to us at any price they want, it's double-dipping we're already paying for this technology as a country why are we allowing companies to then sell it back to us for profit.

Alternatives

Daniel Forkner:

[38:11] So David that brings us to the question what is the point of this episode, what ultimately is the point of Illuminating the perverse incentives in the pharmaceutical industry this need to generate profit on people's diseases. What is the point where I think you know if the story was being aired on NPR or similar platform the answer would be something like. Oh we need to support organizations that can raise money for patients to help pay for their drugs and we need to encourage some reform that will make it more difficult for pharmaceutical companies to put people at risk and their clinical trials and you know we need to support legislation that will require pharmaceutical companies to, publicise their financial data so we can see how much they're actually spending on development that will get them back in line cuz then we can hold them to the fire hold them accountable.

[39:04] But ultimately David incremental reforms will not strike at the rotten core of this problem. It's not okay to own ideas especially when those ideas save lives it's not okay to profit off someone's disease, if we truly want to fix this broken system we need something new now there are multiple ways to go about demanding a new system. We should support policies that would truly socialized medicine and health care and give the ownership and the access to that Healthcare back to us the people everyone in this country but in the meantime we can also simply pick up the tools and start building something better today.

David Torcivia:

[39:44] Right now there are people out there who are looking into other alternatives for the systems and that means regaining control of their health. What does community really engaging in this right now it's a large group of people around the world a collection of hackers doctors, how many people who would just be called patients coming together to create a new class of do-it-yourself insulin pumps automated to the glucose levels in their system making sure that they are always, receiving the correct amount of insulin without these expensive third-party tools that often aren't covered by insurance or are less than adequate when compared to these do-it-yourself offerings, there's a huge Community involved in this practice right now actively creating these devices of which are just as safe as the Professional Medical models.

[40:31] What can be a symbol for $102 rather than purchase 4000 even after the coverage of insurance. Unfortunately some of the manufacturers of these products of the pumps themselves have caught on to this do-it-yourself system and are locking up the firmware of their devices preventing people from modifying them to create a better health product and shutting people out from actually owning these products that they've already bought. This idea of the professionalization of our Medical Care is something that is concerning trend, and while the idea of pharmaceuticals of drugs with complicated chemical equations might seem like he can only exist in his hyper professional medical lab grade environment well there are some people out there who said well you know maybe this is not the case maybe it doesn't have to be this way.

Daniel Forkner:

[41:18] Probably one of the most interesting groups involved in this type of work right now is the four thieves vinegar Collective. They've been introducing ways for people to make their own medicine using off-the-shelf materials to create their own in-home lab reactors using very simple to follow, open source instructionals and computers like the Raspberry Pi in order to synthesize the drugs they need to survive. Michael laufer is the chief spokesman off this group and he has given a number of toxin when she details the technical specs behind some of the products they offer, as well as some of the philosophy behind why medicine should be free and accessible to anyone. What are the most famous offerings is an EpiPen that someone can make for just $30 and refill for just $3 and this comes on the heels of, efforts by the company that owns the EpiPen Mylan to restrict access to it while offering a product that isn't even reliable in some cases.

David Torcivia:

[42:21] I actually first encounter the four thieves vinegar Collective at a recent conference here in New York the whole conference. The presentation that Michael gave was so incredibly inspiring to me that it really sort of kicked off the idea for this entire Healthcare show down the line and a weed we did have an interview with Michael lined up but unfortunately some scheduling conflicts came up but instead we've got some great clips of him explaining exactly why all these concepts are just so important. Can use explaining the recent Mylan EpiPen controversy and how they decided that there had to be a better way.

Michael Laufer:

[42:55] If you have heard about us it was probably through this Wednesday Mile and jacked up the price of the EpiPen would produce the EpiPen so which is made from off-the-shelf parts for $30 you can reload it for about $3 and you can test it, an interesting thing about business of right are YouTube a video on how to do it was taken down because you're endangering the public however it's still host on our website you can also get it on Alexandria project the internet archive there's anything alright in the FDA said, yeah you should make you an EpiPen which was hilarious because the interesting thing was they started to fail and 80000 of them were called and then after they were recalled. They didn't investigate why they why they were failing interesting thing it's a single-use tool so you can't test it until you use it I heard a horrible story about some guy who had to watch his daughter died in an airplane because two of them failed in a row it was just terrible. And then on top of that once they were call happened even with the price hike they still couldn't get them because there was a shortage, and the price didn't go down and that was that was almost 2 years ago.

Daniel Forkner:

[44:06] So what he's referring to Heroes of course massive shortages of Mylan EpiPen as well as failures, that many people have to have experience trying to use this in times of critical need but because they couldn't test it first because I had no idea that it might fail. They were unprepared and in some cases many people died he mentioned how the price hasn't come down, as of right now David the price of one of my lands 2Pac epipens is $650 and remember what he's offering people is the ability to make your own which is tested and which is refillable for just 30.

Michael Laufer:

[44:45] Medical infrastructure actually works it appears to work because you've been fixed but you've been fixed only because you were disallowed from texting yourself.

Daniel Forkner:

[45:00] I think this point that Michael makes is really important and we should take a step back here real quick because when we think about the medical field and in the American Healthcare System we know it has problems but I think many people, tend to fall back on the idea well we need these doctors are highly specialized and we wouldn't be able to solve our health problems on our own, but you makes a great Point here which is that we might be missing the alternative reality which is that we're perfectly capable of managing so many of these health concerns that we think is out of our reach, but in reality we've only been led to believe that because there is a monopoly on access2care.

David Torcivia:

[45:37] Will think even further than that we believe we have this sort of body autonomy these days like my body is my body and I can take care of it, I have the tools available to me in this world to hurt myself or to make myself. Healthier unfortunately because of the way our medical system has evolved the way that so many of our Pharmaceuticals are locked behind these prescriptions and high prices this autonomy. Continuously fails I can't afford the treatment that I need if I can't afford the surgery that my body requires and I've lost the ability to regain that body autonomy to repair something that I desperately need and because these things are hidden behind the high price the walls of the medical establishment and there is no alternative for something outside of existing within this Paragon of Health Systems then what options do I have, nothing my time has been taken away from me because somebody somewhere has a side of that health and maintaining Health require somebody else to profit off of that.

Daniel Forkner:

[46:41] And David this is this really comes down to a philosophical question of what does it mean to be denied access to something. And what does it look like when we open that back up to universal access in, Michael goes on here to Define oppression generally and how that relates to this Healthcare System that were were left to deal with.

Michael Laufer:

[47:03] Often times people are disenfranchised from access to Services access to financial institution access to Firearms access to food access to medicine and medicine is the one where we fall in. Looking at a person what is the structure that typically shows up well there's a control of some sort of resource access to something. Again banking services Manufacturing. Comes from information control always what allows you access to resources the understanding of how that works and this goes to a further layer that information is only a commodity if it's shrouded somehow. When you forced to become a commodity. And the only way that that's possible Sweeney understanding of that conceptual idea has been buried and this happens all the time. And sadly as everybody sees these difficult things were we have all this technology we have all of his act us somehow people aren't getting it and the people in this room I think understand that better than most we have so much that we can do so much with and yet it's not doing what we hoped why not.

Daniel Forkner:

[48:14] And so in this club he's defining oppression as a structure that controls resources and then blocks access to those resources Often by modifying the information in the knowledge of how to use those resources. And what's interesting is that he uses this definition to inform how his work at the four thieves vinegar Collective should strive towards avoiding what he calls the distilling process. In which when we strive to create a new system to get around an oppressive one often times we bring a lot of technological innovation to skirt the old system but if we allow those Innovations to then go through this process where the information on how to use that technology, again becomes institutionalize and commodified then we end up in the same exact place that we began from which is a great thing to keep in mind when we go for Designing new systems is how can we prevent, does better in new way of doing things from becoming monopolize in the future.

David Torcivia:

[49:18] And I mean they're really putting these sorts of ideas into Praxis you mentioned earlier they designed is automated lab reactor you simply Abby is very safe controlled precursors let the software do with work and next thing you know you have estrogen pills you have abortion pills you have antibiotics if you have HIV prophylactic these are all medicines his successor figured out how to produce created and even distributed in many cases, this is something that's actually happening right now and again for price it's just a couple of hundred dollars Prestige systems where the HIV prophylactic for example can cost tens of thousands of dollars if you don't have a municipal program is coming to help you with this unbelievable how much money is being properly. Be very simple chemical reactions that these people have figured out how to liberate for us in order to better all of our help.

Daniel Forkner:

[50:07] It's a Michael asks an important question how did we get here.

Michael Laufer:

[50:11] How do we get here why why did it end up that we have all this technology we're not delivering it somehow there was this or demon that we gave science and don't get me wrong sizes to my love it. But. There's this face that we have but it's the greatest thing it will fix everything and that only those people who have letters after their name should really be trusted to talk about it and this is why I love being in a hacker Community because. That was little bit we can saying that you understand that's enough Show an example is a dental dams latex for you know having. Well protected sex or safer sex controlled is a medical device in certain states in the US which is ridiculous you shouldn't need, the permission of a doctor to have safe sex and there are million examples of this what you're really frightening and bizarre. Know why we still going to talk to her then well the traditional answer is well the doctor's the expert but that's not why.

[51:18] The reason is and if you don't you're breaking the law in the state of New York where I lived for some time if somebody says, to me do I have a headache when I said have you thought about taking an aspirin for that that is a felony and I am practicing medicine without a license punishable by up to a quarter million dollars fine in five to seven years in prison now it's not usually prosecuted that way but that's how blank the laws are and so instead of, if somebody if you go to a doctor and they actually fix you you think you should be grateful but what really happened was your disallowed the access to do it yourself. And then you were forced to go somewhere we had to pay for it to get sold back to you. Looking at Medical infrastructure where we got most of the institutions that are trying to keep people healthy. Are looking at. A macro ethical structure they're saying how do we keep the greatest number of people as healthy as we can with the resources which were given.

[52:25] We all know that that is not anything that a sick person cares about. If you come in to the doctor and you say listen I'm dying and they say yeah we know you're dying but the structure that we have most people aren't so. It's not okay no it's not okay and so we need to think about things on a micro ethical scale as well so we have to ask this question. How would we like to approach help what is the better way and when you see medical institutions most of the time what they're doing is the factory model they're just trying to mitigate risk. They're trying to say what is the least amount of money that we're going to lose on malpractice and stay in business and. They're very impolite things I want to say about that. On the flip side instead we can have an artist model we have this idea of saying how do you take somebody who will take an interest in your house specifically. Not say oh how can you keep the doors open how can we keep things running but specifically I can leave a queen make you healthy that Artisan problem can be. Applied to everything and it should be because your body isn't like everybody else's your gut microbiome is different than everybody else is your DNA is different than everybody else's the way you eat and breathe and walk and speak is different in those things affect your health every single part of it.

David Torcivia:

[53:54] In past episodes we've alluded to the idea that Health Care can be personalized especially in episode 8 a better you or we talked about crispr and designer medicine, but yeah idea that this way of customizing medicine solely to RH individual needs is something nice to me. Behind you. Very expensive procedures and only the most wealthy will be able to for this is something that's disappointing this is one of the largest most important medical breakthroughs, possibly ever in human history since the first discovery of antibiotics this should be something that we can all benefit from without having to. Can I afford this should I save myself but have to face medical bankruptcy these types of choices are not choices. And any system that can push this board and avoiding this catastrophe that is looming on the distant Horizon is something that we need to be. Investing as much energy into as possible.

Michael Laufer:

[54:49] Large-scale structural changes don't come from doctors Dodgers and breaks down the things that actually build Health it only happens when a communal level. On an individual level when people take control of their own health when people are invested in their own health. No going back to the idea of all these institutions that we should have born into that were sort of forced to take part in because it doesn't seem like there are options often times when I give talks to. What's Enlighten people to get these Twitter stations were people say but you're not an expert. How can you do that you have to remember that anything anything any Discovery was done by one person. Alone and some lab for the first time it was done first. Everything was DIY first because there wasn't an institution just because the institutions been around longer than we can remember doesn't mean that there wasn't somebody who tried something first.

Daniel Forkner:

[55:47] But any discussion David that revolves around medicine especially, liberating the access to medicine to everyone breaking down those prescription barriers breaking down those patent barriers. Inevitably is going to be met with the counterclaim that doing so is going to endanger Public Health right if we give everyone the ability to make aspirin David won't they won't they get it wrong what they miss use it.

David Torcivia:

[56:13] This particular line of argument frustrates me so much because it's only very recently the professionalization of the medical industry has really taken off especially in pharmaceutical for the vast majority of human history and Legend Healthcare wasn't as refined it is now but it's very much about making your own medicines about reaching into the community for for the witch doctor or whatever you want to call it's a local shaman. Has some sort of cure for you and all the times he's cure still feed into the prescriptions and drugs that we have today such as we talked about earlier in this episode with Colcrys and medicine used to treat gout but it's based on a hundred-year-old treatment Bank of America patents were even a glimmer of an idea in any sort of industry or Monsters heart it's only recently that we locked. Valuable treatments behind this wall of ideas and access, and granted yes it is easy to make mistakes if you don't know what you're doing don't people like or on the line I mean that the medical industry itself is filled with mistakes with wrong amount of things with drugs that are bad as we talked about in Milan already, I mean these are things already sold out supposed to be regulated and they still have problems. If the choice is let people die without any treatment or let them try and take something into their own hands and try and make a difference, I think there really is no choice between these two option.

Michael Laufer:

[57:36] I get another thing that I get off and when I am talking about teaching people how to make their own drugs or make their own medical devices as they say you really shouldn't show people how to do that still get it wrong and then will hurt themselves. Is that better than not telling them this is not telling them really better because then then what happens is they just. Died because they don't have access to the thing. Take your pick for the more we offered to lend you say here look now everybody has access and this isn't just something it's relegated to labs in factories far away. New things are going to come up people are going to discover things that we never thought of before and is that information flows more freely we will all be healthier. Now again the rhetoric here that's important remember is let's assume for a moment it actually is dangerous. You have to have a personal choice first and second even if it were risky which is more risky shrugging and just waiting to die because you're sick or trying something experimental you're already dying is it really going to be worse.

[58:44] That that argument doesn't hold water it's the same way where people are saying oh vaccinations might be risky I'm I'm I'm not going to utilize them for my child well I mean. Even if they are, which is more risky again it's saying when was this bridge last tested I'm not sure if it's up to spec I'm going to swing through the toxic River it doesn't make sense it is important to recognize that living life is about mitigating risk and we have that. And we should all have the freedom to decide which we think is the better part of valor.

Daniel Forkner:

[59:20] You mentioned just before that clip David about the importance that Community plays in health historically, and I think one thing that is missing from these counterclaims is that, when we imagine a better system in which medicine can be liberated for everyone and then people can take control again over their health and over their body. We can also Imagine a world in which there is a lot of trust that we have within our community the people who are involved in helping us procurar are drugs are still people that we we can know and we can trust you have a track record of reputation. Giving people access to drugs doesn't mean that they're going to be isolated in this pursuit of of knowledge and access in fact the opposite is likely to happen if Michael mentioned in the same way that opening access Spurs innovation, it also Spurs us to work together to solve these problems together to compare notes to compare research, that's what happens when we don't lock our information not behind intellectual property and patents we have the ability now to work together for something much larger much bigger that will benefit all of us not just our own individual house but the health of our communities and that's ultimately what medicine and Health Care should be about right David is. The health of me as an individual but also the health of you and my community and the population of our country and that the world. And speaking of intellectual property years Michael laufer one more time.

Michael Laufer:

[1:00:46] The history there have been times when economics and morality of come to an impasse. Those who have been coming from a moral space have said what's occurring is not okay and those two were defending the status quo have said yes finished and that is very unfortunate but this is the way are coming work. So we just have to live with it and the response comes well that's not good enough. Classic examples of course the Reformation the Cold War in the United States that classic example of slavery people were saying people can't be property, how many people you know that's weird and sort of an old idea but it's what are economies based on so we just have to deal with it and many people said well that's just not good enough I think that's happening now again specifically. Reason why she property Yadira saying ideas can't be property belongs to humanity We're All in This Together, and he will say well yes you know it's kind of strange that is based on a hundred year old ideas but we're really working for here is is is just trying to stabilize the economy and there's some of us were saying let's just not good enough.

[1:01:51] Is some more dying and you knew how to save them would you ever refused to tell them how and say that's my ID and I'm not going to share. Nobody would and yet being complicit. In the structure of intellectual property law that disallows people access from medical technologies that could otherwise save them what part of the problem so. Can you make your own medicine of course you can it's been done since time immemorial the first people who made medicine made their own medicine and again. Is it okay has to be has to be because you tell me I don't have the freedom to save my own life as capital punishment by proxy.

Daniel Forkner:

[1:02:31] I think what he just said there that restricting access to medicine is capital punishment by proxy is a really important statement. Because David we already have an established pharmaceutical industry we already have an established American Healthcare System, that millions of people are suffering and dying because they can't access it who are those people. Most likely they are the vulnerable and marginalized in otherwise poor communities in our country. We are collectively punishing these people for being vulnerable we are punishing them for being poor, a lot of ways this is what we decided as a society but if you want to be healthy if you want to be successful if you want to enjoy life because isn't good health a precursor to enjoying life to living you can't live life when you're on a sick bad or you're stuck in the dialysis center we've decided collectively that those who can't afford access deserve this capital punishment they deserve to be left behind. And frankly that's not a world I want to live in and I don't think it's a world that we should continue to allow.

David Torcivia:

[1:03:41] Information wants to be free the knowledge that we collectively create belongs to all of us but when you take that knowledge and you lock it up. And hurt people because of that process preventing people from being healthy and ultimately doing some to death will the new cross that idea of wrong and you enter the world of just plain evil.

Mylan: [1:04:04] I know there is considerable concern and skepticism about the pricing of epipens and I think many people incorrectly assumed that we make $600 off of each pen it's simply not true. After subtracting EpiPen related caused our profit is 100 or approximately $50 per pen. I wish we had better anticipated the magnitude and acceleration of the rising Financial issues for a growing minority of patients who may have ended up paying the full wholesale acquisition cost or more, we never intended this we listened and focused on this issue and came up with an immediate and sustainable solution, going forward we will continue our leadership in developing high-quality medicine and expanding access.

Martin Shrekli:

[1:04:45] If you could rewind the clock a few months I wonder if you would do anything differently, I probably would have raised the price higher this is probably what I would have done I think healthcare prices or inelastic I could have raised the tire and made more profit. Which is my primary Duty and again no one wants to say it no one's proud of it but you know this is a capitalist Society Capital system in calculus rules, my Buster's expect me to back to my prophets not to minimize them or go half or go 70% what to go to 100% of the profit curve. That were all cotton in NBA class. Try to be a CEO yourself see how it goes try to maximize profits and knock it kicked out of a company and and. And let me know how that goes for you you know price drugs really low it won't last very long. No it's people that that are willing to make these are choices arranged for their shareholders and again try to do the right thing with those profits and make sure that no patient Left Behind make sure that we invest in the disease that hasn't had a new. New investment 70 years we're building three new drugs for toxoplasmosis which by the way will be very expensive if they ever get approved.

Daniel Forkner:

[1:05:58] Take a listen to ashes Ashes to spend production of Daniel forkner David torcivia the desire to dismantle the truss system for a better one and in general things only one popular at the various parties that you go to in society David Daniel not responsible for any of these effect if you do want to lash out that pounds would like to speak about them you can email us at contact at ashes ashes. O RG.

David Torcivia:

[1:06:21] As always you can read much more on our website we have tons of Articles links and a video of Michael speaking about all of this as well as a full transcript of this episode you can find all that and much more at ashes ashes. Org.

Daniel Forkner:

[1:06:36] A lot of time and research goes into making these episodes possible and we will never use ads to support this show so if you like it and would like us to keep going you our listener can support us by giving us a review and recommending us to a friend or simply hit that five star button on iTunes podcasts or 4 I'm not telling you what to do.

David Torcivia:

[1:06:58] Next week we're wrapping up this pharmaceutical series by taking in all these elements and we've learned about Health Care Pharmacy and a lot of things that we discussed throughout this show and turn it into something very personal very real and confronting what are the greatest crises currently occurring in the United States today we hope you'll tune in for that but until then. This is ashes ashes. Dubai.