Medication Shortages Could be good for your Health
Medication Shortages Could be good for your Health
Introduction and Topic Overview
(0:00 - 0:39)
(0:00) Hello, this is Dr. Daniels, and you're listening to Healing with Dr. Daniels. It is Sunday, January 26, 2020. Today's topic is medication shortages, what is behind it, and could this be good for your health? Today, I will examine the current medication shortage to reveal what is going on and how to position yourself to heal from the crisis. Yay! There's always a silver lining.
Turpentine and Shilajit Routine
(0:39 - 3:44)
(0:39) But first, we have to take our turpentine. I have my white sugar. Yay, white sugar! As the Chinese say, everything has healing powers. Everything. Then we have our turpentine. It's getting low; I have to refill it. I use this plastic pipette, which you can buy on Amazon. I fill it right up to the shoulder. As you can see, right to the shoulder—that's half a teaspoon, and that's what I take. We just squirt that on there. Yay! Squirt, squirt, squirt, squirt, squirt, squirt, yep. I like to put a little water in my mouth; it goes down easier. There goes the turpentine.
(1:43) Now, a lot of people ask me, "Dr. Daniels, which brand of turpentine do you use?" I live overseas, so I use the brand in the hardware store. Yes, I do. This is Shilajit. It's often known as Mumio or Shilajit Gold because it's got a gold label. This is a blend of trace minerals, and this is what makes distilled water quite okay. So there it goes, nice and shiny, yay! And you just take a little stick—any stick will do. You can even use the tines on a fork. All of those are fine. About that much, that might be a little more, but more or less is close enough. Then, with the same water I drank from, I'm going to put it in there. As you can see, when you stir it, nothing happens. So we're going to let it sit, and it will be dissolved in about 10 or 15 minutes.
(2:53) Shilajit is a blend of trace minerals. First of all, it's not manufactured. They just dig it up out of the ground and slap it into the bottle. Yay, totally natural. Your body makes enzymes. These enzymes get stuff done. However, these enzymes need trace minerals. It's almost like a key going into a lock; it energizes the enzyme and makes it more effective and efficient. When you have a trace mineral deficiency, you feel drained. Shilajit, and it's very inexpensive. Depending on where you get it from, you can get $25, and that will buy you a year's supply. Yes, a year's supply.
Turpentine Details and Medication Shortages
(3:44 - 5:39)
(3:03) For turpentine details, people have been mailing in questions about turpentine. You can go to vitalitycapsules.com and download the report. It's at no cost. Now, this report—don't be fooled by the fact that it's free. At one time, it sold for as much as $900 a copy. Yep. And that person was glad they got it. So I should say those are several copies of shows sold at that price. So download that report and read it a couple of times and then decide for yourself if and how you'd like to use turpentine.
(4:22) A lot of people send in questions for the radio show, and we often don't have time to get to all the questions. If your question is not discussed on the show, then you have some choices. You can listen to back shows; maybe your question was answered on a previous radio show. You can keep listening, and maybe your question will be answered on a future show. Or you can make an appointment. You can make appointments at vitalitycapsules.com forward slash appointment. Yes.
(5:01) Now, many people are totally convinced of the danger of the medical industrial complex. However, what to do? And what you can do is educate yourself, become your own healer, not only healing yourself but the healer in your home. For that, I have a monthly subscription program where I train you to be the healer in your home. And that's found at vitalitycapsules.com heal at home.
Medication Shortages Discussion
(5:39 - 9:33)
(5:39) That brings us to our show today. Yay. Oh my God. Medication shortages. First of all, I want to tell you there have always been medication shortages. As I was researching for today's show, I remembered when I went to medical school back in 1979 to 1983, we actually had a shortage of salt water solutions, and we had a diabetic admitted to the hospital who needed normal saline IV. That was the standard of care. There was no saline anywhere in the hospital because there was a shortage. You need to understand these shortages are not anything new, and they happen all the time.
(6:10) So what we have to try to understand is what is the nature of the shortage, what do the people who make such decisions plan to do, and finally, I'll talk about what I think you should do, how you should respond to this. You know, you get to respond too.
(6:55) So let's take a look at the Sentinel Sound the Alarm report that I received in my mailbox. Your doctor gets these things as well. Everyone who has a license or ever had a license gets on the notification list, and they have the opportunity to stay informed.
Analysis of FDA Report
(9:33 - 16:08)
(7:04) So what they say at the top, their headline is "Broken Marketplace." "Broken Marketplace is behind the ongoing drug shortages," the FDA says. The FDA, they're pretty powerful. So we're going to take a look at what they say.
(7:35) This is October. Oh, October 29th, 2019. There are newer stories that are basically regurgitating the same thing. Since this is a re-release—oh, October 26th. So that's only four months ago, three months ago. All right.
(7:56) So a report released today by the Food and Drug Administration (FDA) identifies the root causes behind ongoing drug shortages in the United States and provides recommendations intended to tackle the problem. That's good.
(8:07) Drug shortages have devastating effects on patients, says Dr. Ned, who's the acting FDA commissioner during a media briefing. So this is a publicity stunt, read publicity stunt. Despite efforts to prevent and stop the drug shortages, they continue to occur and persist, he noted. The root cause of shortages involves economic factors that are driven by both private and public sector decision-making.
(8:32) Let's be clear. There is no shortage of ingredients. That's not the problem. The problem is economic incentives. Economic means money. Okay. And the public sector and private sector decision-making. This means that the types of enduring solutions proposed in the report will require multi-stakeholder efforts.
Breakdown of Shortage Causes
(16:08 - 25:47)
(9:00) So stakeholder means you're going to include people who are not actually taking the drug. All right. And you might include people who are taking the drug. Might, might not. Okay.
(9:20) Last year, at the request of Congress, the FDA convened an interagency drug shortage task force to study the problem. The task force analyzed 163 drugs in short supply from 2013 to 2017 and compared them with similar drugs in adequate supply.
(9:42) So of 163 drugs in the sample, 63% were sterile injectables. What does that mean? So sterile injectable means it's inside of a syringe or in a bottle, and the solution itself is sterile, and the doctor injects it into the person with a needle. That's what it means.
(10:00) Now, it can also be injected via an IV bag, just letting it fall into the bag, and the bag gets into the person. The importance of this is most injectables are used at hospitals. So having an unavailability of these drugs limits the hospital billing and what can be done at the hospital.
(10:33) Lack of incentives to produce. So 63% were sterile injectables, and 67% were drugs that have a generic version on the market. Generic means low cost. It's probably the same ingredients but costs less. There are also older drugs with a median time since first approval of almost 35 years. Wow. So 35 years is a long time.
(11:07) So the half-life of medical information is more or less five years. So that's seven half-lives. So one half-life means a 50% chance the drug is even effective for what they say it's good for.
(11:27) Two half-lives means there is a 25% chance the drug is effective for what they say it does. Three half-lives means there's a 12.5% chance the drug is effective for what they say it does. Four half-lives means there's a 3% chance the drug is effective for what they say it does.
(12:00) And five half-lives means there's about a 1.56% chance that the drug is effective. This is because every five years or so, half of all the medical information is found to be totally completely false. All right.
(12:13) So we're looking at a low-yield proposition here. If we can pull out our handy-dandy calculator. In fact, I can do this with my head. If we have a 1.5% chance that any drug on this list of 163 is effective, then fewer than four drugs on this list would actually be medically necessary, right? Because new information would have replaced that drug as being or exposed that drug as being unneeded and ineffective.
(12:57) So you have to ask yourself, how big is this problem really, right? We got four drugs possibly useful out of the 163 that are not available. Okay. So the problem already looks pretty small.
(13:11) So what does the FDA have to say about this? So the FDA says, root cause one, lack of incentives for manufacturers to produce less profitable drugs. What's an incentive? Incentive is cash. Okay. So the manufacturers need to receive more money in order to produce the drugs. The drugs in short supply are likely to be relatively cheap and financially unattractive to the companies. The task force says manufacturers may also stop production of drugs before a shortage for commercial reasons. So the manufacturer creates the shortage by stopping manufacture of the drug because, they say here, loss of profitability. So the remedy suggested here is to make the drug profitable and the government would step in and give the drug company some money, and then they could make the drug and sell it at a subsidized price.
(14:10) So number one is give the drug companies more money. Okay. Next one. The market does not recognize and reward manufacturers for mature quality systems that focus on continuous improvement and early detection of supply chain issues. So the market is not willing to pay a higher price to the drug companies in order to get the companies to focus on preventing shortages. So problem number one, give the drug companies more money. Problem number two, give the drug companies more money. Let's see if we can look at these other ones.
(14:42) The other issue is logistical. That means can't find a car or truck or train or plane. Logistical and regulatory challenges make it difficult for the market to recover from a disruption. So when the shortages happen, during the shortage, production typically does not increase enough from other suppliers to pre-shortage levels, the report notes.
(15:21) So they say, taken together, this suggests a broken marketplace. In the absence of major changes to this marketplace, it's likely that drug shortages will continue to persist. Now, stop right now. So I went to medical school in 1979 to 1984, and there were drug shortages then. I have no clue what's different about this one, right? In fact, I don't know of a year where there has not been a drug shortage. Just saying, you know, from medical school to actually practicing medicine, there have always been drug shortages. Just saying. But this one is different.
(16:07) Now, we need to digress for a moment. We need to ask ourselves about the drugs, right? So first of all, did you know that drugs properly prescribed by the doctor in order to get the right dose for the right reasons to the right patient and properly taken by the patient—the patient was obedient, took just what the doctor told him, and that was it. Took no more. Took it at the time the doctor told him to—killed 128,000 people in 2013.
Comparison of Medical Dangers
(25:47 - 29:05)
(16:38) Now, just so you kind of know where this is going, in 1998, 107,000 people died from properly prescribed drugs. Now, just so you can get the flavor of this, if it is determined that the drug the doctor prescribed and that the patient took is the cause of death, that doctor would not suffer any inconvenience due to malpractice. Why? Because malpractice can only be invoked if the doctor deviates from the standard of care.
(17:07) So what's happened, because of the malpractice rules, because malpractice even exists at all, these 128,000 killings every year will never ever be punished or even discouraged. Now, not to put too fine a point on it, but let's take a look at another one of America's villains, AIDS. So in 2017, there were 16,350 deaths among adults and adolescents diagnosed with AIDS in the United States, and they include the six territories. So this is an inflated number. We're going to use it because it's the best number we have. We're going to say 16,350 people died in the United States from AIDS. Gotcha.
(18:01) So the medication prescribed in the U.S., if it kills 128,000, then it kills 7.8 times more individuals than HIV/AIDS. So imagine, just right now, imagine, what are you willing to do if you had AIDS? Most people would be willing to use a condom. Most people would be willing to maybe even abstain from sex. I don't know. Maybe get their partner screened. Yeah, there's a lot of things people are willing to do to avoid AIDS.
(18:34) But I'll bet you probably would not be willing to pay the government to send someone to your door to give you AIDS or you would not be willing to pay the government or even a private company to make an appointment for you so that you can get AIDS. All right, could you feel it? Yeah. So people should be willing, I say, to take the very same precautions to avoid this cause of death, which is 7.8 times more deadly than AIDS.
(19:05) Now, this only counts the death from properly prescribed medicines, not from properly performed surgeries, not from properly recommended hospitalization. So this 128,000 is not even half because they didn't count deaths from all other types of medical interventions, just from properly prescribed medications. All right.
Response to Medical Risks
(29:05 - 31:57)
(19:31) So again, you need to sit down. I would recommend this. Write down what you'd be willing to do to keep from getting AIDS. Maybe you don't have sex with someone who has AIDS. If you know someone's HIV positive, maybe you wouldn't have sex with them, right? But would you make an appointment with somebody who whips out a prescription pad and a pen, which kills 7.8 times the number of people that AIDS kills? I mean, as soon as you see that prescription pad coming out, you should say, "Whoa, whoa, whoa. I didn't bargain for this." Just saying. Just saying.
FDA and Drug Approvals
(31:57 - 35:00)
(20:17) So let's take a look and see how the awareness that taking prescription drugs is 7.8 times more deadly than AIDS. And also quite a bit more deadly than heroin, by the way, in case you're a heroin user. It's safer than taking cold medicine. Yeah. Let's see the recommendations. So of course, a task force made recommendations.
(20:42) Create a shared understanding of the impact of drug shortages on patients and the contracting practices that may contribute to the shortages. Currently, there's little private or public sector effort to collect and analyze comprehensive information to characterize shortages, measure their effects, or closely observe the contracting physicians that may be driving them. Okay.
(21:13) So first of all, form a committee and gather data. All right. Personally, I think you have all the data we need. And I've gathered some data here. So I'm going to share that with you.
(21:31) More systematic and transparent study of current contracting practices. That means writing for contracts to buy and sell drugs. To promote reliable access to safe, effective, and affordable drugs. Well, these drugs, if you look at 7.8 times deadly as AIDS, are definitely not safe. And you might say they're not effective because they shorten quite a few lives. You don't need to do a study to figure that out. So all we really can do is make them affordable because they're clearly not safe and they're clearly not effective.
(22:08) Develop a rating system to incentivize drug manufacturers. Okay. So a rating system, that means you give them points. You know, like your airline miles points. Give them points to invest in quality management maturity for their facilities.
(22:25) So give these points a rating system that results in drug companies getting money to help them redo old facilities. Hmm. Okay.
Issues with FDA and Drug Companies
(35:00 - 38:10)
(22:56) Now, just saying, I mean, if you want more drugs available, FDA approval is a major barrier to entry. Just remove that entry and say, anyone can make this drug. It's insured. Anyone can make it. So in other words, why give a company a monopoly on a drug called a patent? And then they say, well, we're not making enough money for this monopoly to exercise our monopoly, and no one else can exercise it.
(23:24) Promote sustainable private sector contracts with payers, purchasers, and group purchasing organizations to make sure there's a reliable supply of medically important drugs. Now, they didn't say medically effective, just medically important. What makes a drug medically important? What makes a drug medically important is it shows up in the standard of care and the doctor gets to step one, step two. Oh, prescribe this drug. Oh my God. It's not available. Oh, I can't do step five. Now what?
(23:51) So that's a medically important drug because it's in a protocol somewhere. This can be done with several different mechanisms, such as paying higher prices for drugs manufactured at top-rated facilities. Again, a drug can be manufactured at a top-rated facility, but not be insured. This is a big, big dollar winner for the drug companies. I'm not saying you shouldn't get extra pay. I'm not even saying it shouldn't be done. All I'm saying is it has nothing to do with the problem.
(24:37) So first, you examine the problem, then you propose solutions that have nothing to do with the problem. All right. Requiring a certain quality maturity rating as a condition of contracting or guaranteed purchase of a set volume of products from sites achieving a certain quality maturity rating, they point out.
(24:50) So Dr. Solis told the briefing that several legislative proposals and planned FDA initiatives are focused on preventing future supply disruptions that lead to shortages. Now remember, it's not leading to deaths because there aren't any deaths. No one's dying for lack of these drugs. These include new requests in the president's fiscal year 2020, a request, the only request you make is for money, right? A budget, yeah, money.
Global Regulatory Challenges
(38:10 - 41:41)
(25:18) A new guideline, guidance that the agency intends to release by year's end. So international action is also necessary to combat drug shortages. The task force included the International Council for Harmonization is finalizing a guideline that will provide opportunities for regulatory flexibility in making post-approval changes to the product or its manufacturing process.
(25:40) So in other words, once the FDA approves a product, they're not going to make it easier for the drug company to change the way it's manufactured from the manufactured process the FDA approved and to change literally the content of the drug from what the FDA approved. Now none of this shortage has been caused by a lack of ingredients. They're very clear. It's the drug companies need more money. Kind of sounds like a hostage situation, doesn't it?
(26:11) Global implementation of this guidance guideline once finalized could, which means it could not facilitate, that means make easier the efforts of manufacturers for the international market who wish to modernize processes and equipment to avoid potential disruptions. So now they're going to pay the companies to avoid potential interruptions.
(26:35) You see this? So for the actual interruption, there may be 500 potential ones. So this is 500 opportunities for the drug company to get paid more money because they can just say, hey, it's a potential. It could happen. It never happened before, but it could happen. Give us more money. Okay. But they found the regulatory landscape of different countries to pose a financial burden. Whoa, whoa, whoa, whoa.
(27:01) They're changing the subject, right? The subject was drugs not available in the U.S. And so now what they're going to do is they're going to give drug companies extra money to allow them to cope with regulatory conditions in other countries. That doesn't make any sense.
Examination of Drug Shortage Solutions
(41:41 - 47:02)
(27:27) Okay. So we have a situation, not enough drugs, other situation, drugs killing everybody. And the solutions offered are all demand-side solutions. So give the supplier, drug companies, more money. That's basically what they've said here.
(27:52) So no issues on the demand side. Nothing has been brought up on the demand side. So that's not very helpful. I don't think that's helpful. In fact, even if you believe in drugs, and some people do, the proposals mentioned are not going to solve the shortage problem. All it's going to do is give the drug companies more money, which is fine. I don't have any problem with that, but I am a little concerned when it has nothing to do with the problem.
(28:33) One solution, which again makes no sense, is to have faster FDA approvals. Well, we're talking about drugs that are already approved. They're not available. So what are they talking about? So what they are talking about is making it quicker to approve substitutes for the drugs that are continually out of stock.
(29:00) So here we are. Over the past four decades, that's a long time, four decades. Yeah, a long time. The U.S. Food and Drug Administration, that's the FDA, has loosened its requirements for approving new drugs. That means if you take a look at it, the drugs that are already approved are causing 148,000 deaths a year when properly prescribed, and they're loosening their requirements, it might be making the drugs even more deadly. I mean, just saying.
(29:42) So the FDA has loosened its requirements for approving new drugs, increasingly accepting less data, and more surrogate endpoints. What's a surrogate endpoint? Let's talk about what a surrogate mother is. So a surrogate mother is not the real mother. She's not the biological mother of the baby. Surrogate means in some way not accurate or legit.
(30:06) So what's a surrogate endpoint? You pick an endpoint unrelated to the disease that you're treating, number one, and you pick an endpoint unrelated to survival. And I know this is trend, and I'm trying to read these studies about health disease and the effectiveness of certain drugs, and death from heart disease is not even measured.
(30:35) Well, the average person has a heart attack and is accepting a treatment and wants to know, are they going to live longer because they take this pill? And you say, well, you know, that wasn't measured. That was not measured. So they're now accepting studies that measure things having nothing to do with patient outcome, and they're requiring less data.
Critical Review of Drug Approval Processes
(47:02 - 55:45)
(31:00) So among the evidence is that from 1995 to 1997, 80% of new drugs were approved on the basis of two pivotal trials, but that number dropped to 52%. A number of programs were enacted during the study period that led to faster approval, such as FASTRAC and the Breakthrough Therapy Designation.
(31:27) So in other words, they could have just one study showing a drug is effective. That's it. My favorite is this antidepressant, I won't tell you the name, that entered the market in the late 90s, and they had one study of five people that lasted three weeks. I said, what? Do you expect me to prescribe a drug with this kind of evidence? Forget it. The drug rep, of course, was insulted. Like, well, how can you be so strict? I mean, it's good enough for the FDA. I thought about the FDA.
(32:06) So now Medscape wants to know what doctors think about the FASTRAC. They think it's too strict, not strict enough, it's going to solve problems, it's going to make a bad situation worse. Yes.
(32:22) Now, physicians—this is February 2019—physicians call for action on root causes of drug shortages. First, I have to say, I live in what might be called a third world country, some people call it a second world country, but let's just say it's not America.
(32:42) Okay. So I first got here, I was shocked to find out that once a doctor writes you a prescription, that prescription is good for life, number one. Number two, you can get any blood test you want done without a doctor's prescription. Interesting. I'm not saying you shouldn't be able to, you should, but I'm just saying it's very interesting.
(33:05) And number three, when you talk to people who are taking medications, they only buy a one-week supply at a time, and then they'll get another week's worth when they get enough money. That's just the way it's done. If somebody goes into the pharmacy and says, my doctor wrote for a month's supply, I'd like to buy a month's supply. The pharmacy, literally, his eyebrows will raise up. Who are you? He must be rich.
(33:39) So that's the dominant practice. I would hazard a guess that fewer than 80% of prescriptions here in the country where I live are filled. When I say filled, I mean fully filled. And a person might get a day's worth, two days' worth, a week's worth, they're really like flushed with money. And then the person who's the patient, they spend the whole week taking their pills. But on the phone calling another relative who's wealthier, they might be able to pay for the next week, the next week, and the next week.
(34:12) So what's this got to do with anything? Okay. So the FDA says that 20% of all prescriptions in the United States are not getting filled. They're just not getting filled. Maybe because people don't have enough money. I'm not sure why, but they're not getting filled.
(34:27) And you look at a country, another country, where fewer than, I would say fewer than 20% of prescriptions get filled in their entirety like a person gets a month's supply. And the life expectancy here in Panama is not substantially different from the United States. So those unfilled prescriptions are not making a huge impact.
(35:03) So in Panama, life expectancy is 78 years. That's pretty darn good. In the United States, 78 years. Same life expectancy. And in Panama, 80% of prescriptions don't get filled. They just don't. And a lot of times people do. The doctor will say, okay, one pill a day. What the person will do is since they know they have a weak supply, and the next time a relative might be able to buy the drugs would be maybe two weeks from now, they'll take a pill every other day.
(35:48) And so with this total unavailability of medicines because of income, the life expectancy in both countries is identical. It's shocking. So 78.69 years in the United States and 78.0 years in Panama. Not a huge difference.
(36:16) So we can deduce by inference that those unfilled prescriptions are pretty much irrelevant. Okay, so now we hear from the doctors. What do the doctors say? The doctors say, okay, so physicians and others in the healthcare industry are increasingly expressing their frustration about an inadequate supply of critical care medicine.
(36:41) Medicines and are calling for action from private enterprise and U.S. officials to resolve the root causes of these chronic drug shortages. It's important to notice that most of the drugs on this shortage list are injectable hospital-based. And so making these drugs unavailable slows down or stops the hospital's ability to create expensive hospital charges or to implement expensive protocols.
(37:14) So you might be missing one bag of IV salt water solution, but that one bag allows the hospital to hook that person up and charge not only for the bag, but for the tubing, the administration time, the use of the electrical pump, blah, blah, blah, blah, blah. So it's one little expense that makes many other expenses possible.
Real-life Impact of Drug Shortages
(55:45 - End)
(37:30) So in other words, for every dollar that the hospital would spend on these now unavailable drugs, those drugs enable a hospital to bill maybe a hundred dollars for every dollar that they're spending on this particular drug. Okay, so let's take a look and see.
(37:49) Leah blank, I'll leave my last name, Doctor in New York City recalled once having to use the paddles—that's the defibrillator electrical paddles—to resolve the root cause for a patient in rapid atrial fibrillation because of a shortage of diltiazem. Multiple branches were not available. Diltiazem is a calcium channel blocker. And what's the side effect of calcium channel blockers? Sudden death.
(38:13) All right. So she's complaining that she has a patient close to death and she didn't have a drug available to her that causes a sudden death. Right. So the complaint here has nothing to do with patient welfare. It has to do with the doctor's ability to follow the standard of care and go on to the next step, next step, next step.
(38:40) So the FDA is the center of federal efforts to address the persistent shortages of workhorse products of hospital care. Again, these are workhorse products. These are products the hospital uses every single day. The hospital tries to use the cheapest, cheapest, cheapest thing it can so that it can have the maximum profit per hospital stay. And so what the drug companies are doing is not so fast. They're not going to make those cheap, cheap drugs available. So you can see here is a little strategy.
(39:13) Now then, if you want to kick it up a notch, the insurance companies have an incredible financial interest in not making hospital, inexpensive hospital drugs available because that means the patient has to be sent home, the hospital stays shortened, and literally hundreds of millions of dollars, if not a trillion, are being saved in terms of the insurance companies. I'm not saying it's some kind of plot here. I'm simply pointing out who benefits from the shortage. What about the patient? Well, let's take a look. Let's see.
(39:51) So in response to the agency's request for feedback on addressing drug shortages, many physicians told the agency about having to take special measures because of missing products. But again, no deaths, just extra measures.
(40:13) So Dr. Solis of New York City recalled the situation four years ago—four years ago, wasn't yesterday, it wasn't last week, wasn't last month—four years ago, okay, just make sure you're with me, in which lactated Ringer's solution was unavailable. So if you don't have lactated Ringer's, those are your non-physicians. You just use salt water, normal saline, it's the same. No, it's the same effectiveness.
(40:38) She also told the FDA about a fellow physician who sent an email plea to colleagues to find out where his wife could get drugs she needed to continue treatment for ovarian cancer. Now, between you and me, LAMPOs, ovarian cancer treatments, are not effective. But, so we have two cases, three cases here of drugs that were just, you know, one drug is deadly, one drug has a reasonable substitute, and the third drug we know is ineffective.
(41:02) Federal officials, medical groups, and healthcare companies have been struggling for years to address the fragile U.S. supply of critical hospital products. Okay, so this, like I said, this has been ongoing. I went to medical school, 79 to 83, and this was the case. Back then it was normal saline we couldn't get, and I'll just tell you what we did.
(41:32) Patient came in, diabetic, and the protocol is one liter of water, distilled water, with two teaspoons of salt in the bag. It comes already packed, and she's hanging up, and let it flow. So, you know what we did? We took a liter of water, put two teaspoons of salt in it, stirred it up, and told her to drink it. Yeah, yeah. So, was she worse off because of it? Did her health suffer? Did she die? No, none of the above. In fact, she learned something that she never would have known if we hadn't done that. Oh, I can mix salt and water together at home and just drink that, and my blood sugar will go down. Yeah. So, a lot of this IV stuff is just to perpetuate the appearance of mysticism when working with the patient.
(42:27) Oh, doctor, what's that? It's special stuff by IV. Yes, you need it. Oh, okay. Whereas if you say to someone, here's a coin of water, two teaspoons of salt, drink it, and we're going to charge you $300 for that, you might get a little resistance. I'm just saying. Okay.
(42:49) Approximately 200 drugs have been put on and off the FDA's drug shortage list during the past several years. So, we have the same drugs and the recurrence for those. So, we don't need to guess which drugs are going to be in short supply. We know. We have a history. 2012 law gave the FDA expanded authority to monitor the supply.
(43:04) Drug makers, for example, must notify the FDA about disruptions or discontinuations of manufacturing of critical products. Who decides if it's critical? The FDA has also been extending the use by dates for products in critical need. In other words, the FDA is saying, oh, that product is in shortage. You could just use it even though it's after its expiration date. Really? Why did you put an expiration date in the first place if it can be disregarded, if it's not important?
(43:49) In a mandate annual report to Congress, the FDA said it prevented 145 new shortages in 2017. There were 39 new drug shortages that year compared to a peak 251 new shortages in 2011. Still, shortages of staple products, such as saline, because that's salt water, persist. But in generic hospital drugs are manufactured by a single company. Clinicians scramble to find alternative therapies or engage in compounding, according to the American Society of Health Systems Pharmaceuticals.
(44:17) Adding two teaspoons of salt to a liter of water is called compounding, like mix it yourself. I mean, really. We certainly don't have an easy solution or we would have fixed this problem a long time ago, but it's been going on too long, FDA Commissioner Scott Gottlieb said. And remember, at a 2018 meeting on drug shortages, the risks have mounted over time, and the frustrations have reached a tipping point.
(44:40) Now, again, the risk—what is the risk? You know, we don't have any documented deaths. We have documented 128,000 deaths from people getting the medications that the doctors prescribed. How many deaths happened because someone did not get a prescription medication? Let's see if we can get at that elusive number.
(45:05) So there's a few easily identifiable contributions to shortages, like Puerto Rico's pharmaceutical industry, Hurricane Maria in 2017. Manufacturing troubles at certain companies, like mold in the products causing a halt in production. I mean, what are you going to do about that? You're going to just have people inject mold into their veins?
(45:39) The public debate on the cost of medicines tends to focus on newer products that cause consumer sticker shock. Cancer medications, for example, can cost $15,000 a month. Yeah, that's pretty reasonable. Low prices drug makers get for older generic medicines are not enough to entice more companies into making these products.
(46:01) They may be critical drugs that may sometimes be priced too low relative to the full cost of producing a reliable, predictable product in high-quality pharmaceuticals. So in its comment to the FDA, Pfizer said that it has spent more than $800 million over the past two years on its injectable drug business. It intends to spend more than $1.4 billion over the next several years. But when you contrast that investment with the fact that two-thirds of the generic sterile injectable units Pfizer sells annually cost less than the average gallon of milk. Yeah.
(46:41) It places the challenge of market sustainability into perspective, Jones wrote. Now, how can you sell a quart of saltwater for $4? Most people would consider that to be outrageous. This lack of contractual commitments impedes manufacturers' ability to deploy capital for new capacity and redundancies, which means have a second machine that will work if the first one breaks or excess inventory, which is predicated on reasonable levels of predictability and expected return on investment.
(47:25) Exceptions to the kickback law. So what's happening in New York state is a doctor would write a prescription. The patient takes a prescription to the pharmacy. The pharmacy fills the prescription. The pharmacy has to pay a kickback to the state government for each prescription it fills in a certain class.
(47:47) Who's the middleman there? Yeah, you got to stick to government. So the government demanding this kickback makes it more difficult for the pharmacy to prescribe this medicine or dispense it because now the pharmacy does not have a profit margin. So Congress in 1972 enacted a federal law to prevent kickbacks that could put patients at risk.
(48:21) GPOs were granted an exception to the law, which lobbyists and policy analysts refer to as a safe harbor exemption. This exemption to the kickback law helps politicians use creative strategies to boost their profit, boost profit. They ask manufacturers to pay undisclosed vendor fees as a condition for having their products placed among the offerings available to hospitals.
(48:56) So it's another level of kickback. As a result, one or two manufacturers may be responsible for a regional or national supply chain, the authors add. Although there's limited evidence, that means there's some evidence, to support the direct link between kickbacks and drug shortages, the vendor fee model has the potential to create barriers to market entry for manufacturers by rewarding fewer larger manufacturers and thus increasing dependence on fewer supply chains.
(50:27) Physicians call for action on root causes. Okay, so what the physicians are really saying is they want drugs that are required in the standard of care to be made available. That's a reasonable request on their part because if they're going to be sued for not following the standard of care, if they're going to lose their license for not following the standard of care, then the government in the form of the judicial system and the licensing board have the obligation to at least make the drugs available so they can follow the standard of care. Forget about patient welfare, which went out the window a long time ago.
Final Thoughts and Recommendations
(End)
(51:00) So what's a person to do? So U.S. News and World Report took a look at this situation. They said by far the greatest number of prescription drug-related hospitalizations and deaths occur from drugs that are prescribed properly by physicians and taken as directed. So that's a free pass. That means no penalties anywhere and a good time was had by all. And in a later paragraph, they say, though following a doctor's orders and medication labeling instructions can reduce harms associated with taking prescription drugs, simply taking prescription drugs as directed can expose a person to significant risk. So what they're saying is, do as you're told, but yeah, more risk. Don't worry. So most people die because they follow the doctor's orders. So to prevent death, following doctor's orders makes no sense. You have to cultivate disobedience. This is no time to play the deadly game of Simon Says or Mother May I.
(52:10) So what's a person to do? Well, first of all, let me look at the list. There's a list of drugs that are on the shortage list, and the government is determined to make these available. Fentanyl. This is a drug that's responsible for the heroin overdose deaths. Fentanyl is being put into the heroin. So the government is concerned that the manufacturer of fentanyl has stopped making it. What? They're doing a public service, right? Let it go. Let it go.
(53:41) Lorazepam, that's Valium. Morphine vials. Morphine immediate-release tablets. Oxytocin. So all of these things are literally contributing to and fueling the death rate and shortness in life expectancy in the United States, by the way. And the FDA is bound to make these drugs available. So this is just cherry-picking some drugs that were on the list that the FDA has. You can just google FDA drug shortage list and the list will come up. And it's appalling the deadly drugs that are on that list. And it's really a credit to the manufacturers that they stopped making several of these drugs.
(54:51) So what are you to do? The thing is to realize the danger and where the danger lies. Getting infected by AIDS is trivial compared to taking your prescriptions as directed. I say stop using condoms and stop filling prescriptions. That's the quickest way to be healthy and to reduce your chances of dying sevenfold. So people say, oh, what am I going to do instead? At least don't do that. But I do have a program. It's a subscription monthly program, Heal at Home. It's at vitalitycapsules.com forward slash heal at home. And it teaches you how to handle stuff right there at home on the spot and get results.
(55:45) So go to vitalitycapsules.com heal at home. All right, this is Shilajit. And before we stir it, nothing happens. Now we're going to stir it. Yay! It melted. Okay. So moral of the story, don't fight and struggle with getting Shilajit to melt. Just put it on a stick, put it in water, go do something else, come back, and here we go. Yay. Alrighty, there we go. All right, now we're going to take a look at some questions.
(56:05) Yay, questions. So if your question is not answered, if you'd like it answered personally, then you can make an appointment. And that can be done at vitalitycapsules.com appointment. And that would be the best way.
(56:32) Abby says, I hope all is well with you, Jennifer. Okay, thank you, Abby. What precautions can we take regarding the coronavirus that has just arrived in the UK, supposedly? Cook your meat fully and wash your hands. That's it.
(57:05) Okay, so I have a thumb that I did not get treated. It was injured. The top joint is inclined to bend. I don't know what that means, inclined to bend. Does it mean sometimes it does and sometimes it doesn't? I don't know. I don't want it to stay that way or get worse. What can I do at this late stage? So let's just say it was probably not broken. Probably what happens is the tendon was ruptured. So when you have a thumb, the top part can be like this because the tendon is no longer going across the thumb and down, which would allow you to do this. Instead, what's happened is because of the injury, the tendon split. Half is going down this side, and the other half is going down the other side, and that keeps it in a slightly bent position.
(57:50) So if you can straighten it, straighten it out, straighten it out, and put a splint on it, and then eat lots of connective tissue like cow foot soup or pig ears, and that will cause the tendon to heal back together. And then after about splinting it, I would say give it at least maybe three weeks. Then you can gently see, take the splint off and see if it stays like that. If it stays like that, you're good. If it bends, then put it back straight and splint it.
(58:28) Now my thumb hyperextends. That means it bends further back than just straight. So that's straight. And my thumb, for whatever reason, bends backward. Which is okay too.
(58:49) And he says, is there a substitute for calf liver and chicken livers for energy? Some people cannot eat them. Those really are the best. There's not any good substitutes. Probably ham hocks. Ham hocks with the skin would be your next best.
(59:11) What causes bleeding in the eyes and what will prevent it? My friend has this problem. He has and takes aspirin for cardiovascular health. So the aspirin that he's taking will cause the bleeding in his eye.
(59:37) Do you still recommend Geovinyl GH3 for hair growth and getting rid of gray? Yeah, you can do that. I mean, it will definitely work.
(59:48) Why would someone be lightheaded when they take turpentine? Because they don't have enough water on board. So you just need to increase your water intake. Or you're taking too much turpentine. So cut the turpentine dose in half and increase your water and see how it goes.
(59:57) Is it okay to cook liver with bacon? Absolutely. Any benefits from lamb shake? I've not explored that, so I can't really say.
(1:00:19) Tyler says, do you have a protocol for healing hepatitis C type 2? Hepatitis C type 2 is imaginary. You only have it if you believe you have it. The test does not even isolate the virus. So there you have it. And since it's my philosophy not to treat the imaginary, then I recommend you believe in both.
(1:00:32) Let's see, more questions? We've got so many questions. Kim, I heard something about bright pink tongue is a symptom of something we can't remember. Do you have any idea what it could be? No. So if you don't have any symptoms, then I would not bother with it.
(1:00:33) What do you think of using Tabendazole for killing worms? I think it's excellent. Okay, that is it. We have come to the end of our hour, and I will see you again next week. As always, THINK HAPPENS!