Could Statins be Low Value Health Care?

Could Statins be Low Value Health Care?

Introduction and Topic Overview
(0:00) Hi, this is Dr. Daniels, and welcome to Healing with Dr. Daniels. Today’s show is Sunday, November 10th, and today’s topic is statins. Could taking statins to lower your cholesterol be a low-value health maneuver? Today, I’m going to take a look at this concept, what the research shows, what the FDA has approved, and the research they based their approval on, and I'm going to take a look at what has come out lately. Lately as in a week ago.
Turpentine and Shilajit Routine
(1:01) But first, we’re going to take our turpentine and we’re going to get our white sugar—yay, white sugar. And we’re going to get our turpentine and our little dropper. This is my favorite dropper. I used to use different droppers, other droppers, but they broke, and this one has not broken. It has lasted, so I’m sticking with this one. And there we go. We’re going to drip this on. This is about a half teaspoon, which is the dose that I take. Notice as the sugar gets wet, it gets a little grayish. Yep, and that’s all of it. I like to put a little bit of water in my mouth.
(1:53) I’m drinking so much water, so I’ll have only a little bit left to take my Shilajit because I don’t like the taste of Shilajit. And Shilajit is a black tar. Don’t smell it. It smells bad. I just take a little paddle worth here. You can see how much that is. That goes right in here, and hopefully, I’ll remember to take it later on in the show. All right, there you have it. Turpentine and Shilajit, and I’ve survived it.
(2:30) So I’ve been taking turpentine since about 1994, 1996. Yep, and it’s worked out okay. Pretty happy with it, and hundreds of people under my care have taken turpentine. And now I’m getting emails every week from people all around the world about their wonderful experiences. So I hope that you will go to VitalityCapsules.com and download the free report, The Candida Cleaner, which tells you about turpentine, its benefits, and how to use it responsibly. All right, so today's report.
Latest Breaking News on Statins
(3:15) First, I want to talk about the latest breaking news, number one. Then I want to talk about what the FDA knew—in other words, the data submitted to the FDA for the approval of statins—and see if we can’t get some numbers and sort things out so that you can make a decision about, well, what you think.
(3:39) Okay, so the first thing is the latest breaking news in the medical community. And it says, "Low Value Care? More Controversy for Statins in Primary Prevention." And this, to me, was kind of a shock. More controversy? So I entered the area of medicine in 1979 when I entered medical school. And cholesterol did not become a disease, something to be lowered, until really after 1983. And so it was mentioned in medical school. However, the value of lowering cholesterol at that time was certainly not established.
(4:31) And when I finally opened my own private practice in 1990, the value of lowering cholesterol was still not established. And so, of course, I’m surprised that here we are in 2019 and there’s controversy. What it might be? I don’t know. Let’s check it out.
(4:58) In the title of this radio show, I say, you decide. Well, how can you decide if you don’t have information? So I’m going to give you information, but you’ve got to decide where you draw the line.
Decision-Making and Setting Personal Health Standards
(5:10) You have to decide where you draw the line. And I think it’s so important in your life to draw lines—like, draw lines. And it’s great because once you draw a line, then you have standards, there are things you’ll do, things you won’t do, and basic rules. It makes decision-making so much easier.
(5:26) So you have to decide what is zero. Now, is zero 1%? Is it 0.1%? Is it 1 in 10,000? Is it 1 in 1,000? Over the course of a year, what to you is zero? That’s one thing to decide. The next thing to decide is what’s worth investing in. And you might say, well, I don’t know about investing. We’re talking about what’s worth spending your time on. Is it worth it to spend your time on something that has a 20% chance of happening in the course of a year or not? So you’ve got to make up your mind what that percent is for you.
(6:06) Today, I’m going to give you some numbers and give you some examples. And of course, as always, you decide.
Medical Community Update: Controversy Around Statins
(6:24) Here’s what to realize. This is doctor-to-doctor information that is emailed from a central medical information clearinghouse to your doctor’s email inbox. Okay, and this is Medscape. And you, even though you’re not a doctor, can get in on this by going to Medscape.com and just signing up and saying, “Hey, send me some emails.” And believe me, they will blast you with emails. You’ll get as many as 10 emails a day, depending on what news service you decide to sign up for.
(6:59) So this is hot off the press, October 30th, not even two weeks old. Let’s see what they say. It says, “Controversy around the use of statins for the primary prevention of heart disease is once again in the news.” Now, “once again” means like, this is not the first time. And primary prevention means people who have never had heart disease—should they take statins? So, people who have never had heart disease and want to prevent heart disease.
(7:21) Okay, a new analysis suggesting that statin use in low-risk patients may be an example of low-value care, that means having little benefit and having the potential to cause harm in these patients, and in some cases represent a waste of healthcare resources, researchers conclude. Now, let’s not even use the word “healthcare resources.” Let’s just say your personal resources. So, you should look at this as personal money coming out of your pocket because that’s exactly where it’s coming from. This isn’t some healthcare concept, but they use that word “healthcare resources” because this is written to doctors who write prescriptions, and the doctor’s prescriptions direct healthcare resources. But for your purposes, from a patient perspective, you should look at money coming out of your personal pocket—money that maybe you could spend on something else.
Analysis of Statin Use in Older Populations
(8:19) The analysis was published online in the British Medical Journal on October 16th. I just want to say something about the British Medical Journal. So, the British Medical Journal is a very respected journal, obviously British, but it corresponds to the New England Journal of Medicine, more or less, in the United States. And I can say over the past several decades, I have learned a tremendous amount from the British Medical Journal. They really do some very good research.
(8:45) Researchers were led by a doctor from the National University of Ireland, and he says there is uncertainty about whether the benefits of statins outweigh the harms for people who have never had a heart attack, and whether widespread statin use can be justified from a social or society perspective. Again, you should be looking at it from a personal “you” perspective—just you personally.
(9:12) Okay, we wanted to look at who is using statins and why, and investigate the benefits in the people who are actually taking them, especially those who have not got established heart disease, where there is a debate as to the usefulness of statins.
(9:32) So, for their analysis, the researchers examined the effects of changes to European guidelines on cardiovascular disease prevention from 1987 to 2016, using data from a national cohort of older people in Ireland. So, basically, what they compare is older people who had not taken statins with those who have.
(9:55) Okay, so of those over 50 in this database, 30% were using statins. Two-thirds of them had never had any heart disease. Three-fourths of women on statins were taking them and had never had any heart disease, compared with just over half of men. So, men are less likely to take drugs for diseases they don’t have.
The Problem of Taking Drugs for Diseases You Don’t Have
(10:16) This point brings up another point. When you take a drug for a disease you do not have, then we have to ask ourselves, what are we doing here? Is this the elevation of hypochondria to a socially acceptable level? Just a question, just a thought.
(10:39) Applying guideline recommendations for various times over the past 30 years. Now, this is important—applying guideline recommendations from various times. That means the guideline recommendations are changing constantly. Okay, that’s another red flag, red flag, red flag.
(11:06) According to the 1987 guidelines, 8% of the population would have been eligible for statins. But by 2016, the guidelines were changed and were recommending much greater use of statins so that 61% of the cohort or people examined were eligible for the drugs. This is a huge increase. Can we hear arbitrary and capricious? Yes. Arbitrary and capricious? Okay. But let’s see what they have to say.
Analyzing the Data: Number Needed to Treat (NNT)
(11:38) We found that although there have been many studies and meta-analyses of statin treatment, there’s little evidence separating out the primary and secondary populations, Byrne noted. They found three systematic overviews that reported on primary prevention patients separately—that means healthy patients with no disease.
(12:01) The researchers calculated that based on 1994 guideline recommendations for the use of statins, the number needed to treat (NNT) to prevent one cardiovascular event in healthy people was over 40, which Byrne says was quite a reasonable number. Whoa, whoa, whoa. NNT. Let’s back it up. What is NNT? It is the number of people who need to take a drug for a full year in order for one person to benefit. Okay, so if the NNT is as low as 40, and in medicine, an NNT of 40 is considered to be low, only 2.5% per year would benefit from taking the drug, which means that 97.5% of those taking this pill for a full year would experience no benefit whatsoever. Okay, important to say.
(13:00) You have to ask yourself, would you be willing to do something every day for a full year that had a 97.5% chance of being absolutely no benefit to you? This is your personal decision. I can’t tell you how to decide, but this is what this paragraph is saying—that 97.5% of people taking this pill had no benefit whatsoever. And the 2.5% prevented a cardiovascular event. Well, what the heck is that? Chest pain? A little chest pain? Nothing deadly. Oral heart attack? Silent. Oral heart attack? Non-fatal. So we have to understand what they’re calling a cardiovascular event.
(13:48) But when applying the 2016 guidelines to the data, they found a number needed to treat of 400. So we are getting far less bang out of our buck with the 2016 guidelines, Byrne noted. Now, you’re looking at this—you should be from a very individual, personal level. Would you be willing to brush your teeth every single day for 400 years to prevent one cavity? I don’t know. Personal decision—yours. And so this number needed to treat means in one year, only one person in 400, or one-quarter of 1%, would benefit in any way from taking statins. That means 99.75% of the people taking statins in any given year would experience no benefit.
(14:43) Would you be willing to take a pill every single day if you were assured that your chances of benefit by the end of one year would be—your chances of, sorry, your chances of no benefit would be 99.75%? And you have to decide, is that a reasonable recommendation? Are you willing to accept that?
Drawing Real-Life Comparisons: The Gas Station Analogy
(15:12) So, take a look at other parts of your life. Like, take a look at going to the gas station and putting gas in your car. The gas station attendant walks out to you and says, “Hey, I want you to know it’s Monday.” And you say, “Yeah, it’s Monday.” So, “I want you to know that on Mondays, when you pay to put gas in your car, we charge you for a full tank of gas, but your chances of getting a tank of gas are less than 1%.” In other words, pay me for a tank of gas, and there’s a 99% chance you will not get any gas. What would you do? Would you pay him the money and click the hose to see if you’re going to get any gas? 99% chance—no gas for you. How about that?
(16:11) Now, what if the guy said, “I want you to buy a one-year gas contract from me.” That means I want you to buy from me, pay me the amount of money that for one year would fill your tank, and there’s a 99% chance you will get no gas. Would you pay him? Personal decision. I can’t tell you what to do—your decision. But this is exactly what taking a cholesterol medication is like as of 2016. In other words, if your doctor has recommended cholesterol-lowering medication for you using the 2016 guidelines, the chances of you getting any benefit at all from a whole year’s worth of popping this pill every day is less than one-quarter of 1%.
The Value of Statins: Individual Perspectives
(17:06) And you have to decide, is that a reasonable recommendation? Are you willing to accept that? And so what they’re saying is, they don’t clarify it this much. And there are actually doctors who read this and don’t know what NNT is, and they don’t do the math of this one in 400. They say, “Oh, one in 400. Oh, well, I guess, well, it is something. It is one.” But this comes down to a 99.75% annual failure rate.
(17:43) So, small benefits affect choice. So, the researchers give examples of two primary prevention patients who would have very different absolute benefits of taking statins. One is a 65-year-old man who smokes, does not have heart disease, but has high total cholesterol levels, raised blood pressure, and an estimated 38% absolute risk of having a major coronary event in the next 10 years. He could expect an absolute risk reduction of about 9%. Whoa, whoa, back up, back up, back up, back up. 9% of 38%. So, over 10 years, he’s having a benefit of 3.8%. In other words, his benefit per year is going to be 0.38% instead of 0.25%. Pretty small if you ask me.
(18:45) Second example is a 45-year-old woman who does not smoke and has raised cholesterol levels and slightly raised blood pressure. 10-year risk of 1.4%, but absolute risk reduction by taking a statin would be just 0.6%. Number needed to treat—166. 166 is, again, it’s a lot. Now, again, number needed to treat—let’s clarify this. This is how many people need to take this for one year in order for one person to benefit. In this case, they are calculating 166. I’m not going to question their math. But the question to ask is, do you have 166 years to spend taking a pill every single day hoping that by year 166, you might be a lucky lottery winner and be one of the people to benefit? Now, what are they benefiting from? Is this saving their life? No, no, no, no. If we could only be so lucky.
Analyzing the True Benefit: Lifetimes of Use
(19:47) So, a lot of the events that are being prevented by taking a statin are not events that are life-threatening. So, we still haven’t saved a life. Now, what they’re saying here is, 166 people would have to take this drug for 10 years. Let’s just do the one-year number. The one-year number would be 1,666—would be the number needed to treat on a per-year basis. So, this is even more shocking.
(20:29) So indeed, our analysis suggested that none of those classified as low or moderate risk in primary prevention would reach the levels of risk reduction that patients say would justify taking a daily preventive medicine, they write. So, they checked with some people. I don’t know about you, but the people they checked with said, “That is not worth me taking a pill every day.” And we haven’t even talked about the dollar amount. We were just talking about unscrewing the bottle and popping the pill.
(21:05) And so if you tell them that it’s going to take them 1,667 years to benefit, everyone they talked to said, “No dice.” And again, their definition of benefit is pretty darn loose. It’s not anything deadly.
(21:24) So, when the benefits are of such a small magnitude, the decision to take a medicine may rest on the potential harms caused by the drug, Byrne said. What? So, in other words, if a drug is so useless that you have to take it for 1,667 years before it benefits you, who cares what the side effects are? The human lifespan, if you’re lucky, is 100 years. So, they’re telling you it’s going to take you 16 lifetimes of taking this medication in order to prevent one non-deadly event. Yes.
(22:15) Now, add to this that most people start taking a statin at the age of 40. So that means a lifetime is 40 years of use. Well, this pushes your timeline out from 1,000 to 5, 6, 7,000 years. Again, only you can decide how long you believe you’re going to live. But if you can make it to that 1,667 years, boom, statins are there to help you out with that next year to prevent an event.
Considering Side Effects: A Twilight Zone Scenario
(22:53) Some clinicians—that would be doctors, nurse practitioners, physician’s assistants, and patients—might desire a reduction in the risk of cardiovascular disease, regardless of whether the benefit is small, the authors write. For others, the impact of potential adverse effects heavily influences their decision-making, and even modest estimates of harms caused by daily medication could negate the benefit of statins.
(23:14) Now, we have just entered the twilight zone. We’ve already established that it’s going to take at least four lifetimes—that’s 166 years. You only have 40 years of taking statins per lifetime. That’s four lifetimes. So, we’ve already established that it’s going to take four lifetimes for one person to benefit. Is there anything else you need to know? I mean, really? Now, they’re saying, “Oh, we need to take a look at side effects.” And I will take a look at that later. But the point is, do you really need to look at side effects when the benefits are so minuscule that it takes several lifetimes to achieve them? I mean, how many lifetimes do you have? That’s just—how many lifetimes do you have? And even if you believe in reincarnation, do you think that in your next lifetime, you’re going to have heart disease? I don’t know.
The Lack of Data on Adverse Effects
(24:22) But they point out that the data on adverse effects from relevant studies have not been made available for independent analysis, and there is a high level of uncertainty as to what the harms are. Well, let’s give you the English translation. They did studies on the benefits of cholesterol drugs and did not measure any side effects that showed up during the studies. And if indeed they did measure any side effects, they are not releasing that data. Yes.
(24:59) So, this committee estimates that for every 10,000 patients treated with statins for five years, there will be five cases of myopathy, 50 to 100 new cases of diabetes, and 5 to 100 hemorrhagic strokes. In other words, cholesterol-lowering medications cause strokes, right? Hemorrhagic strokes—they prevent, supposedly, the blood clot strokes, but they cause hemorrhagic strokes. So, per 10,000 patients, we’re going to get 110 or 115 devastating events.
(26:00) Now, diabetes—we know—reduces life expectancy by six years. Okay, so if you’re going to reduce your life expectancy by six years, then already you’ve wiped out any benefit to statins. Now, other data suggested that the frequency of myopathy is much higher—at about 530 cases per thousand. So let’s just add this up. 530 plus 100, 630 plus 50, that’ll be 680 plus 15, 695, call it 700. So, 700 per 10,000 treated for five years are going to have some pretty devastating side effects here.
(26:47) We need to access the data so it can be independently scrutinized to try and estimate this more accurately. So, this person maintains that patients need to be able to make their own decisions on the benefits and harms. But for that to be possible, we need better data. She says we need better data. I see the data’s already there. I’ll show it to you in a bit. Both benefits and harms in the primary prevention population. We also need more trials to determine the in low-risk individuals with enough power to look at subgroups such as women and older people, where there is even more uncertainty.
(27:11) So, this person’s asking for more data. And again, I said this before, I’ll say it again. A lot of times when they ask for more data, it simply is a stalling tactic to say, let’s keep doing what we’re doing till we get more data—get more data. Or it’s written by a researcher who wants to get paid more to do more research when actually there’s already plenty of existing research. So, we’re going to take a look later at what the FDA, what research the FDA based its approval on.
The Need for Better Communication and Transparency
(27:42) Better communication of the uncertainty about the benefits and harms of the statins in these low-risk patients would take the pressure off general practitioners—that would be family practice doctors, which is what I was—in terms of prescribing these drugs. There needs to be more transparency around this uncertainty, which would empower both doctors and patients to make better decisions, she concludes.
(28:04) So, let’s get the English translation on this. So, transparency means availability of information instead of secrecy, right? Around this uncertainty—that means they don’t know that these are helpful—which would empower. Why would doctors need to be empowered? Answer: because prescribing statins in this group of people is the standard of care. And many doctors are penalized—they get financial penalties, may even face licensure penalties—when they don’t put people on statins. And this is probably why your doctor is very nervous about you refusing a statin—not because of your health, because as they say, there’s a lot of uncertainty here.
(28:49) And for patients to make better decisions, she concludes. So, right now, your doctor’s hands are tied because of the standard of care. So, the conclusion is not surprising.
The FDA and Statin Approval: A Look at the Data
(29:01) So, commenting on his latest analysis, another doctor at the British Health Foundation said, “The conclusions are not surprising and align with what we know already, based on the evidence from numerous independent clinical trials.” So, what he’s delicately saying is no more research is needed because the conclusions drawn—which is that it would take at least four lifetimes to benefit, for one person to benefit, from taking a statin—is what’s already been shown from numerous independent clinical trials.
(29:40) So, the evidence from clinical trials going back more than two decades—yeah, that would be back to like 2004—shows that statins are an effective way for people reducing their risk of a heart attack. We already know the benefits are even greater for people who have already had a heart attack or stroke, he said. Again, it reduces their risk of a heart attack, but reduces it from what to what? We’re going to talk about that too. An important area of debate here relates to the magnitude of benefit provided by statin treatment in people who are at relatively low risk, and whether that benefit outweighs the risk of side effects.
(30:07) For people who fall into this category, the decision on whether to take statins should be based on discussions with their GPs, this doctor says. And again, the decision on whether or not to take statins should be based on discussion, but right now it really is not, because doctors are being coerced into prescribing these to literally 61% of people who walk into their office.
(30:45) We recognize people’s concerns about statin side effects, and we want patients and their doctors to be able to make informed evidence-based decisions about taking and prescribing these medicines. And so, of course, the British Health Foundation is doing its part by funding research, blah, blah, blah. Putting an end to this debate should help to stop conflicting reports, which can put people off taking potentially life-saving drugs they have been prescribed for good reason. And these are potentially life-saving drugs—they’re not life-saving drugs. They’re potentially life-saving drugs. It’s like the next lady you meet—potentially could be a wife, but might not be. So, potentially life-saving drugs, this is not a strong ringing endorsement.
(31:31) So, what do we do? Where do we look to get more information on this? I say, let’s look at the FDA. What does the FDA say?
Understanding FDA Approval: The Package Insert
(31:44) So, if we’re going to take a look at what the FDA says, we have to first understand a concept. So, a concept is called a package insert. And when I was in medical practice, the drug reps come by—there’s a new drug. Man, it’s the best thing since sliced bread. Every patient should be on it. It’s unfortunate we can only give it to a certain number, and these are the ones we’re going to start with. And that’s pretty much the spiel for any and every drug.
(32:09) And I would say, you must leave me the package insert. If you do not leave me a package insert, I will not prescribe your drug. Don’t even leave me samples. And I actually read the package insert, which is written in about three-point type. In other words, really small, really small letters.
(32:32) So, what’s a package insert? You need to understand this. And this is a definition that you can find at NIH.gov, and it says a package insert—so the name is drug label, prescribing information, prescription labeling, product label, blah, blah, blah. So, this is drug prescribing information prepared by the drug manufacturer and approved by the Food and Drug Administration. This is important—prepared by the manufacturer, but approved by the Food and Drug Administration.
(33:02) So, this is information the Food and Drug Administration has read, has considered, and has approved, okay? So, that’s what we’re going to use today. We’re going to use this—FDA has read, considered, and approved. So, that’s where we’re going to come down on this.
(33:22) All right. So, I took a package insert from a statin, and one is as good as the other. It’s a class of drugs, and as a class, they have similar side effects. So, you can just pick one, and the side effects are representative. And effectiveness is also representative because it’s a class thing, okay? All right. So, this happens to be for Mevacor, but it could be for any statin. This is lovastatin, but it could be simvastatin. You know, it’s a statin.
(34:02) First of all, lovastatin is a cholesterol-lowering drug isolated from a fungus. In case you’re into red flags, there’s one for you.
The Efficacy of Statins: What the Research Shows
(34:27) Now, let me get my notes over here where I can see them. So, we’re looking at what the pharmaceutical company says about their own cholesterol-lowering drug. This is important to understand that this is what they say. These are their numbers, right there in the package insert. And anyone can read the package insert, see the numbers, and do the math themselves. But I’m going to do the math for you. Make it easy. And then, again, you can decide. This is your decision, not mine—your decision.
(35:01) Okay. So, what they decided in their study—and they look at the Air Force/Texas Coronary Atherosclerosis Prevention Study, which has a lot of different letters in it. And this is a study they published in their package insert as a basis for approval of the drug. So, we can reasonably presume this is a favorable study—not only a favorable study, but maybe one of the more favorable studies. Okay. So, in other words, there might be studies that are less favorable, but this is the one the drug company chose to represent their drug to the FDA as a reason why their drug should be approved. This is important.
(35:58) So, they show, without question, that it lowers cholesterol. But like, who cares? Who cares? Why? Because what you really care about is, is the drug going to benefit those who take it? A number going up and down? Are they going to live longer? Are they going to prevent a heart attack? Are they going to prevent a deadly heart attack? What is the benefit to the individual taking this drug? That is the question. That’s what we’re looking for. We’re looking for benefit to people who take this drug.
(36:21) Okay. So, what they did was they got 6,605 people to be in the study, which is nice. And they split them into two groups—some who took the drug and some who didn’t. And this is what they found. They said, well, each year, four per thousand per year benefited. That means the number needed to treat was 250. And they lumped together people who had high risk for heart disease, low risk, no risk—it was all lumped together. People had normal cholesterol levels, high cholesterol levels—they just put them all together in a group, which is okay. I’m just letting you know what they did.
(37:14) So, one person benefited each year. This means, and they included people who had a non-deadly heart attack, people who had chest pain, and people who died. So, literally, they included mild inconveniences in this and did not include the biggie, which is, did somebody die? And if so, how many deaths were avoided by taking this drug? So, in the first paragraph, they don’t get into that because I guess we don’t really know each other that well, but we’re going to get to that part.
The Reality of Statin Use: The Cost of Preventing One Death
(38:00) So, what happened was 3,304 people took this drug for five years. Yay. And over five years, 3,304 people taking the drug, one—count it—one death was prevented. So, to get the number needed to treat per year, we have to figure out how many deaths were prevented each year. So, that would be one divided by five, which is 0.2. So, we take 0.2 and divide it by 3,304. That’s six deaths per 100,000 per year were avoided. So, then we take 100,000 divided by six. And so, in order to prevent one death in one year, 16,666 people need to be treated. 16,666 people need to be treated to prevent one, one death.
(39:08) How do we get this? People who took no drug—eight deaths. People who took the drug—seven deaths. One death was prevented, five years of these people swallowing this pill. Okay. Now, this is from the research study presented in the package insert by Mevacor in support of why people should take this drug.
(39:32) So, let’s take a look at this. Let’s kind of bend our mind around this a little bit. So, if you take the 16,667 people, each taking the drug for a year, let’s line them up end to end. That means it takes 16,667 years of use of this drug for one person to live. And we’re not talking about immortality. We’re talking about them living longer than they would have lived without the drug. It might be a minute longer. It might be 10 minutes longer. It might be a year longer. But this is one death that was prevented in the course of 16,667 years.
(40:30) Okay. Now, I looked up the cost of Mevacor. It’s much less than it used to be. It’s only $18 a month. If you pay cash, the insurance price might be higher. So, let’s be optimistic and use the cash price, right? Because we want to be as optimistic as possible. We’ve got the most optimistic study here. Yay. Okay. So, that’s $18 a month times 12 months times 16,667 years. That’s $3.6 million would have to be spent to prevent one deadly heart attack in the space of one year.
(41:07) Now, we’re preventing a deadly heart attack in year one. This person could die in year two. All we’re saying is they’re not going to die in the first year of use. Okay. In the second year, we can presume—and I think it’s reasonable—that another 16,667 people may take this drug at a price of $3.6 million to prevent one more heart attack from killing a person. Because remember, there’s going to be several non-fatal heart attacks in this group that the drug does not prevent. But let’s understand what $3.6 million is. I looked this up. In the United States in 2016—the latest year for which we have numbers—why? I don’t know. The average income or wages, household wages, is $59,000. That’s it. $59,000. So, that means 61 years of wages, assuming a zero tax rate, in order to prevent death from a heart attack.
(42:13) 61 years of wages. If we say that the average person works for 20 years and retires, let’s go for that. Then we’re looking at three lifetimes of wages to prevent one deadly heart attack in the space of one year. This is not even logistically—doesn’t even make sense.
The Cost-Benefit Analysis: Is Statin Use Justified?
(42:47) In other words, you have to give your very life, eight hours a day, five days a week, for 20 years—actually 61 years—to prevent one death. And so, using a statin is going to take three lifetimes of wages to prevent one heart attack death. It would be cheaper to treat the one heart attack. You know how much it costs to treat one heart attack? I mean, just saying. I looked this up. $20,246 for all the hospital care and medical care for one heart attack. Just on a dollars and cents basis, it makes more sense to just have a heart attack and pay out of pocket for it.
(43:36) Now, a lot of people say, “Well, Dr. Daniels, I’ve got insurance.” No, no, no, no. You’re paying for that insurance, whether it’s insurance premiums, whether it’s sales tax or property tax or state income tax to pay for the Medicaid if you have Medicaid, or whether, if you don’t have Medicaid, you’re paying that, or whether it’s a Social Security tax if you have Medicare. So, you are paying, believe it or not, through the nose for this. Yes, you are paying. This is not cheap, and you’re paying.
(44:06) So, even by their own package insert, their own package insert says—and they’ve got these cute little graphs I wish I could show you—lovastatin or placebo. At six-year follow-up, 96% of people had no benefit from taking the drugs. And this is even the non-deadly benefits that they’re measuring to help pad the benefits. 96% of people taking the drugs at the end of six years had no benefit whatsoever from taking the drugs. Six years. Only three individuals out of 3,300 benefited from taking statins. And again, this is their measure of benefit. So, they didn’t get chest pain. They didn’t have a non-fatal heart attack. So, we’re counting all these other so-called benefits. So, most people, they think heart attack—they think death.
(45:03) So, we’re taking a drug that does not present deadly heart attacks. Now, people are having heart attacks and dying while on this drug all the time, because 89% of heart attack deaths are never prevented. This is what they admit up front. Up front. This is in a group of people who have mixed cardiac risk but no history of a heart attack.
The Question of Side Effects: What You Need to Know
(45:48) So, other statins have similar figures at even higher prices. Now, how much it lowers cholesterol, as I said, is not relevant. What’s relevant is, is anybody’s quality of life or quantity of life being improved.
(46:06) So, let’s look at side effects. You know, the chances of it saving your life are pretty remote. Like I said, 16,667 years of use. Only you know how long you plan to live. I would just recommend using 100 years as an estimate. So, if you use 100 years as an estimate, it takes 16,000 years to benefit. The chances of this benefiting you in terms of delaying your death is just about zero. Just about zero. And again, only you know what zero is.
(46:38) So, I say if I’m only going to live 100 years, even that’s a loose number, because most people start taking cholesterol drugs around the age of 40. So, even if you live to be 100 years old, it’s only 60 years of use. So, to get 16,000 years of use, you’re going to live more than 16,000 years. But we’re being generous here. We’re rounding in favor of the cholesterol drugs.
(47:15) So, let’s look at side effects. 1 in 500 gets myopathy—that means debilitating destruction of muscles. 2 in 100 get liver damage as measured by blood tests. Notice it’s 2 in 100 per year. This is not like 16,000. So, the liver damage as measured by blood tests is 20 times the liver damage that they see in people who are not taking the drug. And reports of death due to statins is rare. They don’t give the number, but they say it’s rare. Yo, yoo-hoo—benefit from statins is rare. So, it makes sense for them to actually calculate this death number, but no place is it listed.
(48:06) So, reports of death due to statins do happen, although it is rare. But this is no reassurance because benefit is rare, right? Benefit is only 1 in 16,667 years of use. So, death occurs in a lifetime, like less than 100 years, right? Because it means they died early because they used statins. So, this person did not in any way approach 16,000 years of use.
(48:34) Now, there are other side effects, which are annoying, but they don’t count them. But you can count them if you want to. Muscle cramps, myalgia, muscle pain, muscle destruction, dysfunction of cranial nerves—that means your eyes, your hearing, alteration of taste, impairment of extraocular movement, facial paralysis, tremor, dizziness, numbness, peripheral neuropathy—that means like numbness, you can’t feel your toes or your feet, psychiatric disturbance, anxiety, insomnia, depression, and memory loss, forgetfulness, amnesia, memory impairment, confusion. And this is from statin use.
Weighing the Risks: Side Effects vs. Benefits
(49:22) These are things that happen at less than the 100-year mark. You get 16,000 years of use, right? Hmm. Sounds like a long, hard road. So, the reports generally are not serious and reversible upon statin discontinuation with variable times of symptom onset. So, in other words, it takes one day to years to get these symptoms and for these symptoms to resolve. On average, it takes three years—I’m sorry, three weeks after you stop the statin use to notice the symptoms are improving.
(50:03) So, depending on your lifestyle, this could be devastating. I can tell you from my lifestyle, I’m used to not having any of these things. So, if we take the human lifetime to be 100 years, this drug has just about zero chance of benefiting a person in their lifetime. That’s an important concept. So, why would anyone take a statin? Well, you would take a statin because, one, you want to please your doctor. Two, it’s the thing to do, and you’re a conformist, and you like to do what you’re told, and that’s fine. But the reason to take it for your health does not appear to be there. There does not appear to be substantial evidence that it’s going to improve your quality of life or your health.
(50:57) So, you have to decide what zero is in your book. In my book, zero is definitely anything with less than a 1% per year chance of benefit. And I would even go so far as to say anything with less than a 100% per week chance of benefit in my book, I don’t bother with because I am—and I’m sure you are too—pretty busy, and you have a lot of stuff to do in your life that just has to be done. And to even stop, open a bottle, and take a pill is a major delay of game in terms of getting all the stuff done in your life that needs to be done. And then when this pill can give you tremors, dizziness, aches and pains, and forgetfulness, like, no, doesn’t work.
Alternative Approaches: Water and Poop
(51:47) So, what’s a person to do? First of all, you’ve got to decide how long you’re going to wait for benefit and what you define as a benefit. So, hint: NNT—numbers needed to treat—also equals years. So, if NNT is 50, that means that on average, you have to wait 50 years to see benefit. So, you’ve got to decide. And in my book—again, I’m 62, right? So, being lucky, maybe I’ve got 40 years left. Yeah, 40 years left to live. So, obviously, I can’t be messing with any drug with an NNT of 40 or more. That’s one way to do the math.
(52:23) Figure out how much longer you have to live, and I recommend using 100. That’s not an overly pessimistic number. You have 100 years to live. Take your age, subtract it from 100—that’s how many years you have to live. So, any drug with an NNT more than that makes no sense for you to take because you are not going to get benefit in your lifetime. And no one’s going to be able to hand you your cholesterol pill while you’re in the coffin. And even so, who cares? You’ve died of something else already, even if it wasn’t a heart attack. So, no benefit there.
(52:59) So, ask yourself if you’re willing to take a pill every day for a year to see results or for many years. Again, use the example of filling your tank in your car with gas. Are you willing to gas up your car every week for 50 years before you finally receive a tank of gas? Remember, all that money you paid over the 50 years, you’re not getting it back. But if you can just bring this in the realm of reality, bring this in the realm of the same standard of decision-making you would apply to any other purchase, then it becomes a very easy decision to make.
(53:41) So, investigate the cause of your condition. The proposed therapy may have nothing to do with the cause of your disease. If so, it can’t be expected to help you. So, what causes heart disease? Simple. Not enough water and not enough poop. That’s it. So, does cholesterol cause increased water in your system and remove poop from your system? No, it doesn’t. So, it cannot be expected to be helpful. And this research shows exactly that.
The FDA’s Role: Understanding Their Decision
(54:08) Now, the FDA did approve the drug based on this research. And, you know, I wasn’t there. I wasn’t in the room. I don’t know what happened. But that’s their decision, and they’re entitled to it, of course. But you’re entitled to your decision as well.
(54:34) Just philosophically, I would say never, ever take a pill to prevent or test to prevent anything. Why? So, back in the year of our Lord, 1982—yes, 1982—I was sitting in a seat at the Wharton School of Business. And I was so excited to be there to learn all the things they had to teach me. And this was the health insurance course delivered by a, at the time, famous insurance consultant who traveled around the country in the United States, helping insurance companies understand how to make more money and understanding the health care system and how it could make more money as well. And so, he said, we need to get more people to take more drugs to get the industry to grow. How can we do that? Of course, we students were like stumped because you just take drugs for diseases you have to get better.
(55:02) He says, oh no, no. We need to get people to take a pill for diseases they don’t have but are worried about. And so, this is what cholesterol pills are. It’s people taking a pill for a disease they don’t have, call it heart attack, but that they’re worried about.
(55:18) And so, realize that you’re taking a pill for something you’re worried about. I say, go to church and light a candle. I understand most churches, you can go and light a candle for 50 cents, maybe a dollar. Much cheaper than this. And you can light a candle maybe once a week. It’s $4 a month—not bad. And you can get double duty. You can dump more of your worries as you light the candle. And look at other ways you can invest your time and money to have a happier, healthier life. Sometimes a simple glass of water or saying a few kind words to people you love can make all the difference in your sense of well-being.
(56:08) So, I would look at other ways you can invest your time and resources. The other thing too is look at your budget. You only have 100 years on this earth. Why even begin to invest any of it into something that takes 16,000 years in your lifetime to yield fruit? I could see if taking a cholesterol pill for 50 years of your life would help the lifetime of your neighbor or someone else, but it’s not going to.
Wrapping Up: Final Thoughts
(57:03) And be okay with saying no. One thing I was really okay with at a very young age, thank God, was saying, you know what? That costs more resources than what I care to allocate to it right now. And if 3.6 million is all you have to spend, is this a reasonable way to spend it? And if you don’t have $3.6 million, guess what? Don’t even get started because you got to spend the full $3.6 million to get the benefit. And 16,667 years of your life—if you don’t have 16,000 years to spend, cholesterol drugs are not for you.
(57:51) So, I say glass of water and some extra poops. That’s the answer. And we only have three minutes left, so I have to say visit VitalityCapsules.com and check out Vitality Capsules to help you poop and drink some more water. And that’s going to go a lot longer or a lot farther in improving your health. And it doesn’t take 16,000 years to work.
Q&A Session
(58:16) All right, we have time for a couple of questions. Obviously, we can’t get to all of them, but appointments are available at VitalityCapsules.com forward slash appointment. All right, let’s see what we have.
(58:41) Okay, I don’t know what the question is here. Let’s go on to the next one. So, when you’re writing questions, put a question mark somewhere, and then I can find the question. I can latch on to it. It’s easier to answer.
(58:57) All right, so dear Dr. Daniels, I have a son who is bipolar. Do you have herbs to help control this sickness? Hmm, this is the wrong question. Why don’t we just cure it, huh? So, what causes bipolar disease? What causes bipolar disease is a B-complex deficiency caused by eating sugar and white flour. That’s it. Very simple. So, you need to cut all the fruit juice, sugar, white flour. I would even cut the white rice out of his diet. So, cut that out. And you can start feeding this kid some liver—calf liver is good, or chicken liver. And that will take him a lot further than any herbs will.
(59:42) Sylvia says, “Dear Dr. Daniels, I’ve seemingly tried everything I possibly could, naturally speaking, to rid myself of arthritis, but have not had much success, if any. Any help or suggestions you may have for me? I want to be healthy. Thank you very much.” So, Sylvia, go to VitalityCapsules.com, download the Candida Cleaner Report, and follow that. Even in the preparation phase, you might find your arthritis already going away. Now, that cleans out impurities in your joints that might be causing your arthritis. The next step is adding nutrition to your diet that will repair your joints. And that would be maybe eating some, I would say pig’s feet is the easiest to get. You want pig’s feet with the skin. And maybe a quarter pound to a half pound every other day. That would be good.
(1:00:30) All right, I see we are out of time. We have reached one hour. I hope you’ve enjoyed the show. Remember, as always, think happens and let it happen to you. So, we will see you again next week. Bye-bye.