How to Fight Back Against Hidden Regulations that Threaten Your Health

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This is a transcription of Mary Ruwart’s talk at the ISIL 2013 World Conference.

Transcription edited by Kenli S.

Well, thank you, Christian, for that wonderful introduction and as promised I’m going to try to share some things that you may not be aware of, but actually influence your life quite a bit. And to get started I’m going to talk about what we had in the early 1960’s which you may not be aware of. We had, we were on the precipice of a golden age of health.

Now many of you may not be aware of that because of course, unless you’re in the profession, you don’t realise how close we were to really making some breakthroughs.

For example, the big breakthrough that had already been made is that antibiotics, sanitation, and other advances had eradicated the number one killer of human kind of the 20th century and that was infection. That was the number one killer for the early part of the 20th century, but by the second half of the 20th century; it was way down on the list. So we had actually made a big breakthrough.

But just as important; maybe even more important, is we were getting to a point where we were learning how we could prevent disease and this was through vitamins and nutrients. You know, prior to the 1960’s, it was not widely appreciated that vitamin C was good for things; not just preventing scurvy for example. But in optimizing your health and vitamins were not widely available to people like they are today because they hadn’t been synthesised.

We didn’t have good processes for making sure that we have large quantities. That was just coming and it was coming through the pharmaceutical companies who at that time were responsible for most of the vitamin research.

Why is this important? I think maybe the best way is to give you an example. When I was working in the industry, our rats had been bred and had been given such good food that when we tried to do research on diseases we had a hard time because our rats wouldn’t get sick. So what we had to do to get a disease of diabetes or cardiovascular disease, in addition to maybe feeding them a lot of sugar or a lot of fat is we had to take away their vitamins.

And once we did that we got a disease in the rat very much like the kind of diseases we see in people. So this was a little hint that optimized health may depend on optimal nutrition and this was not something that was widely appreciated in the first half of the 20th century and was just beginning to be appreciated in the second half.

Also we had quite a few new drugs every year, I indicated 30-39 what we call new “chemical entities” which are actually really new drugs as opposed to just changing an oral drug to an intravenous drug or something like that. And the new drugs were saving lives and money and because if you think about it, if you treat somebody with a drug instead of just putting them in the hospital, you’re going to save a lot of money.

To give you an example, Tagamet, the first anti-ulcer drug, that came on the market was really a breakthrough because before that if you had an ulcer you had to get surgery which cost about $25,000, took you out of work for several weeks, and of course had the risk of death.

Now when Tagamet came out you could take a year or two of Tagamet for about 1 or 2 thousand dollars which was a horrendous price for a drug at that point of time, but still, much cheaper than hospitalisation or surgery. So you can see how much money you can save when you have a drug treatment instead of hospital or surgery.

But this all changed in the early 1960’s because what happened was we had the Kefauver-Harris Amendments, which probably most of you have never heard about. That’s why I say it’s hidden regulation; these were passed in the United States after the Thalidomide tragedy which actually happened in Europe. And what happened here was that a new sleeping drug, Thalidomide, was put on the market and it was much safer than Barbiturates which was the current drug in use, at least they were safe for adults.

Unfortunately, what was not known is that they were not safe for the unborn child. And so a lot of pregnant women took Thalidomide because they found out it also helped against the morning sickness, but the problem was their children were born sometimes without one or two limbs. So this obviously was a big tragedy, about 10,000 infants in Europe were affected. In the United States it was just a few because it wasn’t yet approved by the FDA.

And of course everybody was very upset and they didn’t want it to happen in the U.S. So they passed this Kefauver-Harris Amendments, which had been languishing in Congress for several years and had nothing to do with safety, but they basically gave the FDA almost total control over the pharmaceutical industry; in ways that had never happened before.

And so what ended up happening was immediately half of the pharmaceutical manufacturers were put out of business though site inspections. The FDA did not give them enough time to ramp up and come to the paper work really that the FDA wanted. Basically, it wasn’t that these manufacturers did not have good facilities.

What it meant is they did not have a paper trail for every little thing that they did and without that the FDA was not impressed. And also of course the regulatory burden sky rocketed; this of course put the smaller firms at a big disadvantage. Prior to the passage of these amendments, the small firms were much more efficient than the big ones.

In other words, they would spend “x” amount of dollars and they would get “x” amount of product. Whereas the pharmaceutical; the larger pharmaceutical firms had to spend many more dollars to get the same good products and this changed dramatically after the Kefauver-Harris Amendments.

Now as you might imagine, since the FDA had basically carte blanche, they started requiring more and more things that the pharmaceutical company had to do before it could get a drug to market. In this graph, here we see in these blue bars that from the 1940’s and 50’s to the 1960’s basically, the time that it took a drug to get from the lab bench to the market was a little more than 4 years and it was pretty stable as you can see. But after the amendments were passed, you can see, every year the time to get to market for a new drug increased dramatically. In fact, it went from about 4 and half years to about 14 and a half years; adding 10 years to the development time.

Now when I was in AIDS research, what happened was by the time the FDA gave us permission to test, just to test our AIDS drug on people, every AIDS patient in the United States who wanted them had already had them.

Why? They hired black market chemist to make the drugs we were working on and they distributed them throughout the AIDS community because these people couldn’t wait. They had a terminal diagnosis, they didn’t have an extra 10 years to wait and so we had to wait for new cases to be diagnosed before we could do the testing.

Now of course, these AIDS patients were violating the law, but the FDA didn’t prosecute them which is probably a good thing in one sense because that was the compassionate choice, but bad in another because had they prosecuted, it would have made everyone aware of how the delays caused by the FDA caused people to die prematurely.

Recently in the United States there have been cancer patients that sued the FDA. Just as Dr. Crespo said, they wanted the right to buy drugs from the manufacturers after they had had some human testing. We weren’t sure if they worked yet or not. They just wanted to buy them, in an attempt to save their life and they sued the FDA on the grounds that the life, liberty and the pursuit of happiness promised by our constitution actually should allow people to buy drugs to save their lives. And the courts ruled there was no such constitutional right, Americans did not have the right to buy drugs to save their lives if they had not been approved by the FDA.

Now I mentioned this to you and I know many of you feel well, you know, I live in Europe or somewhere else and am not affected by the FDA, but you are. And the reason you are is that most new drugs are discovered in the United States.

So as I’m going to talk about in a little bit, anything that affects drugs coming to the market in the United States or prevents a new drug from being developed and put on the market in the United States, really affects the whole world. So although I’m going to talk to you about what happens in the United States, please be aware that wherever you are in the world, you are greatly affected by this and that’s why these hidden regulations not only kill Americans, they kill people worldwide and all the numbers I’m going to show you for Americans is just a drop in the bucket.

So I need for you to understand that. Now you might expect that if you add 10 years to development time, you’re going to add greatly to the cost of development and of course you would be right. In this graph, you can see that the research and development cost for each new drug in 2003 dollars is shown here against years from 1940 to 2010.

Now what I want to show you is that before the amendments passed, the cost of development was going up slowly. And if that trend continued it would come to about here, but since the amendments were passed, of course; in these black squares, you can see the actual cost has increased greatly. And this number keeps going up.

So basically, since you know that you can actually demonstrate this, I didn’t bring the slide to demonstrate this. But there’s a very close correlation between the amount of money that a manufacturer spends to develop a product and what its cost is going to be when it enters the market. You know, it’s just common economic sense.

I figured for this audience I could say it, you didn’t need the proof; you know it. So, basically, you can actually calculate what the difference would be if pre-amendment trends had continued on research and development. And basically, the bottom line is the drugs cost that we pay at the pharmacy would be about 15% of what it is today; if we hadn’t passed these amendments and the pre-amendment costs acceleration, that very low acceleration had continued.

You know we might be willing to pay that price if these amendments made the drug safer, but in fact they don’t. And the reason that they don’t is that most safety issues, back when the amendments were passed and even today, are really; are really things that we can’t predict with our current testing systems because we maybe aren’t aware of the impact on different populations or whatever. It’s not that people; it’s not that manufacturers don’t do safety studies.

It’s that sometimes we don’t know what safety studies to do. And sometimes there are genetic differences in the populations; that only a small portion of the population is affected, but when a drug gets out on the market, that’s a lot of people. And you just don’t pick it up in early testing. And so you can see why adding more regulations do not necessarily make drugs safer.

In fact, although I cannot demonstrate this conclusively, my observations tell me, that the drugs we have on the markets today are actually less safe than the drugs we had prior to the amendments. There is some evidence to actually support that and I don’t have time to go through why that is today, but I just through that out there so you are aware there is some evidence in that direction.

So how many people died prematurely because of these regulations? You can actually calculate some of it. For example, we know how many drugs, I’m sorry, how many lives our current drugs save. So now that we know how much longer it takes to develop them, depending on the decades, we can actually calculate.

And the bottom line here is that there are about 4.7 million Americans who lost their lives prematurely just because of this delay due to the amendment. And remember, this number is just for the U.S., worldwide, it’s probably much more.

But this isn’t even the biggest problem. Another problem is that it’s pretty clear that we’re losing a lot of innovations. And we’re losing at least half. That’s what the studies show. In fact, that’s a minimum; we’re probably losing much more. And what we’re losing are the breakthroughs.

And to illustrate this I’d like to talk to you about an example that happened to me. I had the FDA call me up one day when I was working for the Upjohn Company. And they said, “Dr. Ruwart, we understand you just filed a patent for prostaglandins and liver disease. Is that correct?’ I said yes it is. They said, “We are so excited. 100,000 people die every year and there’s nothing for liver disease. So this is a real breakthrough. We want to help you get it to the market.”

Well, I of course was very excited. I thought wow this is a shoe in, right? No, it’s not right. Why isn’t it? When you’re looking at a cure for a new disease, you don’t really know how to test it to get what we call the “statistical significance” that the FDA requires. And the reason for that, in other words you have to be sure that it’s not a chance observation.

And the reason you don’t is for example, liver disease is a disease that develops over many years. So the treatment would probably have to be over many years. How many? Well, we weren’t sure. How big of a dose do we have to use for a new drug? How many times a day do we have to give it? How do we check to see that the liver disease is getting better? Do we take a piece of liver out of a person every time? Ooh, that’s not a good idea.

So we would have to develop tests to, in people, in a way that we hadn’t been able to do in animals. In animals, we could take their liver out and look at it; obviously, we couldn’t do that in people. So we would have to treat for years.

The studies would go on for years and if we didn’t guess right and get the statistical significance required by the FDA; we’d have to start over. And if we had to do that, it’s very likely that our patent life would run out before we could complete the studies. The drug would go generic the first day that it hit the market. And we would never recover our development costs.

So new drugs; really breakthrough drugs, are very hard to get to the market. And these regulations make it even harder because it adds such a great cost and so much time.

So we can actually calculate to some to degree what this cost. And the way we do it, is we look both in money and lives. Now we talked about the money issue earlier. How new drugs can save money in hospitalization for example. And of course in lives, that’s pretty obvious. And I’d just like to point out that depending on what assumptions you make about how effective these loss stripes are, we’re talking between 4-16 million people in the U.S. Those have lost their lives prematurely because of these amendments.

And as far as cost, notice that in 2003 total healthcare expenditures were about $16 billion, $1,600 billion and notice that’s somewhere between; as you can see, could be as much as 25% or more of the healthcare cost, and of course I’m just talking about the loss due to innovation. I’m not talking about the loss due to the delays and other things, like the cost of the pharmaceuticals themselves. When you have things like this you realize that our healthcare costs, they are probably 25-55% higher than they would be, if these amendments had not been passed.

Now I’ve told you a lot of bad news, but I don’t think I’ve told you the big one yet. Believe it or not, it gets worse. Yes, I know, it’s hard to believe isn’t it, but really these amendments outlawed prevention and other breakthroughs and prevention. How did they do that? Well, we know that again, nutrition can prevent a lot of damage from environmental toxins.

You know one of things I did when I first came to the Upjohn Company, I was working on alcoholics liver disease. And I realized that the B vitamins really helped prevent that. You know, our animals could take a lot more alcohol into their systems if we gave them B vitamins. So I rushed up to my supervisor and I said,” Hey maybe we should recommend that we put B vitamins in alcohol.” It could at least be safe for alcohol, right?

Well, talk about hidden regulations, he said, “Well, you know the Bureau of Alcohol, Tobacco, and Firearms has already ruled that to add B vitamins to alcohol would adulterate it. In other words, it wouldn’t be pure alcohol anymore. The purity would be compromised and you can’t do that. I mean, it’s just crazy. So we know that you can actually help yourself out with proper nutrition.

Okay, and to give you an example, it’s ironic, sadly ironic that the amendments were passed in order to prevent the Thalidomide type tragedy. And here we go folic acid, a “B” vitamin, was shown to prevent spina bifada and other really tragic problems in young children. These children when they are born with these birth defects, they have to be institutionalized.

That’s how bad it is and the FDA actually prevented the American public from learning about this because we knew about this in the 1980s. And folic acid manufacturers were told if they talked about this they would be shut down because they hadn’t gone through all these hoops that pharmaceutical drugs go through.

And if you make a claim you can prevent disease in the United States you have to go through the FDA process because commercial speech is not protected by the first amendment in the United States. So that was very sad; about 25,000 babies were probably born with these defects that they didn’t need. And many more were aborted.

Fish oil is becoming a very popular supplement for very good reasons. It helps with cardiovascular disease. But because of the FDA, doctors cannot be, you cannot go into a doctor’s office as a manufacturer and talk about fish oil unless again you jump through all these hoops. Well one manufacturer of fish oil said,” Fish oil is so good we’re going to jump through the hoops.”

So they did. They spent a lot of money developing prescription fish oil. They are the only manufacturer now who can go into doctor’s offices and say to the doctor, this is the only FDA approved fish oil that will help your patients with cardiovascular disease. And the co-pay that the patients have to pay is almost the same as they would have to pay if they went to Wal-Mart and basically bought the same thing. So the insurance company is picking up the other 80% or so and that’s another reason why that healthcare costs are so high.

And then of course, the FDA actually shut down a group of doctors in Denver who were taking stem cells out of people, growing them in culture for a week and then injecting them back into the same person. And this was taking care of the need for knee replacements for example. This is great stuff.

Some athletes actually got this and were saying how wonderful it was and the FDA said if you manipulate the stem cell for a week it is a drug. You have to go through all our processes which is actually impossible for a procedure like that; for reasons I won’t get into. So, of course these doctors went offshore. And so now only the wealthy have access to this great technique.

And again as I said this really affects everybody because the Codex, the group, has picked up these FDA like stands on nutrients and it is actually enforcing it through the World Trade Organization trying to harmonize the regulations. I understand that Germany did adopt these several years ago and this slide is several years old, so if anyone has more information for me on this or any other country on how this is handled, I’d like to hear it.

In Germany if you want to get over 225 mg of vitamin C my understanding is you need a prescription. To give you an example of how low this is, I take 10 times this much every day. Vitamin E probably 800 IUs is the optimal dose for people, something in that neighbourhood. Vitamin D, especially vitamin D3, which has been shown to be a really a good preventative for cancer, you know, the recommendation is usually around 5,000 IUs. So there’s, and fish oil, it wasn’t even on their list when I made this slide. It may be different now.

So basically what I’m telling you is our golden age of health has been compromised by the FDA for all of these reasons that I’ve already talked about. And the sad thing is that government controls research, too. You know, most of the private research in the U.S. takes place in the pharmaceutical firms. And you can see how the FDA is controlling that and manipulating it by the way they, you know, are making only new to drugs really to be developed, you know, breakthroughs are difficult. And research at universities depends on government grants, they control that. And of course that creates the status quo which then controls maybe 10% of privately funded research that‘s left. So this is very sad.
Now, so given this situation, how can you protect yourself? Okay, so well of course, obviously you need to fight any regulations for drugs, nutrients, and medicine that take choice away from you. But, there are also things you can do yourself. Basically you need to educate yourself on prevention. I know it’s tough, especially if you’re not in the industry.

But an ounce of prevention is indeed worth a pound of cure. So my recommendation to you would be to check in on some things that you can do. For example, let’s talk about some prevention. One thing all people who study longevity agree on; they don’t agree on much, but they do agree on is caloric restriction will extend your life. It’s been tried in every species. The human data is almost impeccable and basically that means you eat 80% of the calories you crave, which isn’t fun for most of us.

So there’s been further research done about how you can balance your carbohydrates, proteins, and fats to enable you to eat much less without having hunger. And also there’s been research that shows that certain drugs will also turn on the same genes that caloric restriction does. So that’s pretty interesting. There are also combinations of nutritionals and vitamins and minerals that you can take that also seem to turn on these same genes. So what’s likely is there is a way out if you don’t want to practice caloric restriction which I have a hard time doing myself.

Okay so then also, exercise. The lung capacity, I say is purported because I am not sure everyone agrees on this is the best predictor of longevity. And high intensity interval training which gets your heart rate up for very short periods of time, but gets it up very high really helps maintain your lung capacity. And again there’s been some genetic work done on this type of exercise showing that it does turn off the genes that accelerate insulin resistance which is something that basically increases your aging.

Now I know I don’t have a lot of time to go through all the ins and outs of this. So what I have done for you. Oh, one more thing I did want to mention, meditation. Yes, this is another great thing to do. Now I know that some people associate meditation with spiritual practices. I mean it can be, but it doesn’t have to be; meditation, basically, think of it as getting your mind to focus on a single thing. That’s actually not very easy to do. But when you do it, it does relax the body and the reason that a lot of spiritual groups are kind of “into it” is because they can create a state of bliss very similar to taking drugs, but without the bad side effects. Okay and there’s some evidence it does turn on longevity genes.

So I prepared for you a little list of resources. If this appeals to you and actually given the state of healthcare today in most of the European countries and in the United States if you want to learn more about nutrients and anti-aging research the life extension foundation is the first reference here.

It’s founded by libertarians, by the way. The FDA has tried several times to shut them down, unsuccessfully. And so they’re a really good group to get to know. They evaluate nutrients, they evaluate pharmaceuticals. I think they have the most balanced presentations in a way that lay people can understand.

And then drsears.com, Gary Sears was the inventor of the zone diet. He’s the one who really started the fish oil craze. I’ve met him personally, he’s a great guy. And the reason I like his research is he and I were working on the same things in prostaglandins. So I understand his research. I actually was going along the same lines, except not in diet. So I’m very big on that. And then Al Sears, who I don’t think is related, has these exercise programs for high intensity interval training. He does a lot of gnomonic, gene-type research. And of course meditation there’s many places you can learn meditation. And I put transcendental meditation up there only because it is probably the most well known meditation group.

I’ll wrap up because I’d just like to say, I don’t really think given today’s healthcare system that there’s anything better that you can do, other than prevention.

Resource List:
www.lef.org (nutrients; anti-aging research)
www.drsears.com (Zone Diet; fish oil )
www.alsearsmd.com/ (exercise/anti-aging research)
www.tm.org (meditation)

See more videos from the Lausanne Conference
This is a transcription of Mary Ruwart’s talk at the ISIL 2013 World Conference.

Transcription edited by Kenli S.

Dr. Mary J. Ruwart is a research scientist, ethicist, and a libertarian author/activist. As a senior research scientist at The Upjohn Company, Dr. Ruwart was involved in developing new therapies for a variety of diseases, including liver cirrhosis and AIDS. She is the author of Healing Our World and Short Answers to the Tough Questions.

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