Truth, Freedom, and the FDA:
An Interview with
Durk Pearson and Sandy Shaw
By David Jay Brown
Durk Pearson and Sandy Shaw co-authored two of the first and most widely read books on the subject of human longevity—Life Extension: A Practical Scientific Approach and The Life Extension Companion—which triggered a large amount of popular interest in the subject (including my own), and their many television talk show appearances have reached a large number of people over the years.
Although, perhaps, the ultimate goal of medicine all along, the idea of extending human life in otherwise healthy individuals was a relatively novel concept for most people when Pearson and Shaw published their first book back in 1982. How many people could have predicted back in the early eighties that in just a few years after the publication of Pearson and Shaw’s groundbreaking book that there would be such a huge worldwide interest in life extension, anti-aging, and preventative medicine? Pearson and Shaw were not surprised by this new and growing interest and had, in fact, been anticipating it.
Pearson and Shaw have been studying life extension since 1968. They are largely self-educated. Pearson graduated from MIT with a triple major in physics, biology, and psychology, and Shaw graduated from UCLA with a double-major in chemistry and zoology. However, most of their knowledge comes from consuming scientific and medical journals with a voracious appetite, talking with colleagues, and experimenting on themselves. In this manner, they have become two of the most well-informed people on the planet regarding the biochemical mechanisms of aging, and they continue to study it full- time. Pearson and Shaw then apply this knowledge in designing nutritional supplement formulations for their own use, some of which are available commercially.
Pearson and Shaw have also been very politically-active over the years with regard to protecting people’s rights in America to access nutritional supplements, and to easily obtain available accurate information about the supplements which may benefit their health. To this effect, they wrote the book Freedom of Informed Choice: FDA Versus Nutritional Supplements (Common Sense Press, 1993), and won a landmark lawsuit against the FDA—Pearson v. Shalala—charging the government agency with unconstitutionally restricting manufacturers from distributing truthful health information (which was viewed as a violation of the constitution’s First Amendment guarantee of free speech) that could save many people’s lives. This was a landmark achievement for the dietary supplement industry and for the availability of truthful scientific information to consumers.
Durk and Sandy are responsible for inspiring my own interest in life extension and they have long fascinated me. The couple makes a great team, often completing one another's sentences, and bouncing ideas and facts back and forth off each other as they speak. It’s as though their nervous systems are symbiotically intertwined, and the breadth of their knowledge is staggering. It doesn’t take much to get them talking passionately about their favorite subjects—life extension and freedom. A few questions can ignite an information explosion. We spoke about how fish oil can improve cardiovascular health, about how the FDA tried to suppress this information, and how they legally forced the FDA into reversing their unconstitutional attempt to suppress the distribution of truthful information.
Q: What do you think are the most important nutritional supplements that people should be taking?
Durk: Let me just preface my answer to this question by stating that we’re dealing with a system here—a system for handling free radicals and for doing a lot of other things—and just saying, here’s the most important three or four nutritional supplements really does a disservice to people. This is because free radicals are in fact handled by a rather elaborate system that’s evolved over the past few billion years that the planet’s had oxygen, and just having one of them doesn’t really do you anywhere as much good as having a set of them. But If I wanted to mention just one, I would say EPA and DHA, particularly DHA found in oils from cold water fatty fishes. The reason for that is that it can reduce the risk of a sudden-death heart attack by anywhere from about fifty percent to eighty percent, depending on the dose. As little as two meals per week of fatty cold water fish could give you about a forty to fifty percent reduction on your risk of sudden-death heart attacks.
Sandy: Three hundred thousand people die of sudden death heart attacks every year in the United States, so if all of those people were taking the recommended amounts of fish oil supplements, or the two fatty fish meals a week, then there’d be about fifty percent fewer that would have died. In other words, a hundred and fifty thousand people would not have died.
Durk: They’re very inexpensive, very safe, and very effective. You see these sort of heart attacks on TV all the time. Somebody has a heart attack, the ambulance arrives, and they defibrillate and resuscitate the person and everything is okay. Well, it doesn’t work that way outside the hospital, because they have to get that defibrillator to the person within a few minutes.
Sandy: But most of the incidences of fibrillation occur outside of a hospital, usually in a person’s home or where they work, and they don’t get to the hospital right away. If you lose several minutes, by that time you’ve either already died or you’ve suffered irreversible brain damage, so if you do survive you’re in very damaged condition.
Durk: Under the usual conditions, your brain starts dying after about five minutes from a lack of circulation, which occurs when your heart fibrillates—just vibrates and stops pumping blood. Incidentally, that’s what happens when you are electrocuted. At about ten minutes your brain is irreversibly and completely gone. A response time for a really good paramedic operation is about eight minutes. So you can see that there’s not much of chance for revival, and in fact, paramedics in the field are actually able to revive about two percent of people whose hearts have gone into fibrillation from a sudden-death heart attack. The DHA is very effective in preventing this from occurring. It doesn’t stop the heart attack from happening, but it turns a sudden-death heart attack, which gives you very little chance, into a ...
Sandy: ... survivable heart attack, where you do recover, and you don’t have irreversible damage to the brain. You can have a full recovery.
Durk: They can get you to the hospital, and then they can do angioplasty, or put in a standard, quadruple bypass or whatever.
One thing that’s very important for people to know about this is that the FDA tried to suppress this information ...
Sandy: ... about the benefits of fish oil. We actually sued the FDA in 1994 because they would not permit a health claim that fish oils may reduce the risk of cardiovascular disease.
Durk: It’s not that they merely would not permit it, they actually issued a regulation that stated that it was a crime to state that the cold water fish oils, with omega-3 fatty acids, could reduce the risk of cardiovascular disease. It was actually illegal. They specifically made it illegal.
Sandy: So we filed suit for violation of the First Amendment, because they were not permitting the communication of truthful information.
Durk: At the time we filed suit against them in 1994 there were one hundred and seventy-four papers on the subject in the scientific literature. A hundred and seventy of them supported our position; four did not. The four that did not were very small preliminary studies that didn’t have the statistical power to detect the fifty percent reduction in sudden-death heart attacks. During the seven years that we litigated against the FDA, one million Americans died premature preventable deaths.
Sandy: Half of the three hundred thousand people dying every year from that wouldn’t have died if they’d have been taking fish oil. However, dietary supplement companies, and also food companies offering fish, couldn’t tell people about the benefits of fish oil. And because of that, people simply didn’t have the information.
Durk: Since the legal case was resolved in our favor in 2001, you’re now starting to see claims on fish oil supplements, and recently the FDA even caved in and is allowing claims on fish. So I think we’re going to see a very dramatic reduction in people dying of heart attacks as a result of this.
Sandy: I wanted to add that one of the ways that we study the effects of the various supplements is to look at metabolic pathway charts. You see, what happens with free radicals is that they’re handled by a chain of antioxidants in the body. It’s not just one or a couple that take care of the free radicals that are constantly around in the body. They’re constantly there because you’re producing them naturally through metabolic activity, and your body has got to handle these free radicals.
The metabolic pathways show you that once a free radical scavenger like Vitamin C reacts with a free radical, then it becomes a free radical itself. It becomes an ascorbyl radical. That radical then has to be taken care of by another antioxidant. Glutathione usually takes care of the Vitamin C radical, and converts Vitamin C back to its reduced state.
Durk: And the way Vitamin E works is that it becomes a free radical when it either gives up or attracts an electron. When it has an unpaired electron it’s called a tocopheral radical, and that’s less reactive and less dangerous than what you started out with, which might be, say, a hydroxyl radical, but it’s still dangerous. So the Vitamin C hands off the unpaired electron to reduce the Vitamin E radical back to Vitamin E.
Sandy: Exactly, and this is one reason why clinical trials, where people are supplemented with just one antioxidant, like Vitamin E or Vitamin C, have not shown very good results. Because, what happens when you give people a large excess of Vitamin E, is you end up with a bunch of tocopheryl radicals after the Vitamin E reacts with the free radicals. The Vitamin E is just doing what it should do, but then you don’t have enough of, let’s say Vitamin C, in order to take care of the tocopheryl radicals and convert them back to Vitamin E.
Durk: If you go back ten or fifteen years and look at the medical literature for large-scale, double-blind, placebo-controlled trials, like where GSSI researchers gave people things like large doses of Vitamin E, the epidemiological data are positive in terms of Vitamin E providing cardiovascular protective effects. However, if you look at the more recent trials it seems that Vitamin E isn’t working any more. What’s going on here? Were these huge early trials wrong? No, what’s going on is very simple.
Essentially everybody who is a subject in these new trials is at relatively high cardiovascular risk, or they wouldn’t be in trial. You can not afford to have most of the people in trial not be at high risk or the statistical noise will overwhelm the signal you’re trying to find. However, almost everybody who is at high cardiovascular risk nowadays is taking a statin. Now the statins work by suppressing the synthesis of a compound called mevalonate, which is used to make cholesterol. This is how the statins work; they block cholesterol synthesis. However, mevalonate is also used to make a substance called Coenzyme Q-10, which is part of the single electron transfer chain controlling chemistry in the mitochondria.
Sandy: It’s also part of the pathway that converts the tocopheral radical back into Vitamin E.
Durk: So if a person is taking a statin it’s very important that they replace the missing Coenzyme Q-10, particularly if they’re taking Vitamin E. We would suggest if someone’s taking a statin that they take a couple hundred milligrams a day of Coenzyme Q-10. If they’re not taking a statin, but are taking Vitamin E, we suggest about 120 milligrams a day. Your ability to synthesize the Coenzyme Q-10 degrades as your mitochondria get worse and worse with age.
Sandy: There’s another example of the FDA suppressing information. The FDA does not provide any information about this in the Physician’s Desk Reference, the PDR, or the drug inserts for the statins. All this information is approved by the FDA, so it’s only FDA information, and they do not provide any information concerning the fact that you have lower levels of coenzyme Q-10 because of your ability to synthesize it is decreased by statins. Actually, Dr. Julian Whitaker—a colleague and a friend of ours—petitioned the FDA to have a warning put into the statin literature that people should take Coenzyme Q-10 because they’re less able to make it. The FDA refused to do it, so people still don’t know about this.
Durk: In fact, Merck Pharmaceutical has a patent on the combination of any statin plus Coenzyme Q-10 that dates back to 1990. What happens though is that nobody—even Merck—is producing a combination of a statin and Coenzyme Q-10. One of the reasons for that is that it’s far more difficult to get FDA approval of a combination of drugs than of a single entity.
Also, by the time that they have found out about the effects of statins on Coenzyme Q-10, the approvals for the statins alone were well under way. It would have delayed the introduction of statins by years if they said, okay, we have to start over again with a combination of a statin and Coenzyme Q-10.
Sandy: Moreover, there’s a legal liability problem. If people all of a sudden find out that they were at risk by taking statins because they didn’t have Coenzyme Q-10—and that alone could cause heart damage—then there is the possibility of having a huge number of lawsuits.
Durk: It’s very much like the cigarette companies. Some of them, the smaller ones have actually done a lot of work on developing safer cigarettes—R.J. Reynolds, for example. However, there’s a legal problem with coming out with a safer cigarette. First, the FDA won’t let you say that it’s less carcinogenic. Secondly, that’s also an admission that your prior cigarettes were more carcinogenic and more dangerous.
Sandy: Whether something is true or not is not the standard the FDA uses in deciding what they will allow you say—it’s whether or not you meet the agenda that they have for regulating information. For example, the FDA will not allow any information concerning the use of a natural product that is sold as dietary supplement in the treatment of disease, and yet there is a considerable amount of information that supports doing so. For example, fish oils have been used to treat people who have a very high risk of having a cardiac arrest from fibrillation.
Durk: For example, a friend of ours, his mother had very severe cardiac arrhythmias. She would have about half a dozen attacks a day, even though she was taking multiple prescription drugs to help prevent the cardiac arrhythmias. She wasn’t expected to live a year.
We said, continue with the prescription drugs, but add the cold water fish oil, a couple grams a day of EPA plus DHA, plus about four grams a day of taurine, which is a natural nutrient that stabilizes electrically-active tissues against excessive stimulation.
Sandy: Like the heart, the brain, and the eyes, for example.
Durk: She’s now down to having an arrhythmic episode about once every six months, instead of half a dozen times a day, and is doing just fine.
Sandy: But that’s just a case that we know about. This information is in the literature. It’s been in peer-reviewed, scientific publications, that people who have a high risk of arrhythmia can be treated with fish oils, and the fish oil is actually safer than the anti-arrhythmic drugs that people are being treated with these days. Believe it or not, if you don’t get exactly the right dose, if there’s a little bit too much, they can cause arrhythmias.
Durk: We have a lawsuit against the FDA concerning this. There is a dietary supplement called SAM-e, S-adenosylmethionine. It occurs naturally in every living cell. It takes part in about two hundred different reactions in every cell, primarily methylation reactions.
Sandy: It’s extremely important for regulating the turning on and turning off of genes. I mean, you’re talking about a very basic function here.
Durk: And there is a government report, a meta-analysis from the Agency for Healthcare Research and Quality that examined the literature on SAM-e for treating three different conditions: depression, osteo-arthritis, and liver disease. And what they found is that the prescription drugs were better for liver disease but that for treating osteo-arthritis and depression the SAM-e was quite effective and quite comparable to the prescription drugs. It works much faster in treating depression than Prozac. It works much slower than Celebrex in treating osteo-arthritis, but by an entirely different mechanism. It’s not a painkiller like Celebrex; that’s why Celebrex works within a couple hours after you take it. However, if you stop taking the Celebrex, or other painkillers—whether it be naproxen, aspirin, or whatever—the pain relief goes away and you’re right back where you were before. That’s because those drugs do nothing to treat the underlying mechanism of damage, whereas the SAM-e actually stimulates repair.
Sandy: Now that’s serious, because the government itself published this report. It was published by a government agency and it’s available at seven public government Web sites, so there’s nothing secret about this information. It’s already available, and what we proposed to do was simply distribute the information widely—to people who don’t know about these seven Web sites.
Durk: Yeah, we just wanted to print it up, and, incidentally, right on the first page of the government report, permission is explicitly given for anybody to reprint it. Right on the very first page. Reading two hundred pages off a CRT screen is a real bummer. Reading it nicely printed is a whole lot easier on your eyes.
Sandy: Would you believe that the FDA is spending taxpayers’ money to fight us, simply because we want to distribute information that’s already been made public? This is information that the government itself has made public in official statements.
Durk: The FDA is not claiming that the report is false, misleading, or erroneous in any way. What they’re saying is that SAM-e is a legal dietary supplement—so long as you don’t sell the report. If you sell the report, that turns it into an illegal, unapproved new drug.
Sandy: So our counter-argument to that is, if it’s legal unless you provide certain information—and therefore the only issue that exists is the communication of the information—then that makes it a pure First Amendment case.
Q: What do you think are the primary causes of aging?
Durk: One of the most important mechanisms is free radical damage in the mitochondria. Dr. Denham Harman’s Free Radical Theory of Aging and Age-Related Diseases is holding up very well.
Sandy: But one thing that he actually realized quite early on was that most antioxidants do not get into the mitochondria—where the free radicals are generated. That’s actually where you have the most serious problem with free radicals—inside the mitochondria themselves.
Durk: Remember, the mitochondria are your little subcellular energy factories. They produce the universal energy molecule ATP by burning carbohydrates and fats, and they do this by a free radical mechanism. There are single electron reactions going on there on purpose. That’s an essential part of the way it works, so you can’t just suck up all the free radicals. For example, cyanide will do a beautiful job of killing you—and the reason it does this is because it sucks up those single electrons in the mitochondria so you can’t make ATP and you die.
Sandy: Yeah, so it’s a perfect free radical quencher, which just goes to show that you have to be selective about free radical quenchers. Not just anything that prevents free radicals is going to be good for you.
Durk: A recent paper in Science reported that it is possible to stimulate biogenesis of new mitochondria in old cells.
Sandy: That means making new mitochondria. This is critically important when you consider that part of the aging process involves the decreasing numbers of mitochondria per cell, whereby you end up with less energy per cell, because the mitochondria are converting all the energy. But that’s what happens with aging—you end up with fewer and fewer mitochondria per cell. Also, a lot of the ones that still exist are damaged and not working too well.
Durk: And leaking a lot of free radicals.
Sandy: One way that you can make new mitochondria is through exercise. One of the beneficial effects of exercise is that it stimulates the biogenesis of mitochondria. So that’s one good reason to do exercise, but there are other ways of doing it.
Durk: Arginine, particularly in conjunction with choline and Vitamin B-5, that is pantothenate, is able to do this. This increases the production of endothelial-derived nitric oxide.
Sandy: Nitric oxide synthase is the enzyme that makes nitric oxide, and there are three forms of it. One of those forms of nitric oxide synthase is in the endothelial cells, which line blood vessels.
Durk: And it’s not only there, it’s in all other cells and organelles called caveolae, which are little sub-organs inside of the cells.
Sandy: This endothelial nitric oxide synthase is critically important for preventing cardiovascular disease, for example. A major factor in what happens to people when they get cardiovascular disease is that their endothelial nitric oxide synthase is no longer producing the nitric oxide that they need to keep the blood vessels open.
Durk: So the people end up hypertensive. But it’s a lot more than that. Without this endothelially-derived nitric oxide, which is made from arginine, what happens is you don’t get a bunch of new mitochondria. However, you can stimulate the biogenesis of mitochondria with compounds that either mimic nitric oxide or nitric oxide itself—and I think this is a tremendously important finding in terms of life extension.
Sandy: Arginine is used by nitric oxide synthase to make nitric oxide.
Durk: And acetylcholine is what stimulates the endothelial caveolae synthesis of nitric oxide from arginine. You can make the acetylcholine from choline and pantothenate, that is Vitamin B-5.
Q: What are some of the new anti-aging treatments that you foresee coming along in the near future?
Durk: I think we’re going to see a lot more work on stimulating mitochondrial biogenesis. Just as an example, the erection drug Cialis works by inhibiting the enzyme that breaks down cyclic GMP. Now cyclic GMP is the second messenger for nitric oxide, and it’s in the pathway of mitochondrial biogenesis.
Sandy: In other words, the cyclic GMP actually takes the information that the nitric oxide release is providing and then transfers that to other parts of the metabolic pathways, which continue to pass down the message.
Durk: And long-acting, cyclic GMP-inducers—ones that work in things like skeletal muscle, and in neuronal tissue, as well as the smooth muscle in the penis—may increase longevity if they’re long-acting like Cialis, and they’re not too selective. I think that this could help with mitochondrial biogenesis, and they may be life extension drugs, although this hasn’t been tested. A lot of drugs have been developed for erectile dysfunction and have been thrown out because they weren’t sufficiently selective for the particular enzyme subtype that occurs in the smooth muscle in the penis. I think they need to go back and look at a lot of the drugs that have been thrown out, and examine their effect on lifespan in mice.
Sandy: One of the real problems right now in the development of life-extending substances is that nothing is going to be approved by the FDA for life extension—not prescription drugs, and certainly not dietary supplements. You can’t even provide information about how dietary supplements can be used in the treatment of disease. There’s still a large number of people that are fighting this in the courts, and by appealing to the political process. We’re involved in litigation and are a part of that. But until it is possible for people to provide truthful information concerning potential life-extending effects, then people aren’t going to be finding out about this research.
Look at what the NIH is getting now—some 40 billion a year that they’re spending on scientific research. Well, most of the biomedical research that’s done you never find out about. Unless you’re reading the journals like we do, the only way that you’re going to get that information is occasionally the media will cover something. But that’s a very short-term appearance. So you’re not going to get that information into a product that then can be sold to people on the basis that it does a certain thing, because you can’t provide that information.
Durk: Incidentally, we won in the U.S. Court of Appeals, for the district of D.C., in a case against the FDA called Pearson v. Shalala in 1999. They ruled three to zero that it was unconstitutional for the FDA to be prohibiting these four claims which we had brought—one of them was the fish oil claim.
Sandy: Yeah, one of them was that fish oil may reduce the risk of cardiovascular disease, and that it was unconstitutional for them to prohibit those claims.
Durk: The FDA asked for a rehearing, and that was turned down eleven to zero. Not only was it turned down eleven to zero, normally when that happens there’s just a note, a one-word note: refused. In this case they wrote another page and a half blasting the FDA for not getting it. In fact, the FDA had actually told a federal judge, the FDA lawyer, that they didn’t think the First Amendment applied to them. That was at a magistrate settlement hearing before a federal mandestrate. Now that’s really scary.
Sandy: It just goes to show where the FDA comes from. They didn’t think the First Amendment applied to them?
Durk: They didn’t appeal it to the Supreme Court, probably because realizing that if they did they’d lose on that, and they’d lose even more.
Sandy: That’s undoubtedly the reason they did it.
Durk: So what they did is they actually announced in the federal register that their regulations have been declared unconstitutional, but they also announced—and this takes your breath away—that they were going to continue to enforce them.
Sandy: That is, until they had developed a process and decided what they were going to do. So, in the meantime, until they decided what they were going to do about it, they were going to continue to enforce these unconstitutional regulations.
Durk: Now, our attorney, Jonathan Emord, said nothing like that had happened since the Civil War, when Lincoln tried to arrest Chief Justice Tawny and put him in prison. The executive branch of the government normally just does not ignore the courts—or I should say defy? They weren’t merely ignoring it, they were willfully defying the courts. So what we did is we asked the judge for a declaratory judgment.
Sandy: The judge at the district court level.
Durk: The Court of Appeals returned it to the district court for final action in terms of enforcing their ruling. She ordered the FDA to recind the regulations, and they published this thing—no, we’re not going to be withdrawing them, even though they’ve been declared unconstitutional. So we asked the judge for a declaratory judgment that the FDA decision makers were willfully and knowingly violating our constitutional rights. The response from the judge was quicker than anything we’ve ever seen from a federal court. It was just a few weeks, not six months or a year. The declaratory judgment comes back—they’re willfully and knowingly violating our constitutional rights. At that point, we warned them that we are going to sue them as individuals.
Sandy: And take their homes, their cars, everything!
Durk: Yeah, to impoverish them, and sue them for all the legal fees that we have paid to date. A couple of weeks later they decided, whoops, no, we’re not going to enforce these anymore.
Sandy: But it took two years. Our victory in Pearson v. Shalala occurred in January, 1999, but it took until 2001 before they stopped enforcing the unconstitutional regulations. All this additional stuff had to go on, and the final threat to sue them individually was what did it.
Durk: And during those additional two years another 300,000 Americans died from preventable sudden-death heart attacks.
Q: Couldn’t they be charged with murder?
Durk: Unfortunately, no. They’ve got sovereign immunity. However, all I can say is the FDA is not at the scale of Chairman Mao or Joe Stalin, who killed maybe 60 or 80 million people. Or Hitler, who killed about 20 million. But they’re getting pretty close to Pol Pot.
Sandy: With the fish oil claim you’re talking about over a million people who died unnecessarily—and that’s just one claim.
Q: What do you think are some of the strengths and weaknesses of Western medicine?
Durk: I think the greatest strength is the mechanistic viewpoint. That is, a disease is caused by a mechanism or mechanisms. If you understand what those mechanisms are, you can rationally design a process for intervening in those mechanisms to prevent the disease from causing damage and to eliminate the disease.
Sandy: For example, one of the things that you can do is this. Suppose that you know about some prescription drugs that are able to provide some effective treatment for a particular disease, but you don’t want to take those drugs. There could be a variety of reasons. They might be dangerous. They have nasty side-effects. Or they’re extremely expensive. That sort of thing. You may not want to take them, but what you can do is study the mechanism whereby the drug works. The way that the drug effects the disease is by affecting a part of a metabolic pathway. You look at that pathway, and that tells you what the target of the drug is. It also tells you if you’re able to target that particular part of the pathway with something else, then you may be able to treat a disease that way. So then what you can do is look at a large variety of natural products. There’s a lot of research being done now on the mechanisms of things like flavonoids that you find in fruits and vegetables that are very healthful, on how they work.
Durk: And the curcuminoids that you have in the spice turmeric, which appears to be able to reduce the risk of Alzheimer's disease and cardiovascular disease. And the mechanisms are becoming understood, it’s not just that you feed the mice this stuff and they have less Alzheimer's.
Sandy: It’s that you have more of an idea of why the substance is having the beneficial effect. You know a lot more than just when you take something that gives you a beneficial effect.
Durk: On the other side, that’s the great weakness of the traditional medical systems, like Ayurvedic medicine and Traditional Chinese Medicine. The mechanisms that they talked about were like “hot” and “cold.” This sort of thing. They’re not really biochemical mechanisms.
Sandy: Yeah, it’s not helpful.
Durk: But they didn’t know enough chemistry to have that. However, the good news is that a lot of Ayurvedic universities and Traditional Chinese Medicine universities are now looking at the basic mechanisms, and guess what? Chinese red yeast rice, which has been used for at least two thousand years to strengthen the pulse—that is the distant pulse at your wrist—well, guess what? The reason it works is that it’s got lovastatin and some analogs of lovastatin in it.
Sandy: Yes, it’s a natural constituent in the red yeast rice.
Durk: So if you understand mechanisms you could go a whole lot farther, a whole lot faster, a whole lot more effectively. The greatest weakness of Western medicine is the FDA. A great many things are never going to get approved because of the high approval costs. For example, most natural substances, you really can’t patent them.
Sandy: And it’s just as well. I mean, you don’t want somebody to be patenting orange juice or something.
Durk: Legally, these natural substances are a discovery rather than an invention, and you can not patent a discovery. And without a patent you can’t afford to do the research necessary for FDA approval.
Sandy: And then because of the FDA, you can’t provide the information about any treatment effect. For example, there’s a recent study that showed that people who drank three eight ounce cups of orange juice a day had a significant increase of twenty-one percent in their HDL level. That is a very substantial increase in HDL. This was a small group of people, but it was a significant effect.
Durk: That’s the sort of increase you get with the four dollar-a-day statin—if you got one of the best ones.
Sandy: But you can’t provide that information. It’s just one of the many things that the FDA will not allow you to communicate.
Durk: As we win more and more cases, and establish more and more precedents about being able to say what’s truthful and non-misleading, eventually more and more information is going to get out—because of this litigation that we and others, including friends of ours, are involved in. What we’re trying to do is to strip the FDA of its unconstitutional power to suppress truthful, non-misleading information about the health effects of dietary supplements.
Sandy: Certainly they’ll complain that that’s going to be a hassle and a half, because then they’re going to have to do all this sorting, and go through all these claims to make sure that there’s not going to be any frauds. There’s always frauds out there, but that’s no excuse. That is simply no excuse for prohibiting truthful information from being communicated. Enforcing the fraud laws is their problem. They’ve got to work out how they’re going to enforce the fraud laws. In fact, if you look at what they’re doing with their budget, they’re not putting very much money at all into enforcing fraud laws, and they have a lot of money. Most of their budget is being used for salaries and stuff. They’re not protecting the public from frauds.
Durk: In fact, when Pearson v. Shalala was finally enforced in 2001 (when we got the ruling that they’re willfully denying our constitutional rights) we forced them to cave in by threat of personal suit, stripping them of their sovereign immunity, which you can do under those conditions, and personally suing them. They held a public seminar about the effects of Pearson v. Shalala, and they actually said publicly they were spending more money on fighting our First Amendment lawsuits than anything else—than any single other item in enforcement. And there are lots and lots of obvious frauds out there, with people selling magical water which will cure cancer and crap like that.
Sandy: One of the problems with having the truthful communication of information is that it would upset the way that they do things at the FDA, because right now the FDA favors drug companies. There’s no doubt about it. The drug companies are in bed with the FDA. The FDA is in bed with the drug companies.
Durk: The big drug companies. The reason for that is that the big drug companies want high approval costs so that the small drug companies can’t get drugs approved. Then the small drug companies have to sell out to the big drug companies at a nickel on the dollar.
Sandy: That’s precisely right. So what the FDA is trying to do is to reserve treatment information only for drugs, and that way there’s no competition from dietary supplements. Supposing that you could advertise that fish oil could be used to prevent arrhythmias. Then you’d have a competitor for the anti-arrhythmia prescription drugs. The FDA doesn’t want that because the drug companies selling these drugs don’t want that. And that’s the reason that you have this battle going on.
Durk: Then after retirement high FDA officials either end up going to a pharmaceutical company, a paid for chair of medicine of some sort at a university, or they go on to the board of directors and receive six figure salaries for doing nothing, or working for them in their legal department. If you have taken care of your pharmaceutical company buddies, you really get rewarded when you retire from the FDA.
Sandy: Anyway, the two of us would like to live a long time. This is something that we’ve been thinking about since 1968 and studying the literature to the extent that we can, and that involves a lot of searches. We subscribe to about twenty-five scientific journals and medical journals, and we read them.
Durk: The cost of all this—including the journals, computer searches, scientific texts and so forth—is about $15,000 a year.
Sandy: That’s how we keep up with what’s going on, and hopefully we will be able to live a lot longer than we otherwise would have. But the thing is that until the market is opened up, so that it’s possible to have competition based on truthful information concerning the effects of all substances—whether they’re drugs, foods, or dietary supplements—we’re going to have this slow progress in anti-aging medicine.
Q: How long do you think that the human lifespan can be extended?
Durk: If you take a look at a plant like say the chaparral bush you’ll discover that it is as genetically-complicated as human beings, it’s a multicellular differentiated type thing with a lot of terminally-differentiated cells, and yet they live 12,000 years. I see no reason in principle why human beings couldn’t live a lot longer than now—not necessarily 12,000 years, but nevertheless a lot longer, like the tortoises. Some of the sea tortoises live well over two hundred years. Even more interesting is parrots, which have a higher body temperature and a higher metabolic rate. There are certain species of parrots that live over a hundred and fifty years. That’s not in the wild; I mean in captivity, where they’re well taken care of, protected from predators, and have their food given to them every day and so forth.
Sandy: But, nevertheless, people don’t live in the wild either. Not really. (laughter)
Durk: Exactly, and I see no reason, in principle, why people couldn’t outlive the longest lived parrots, because, as I said, they actually have a higher body temperature than human beings.
Sandy: It really depends on finding out how aging takes place, which is being studied. There’s a huge quantity of information about aging, and the body of literature is growing at a dramatic pace. Researchers are studying how aging takes place, the different critical points in the aging process that control a lot of what’s taking place, and ways that you can alter how the critical points are functioning.
Durk: Now the government funding of research on aging mechanisms has both an up and a down side. The up side, of course, is that they’re funding a lot of research, and much of this research is really interesting and good. The down side is something that Milton Freeman pointed out back in the early 1980s—that it can cause scientists to go astray. If you’re offered a lot of money to do research here, and not offered any money to do research over there, you’re going to do research here rather than there.
Sandy: For example, for years a huge amount of research has been done on calorically-restricted animals, looking at what changes take place in the animals compared to the animals that are normally fed—that is, that eat as much as they want. Of course this is a very interesting thing, but in the long run this is not telling anybody anything other than, maybe if you starve yourself you can extend your lifespan. In fact, it’s still not even established that this mechanism would increase the maximum human lifespan.
Durk: I’d love to see some research done on the metabolic differences in parrots versus human beings—old parrots versus old human beings. Particularly, I’d like someone to look at mitochondrial biogenesis, because parrots have to fly and that’s a very energetic task. And yet, even a hundred year old parrot can still fly. I mean, how many hundred year old humans can run a hundred yard dash? In 20 seconds, let alone 10?
Sandy: Another thing about birds is that they have very high blood-glucose levels. In humans, when you have high blood-glucose levels it causes all sorts of problems. You can end up with diabetes, but even if you don’t get diabetes, high blood-sugar levels causes a variety of chemical changes. For example, glucose attaches to protein molecules. It’s something that happens very readily, and as you age you have more and more proteins that have been altered by glucose.
Durk: Which could result, for example, in kidney failure. Even though the parrots have much higher levels of glucose, they don’t have these problems. They have some sort of anti-glycation mechanism that either prevents the glycation from occurring in the first place, or reverses it after it happens.
Sandy: Exactly, and I’d sure like to know how that works.
Durk: I know. If a way could be found that could prevent or repair glycation, that would be real good news for a whole lot of diabetics.
Sandy: It will also be a way of slowing aging, because as you get older these glycated proteins are major factors in the increase of free radical activity, and they decrease the ability of proteins to function.
Durk: They cause loss of elasticity in elastic tissues. They can act as antigens that will stimulate autoimmune diseases. I mean, there are all sorts of nasty things they could do, and yet you’ve got parrots living for well over a century.
Sandy: If we were the ones that were giving out the money, we’d be giving it for different things. But you know what, we’d never take that job, because we don’t want to be giving out other people’s money. Another problem with this government-funded research is that, in the end, it’s just another special-interest group. It makes the scientists into another special-interest group that are all begging for money from the government. If you read the scientific journals now, it’s sort of pathetic—disgusting, in fact—how researchers are always complaining that they’re not getting enough money. But what’s enough? How do you define enough? When you’re getting the money from the government, there’s never enough. So it’s become part of the political process which the two of us avoid like the plague.
David: One of the people that I interviewed for this collection is John Guerin, who started the Ageless Animals Project. According to John, there’s a number of animals that don’t appear to age. For example, a healthy whale was captured at the age of two hundred and eleven years.
Durk: How did they determine that the whale was two hundred and eleven years old?
They used a technique called used aspartic acid racemization. Recent research by Jerry Shay at the University of Texas in Dallas showed that whales can live over two hundred years in good health.
Durk: I’d really like to see the scientific references to that, because whales operate at a relatively high body temperature too. They’re not cold-blooded, like a sea tortoise.
Rockfish don’t appear to age either. Rockfish caught around Alaska have been discovered to be hundreds of years old.
Durk: Well, rockfish operate cold, and free radical reactions double for every seven degrees Fahrenheit. So I can see how a fish that’s living just above the freezing point could live a real long time, because that’s going to suppress the hell out of free radical reactions. However, when you’re dealing with a warm-blooded animal, like a whale, that’s a whole lot more interesting. Whales are hot, like parrots and people.
Q: What suggestions would you make for someone who is looking to improve his or her memory and cognitive performance?
Durk: The first thing is you take a look at the raw materials that are required for it, and one of them is choline. Acetylcholine plays a very important role in memory in the brain, and it’s very easy to increase the amount of choline and acetylcholine in the brain. There was a paper in JAMA which showed that by the time you get into your sixties the amount of choline that you are transporting into your brain drops. It gets into your brain by active transport.
Sandy: Yeah, this is either choline that you’re taking as a supplement or choline that you’ve gotten from your diet. It’s in the bloodstream, and is able to get across the blood-brain barrier—but that’s where the bottleneck takes place.
Durk: It’s active transport that moves the choline into the brain, and by the time you’re in your sixties you have maybe twenty or thirty percent of the transport capability moving choline into your brain that you had as a young adult.
Sandy: But you can overcome that by taking a choline supplement.
Durk: If you don’t have enough choline in your brain, your brain will actually take apart nerves to scavenge the choline from phosphatidylcholine.
Sandy: Nerve membranes, actually. You have phosphatidylcholine in the nerve membranes.
Durk: And the cholinergic nervous system is a “use it or lose it” type system. That is, the activity of cholinergic nerves in the central nervous system causes the release of neurotrophic factors that keep the nerves alive. If you don’t have enough cholinergic activity the nerves start dying back.
Sandy: It’s just like muscles that aren’t used. The same kind of “use it or lose it” type thing.
Durk: So choline works very nicely. You increase the amount of choline turned into acetylcholine with cofactors that are involved in the synthesis. If you look up on the metabolic pathways chart, one of them is Vitamin B-5, calcium pantothenate (pantothenic acid). That works through coenzyme A to increase the acetylation of the choline to form acetylcholine. Another thing that you can do is to take betaine, also called trimethylglycine. It’s another methyl donor. A considerable amount of choline gets eaten up, not to make acetylcholine, but to provide methyl groups—because methylation is an important reaction for all sorts of things, including gene control.
Sandy: So if you have a lot of betaine your choline doesn’t have to be used for the methyl group, and it can be used to make acetylcholine.
Durk: Right. Of the choline that you take, a lot of it gets oxidized into betaine, and by providing the betaine you can reduce that loss. Another thing that you can do is provide other ingredients for neurotransmitters. For example, phenylalanine can be used to make the neuromodulator betaphenethylamine. You need Vitamin B-6 and you need copper. It’s interesting to note that, according to the old FDA standards, before they lowered the amount of Vitamin B-6 that they recommended, something like sixty percent of the population was getting less than the RDA of B-6, which is necessary to form noradrenaline, dopamine, and betaphenethylamine. So you can take a formulation containing phenylalanine and Vitamin B-6, a little bit of copper. Forty percent of the population is not getting the RDA of copper.
Q: What suggestions would you make for couples who are looking to improve their sex lives?
Durk: One of the things that I would suggest is that about 45 minutes before sex they could take something that will provide them with more nitric oxide, particularly the man—that is an arginine, choline, Vitamin B-5 formulation. Another thing is, of course, a drug like Viagra or Cialis. I think that Cialis is more interesting. First, because the timing isn’t anywhere near as critical. It’s effective for thirty-six hours. And secondly, because I really do think that Cialis may have life-extending effects mediated by mitochondrial biogenesis.
Sandy: I think it’s important to realize that we’re saying that may have that effect.
Durk: May. Repeat, may have that effect.
Sandy: This is a hypothesis.
Durk: But, in the meantime, you can have a lot of fun with it!
Sandy: Hahahaha. (laughter)
Q: What are you currently working on?
Durk: Well golly, in addition to our suits against the FDA, we have a ranch with cattle with mitochondrially-elite genomes—and that’s really proving to be very important.
Sandy: Yeah, we selected the cattle so that they were very efficient in feed conversion, and an awful lot of the genes that are involved in feed conversion are those that are used by the mitochondria, because the mitochondria are the center of energy conversion.
Durk: The mitochondria are also what are responsible for being able to survive a blizzard, a drought, or a famine, and they have lot to do with the ability to produce calves and feed them to adulthood.
Sandy: Right, because the mitochondria have their own genome. A lot of people probably still don’t know this but the nuclear genome—the genome that’s found in the cell nucleus—contains most of your DNA, but not all of it. There’s a separate genome that is in the mitochondria. That’s their own genome, and the genome of the mitochondria is handed down only from the mother.
Durk: If you look at ranching publications you’ll see full page ad after full page ad for prize bulls, bull semen, and so forth, and you do need to have good bulls if you want to have good calves, because fifty percent of the nuclear genome is supplied by the bull. Also, some of the proteins that are produced by the nuclear genome are imported into the mitochondria. But there’s a limit as to how far you can go if you don’t have the right mitochondrial genome to start with. So we developed a selection process to get a very good and efficient mitochondrial genome. In fact, it’s so efficient that our calving efficiency this year is ninety-seven percent.
Sandy: Ninety-seven percent of the cows had calves. And remember, these cattle are living like wild animals. They have to take care of themselves in the winter. There’s nobody out there helping them have a calf. They’re doing that all on their own.
Durk: Most ranchers consider themselves doing well if it were in the low to mid eighties, and the University of Nevada brags about their experimental cattle herd. They had a ninety-one percent calving efficiency this year, but they admit that they have calving barns. The calves are born in the barns, and they have veterinarians on call 24 hours a day to help the cows. Ours did it all by themselves out in the field. Ninety-seven percent is absolutely unheard of.
Sandy: So what we did was we got the cattle from herds where they had these very widely distributed cattle over thousands and thousands of acres, and where the cattle were basically taking care of themselves. They were also from these areas where there’s very little scrub to eat. They’re able to manage on very small amounts of food.
Durk: What we did was we found the worst ranges in Nevada, and Nevada’s got a lot of desert. It’s got a lot of pretty hard scrabble range, and I found the worst I could find in Nevada. The rancher was going out of business there. I didn’t buy the cattle that hung around the ranch house and got supplementary feed during the winter. I waited until they were just catching what they call the “wild cows”, where a whole team of cowboys might catch one or two or three of them a day, far far out in the middle of nowhere. And, incidentally, the winter range for these cattle was—so help me God—a place called Last Chance Gulch (laughter), which is a canyon coming off Death Valley. And, man, I have never seen such a barren place. (laughter)
Sandy: So it worked like a charm. Our cattle do extremely well.
Durk: So to make sure that our hypothesis about the cattle was right, for two winters we put them up in a seventy-four hundred foot high valley during the winter—something that you’d never do if you were in your right mind. And they not only survived, they had calves during the winter.
Sandy: Yeah, that’s amazing.
Durk: And the calves survived.
Sandy: And we keep the same maternal line, so we’re continuing with the maternal genome for the mitochondria that we selected them for.
Durk: Yeah, it doesn’t get diluted by the bulls. A hundred generations from now it’ll be the same mitochondrial line.
Q: When I interviewed British biochemist Aubrey de Grey for this book he suggested that we move the DNA from the mitochondria into the cell nucleus as a step toward extending human life.
Durk: I think that there may be problems with that. It’s an interesting hypothesis. Aubrey de Grey thinks that maybe we should move the DNA from the mitochondria into the nucleus because there’s far less free radical activity in the nucleus than in mitochondria. Now, the thing is a lot of genes have moved from the mitochondria to the nucleus. It’s happened over the past couple of billion years. So it’s already happened to some extent. What I think is that it’s going to be very difficult to move the remainder because if it weren’t it would have already happened. Many of the genes that are involved in specifying proteins for the mitochondria, in fact, are now found in the nucleus.
Sandy: Yeah, and presumably they remain there because it was an advantage to the animals that had that happen.
Durk: I suspect that if you move the remaining genes from the mitochondria to the nucleus you’ll end up frying the nucleus, just like the mitochondria fry themselves. But you’ve only got one set of genes in the nucleus, whereas a typical cell has about twenty thousand sets of mitochondrial genomes in twenty thousand mitochondria.
Sandy: Yeah, because remember that there’s a tradeoff. It’s true that the mitochondria genome does not have anywhere near the kind of DNA repair mechanisms as the nuclear DNA, but there’s a lot more of it. There are large numbers of mitochondria in each cell, so you have a large number of sets of the mitochondrial genome in each cell, whereas you only have one set of the nuclear DNA in each cell. So it’s a tradeoff. And I think that if we’re able to use those mechanisms that we were discussing before, for increasing the number of mitochondria, and regenerating the mitochondrial genome, then, actually, it could be an advantage to leaving the genes in the mitochondria.
Q: Is there anything we haven’t spoken about that you would like to add?
Durk: I think that one of things that people really need to look at is the government entitlement systems for people as they age. They are really completely unsustainable, and if something isn’t done about it now, there’s going to be a crackup and perhaps even a war between generations. And that would be very bad for life expectancy.
Sandy: Yeah, when you think about it, the Constitution was a very noble model for a government, but perhaps they didn’t realize the problems that it would cause. And maybe you couldn’t even write this into a constitution, really. The problem is that once people find out that they can vote for benefits to themselves, and that other’s people’s stuff can be taken and given to them, it just becomes very difficult to control that. I mean, how do you prevent people from taking advantage of a system where you can just vote yourself money out of somebody else’s pocket?
Durk: It’s inherently unstable. Now, one of the ways of dealing with that would be to have a system where to increase a tax you might require a three-quarters vote, or to expend money in an appropriations bill you might require three-quarters vote, effectively. If one quarter plus one vote voted against it, then the money couldn’t be spent. That would be a very effective limit on spending money. But, of course, you’re going to have a very hard time getting that put into the Constitution nowadays, because so many people are getting so much money from the federal government.
Sandy: Actually, you can put anything that you want to into the Constitution, but you can’t change people’s natures. That’s a problem that we’re going to have to deal with. Whatever the Constitution is that you have, people can decide that they want to misunderstand or modify the meaning of what was originally put into it, so as to get benefits for themselves at someone else’s expense. That’s a problem.
Durk: One thing we’d like to suggest that you do is you interview a gentleman named Don Ernsberger, whom we’ve known from the 1960s.
Sandy: He’s an aide to Congressman Rohrabacher.
Durk: Dana Rohrabacher. Don Ernsberger has written a bill, which Rohrabacher has introduced, which would eliminate most of the problems with the high cost of drugs.
Sandy: That bill was introduced last year.
Durk: Yeah, and what this does, effectively, is it eliminates the Kefauver amendments to the Food, Drug, and Cosmetic Act. Before the Kefauver amendments of 1962 the FDA simply ruled on safety. They left efficacy determinations to the marketplace, to doctors and patients. And in fact a good economist by the name of Sam Pelzman examined the record since, before and after 1962, to see whether the Kefauver Act resulted in fewer ineffective drugs, and there’s no difference in the percentage of drugs that are ineffective. But the proof of efficacy costs an order of magnitude more than proof of safety. So that’s a big part of the cost and it’s also a big factor in slowing down the availability of drugs. Another factor that really jacks up the cost of even generic drugs is the FDA’s Good Manufacturing Practices, which are 747 pages of bad manufacturing practices.
Sandy: Yeah, they have them for drugs, and they’re about to introduce them for dietary supplements.
Durk: Effectively, they prevent the use of modern techniques, such as statistical quality control, which is what turned Japanese products from a laughing stock that was synonymous with crappy quality to the best products in the world. You can not use that under Good Manufacturing Practices.
Sandy: With the Good Manufacturing Practices they actually design your plant for you. It’s a lot more than telling you how to manufacture. They tell you how your plant needs to be laid out, and where your various machines have to be located. Also, you’ll notice—and this has been the case since the 1930s—you have no 4th Amendment rights anymore. The FDA doesn’t require a search warrant in order to go in and examine your plant. They send inspectors around. Those people don’t need warrants. These are warrantless searches, and nobody’s thinking anything about them, I guess, because they’ve been around so long.
Durk: Now, the Health Freedom Act would eliminate the requirement for GMPs on off-patent, generic drugs imported from overseas. The FDA would be allowed to test them for purity, and if they meet the same purity specifications as the American drugs that the FDA has approved, then that’s it. It doesn’t allow importing drugs that are in violation of a valid U.S. patent. But what this would mean is that you would be able to get a suite of antihypertensive and antihypercholesterolemic drugs for fifty cents a day instead of five dollars a day. So this thing about the Medicare drug benefit would be irrelevant. Nobody would be screaming for help to pay for their drugs if everyone could get everything they needed for four bits a day.
Sandy: All of the reputable economists agree that if we’re going to have regulations concerning manufacturing, then what you should have is a standard that the final product has to meet. The final product would have to meet the standard, and that would be how they would regulate it. But that’s not the way the FDA does it. Rather than that, what they have for the Good Manufacturing Practices is they design the entire process of how you do the manufacturing. It’s an incredibly complex list of regulations, and it’s probably impossible for anybody to really comply with all of them.
Durk: The thing is, the biggest barrier between life extension and people is the FDA, by far. It’s not ignorance. It’s the FDA.
David Jay Brown is the author of four volumes of interviews with leading-edge thinkers, Mavericks of the Mind, Voices from the Edge, Conversations on the Edge of the Apocalypse, and Mavericks of Medicine. (Mavericks of Medicine will be published by Smart Publications as a book in late 2006.) He is also the author of two science fiction novels, Brainchild and Virus. David holds a master’s degree in psychobiology from New York University, and was responsible for the California-based research in two of British biologist Rupert Sheldrake’s bestselling books on unexplained phenomena in science: Dogs That Know When Their Owners Are Coming Home and The Sense of Being Stared At. To find out more about David’s work visit his award-winning web site: www.mavericksofthemind.com.
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