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Durk Pearson and Sandy Shaw – 2
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.
David: 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.
David: 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 becomming 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 law suits than anything else–than any single other item in enforcement. And there’s 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 for only drugs, In 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 al 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.
David: 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