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Durk Pearson and Sandy Shaw – 2

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 causearrhythmias.

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.


Durk: One of the most important mechanisms is free

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