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Rolling Back the Red
| Statin Drugs Cure Alzheimer's Disease!
Statin Drugs Prevent Heart Disease!
These are the fantasy headlines you surely dream about if you're a major player for one of the pharmaceutical companies that manufactures statin drugs. But those headlines won't just magically appear - you have to MAKE them appear. And if you have to enlist the FDA to outlaw a natural over-the-counter supplement that's virtually identical to a statin drug, well that's just part of the marketing process.
Last week I sent you an e-Alert ("Burst of Inflammation" 11/21/02) about a major new study that showed how a marker for inflammation called C-reactive protein (CRP) may be a far more accurate risk assessment for heart attack than elevated LDL cholesterol levels. Statin drugs (like Zocor, Lipitor, Mevacor) are commonly prescribed to lower LDL cholesterol. So this new study is a blow to the statin manufacturers, right?
No. Not in the least.
As I mentioned in that e-Alert, the lead author of the CRP study, Dr. Paul Ridker, announced that he will be the primary investigator in a major four-year study of 15,000 subjects to examine the possibility that CRP levels can be lowered with the use of statins. Wait - it gets better: The trial is being sponsored by AstraZeneca, the maker of Rosuvastatin - the drug that will be used in the trial. And the trial will be overseen by the FDA.
It's too bad that this same sort of major study can't be conducted to test a natural, over-the-counter supplement called Cholestin that has been shown to be just as effective as statins at lowering LDL. But that would be pointless because the FDA outlawed Cholestin. That's right - the FDA forced Cholestin off the market - not because it was dangerous (it wasn't) and not because it didn't work (it did), but because its natural active ingredient was identical to the synthetic active ingredient of one of the major statin drugs.
A supplement called Cholestin is currently available, but it's not the same formula that the FDA sent packing a few years ago. The active ingredient in the original Cholestin formula was red yeast, used for centuries in China as both a spice and a medication to improve blood flow. This nutritional yeast has been used in the U.S. for many years, and tests have shown that it lowers both triglycerides and LDL, while increasing HDL.
One of the components of red yeast, mevinolin, is chemically identical to lovastatin - a synthetic compound (and the active ingredient) in the statin pharmaceutical called Mevacor. Therefore, it's the FDA's position that Cholestin is a drug, not a dietary supplement, because it contains mevinolin. And because the Dietary Supplements Health and Education Act of 1994 (DSHEA) states that substances approved as drugs cannot be marketed as dietary supplements, the FDA banned Cholestin in 1997.
The ban hinges ever so slightly on a timing technicality. If mevinolin had been marketed before lovastatin was approved as a drug in 1987, then the FDA would have to allow its continued use and Cholestin would be in the clear. Never mind that mevinolin was used by many long before 1987 - it just wasn't packaged and marketed, as it later was in Cholestin. If only Mother Nature had been a more astute marketer…
The FDA was supposedly created to protect consumers. But it seems that Merck (the producer of Mevacor) and the other major drug companies that produce statin drugs (Pfizer, Novartis, etc.) are the only ones receiving "protection" here - protection from a highly competitive natural product.
The pharmaceutical giants devote huge amounts of advertising money to sell the public and the medical establishment on the idea that cholesterol is the number one marker for heart disease. So when Cholestin horned in on their little cholesterol party, the drug companies almost certainly "encouraged" the FDA to show Cholestin the door. And they did.
Now, with the anti-cholesterol market all to themselves, the drug companies have recently stepped up their efforts to portray statins as much more than a cholesterol drug. For instance, last month I sent you an e-Alert ("The Light at the End of the Tunnel Vision" 10/31/02) about a major statin study that made the audacious speculation that if 10 million people at risk of heart disease were to use statins as a preventive measure, it would save 50,000 lives each year - almost 1,000 each week. They went on to say that statins work equally well for men and women, young and old, and are safe and effective for all. This is quite a sales pitch: Everyone line up for your "safe" dose of statins.
I see articles similar to this all the time - the most recent claiming that statin use may prevent Alzheimer's disease. The key concept here is "prevention." In other words, Merck, Pfizer, et al, would love to see the day come when everyone everywhere takes a statin capsule right along with their daily multivitamin. Side effects? Oh just a little liver damage, nerve damage, sexual dysfunction, depletion of antioxidants and insulin resistance. But not to worry! Because they have plenty of other drugs to address all of those problems, too.
In the controversy over C-reactive protein last week, perhaps the most amazing detail revealed by the extensive study of over 27,000 subjects was this: Those with high CRP levels were found to be at a substantially higher risk of heart attack and stroke, EVEN WHEN THEIR LDL WAS LOW - completely contrary to what the conventional thinking (so aggressively promoted by the drug companies) would have us believe.
On the heels of this information, when one doctor observed that an intake of omega-3 fatty acids has been associated with lower levels of CRP, I couldn't help but wonder if someone at the FDA may have already set the wheels in motion for a campaign to "protect" us from flaxseed and fish oil capsules. Knowing how they work, I'm going to stock up now.
To Your Good Health,
Jenny Thompson
Health Sciences Institute
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