The Other Drug War

The FDA is wasting its time impeding harmless rice imports while ignoring what may be the fourth-leading cause of death

Last spring, scientists at the University of Toronto announced the results of a new study: By their calculations, the fourth-leading cause of death in the United States is prescription drugs. They weren't talking about drug abuse or overdoses, but rather, appropriately administered, FDA-approved drugs. Side effects, they determined, cause close to 106,000 deaths per year. That's more deaths than the annual totals for AIDS, suicide, and homicide combined, and equal to an astonishing 290 deaths per day.

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As if this news isn't disturbing enough, the Food and Drug Administration -- the government agency charged with monitoring drug safety -- appears to be doing very little to address the problem, and, in some cases, seems to be actively working against less-toxic alternatives to prescription drugs.

While the FDA requires manufacturers to report adverse drug reactions (ADRs), manufacturers depend on doctors to volunteer that information. The agency's mortality numbers pale in comparison to those in the Toronto study: In 1997 the FDA reported "only" 3,200 deaths from side effects. The Toronto researchers, on the other hand, combed 30 years of medical literature (1966-96), extrapolating from 39 studies that met their strict criteria, to arrive at the 106,000 figure. The FDA maintains that its reporting system is not meant to be comprehensive. Rather, its goal is to identify new, previously undescribed reactions. The implication is that the agency is unconcerned with deaths from side effects it already knows about.

"There is nothing we can say about the study," says FDA spokeswoman Susan Cruzan. "The study was an estimate, a meta-analysis. While a significant number of people are affected by ADRs, greater numbers are saved [by prescription drugs]."

Granted, it's not clear-cut -- a drug that stabilizes a life- threatening heart problem may eventually prove fatal to another organ. The need to document such complications is precisely why the Toronto scientists initiated their research in the first place, says Bruce Pomeranz, a doctor who worked on the study. While about one quarter of ADRs are due to allergic reactions, the rest are the result of drug toxicity. "For most drugs, you could take half the [dosage] and still get an effect," he says. "Almost every drug is culpable. A drug as simple as aspirin kills a lot of people." Better hospital monitoring systems, Pomeranz notes, can significantly reduce ADRs by alerting doctors to early signs of problems.

Cruzan says the FDA has no plans to require such monitoring systems, but adds that the agency is revamping its ADR computer system to accommodate the increase in newly approved drugs.

A closer look at the FDA shows that the agency may have its priorities skewed. Take Mevacor (from Merck & Co.), an expensive prescription drug for controlling cholesterol. Elevated cholesterol, a leading risk factor for heart disease, affects some 50 million Americans. By all accounts, Mevacor, with U.S. sales at $875 million last year, has made miraculous inroads in fighting heart disease, the nation's No. 1 cause of death. At the same time, like many prescription drugs, it can aggravate liver problems and cause nausea, headaches, stomach cramps, and diarrhea. Combined with certain other drugs, it can lead to muscle weakness and degeneration. Animal studies hint that it may even raise cancer risk.

Fortunately, there are alternatives. People with somewhat elevated cholesterol may not need Mevacor. They might be treated more easily and cheaply with Cholestin, a safe, natural dietary supplement that has been proven to reduce cholesterol in people with mildly elevated levels.

If the FDA were truly committed to promoting public health, it would welcome Cholestin. But even though it has neither accused Cholestin of being hazardous, nor questioned Cholestin's label claim that it promotes a healthy cholesterol level, the FDA is trying to restrict its sale in the United States.

Cholestin is a variant of Hongqu, a product long marketed in China, made entirely from Chinese red yeast rice. On June 11, 1997, the FDA prevented the importation of several tons of red yeast rice by Cholestin's maker, Pharmanex. The FDA's reason: Cholestin contains lovastatin, a potent cholesterol-lowering compound -- and the active ingredient in Mevacor. (Merck holds the patent on it.) Never mind that lovastatin appears naturally in red yeast rice; the FDA claimed that because Cholestin contains lovastatin, it violates the 1938 Food, Drug, and Cosmetic Act and the 1994 Dietary Supplement Health and Education Act (DSHEA). These laws state that supplements cannot contain prescription drugs.

Now, I'm all for the FDA insisting that supplements be safe, unadulterated, and truthfully labeled. I support the FDA's seizure of supplements that violate these requirements. I also believe that supplements should not contain prescription drugs -- but in the sense that Congress intended, meaning that no supplement maker can mix a prescription drug into a supplement and call the result a supplement.

But Pharmanex does not mix the prescription formula of lovastatin -- which is a purified, crystallized, 100 percent laboratory-synthesized compound -- into Cholestin. Cholestin contains the lovastatin that occurs naturally in a noncrystallized form in red yeast rice.

Shortly after the FDA halted the import of Pharmanex's red yeast rice, the company sued, arguing that, because Cholestin does not include pharmaceutical lovastatin, it does not violate federal laws. This past June, Pharmanex won in federal court. U.S. District Judge Dale Kimball allowed the importation of the rice and ordered the FDA to stop interfering with Cholestin's manufacture and marketing. In his ruling, Kimball wrote that Pharmanex had "raised substantial and serious questions regarding the lawfulness of [the] FDA's interpretation" of the federal statutes that govern it.

Already the FDA is pursuing the matter further. It has a long history of prejudice against herbal medicines and dietary supplements. That's why Congress passed DSHEA -- to discourage the FDA from persecuting products like Cholestin. The agency has chafed ever since. The fight over Cholestin is a test of DSHEA's limits; the battle isn't over.

So, if you have mildly elevated cholesterol and want to try a safer, less expensive natural product before opting for a pricey and possibly more problematic prescription drug, stock up on Cholestin while you can.

Additional reporting by Vicki Kratz.

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