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Could you get mad cow from a pill ?

Could you get mad cow from a pill ?
Some doctors say a class of pills that promise smarts, energy, and sexual vitality may cause mad-cow disease.
The government isn't worried. Should you be?

June 1, 2001 Health Magazine by Susan Freinkel

DATELINE: SIDNEY, Neb.

BODY: ON SEPTEMBER 27, 1997, an otherwise healthy Barbara Poulter noted in her journal that she was seeing brown spots. Ten days later she was blind. In another week, her coordination went missing and her speech failed her. By the end of November, she was bedridden with violent seizures. On December 14, she died. Her son, Terry Singeltary, was by her side through her rapid decline, and he became obsessed with the sickness that destroyed her: Creutzfeldt-Jakob disease. As he soon learned, CJD belongs to a lethal family of diseases that waste victims' brains by riddling them with spongelike holes. The more the retired machinist dug into the issue, the more he was convinced that what had really killed his mother, and countless others diagnosed with CJD, was the related, better-known scourge, mad-cow disease.

A weird coincidence helped cement this belief in Singeltary's mind. Though CJD is a rare disease, his next-door neighbor's mother also succumbed to it. When the neighbor was clearing out his mother's effects, he came across some strange nutritional supplements the woman had been taking. "Hey, Terry," the neighbor called across the backyard fence, "take a look at these." The pills were what is known in the industry as glandulars--ground-up dried animal glands and tissue, most often derived from cows. Though glandulars make up just a minute part of the supplement industry's sales, you can find them in any health food store, marketed under no-nonsense terms such as Raw Pituitary (taken for energy) or coy names such as Brain Nutrition or Ultramale (a formula containing, the industry's euphemism for testicle). When Singeltary saw what was in his neighbor's pills, he gasped. There was bovine brain, eye, and bone--the tissues most likely to harbor the rogue proteins known as prions that are thought to cause mad-cow disease. "These are the most infectious parts," Singeltary exclaimed. As he later began insisting to anyone who would listen, "This isn't merely cow in a pill, it's mad cow in a pill."

It's easy to dismiss Singeltary as a grief-stricken crank, and many have. He's a high-school dropout; most of what he's learned about mad cow has been garnered from obsessive Web surfing. But lately folks with much better credentials than his have been echoing his concerns. In a letter last year to the prestigious New England Journal of Medicine, a Maryland doctor pointed out that the supplement industry is so loosely regulated that prion-contaminated products could easily find their way onto American shelves. The scientific experts who advise the Food and Drug Administration on mad-cow policies came to much the same conclusion when they met in January. "It's important to know these products are safe," the group's chairman, Paul Brown, a neuroscientist at the National Institutes of Health, said at the close of the meeting. "I think we've heard enough evidence to suggest they may not be."

Nonsense, say U.S. regulators. Experts agree there's no evidence that anyone, including Singeltary's mother, has caught the human version of mad-cow disease in this country. What's more, regulators say they've blocked the routes by which pills could be tainted. There's no way, according to them, that manufacturers could use diseased cattle, whether raised here or in countries where bovine spongiform encephalopathy--the scientific name of mad-cow disease--has become a crisis.

Is the source safe?

In ten years of testing, the USDA has only 13,000 cows.

"Hell, we raise 100 million cattle a year in the United States," says one critic.

On the domestic front, the U.S. Department of Agriculture has monitored American cattle for the disease since 1990 and has yet to find a single case. "There's no evidence of BSE in this country,'' asserts USDA veterinarian Linda Detwiler, the agency's point person on mad cow. And the USDA says a 1989 ban on the importation of cows or sheep from the United Kingdom (later expanded to include all of Europe and to cover organs and glands) has kept potentially infected animal parts from crossing the U.S. border. Meanwhile, for nearly a decade the FDA has cautioned supplement makers about the risks of using bovine ingredients, and since 1995 it has threatened to detain shipments of high-risk animal parts unless the organs come from safe countries.

Phillip Harvey, scientific director of the National Nutritional Foods Association, says "most, if not all" companies use tissue only from cows from disease-free countries. Some have switched from bovine tissue to tissue from pigs. To Harvey's thinking, a person is more likely to be hit by lightning than to catch a prion disease from a supplement. "The risks are basically zero, he says, pointing to the formidable barriers the United States has put in place against BSE. "And the walls are getting thicker and taller."

So why are top-notch scientists concerned? When the FDA advisory task force on glandulars met last winter, the group asked the FDA to consider barring people who use the supplements from donating blood. As task force chairman Brown wryly said, "There is a spongy quality to the precautions."

First, the trade bans have been leaky. At the height of the BSE epidemic in England, and after the USDA ban had gone into effect, that country shipped tons of bovine by-products to the United States.

And critics question the much-vaunted safety of American cattle. In ten years of testing, the USDA has checked about 13,000 cows. "Hell, we raise 100 million cattle a year in this country, notes investigative journalist John Stauber, coauthor of Mad Cow USA, Could the Nightmare Happen Here? Stauber and others believe the agency isn,t testing enough cows to detect a low-level outbreak of BSE. By contrast, Germany--which for years insisted its herds were free and clear--checked 270,000 cattle between last November and March and found 40 infected with the disease.

But the FDA advisory committee believes the biggest problem is the limited power of the FDA. Though the agency is the official watchdog of the supplement industry, it has no teeth--it cannot pull a single box from a store shelf unless it can prove beyond a doubt the product pose a danger.

Nor does the agency have the man power to regularly check imports entering the country or to inspect more than 60 supplement-manufacturing plants out of 1,O00--a year. And currently it can't require the makers of glandulars to tell people if they're buying bovine tissue. Even if companies wanted to, there's no method available to test the pills for prions. "The plain fact of it is the FDA is so feeble that there's no way of knowing whether a dietary supplement has British cow brain in it," says Peter Lurie, deputy director of the Public Citizen's Health Research Group and a member of the advisory committee.

To be sure, many companies follow the rules, buying organs only from BSE-free countries and opening plants to USDA and FDA inspectors. But the supplement industry is also rife with shadowy, hard-to-trace outfits. One pill with the name Meganephrine--it contains 190 milligrams of brain tissue--is made by Cardiovascular Research. The label places CR in Concord, California, but there's no phone listing, nor does it turn up on an Internet search. The company may scrupulously follow regulations. Or it may not: It'll be tough for a regulatory agency to find out. As one FDA official recently told the New York Times, "We rely on the industry to do the right thing."

That's scant comfort to skeptics like the NIH'S Brown. "As long as the FDA has no power to compel companies to prove that the source of their glandulars is safe, then we're working on faith. And faith generally doesn't work in business." In the end, Brown thinks the strongest argument against glandulars has nothing to do with mad-cow disease. Extracts of pituitary, thymus, ovary, or other glands are powerful enough to upset a person's hormonal balance. Endocrinologists report seeing women who sprouted facial hair because an adrenal formula sent their testosterone levels soaring. Others suffered heavy menstrual bleeding when they went off an ovary preparation. In the worst cases, a supplement can cause a person's own glands to cease working altogether.

And there's no research to suggest that the pills have any health benefits. Add up the potential risks, and you might wonder why anyone would take these supplements. "I just don't think it's very smart to eat materials derived from animal glands," says Brown. "As long as people are taking these pills, any mistakes could have terrible consequences."


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