‘All-natural’ Viagra alternatives can be dangerous

LOS ANGELES – Many of the pills marketed as safe herbal alternatives to Viagra and other prescription sex medications pose a hidden danger: For men on common heart and blood-pressure drugs, popping one could lead to a stroke, or even death.

“All-natural” products with names like Stamina-RX and Vigor-25 promise an apothecary’s delight of rare Asian ingredients, but many work because they contain unregulated versions of the very pharmaceuticals they are supposed to replace.

That dirty secret represents a special danger for the millions of men who take nitrates – drugs prescribed to lower blood pressure and regulate heart disease. When mixed, nitrates and impotency pharmaceuticals can slow blood flow catastrophically, leading to a heart attack or stroke.

An investigation shows that spiked herbal impotency pills are emerging as a major public health concern.

Emergency rooms and poison control hot lines are starting to log more incidents of the long-ignored phenomenon. Sales of “natural sexual enhancers” are booming – rising to nearly $400 million last year. And dangerous knockoffs abound.

At greatest risk are the estimated 5.5 million American men who take nitrates.

James Neal-Kababick, director of Oregon-based Flora Research Laboratories, said about 90 percent of the hundreds of samples he has analyzed contained forms of patented pharmaceuticals – some with doses more than twice that of prescription erectile dysfunction medicine. Other testers report similar results.

While no deaths have been reported, the investigation found records of emergency room visits attributed to all-natural sex pills in Georgia, Chicago, Philadelphia, San Diego and elsewhere.

An elderly man in a retirement community north of Los Angeles took an in-the-mail sample and landed in the hospital for four days. A Michigan man sued the maker of Spontane-ES, blaming it for the stroke he suffered 20 minutes after taking a freebie that was advertised as “extremely safe.” Tim Fulmer, a lawyer representing Spontane-ES, said the pill did not contain any pharmaceutical and was not responsible for the stroke.

Mark B. Mycyk, a Chicago emergency room doctor who directs Northwestern University’s clinical toxicology research program, said he sees increasing numbers of patients who unwittingly took prescription-strength doses of the alternatives, a trend he attributes to ease of purchase on the Internet and the desperation of vulnerable men. Some herbal labels warn off users with heart or blood-pressure problems if they have taken their medicine within six hours; some doctors say 24 hours or more would be safer.

Some men in their 30s who went to emergency rooms after taking herbal sex pills were presumably otherwise healthy, but they showed the transitory side effects of the active ingredients in regulated impotency pharmaceuticals, such as difficulty seeing clearly or severe headaches, records show.

While public health officials don’t know the extent of the problem, they agree that incidents are vastly underreported, with national tracking systems capturing as little as 1 percent of them. Since 2001, sales of supplements marketed as natural sexual enhancers have risen $100 million, to $398 million last year, including herbal mixtures, according to estimates by Nutrition Business Journal. Some legitimate herbal mixtures claim to work gradually over weeks; it’s the herbals marketed for immediate trysts that often are the problem.

Tight budgets, weak regulations and other priorities limit the FDA’s ability to police the products, often promoted via blasts of e-mail spam and fly-by-night Web sites.

“The Internet poses many enforcement challenges,” said Dr. Linda Silvers, who leads an FDA team that targets fraudulent health products sold online. “A Web site can look sophisticated and legitimate, but actually be an illegal operation.”

In many cases, the ingredients used to alter herbal pills come from Asia, particularly China, where the sexual enhancers are cooked up in labs at the beginning of a winding supply chain. The FDA has placed pills by two manufacturers in China and one from Malaysia on an import watch list.

Pills like Cialis generally retail at pharmacies for between $13 and $20, while herbals can cost up to about $5.

Many health insurance plans provide limited coverage for prescription sex pills, especially for those with health-related difficulties. Few over-the-counter treatments are covered, and herbals aren’t likely to be among them, in part because they’re classified as foods not pharmaceuticals, said Mohit M. Ghose, spokesman for America’s Health Insurance Plans, which represents major health insurers.

Spiked pills have turned up in Thailand, Taiwan, Canada, Australia, New Zealand, Hong Kong, Malaysia, the United Kingdom and the United States, according to testing done by Pfizer Inc., the New York-based pharmaceutical giant that developed Viagra. The company said 69 percent of 3,400 supplements it purchased in China contained sildenafil citrate, the main ingredient in Viagra. Pfizer didn’t check for the patented ingredients of its rivals.

Under U.S. law, because such pills are “dietary supplements” they’re far less regulated than pharmaceuticals and face few barriers to market.

While herbal alternatives often contain exact copies of the patented drugs, some makers tweak the molecules to keep the effect of the original pharmaceutical while avoiding the scrutiny of the FDA and outside testing labs.

Federal officials have only recently stepped up investigations and prosecutions, and in any case the FDA’s recall power is limited. Last week, in response to safety concerns about imported toothpaste, dog food and toys, President Bush recommended that the FDA be authorized to order mandatory recalls of dangerous products.

Currently, recalls are voluntary, and even if the agency determines that a product poses a “significant health risk,” a company can refuse to cooperate. Plus, recalled products are widely offered on the Internet and pills are hard to round up.

During the past year, the FDA has orchestrated eight recalls of “herbal” pills that contained the ingredients found in Viagra, Cialis or Levitra, or their unregulated chemical cousins. Many of the companies were based around Los Angeles.

Spontane-ES and Stamina-RX were made by companies run by Jared Wheat, who’s facing federal charges in Atlanta that he peddled knockoff pharmaceuticals cooked in a Central American lab. Prosecutors tried to keep Wheat from posting bail by asserting that he contemplated killing an FDA investigator and bribing a prosecutor.

Wheat was granted bond after pledging approximately $7.5 million in cash and property; he’s free under home confinement.