All-natural sex pills pose hidden dangers

Pills like Cialis generally retail at pharmacies for between $13 and $20, while herbals can cost less than $1, 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 that 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.

Limited regulation
Under U.S. law, because such pills are “dietary supplements,” they’re far less regulated than pharmaceuticals and face few barriers to market. Viagra, by contrast, underwent years of testing before it was publicly available.

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 firm may refuse to cooperate. Plus, recalled products are widely offered on the Internet and pills are hard to round up.

Before a product called Nasutra was recalled a year ago by its manufacturer, the FDA had received a 30-year-old man’s report of a raging headache and an erection that wouldn’t go down. Following the recall, a 32-year-old man reported having spontaneous nose bleeds after taking the pill, records show.

E-mails requesting comment from Nasutra LLC, the company that voluntarily recalled the product in September 2006, were not returned. The FDA says the firm is located in Los Angeles; there is no listed phone number in the region.

Recalls of herbal pills
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 firms were based around Los Angeles, their offices ranging from an unsigned door in a grungy hall on the fringe of downtown to a gated complex near Beverly Hills.

One recall involved a pill called Liviro3.

The current owner of the drug’s marketing and distributing firm said that after he tried the product, he quit his job at a car dealership and bought the brand name and stock of several thousand pills in 2004 for $450,000. In January, he said, FDA agents seized his stockpile after an agency lab found that Liviro3 contained tadalafil, the main ingredient in Cialis. The man told the AP he’d had no idea the pills were drug-laced.

One prosecution involved V. Vigor Corp., the Long Island-based maker of Vigor-25. While the product was advertised as containing Asian ginseng, lycium fruit and Chinese yam rhizome, FDA testing indicated that the pills contained Viagra.

Company executive Michael Peng had agreed to stop selling Vigor-25 following an FDA agent’s visit in late 2004, according to an arrest warrant affidavit. But between then and his arrest in September, at least 4.5 million pills were packaged for distribution, the affidavit said. According to prosecutors, Peng thought he could evade tests simply by switching from the sildenafil citrate he imported from China to Levitra’s active ingredient, vardenafil — a shipment of which U.S. Customs intercepted from Thailand.

Peng, who said through his attorney that he was “unaware that there was anything other than natural supplements” in Vigor-25, faces a charge of misbranding — in this instance, claiming that a pharmaceutical is a dietary supplement.

Two other pills, 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.

Fulmer rejected those assertions, which did not lead to charges, saying Wheat is hardworking and nonviolent. Fulmer said Wheat’s two businesses are legitimate and continue to be successful.

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

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