The Real Scandal in Virginia Is the Supplement Gov. McDonnell Was Pushing

Health and medicine explained.
Jan. 29 2014 11:49 PM

The Real Scandal in Virginia

The governor said an unproven dietary supplement in trouble with the FDA “works for me!”

(Continued from Page 1)

During the launch, Williams presented $25,000 checks to U.Va. and VCU scientists to encourage them to prepare research proposals for studies of anatabine. Although neither university would discuss the matter with me, the indictment indicates that Virginia’s academic authorities, at least, could tell a sow’s ear from a silk purse. According to the indictment, Williams pressed U.Va. officials to plan the trials over the next few months, but they stopped answering his calls. The indictment doesn’t say what happened to the checks.

Star Scientific couldn’t afford the research—which it wanted the commonwealth of Virginia to finance—and it needed the prestige that would come if the studies were conducted at a research university. Whether or not anatabine did well in a trial, the publicity of a trial launch could lift the company’s stock—large chunks of which had been gifted to or bought by the McDonnells. The stock rose in January 2013, for instance, after Star Scientific announced research in mice conducted with scientists from Johns Hopkins—although the university later disavowed any relationship with Williams.

McDonnell was a regular Anatabloc pill popper: “They work for me!” he told his staff. He periodically nagged his staff about U.Va.’s lack of response to Williams, according to the indictment.

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The McDonnell affair is indicative of the supplement industry’s political clout. Supplements are now the biggest industry in Utah—worth more than $7 billion a year—and the industry has provided hundreds of thousands of dollars in contributions to Sen. Hatch, some of whose relatives are in the business.

Doctors prescribe vitamins and other supplements on occasion for people with certain health conditions. But most of the supposed benefits to healthy people are unproven. And “the crazy regulatory quilt has created lots of opportunities for very shady companies to make a lot of profit,” says Pieter Cohen, a Harvard internist who has researched the industry. “It doesn't surprise me that a questionable supplements company would have a lot of money to throw around.”

The FDA made clear in a Dec. 20 warning letter to Star Scientific that the company must stop selling the product. As of last week—two weeks after the FDA’s deadline passed—Anatabloc was still available through a toll-free number and company website.

The company has marketed its product as a “natural” supplement, since anatabine is contained in trace amounts in tobacco and related plants such as tomatoes and eggplant. But the FDA’s letter shot that claim down. The drug is produced synthetically in concentrations well above anything in nature. This means it technically is a “new dietary ingredient.”

That designation requires Star Scientific to conduct some trifling toxicity tests for the FDA. These tests meet a ridiculously low standard—most supplements have not been evaluated with the same scrutiny as the pesticide residues on grapes or the food coloring in Jell-O—but Star Scientific hasn’t submitted even that data to the FDA, according to the warning.

However, in 2012 Star Scientific did file an “investigational new drug” license for anatabine. At that point, according to FDA regulations, the company should have stopped selling the stuff (which it shouldn't have been selling anyway) as a dietary supplement. “That would be like telling FDA you had a new experimental cancer drug, and selling it over the counter while you tested it,” says Cohen. “It makes no sense.”

The FDA also chided the company for suggesting that anatabine had medical qualities. Such claims, often couched in careful language, are the bread and butter of the supplements pitch. The products can legally claim they are “helpful in building a strong immune system” and the like. But Star Scientific, according to the FDA, also broadcast testimonials touting its value against diseases like Alzheimer's, traumatic brain injury, and ulcerative colitis. Such claims are illegal for a drug that isn't FDA-approved.

Anatabloc may fade, but individual supplements regularly come and go, replaced by new products with fresh ridiculous claims. It may take a large lawsuit—possible if someone can produce evidence that a leading supplement is dangerous and not just useless—to slow the industry, says Paul Offit, a University of Pennsylvania pediatrician and author of Do You Believe in Magic?: The Sense and Nonsense of Alternative Medicine. Consumers show no sign of losing their appetite for supplements, despite studies showing they are a waste of money at best, and in some cases dangerous.

“We're back in the Wild West medicine show,” Offit told me. “I have to hand it to the industry—they are so good at convincing people that this stuff is made by elves and hippies in flowing meadows somewhere.”

Actually, much of the stuff is produced in grubby kitchens in China. But the business, as we've seen, is carried out in the halls of Congress and (allegedly) in the Virginia governor’s mansion.

Arthur Allen is the author of The Fantastic Laboratory of Dr. Weigl, Ripe, and Vaccine. He is a health writer and editor at Politico.

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