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!”

Virginia Gov. Bob McDonnell (R-VA) answers questions following a battleground preservation announcement, August 15, 2013 in Leesburg, Virginia.
It turns out Anatabloc may not have worked so well for former Virginia Gov. Bob McDonnell.

Photo by Win McNamee/Getty Images

Last week, the former governor of Virginia and his wife were indicted for taking more than $140,000 in gifts and loans to allegedly pimp for a small, money-losing dietary supplement company run by a flamboyant businessman with no scientific background. The governor's wife even talked of turning state employees into guinea pigs to test the company's product, according to the indictment.

Ex-Gov. Bob McDonnell and Maureen McDonnell may go to jail for their sins. What’s weirder is this: Star Scientific is still selling its product, despite an FDA warning that this violates the law. The company's former boss, the man who bestowed on the McDonnells golf outings, designer clothes, and a Rolex monogrammed with “71st Governor of Virginia,” is free and cooperating with the feds.

Unseemly as it may have been, the McDonnells' alleged corruption is pretty small beer. The more important issue is why the owner of a small dietary supplement company required—and had the wherewithal to obtain—private help from a top politician.

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The $32 billion dietary supplements industry is the natural home of the American scam artist. The industry relies on the credulity of customers who gobble up weeds and pills and powders that often do not contain what's on their labels, which often make unproven health claims. The industry’s machinations are enabled by weak regulation, and Food and Drug Administration oversight of the industry has been limited by politicians such as Orrin Hatch and Tom Harkin, who despite their political differences share a wonder of vitamins and other supplements.

Is it too much to hope that the humiliation of Bob and Maureen McDonnell could open a few eyes to the vileness of this industry—if only by revealing how influential it has become?

The man who bought down the McDonnells, Jonnie Williams, has a long history of starting companies that get sued and go bankrupt, and of walking away with the cash—he's said to be worth $100 million.

His latest company, Star Scientific, has had a particularly odd run of luck. The company, from which Williams resigned last month, lost money almost every year after going public in 1997. But Williams had a private jet, membership in country clubs, and plenty of spending cash.

One former Capitol Hill staffer spoke of being lobbied around 2000 by Star Scientific executives who claimed they were making safer tobacco products, although the core business was selling generic smokes to poor people. “The whole thing didn't make sense,” he told me. “They claimed to have a public health mission they were financing by selling cheap cigarettes.”

In 2007 Star Scientific stopped selling cigarettes and focused on smokeless tobacco products that it claimed were low in nitrosamines, some of the dozens of carcinogens found in tobacco. In 2012 it dropped the tobacco business altogether and created a partnership with the Roskamp Institute, a private research organization in Sarasota, Fla., to test a product called Anatabloc, which contained vitamins and a synthetically produced tobacco derivative called anatabine.

Star gave Roskamp a large chunk of company stock, and Roskamp started doing research on anatabine.

On July 31, 2011, the day Williams lent Bob McDonnell his Ferrari, the governor ordered the Virginia secretary of health to help arrange trials for Anatabloc as a treatment for autoimmune diseases “at vcu [Virginia Commonwealth University, in Richmond] and uva [the University of Virginia].”

Two weeks later McDonnell and his son played golf at a country club as Williams' guests and charged about $900 in fees, food, and merchandise to Williams' account. On Aug. 30 the gubernatorial couple hosted a launch event for Anatabloc at their mansion. The invitees included academic research scientists whom Star Scientific was wooing to perform clinical trials of Anatabloc. The company's news release said that senior Virginia academic scientists were “interested in studying further potentials for Anatabloc.”  Maureen McDonnell and Williams placed samples of the product at each table setting. Later, she and Williams discussed Star Scientific’s proposal to “perform a study of Virginia government employees ... to determine the prevalences of autoimmune and inflammatory conditions," with some in the group getting Anatabloc.

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.

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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