Pro golfer Fred Couples takes the dietary supplement Anatabloc “to help him stay on top of his game”

The supplement, sold in bottles of 300 tablets costing $99.99, reduces inflammation in the 53-year-old golfer’s fingers and shoulders, according to advertising for the product.

Tennis pro John Isner, too, is an Anatabloc fan, saying that the supplement has “enabled me to stay on the court longer and in the gym longer, while at the same time helping with the recovery process.”

“I simply do not feel as sore and fatigued as I have in the past,” Isner, 28, was quoted as saying in a January news release announcing that he had become Anatabloc’s second “brand ambassador,” along with Couples.

The athletes’ paid endorsements, along with other testimonials by a marathon pioneer, an NFL tight end and former professional tennis players, have been part of an advertising and marketing campaign by the company that makes Anatabloc.

Henrico County-based Star Scientific Inc., a small, publicly traded company, is now at the center of a political and legal firestorm surrounding its securities transactions, its research on Anatabloc, and its top executive’s gifts to, and associations with, state politicians.

The company produces the dietary supplement through its Rock Creek Pharmaceuticals subsidiary.

Anatabloc is sold at stores of health and wellness chain GNC, and Star Scientific is trying to get other stores to carry it. For instance, Westwood Pharmacy on Patterson Avenue and Westbury Pharmacy on Three Chopt Road carried the product but have not stocked it for about three months.

Star Scientific promotes Anatabloc through radio and online advertising — and it even has a billboard at The Diamond in Richmond.

Beyond the celebrity endorsements for Anatabloc, Star Scientific has suggested in public statements that the supplement, which contains an ingredient called anatabine along with Vitamin A and Vitamin D3, might be able to do a lot more than just soothe aches and pains.

In its marketing of the product, the company says Anatabloc helps users “reduce inflammation and support a healthy metabolism.”

While Star Scientific has not made any explicit claims that Anatabloc can cure diseases, it has put out at least 15 news releases since April 2010 announcing or detailing various scientific studies backed by the company and indicating that anatabine could mitigate the underlying causes of conditions such as Alzheimer’s disease, multiple sclerosis, thyroiditis and traumatic brain injuries.

The reason for all that, the company says, is because of anatabine’s anti-inflammatory properties.

But no independent research has been done, and Anatabloc, like other dietary supplements, is not directly regulated by the U.S. Food and Drug Administration in the same way that medical drugs are regulated.

Anatabine does appear to be anti-inflammatory in test tube and animal studies, but absent clinical trials in humans, its long-term health effects for people are unclear, said David Schardt, senior nutritionist for the Center for Science in the Public Interest, a nonprofit health advocacy group.

“In this respect, Anatabloc is like a lot of other dietary supplements that make explicit or implicit claims that exceed the scientific evidence,” Schardt said.

Star Scientific declined to comment for this article. A spokeswoman said it would be inappropriate for the company to participate in an article about Anatabloc at this time.

Various websites and social media pages that sell or promote Anatabloc have plenty of consumer comments touting its benefits.

Consumer product reviews on, for instance, include claims that the product helped with chronic sinusitis, skin rash, gingivitis and joint pain, among other maladies.

Yet other consumer reviews say it caused upset stomach, is too expensive, and produced no results.

Richard L. Sharp, the former Circuit City and CarMax executive who suffers from early-onset Alzheimer’s, said in an interview in May while talking about his disease that he took several tablets a day for more than a year until 2012.

“I was popping them like they were Tic Tacs,” said Sharp, who had been named to Star Scientific’s board in March 2011 — five months after officially being diagnosed with Alzheimer’s — but he stepped down nine months later in December 2011.

Sharp said he didn’t think taking Anatabloc helped improve his condition — except he said he lost a lot of weight. Anatabloc is “a great weight loss product,” Sharp said.

The FDA does not directly regulate dietary supplements, but it can order supplements removed from the market if there are health problems.

A spokeswoman for the agency said last week that it has received seven “adverse event” reports related to Anatabloc. An adverse event, according to the agency, is “any undesirable experience associated with the use of a medical product in a patient.”

The Anatabloc tablets, which are smaller than aspirin and come in unflavored and mint-flavored varieties, are meant to be consumed by taking two at a time and allowing them to dissolve in the mouth.

According to the product label, a consumer should take anywhere from six to 12 tablets a day, depending on body weight.

A person weighing more than 220 pounds, for instance, should take two tablets, six times a day, the label says. Someone weighing 121 to 170 pounds should take two of them four times a day.

So, a consumer could go through a $100 bottle of 300 tablets in about one month or so.

At one GNC store in the Richmond area, Anatabloc is sold only behind the counter. A spokeswoman for the retail chain said it does not comment on product placement in stores.

Anatabine itself is an alkaloid found in tobacco and related plants of the Solanaceae family, such as tomatoes, peppers, eggplants and potatoes.

Nicotine, the addictive agent in tobacco, also is an alkaloid. So are opiates and caffeine.

Anatabine, however, typically exists only in trace amounts in plants, said David A. Danehower, a natural products chemist and a North Carolina State University professor emeritus who worked for 31 years in the school’s crop science department.

Alkaloids can have toxic effects, and the reason that some plants produce alkaloids is for defense. “The primary function is to protect the plant against some predator or pathogen,” Danehower said.

The genesis of Star Scientific’s introduction of Anatabloc seems to lie in a controversial area of scientific research on tobacco chemistry indicating that some compounds in tobacco may have beneficial effects, even though cigarette smoking is overwhelmingly bad for a person’s health.

Research into chemicals derived from tobacco for uses other than smoking is not a new field.

In 2000, for instance, cigarette maker R.J. Reynolds Tobacco Co. spun off a drug development subsidiary, Targacept Inc., to develop compounds that the company said could help treat Alzheimer’s disease, Parkinson’s disease, ulcerative colitis and other disorders.

In June 2012, Star Scientific’s Rock Creek Pharmaceuticals subsidiary obtained a U.S. patent covering methods for making anatabine synthetically. In its patent filing, the company said anatabine “is known to inhibit monoamine oxidase, an activity beneficial for treating depression and various other disorders.”

Star Scientific, a former maker of discount cigarettes and smokeless tobacco, has not been profitable for 10 years and is now depending heavily on sales of Anatabloc.

In late 2012, the company exited the tobacco business to focus on dietary supplements.

Star Scientific said sales of Anatabloc rose 127 percent in the first quarter of 2013 compared with the same period a year ago. The company’s revenue of about $2.5 million was almost entirely derived from sales of the product.

In addition to selling Anatabloc tablets, Star Scientific has two other products — Anatabloc Revitalizing Facial Serum, which the company says “can significantly improve tone, firmness and skin elasticity while restoring a youthful-looking eye contour,” and Anatabloc Facial Creme, which the company says could improve skin health.

Star Scientific began selling the cosmetic products at GNC stores this year.

The company has continued to introduce products, promote the supplement and tout scientific research on it, even amid controversy surrounding its chief executive officer, Jonnie R. Williams Sr., and gifts he gave to Gov. Bob McDonnell and his family.

Earlier this year, Star Scientific disclosed a federal investigation of its securities transactions, and several of the company’s shareholders have subsequently filed lawsuits in federal court — and this month in Richmond Circuit Court — alleging that the company misled its investors about scientific research on Anatabloc.

The lawsuits have focused on the company’s statements about research by two scientists who work at the Johns Hopkins University School of Medicine.

The research looked at anatabine’s potential for treating certain types of thyroid disease, but Star Scientific’s stock price took a hit after Johns Hopkins University said the researchers were acting as consultants for the company and not on behalf of the university.

Thyroid disease is just one area of research on anatabine that Star Scientific has been publicly touting.

Much of the research on Anatabloc has been done by the Roskamp Institute, a private research institution in Sarasota, Fla., that focuses on neuropsychiatric and neurodegenerative disorders and addictions.

Star Scientific announced a research partnership with the institute in April 2010, saying that the goal of the venture “is to work as fast as possible to bring to market the first product capable of halting Alzheimer’s and other neurological diseases.”

In the same release, the company suggested that Williams, its CEO, stumbled upon anatabine’s beneficial properties during the years when Star Scientific was selling tobacco products and attempting to find ways of reducing harmful chemicals in tobacco.

“Jonnie R. Williams’ decade-long search for innovative ways to reduce tobacco-related harm fortuitously led to a discovery of a compound that respected and knowledgeable medical researchers at Roskamp Institute believe could play a major role in addressing a variety of neurological conditions, including Alzheimer’s disease,” the company’s president, Paul Perito, said in an April 7, 2010, release.

The Roskamp Institute has performed anatabine studies under a research and royalty agreement with Star Scientific. The company pays royalties of 5 percent of its Anatabloc sales to a for-profit affiliate of the institute.

The affiliate, SRQ Bio LLC, was issued 100,000 shares of Star Scientific stock in April 2010. In 2010 and 2011, Robert G. Roskamp, the founder of the Roskamp Institute, bought thousands of shares of Star Scientific’s common stock, according to regulatory filings.

In October 2010, the Roskamp Institute announced that it was starting clinical trials for the treatment of Alzheimer’s disease using RCP-006, a compound developed by Rock Creek Pharmaceuticals.

Laboratory tests showed that the RCP-006 compound “inhibits inflammation and the production of amyloid, both of which cause Alzheimer’s disease,” the institute said.

“Previous studies have shown that certain tobacco components may be protective against Alzheimer’s disease, but the mechanism was unknown, and the negative effects of smoking and tobacco use outweigh these positive benefits,” the institute said.

Since the announcement of the initial research agreement with the Roskamp Institute, Star Scientific has put out a number of news releases touting positive results in the institute’s studies of anatabine.

Those announcements included the publication of a peer-reviewed article in the European Journal of Pharmacology in October 2011 in which Roskamp scientists described how anatabine, when given to laboratory mice, reduced the amounts of a substance called A-beta that leads to brain tissue damage.

In October 2012, Roskamp researchers presented findings at the annual meeting of the Society for Neuroscience, showing that anatabine could help lessen or reverse the effects of certain neurological conditions, at least in laboratory mice.

In one presentation at the New Orleans meeting, the researchers described a study in which mice were induced to have symptoms similar to Alzheimer’s disease. The mice that were given anatabine “retained their memory and learning compared to untreated Alzheimer’s mice,” Star Scientific said.

In another presentation, Roskamp researchers said that lab mice with traumatic brain injuries had a less severe loss of spatial memory when given anatabine. The researchers said that may have been because anatabine reduced inflammation.

On Oct. 15, 2012, Star Scientific made an announcement that the study indicated anatabine “has the potential to alleviate the negative consequences of traumatic brain injury” which, the company said, affects about 1.7 million people in the United States every year.

In the same release, Dr. Michael Mullan, president and CEO of the Roskamp Institute, said, “Dietary supplementation to prevent memory loss after head injury has a potentially rapid development path for human use.”

In yet another presentation at the Society for Neuroscience meeting, Roskamp researchers said that laboratory mice with induced progressive paralysis — a condition similar to multiple sclerosis in humans — had “reduced neurological disability and improved motor coordination” after taking anatabine.

Researchers from two Virginia colleges — Virginia Commonwealth University and the University of Virginia — received research funding from Rock Creek Pharmaceuticals.

The grants were announced in August 2011 — during a luncheon at the Executive Mansion organized for the launch of Anatabloc by Virginia first lady Maureen McDonnell’s office.

VCU researchers received three grants, each $25,000, to plan clinical trials that would explore the ability of anatabine to reduce inflammation in various disease states, school spokeswoman Pamela Lepley said.

At U.Va., one research project on anatabine was conducted by researchers at the School of Medicine under a $40,000 grant.

The U.Va. research, which also used laboratory animals, looked at the effects of anatabine on inflammatory bowel disease, Crohn’s disease, and ulcerative colitis, according to the company.

A university spokesman said the school cannot disclose or discuss details about the research without approval from Rock Creek Pharmaceuticals. Under the terms of the research agreement, the company would have 30 days to review any disclosure to make sure proprietary or confidential information is not released.

In March, Star Scientific issued a news release saying that the U.Va. research showed “positive preliminary results” in animal models and that based on the preliminary results “a study of the safety and effects of anatabine supplementation in human ulcerative colitis may be warranted.”

According to the company, the study involved giving mice a chemical in their drinking water to induce bowel inflammation.

Mice that also were given anatabine in their drinking water “had a statistically significant lower score in the primary clinical disease activity index,” compared with mice that were given only the disease-inducing chemical.

“Anatabine treatment significantly reduced diarrhea and watery stool during induction of the inflammatory condition,” the company said.

However, once the mice had already developed bowel inflammation, the results were “less conclusive” because the animals drank less water, the company said.

“The initial results of this study suggest that anatabine dietary supplementation may prevent the recurrence (flare-up) of ulcerative colitis or reduce the severity of symptoms in vulnerable individuals,” the company said.

At VCU, each grant provided was aimed at a specific disease area: diabetes, liver disease and HIV/AIDS, Lepley said. The grants were awarded to VCU researchers after a competitive request for applications was issued by Rock Creek Pharmaceuticals in July 2011.

“Our researchers responded to this in order to compete for grant funding,” Lepley said.

Work on the diabetes-related planning grant is still underway, while work on the two other planning grants is complete.

“No physical or clinical research was done with anatabine,” Lepley said.

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Business Editor Gregory J. Gilligan and staff writer Tammie Smith contributed to this report.

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