A federal corruption investigation involving a prominent US governor and his wife over potential gifts from a wealthy CEO of a dietary supplement company?
So what do I find most interesting?
What is in these supplements that made CEO wealthy?
Last week, former Virginia Governor Robert F. McDonnell and his wife, Maureen, were charged with allegedly accepting “loans and gifts of money, clothing, golf fees and equipment, travel and private plane rides ”valued at $ 165,000 from Jonnie R. Williams, Sr., former CEO of Star Scientific.
The 43-page indictment includes the charge that Williams’ backing would in turn garner favor from the governor’s office for his company based in Glen Allen, Va., Under McDonnell’s expressed priority of “promoting the issue and cause of the economic development of businesses and industries in Virginia. ” McDonnell’s campaign slogan was “Bob’s for Jobs”.
Star Scientific has been in trouble lately in part because of US Food and Drug Administration action challenging the company’s marketing of its two main products: Anatabloc, “anti-inflammatory immune system support” and CigRx , for smoking cessation. These concerns culminated in a well-documented warning letter from the FDA to Williams and Star Scientific dated December 20, 2013.
What is anatabine and what is it used for?
The supplement lines contain a natural chemical called anatabine, a close relative of nicotine. Anatabine is a minor component of tobacco and has been used as a biomarker of tobacco use in human studies of nicotine patches for smoking cessation. Anatabine is also found in plants of the nightshade family, food plants such as tomatoes, peppers, cauliflower, eggplants and potatoes.
Anatabine is certainly an interesting chemical from a pharmaceutical point of view. In vitro data with human blood and in vivo studies in mice indicate that it can inhibit the production of cytokines triggered by inflammatory stimulators by preventing the activation of a transcriptional regulatory protein called STAT3. What it is not known is whether anatabine would reach these active levels in people taking the supplements. But that’s what a Phase I clinical trial is for, something that isn’t required for dietary supplements.
In October, the results of a human trial of anatabine (curiously promised in a press release last January) were published online in the Journal of Clinical Endocrinology and Metabolism. Rock Creek funded a nine-site, placebo-controlled clinical trial of anatabine three times a day in 165 patients with Hashimoto’s thyroiditis.
Responses varied greatly from patient to patient: “The mean ± SD TgAb values decreased from 46.2 ± 101.1 and 3.9 ± 83.9 World Health Organization units for the groups. anatabine and placebo, respectively. ” But a significantly higher number of subjects treated with anatabine experienced a ≥ 20% decrease in anti-thyroid antibodies compared to the placebo group. However, 36% of patients reported dizziness even though researchers started with a low dose to prevent this nicotine side effect.
Hashimoto’s chronic lymphocytic autoimmune thyroiditis was the first autoimmune disease described and is characterized by an attack of the thyroid gland mediated by antibodies. The rationale for the study was that tobacco smokers and airline flight attendants occupationally exposed to tobacco smoke in the past suffer from Hashimoto’s thyroiditis at a lower incidence than the total population. These observations have led researchers to hypothesize that something in tobacco smoke could protect individuals against this thyroid disease.
The accounts of this work are tangled and were inaccurate in earlier versions of this article. Some Star-sponsored work on anatabine in mice has been published by Dr. Paul W. Ladenson of Johns Hopkins University, director of their division of Endocrinology, Metabolism and Diabetes. He also commented in a press release from Star about the human studies of the drug he was not involved in. Adam Feuerstein of The Street accused Star Scientific of inappropriately promoting their human essay as being associated with Hopkins. Feuerstein wrote a scorching review of this episode last January. Legal action has been filed alleging wrongdoing by Star Scientific; the company denies any wrongdoing.
(Star Scientific’s vice president of communications and investor relations, Tahlia Tuck, reminded me that Dr. Ladenson was involved in the ASAP trial, not as a site manager but as a “consultant principal in endocrinology for the study, ”as described in their Jan. 7. 2013 press release report.)
Ladenson’s work was supported by private philanthropy, so I took a look at the NIH grants database to see if the country’s medical research agency had funded work on anatabine as a therapeutic agent. So far, only three researchers have received support for work on anatabine, all from the National Institute on Drug Abuse and solely as a biomarker in smoking cessation studies (Dr. Sharon M. Hall , UCSF, 2001-2008; Dr. Stephen S. Hecht, University of Minnesota, 2004-2008 and Dr. Cheryl Ann Oncken, University of Connecticut, 2002, 2006).
Sorry – it’s a drug, not a supplement
From a regulatory standpoint, Star Scientific appears to have started digging its grave since 2010, when they started citing scientific studies on anatabine, carried out primarily on rodents, to make drug claims for their. products on their website. In addition, they marketed their products under dietary supplement claims that anatabine was a natural food constituent.
However, the FDA warning letter of December 20 states,
To the knowledge of the FDA, there is no information demonstrating that anatabine has been present in the food supply as an item used for food in a form in which the food has not been chemically modified. . Although anatabine is present as an inherent constituent of foods such as cauliflower, eggplant, potatoes, and tomatoes, the FDA is not aware of any information indicating that anatabine does. – even is an article used for food. In the absence of such information, anatabine is a novel food ingredient subject to the pre-market notification requirement of section 413 (a) (2) of the Act. [21 U.S.C. § 350b(a)(2)] and 21 CFR 190.6.
As such, the FDA has ruled that Anatabloc and CigRx are adulterated with an unapproved drug, especially since an unidentified company filed a New Drug Investigation (IND) with the FDA in June. 2012. The sponsor is not Star Scientific or Rock. Creek because they still don’t talk about filing an IND until their shareholders’ meeting at the end of last year. When I contacted the FDA for information on the IND sponsor, media manager Juli Putnam reminded me:
The FDA cannot comment on pending / pending product requests. The FDA is only able to provide information on approved pharmaceutical applications. Any information on an application that has not yet received approval or has been denied approval rests with the manufacturer / sponsor developing the drug (21 CFR 314.430).
Star Scientific and their affiliate, Rock Creek Pharmaceuticals, did each other a disservice when they promoted Rock Creek’s U.S. patent for an “improved method of synthesizing anatabine that facilitates large-scale commercial production of anatabine. high purity (US Patent No. 8,207,346) .And just in October, they got another US patent for the citrate salt of anatabine, the form of the drug in their products.
The implication is that the company was not using a plant extract like a herbal medicine company might. Instead, they were making an unapproved synthetic drug that was then formulated into tablets for Anatabloc and CigRx, as well as two facial cosmetics under the Anatabloc brand. While the company claims to have a two-pronged business plan – one for dietary supplements and one for a single-molecule drug product – the FDA makes clear in its warning letter that the supplements are marketed as a non-drug. approved.
In a New Years report, WAMU-FM’s Rebecca Blatt quoted Dr. Daniel Manufacturer from the Food Supplement Programs Division of the FDA,
“The question they are asked is how the ingredient in Anatabloc is a legal dietary supplement? Says Manufacturer. “How can it be sold? “
Putting the chemical structure of anatabine on their labels – incorrectly drawn, by the way – implies for the consumer that a real drug can be found inside.
It’s unclear how Star Scientific, now known as Rock Creek Pharmaceuticals, will react to the FDA warning letter. But following that and the McDonnell scandal, Jonnie Williams stepped down as CEO but will remain for a year as a non-executive. He was replaced by Dr. Michael Mullen, Scientific Director of the Roskamp Institute in Florida, sponsor of an anatabine trial in patients with Alzheimer’s disease.
If you’re interested in learning more about the company, Richmond-based freelance writer Peter Galuszka has a detailed backgrounder on Williams at The hook.
*Correction: I had stated in the original version of this article that Star Scientific inappropriately promoted its ASAP essay as having been done at Johns Hopkins, which Star Scientific denies. A press release of January 7, 2013, which is no longer available on their site but archived at PR Newswire, could give this impression. In a second version, based on reader complaints, I challenged Feuerstein’s report. Upon further examination of the company press releases and Feuerstein columns, I confirm that Feuerstein’s reports accurately indicated that Star Scientific and analysts had presented the ASAP study as being associated with Hopkins and, on the 23rd. January, that Hopkins categorically denied any involvement. Feuerstein also correctly stated that the only real relationship between Star and Hopkins was with the previous preclinical study of anatabine in a mouse model of thryoiditis. I regret the mistakes.