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Star Scientific Under Scrutiny by FDA – The Hits Keep Coming. . .

20 comments

Star Scientific, Inc., the Virginia based corporation being investigated for its role in giving money and other gifts to the family of Governor McDonnell, is also facing the scrutiny of the FDA. Just this week the FDA issued a warning to Star Scientific regarding violations in the marketing of the dietary supplement, Anatabloc, and the smoking cessation product, CigRx.

In 2012, Star Scientific was primarily known for the “manufacturing, distribution and sale of [the] company’s dissolvable smokeless tobacco products, Ariva® and Stonewall Hard Snuff® “. The company announced the discontinuation of its tobacco product line on December 14, 2012, citing, ”continued losses and low sales for our dissolvable tobacco products over the last several years.”  It went on to say, “The Board’s action was further influenced by the fact that continuing to manufacture dissolvable tobacco products has had a negative impact on our ability to interest leading scientific and medical research centers in undertaking clinical research related to our anatabine compound in managing excessive inflammation.”

Anatabine,  a naturally occurring substance found in tobacco and other foods, is the main ingredient in Anatabloc.  Anatabine is new to the market with little research to substantiate Star Scientific’s claims.  This week the FDA issued a warning to the former tobacco product manufacturer about Anatabloc, Star Scientific’s so-called dietary supplement. The FDA letter stated that the dietary ingredient was being promoted as having curative properties and therefore required pre-market approval from the FDA.  Star Scientific claims that Anatabloc can be used to treat various diseases such as multiple sclerosis, Alzheimer’s disease, and ulcerative colitis. By claiming that the supplement may ‘cure’ conditions, Anatabloc falls in the “drug” category and as such must seek premarket approval.

Star Scientific is located in Richmond, VA, where Altria (formerly Philip Morris) calls home.   According to the Washington Post, the company became involved with the governor of Virginia, Bob McDonnell, giving money and other gifts, to the family as early as 2010. Governor McDonnell has apologized to the citizens of Virginia (but he should also thank them because the taxpayers have paid tens of thousands of dollars of his legal fees) , claiming that Star Scientific and its CEO, Jonnie R. Williams, Sr., never received anything in return for the “gifts”.   He has returned the $160,000 and is currently under investigation for his relationship with Mr. Williams. Williams resigned in December 2013, as did the chairman of the board, Paul Perito.

To briefly summarize:  Star Scientific is under investigation for its relationship with the governor of Virginia (i.e., allegedly getting favors from the Governor in return for giving gifts like expensive clothes, a Rolex watch, trip to New York, among others); and the FDA has now issued a warning about Star Scientific’s 2 main products, dietary supplement Anatabloc, and CigRx, a smoking cessation product. The first product contains a tobacco derivative and the second one, CigRx, helps people stop smoking. It’s been less than a year since the company stopped manufacturing and selling ‘dissolvable smokeless tobacco products”. Yet a sizeable portion of its bottom line is still tied to tobacco—whether using it to ‘cure’ illnesses or to help people stop smoking.   It is a rather interesting, and ironic, business model for a self-described company promoting “healthy . . . lifestyles”. [See:  http://www.starscientific.com/2013-09-12-Star-Scientific-Announces-Patent-Claims-to-Anatabine-Citrate-to-be-Granted-by-PTO ]

In an attempt at damage control, last week the stockholders voted to allow the new CEO to change the company’s name to Rock Creek Pharmaceuticals.  Perhaps re-branding will allow the company to hide?  We have seen multiple stories over the past few years about dietary supplement manufacturers’ questionable practices.  For those who argue that the FDA should have stronger regulatoryauthority over supplement manufacturers, the above tactics are yet more evidence in support of that argument.

Changing  a company name does not change the company.  Remember that old saying about putting lipstick on a pig?   It is hard to trust Star Scientific/Rock Creek with the FDA examining it”s conduct with a microscope, and the U.S. Department of Justice investigating the company’s relationship with Governor Bob McDonnell and his family.  Unfortunately, there is little reason to trust anything coming out of Star Scientific, Inc. or Rock Creek Pharmaceuticals.  And, one might say the same about much of the dietary supplement industry.

20 Comments

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  1. D says:
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    Mr. Webb, the company Star did not give the gifts JW provide those gifts under the auspice of Star. As for the science of Anatabine it has and will continue to be proven beneficial. (My personal experience and countless others). What I have found is the increbile coordination on this small company by the media and Hedge Funds. If you want proof of this collusion and coordinated attack simply read “Deep Capture” at DeepCapture.com. Doctors have specifically stated that Anatabloc is a safe and effective product.
    I would only ask that you read the scientific articles on this supplement before passing judgement based solely of the actions of it’s former CEO.

  2. Greg says:
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    I cannot find where the company has ever made these “claims”. There have been (or are currently underway) studies on using anatabine to treat those diseases, but Star has made no such claim.

    You said, “Star Scientific claims that Anatabloc can be used to treat various diseases such as multiple sclerosis, Alzheimer’s disease, and ulcerative colitis.”

    The only thing that I can find are actual published studies or Press Releases that report the results of such studies. In none of these does Star Scientific make “claims” that anatabine can be used to treat a specific disease. Please provide a cite to support your accusations.

  3. Greg says:
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    You said, “The first product contains a tobacco derivative and the second one, CigRx, helps people stop smoking.”

    Both of these products contain the same synthesized form of anatabine. In other words, that anatabine was not “derived” from tobacco. Anatabine is found in tobacco but it is also found in others plants such as tomatoes and peppers.

    My wife and I have been taking Anatabloc for over two years and are praying that the FDA does not screw this up. We do not want to be without our Anatabloc.

  4. Leif Smith says:
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    Please provide evidence that Star has claimed that Anatabloc “cures” a disease. I don’t think they have ever done that.

  5. Dave says:
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    Mr. Webb, I would like to know if you or any of your clients are or have been short sellers of STSI as statements such as yours that do not understand Anatabloc seem motivated at manipulating the value of the stock with false propaganda.

    • Greg Webb says:
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      Dave – I own no Star Scientific of which I am aware, unless it is part of some mutual fund in my 401(k). I certainly am not trying to manipulate the market – I really do not think this little ole’ blog has that kind of reach. Sorry to disappoint you.

  6. Tom says:
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    Mr. Webb, as a user benefiting from Anatabloc and a Star shareholder, I am happy with the new management. I’ve heard from other shareholders we agree that Dr Mullen’s qualifications lend perfectly to certain needs at Star. Dr Mullen through his work at Roskamp Institute knows anatabine probably better than anyone. I disagree with you, there is reason to trust.

    Lipstick on a pig, really!? I don’t think Dr. Mullen or the share holders see it that way. There are many of us, satisfied users who trust Anatabloc and don’t what anyone to prohibit our access to the product or use. Anatabloc is a wonderful product.

    Thank you for letting me share the good news.

    Turn back the clock with Anatabloc!

    • Greg Webb says:
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      Tom – I hope Antabloc continues to work for you – hopefully there are no bad side effects. The tobacco connection would concern me some – just make sure you know what you are taking. Again, no class action trolling (I do not handle that type of litigation), just want to get the word out. I am actually interested in people taking safe products and not getting taken advantage of by companies selling snake oil. Thank you for commenting.

  7. Tom says:
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    Check your facts before writing your next article! Trolling for a class action suit?

    • Greg Webb says:
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      Tom – No, not looking for a class action suit. FYI, Virginia does not have a class action statute available under its state law. It would have to be a federal case. Furthermore, I do not see any grounds for a class action at this point. Sorry to disappoint you.

  8. Dave says:
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    Mr. Webb: Your are an attorney where is your full discloser statement do you own any shares or have your or clients sold shorted shares or Naked shares of STSI seems your articular is nothing more than manipulation which is illegal. Cheers!

  9. greg booth says:
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    My doctor told me about Anatabloc. It does work for many people for a variety of inflammation-related ailments and with no adverse side effects. I think the company has been very careful about making any claims about its product. And by the way, a study done with the active ingredient and its effect on head trauma in mice was funded in part at least by the DOD. That is a fact.

  10. dave ferguson says:
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    I have been a grateful and very satisfied user of Anatabloc since Oct. of 2011. I am 73 years old and am feeling better than I have in at least 20 years. My last CRP reading was .10 and my Dr. asked me to bring my bottle of A to my next appt. I did and he was suprised to see it was the same compound another patient had shown him as it was helping her joint pain. Your incorrect statements regarding the company’s claims as referenced above needs to be corrected by you.

  11. AntBloc hater says:
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    Star is the worst company I have come across in the last few years, the company is has been Unloading millions of shares on the public for years and just recently increased their total share count by a whopping 50%. I have no idea why this trades on the Nasdaq in the first place, hoping the SEC shuts them down soon…
    PS I love all the morons who come on trying to defend their snake oil company by attacking a legitimate write up. this Bozo the Clown operation needs to be Exposed!

    Mr Webb, please appeal to the SEC to shut this company down before they are allowed to dump even more share onto the naive public!

  12. Tom says:
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    Dave, Mr webb answered part of your question, why didn’t he give you a full answer?

  13. David Lloyd-Jones says:
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    My father was a brilliant pharmacist: he and my mother were leeaders in bringin our village, then township, then county kicking and screaming into the twentieth century when we immigrated in 1954.

    I have an uncle who always carried $50,000 around in his pocket. Once or twice in his life he’s used it to buy a horse, but a a rule it’s for “anything you buy by the tank-car, and sell in little itsy-bitsy bottles.” That’s an investment he makes every few years, every time he sees a fun proposition.

    This thing here looks to me like one of those fun propositions: a couple or three generic medicines that won’t do any harm, and ust might do a wee bit of good, put your own label on it, and jack up the price.

    At $4.95 it might be a fine anti-inflammatory — but green veggies and a baby aspirin might better. At ninety-nine buck, three for $270.00, it’s Nutsy the Squirrel time — one of those things that lets my uncle buy horses, which don’t show much of a profit, or so he can invest in the next tank-car of anti-inflammatories or whatever’s in fashion…

    Your Governor? Hunh? He believes in truth-in-labelling, too. You folks knew he was a Republican. What got inta’ yas?

    -dlj.

  14. greg booth says:
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    I just came across this story while doing research on anatabine. It is unfortunate that this company is experiencing so many distractions as hundreds of people benefit from Anatabloc for a variety of ailments related to inflammation–including their three professional athlete spokespersons. My doctor told me about Anatabloc and takes it himself. I think some people need to do some more research here.

    • Greg Webb says:
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      Mr. Booth,

      Where are these “hundreds of people”? Who is your doctor and what is his specialty? What type of doctor is he and what are his qualifications? Has he received any payment(s) from Star Scientific, directly or indirectly? I agree that some research needs done – on Anatabloc and its long-term efficacy. I do not dispute that there are some beneficial “dietary supplements”, but this one comes with a lot of skepticism, not just by me, but by a whole pile of people a lot more qualified, including the former Virginia Secretary of Health and doctors at the UVA and VCU Medical Centers.

      Greg Webb