Terra Sigillata

Perhaps the #1 reason I started this blog was to distinguish therapeutic natural products (i.e., single chemical entities derived from plants, microorganisms, etc.) from questionably-marketed herbal and non-herbal dietary supplements. After doing research and teaching in this area for at least 13 or so years, I have found that patients with cancer and HIV/AIDS are most often preyed upon by unscrupulous marketers.

Hence, I was delighted to see this action from the US FDA today. I can add nothing more to their press release other than my thanks and encouragement to do more in this regard:

Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet.

Those companies and individuals warned, the complete list of fake cancer ‘cure’ products and their manufacturers along with a consumer article on health scams can be found here, http://www.fda.gov/cder/news/fakecancercures.htm.

“Although promotions of bogus cancer ‘cures’ have always been a problem, the Internet has provided a mechanism for them to flourish,” said Margaret O’K. Glavin, the FDA’s associate commissioner for regulatory affairs. “These warning letters are an important step to ensure that consumers do not become the victim of false ‘cures’ that may cause greater harm to their health.”

The FDA urges consumers to consult their health care provider about discontinuing use of these products and to seek appropriate medical attention if they have experienced any adverse effects.

The products contain ingredients such as bloodroot, shark cartilage, coral calcium, cesium, ellagic acid, Cat’s Claw, an herbal tea called Essiac, and mushroom varieties such as Agaricus Blazeii, Shitake, Maitake, and Reishi.

Because these products claim to cure, treat, mitigate or prevent disease, and these products have not been shown to be safe and effective for their labeled conditions of use, they are unapproved new drugs marketed in violation of the Federal Food, Drug, and Cosmetic Act.

Examples of fraudulent claims for these products include:

* “Treats all forms of cancer”
* “Causes cancer cells to commit suicide!”
* “80% more effective than the world’s number one cancer drug”
* “Skin cancers disappear”
* “Target cancer cells while leaving healthy cells alone”
* “Shrinks malignant tumors”
* “Avoid painful surgery, radiotherapy, chemotherapy, or other conventional treatments”

The Warning Letters are part of the FDA’s ongoing efforts, in collaboration with the Federal Trade Commission (FTC) and Canadian government agencies, to prevent deceptive products from reaching consumers. The initiative originated from consumer complaints and a web search for fraudulent cancer products conducted by the FDA, FTC and members of the Mexico-United States-Canada Health Fraud Working Group. Earlier this year, FTC sent Warning Letters to 112 Web sites falsely promoting cancer “treatments” and referred several others to foreign authorities.

Parties that fail to properly resolve violations cited in Warning Letters are subject to enforcement action up to and including seizure of illegal products, injunction, and possible criminal prosecution.

Consumers and health care professionals should notify the FDA of any complaints or problems associated with these products. These reports may be made to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.

To read about efforts in Canada to educate consumers about health scams, go to http://www.competitionbureau.gc.ca/epic/site/cb-bc.nsf/en/02614e.html .

Comments

  1. #1 blf
    June 18, 2008

    Some of them are bogus. Not all! But what REALLY happened is one of them’s real and works, and Big Pharma’s Lizard Overlords were worried that if the news got out, the captive market for toxic-laden worthless pills and potions would vanish. So Ultra Top Secret orders were sent to Teh Shrills to Exterminate! Exterminate! Exterminate! the cures. So the FDA got busy, dusted off its one inspector, and banned the real cure plus, as a distraction, lots of others (providing a further distraction in that most of those really are bogus). Now Teh Big Pharma Lizard Overlords can rest easy for awhile, raking in the massive bucks whilst the people SUFFER!!1!

    </snark>

  2. #2 Abel Pharmboy
    June 18, 2008

    blf wins the internets (yes, we have a sense of humour here!)

    Interesting that of those on the list of fake cures, ellagic acid may at least have cancer chemopreventive activity in rodents at reasonable doses. Gary Stoner at Ohio State recently published a series of articles on the chemopreventive activity of black raspberry extract, of which ellagic acid makes up a significant fraction. They’ve even formulated it into a mucoadhesive gel for direct use on oral cancers and Barrett’s esophagus.

    But what often happens is that when a natural compound or extract is shown to kill some human cancer cell line in culture, marketers jump to use the in vitro publication to provide “scientific support” to market their “cancer cure.” A fine balsamic vinagrette will also kill cancer cells in culture yet we don’t market it as a cure for cancer.

    I’ve got to say that I’m really impressed to see FDA taking a stand against “23 U.S. companies and two foreign individuals.” But just a simple internet search tells me that there are a few hundred others out there.

  3. #3 J-Dog
    June 18, 2008

    But, what will noted DCA advocate DaveScot Springer do now?

  4. #4 Karl Schwartz
    June 18, 2008

    Abel,

    Welcome back, dear prodigal son!

  5. #5 James C. Coyne
    June 18, 2008

    I would not expect them to, I but wonder if they should include claims about psychotherapy extending the lives of cancer patients? Claims that psychotherapy extends lives are medical claims and ought to be evaluated accordingly.

    My recent review article carefully considered and rejected widely publicized claims that psychotherapy promote survival, including claims based on Spiegel’s 1989 study in the Lancet. We should stop misleading cancer patients about the promise of psychotherapy.

    Coyne, J. C., Stefanek, M., & Palmer, S. C. (2007). Psychotherapy and survival in cancer: The conflict between hope and evidence. Psychological Bulletin, 133(3), 367-394.

    jcoyne@mail.med.upenn.edu

  6. #6 Mike Tripp
    March 7, 2009

    Some of you may write me off as a Bozo, but the herbal tea, Essiac, has proven to me that natural medicines work! My mother presented with Stage 2 breast cancer that was surgically resected with clear margines and no lymph node involvement. After a toxic reaction to tamoxifen, against her doctors advise, she began using Essiac instead. There is NOTHING toxic in it so she decided to give it a try. 7 years later there has been no recurrence of cancer.

    My father in law presented with Stage 4 colon cancer that was resected and followed with the FOLFOX regimen (standard practice for advanced CRC). He asked me about Essiac and, after careful consideration and consultation with his doctor, began using it. His dietician actually gave him a “fact” sheet about alternative medicine that stated Essiac causes atropine poisoning. I’d heard that lie before. A quick Google search will turn up the story of a guy who did OD on atropine, but he was playing amateur herbalist and gathering his own herbs out in the woods. He mistook Belladonna (the medical source for atropine) for Burdock Root, one of Essiac’s ingredients. When I pointed out the fact that she was spreading misinformation and invited her to look at the story I was dismissed like a first grader. My father in law did eventually die, but not before he lived for nearly 2 1/2 years longer. Median survival rates for Stage 4 CRC is usually 7-11 months! Did Essiac, along with conventional chemo, make him live more than twice as long as he should have? It sure as hell didn’t hurt him!

    My neighbor presented with Stage 4 NSCLC. Hers was unresectable and she was treated with Gemzar and Cisplaten and given 6 months to live. I told her about Essiac and she began taking it. After she passed the 1 year mark her oncologist asked her if she was doing anything herself and she told him about the Essiac. She asked him if she should stop using it. He said, “No, it seems to be working for you”. Amazingly, he asked her for website information so he could check it out for himself! She lived for another 27 months after diagnosis, more than 4 times the median survival rate for lung cancer. A week before she passed away she called me from the hospital to say goodbye and to “thank me for the wonderful tea”. She said that she was confident that it had made the difference in her survival as ALL of her “chemo only pals” died long before she did.

    Placebo effect? I don’t give a shit what you call it, but this stuff DID seem to work for all of these patients. I don’t advocate using it instead of conventional medicine, I advocate using it in addition. It clearly had synergistic properties when used as an adjuvant to chemo.

  7. #7 Essiac Tea
    April 14, 2009

    Very interesting read! Welcome back abel.