I was going to write about this yesterday, but seeing a family of a child with terminal cancer seduced by the siren call of Stanislaw Burzynski and his antineoplaston quackery distracted me and I had to blog about it. It’s actually an appropriate lead-in to this story, which was based on an announcement by the FDA that it was sending warning letters to 14 companies for selling products that they claimed were treatments for cancer:
The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms.
“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,” said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs. “We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work. Patients should consult a health care professional about proper prevention, diagnosis and treatment of cancer.”
It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses. The illegally sold products cited in the warning letters posted today include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices). They include products marketed for use by humans or pets that make illegal, unproven claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims.
Given the current mania of the Donald Trump administration for deregulating basically everything, especially the FDA, for which the rationale is the fantasy that removing the “heavy hand of government” will unleash a flood of cures from the free market, I can’t help but wonder if this sort of action is a dinosaur, at least for now. Be that as it may, as I mentioned yesterday, Stanislaw Burzynski is about as perfect example as I can recall of a major failure by the FDA. After all, he’s been peddling his unproven cancer treatment for over four decades now, most recently under the guise of experimental therapy, and neither the FDA nor the Texas Medical Board has been able to stop him. From my perspective, this failure is on the FDA and the Texas Medical Board. The FDA has the tools to shut Burzynski’s clinical trials down, given that he has published next to nothing in nearly 20 years and regularly flouts human subject protection regulations and basic clinical research requirements under the law, but thus far it has failed.
In fairness, other failures are not of the FDA’s making, but rather defects within the law that the FDA must function under. Indeed, that’s what makes this latest announcement so encouraging; this sort of crackdown is, by law, difficult for the FDA to carry out—and intentionally so. The reason is the Dietary Supplement Health and Education Act (DSHEA) of 1994, a law that greatly weakened the FDA’s ability to regulate dietary supplements, as I’ve written about in the past. Basically, the DSHEA created a new class of regulated entities known as dietary supplements and liberalized the sorts of information that supplement manufacturers could transmit to the public. The end result was:
It [the DSHEA] also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.
Since the passage of the DSHEA, the supplement industry has become very clever at getting around even this law. The Food, Drug, and Cosmetic Act defines “drug” as any article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or function of the body.” (Medical devices fall under a separate category.) These parts of the statute give the FDA the power to FDA to ban the marketing of products with unsubstantiated “drug” claims on their labels. The DSHEA doesn’t change that, but it makes it easier for companies to evade bans for drug claims as long as they can couch their claims as a “structure-function” claim, usually vague, such as “supports the immune system” or “boosts prostate health” and remember to tack on what Peter Lipson so famously coined as the “Quack Miranda warning” with words to the effect that “these statements have not been evaluated by the Food and Drug Administration” and “this product is not intended to diagnose, treat, cure or prevent any disease.” Of course, companies get around these prohibitions by playing it straight on their websites and official publications and behind the scenes encouraging more—shall we say?—grandiose claims.
So basically, as long as they append a Quack Miranda warning, supplement companies have to go pretty far in their claims for the FDA to be able to take action. One example of how bad the situation is was the marketing of OSR#1, an industrial chelation agent, as a treatment for autism under the rationale that it’s a supplement, which went on for quite some time before the FDA finally stepped in. There are numerous other examples in the archives of this blog. It’s not for nothing that I’ve asked on more than one occasion, “Will the government ever regulate dietary supplements?”
So, out of curiosity, I perused some of the warning letters to see what sort of claims triggered the FDA to act. For instance, there is this letter to Amazing Sour Sop, Inc. about its products Sour Sop Capsules, Sour Sop Tea Bags, and Sour Sop Leaves. Examples include:
On the product label of Sour Sop Leaves & Sour Sop Tea Bags:
- “Sour Sop known to many as graviola or (Spanish guanabana) has been known for ages for its medicinal uses and properties. Research has proven it to be 10,000 times stronger than the chemotherapy drug Adriamycin. Recently there has been an increase in the demand for Sour Sop (Graviola) leaves…which studies suggest to be effective in helping with prostate, lung, breast, colon and pancreatic cancers. It is also said to be used in the treatment for tumor, arthritis…bladder infections, high blood pressure, high cholesterol…and protection of your immune system to avoid deadly infections.”
- “Testimonials has suggested it helps with infertility, impotence…etc.”
Then, on social media:
In an August 26, 2016 Facebook post which links to the blog authored by Dennis Grant and accessible at http://amazingsoursop.blogspot.com/ titled, “Health Benefits Of Sour Sop amazingsoursop.com” that includes a link to your website, www.amazingsoursop.com:
- “Soursop Leaves Benefits:…[B]lood & organ disorders, cancer…insomnia, arthritis and more”
- “Guyabano, or the soursop fruit, came into limelight when researchers found its ability to cure cancer.”
Under the subheading, “Is soursop really a cure for cancer?”
- “Many would be surprised to know that soursop has miraculous cancer cell killing properties, almost 10000 times stronger than Chemo.”
You get the idea, although in this case Sour Sop appears to have so far as to actually make these claims on product labels, rather than just on social media.
Another manufacturer, Hawk Dok Natural Salve, ran afoul of the FDA because of these claims:
Skin Cancer Treatment
- “Hawk Dok Natural Salve is used to treat skin cancer.”
- “attacks and destroys abnormal tissues and dose [sic] not harm the surrounding healthy tissue.”
- “If there is a virus in the wart of skin tags and moles then the salve will attack it and if not it will harm your skin.”
- “the herbs pull out the virus and cancer . . .”
- “It cleans cancer out of the body.”
- “It also helps with PMS and menopause.”
- “It pulls out bad cells, it helps draw out inflammation and pain.”
Then there’s Oxygen Health Systems:
Liposomal Vitamin B17 Amygdalin
- “Laetrile (i.e. Vitamin B17) therapy is one of the most popular and best known alternative cancer treatments.”
Laetrile? Seriously? That’s so…1970s. Indeed, it’s a quack cancer treatment that was shown well over 30 years ago to be neither effective nor safe. Notice, though, how laetrile has been renamed to “vitamin B17” or “amygalin” and sold as a “supplement.” I have seen this myself in my own practice, where I’ve encountered patients taking “vitamin B17,” with no idea of its prior history as laetrile.
Although my main emphasis has been on the DSHEA and various supplements with claimed cancer-preventing or -curing properties, there’s also one letter about a diagnostic test that I’ve written about before, namely thermography, marketed by Nature’s Treasures:
However, your firm’s promotion of its thermographic camera provides evidence that the device is intended for diagnostic screening for detection of breast cancer, including as a sole screening device. Examples include:
On the webpage titled “Breast-Cancer-Awareness”:
- “[A]ll women 25 and older should get annual Thermography screenings…”
- On the webpage titled “Mammography Vs Thermography”:
- “[T]hermography looks for the body’s physiological response to cancer cells. These changes can often occur 8-10 years before the cells are large enough to be seen by a mammogram.”
- “Thermography can detect the possibility of breast cancer much earlier…”
- “Breast Thermography has: 99% Sensitivity, 90% Specificity, 90% Accuracy.”
- “Thermography is far more sensitive than mammography.”
- “Thermography benefits all women. They may be particularly useful for young women who want to monitor their breast health should start as early as possible.”
- On the webpage titled “What is Breast Thermography”:
- “As more and more women become knowledgeable in thermography they choose not to do mammography.”
- “I myself have not done mammography since 2006, but have gone through the procedure of ultrasound twice.”
As is the case with most quacks marketing thermography, Nature’s Treasures uses a bit of a dodge in the language to claim that its system is FDA-approved when it is not:
Furthermore, you also state on your website www.mynaturestreasures.net/thermography/what-is-breast-thermography/ that “Digital Infrared Thermal Imaging is approved by the F.D.A.” This statement is misleading in accordance with 21 CFR 807.97 because such statements create an impression of official approval of a device due to clearance of a premarket notification submission. Telethermographic systems have only been cleared by FDA with an intended use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of differences in skin surface temperature changes. Thermography can be used to visualize, document temperature patterns and changes. FDA has never approved any telethermographic system for sole diagnostic screening a class III device under 21 CFR 884.2980(b).
I’ve discussed why thermography is not an effective screening modality for breast cancer (or any cancer) in my usual inimitable way with my usual ridiculous level of detail before.
Most of the people writing about this latest FDA crackdown appear not to realize that it is nothing new. In searching for information on the FDA and its regulation of supplements whose manufacturers claim to be able to treat or cure cancer, I came across an old post, Can it be real? The FDA brings the hammer down on bogus cancer cures. It was 2008, and instead of 14 bogus cancer treatments, the FDA sent warning letters to 23 U.S. companies and two foreign individuals marketing 125 products. In its press release, it pointed out red flags for bogus cancer treatments:
- “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”
Same as it ever was.
In fact, recalling the 2008 effort by the FDA to crack down on bogus cancer cures, which was larger than this week’s flurry of warning letters, I can’t help but be pessimistic. Over the last 9 years, apparently little has changed. Indeed, the only thing that appears to have changed is the cleverness and political power of the supplement manufacturers, not to mention the regulatory atmosphere given the new Donald Trump administration and its seeming commitment to deregulate, well, everything. On the one hand, I’m glad that the FDA has taken this action. I wish it would do this sort of thing more often, because I know that the 14 companies targeted this time are the proverbial tip of the iceberg. yet, even so, I have a hard time not thinking that now, more than ever, the supplement manufacturers and woo peddlers are winning. After all, it is estimated that by 2022 supplement manufacturing will be a $220 billion industry.