Alaska Injury Law Blog
The coming issue of Clinical Cancer Research will publish two case reports concerning the progression of prostate cancer believed to have been caused by a dietary supplement “spiked” with pharmaceutical compounds. “Spiking” is, unfortunately, an all too common practice in that industry. While claiming to sell “all natural” products, and taking advantage of the regulatory limitations imposed on the FDA under the Dietary Supplement Heath and Education Act (DSHEA), www.fda.gov/opacom/laws/dshea.html , diet supplement manufacturers put consumers at risk by “spiking” their products with pharmaceutical compounds they know to work, when the herbal compounds do not. Unlike prescription and over-the-counter drugs, current law does not require nutritional supplements to undergo pre-market testing or approval for safety and efficacy.
This was a key issue in the first jury verdict in the nation against an ephedra manufacturer, a case the Alaska Personal Injury Group brought: Talbert v. E’ola Products, Inc., www.cfsan.fda.gov/~dms/ds-ephed.html . There, the manufacturer, whose product has since been confiscated by the FDA, “spiked” its ephedra product with the pharmaceutical drug, ephedrine hydrochloride. www.fda.gov/bbs/topics/ANSWERS/2001/ANS01114.html . In that instance, it caused a healthy young woman to suffer a cerebellar stroke.
The product analyzed by the researchers at University of Texas Southwestern Medical Center has led to an equally horrific outcome–virulent prostate cancer. The researchers report in the journal that the diet supplement, which they have declined to identify by name, contained the sex hormones testosterone and estradiol. Laboratory tests of the product on human prostate cancer cells found it to be a more potent stimulator of cancer cell growth than testosterone alone. Such compounds cannot be sold except by prescription. The spiked hormones are believed to have caused the two men to develop rapidly advancing prostate cancer within months of using the dietary supplement. Both men, before using the product, had low levels of prostate-specific antigen (PSA), a signal for prostate cancer and then presented with widespread cancer within six months, which is unusual. One of the men has died; the other is in the final stages of the disease and is expected to die within months. Notified of these findings, the FDA sent a warning letter to the manufacturer, and the supplement has now been removed from the market.
In addition to failing to list all the steroid hormones contained in the product, the researchers also found that the product’s label stated ingredients that were not present, and it also misrepresented the concentrations of the ingredients present. These kinds of failings are very common in this industry, and arise because of the lack of regulation over the industry’s manufacturing processes. This type of misrepresentation and mislabeling is not just blatant consumer fraud, it can be dangerous when the concentration of an ingredient is too high.
Consumers use diet supplements without realizing the impact they have on the efficacy of prescription medications they may otherwise be taking. In the care provided to these two men, they were treated with the anti-cancer drug bicalutamide. Their physicians now believe this supplement caused the cancer drug to be less effective.
The response by the dietary supplement industry echoed its standard responses. The euphemistically-named Council for Responsible Nutrition (CRN) countered that no causal link was established by the case reports. www.washingtonpost.com/wp-dyn/content/article/2008/01/18/AR2008011802653.html This was the exact position taken by the supplement industry in response to thousands of adverse events associated with ephedra, which the FDA finally banned from the market. The American Herbal Products Association (AHPA) chided the researchers for calling the product a diet supplement, since it had been “spiked”–which was sophistry since the product had clearly been sold as a diet supplement. www.washingtonpost.com/wp-dyn/content/article/2008/01/18/AR2008011802653.html These responses avoid the critical questions about why a diet supplement manufacturer would ever be permitted to continue to operate when such a travesty occurs. The answer to that question is money. DSHEA was passed as the result of lobbying, and successfully shackled the FDA, keeping it from properly regulating the supplement industry. The industry is now a multi-billion dollar enterprise capable of raining lobbyists down on any attempt to impose limits on the industry.
These kinds of lab findings showing that a product is “spiked” cannot be explained away by contamination, as they involve specific pharmaceutical compounds that do not naturally occur and do not enter products through inadvertence or faulty manufacturing. They can only be found in supplements because they have been intentionally put there by the manufacturer. These acts represent the most callous of corporate conduct, demonstrating a corporation’s willingness to jeopardize the health and, as here, the lives of unsuspecting consumers who have blithely trusted the marketing hype that the product is “all natural,” and therefore safer than a pharmaceutical product.
Many carp about frivolous lawsuits in our society. Ask the families of the two gentlemen struck down by these products, and I suspect you would get a different response about whether what happened here was frivolous. The regulation of corporate fraud and malicious acts in this industry, especially when it has hog-tied Congress and the FDA, can only be stopped in the courtroom. Until our society says otherwise, that is the only remedy left to families such as these.
Source: Herbal/Hormonal Dietary Supplement Possibly Associated with Prostate Cancer Progression, Clin. Cancer Res. 2008 14: 607-611 ; www.utsouthwestern.edu/utsw/cda/dept353744/files/437809.html