Alaska Injury Law Blog

The Alaska Personal Injury Law Group has long been involved in the analysis of defective products sold by the diet supplement industry. (Talbert v. E'ola Products, Inc., http://www.alaskainjurylawgroup.com/lawyer-attorney-1286823.html). We have watched this industry repeatedly use unqualified personnel to design and sell products that are, in a word, dangerous. The industry has run amuck with virturally no regulatory oversight, and the consumer is repeatedly defrauded or hurt by exposure to the rapacious and dangerous practices of this industry.

It is thus with some appreciation of the legal and karmic forces at work in the universe to read today's news that Michael Ellis, former CEO of Metabolife, was sentenced to prison for 6 months based on pleading guilty to a single count of lying to the FDA about the effects of Metabolife 356 and its notorious ingredient, ephedra. Despite the millions the company relieved consumers of, he was fined just $20,000. In 2005, William Bradley, who was Ellis’ partner in Metabolife, pleaded guilty to seven felonies, including tax evasion, and sentenced the following year to six months in custody.

Metabolife and Ellis had sent letters to the FDA stating that they had “never received a notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356.” Metabolife's own documents, however, showed that it had received many reports from consumers of strokes, heart attacks, seizures, and other serious illnesses. The company ultimately turned over the reports of 14,000 ephedra-related adverse events that the company had previously not disclosed to the FDA, which ultimately was a key factor in the FDA's ban on ephedra imposed on the industry in 2004.

Metabolife became the target of hundreds of lawsuits, and to outrun the posse, went into Chapter 11 bankruptcy in 2005. We have seen this bankruptcy ploy used by a number of diet supplement companies wanting to "hide out while on the lam."

Source:

www.usdoj.gov/usao/cas//press/cas71105-Metabolife.pdf

http://www.signonsandiego.com/news/business/20080610-9999-1b10metabo.html

A federal jury today convicted the president of Berkeley Nutraceuticals, Steve Warshak, on charges of conspiracy to commit mail fraud, bank fraud, and money laundering. Warshak’s mother, Harriett Warshak, was also convicted. They now face more than 20 years in prison, and the company could be forced to forfeit tens of millions of dollars. Seven former company officials pled guilty to conspiracy charges before the trial began.

The company bilked thousands of customers out of millions of dollars using fake product warranties, fake medical spokesmen, and fake credit card transactions. The company's main product, Enzyte, was advertised as a "natural male enhancement" and was hawked on TV ads by a constantly grinning character nicknamed Smiling Bob.

We suspect that Bob isn't smiling anymore.

Source: AP Wire, February 22, 2008:
http://ap.google.com/article/ALeqM5gk4wBhEIdtWWF7hvr9C3Jl7pZ1XQD8UVNMKG0

Under the dubiously named Dietary Supplement Health and Education Act (DSHEA), diet supplements and herbal preparations are not approved by the Food and Drug Administration for medical use in humans. Thus, safety and formulation are solely the responsibility of the manufacturer; evidence of safety and efficacy is not required as long as they are not advertised as a treatment for a medical condition. As we have seen in diet supplement litigation (Talbert v. E'ola Products, Inc.), diet supplement manufacturers often promise the moon in selling their products to the consumer, while having little other than anecdotes to show when it comes to providing data for the safety or effectiveness of their products. Even assuming that the products are not adulterated (because of shoddy manufacturing protocols), have not been spiked (pharmaceutical drugs intentionally put into the supplement), and actually contain the ingredient at the levels claimed (often the “active” ingredient is missing or varies wildly), it is the exception, not the rule, that the manufacturer will have evidence that the supplement is safe for human consumption and actually works. With pharmaceutical drugs, the manufacturer foots the bill for such research. In the world of diet supplements, however, it is often independent researchers or the government (read: the taxpayer) that is burdened with the duty and cost of proving the safety and efficacy of a particular diet supplement.

At the Alaska Personal Injury Law Group, we are frequently asked to help those with serious orthopedic injuries. And our clients commonly face the debilitating consequences of arthritic changes that come from these injuries. So a discussion about glucosamine is in order. Luckily, unlike ephedra and other more dangerous diet supplements, glucosamine has not had a string of serious adverse events (it is not without side effects, however, so you need to read carefully before using glucosamine). But does it work?

Glucosamine is a natural compound that is found in healthy cartilage. Glucosamine sulfate is a normal constituent of glycoaminoglycans in cartilage matrix and synovial fluid (this is the “hydraulic” fluid in your joints). It is believed that the sulfate moiety provides clinical benefit in the synovial fluid by strengthening cartilage and aiding glycosaminoglycan synthesis. The question is, if you take the supplements, will the body put the critical compounds into your blood stream and use them where the arthritis lies? There have been multiple clinical trials of glucosamine as a medical therapy for osteoarthritis, but the results have been conflicting. Early clinical trials sponsored by a European patentholder, as expected, demonstrated a benefit from glucosamine. However, these studies were of poor quality due to shortcomings in their methods, including small size, short duration, poor analysis of drop-outs, and unclear procedures for blinding. Subsequent independent studies did not detect any benefit of glucosamine. This situation led the National Institutes of Health (yes, you the taxpayer) to fund a large, multicenter clinical trial studying reported pain in osteoarthritis of the knee, comparing groups treated with chondroitin sulfate, glucosamine, and the combination, as well as both placebo and celecoxib (Celebrex). The results of this 6-month trial found that patients taking glucosamine HCl, chondroitin sulfate, or a combination of the two had no statistically significant improvement in their symptoms compared to patients taking a placebo.

Today’s news is that the Annals of Internal Medicine has just published a study concerning the effect of glucosamine sulfate on the symptoms and structural progression of hip arthritis. Following 222 patients over a 2-year period, the researchers evaluated the patients’ pain, function and stiffness at regular intervals in the 2-year period. They concluded that “glucosamine sulfate was no better than placebo in reducing symptoms and progression of hip osteoarthritis.” Translation: glucosamine supplements will do nothing for the pain in your hip—the pain is likely coming from what the cost of the supplements did to your wallet.

Source: Annals of Internal Medicine, Effect of Glucosamine Sulfate On Hip Osteoarthritis, 19 February 2008, Volume 148 Issue 4, at 268-277, >http://www.annals.org/cgi/content/abstract/148/4/268.

Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT), http://www.clinicaltrials.gov/show/NCT00032890; AND http://www.ncbi.nlm.nih.gov/pubmed/16495392.

Testimony offered in a federal trial in Ohio against Berkeley Nutriceuticals has disclosed that the company faked data regarding the effectiveness of its sexual enhancement product, Enzyte. When I previously wrote about this trial, www.alaskainjurylawblog.com/2008/01/dietary_supplement_company_fac.html, I fully expected to hear that such evidence had been uncovered. The diet supplement industry is virtually unregulated, and manufacturers are not required to provide scientific data or obtain pre-market approval for their products before they are placed on the market. Borrowing a page from the playbook of ephedra manufacturers, supplement manufacturers like Berkeley often go even further to make up data to show that their products are safe and supposedly work. Such faked data can be very effective in bilking consumers out of millions. I encountered this unfortunate fact in the litigation the Alaska Injury Law Group brought in Talbert v. E’ola Products, Inc., the first successful jury trial brought against an ephedra manufacturer.

James Teagarden, VP of Operations at Berkeley, testified that the company created fictitious doctors to endorse the pills, faked a customer satisfaction survey, and made up data to back up claims about Enzyte’s effectiveness. He also testified that the company’s president, Steve Warshak, was intimately involved in the fraud.

In addition to the fraudulent data, the company’s first-time customers were automatically enrolled in a “continuity program” that sent them Enzyte every month and charged their credit cards without authorization. If customers complained, employees were instructed to “make it as difficult as possible” for them to get their money back.

Source:
http://news.enquirer.com/apps/pbcs.dll/article?AID=/20080115/NEWS01/301150105

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.

Continue reading " Diet Supplement Found To Exacerbate Prostate Cancer--Another Spiked Product " »

On January 17, 2008, the New England Journal of Medicine released a study that put numbers to what we already knew to be true: drug manufacturers have more data, particularly negative findings, that they are not making public. Examining the literature concerning antidepressants, the study showed that 94% of the studies published by drug manufacturers discussed only the positive effects of the medication being studied. Drug manufacturers must report the results of all clinical trials to the FDA. When the entirety of the data submitted to the FDA from the manufacturers’ trials was examined, however, efficacy was shown in only 51% of the studies.

Why would this be the case? One could suppose that journals are more interested in publishing data establishing efficacy, as it may be deemed more “exciting,” perhaps medicine’s version of the newspaper adage, “if it bleeds, it leads.” But the more likely reason is what is found in most drug and products liability litigation: it is not in the corporation’s economic interests to release negative information about a product. This is the prime motivator behind the drug manufacturers’ decisions to focus its publication efforts on only those studies that show efficacy, which would, of course, encourage physicians to prescribe and consumers to use the medications, thereby increasing sales.

The FDA Amendment Act of 2007 passed by Congress last September offers a partial solution to the dilemma. It requires that the data from all the clinical trials performed by the manufacturer and submitted to the FDA be made available to the public. The NIH and FDA will be responsible for maintaining a database of the clinical trials completed by manufacturers. The public will have access, however, only to data on drugs the FDA has approved for sale.

We have seen stunning and regressive changes during the Bush administration concerning information such as this, where scientific data and thought were suppressed for political purposes. Allowing researchers, clinicians, and the public access to this type of scientific data is the only responsible thing to do, and it should have happened long ago. Let the sun shine in.

Source: New England Journal of Medicine, Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy, Volume 358:252-260 January 17, 2008 Number 3 ; www.fda.gov

The federal government has brought fraud charges against a dietary supplement company, Berkeley Premium Nutraceuticals, claiming the company bilked consumers out of $100 million using unauthorized credit card charges. Berkeley Nutraceuticals marketed a number of products it said would help in weight control, memory loss and clear skin, but its main business was sexual enhancement products such as Enzyte "male enhancement" pills. According to the indictment, consumers were put into an automatic shipping program, through which their credit cards were billed without authorization. The company also offered full refunds, "double your money back," and "triple your money back" guarantees that were false. It also is accused of referring complaints to a director of customer care who did not exist. Defendants include Berkeley, its president Steve Warshak, his mother, an in-house lawyer, a computer expert and a warehouse manager. They are accused of fraud, conspiracy to commit money laundering, and of obstructing two federal agencies in their investigations. Last year, Berkeley agreed to pay $2.5 million to settle allegations by attorneys general in Ohio and other states that the company engaged in deceptive practices in the sale of its products. The safety and efficacy of the products were not on trial.

Source: AP Wire, January 9, 2008.

On January 9, the FDA warned seven compounding pharmacies to cease marketing estrogen/progestin products containing estriol. The FDA also warned the pharmacies to stop making claims that the compounded products could be used to treat Alzheimer's disease, breast cancer, depression, and colon cancer. The FDA also demanded that the pharmacies stop using the non-scientific term "bio-identical", which the FDA concluded made the products “misbranded” drugs.

The seven pharmacies were targeted after an FDA review of their websites revealed that they were marketing products with estriol. Estriol is an estrogen produced during pregnancy that has not been FDA approved for clinical use. The FDA review identified what it considered to be “patently false” claims. The FDA also questioned the manner in which the products were marketed to suggest to the consumer that the products were “natural” and therefore safer than FDA approved hormone replacements.

Source: FDA--http://www.fda.gov/bbs/topics/NEWS/2007/NEW01766.html