Articles Posted in Diet Supplement, OTC, Pharmaceutical Claims

Another reason to question what your doctor and the FDA tell you about the safety and efficacy of any drug has now come to light. The Annals of Internal Medicine has just reported that Merck used the unsavory tactic of a “seeding trial” in its development of Vioxx. (This has come to light as a result of Vioxx litigation, and is not data the public would know if only the FDA, rather that the courts, were looking over Merck’s shoulder.) A seeding trial is carried out by a drug manufacturer just prior to or shortly after FDA approval of a new drug. Ostensibly, such a clinical trial is completed for the obvious medical research benefits, for example post-approval surveillance for safety and efficacy. In reality, there is an unspoken agenda: to get the drug in as many physicians’ hands as possible, enlisting them as investigators while picking up the support for monitoring and paperwork. The physicians receive the prestige of participating in a drug trial as clinical investigators and are financially reimbursed, and the drug manufacturer is familiarizing physicians with the drugs, thereby shortening the path to profitability, or “accelerating uptake” in the parlance. Such trials should be initiated for a legitimate research purpose, not as a pretext for profit.

The guidelines imposed by science, the FDA and institutional review boards are there for a purpose–to be sure that evidence-based science guides critical decisionmaking. When medical journals, the FDA, and the public are deceived with these kinds of tactics, the credibility of the system is corroded. Such deception cannot be permitted to stand without penalty by the FDA, and Merck should be subjected to professional and public scorn.

It is a difficult enough proposition for science to drive decisionmaking in America today. Too often, politics and the mythical thinking justifying the herbal phenomenon win the day. When money corrupts the scientific process, its credibility is undermined and the public increases its distrust of conventional medicine. Simply put: seeding trials are a pernicious practice that should never be permitted.

The Bush Administration has consistently sought to undermine consumer-oriented regulatory practices in favor of corporate interests. If it could also take a shot at plaintiffs and their demon trial lawyers, all the better. One of its more spectacular successes was the Supreme Court’s recent decision in a medical devices case, Riegel v. Medtronic, which stands for the proposition that the FDA’s approval of a medical device should preempt any litigation against the manufacturer in state claims by someone the product injures. As expected, every defendant with any conceivable preemption argument is now injecting that defense into products liability and negligence claims all across the country. FDA and Mercury Regulation;FAA Regulation. The Alaska Personal Injury Law Group just defeated a similar move by a defendant arguing that the FAA’s regulation of aircraft should preempt state claims against an air carrier.

The Supreme Court will next consider the application of the preemption doctrine in an injury claim against Wyeth by a Vermont guitarist who lost her arm below the elbow after she was injected with Phenergan, a nausea medicine. Wyeth v. Levine, Docket No. 06-1249. At issue is Wyeth’s claim that it should be immune from suit because of the FDA’s approval of Phenergan’s label. It reasons that the FDA’s regulatory approval should be enough to preempt the plaintiff’s claim that the manufacturer failed to warn about the dangers of IV injection of the drug. Remarkably, The New England Journal of Medicine has joined 47 state attorneys general and two past FDA commissioners in submitting amicus briefs to the Supreme Court warning that the FDA lacks the ability to serve “as the sole guarantor of product safety”.

It is well known that the FDA simply cannot know all the risks of a product or warning label it approves. This is especially true when the manufacturer intentionally skews clinical trial results, Newsday, Annals of Internal Medicine or otherwise keeps product risks from the FDA to achieve the lucrative benefits that come with the approval of a new drug or device, NEJM, Synthes Story. The FDA is not constituted to truly regulate this industry, and it cannot get to bedrock truth the way litigation can. Often, the FDA does not act until litigation proves the product’s dangers and makes public the evidence the manufacturer kept from the FDA when the drug or device was approved. Talbert v. E’ola Products, Inc.. If Big Pharma succeeds in the Wyeth matter, millions of Americans will be at risk from dangerous drugs. Without the protections of the legal system, their claims will be unrepresented, and corporate interests will run roughshod over the FDA. At this juncture, Congress will likely have to act to restore the balance of regulatory and legal interests the courts previously forged in protecting the rights of individuals to pursue state claims when injured by dangerous products approved by the FDA.

At the Alaska Personal Injury Law Group, we commonly face the unpleasant task of explaining to prospective clients the way in which “tort reform” has dramatically taken away the legal rights they thought they possessed. One of the recent unsung accomplishments of the Bush Administration is the silent destruction of the legal rights of those hurt by the malfeasance of corporations–stealth tort reform at the FDA.

Utterly unnoticed by the American public was an unheralded aboutface at the FDA. Although it had been silent on the issue before, the FDA began taking an active role in pending private litigation espousing the proposition that, if the FDA had approved a drug or medical device, then that approval should shield the manufacturer from any liability if the product were to injure or kill. In legal terms, that shield is called “preemption, ” the argument being that the federal government, by regulating the industry, has preempted state regulation and state tort claims. Manufacturers have long sought this shield, but the courts recognized the argument for the folly that it is, and commonly rejected it. Not surprisingly, this policy reversal by the White House was implemented by Dan Troy, one of 100’s of industry lobbyists President Bush put to work in positions responsible for public advocacy. Before his appointment, Troy’s practice was based on representing drug and tobacco companies in challenging FDA regulations. It was under Troy’s guidance that the FDA flip-flopped its position on preemption, much to the delight of the industry the FDA was supposed to be regulating.

The United States Surpeme Court, its makeup another Bush Legacy, has recently breathed life into the preemption defense, with its ruling in Riegel v. Medtronic. The ruling effectively wipes out all pending medical device litigation, from faulty pacemakers to defective insulin pumps. The natural extension of the legal argument will be to apply this ruling to preemption arguments in drug claims. And from there the erosion of legal rights will spread to every area of American society touched by the FDA (and by logical extension, any federal agency), whether the injury comes from a toxic chemical exposure or tainted hamburger.

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. 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.

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.

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.

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,, 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.

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), , 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., . There, the manufacturer, whose product has since been confiscated by the FDA, “spiked” its ephedra product with the pharmaceutical drug, ephedrine hydrochloride. . 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.
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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.

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.

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