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.

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.

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, https://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.

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.