Diet Supplement, OTC, Pharmaceutical Claims

September 25, 2008

Prescription Drug Maker Moves Toward Transparency Re: Payments to Doctors

Eli Lilly and Co. has announced that it will now begin disclosing information about the money it pays to individual doctors for advice, speeches, and other services. The company is riding out ahead of legislators at the state and federal levels who have pushed disclosure bills that would impose a legal mandate upon drug manufacturers to make such payments public. Lilly will disclose payments above $500 made in 2009, but will not make disclosure about payments in past years.

A handful of states have legislated disclosure from drug manufacturers: Minnesota, Vermont, West Virginia, and Maine. No disclosure requirements have been imposed on medical device manufacturers, although the obvious ethical concerns apply there as well. ( See our previous posts here, and here.

Source:

September 18, 2008

The FTC And FDA Take On Peddlers Of Fraudulent Herbal Cancer Cures

by Richard E. Vollertsen

The Federal Trade Commission announced today 11 law enforcement actions taken against firms deceptively advertising bogus cancer cures. The companies have been charged with making unsupported claims that their products have treated or cured various cancers, and some were charged with falsely stating that they had clinical or scientific proof of their products’ efficacy. The FTC’s Director of the Bureau of Consumer Protection stated that, “There is no credible scientific evidence that any of the products marketed by these companies can prevent, cure or treat cancer of any kind.”

Of the 11 complaints, six were resolved by proposed settlements with the remainder to be litigated by the FTC. The companies will all be required to notify consumers that there is little to no scientific evidence demonstrating the efficacy of the products to treat or cure cancer. The complaints arose out of a year-long effort by the FTC, the FDA, and a corresponding Canadian agency in which 112 websites were targeted. Of those, over 30% responded to the governmental warnings and closed their websites or altered the fraudulent claims. Warning letters were then sent to 23 companies.

To identify the companies and products targeted, follow the links below.

September 12, 2008

Spiked Chinese Herbal Pills: Is Weight Loss Worth Having A Heart Attack?

by Richard E. Vollertsen

We have learned the lesson repeatedly, with drugs like Fen-Phen, Ephedra (see our litigation here), and similar magic pills, that there is no free lunch when it comes to weight loss. If drugs are being used to amp up the engine of the body’s metabolism, something is eventually going to seize up. Yet, the pharmaceutical industry and the unregulated diet supplement industry keep trying.

Here’s a case report concerning their latest victim, reported in the September 11, 2008, issue of Clinical Toxicology. A 37-year-old woman suffered a heart attack after using an herbal weight loss product for just 3 days. A urine screen, however, disclosed the presence of sibutramine. (The article doesn’t disclose this fact, but one would assume that the herbal product was spiked with sibutramine, and the drug was not listed on the label as an ingredient.) Sibutramine is a serotonin-norephinephrine reuptake inhibitor that is structurally related to amphetamine, although its mechanism of action is distinct. Sibutramine is the active incredient in Abbott Labs’ Meridia, a prescription weight loss product. The patient was not obese, did not smoke, and was not known to have hypertension or diabetes. No other stimulants were found in her blood stream. The author reports a similar case involving a young woman in their clinic who had also suffered myocardial infarction after using sibutramine for 30 days.

There have been 397 adverse events reported to the FDA concerning sibutramine between 1998 and 2001. There were 152 hospitalizations. Of the 29 patients who died, 19 suffered cardiac problems that led to their deaths. Sibutramine is one of drugs Dr. David Graham, the FDA whistleblower, and Public Citizen, have warned the public about.

September 6, 2008

Herbal Roulette: Taking Supplements While Pregnant

by Richard E. Vollertsen

According to a recent study presented at the British Pharmaceutical Conference in Manchester, England, 60% of woman may be risking the health of their babies by taking herbal remedies while pregnant. The study was authored by Lone Holst, a researcher in Norway, who studied 578 women giving birth in the UK. In the study population, 49% knew nothing about the safety risks of the products they were taking, and had taken the products on the advice of their family or friends, rather than their healthcare providers. In pregnant women over 40, 72% of women had used herbal preparations during their pregnancy.

The reasons for caution are many. Unlike prescription drugs, herbal preparations are not tested for safety and efficacy. Moreover, the active ingredients often vary from the amounts stated on the label. Manufacturers also fail to test the products to be certain that toxic contaminants are not present, and intentionally “spike” their products with pharmaceuticals to make the concoctions are more potent, without disclosing this to the consumer.

Even in the best of circumstances, it is difficult to test a single active ingredient for safety and efficacy. Diet supplements and herbal preparations are manufactured with a “kitchen sink” approach using the dangerous notion that a combination of ingredients are better for you, than a single, active ingredient. In fact, the interactions between these ingredients, and between the ingredients and other medications that the consumer may be taking, is not known and can be a set up for disaster and cause fetal harm.

September 5, 2008

FDA Lists Drugs Under Investigation For Safety Concerns

by Richard E. Vollertsen

The FDA has issued its first public disclosure of 20 drugs it is now investigating for safety concerns. The disclosure is the result of the 2007 Food and Drug Administration Amendments Act that mandated that the agency post on a quarterly basis information about drugs it is investigating based on adverse events reported by doctors. The information does not disclose the nature of the adverse events or the extent of the problem. The fact that a drug is listed is not intended to suggest that the agency has, in fact, concluded that the risk exists. The posting does not include all of the drugs currently being subjected to a further safety investigation.

The consumer now has more information at hand to make an informed decision about drugs a doctor prescribes. Hopefully, these disclosures will prevent unnecessary injury when the FDA and the manufacturer are aware of potential risks, and the unsuspecting patient is not. That is a gap that should, and must, be closed. Here is the list:

Arginine Hydrochloride Injection (R-Gene 10): Pediatric overdose due to labeling / packaging confusion

August 29, 2008

Last Of The Berkeley Nutraceuticals’ Executives Sentenced; Lawyer Goes to the Big House, Too

by Richard E. Vollertsen

U.S. District Court Judge Arthur Spiegel sentenced the remaining employees of Berkeley Premium Nutraceuticals this week, each receiving prison sentences. The Berkeley executives, Greg Cossman (former President), Susan Cossman (Warshak’s sister), Shelly Kinmon (Sales Director), James Teegarden (Chief Operating Officer), Michael Wagner (Financial Officer), and Steven Pugh (Warehouse Manager) received sentences ranging from 12 to 13 months. Berkeley’s accountant, William Bertemes, and its bookkeeper, Sam Grote, cooperated with authorities and drew the lightest sentences of one month in prison.

Berkeley’s in-house counsel, Paul Kellogg, was the last of those convicted to be sentenced. He also received a sentence of a year and a day. Despite his professional training, Kellogg claimed that he was following the orders of Steve Warshak, Berkeley’s President, and did not realize what he was doing was wrong. (Surely he couldn’t have been clueless when he told a night manager to hide potentially damning evidence from FDA inspectors and had it returned to the warehouse when they left.)

All told, 11 Berkeley executives and employees were convicted on fraud, money laundering, and conspiracy charges.

August 28, 2008

Smilin’ Bob Is Headed To The Big House

by Richard E. Vollertsen

Steve Warshak, the founder of Berkeley Premium Nutraceuticals, has been sentenced to 25 years in prison and ordered to pay $93,000 in fines. He had been convicted in February on 93 counts of conspiracy, fraud and money laundering. His mother, Harriet Warshak, was sentenced to 2 years in prison arising from her conviction for conspiracy, bank fraud and money laundering. U.S. District Court Judge S. Arthur Spiegel, also ordered Warshak, his mother, and the company to forfeit more than $500 million in ill-gotten gains. Several other employees will be sentenced this week.

Most of the charges relate to the sale of Enzyte, a supplement supposedly capable of boosting male sexual performance. The company, however, falsified medical studies, used fraudulent bank documents, and ran up charges on the credit cards of customers, while refusing to give refunds or stop serial transactions on the cards.

The company’s logo included the Latin phrase suffragium asotas, which Warshak claimed translates to English as “enhanced sexuality”. He may have meant to use the phrase suffragor asotis, an awkward way of saying, “refuge for the dissipated”. Perhaps that is what the Big House will be for him.

August 26, 2008

More Contaminated Supplements: Toxic Metals Found In Ayurvedic Supplements

by Richard E. Vollertsen

The Jounal of the American Medical Association reported today that the toxic metals lead, mercury, and arsenic have been detected in traditional Ayurvedic medicines being sold in the United States. Of the 230 products evaluated by x-ray spectroscopy, detectable levels of the toxic metals were found in 20.7% of the products. The contaminants were found in products manufactured in India and in the United States, but 95% of the contaminated products were being sold by US websites. Most troubling, 75% of the manufacturers claimed to be using Good Manufacturing Practices.

Source:

JAMA, August 27, 2008

August 23, 2008

How Do You Know If Your Doctor Is On The Take?

by Richard E. Vollertsen

With increased attention being put on improper financial influences in medicine, by both the lay and professional press, you may be wondering how you can find out if your doctor is getting brown paper bags of cash from Big Pharma or a medical device manufacturer. The next time a doctor recommends a drug or a medical device, check with the Association for Medical Ethics to see if your doctor has improper financial ties with the manufacturer. As a result of a U.S. Department of Justice settlement with four medical device companies, Zimmer, Inc., DePuy Orthopaedics, Inc., Biomet, Inc., and Smith & Nephew, Inc., these back door consulting agreements must now be made public. (See our earlier post about this: Financial Ties) The Association for Medical Ethics maintains a searchable database that will tell you if your doctor is on the payroll of the company whose product he has just recommended: www.ethicaldoctor.org. Some of the information is shocking: two physicians listed made more than $8 million each from Dupuy Orthopaedics.

Now that’s a fact you would want to know before the doctor operated, isn’t it?

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August 22, 2008

More Diet Supplement Executives Head to Prison

by Richard E. Vollertsen

Three executives of Hi-Tech Pharmaceuticals, Inc. of Norcross, Georgia have pleaded guilty to conspiracy and fraud charges for illegally selling prescription drugs. President and CEO, Jared Wheat, Vice President, Stephen D. Smith, and company co-founder Tomasz Holda admitted to conspiring to import and distribute adulterated, mislabeled and unapproved new drugs, and to commit mail and wire fraud. The company was selling via the internet generic forms of Xanax, Valium, Ambien, Vioxx, Zoloft, Viagra and Cialis manufactured in their lab in Belize without requiring a prescription.

As a result of the plea bargain, the government dropped assertions that the company was spiking its diet supplements with ephedrine alkaloids after the FDA’s 2004 ban on the marketing of ephedra products. See Alaska Personal Injury Law Group’s litigation over this practice of illegal spiking of diet supplements, Talbert v. E’ola Products, Inc.. Also absent were the earlier assertions that the executives had conspired to murder an FDA agent and blackmail a former US attorney general. (Holda also pled guilty to ordering a silencer over the internet.) They face prison terms up to 5 years each, with fines of as much as $250,000, and the company itself faces fines as much $500,000. In June, a different federal court issued a preliminary order against the company for FTC violations for deceptive advertisements of weight loss and sexual performance products. Among the company’s diet supplement products is Lipodrene, a weight loss product, and Stamina-Rx, a sexual stimulant.

Wheat had previously been arrested for selling ecstasy, and Holda had been convicted of steroid possession with intent to distribute. The FTC had also previously accused the company of falsifying medical research regarding sexual impotent products.