Consumer Health Digest #04-20

Your Weekly Update of News and Reviews
May 19, 2004

Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., and cosponsored by NCAHF and Quackwatch. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.

Warner-Lambert to pay $430 million for illegal marketing of Neurontin. The pharmaceutical firm Warner-Lambert has agreed to plead guilty and pay more than $430 million to resolve criminal charges and civil liabilities in connection with its Parke-Davis division's illegal and fraudulent promotion of unapproved uses for Neurontin, one of its drug products. Federal law requires manufacturers to specify the intended uses when they apply for FDA approval. Once approved, the drug may not be marketed or promoted for other purposes ("off-label" uses). Neurontin was approved by the FDA in 1993 solely for supplemental anti-seizure use by epilepsy patients. However, Warner-Lambert promoted it for treating bipolar mental disorder, various pain disorders, Amyotrophic Lateral Sclerosis (ALS, a degenerative nerve disease commonly referred to as Lou Gehrig's Disease), attention deficit disorder, migraine, drug and alcohol withdrawal seizures, restless leg syndrome, and as a first-line treatment for epilepsy (using it alone rather than in addition to another drug). The government charged that Warner-Lambert promoted Neurontin even after scientific studies had shown it was not effective for bipolar disease or as a sole treatment for epilepsy. Warner-Lambert's strategies included:

• Encouraging sales representatives to provide one-on-one sales pitches to physicians about off-label uses of Neurontin without prior inquiry by doctors. The company's agents also made false or misleading statements to health care professionals regarding Neurontin's efficacy and whether it had been approved by the FDA for the off-label uses. Warner-Lambert also utilized "Medical Liaisons," who represented themselves (often falsely) as scientific experts in a particular disease, to promote off-label uses for Neurontin.
• Paying doctors to attend so-called "consultants meetings" in which physicians received a fee for attending expensive dinners or conferences during which presentations about off-label uses of Neurontin were made. These events included lavish weekends and trips to Florida, Hawaii, and the 1996 Atlanta Olympics. There was little or no significant consulting provided by the physicians.
• Implementing many teleconferences in which physicians were recruited by sales representatives to call into a prearranged number where they would listen to a doctor or a Warner-Lambert employee speak about an off-label use of Neurontin.
• Sponsoring purportedly "independent medical education" events on off-label Neurontin uses with extensive input from Warner-Lambert regarding topics, speakers, content, and participants.
• Misleading the medical community about the content, as well as the lack of independence from the company's influence, of many of these educational events. In at least one instance, when unfavorable remarks were proposed by a speaker, Warner-Lambert offset the negative impact by "planting" people in the audience to ask questions highlighting the benefits of the drug.
• Paying physicians to allow a sales representative to accompany them during patient visits in which the representative offered advice that was biased towards Neurontin use.
• Deciding not to seek FDA approval for any of the non-epilepsy indications for fear that approval would allow generic competitors to compete with a patented "son of Neurontin" drug that the company hoped would be approved for broad use.

The plea agreement includes the following components:

• Warner-Lambert will plead guilty to two counts of violating the Food, Drug & Cosmetic Act with regard to its misbranding of Neurontin by failing to provide adequate directions for use and by introduction into interstate commerce of an unapproved new drug. Warner-Lambert has, as punishment for these offenses, agreed to pay a $240 million criminal fine, the second largest criminal fine ever imposed in a health care fraud prosecution. The plea agreement specifies that Warner-Lambert's criminal conduct caused losses of $150 million and that the violations are felonies as a consequence of a prior Food, Drug & Cosmetic Act conviction.
• Warner-Lambert will settle its federal civil False Claims Act liabilities and pay the United States $83.6 million plus interest for losses suffered by the federal portion of the Medicaid program as a result of Warner-Lambert's fraudulent drug promotion and marketing misconduct.
• Warner-Lambert will pay the fifty states and the District of Columbia for $68.4 million plus interest for losses the state Medicaid programs suffered as a result of Warner-Lambert's fraudulent drug promotion and marketing misconduct.
• Warner-Lambert will settle its civil liabilities to the fifty states and the District of Columbia for $38 million plus interest for harm caused to consumers and to fund a remediation program to address the effects of Warner-Lambert's improper marketing scheme.
• Pfizer, Inc., Warner-Lambert's parent company, will comply with the terms of a corporate compliance program, which will ensure that the changes Pfizer made after acquiring Warner-Lambert in June 2000, are effective in training and supervising its marketing and sales staff, and ensures that any future off-label marketing conduct is detected and corrected on a timely basis. In addition, Warner-Lambert agreed to an injunction by a state court against continuing the improper conduct.

The allegations pertain to marketing that was done before Pfizer acquired Warner-Lambert. [Warner-Lambert to pay $430 million to resolve criminal & civil health care liability relating to off-label promotion. USDOJ news release, May 13, 2004] In 1995 Warner-Lambert was fined $10 million after pleading guilty to one felony count of fraud for failing to notify the FDA about stability problems with its anti-epileptic drug Dilantin.

FTC sues "Balance Bracelet" marketers. The Federal Trade Commission has charged California-based marketers of the "Balance Bracelet," a purported pain relief product, with making false and unsubstantiated claims. In its complaint filed in federal district court in Los Angeles, California, the FTC alleges that Media Maverick, Inc. of San Luis Obispo, California, and its officers Mark Jones and Charles Cody, have deceptively claimed that the bracelet provides a fast-acting, effective treatment for many types of pain. The bracelet is a C-shaped metal bracelet that is allegedly "electro-polarized" by an undisclosed process. The defendants promoted the bracelet through nationally disseminated 30-minute infomercials and on the Internet. Their advertisements claimed that the bracelet relieves arthritis pain, joint pain, back pain, and injury-related pain, among other things. The ads also claimed that pain is caused by excess static electricity in the body, which purportedly comes from an imbalance of positive and negative energy, and that the Balance Bracelet returns the body to its "natural ionic balance." However, the rationale is complete nonsense and clinical testing has found that "ionized bracelets" are no more effective at relieving muscular and joint pain than placebo (non-ionized) bracelets. The bracelet sells for $79.90, plus shipping and handling. In May 2003, the FTC charged the marketers of a similar product, the Q-Ray Ionized Bracelet, with making false and unsubstantiated pain-relief claims as well as failing to honor their advertised money-back guarantee. The defendants in the Q-Ray case entered into a stipulated preliminary injunction halting the pain-relief claims for the product. That case currently is pending in the U.S. District Court for the Northern District of Illinois. [FTC Challenges claims that the "Balance Bracelet" relieves pain. FTC news release, May 18, 2004]

Echinacea flunks another test. A randomized, double-blind, placebo-controlled clinical trial has found that an Echinacea purpurea preparation did not prevent infection with rhinovirus type 39 (RV-39). The study involved 48 previously healthy adults who received echinacea or placebo, 2.5 mL 3 times per day, for a week before and after intranasal inoculation with the virus. Viral culture and serologic studies were performed to evaluate the presence of rhinovirus infection; and symptoms were assessed to evaluate clinical illness. A total of 92% of echinacea recipients and 95% of placebo recipients became infected. Colds developed in 58% of echinacea recipients and 82% of placebo recipients. This difference was not statistically significant, but the authors noted that the study could have been too small to detect a significant difference. [Sperber SJ and others. Echinacea purpurea for prevention of experimental rhinovirus colds. Clinical Infectious Diseases 38:1367-1371, 2004] Last year another study found echinacea use did not lessen the duration or severity of colds among 524 children who received either echinacea or placebo for up to 3 upper respiratory infections over a 4-month period. [Taylor JA and others. Efficacy and safety of echinacea in treating upper respiratory tract infections in children. JAMA 290:2824-2830, 2003] Although smaller studies have suggested benefit for adults, none were as well-designed as this one. The overall picture is difficult to interpret because (a) study results have been mixed, (b) there are three species, and (c) echinacea root, stem, and flower have different chemical profiles. Moreover, a recently published study found that fewer than half of "standardized" echinacea products purchased from retail stores in the Denver area contained the dosage stated on the product label. [Gilroy CM and others. Echinacea and truth in labeling. Archives of Internal Medicine 163:699-704, 2003]

Chiropractic book bargain. Two classic critiques of chiropractic are available from Quackwatch at sharply discounted prices. Inside Chiropractic: A Patient's Guide, by Samuel Homola, DC (published 1999, list price $28) provides a comprehensive look at chiropractic's history, theories, and practices, both good and bad. Chiropractic: The Victim's Perspective, by George Magner (published 1995, list $32) covers most of this but focuses more on the risks to patients. Both books were edited by Stephen Barrett, M.D. A limited supply is available for $9 per book plus postage of $3 for the first book and $1 for each additional book. This offer is available only for orders within the United States. Payment should be sent to Quackwatch, P.O. Box 1747, Allentown, PA 18105.