Industry voices opinion on Ninth Circuit decision of Matrixx Initiatives suit
WASHINGTON Industry lobbyists last week weighed in on a Ninth Circuit ruling that allowed for a class action lawsuit to proceed against Matrixx Initiatives because that company failed to disclose adverse event reports to its shareholders.
Both the Consumer Healthcare Products Association and the Council for Responsible Nutrition — and separately, the Natural Products Association — filed supporting briefs to the U.S. Supreme Court arguing that the mere nondisclosure of adverse event reports should not give rise to liability under federal securities laws without applying a statistical significance standard. The Supreme Court had agreed to place the case on its docket in June.
The statements were in regard to Matrixx Initiatives vs. James Siracusano and NECA-IBEW Pension Fund.
“The statistical significance standard recognized by most courts of appeals appropriately recognizes that adverse event reports, standing alone, are not ‘material’ for purposes of federal securities laws,” CHPA/CRN wrote in its amicus curiae. “The statistical significance standard addresses the quality of the evidence of a relationship between an adverse event and a product, and therefore it is not the kind of ‘bright-line’ rule that [the Supreme] Court rejected in Basic Inc. vs. Levinson, 485 U.S. 224 (1988).”
“The practical consequence of the Ninth Circuit’s decision, if it is not reversed, is that manufacturers … very likely will be forced to disclose all AERs, however insignificant, in order to avoid meritless — but expensive — strike suits against the supplement industry,” said Jonathan Cohn, who authored NPA’s separate amicus curiae.
CHPA/CRN also argued that the indiscriminate disclosure by public companies of all adverse event reports potentially associated with their products before being actually scientifically vetted may negatively impact consumer selection in one of two ways: Either a consumer will buy wholeheartedly into the alleged link between the use of a particular product and potential harm, and choose not to medicate or supplement with a product that could improve his or her health, or, conversely, a consumer may become so inundated with reports of AERs that he or she becomes numb to the announcements.
“The Food and Drug Administration has recognized that ‘overwarning’ has the effect of not warning at all, because the reader stops paying attention to excess warnings,” CHPA/CRN wrote in their brief.
“The [Ninth Circuit] decision is wrong because evaluation of safety signals is a scientific judgment ultimately made by the FDA,” stated John Gay, executive director and CEO of the NPA in a press release issued Friday. “Companies cannot possibly guess in advance what will be deemed adequate disclosure years later in collateral litigation,” added Scott Bass, a partner at Sidley Austin, which is counsel for NPA. “The [Dietary Supplement and Nonprescription Drug Consumer Protection Act] explicitly states that AERs are not proof of causation.”
Gay added, “The Ninth Circuit’s action is not good for manufacturers, not good for consumers and just is not good law. We hope the Supreme Court will agree.”
Research finds risk of developing Type 2 diabetes lower in breast-feeding mothers
PITTSBURGH Researchers at the University of Pittsburgh found that mothers who did not breast-feed their children have higher rates of Type 2 diabetes later in life compared with those who breast-fed.
"We have seen dramatic increases in the prevalence of Type 2 diabetes over the last century," stated Eleanor Schwarz, assistant professor of medicine, epidemiology, and obstetrics, gynecology and reproductive sciences at the University of Pittsburgh. "Diet and exercise are widely known to impact the risk of Type 2 diabetes, but few people realize that breast-feeding also reduces mothers’ risk of developing the disease later in life by decreasing maternal belly fat."
The study, published in the September issue of the American Journal of Medicine, included 2,233 women between the ages of 40 and 78 years.
Overall, 56% of mothers reported they had breast-fed an infant for at least one month. Twenty-seven percent of mothers who did not breast-feed developed Type 2 diabetes and were almost twice as likely to develop the disease as women who had breast-fed or never given birth. In contrast, mothers who breast-fed all of their children were no more likely to develop diabetes than women who never gave birth. These long-term differences were notable even after considering age, race, physical activity, and tobacco and alcohol use.
"Our study provides another good reason to encourage women to breast-feed their infants, at least for the infant’s first month of life," Schwarz added. "Clinicians need to consider women’s pregnancy and lactation history when advising women about their risk for developing Type 2 diabetes."
The research was funded by grants from the National Institutes of Health’s National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Child Health and Development.
Topical BioMedics earns patent for product used to treat fibromyalgia pain
RHINEBECK, N.Y. Topical BioMedics on Thursday announced that its Topricin pain relief and healing cream has been awarded a patent as a treatment of pain associated with fibromyalgia. A Food and Drug Administration-regulated topical biomedicine, Topricin was introduced by the company in 1994, the company stated.
More than 5 million people suffer from fibromyalgia, with the vast majority of them being women. The condition is characterized by chronic, widespread pain in muscles, ligaments and tendons; multiple “tender points”; fatigue; and sleep disturbances. Other symptoms include numbness and tingling, irritable bowel syndrome, palpitations and tension or migraine headaches. The soft-tissue pain of fibromyalgia is described as deep-aching, radiating, gnawing, shooting or burning, and ranges from mild to severe.
Topricin delivers a combination of homeopathic medicines to relieve pain. “Topricin has been effective in resolving pain for the many women suffering with fibromyalgia, with many reporting they have more energy [and] are staying more active, and [reporting] that [Topricin] has helped to reduce or eliminate their dependency on oral pain medications,” stated Lou Paradise, Topical BioMedics CEO.