HEALTH

Industry voices concern over Matrixx Initiatives AER case

BY DSN STAFF

WASHINGTON —The pharmaceutical industry earlier this month weighed in on the case “Matrixx Initiatives vs. James Siracusano and NECA-IBEW Pension Fund.”

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 to shareholders 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 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 and 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 the NPA’s separate amicus curiae.

“Companies cannot possibly guess in advance what will be deemed adequate disclosure years later in collateral litigation,” said Scott Bass, a partner at Sidley Austin, which is counsel for the NPA. “The [Dietary Supplement and Nonprescription Drug Consumer Protection Act] explicitly states that AERs are not proof of causation.”

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Dr. Siegal’s Cookie Diet introduces CalciOs

BY Allison Cerra

VIENNA, Va. Dr. Siegal’s Cookie Diet has expanded its offerings to include calcium-fortified cookies designed to treat occasional heartburn.

CalciOs cookies are vanilla-flavored cookies, each one providing 30% of the daily value of dietary calcium, Dr. Siegal’s Cookie Diet said. The cookies contain calcium carbonate, designed to treat heartburn relief. CalciOs also are free of artificial colors and preservatives.

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Pharmacies should get out of tobacco-selling, into smoking-cessation game

BY Antoinette Alexander

WHAT IT MEANS AND WHY IT’S IMPORTANT The news that San Francisco’s board of supervisors gave preliminary approval to ban tobacco sales at all retailers that operate pharmacies, including mass merchants and grocers, is a step in the right direction, because if drug stores are going to be banned from selling them, then all retail pharmacy outlets should be banned. However, there’s an even bigger picture to consider.

(THE NEWS: Report: San Francisco supervisors OK tobacco sales ban at pharmacies. For the full story, click here)

As many dollars as pharmacy retailers made selling cigarettes, there is much more to be gained in medication therapy management, and there is a significant opportunity for retail pharmacy to have a greater stake in the future of health care.

Cigarette smoking has been identified as the most important source of preventable disease, illness and death worldwide, according to the American Lung Association. Smoking-related diseases claim an estimated 443,000 American lives each year, including those affected indirectly by "secondhand" smoke.

Furthermore, smoking-related healthcare expenditures are a major drain on the U.S. healthcare system. According to the Centers for Disease Control and Prevention, smoking cost the United States more than $193 billion in 2004, including $97 billion in lost productivity and $96 billion in direct healthcare expenditures, or an average of $4,260 per adult smoker.

Clearly, there’s a positive role that pharmacists can play in smoking cessation. To further support this, a recently published study on the "effect of a pharmacist-managed smoking-cessation clinic on quit rates" found that pharmacists can play a vital role in smoking cessation, especially in a group setting, as they can reach more people within the same time frame.

The study found that at three months and six months, 47.6% and 52.4% of patients reported being smoke-free, respectively. The study was conducted on patients that had participated in the pharmacist-managed Smoking Cessation Group Clinic at the University of Iowa Hospitals and Clinics. Participants received structured group counseling on various topics associated with cessation.

It also should be noted that in August, the Centers for Medicare and Medicaid Services announced that Medicare coverage for seniors trying to quit smoking was expanded to include everyone on Medicare.

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