HEALTH

CRN CEO responds to dietary supplements article by ‘Sports Illustrated’

BY Michael Johnsen

WASHINGTON The Council for Responsible Nutrition on Tuesday strongly criticized an article — “What you don’t know might kill you” — that was published in the May 18 issue of Sports Illustrated for mischaracterizing the dietary supplement industry. The industry, the association charged, has suffered from a chronic dose of misperception around safety and regulatory requirements in part because the Food and Drug Administration has not actively utilized enforcement powers afforded the agency under the Dietary Supplement Health and Education Act of 1994.

Steve Mister, president and CEO of CRN, noted that the Sports Illustrated article suggests DSHEA severely curtailed FDA’s ability to regulate dietary supplements — for example, shifting the safety burden of new supplement products to FDA and eliminating any pre-market approval authority.

“Contrary to [former FDA commissioner] Dr. David Kessler’s statements [in the Sports Illustrated article], and to common misunderstandings about the law, rather than shifting the safety burden to FDA, DSHEA actually provided FDA with new enforcement authority not previously available,” Mister argued. “Dietary supplements were regulated as a category of food prior to DSHEA, and continue to be regulated as a category of food today. Further, FDA never had legal pre-market approval authority for dietary supplements — DSHEA did not change that fact.”

Instead, Mister suggested that the FDA, under Kessler’s leadership, did not enforce DSHEA at the time of its creation, and that the agency has only recently begun to realize the full regulatory powers afforded FDA under DSHEA.

“The extreme examples the article describes appear to be a product of DSHEA, when in fact, they more likely result from FDA’s lack of enforcement of that law over the past 16 years, starting with Dr. Kessler’s decision to allow FDA to turn its back on supplement regulation once DSHEA — a bill he strongly opposed — was enacted,” Mister said. “In actuality, FDA chose to sit on its collective hands, refusing to take advantage of the new tools it now had [under DSHEA], even ignoring the simplest requirements from Congress to issue new Good Manufacturing Practices specific to dietary supplements. … It wasn’t until Dr. Mark McClellan became FDA Commissioner in 2002 that the agency emerged from its fog of inertia concerning the dietary supplement industry, and began to look at and use some of the additional authority provided to it by DSHEA,” he said. “In the past five years or so, the industry and the agency have both come a long way: with industry lobbying for GMPs that are supplement-specific and FDA finally issuing these rules; with industry urging for passage of a mandatory reporting system for serious adverse events, and FDA getting the system up and running; and with FDA taking strong enforcement action — ranging from warning letters to significant fines to product seizures against companies that manufacture unapproved drugs masquerading as dietary supplements.”

Mister also took exception to the suggestion that such performance-enhancing drugs as anabolic steroids are legal under current DSHEA regulations, and that it’s up to the Drug Enforcement Agency to track down and stop production of these supplements containing illicit ingredients. That couldn’t be further from the truth, Mister argued.

“Under DSHEA, most of these substances are not even legal dietary ingredients, i.e., they cannot be legally included in dietary supplements, period,” he said.

For starters, supplement manufacturers can’t legally go to market with a new-to-the-U.S. supplement ingredient without first filing a “new dietary ingredient” notification to FDA. Products containing new ingredients without that NDI notification are adulterated under the law, Mister said.

Couple that NDI filing requirement with the fact that, under current GMPs, manufacturers must also seek and secure FDA approval of any new manufacturing plant, and the FDA has de facto powers to prevent potentially illegal substances marketed as supplements from ever reaching the market.

“[DSHEA] provides that any food, including supplements, that is adulterated is subject to a range of penalties including seizure, fines and imprisonment for the manufacturer, Mister said. “Completely independent of DEA’s jurisdiction in this area, FDA has clear and powerful authority to address supplements that contain performance-enhancing drugs or anabolic steroids. These various new chemical cocktails are illegal under DSHEA simply because no NDI has been filed for them or because they are not legal dietary ingredients in the first place.”

“Every industry has its outliers, the underbelly that ignores the laws, cuts corners in manufacturing and puts profits ahead of long-term confidence of their consumers,” Mister added. “This industry is no exception, but that is not the fault of the law itself. No law works unless it is enforced.”

Mister also noted that the Sports Illustrated article overstated the size of the sports nutrition industry, and in so doing overstated the size of the potential bad players within that industry.

“[The] Sports Illustrated’s article … starts by referring to sports nutrition supplements as a ‘$20 billion obsession,’ portraying the industry as eight times larger than it is,” commented Steve Mister, president and CEO, CRN. “The entire dietary supplement industry has U.S. sales of approximately $24 billion, with vitamin sales alone representing approximately $10 billion of the total market. But the sports nutrition supplements that are the focus of this article represent sales somewhere closer to $2.5 billion.”

Mister noted that the Sports Illustrated estimate did include sales figures from categories outside of dietary supplements, such as functional foods, for example.

“Ironically that inflated figure seeks to portray a problem that, if it exists at all, represents only a very small portion of companies in the supplement industry not representative of the mainstream companies that manufacture products that consumers choose to include in their cadre of personal healthcare options,” Mister said.

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RelayHealth collaborating with CDC to provide H1N1 information

BY Michael Johnsen

ATLANTA RelayHealth, a provider of healthcare connectivity services, is helping healthcare providers cope with the recent outbreak of influenza A (H1N1), and aiding the Centers for Disease Control and Prevention with monitoring of influenza antiviral prescribing activity nationwide via an authorized prescription data feed, the company announced Monday.

“Our hope is that the H1N1 threat continues to moderate,” stated Jim Bodenbender, RelayHealth’s SVP and general manager. “But whatever the threat level, our secure online interactive tools are available to assist physicians enrolled on the RelayHealth network to keep their patients informed of the latest credible health information at any time.” 

Already, physicians are using RelayHealth’s HIPAA-compliant interactive service to broadcast messages securely over the Internet to their patients about the symptoms of H1N1 influenza and what to do if those patients think they have the disease, RelayHealth reported. RelayHealth has also made available H1N1 flu educational content on its network, which doctors can transmit to their patients

And RelayHealth’s Pharmacy Solutions Group is contributing to the national effort to track and limit the spread of the H1N1 flu by providing the CDC with a HIPAA-compliant data feed of antiviral prescriptions filled by a cross-sectional sample from more than 35,000 major chains, regional chains and independent pharmacies throughout the U.S. that have allowed their information to be shared.

RelayHealth provides the CDC with this authorized data feed every four hours, the company stated. On average, RelayHealth sends 400,000 to 500,000 prescription records daily to the CDC.

According to RelayHealth, the agency uses this data to monitor influenza antiviral prescribing activity across the country and shares the data with the U.S. Department of Health and Human Services.

“Our ability to swiftly assemble the data on antiviral prescriptions for the CDC is playing a role in the nation’s emergency preparedness effort,” stated Jeff Felton, president of RelayHealth’s Pharmacy Solutions Group.

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ASGE: Electronic diagnosis provided inaccurate results for Barrett’s esophagus patients

BY Michael Johnsen

OAK BROOK, Ill. In a review of more than 2,000 patients coded for Barrett’s esophagus, electronic diagnosis overestimated the prevalence of the disease, according to researchers in California, the American Society for Gastroinestinal Endoscopy announced last week.

According to the review, researchers found that only 61.9% of patients assigned a billing diagnosis code for Barrett’s esophagus actually had Barrett’s esophagus after a manual record review.

The misdiagnosis could potentially undermine or skew future research into patients diagnosed with Barrett’s esophagus, a condition where the lining of the esophagus changes due to chronic inflammation, generally from gastroesophageal reflux disease. Definitive diagnosis requires a biopsy, taken at upper endoscopy, demonstrating replacement of the normal cell lining with one more like the cell lining of the small intestine. This is also known as intestinal metaplasia. Barrett’s esophagus itself has no specific symptoms, but this change can increase the risk of esophageal adenocarcinoma (a type of esophageal cancer).

Researchers concluded that electronic coding alone overestimates the prevalence of Barrett’s esophagus, and most clinical and research uses will require a manual verification of disease status.

The study appears in the May issue of GIE: Gastrointestinal Endoscopy, the monthly peer-reviewed scientific journal of the ASGE.

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