HEALTH

Vitamin D intake can help asthma, COPD patients

BY Michael Johnsen

SAN DIEGO Vitamin D may slow the progressive decline in the ability to breathe that can occur in people with asthma, as a result of human airway smooth muscle proliferation, according to researchers at the University of Pennsylvania in a study released Wednesday.

The group found that calcitriol, a form of vitamin D synthesized within the body, reduced growth-factor-induced HASM proliferation in cells isolated from both persons with asthma and from persons without the disease. The proliferation is a part of process called airway remodeling, which occurs in many people with asthma, and leads to reduced lung function over time.

The researchers believe that by slowing airway remodeling, they can prevent or forestall the irreversible decline in breathing that leaves many asthmatics even more vulnerable when they suffer an asthma attack.

“Calcitriol has recently earned prominence for its anti-inflammatory effects,” stated Gautam Damera, who presented the research at the American Thoracic Society’s 105th International Conference on Wednesday. “But our study is the first to reveal the potent role of calcitriol in inhibiting ASM proliferation.”

The investigators have also conducted experiments to determine whether calcitriol, which is currently used to treat psoriasis, could be an effective therapy for COPD.

Although preliminary, their data shows that calcitriol appears to reduce pro-inflammatory cytokine secretions in COPD. As with asthma, the researchers believe, calcitriol may also have the added benefit of slowing, if not stopping, the progression of airway remodeling. Others in the field believe calcitriol may also have the potential to inhibit the development and growth of several types of cancer.

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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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Schering-Plough rolls out new antifungal spray

BY Michael Johnsen

KENILWORTH, N.J. Schering-Plough Consumer Healthcare on Tuesday launched Tinactin Chill, an antifungal spray for the treatment of athlete’s foot.

The new antifungal is available in two formulations, liquid spray and deodorant powder spray.

With the product launch, Schering-Plough is targeting first time athlete’s foot sufferers, which are primarily young males ages 14 to 22.

“Research shows that experiencing athlete’s foot for the first time can be very frightening and intimidating for young men,” stated John O’Mullane, group VP, research and development, Schering-Plough  Consumer Healthcare. “Our research indicated that to reach this age group we would need to go beyond the traditional methods of communication with our customers.”

Accordingly, Schering-Plough developed www.meettheburns.com, a site that features a series of “Webisodes” highlighting the fictitious Burns family and a character named “Gus” representing fungus. Each segment presents an athlete’s foot treatment message in a situation comedy style that is entertaining and identifies well with teens.

“Many young men are reluctant to talk about their situation when they first experience athlete’s foot,” O’Mullane said. “However, they often seek information on the Internet. By developing this Web site, we can reach young men and help inform them and their parents that there are effective and easy to use treatments for this common condition.”

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