It?s a hard fall when you reach the top, only to be knocked down and trampled. Vioxx (rofecoxib), Celebrex (celecoxib) and Bextra (valdecoxib) have fallen. Safety concerns have halted several studies on these selective nonsteroidal anti-inflammatory drugs due to increased risk of serious cardiovascular events—heart attack and stroke—and Merck & Co. voluntarily pulled Vioxx in September. For millions of users, this is alarming news.
The U.S. Food and Drug Administration issued a health advisory on Dec. 23, stating it was ?requiring evaluation of all prevention studies that involve the COX-2 selective agents Celebrex and Bextra to ensure that adequate precautions are implemented ? in light of the new evidence that these drugs may increase the risk of heart attack and stroke.?
The agency also announced preliminary results from a clinical trial that suggest long-term use of the nonselective NSAID naproxen (in products such as Aleve) may be associated with an increased cardiovascular risk compared with placebo.
The EMEA (European Medicines Agency) issued a release in late December stating it had decided to accelerate its review of COX-2 inhibitors. According to EMEA, COX-2 inhibitor medicines available in Europe already contain stringent warnings and precautions on cardiovascular risks. ?The ongoing review of this class of medicines by the EMEA is looking at whether there is a need to make changes to the existing marketing authorizations throughout the European Union (e.g., precautions, warnings, etc.) and whether additional studies are needed,? according to a release.
FDA?s claim of new evidence of CV risk may ring untrue to Canadians. Back in the winter 2001-2002 issue of Therapeutics Letter, a publication of The University of British Columbia department of pharmacology and therapeutics in Vancouver, researchers concluded ?COX-2 selective inhibitors are associated with an increased incidence of serious adverse events? including ?cardiovascular toxicity.?
Recently, and to the further alarm of NSAID users, the mid-December issue of the Archives of Internal Medicine published a report by researchers at the Basel Pharmacoepidemiology Unit, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, Switzerland, which found that people who have recently stopped using NSAID therapy are 52 percent more likely to experience a heart attack than nonusers. The effect was most pronounced in patients with rheumatoid arthritis or lupus, according to the researchers.
According to Kalorama Information, a publishing division of MarketResearch.com, 2004 sales for over-the-counter pain products have been estimated at nearly $4 billion. U.S. sales of prescription pain medications were approximately $14.2 billion, or nearly 60 percent of the worldwide figure. In fact, ?Prescription analgesic products have the highest ad spends, with major brands like Vioxx and Celebrex being the top two most-advertised brands among all prescription products in the [United States],? the report said.
And while the news is bad for those who suffer from illnesses and now use NSAIDs for relief, the news for naturals retailers can be good.
Tom Newmark, president of Brattleboro, Vt.-based supplements maker New Chapter, recommends a positive approach to getting the message of natural COX-2 alternatives to consumers by ?highlighting what we?ve always known: Wholesome nutrition, both from quality food sources and dietary supplements, can help promote a healthy inflammation response. The key is to avoid the disease discussion and focus on our strengths—the natural promotion of a healthy inflammatory system.?
Newmark said sales of Zyflamend, New Chapter?s COX-2 alternative, have seen a sales jump, which is ?escalating.?
According to Henry Kriegel, president of Kriegel Marketing Group, the pharmaceutical industry is suffering a crisis of confidence. ?The Chinese define crisis as danger and opportunity. For natural products retailers this is a great opportunity to promote safe, natural and effective products that promote joint and cartilage support.? His company?s SierraSil ?experienced spikes in certain geographic areas where the media has supported our efforts to increase awareness of natural alternatives for arthritis and dietary supplements for health.?
Pierre Brunschwig, M.D., a Boulder, Colo.-based board certified physician in family medicine and holistic medicine, said that a limited course of NSAIDs can be difficult to avoid for some patients, ?though a careful review of nonpharmacological treatment for arthritis allows patients to avoid or limit their use.? Of course, he recommended that retailers not wade into the murky waters of diagnosis. ?Retailers should always advise their customers to consult their health care provider before initiating a change in medication,? he said. ?There is such a growing body of information regarding supplementation that negotiating the database requires some skill. Consulting with a professional with such skills is indispensable.?
Newmark and Kriegel recommend getting the word out using positive public relations methods. Kriegel encourages retailers ?to use whatever media [is available] to communicate to their customers: newsletter, e-newsletter, radio advertising and interviews, and special offers on joint support? to take advantage of the national media attention on NSAIDs. Newmark said, ?Explaining that there are natural approaches to promoting a healthy inflammation response that are easy to integrate into one?s life? is a great way to ?shine a very positive light on our industry.?
An FDA advisory committee meeting is planned for February, which the agency said will ?provide for a full public discussion of [regulatory] issues.?
Natural Foods Merchandiser volume XXVI/number 2/p. 1, 10