News in brief - March 10, 2003

OxyContin ads pulled - Colds cost $40 billion annually - Smallpox vaccinations uneventful - Majority of physicians oppose widespread smallpox shots - Blood test would rule out heart attack - HIV drugs, vascular disease connection dispelled - New nicotine gum gets good reviews

OxyContin ads pulled

Purdue Pharma LP has pulled two versions of its physician-directed advertisements for oxycodone HCl controlled-release -- OxyContin -- in response to a warning letter from the Food and Drug Administration.

One version of a two-page ad, which ran during October 2002 in the Journal of the American Medical Association and American Medical News, featured an image of two sets of pill cups on the first page. One set was a set of six, representing the number of ordinary analgesic pills required to alleviate moderate to severe pain. The other was a set of two, meant to indicate the number of OxyContin doses required for the same effect. The second page featured extensive information about usage, contraindications and safety warnings.

The other ad, which ran in November 2002, featured a man fishing with a boy, the two pill cups and the tag line, "There can be life with relief."

The warning letter from the FDA issued in January charged that the ads minimized safety risks associated with the drug and made unsubstantiated efficacy claims by failing to include important information about the drug in the advertisement's main body, rather than on the second page.

"The typical physician reviewing an advertisement for a prescription drug would expect the most serious risks associated with the drug to be included in the body of the ad," according to the FDA letter.

Purdue Pharma said the warning letter was the result of a misunderstanding and that they would be pulling the ads in compliance with the FDA's request.

"It is Purdue's opinion that the letter was the result of an honest misunderstanding, which we regret, regarding the featuring of safety information already presented in the brief summary that is part of the two new ads for OxyContin tablets. The boxed warning was prominently referenced in bold print on the front page of each ad and printed in its entirety on a subsequent page," said the company in a statement.

OxyContin is not advertised direct to consumers.

Colds cost $40 billion annually

Upper-respiratory tract infections -- common colds -- cost the United States $17 billion in direct costs such as medical treatment and $22.5 billion in indirect costs such as lost workdays for patients and their caregivers, according to a study published in the Archives of Internal Medicine last month.

Researchers at the University of Michigan Health System in Ann Arbor conducted a nationwide telephone survey of more than 4,000 households and found that nearly three-quarters reported a cold within the past year. Of those who had colds, respondents reported an average of 2.5 annually. When these numbers were extrapolated, researchers concluded that there are about 500 million colds annually.

In addition, $2.9 billion is spent on over-the-counter remedies and $400 million on prescription medications. Colds also translated to 100 million doctor visits per year.

"From a bottle of cough syrup to missed time at work and school, the price tag of catching a cold really adds up," said A. Mark Fendrick, MD, lead author on the paper and co-director of the Consortium for Health Outcomes, Innovation, Cost Effectiveness Studies at the university.

Researchers were particularly concerned that many respondents reported receiving antibiotics for their colds which could add to the growing problem of antibiotic resistance.

Smallpox vaccinations uneventful

No serious adverse effects were reported during the first three weeks of the ongoing campaign to vaccinate physicians and other health professionals against smallpox, according to the Centers for Disease Control and Prevention.

From Jan. 24 to Feb. 14, the vaccine was administered to 4,213 civilian health care workers, the agency reported in the Feb. 21 issue of the Morbidity and Mortality Weekly Report. President Bush has said he would like to immunize 500,000 health care workers in the short term and as many as 10.5 million over the long term.

During the initial weeks of the new vaccination effort there were no potentially life-threatening or moderate-to-severe adverse events reported, said the CDC. Among seven individuals who reported nonserious events, the most common were fever, rash, malaise, pruritus, hypertension and pharyngitis.

The CDC plans to publish surveillance reports on adverse events on a regular basis.

Majority of physicians oppose widespread smallpox shots

Most doctors are against populationwide smallpox vaccination, according to a survey conducted in January and February by ePocrates Inc., a manufacturer of software for handheld computers.

Of the nearly 2,000 doctors polled, 68% did not feel that all Americans should receive the shots within the next two years. Pediatricians were most against widespread vaccinations, with 77% opposed

No significant differences were found, however, based on location of practice. New York physicians were just as likely to be opposed as their peers across the country.

"We found this particularly interesting considering that the events of [Sept. 11, 2001] and the anthrax attacks were close to home for New York City-area physicians," said Matt Campion, vice president of pharmaceutical services.

Blood test would rule out heart attack

The Food and Drug Administration approved on Feb. 14 a new laboratory blood test that is expected to heighten the ability of physicians to rule out a heart attack when a person has severe chest pains.

The Albumin Cobalt Binding Test, which measures how much cobalt is bound to the blood protein albumin, would be used with an electrocardiogram and a blood test for troponin. A normal ACB test that accompanies a normal electrocardiogram and troponin test is expected to provide increased confidence that a patient did not have a heart attack.

An estimated 3 million to 5 million Americans come to emergency departments each year with symptoms of a heart attack, according to the FDA. Only an estimated 22% actually have a heart attack. The rest have a variety of other ailments, including severe indigestion, pneumonia, gallstones and hepatitis.

HIV drugs, vascular disease connection dispelled

Concern that HIV drugs could be causing an increase in vascular disease was at least partially negated by a large study of 36,766 patients treated for HIV in the Veterans Affairs health care system from 1993 to 2001, published in the Feb. 20 issue of the New England Journal of Medicine.

Study leader Samuel A. Bozzette, MD, PhD, an infectious disease specialist with the VA San Diego Health Care System, did caution that the study may not reflect the longer-term effects, noting that HIV patients must be monitored carefully for vascular disease and other side effects and treated accordingly.

New nicotine gum gets good reviews

An investigational rapid-release nicotine gum may provide faster and better craving relief for smokers than does Nicorette, according to study results released on Feb. 21 at the Ninth Annual Meeting of the Society for Research on Nicotine and Tobacco. The results were presented by Raymond Niaura, PhD, a professor at Brown University Medical School in Providence, R.I.

"Successful quitting for most smokers requires dealing with intense cravings for nicotine that arise in tempting situations," said Dr. Niaura. The new gum releases nicotine more rapidly in the first few minutes compared to other nicotine gums and continues to deliver a controlled, gradually reduced dose while it is chewed.

The new gum has not been evaluated or approved by the Food and Drug Administration. The study was funded by Bayer Consumer Care.