March 2007 Archives

NEW YORK (Reuters Health) Mar 20 - Laws that mandate disclosure of payments to physicians by pharmaceutical companies provide limited public information, according to a new report.

At present, five states and the District of Columbia have legislation requiring payment disclosure. Among these states, Minnesota and Vermont require that the information be made available to the public.

In the current study, reported in the March 21st issue of the Journal of the American Medical Association, Dr. Joseph S. Ross, from Mount Sinai School of Medicine in New York, and colleagues examined the accessibility and quality of information provided by the disclosure laws in Minnesota and Vermont.

LONDON, March 7, 2007-The Medicines and Healthcare products Regulatory Agency (MHRA) has requested Pfizer to withdraw an advertisement making potentially misleading claims about Zyvox (linezolid), an antibiotic used to treat certain types of serious infection.

The MHRA became aware of the advertisement in the British Medical Journal (BMJ) claiming that Zyvox has superior cure rates compared to products containing the active ingredient vancomycin. At the time, Pfizer was in discussion with the MHRA about emerging concerns relating to the efficacy and safety of Zyvox compared to vancomycin in a clinical trial in patients with catheter-related infections.

U.S. senators vowed on Wednesday to move forward with legislation to legalize the importation of cheaper prescription drugs from certain countries, despite resistance from regulators and drugmakers.

One Democrat and three Republicans said their plan would provide money and safeguards for the Food and Drug Administration to assure the imports were not dangerous.

"I believe this legislation puts in place an effective regulatory framework to make importation of FDA-approved drugs safe for consumers," Sen. Byron Dorgan (news, bio, voting record), a North Dakota Democrat, said at a hearing.

The use of drugs to treat attention-deficit/hyperactivity disorder, or ADHD, has more than tripled worldwide since 1993, U.S. researchers reported on Tuesday.

And spending on such drugs rose nine-fold between 1993 and 2003, the team at the University of California, Berkeley reported.

"ADHD could become the leading childhood disorder treated with medications across the globe," Richard Scheffler, an expert in health economics and public policy who led the study, said in a statement.

BOSTON, MA -- March 6, 2007 -- For years, pharmaceutical companies have sought to restrict public access to drug safety data collected in clinical trials on the basis that it is proprietary information, arguing that competitors could use that information in the development of their own products. However, a number of recent cases of drugs found to have dangerous side effects after coming to market, such as the anti-inflammatory drug rofecoxib (Vioxx), have raised concerns about safety data being treated as confidential.

A new analysis by researchers at the Harvard School of Public Health and Brigham and Women's Hospital of laws and regulations governing public disclosure of clinical trial data submitted to the FDA suggests changes should be made to the way the FDA implements its policy regarding the confidentiality of those data. Allowing greater access to safety data would enable researchers to independently evaluate risks, resulting in more timely risk detection. The review and commentary appears in the current issue of Health Affairs.

"Although the current pharmacovigilance system is good and safe, there are now more countries in the EU, and therefore there is a need for an improved system," Ton Van Lierop, a Commission spokesperson told In-PharmaTechnologist.com.

The move comes hot on the heels of a consultation conducted by the Commission last year which found that that the current system is "contradictory, confusing, unclear and complex."

The feedback from the consultation suggested that there are complex reporting rules implemented differently by different EU member States, a lack of robust safety studies and complex decision-making at EU-level.

Worries are emerging about the safety of new diabetes medicines Januvia and Galvus, drugs expected to be big sellers for makers Merck and Novartis. But it is unclear if the concerns are justified or just the result of a hair-trigger tendency concerning drug safety on the part of doctors and regulators.

On Monday, Novartis said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus. Analysts say that could take another year; the pill has already been delayed for three months.

That follows a Feb. 1 article in The New England Journal of Medicine that questioned the safety data available for these drugs. David M. Nathan, a Harvard Medical School endocrinologist, wrote that it is "surprising" that the FDA decided to clear Januvia at all, given the "paucity of published data from long-term clinical trials on its safety and efficacy." Nathan, who is a consultant for Novartis and other drug makers but not Merck , did not return requests for comment.

Abuse of prescription drugs is about to exceed the use of illicit street narcotics worldwide, and the shift has spawned a lethal new trade in counterfeit painkillers, sedatives and other medicines potent enough to kill, a global watchdog warned Wednesday.

Prescription drug abuse already has outstripped traditional illegal drugs such as heroin, cocaine and Ecstasy in parts of Europe, Africa and South Asia, the U.N.-affiliated International Narcotics Control Board said in its annual report for 2006.

In the United States alone, the abuse of painkillers, stimulants, tranquilizers and other prescription medications has gone beyond "practically all illicit drugs with the exception of cannabis," with users increasingly turning to them first, the Vienna-based group said.