PHARMACY

Study shows no link between ADHD medication and drug abuse

BY Diana Alickaj

WASHINGTON A new report published in the March issue of the American Journal for Psychiatry states that children who are given psycho-stimulants for attention deficit-hyperactivity disorder are not more susceptible to begin abusing drugs and alcohol than their peers.

ADHD is a disorder that includes systems of inability to focus, hyperactivity and impulsiveness. According to the Wall Street Journal, 9 percent of children have ADHD in America, but only 32 percent get the medication needed to treat it.

The report was funded by the National Institutes of health and was designed by the Massachusetts General Hospital investigators whose main goal was to make sure to cover all necessary angles in order to receive the correct data for the relationship between drug abuse and ADHD medication.

The researchers interviewed 112 men between the ages of 16 and 27, a decade after they were diagnosed with ADHD and asked about their consumption of tobacco, alcohol, drugs and the type of medication they used. The study concluded that there was no relationship between substance abuse and the prescription ADHD medicines.

“This study is a continuing effort to explicate the factors that mediate risk. It is methodologically sound and suggests that, as always, things are more complicated than we want them to be. The study demonstrates that the use of psycho-stimulants for ADHD children does not increase the risk for substance abuse in adulthood, but it also suggests there is no protective effect,” said Jon Shaw, director of the Division of Child and Adolescent Psychiatry and Behavioral Science at the University of Miami.

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Mass. D.A. looking into Vioxx allegations against Merck

BY Drew Buono

WHITEHOUSE STATION, N.J. The U.S. Attorney’s Office for the District of Massachusetts is investigating Merck over the promotion of its painkiller Vioxx, which was pulled from the market in 2004, according to the Wall Street Journal. The investigation is over whether Merck promoted the drug to health care professionals for uses other than those approved for by the Food and Drug Administration.

In February 2007, Merck released in its regulatory filings that the Justice Department issued a subpoena requesting information relating to the company’s research, marketing and sales of Vioxx as part of a federal investigation under criminal statutes.

Merck disclosed in that filing that 31 state attorneys general and the District of Columbia are investigating its sales and marketing of Vioxx. The company said it is cooperating with authorities in all of these investigations.

Merck withdrew Vioxx after a study linked it to increased risk of heart attacks and strokes. The company faced some 27,000 lawsuits from people alleging injuries from the drug. In November, Merck struck a tentative $4.85 billion settlement. The grand-jury investigation comes at a time when thousands of plaintiffs are weighing whether to enroll in the pending settlement.

Justice Department probes into drug marketing have resulted in settlements of $875 million with TAP Pharmaceuticals in 2001 and $355 million with AstraZeneca in 2003. Eli Lilly is negotiating with federal investigators regarding its marketing of antipsychotic drug Zyprexa.

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FDA rejects Labopharm’s Tramadol after response to second approvable letter

BY Drew Buono

WASHINGTON Labopharm’s appeal of a second approvable letter from the Food and Drug Administration for a once daily formulation of its pain drug Tramadol has been rejected by the agency.

The director of the Center for Drug Evaluation and Research’s Office of New Drugs, John Jenkins, “has suggested additional statistical analysis of existing data as a means to potentially satisfy the agency’s requirements,” according to Labopharm.

The method Jenkins is proposing is different from the method the FDA requested following its first approvable letter in May 2007, the company said. Jenkins also recommended the company meet with the agency prior to any resubmission.

Labopharm is trying to introduce the once-daily formulation of tramadol, which is its lead product, in various international markets, including Canada, France, Germany, Spain, Italy and the UK.

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