Tuesday, September 14, 2004

Veil of secrecy to lift on drug tests
Christian Science Monitor story - "Growing concerns over the safety and efficacy of anti- depressant drugs prescribed to children have caught the eye of Congress and the New York state attorney general. Now they're becoming the catalyst for calls to reform the way clinical trials of all drugs are reported. Pressure is already causing some changes within the pharmaceutical industry. And it has put the US Food and Drug Administration (FDA), which approves new drugs, in the hot seat. If reforms are carried out, they could bring an unprecedented level of transparency to drug research. The solution now under consideration: a public database, or registry, of drug trials, where companies would post the results of those trials..."  
  

Feds Warn on Children and Antidepressants
AP story reprinted at The State (South Carolina) - "Federal health advisers considering more stringent warning labels for antidpressants linked to suicidal thoughts among children told the Food and Drug Administration on Tuesday that they may consider more than just a label change. One member of the panel asked the drug agency whether they could require that those prescribing the drugs undergo training to better recognize warning signs. ... Data presented to the FDA show that 65 percent of antidepressants taken by children are prescribed by psychiatrists. Independent experts and FDA scientists have said there a definite link between antidepressants and the worsening suicidal fixations of children taking the drugs. The latest analysis forms the heart of data FDA advisers were considering during the second day of hearings on antidepressants. Even Prozac - shown in earlier studies to be the most benign antidepressant for youth - increases the odds of suicidal thoughts and actions." See also FDA Confirms Antidepressants Raise Children's Suicide Risk (Washington Post, reprinted at PsycPORT), US Reviewer Maintains Antidepressant/Suicide Link (Medscape - free registration required) and Health advisers weigh emotion, science in anti-depressant inquiry (Boston Globe).