sexta-feira, 25 de maio de 2007

Avandia: the Empire strikes back

The Wall Street Journal (ver parte do texto abaixo) mostra o contra-ataque da Glaxo Smith Kline e a situação aflitiva dos propagantistas farmacêuticos. O interessante não é bem o risco causado aos pacientes, mas a queda das ações da empresa. Em negrito, as mudanças da bula que na Europa já indicava risco de infarto do miocárdio. Glaxo Courts Doctor Support of Avandia Similar Consumer Ads Aren't Yet Planned But Won't Be Ruled Out By JEANNE WHALEN and ANNA MATHEWS May 25, 2007 GlaxoSmithKline PLC, under pressure to protect its diabetes drug Avandia, is reaching out to physicians to defend the drug's safety but isn't currently planning a similar ad campaign for consumers.In meetings with doctors, Glaxo sales representatives are focusing on data from a large clinical trial called A Diabetes Outcome Progression Trial, or ADOPT. "We are reassuring physicians about the safety data we have, particularly looking at ADOPT," said Alice Hunt, a Glaxo spokeswoman. (…..) Dr. Nissen's analysis led to a sharp drop in Glaxo's stock price, and some analysts have predicted Avandia sales could be cut in half because of physician and consumer concerns. The Glaxo spokeswoman said the company isn't planning consumer ads defending Avandia but won't rule them out, either. "At the moment, there is an information vacuum, and GSK may need to step into the void," she said. (…….) When Avandia was approved, its label held a mild precaution noting that in animal studies, there had been signs of plasma volume expansion and heart hypertrophy, signals of a heart-failure risk. It also noted that while LDL, or "bad cholesterol," went up in Avandia patients, HDL, or "good cholesterol," ended up rising, as well. Later, the drug's label got a new warning that Avandia, like similar treatments, might exacerbate or lead to heart failure. The warning also noted that when taken with insulin, such drugs may "increase the risk of other cardiovascular adverse events." Last year, the Avandia label warning got beefed up a bit, saying patients with heart failure who took Avandia had a higher risk of cardiovascular events. The Glaxo analysis showing potential heart-attack risk hasn't been placed in the U.S. label, although it is mentioned in the European label. On Internet sites popular with drug-industry sales representatives, people claiming to work for Glaxo have been posting hundreds of messages this week bemoaning the difficult position Dr. Nissen's study has put them in.

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