By John Fauber
Milwaukee Journal Sentinel/MedPage Today

Excerpts:

The 2001 product launch of the asthma drug Advair (fluticasone/salmeterol) was a lavish, Las Vegas affair.

Using images of a slot machine to illustrate their message, top GlaxoSmithKline executives took the stage in front of thousands of assembled sales reps. “There are people in this room who are going to make an ungodly sum of money selling Advair,” one executive told the group.

He was right.

Millions of people with asthma, including many children, have gone on the drug and, according to data from IMS, Advair sales have exceeded $4 billion every year since 2007.

Yet even as profits mounted evidence began to emerge from independent medical studies and court records suggesting that the drug can be dangerous, especially to children and that overuse of the drug exacerbated the danger.

At a 2008 FDA advisory panel reviewing the use of the drugs, agency physician David Graham, MD, questioned whether it was worth putting an entire population on the drugs just to find that occasional patient who gets better control of their asthma, according to a transcript of the meeting.

“We have no way of identifying who’s going to have that miraculous response to Advair,” he said, “just as we have no way or predicting who’s going to end up in the cemetery because of Advair.”

Graham has a long-standing reputation as a FDA whistleblower, who has testified at Congressional hearings investigating the marketing of Merck’s arthritis pain drug Vioxx, withdrawn after it was linked to heart attacks, and the diabetes drug Avandia, a GlaxoSmithKline drug, which was linked to increased risk of heart attacks.

Read the Full Article Here: http://www.medpagetoday.com/AllergyImmunology/Asthma/36000