Going down the wrong path
Why I openly question the "New Normal" or "New life style"
The growing reach of Big Pharma
is a trillion dollar industry, surpassing the earnings of
most nations in the UN system.
Its grip stretches far beyond the
academic community and medical practitioners
exert undue influence on
national pharmaceutical regulators.
THE NEW FDA: How a New Policy Led to Seven Deadly Drugs, Los Angeles Times , Dec. 20, 2000
The approval of Relenza and Tamiflu
In early 1999, FDA had rejected Glaxo Wellcome's Relenza (zanamivir) as an antiviral for influenza because its advisory committee concluded that Relenza had not been proved safe and effective. However, pressed hard by Glaxo, the FDA management approved the drug in July 1999.
On Jan. 12, 2000, FDA issued an unusual
public health advisory to doctors, warning of the limited role of Relenza and Tamiflu on influenza -- by that
time seven Relenza patients had died of
It is ironic that even Glaxo Wellcome (now GSK) harbours doubts about the safety of Relenza. Further reading: Fed decision backs GSK lawsuit, says Biota, Melissa Trudinger, Lab+Life Scientist magazine, 25 May 2004
GSK alleges that Tamiflu, which Japanese regulators this year warned against prescribing to teenagers after a spate of fatalities, is safer than Relenza.
"Unlike Relenza, Tamiflu is not, and was not … the subject of mandatory safety warnings relating to bronchospasm … asthma and other underlying airways diseases or cardiac conditions, or the risk of death," the document says. Biota would not comment on GSK's defence.
Dr. Elashoff barred from reviewing Tamiflu
Dr. Michael Elashoff, a PhD from Harvard, was the biostatistician who discovered the problems with Relenza's clinical trial data. He was scheduled to review the data for Tamiflu, but that never happened.
What happened to you after the advisory committee meeting?
The next day after the advisory committee, several people in FDA management told me that they blamed me for the drug getting turned down in the advisory committee; that I wouldn't be allowed to present at the advisory committee meetings in the future for any other drugs.
At the time, I was also scheduled to be the reviewer for another flu medication, Tamiflu. That review was taken away from me. I guess they were worried that I might apply the same level of review to that application as I had for Relenza. So they gave it to someone else.
Little did Elashoff realize at the time of
his review that the FDA's priorities had
already changed from
Should we approve this drug? to
Hey, how can we get this drug approved?