Misdirected Studies on Avandia
Eight years and seven million patients later, we still don’t
know whether the diabetes drug, Avandia, is safe or effective. This is
largely because the manufacturer, GlaxoSmithKline, failed to vigorously
pursue questions about cardiac safety and the Food and Drug Administration
acquiesced in its feeble efforts. Both either ignored or tried to silence
scientists who raised the alarm.
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Prescription Info Now Available Online
In an Emergency
Doctors and pharmacists caring for disaster victims
can now obtain medication histories through a new Web service.
The service is named ICERx.org, which is shorthand
for In Case of Emergency Prescription Database, makes permanent the type of
service cobbled together on short notice in 2005 after Hurricane Katrina
wiped out thousands of personal medical records and many of the local drug
stores that filled prescriptions.
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Deadlines
Set For Unapproved Drugs
The Food and Drug Administration on Friday announced it is
giving manufacturers of unapproved cough and cold remedies containing
timed-release guaifenesin, an expectorant, until Aug. 27 to stop making their
products. They have until Nov. 26 to stop shipping such products across state
lines.
Because the companies never sought approval for the products,
"FDA has not determined that they are safe and effective as formulated
and manufactured," Deborah Autor, director of the Office of Compliance
at the FDA's Center for Drug Evaluation and Research, said at a press
conference.
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Birth Control Pill That Stops Periods
Wins FDA Approval
The Food and Drug Administration approved the first birth control pill that
eliminates a woman's monthly period.
Taken daily, the contraceptive, called Lybrel, continuously
administers slightly lower doses of the same hormones in many standard birth
control pills to suppress menstruation. It is designed for women who find
their periods too painful, unpleasant or inconvenient and want to be free of
them.
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Drug, ad firms gird as House takes up
FDA revamp
Advertising for pharmaceuticals was a $1.3 billion business in the first
three months of this year, on pace to rival the $5.6 billion spent in 2006,
according to Nielsen Monitor-Plus . The industry says that such ads can alert
patients to undiagnosed medical conditions. But critics say the ads overstate
the benefits of prescription drugs and boost
spending on expensive new medications.
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