Sen. Charles Grassley, R-IA, was sent home empty-handed today by
federal health officials who refused the powerful Republican access to
information on a controversial drug approved by the FDA.
"I smell a cover-up," Sen. Grassley said as he emerged from the headquarters of the Department of Health and Human Services.
Grassley has been investigating why FDA officials approved the sale
of the antibiotic Ketek even after the government learned safety tests
on the drug had been forged. Grassley wanted to speak with the FDA
investigator who uncovered the fraud.
According to an FDA document obtained by ABC News, there have been
reports of four deaths and 35 liver failures or serious injuries among
people taking the drug, which is used to treat bronchitis and other
respiratory infections.
"I can say without a doubt that this drug should have been withdrawn," Grassley told ABC News.
The study with the forged test results was conducted at a former
weight loss clinic in Gadsden, Alabama. Dr. Maria Anne
Kirkman-Campbell is serving five years in prison for falsifying safety
test results on Ketek.
A former nurse, Michelle Snedeker, told ABC News she was ordered to
forge documents and report data on people who had not even been given
Ketek. The doctor was paid $400 for each of the 407 subjects that she
enrolled for the study.
The maker of Ketek, Sanofi-Aventis, says "the benefit of Ketek
outweighs any known risk." Along with the FDA, the company insists
Ketek is safe, based on tests that were done in Europe.
The FDA would not comment on Sen. Grassley's investigation but says
there are no plans to take Ketek off the market, despite the recent
death and injury reports.
An FDA spokesman said the agency was considering the addition of a
warning label on the outside package of the prescription drug.
I've always believed that a person should be an active participant in
any healthcare they receive. Understand any illness, and research all
that you can, especially any medications that you might have to take.
It
also occurs to me what an invaluable tool the internet can be for such
information. A 'google' search and you can find the information on the
doctor who's in prison for falsifying the safety test results on Ketek,
and take any concerns to your doctor.
And it occurs to me as
well that if net neutrality is not protected, will this information
still be available? I certainly don't think the FDA is going to start
labeling certain drugs with the warning that they may cause sudden
irreversible death if taken as directed.
Sen. Charles Grassley, R-IA, was sent home empty-handed today by
federal health officials who refused the powerful Republican access to
information on a controversial drug approved by the FDA.
