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"I can say without a doubt that this drug should have been withdrawn," Grassley told ABC News.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.
NSA Wiretaps Reveals Most People Pay Too Much For Long Distance From The Onion
FORT MEADE, MD—The director of the National Security Agency announced
at a press conference Tuesday that the ongoing phone surveillance of
Cincinnati resident Greg Wyckham has yielded "overwhelming and
incontrovertible" evidence that the 37-year-old high-school teacher and
married father of three is wasting money on a long-distance plan that
does not suit his calling needs.
According to Lt. Gen. Keith B. Alexander, Wyckham, who caught the
attention of authorities in July 2004 when he placed a call to his
first wife, has spent an average of $75 a month on long distance, "when
he could have been saving as much as $30 per billing period."
Alexander cited additional examples of Wyckham's reckless
long-distance use, which included a late-afternoon call to his mother
in Colorado last spring and several March 2005 calls to old college
friends to plan a summer mini-reunion. In January, a lengthy
conversation with his cousin in California cost nearly $10.
"We have stacks of logs showing phone calls placed on weekdays
before 9 p.m., as well as calls made with flagrant disregard for the
per-minute rate," Alexander said. "In addition, not once did Mr.
Wyckham ask his out-of-state friends and family members with the same
long-distance carrier to join him in a money-saving service plan."
Added Alexander:"Bear in mind that this is a man who earns only
$43,220 a year. Withboth a Dodge minivan in desperate need of repair
and the upcoming vasectomy to pay for, he should be more concerned
about these expenses."
NSA analyst Lawrence Reinhard, who headed the team conducting the
wiretapping, said Wyckham has several cost-cutting plans to choose from.
"If Mr. Wyckham switched to a residential unlimited plan, such as
the AT&T Unlimited Plus Plan, he'd be able to make all his
long-distance calls for one low monthly fee of just $29.95," Reinhard
said. "He'd be able to take $20 off his bill in calls to his
ex-girlfriend in Washington, DC alone."
Reinhard also recommended that Wyckham consider switching his
long-distance service over to Verizon, his cellular phone carrier. "In
addition to their competitive rates, Verizon is now offering a special
discount on long-distance night and weekend calls to their cell-phone
subscribers," Reinhard said. "But only for a limited time."
Although the Wyckham eavesdropping was a closely guarded operation,
Alexander revealed that the NSA considered asking the CIA and British
intelligence to directly intervene in April after Wyckham accepted a
collect call from his 16-year-old son Jeremy, studying in London as
part of a foreign-exchange program.
"The collect call concerned us," Alexander said. "There is no
reason why an American traveling abroad should not be equipped with an
international calling card, which can be purchased cheaply in corner
stores everywhere."
Added Alexander: "If Wyckham simply joined the Family Share Plan, he
would not only save money himself, but also for his wife Shelly,
Jeremy, the twins, Ashley and Courtney, and, if he were reasonably
discreet, teacher's aide Janet Molina, with whom he's having an
extramarital affair."
Alexander said it is difficult for the NSA to keep its operations
secret when Wyckham and other Americans do not take advantage of
potentially enormous savings with a good long-distance plan.
"With companies like Skype and Vonage providing inexpensive
Internet phone service, high long-distance bills are a senseless
waste," Alexander said. "Sometimes an agent wishes he could physically
emerge from the phone receiver and shake some sense into these
citizens, but that technology is at least 10 years away."
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.
FORT MEADE, MD—The director of the National Security Agency announced
at a press conference Tuesday that the ongoing phone surveillance of
Cincinnati resident Greg Wyckham has yielded 
