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FDA to Sen. Grassley: Go Home
June 14, 2006 7:04 PM
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"I can say without a doubt that this drug should have been withdrawn," Grassley told ABC News.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.
June 14, 2006 | Permalink | User Comments (13)
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Warning: This product was approved for use despite known forged documentation and fraudulent testing methods, by Idiot FDA officials who refuse to accept reality and substitute thier own.
Product may cause minor side effects, such as Death, Liver Failure, Congressional Backlash, Demonic Possesion, or other trivial life threating complications.
Huh? ... Oh, you don't think thats what they'll put?
Posted by: Mango | Jun 14, 2006 10:03:50 PM
Thank you for doing this story.
It took guts to air it, and for
Sen. Grassley to stand up to the
FDA and try to demand some answers.
It was amazing to see him
treated as shabbily as I've been
by the FDA since 1982-83, when the
agency allowed Synthroid thyroid
medicine to be changed by the
manufacturer, without requiring it
to be tested for safety and
effectiveness on ANYONE.
I'm still suffering greatly
from this, so many years later.
And my mom and other relatives have died from the FDA's lack of caring, because thyroid drugs directly affect the heart, and none of the other available
thyroid drugs helped us as well as
as Old Synthroid did.
The sad thing is, a top thyroid
professor at UC San Diego Medical
School told us the only reason
Synthroid was changed in the early
1980s was to be "cost-effective"
for the company. Well, it cost
lives, too--and I'm so sick of it.
If you'd like any more details
on the Hell that the FDA has
created for me, my family, and
other thyroid patients I've come
into contact with, too, please
feel free to contact me.
I have made many attempts to
try to reason with the FDA over
the years, to plead that patients
like me need its help--but much
like Sen. Grassley, the door was
slammed in my face. And it hurts.
Again, thank you for your great
work on this piece. It was an
important story to run, because
it shined some light on how the
FDA, once again, is not looking
out for taxpayers who fund it.
Sincerely, Starr D. Downey, CA
Posted by: Starr D. | Jun 15, 2006 12:20:41 AM
The FDA only exists to protect the profits of the drug companies and the food manufacturers. They allow food producers to put chemicals into the food to make you addicted and fat. The FDA allows drug manufacturers to put poisonous chemicals into prescription drugs to make you sicker. They also dilute the drugs in order to treat the symptoms of disease instead of curing them. They make more money this way.
Posted by: Bobby | Jun 15, 2006 3:03:12 AM
I was given Ketek earlier this year for Bronchitis. After the 3rd dose I was so violently ill that I thought I was going to die. I'm not at all surprised by this report.
Thank you for investigating.
Posted by: Sue | Jun 15, 2006 8:09:42 AM
The NTSB called for stronger cockpit doors years ago. they were over ruled because it would have hit the airlines pocketbook. Remember 9-11?
This is just another example of the government protecting the drug companies profits at the expense of the public welfare.Deaths and serious medical problems..AND they new the research was falsified before they approved it
NOTHING NEW!
Posted by: dan | Jun 15, 2006 1:02:30 PM
I'm sure one of the FDA arguments will be that technically because it was tested, albeit, on the public without their consent; the number of serious side effects are probably better than most drugs already approved.
Regardless, this is a direct violation of consumer rights and the fact it is still on the market, even if it was a world changing drug like the cure for cancer. This poor decision to leave it on the market INVITES drug companies to use the American people as guinea pigs at their leisure.
A fine? A cruel joke.
Not everyone works for the government; some chose not to - simply because history has implied the government’s right to use its employees as test animals.
To be clear, this drug should be removed from the market regardless of the benefits or we risk future death on a larger scale.
The decision makers at the FDA should be indicted for terrorist acts against the American people and there should be a complete restructuring of this approval system.
Let’s speculate… If I falsified my driving license and drove an ambulance, would they let me continue to do so if they found out? "The benefits outweigh any known risk", I mean even if as an ambulance driver I killed 35 people and severely injured 4; who cares?! I should not be driving an ambulance - even if I was driving in Europe and passed all of their ambulance driving tests too.
Where has all the common-sense gone?
Posted by: The People | Jun 15, 2006 3:11:42 PM
I spent 15 days in the hospital over Christmas 2004. I was out of work for three months, not to mention I nearly died thanks to Ketek. I am now living with the repurcusions of kidney failure - my arthritis can no longer be treated by medication and my eyesight has failed to the extent I now wear glasses although I had lasix years before. This medication has changed my life to a point that is hard to phathom. I will suffer repurcussions for the rest of my life. Did they really say the benefits outweighted the risks? You've got to be kidding me.
Posted by: Kathleen | Jun 15, 2006 10:21:04 PM
Oh where..oh where is a good PI Attorney when REALLY NEEDED.
Posted by: Barbara | Jun 19, 2006 5:02:34 PM
Ketek has been found to be safe and effective if used as directed. The study 3014 that is being referenced was not used in approval because of Doctor fraud. The study was thrown out and the doctors were punished. The FDA lead the charge. Other studies were used in to approve the drug.
The American people complain that the government is invading our privacy and then it is a news story when a senator can not access the FDA files.
I hope the facts that Ketek is an excellent antibiotic in an age where bacteria is resisting older antibiotics shines through.
Posted by: JoyBoy | Jun 20, 2006 1:20:35 AM
My son was a healthy 14 year old kid with no health issues at all. He was given Ketek for strepth throat and is now waiting for a liver transplant! Hows that for safe and effective. It has effected all of us,we know watch have him get sicker and sicker waiting for a new liver.Because he was prescibed this medicine. Hows that for your hope that this will be an excellent antibiotic? My hope is that he gets a liver before the damage to his liver due to this med kills him!
Posted by: Kevs Mom | Jun 21, 2006 1:09:05 AM
I was prescibed Ketek 3 weeks ago and 2 days after taking it I almost died! I woke up and had a unbearable pain in my lower right back and suddenly I passed out and started convulsing with my eyes wide open, my legs went straight as a board, and I stopped breathing. My girlfriend dialed 911 and ambulance was here in minutes to revive me. I am waiting to have tests done to see what damage has been caused to my liver from taking this medication.
Posted by: JOE MCMANUS | Feb 12, 2007 10:28:43 PM
I took Ketek in September of 2005. I had a sinus infection. I ended up in the hospital with a severe case of hepatatis and they concluded it was drug induced. However, I did not get better but then suffered from pancreatitis and then cholycestitis. I had my gall bladder removed 2 months later and then 2 months after that I got another full blown case of hepatatis. This time i went to Mayo Clinic and they were nto sure what was happening to me but thought maybe the drug had induced an autoimmune response and so then I suffered from that and now I have rheumatoid arthritis. All of this is a result of the one time taking of Ketek. Most specialists that I have seen believe this is the case. Wondering if anyone else got hepatatis twice from taking the drug only once and ended up with autoimmune disease?
Posted by: Maureen Toomey | May 25, 2007 3:32:12 PM
"Chuck" or Charles Ernest Grassley is the senior United States Senator from Iowa. He is a member of the Republican Party and has served in the Senate since 1981. He was chairman of the Finance Committee from January to June 2001 and from January 2003 to December 2006; currently, he is the committee's ranking member.Sen. Charles Grassley has said that Microsoft should lay off workers employed on H1-B visas first, which the company has flatly refused. The company said that they practice nothing but fairness in its hiring practices, and the same in layoffs.
Posted by: Bryce Z. | Mar 18, 2009 5:51:26 AM
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