Doctor: FDA-Approved Drug A 'Time Bomb'

In Exclusive Interview, Doctor Who Reviewed Ketek Says He Warned Agency Of Antibiotic's Dangers

(CBS)  Iraq war veteran Chuck Gregg was back home with his family last winter when he got bronchitis. His doctor prescribed Ketek, a relatively new antibiotic, CBS News chief investigative correspondent Armen Keteyian reports. Five days later, Gregg was in the hospital with liver failure.

"They run their battery of tests, and they come back and it's definitely what's called 'drug induced' or 'pharmaceutically induced hepatitis," Gregg explains.

"He survived 13 months in Iraq, you know, all over Iraq, to come home for this," adds Sherry, his wife.

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Iraq War veteran Chuck Gregg and his wife Sherry describe how his health failed after taking the antibiotic Ketek.

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The FDA has continuously updated warnings of Ketek's possible side effects, including "signs ... of liver problems." Gregg says because he had no previous liver problems, he had no reason to be concerned. Now he's pointing a finger at the FDA.

"Based upon the data available to me, I believe this drug is far more dangerous than other drugs that fight the same infections," says Dr. David Ross.

In an exclusive interview with CBS News, Ross, who reviewed Ketek's safety for the FDA, says he warned his superiors that the drug was, in his words, a "time bomb," and was shocked last summer when the acting head of the agency, Dr. Andrew Von Eschenbach, told employees to keep concerns about the drug in-house — and out of the press.

"He said, 'If you don't follow the team, if you don't do what you're supposed to do, the first time you'll be spoken to, the second time you'll be benched, and the third time, you'll be traded,'" Ross says.

Instead, Ross says, he quit the FDA in disgust.

"The leaders of an agency should not be holding a meeting to suggest dissenters should be kicked off the team," says Sen. Charles Grassley. "Particularly when the life of American people are at stake."

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Read Grassley's letter to von Eschenbach

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Sen. Grassley today issued a scathing report criticizing the FDA's oversight of Ketek. CBS News has learned there is a new Congressional probe under way to determine whether Ketek should remain on the market.

The manufacturer says Ketek is safe to use. Von Eschenbach declined to speak with CBS News, citing a FDA meeting about Ketek beginning tomorrow.

[teamkristen]

I have been working for three years for FDA reform. My 23 year old daughter died as a result of an adverse reaction to another highly debated antibiotic called Avelox. She too suffered complete liver failure and the most severe form of Stevens Johnson Syndrome (toxic epidurmal necrosis) after taking three doses of this medication. The FDA needs to bee taken out of control of big pharma and let un-biased professionals take care of us. Just because the FDA says a medication is safe..just isn't so. I ask everyone to support Sen. Grassley in getting answers from the FDA and to see where your US Senators and Represenatives stand on this important issue. I do not belive that the politicians from my state of Indiana (Lugar, Bayh)support FDA reform at any level.

[stoeast]

This too will be swept away...

[gaye5]

DRinUK, you are DEAD right, you say,,,
The same reason they are buying up successful Natural Health Companies worldwide......
Then DRinUK, they lower the amount in the natural products and make government believe that any higher doses will be dangerious for us. With the amount that they lower it to, you might as well go and eat white bread.... there is no discussion on the exceedingly high doses in their drugs eh. EVery day there is reports on a drug which is killing us or dangerious, I have read that even antibotics can cause breast cancer if taken often enough and or long enough...
Soon they will not allow newsoutlets to publish the drugs which go wrong...

[gaye5]

oh dear WHAT yet another drug to destroy the people, under the guise of helping us...
Why should we be supprised when death from pharmaceuticals drugs and Dr's are the fourth cause of death in America, but of course these drugs are all tested, or so they tell us,, yep they are tested on us. hmmmmm...look up "The pharmaceutical Drug Racket", and see what they have to say...
As I have said before, if this was a natural product, it would immediately be off the counter for good.

[dcm5150]

Of course, that's it, it must be the President's fault. He is responsible for everything. It was under his occrruption that he guided the military to create a hurricane to destroy New Orleans.

Well at least there is a resolution. Next election, we will be able to get him out of there and there will be no more corruption in our federal government. Its hard to beleive that just 6 short years ago we had a government and was free of corruption and greed and now look where we are. We now have hurricanes and other natural disasters, starving people all over the world, terrorism, rascism. Oh how I wish for the good old days of the 1990s when none of these problems existed.

[tibu987]

Corruption has no boundaries even when lives are involved.
This just another example of the greed and corruption by people in government.
Never has the U.S. been victim to so much moral and financial corruption.
Will the last corrupted official please turn off the light.
'Nuff said.

[olgreyghost]

Has everyone got their government recommended "flu shots" yet?

[drinuk]

Googled Eschenbach, surprise, surprise, he's a Bush Buddy!! Where have I been all this time?
Bush+Eschenbach=FDA = Another Bloody Mess!!
We now know what the "Decider" is going to do in the New Year regarding Iraq, Eschenbach is going to prescribe all the people of Iraq "KETEK"
That should sort 'em out and get rid of the stock. They all Die happy ever after.

[drinuk]

Plantotiger.
I was trying to be polite but you got in in ONE, he's a "Stooge"

[drinuk]

KeniCox.
Very well informed?? Of course the politicians will not find the next big cure in their garage, they may however find it in the forest but they will not be able to patent it. I would suggest that Big Pharma actively prevent research into natural remedies for that reason alone. The same reason they are buying up successful Natural Health Companies worldwide.

[planotiger]

well, KeniCox, if it worked for you, then who the hell are WE to care about the numerous people it caused grave damage to, right? BTW, what drug company do you work for?

[drinuk]

If anyone as any information on Von Eschenbach, let us have it, anything will do especially any stocks he has held or holds now. If he his not working soley for the American taxpayer we should know about it.

May I suggest respectfully that Senator Grassley personally sets up an investigation into Big Pharma activities and in particular their tenticles into Government.

[drinuk]

The Big Pharma companies have become far too powerful, they have medicine control agencies all over the world in their pockets, whilst at the same time encouraging governments to hound and prosecute those selling proven natural cures which they cannot patent,they are truly evil.

They "Buy" Doctors, consultants, research specialist and universities. Their lobby is deep into all governments at a tremendous cost to the tax payer. The FDA in particular is totally responsible along with "Rumsfeld" for approving the poison "ASPARTAME" causing misery worldwide.
Bush was asked by the Senator from NM to ban it, he did nothing as usual...WHY ?

One thing we can be sure of is that BIG PHARMA ain't looking for a cure, the big bucks are in comfort and dependency. WE should name, shame and jail everyone taking "Back Handers" from them.
Good on you, Dr Ross, you are a good man and an example to all those in your profession.

[chach_girl]

The drug mafia has yet to recognize the most prevalent disorder among us --- and everyone has it! What a boon to the drug and mandatory doctor visit industries! What is it? W and B Syndrome (that's Warm and Breathing Syndrome). Everyone is born with it, and has it until their dying day. Watch for the new ads on TV - the primary drug to treat this dangerous syndrome, plus 3 or 4 other drugs to treat the debilitating side effects of the primary drug. And of course, one or two more to treat the side effects of the side effect drugs... well, you get the picture. Here's to your health, courtesy of the FDA.

[jhindson1]

FDA like most Government Institutions, is owned by the Drug Corporations.

[p69rr]

FDA needs to be investigated. Black label warnings mean nothing. FDA allows doctors of all fields to give out drugs under white label. Children are given Ritalin, Adderal and Risperdal at alarming rates. What test can you give a 2 year old child to determine that they need Ritalin? Risperdal was designed for adults, but yet it is given to children to counteract the side affects of Adderal. Drug manufactures are making millions of dollars off our children. Drs are involved too by knowing the child has to come back every 30 days. Now you have Teen Screen programs to get more children on mind altering drugs, sponsored by drug manufactures. Yes some people and children may need medical help, but not at the rate they make us believe. A lot of problems with children now today are the Family Law Courts who consistently remove fathers out of the children%u2019s life. Why do people want to drug our children just because they are children? Now they are saying adults needs all these drugs too. Remember, these types of drugs are class 2 drugs, addictive, but yet they fill our children, and now adults with this junk. They keep saying: Say No To Drugs, but yet they are legally selling them to the public. College kids can get them now. Yes the government needs to step in and put a stop to this money making problem created by the drug manufactures and FDA.

[symc655]

I have been a nurse for 25 years and I have watch numerous different medications pushed to the market before properly trialed. Politicians promoting patient safety while in the pockets of the pharmaceutical companies. The misleading ads they now allow on TV in record numbers, the free samples given to the average consumer that don't know any better. KETEK on pins, pads, tote bags in the doctors offices. THE DRUG KILLS PEOPLE, WAKE UP. My friend had an allergic reaction that I recognized immediately because I am a health care professional. Thank God someone had the courage to blow the whistle on the FDA....My name is McNeill and this is a public service announcement!!!!

[kenicox]

KEEP YOUR NOSE OUT OF MY MEDICINE CABINET
Part III

Currently the older medicines are not as effective as they should be, Drs are jumping to a broad-spectrum ANTIBIOTIC like Levaquin or Avelox, and they are misusing these last resort meds, to the point when patients are getting urinary tract infections they are having to be admitted into the hospitals for IV antibiotics%u2026 this shouldn%u2019t be. Ketek plugs the gap between the useless older meds like Zithromax and Biaxin, and keep the heavy hitters like Levaquin and Avelox for when they are really needed, the hospital or ER setting, and not family care! %uF0E0 If politicians scare Drs away from this drug, and back to older Antibiotics that have a higher risk of hepatotoxicity, then what incentive is there for any other Antibiotic company to bring a novel antibiotic to the market? They would make far more money selling a birth control, cholesterol, or diabetic medicine that is 365 day/year script, or even an allergy Medicine that is at least seasonal, than a 1X 5 day script for $40 dollars Wholesale! So politicians unless you can go to your garage and create our next SMART DRUG, I think you should keep your nose out of my Medicine Cabinet!

[kenicox]

KEEP YOUR NOSE OUT OF MY MEDICINE CABINET
Part II

I have used this product on three occasions, 2X with sinus infections, and 1X with bronchitis. It is amazing! Three doses any my symptoms were gone! Guess what not a scar on me.

What worries me the most about this is when a Pharmaceutical company is willing to put out a novel ANTIBIOTIC... This is a one time script at best they get $40 wholesale, the drug works so fast you only need one script. They spent Millions and Millions of dollars to bring this to market in the US. (Oh by the way it%u2019s in 30 countries and has been used over 26 million times, and only Grassley in the US has a problem!)

[kenicox]

KEEP YOUR NOSE OUT OF MY MEDICINE CABINET!!
PART I

THIS IS A JOKE. Will FACTS be the TRUE FATALITY HERE? Grassley is looking for gullible reporters, look who he found. BioCentury put out the most resent fact-FILLED article (June 26, 2006) I quote, "Calls by politicians to change the way antibiotic trials are run may be politics as usual, but in the case of Ketek, arguably reckless and blatantly misleading pronouncements in the name of patient safety actually pose a hazard to public health." Where is the comparison data? Are you so gullible to think that a politician knows best, an easily bought politician like Grassley!

Let%u2019s try balancing risks against benefits... There is no mention of Ketek's role in preventing antibiotic resistance, nor is there any comparison of its safety profile to that of other antibiotics. A quick literature scan reveals that other antibiotics for the same conditions as Ketek have been reported to cause hepatotoxicity in up to 10 of 10,000 patients.

Did you forget when the older antibiotics like Zithromax, Biaxin, and Augmentin first came out (12 years ago... we forget because it has been so long) there were case action law-suits, and legal teams that changed their names to the Zithromax legal team? Do you recall Biaxin killing people for this very thing? This is a class effect; all antibiotics require the liver to metabolize. If your liver is damaged, it will have a harder time processing the ANTIBIOTIC.