Doctor: FDA-Approved Drug A 'Time Bomb'

(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.

---

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

---

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."

---

Read Grassley's letter to von Eschenbach

---

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.