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Tuesday, November 14, 2006


Go, FDA, Go!!! Our hard working FDA is on the ball with an antibiotic called Ketek, the news reported today, or is it? I can't help but get slightly annoyed when I see such 'news breaking stories' hitting the mass media. Now with the shift in power at the Hill I had thought that perhaps the media would once again start reporting facts without mis-direction by omitting. I guess I expected too much from our media, whatever was I thinking?

Although to hear the news today, the FDA is on the ball watching out for new medicine and the possible side-effects such medicine might cause. Well don't be too quick on jumping on that 'Go, FDA, Go' bandwagon. I want to re-post a thread I did back in June of this year about the FDA and get this, it even had to do with the FDA's actions on this same antibiotic Ketek (you can see the original thread here), I'm taking this time to re-post the thread, I think some will be amazed at what they discover.

Well lets see how well the FDA is doing

Well lets see how well the FDA is doing to protect our children from antibiotics that just might have a high risk of liver damage, live failure or even death. This 'new' antibiotic is manufactured by Sanofi-Aventist under name of Ketek. Now the FDA in May called for Sanofi-Aventist to halt clinical trials of an antibiotic in children because the drug could be deadly, according to internal memorandums sent to other F.D.A. officials. The drug Ketek is being testing in about 4000 infants and children for ear infections world wide, including United States.

There is growing evidence that Ketek is toxic at unusually high numbers from trials over the past two years. So far there has been as least four deaths caused from Ketek. Well the FDA is doing it job, right? Well…. read on then decide. More than 5 million scripts have been written to adults since its approval 2 years ago, now some safety officials of FDA wrote in their review that the agency should consider forcing Sanofi-Aventis to withdraw Ketek from the market, severely restrict its uses, even in adults, or add a prominent warning to its label about potentially fatal side effects.

Dr. Rosemary Johann-Liang, an official in the Office of Drug Safety at the agency, had this to say "How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" (sounding good so far….right?) Sanofi-Aventis first asked the agency to approve the drug in February 2000. But officials demurred, citing reports of side effects. So the company undertook a study of Ketek in 24,000 patients to prove its safety. The trial was marred by fraud. One of the investigators on the study is now in federal prison; another lost his medical license.

(Now here comes the part with FDA) The F.D.A. said it dismissed the study's results and instead asked the company to report its experience with Ketek in Europe, where it was approved in 2001. Although it is unusual for the agency to approve a drug based upon its use elsewhere, in April 2004, it did just that, approving Ketek to treat sinusitis, bronchitis and pneumonia. Sanofi-Aventis had planned to give Ketek as a first-line therapy, in laymen terms they planned on Ketek being given out as first option for antibiotic treatments.

Since this company report to FDA it seems that Ketek problems have grown, by April, the agency had reports of 110 cases of liver problems associated with Ketek, most of which occurred in otherwise healthy people, according to the safety review. In one, a 49-year-old woman took no more than two doses of the drug before becoming nauseous and vomiting. She was hospitalized five days later and died.

Since then it has been estimated that Ketek caused acute liver failure in 23 people for every 10 million prescriptions, about four times the rate of such events seen in other antibiotics.

Dr. Johann-Liang answer to this disturbing news was that Ketek's risks outweighed its benefits, she went on to note that powerful antibiotics known as fluoroquinolones can also damage the liver; but here's the kicker, fluoroquinolones are in intravenous form and for the use of serious infections unlike Ketek which is used for ear infections, tonsillitis and minor upper respiratory indications.

Dr. Danny Benjamin, an infectious-disease specialist at Duke University who was consulted separately by the drug agency, concluded that the pediatric trials with Ketek were a cause for concern and "hard to support," according to the memorandums obtained by The New York Times.

Asked about the memorandum written by Dr. Johann-Liang, an F.D.A. spokeswoman, Susan Bro, said that it was "a preliminary, raw assessment" and that "the final decision will be made by experts who have the full benefit of a large section of opinion and scientific fact." Melissa Feltmann, a spokeswoman for Sanofi-Aventis, said in an e-mail message, "We are engaged in ongoing discussions with the F.D.A. regarding Ketek."

The drug agency's actions in regard to Ketek are being investigated by Senator Charles E. Grassley, the Iowa Republican who is chairman of the Senate Finance Committee, as well as by Representatives Edward J. Markey of Massachusetts and Henry A. Waxman of California, both Democrats.

Since they are submitted voluntarily, these kinds of case reports usually represent only a small fraction - estimates range from 1 percent to 10 percent - of actual drug problems. The reports that the F.D.A. has received so far are unusual because of their "rapid tempo and severity," the agency's internal safety report said.

Now don't go fretting yet, some are saying there needs to be precautions like perhaps as the safety officials wrote in their review that the agency should consider forcing Sanofi-Aventis to withdraw Ketek from the market, severely restrict its uses, even in adults, or add a prominent warning to its label about potentially fatal side effects. Also as a precaution Dr. Johann-Liang added that the parents "need to know that the 'close monitoring' for visual events is not possible in very young children, and the long-term consequences of such adverse reactions are unknown for the developing system and Dr. Benjamin agreed that the brochure about the trials and informed-consent material given to parents "must address in plain language the risks, and severity of risks, of adverse events."

Now wouldn't you think that parents would have been warned of the possible side effects (including death) could be the result of this medicine? Why is it that the FDA allowed such unusual exceptions for Ketek?

Well Ladies and Gentlemen I am starting to think my grandfather has been right all along. Those pharmaceutical companies are profit only and if a few hundred, thousand, million people died (including children and infants) it's ok as long as it is in the name of science.

So what do you think about this? I know one thing I'm now wondering what other 'medicines' that are out there worst than the ailment.

Although, today's 'News Breaking Story' did include even more possible side-effects from Ketek, I did NOT see one news station informing people of all the other side-effects of this antibiotic. There was no reference made to the fact this is NOT the first time Ketek has 'come under fire', it seemed all the mass media was reporting this story as though Ketek has been gewtting rave reviews till now.

Now I'm in a pickle, is the FDA that slow moving on information given to them, or is our media too busy reporting sensitizing news to know a Real News Story, when one comes around?

We, as the general public, should demand the media holds up to it's obligation to the public and report the news, I mean if I want to know about Britney Spears, I would tune into "E".

~~~~~~Forever A Facetious Pain~~~~~~


Eff25 said...

I have to admit that it's not easy to get inspired by this story. I think it's because, although the numbers are high when some comparisons are made, the numbers still total what seems like a small fraction. It may be above standards, but they still are not a great percentage to most of us. Certainly the apparent behavior is shameful, but I don't think many will react unless there's a pandemic. A greater smoking gun is needed for there to be an outcry. Generally speaking, we accept a lot unless there's a real villain tweaking his moustache and laughing at his victims.

Facetious Muse said...

Eff, one thing that stood out to me was how Ketek, is being used for first line, meaning it is used for small infections, yet the side efects a re truly greater than what should be acceptable.

Also how Ketek, was not "investagated as most meds are in the States by the FDA, that really does bug me. Also how it seems the longer that Ketek is out there, the more reports come in that are less than shining reviews.

I could understand if Ketek was being used as a last attempt drug for those that shown no respond to other antibiotics, but that simply is not the case. I can't help but wonder why is it that our children are bing the clinical trial with most parents not knowing the true possible effects of Ketek.

I am sorry, but I think that FDA really needs to be held accountable for allowing so many meds pass that later seem to have unacceptable side effect(s). Also the media needs to start reporting on News instead of what cele is sleeping which what celes gardener.

Eff25 said...

No argument here.

Facetious Muse said...

Always a pleasure, eff :>)

Eff25 said...

Thanks. You, too.