Ketek: Why Did the FDA Approve This Deadly Antibiotic?
Five years ago, the FDA did not approve Ketek, an antibiotic with the generic name telithromycin, for use in the United States. In their decision, they cited toxic effects such as liver damage.
Arrests and Prison Terms
However, in response to the FDA's decision, the drug's manufacturer Sanofi-Aventis launched a new trial, study 3014, to test its safety. Study 3014 included fabricated data, and led to arrests and prison terms, forcing the FDA to throw out the results. The study is still defended as legitimate by Sanofi-Aventis.
Still Cited Today
Despite this, the FDA reversed its original decision and approved Ketek, based on previous data collected and rejected by the FDA, along with smaller studies and the drug's European safety record. Study 3014 is still being cited by medical journals to back up Sanofi-Aventis' claim that Ketek is safe.
You may recall a recent study I posted about Ketek, an antibiotic tested recently that treated some asthma symptoms, but worsened others. After reviewing the Reuters summary of this important Wall Street Journal piece (you can only review Wall Street Journal directly with a paid subscription), however, you'll be wondering why Ketek was ever approved for sale by the FDA at all.
Just one more reason to believe the FDA, in its current state, can't protect your health.
As currently configured, the FDA is more interested in protecting the interests of the drug industry than your health -- it views the drug industry as its client, and the client is someone whose interests you represent.
Within the Center for Drug Evaluation and Research, about 80 percent of the resources are geared toward the approval of drugs, and 20 percent is for everything else. Drug safety is a measly 5 percent.
This speaks loads about their priorities. It is NOT about protecting you -- it is about approving drugs as quickly as possible so the drug companies can reap their profits.
Congress has not only created that structure, but they have horribly worsened it with the Prescription Drug User Fee Act (PDUFA), by which drug companies actually pay money to the FDA so they will review and approve their drugs. This creates an absolutely massive conflict of interest and a fox-guarding-the-henhouse phenomena.
It is my passion to serve as a catalyst to change this fatally flawed system. But because I don't have $3 billion to invest in marketing like the drug companies, I can't do it without you!
You can have a major impact on improving the speed at which the migration away from the current dysfunctional health care system, to one truly based on prevention and real cure, occurs -- by sharing the information in this newsletter with as many of your friends and relatives as possible.
As for Ketek, clearly it's yet another dangerous drug to avoid. And in fact, while I'm not opposed to all uses of antibiotics in general, I believe patients have been harmed far more often by them than they've been helped. In fact, it's been my experience antibiotics are used inappropriately well over 95 percent of the time.
So follow the Total Health Program and limit your need for potentially toxic and frequently inappropriately studied drugs.
Related Articles:
Another Antibiotic Found to be Killing People
Families Sue Pfizer on Test of Antibiotic
USA Today Exposes Conflicts of Interest in FDA Drug Approvals
-------------------- Julie _ _ ___ _ _ lymeinhell
Blessed are those who expect nothing, for they shall not be disappointed. Posts: 2258 | From a better place than I was 11 yrs ago | Registered: Sep 2003
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Mathias
Frequent Contributor (1K+ posts)
Member # 5298
posted
It helped my tremendously. I never had any liver problems from it and I was on it for 6 months.
-------------------- Mathias Posts: 1242 | From New Jersey | Registered: Feb 2004
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AZURE WISH
Frequent Contributor (1K+ posts)
Member # 804
posted
I am glad they approved it. Don't know where I would be if it had not been available.
posted
I think that Dr. Mercola doesn't have a good understanding of FDA and the work they do. The Office of Drug Safety is not the only office looking at drug safety. Part of the mission of Center for Drug Evaluation and Research (CDER) is making sure drugs are safe before approving them, and logging all adverse events before and after approval. I would also add that the good people at FDA know exactly who their client is: the head of this Administration (and I have heard that stated publicly). I am personally more concerned over safe and effective drugs being taken off the market because of religious beliefs than unsafe drugs being approved because of financial benefit.
Just my opinion.
Posts: 393 | From Washington, DC | Registered: Jun 2005
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posted
Although I have no doubt that the FDA has its fair share of problems and questionable interests, I am nonetheless glad to have Ketek available.
I know the risks, and have decided to take it anyways, with appropriate precautions (no drinking alcohol at all (duh!), good liver support, regular liver-enzyme panels) -- it is helping me a great deal!
-------------------- "Looks like freedom but it feels like death.. It's something in between, I guess"
Leonard Cohen, from the song "Closing Time" Posts: 822 | From California | Registered: Jan 2006
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posted
I, too, had the most improvement on/after ketek in combo with a pulsing of tiniazole. never had any liver problems and i was on it for 6 months.
On the other hand, less than 2 months of mepron with zith and my liver enzymes went sky high. fortunately they were back down within a week of stopping abx.
Sometimes it just amazes me how different we can react to the same drugs.
Posts: 132 | From SE Pa | Registered: May 2006
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posted
some docs say that the high numbers from liver tests while on ketek have only to do with the infection bieng fought in that area and when the inflamation goes down so do the numbers... eric
Posts: 593 | From long island ny | Registered: Apr 2006
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posted
I've been on Ketek for 5 months and have been monitoring my liver and taking liver support supplements. So far I have really made huge strides in getting better and have had no ill effects from Ketek.
I know our system for drug approval is faulty. I have previously been on a few of the NSAIDs that have been taken off the market due to poor studies and bad reactions. Thankfully I didn't have problems related to them either.
Prior to having Lyme I was a person that would only take antibiotics as a last resort. I really would love to fight this terrible disease naturally but I need to have my life back. Ketek is helping me get it back.
I don't drink, I monitor my liver, and I am going to continue.
-------------------- Lucy Posts: 342 | From Hawaii | Registered: Nov 2005
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dontlikeliver
Frequent Contributor (1K+ posts)
Member # 4749
posted
I have been on (and off) Ketek since April 2005. No liver problems and do have regular liver monitoring.
I have had to take breaks from it for other reasons, not related to the Ketek itself or the liver.
My LLMD did say that IF liver problems are going to happen, they will happen in the first 1-2 weeks of treatment.
Posts: 2824 | From The Back of Beyond | Registered: Oct 2003
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Dave6002
Frequent Contributor (1K+ posts)
Member # 9064
posted
I have done two rounds of rotating Ketek/Tini, each for 28 days.
While I was on Ketek, I did feel more uncomfortables of stomach and liver area both time.
But I noticed that my symptoms were lessed in the second round.
And I feel better than before Ketek.
So I assume that these uncomfortables were Herx reactions, not the side effects of Ketek. Cause my recent blood tests were all normal.
One thing that is always in my mind is that if we could reduce the dose of Ketek by half yet still keep its effecacy on Bbs so that the toxicity of Ketek could be significantly reduced, and we would have stronger immune system to fighjt the disease.
Another good thing for Ketek if that it may act on Babs(Not sure).
I hope we could explore this drug further.
Posts: 1078 | From Fairland | Registered: Apr 2006
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