Posted on 11/17/2005 11:08:59 PM PST by BurbankKarl
Federal health advisers are looking into the deaths of 12 Japanese children who took Tamiflu, part of their annual safety review of the anti-flu medication and seven other drugs.
There are no reports of deaths in the United States or Europe associated with Tamiflu.
"Based on the information we have right now, we cannot say definitively there is a causal relation between the drug and the children's death," Dr. Murray Lumpkin, the deputy commissioner of the U.S. Food and Drug Administration, said Thursday.
The Japanese deaths were detailed in papers released in advance of a Food and Drug Administration advisory committee meeting Friday.
An update by FDA staff also includes reports of 32 "neuropsychiatric events" associated with Tamiflu, all but one experienced by Japanese patients. Those cases included delirium, hallucinations, convulsions and encephalitis.
"Clearly, any time you get a report of a death or a serious occurrence, you want to look into it," Lumpkin said.
The FDA sought and received more information from the Swiss pharmaceutical company Roche Holding AG, which makes Tamiflu, and from Japanese health authorities. It has not issued any warnings or initiated any other action, spokeswoman Susan Bro said.
Lumpkin said "millions and millions" of patients have safely used the drug to treat the flu.
Complicating the issue is that many of the Japanese death and adverse reaction reports list symptoms commonly associated with the flu, he said.
"It is very difficult, when the underlying disease causes what it is being reported, to figure out: Is it the underlying disease? Is it the drug?" said Lumpkin.
Roche said that several studies in the United States and Canada had shown that the death incidence rate of influenza patients who took Tamiflu was far below those who did not.
"The mortality was actually lower versus those who did not receive the drug," said Joseph Hoffman, who heads pharmaceutical development for virology and transplantation at Roche.
Roche has supplied the FDA with two additional studies it commissioned that evaluated the safety of Tamiflu in pediatric patients.
Japan's Health Ministry warned last week that Tamiflu may induce "strange behavior" after reporting that two teenage boys died shortly after taking the medicine.
"Roche has carefully reviewed these events and has concluded that a causal link cannot be established," the company said in a statement released on Monday.
However, the Japanese distributor of the Roche-patented drug told health officials it could not rule out a link between Tamiflu and the deaths.
Roche said the high number of deaths and adverse neuropsychiatric events in Japan was also due to the fact that two of three people taking Tamiflu are in Japan. Of 32 million people treated with Tamiflu since its approval in 1999, 24 million were in Japan.
The U.S. labeling for Tamiflu lists nausea and vomiting as its most serious side effects. Its labeling in Japan includes any adverse effects that have been reported -- including impaired consciousness, abnormal behavior and hallucinations -- regardless of whether they can be attributed to the drug, according to Roche.
Tamiflu is one of the few drugs believed effective in treating bird flu, which health officials fear could spark a pandemic should it mutate into a form easily passed from human to human.
Yet another vaccine that I will not allow to be injected into my children...
Believe me, if Bird flu hits, use the vaccine. The odds favor your children Bird flu has a 55 % fatality rate.
Tamiflu is not the panacea it's being touted to be. Some SE Asia cases of bird flu were resistant to Tamiflu.
http://www.cbc.ca/story/science/national/2005/09/30/tamiflu20050930.html
I, personally, think that since there is no other course to be taken at this time (since a vaccine can't be made until the flu mutates to a person to person form), Tamiflu is being hyped in order to "calm" those that might be worried that there is no remedy.
Read an interesting article on FR a few days ago about this particular flu inducing a "cytokine storm" and thus being similar to an autoimmune attack against one's lungs. I'd be interested in hearing how corticosteroids work against the disease, if the "cytokine storm" is what causes the severe form of the disease, and is why the healthy have a higher mortality rate with the disease than the immune compromised.
Abolish the hurtful FDA already....
Were such a thing to happen in a manner that was not limited by its own lethality (Ebola), the human race would have been long extinct, human intervention by antiviral or not.
However, viruses do not progress/mutate in that exact manner.
It's a pill. It's a treatment, not a mandated vaccine for prevention.
Tamiflu Pediatric Adverse Events: Questions and Answers
12 Japanese children out of 24 million total who were in Japan is equal to 1 dead, not necessarily from the Tamiflu but possibly from influenza itself, out of 2,000,000 courses of treatment.
Annual seasonal influenza mortality is 36,000 dead in a total population of aproximately 300,000,000 folks in this country is equal to 1 dead out of 8,333 potentially exposed.
It appears the odds are with Tamiflu.
12 Japanese children out of 24 million total who were in Japan is equal to
That does not in any way state that 24 million were taking Tamiflu.
When did you start swallowing MSM swill without questioning the methodology?
How many Japanese children were actually ingesting Tamiflu, and how many who were not died of the flu?
How many American children who were inoculated with the polio vaccine came down with serious side effects vs how many who were not died of polio?
Look, the vaccines and other pro-actives have caused more side effects and deaths in this country than most of those diseases themselves, period.
If you don't agree, inject your own kids.
And this government has decreed that these substances must be injected into your children on a regular basis or they cant even go to school.
Tamiflu and any other anti bird flu may well be next.
I don't expect anyone to remember Ford's Swine Flu fiasco.
"Roche said the high number of deaths and adverse neuropsychiatric events in Japan was also due to the fact that two of three people taking Tamiflu are in Japan. Of 32 million people treated with Tamiflu since its approval in 1999, 24 million were in Japan."(3rd paragraph from the end of the NY Times story quoting Roche)
Roche is supposed to have claimed two of three people taking Tamiflu are in Japan. Two thirds of 32 million is slightly less than 22 million. I used the 24 million number given in the story just for the convenience for the 1:2000000 ratio. Whether it's two thirds or three quarters, it makes little difference when it may happen once out of more than millions.
When did you start swallowing MSM swill without questioning the methodology?
When they're quoting the FDA, and I link the FDA statements, I think it's OK.
How many Japanese children were actually ingesting Tamiflu, and how many who were not died of the flu?
I have no idea about the former, but I would guess at least a thousand per year for the latter, considering Japan's total population is about 125,000,000, and assuming they have a rate similar to our's, i.e. 1 per 8,333 of the total population, and that the younger and older segments of the population have the typically worse prognosis.
How many American children who were inoculated with the polio vaccine came down with serious side effects vs how many who were not died of polio?
None with the Salk vaccine which is the only one used now, unless there is the rare allergic reaction. The oral Sabin vaccine which used a live, attenuated virus is no longer used in this country.
Look, the vaccines and other pro-actives have caused more side effects and deaths in this country than most of those diseases themselves, period.
Do you have any links to substantiate that assertion?
If you don't agree, inject your own kids.
Tamiflu is not injected. It is not a recommended vaccine. Tamiflu is a treatment that is supposed to be started within 48 hours of the onset of suspected flu symptoms. If I had kids, I can and would give recommended vaccines to them myself if there were no contraindications.
Did you look at the links in comments 5 & 8?
I should have written: "3rd paragraph from the end of the story that started this thread quoting Roche"
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