Tamiflu Still Sucks, page 1

posted on Nov, 14 2006 @ 09:03 PM

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Tamiflu treatment was linked to 103 cases of "bizarre behavior" between August 2005 and July 2006, and reported to the US Food and Drug Administration (FDA). The "bizarre behavior" included delirium, hallucinations, suicidal tendencies, suicide and cardiac arrest. The FDA is unsure if the "bizarre behavior" is caused by Tamiflu, the flu - or a combination of both. As it happens, the FDA decided in November of 2005 that Tamiflu did not cause the deaths of 12 children in Japan, as was reported last year. It's deja vu all over again.

www.earthtimes.org

One of the most common drugs given for seasonal flu, Tamiflu, seems to having some neuropsychiatric effect on patients, especially children.

Tamiflu is one of the four drugs which are administered for seasonal flu in the US. Over the past one year that is from August 2005 to July 2006 The US Food and Drug Administration (FDA) has received 103 cases of bizarre behavior after the consumption of the drug. Strange behavior included delirium, hallucinations and suicidal tendencies. Out of the 103 cases 95 were reported from Japan and mostly in Japanese children below the age of 17.

The agency is still to decipher if the strange behavior is caused due to the drug, the flu or a combination of both.

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Tamiflu to carry warning about abnormal behaviour

The Food and Drug Administration in the U.S. (FDA) is recommending that patients who take Tamiflu be closely monitored for signs of abnormal behaviour. ...The announcement is the latest update on the drug which is currently the first line of defence should a bird flu pandemic erupt, and comes as a result of 12 deaths and psychiatric symptoms among users in Japan.

Of the 103 reported new cases of delirium, suicidal behaviour and other mental problems between August 2005 and July 2006, three cases were fatal. ...Ninety five of the cases were apparently Japanese children treated with the drug.

The agency's review found that of the 12 deaths there was one suicide, four cases of sudden death and four cases of cardiac arrest. ...There were 32 reports of psychiatric "events" among children, including hallucinations and abnormal behaviour and in two cases a 12-year-old and 13-year-old jumped out of second-floor windows of their homes after taking the medication.

Tamiflu does not prevent flu (but) can reduce the length and severity of its symptoms.

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Flu drug carries new warning after delirium reports

The drug Tamiflu now carries a new warning following reports of delirium among some people, mostly in Japan, taking the medication to treat influenza, the manufacturer and US regulators announced. ...The notification to doctors from the US Food and Drug Administration (FDA), which regulates medicine, and the Swiss pharmaceuticals giant Roche, which manufactures Tamiflu, also used to fight the deadly strain of bird flu, was reported on the FDA website Monday.

The antiviral drug's "precautions section" notes that "there have been postmarketing reports (mostly from Japan) of self-injury and delirium with the use of Tamiflu in patients with influenza," according to a copy posted on the FDA site. ..."The reports were primarily among pediatric patients. The relative contribution of the drug to these events is not known," the text says. ..."Patients with influenza should be closely monitored for signs of abnormal behavior throughout the treatment period," it adds.

There have been 103 cases, 95 of them in Japan, of delirium among people with the flu who took Tamiflu, especially among children and adolescents, the FDA said, adding that 60 percent of the patients were under 17. Suicide was reported in some cases. ...The "possible side effects" section of the drug's "patient information" insert now notes: "People with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior."

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19/11/05: US clears bird flu drug Tamiflu

America's powerful medicines regulator has ruled there is no evidence of a link between the bird flu drug Tamiflu and the deaths of 12 children in Japan.

A Food and Drug Administration panel found no "causal link" between the deaths over the past 13 months and the drug, which is widely distributed.

Swiss manufacturer Roche welcomed the ruling, saying: "The positive role of Tamiflu remains unchanged."

Please visit the link provided for the complete story.

Factoid: Tamiflu doesn't work on the new H5N1 bird flu strains - most developed resistance a while ago. But US, British and Canadian governments are still spending fortunes to stockpile the drug for "key government officials."

Roche is feathering its nest with windfall profits from the bird flu drug, with 2005 third-quarter group sales approaching $20 billion.

Roche is no stranger to price fixing. In 1999, the corporation pleaded guilty to a worldwide conspiracy to form a cartel to criminally "raise, fix and maintain" prices for vitamins sold in the United States and elsewhere. Roche was fined $500 million. According to the U.S. Department of Justice, this record fine was the highest criminal fine in history.

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The United States has only enough Tamiflu stockpiled to cover about 2% of its population. Who’s going to get it?

Countries have formulated different priority lists. While Australia embraces funeral directors among those first in line, Canada places key "decision-makers" such as "elected officials" at the top the list. Britain also includes prominent politicians and adds workers at the BBC over pregnant women, children, and sick patients. The mayor of London has stockpiled more than £1 million worth of Tamiflu for his personal office and staff—nearly 100,000 tablets. The United States also intends to prioritize "key government officials." "That’s a different mind-set than people are used to," explained Nebraska’s chief medical officer, "and it’s going to be a little bit controversial."

The Pentagon has long claimed first dibs on the U.S. Tamiflu stockpile, insisting that "top priority for use of vaccine or antiviral medications is in forward deployed operational forces." Given President Bush's suggested militarization of the pandemic response, imagine the conflict this could create between troops in the streets and critical first-responder medical personnel, fighting over the limited supply and further threatening the public health response.

At this point, there will be none left over for the general U.S. population. Do the math: Excluding military appropriation, there are nearly ten million health care workers and more than two million public safety workers such as police and firefighters, more than twice the mid-2006 stockpile. Even among countries with the highest per-capita stockpiles in the world, like Australia, only 10% of the national stockpile is expected to reach the general population.

Okay. There aren't enough anti-virals in the world for everyone. So the big guys are using our tax dollars to save themselves.

But. Tamiflu doesn't work, and just might push our "key government decision-making officials" right over the edge. Where many are already precariously (un)balanced.

So I'm wondering. Do we really want to let this happen?

Check this out too:
Bird Flu Vultures Lining Up

Related AboveTopSecret.com Discussion Threads:
NEWS: Report: Tamiflu "Useless" Against H5N1 Bird Flu
FDA clears Tamiflu

apc

posted on Nov, 14 2006 @ 09:23 PM

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Someone should write a big fat "DUH" on the forehead of all parties involved. I was given Tamiflu last year during a rather severe case of the flu (heart almost failed), and while in the hospital I took some time to ask the doctors about the drug. One common element of the conversations was that it was NOT for children. Why is there so much surprise over the fact that kids react adversely to it, when everyone knew in the first place that they shouldn't be taking it?

While I'm not sure what Bird Flu has to do with kids offing themselves as a result of taking the drug, Tamiflu does work... it works great. Just not on H5N1.

soficrow

posted on Nov, 14 2006 @ 10:04 PM

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Not "duh."

It's just more gag orders, and rewriting the science to fit political agendas.

So Rumsfeld (Cheney?) is using the FDA to protect their profits. What else is new?

apc

posted on Nov, 14 2006 @ 10:28 PM

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Japan bows to US administration.? Or are you referring to the FDA? If the latter, then agreed... but like you said... what else is new? As far as the underlying facts concerning side effects of the drug, I don't see anything along the line of gag orders. My experience tells me these effects have been common knowledge. However, that experience is limited to the doctors I dealt with personally. If those few were part of an isolated group enlightened to these side effects, while everyone else was not, then that would be unfortunate.

soficrow

posted on Nov, 14 2006 @ 10:43 PM

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posted by apc

As far as the underlying facts concerning side effects of the drug, I don't see anything along the line of gag orders.

It's in the opening paragraph and linked in the clips:

19/11/05: US clears bird flu drug Tamiflu

America's powerful medicines regulator has ruled there is no evidence of a link between the bird flu drug Tamiflu and the deaths of 12 children in Japan.

A Food and Drug Administration panel found no "causal link" between the deaths over the past 13 months and the drug, which is widely distributed.

Swiss manufacturer Roche welcomed the ruling, saying: "The positive role of Tamiflu remains unchanged."

...You don't think it's a gag order when the FDA says "there is no evidence of a link between the bird flu drug Tamiflu and the deaths of 12 children" ...?

I was given Tamiflu last year during a rather severe case of the flu (heart almost failed), and while in the hospital I took some time to ask the doctors about the drug. One common element of the conversations was that it was NOT for children. Why is there so much surprise over the fact that kids react adversely to it, when everyone knew in the first place that they shouldn't be taking it?

As you asked, "Why is there so much surprise over the fact that kids react adversely to it, when everyone knew in the first place that they shouldn't be taking it?"

Answer - because the FDA imposed a gag order with its ruling, and misinformed family physicians and pediatricians who do not have time to read everything.

.

apc

posted on Nov, 14 2006 @ 11:13 PM

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I don't see how this translates to a "gag order". A gag order implies a directive of silence about a known issue. I'm no pharmacologist, but I don't think you can explicitly say "drug X will cause you to kill yourself." So, technically there is no "causal link". SSRI antidepressants have recently shown a correlation in the number of suicides among adolescents, but you can't really say they "cause" the kids to kill themselves. So on the issue of the language, I see no true fault. Implied fault however, yes it would appear that the FDA is trying to sweep aside this issue. But, it is the responsibility of the prescribing doctors to know what they are writing scripts for, is it not? If people are seeing GPs who don't put enough effort into their practice to do the research, then where does the fault really rest?

soficrow

posted on Nov, 14 2006 @ 11:35 PM

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...on the issue of the language, I see no true fault. Implied fault however, yes it would appear that the FDA is trying to sweep aside this issue. But, it is the responsibility of the prescribing doctors to know what they are writing scripts for, is it not? If people are seeing GPs who don't put enough effort into their practice to do the research, then where does the fault really rest?

!!!

A legalistic quibble - designed for the courtroom, not public good.

GPs work their butts off and do NOT have time to research and sort through evidence. So if the FDA says no problem - why wouldn't a humble GP believe the FDA?

Now - The FDA is "recommending that patients who take Tamiflu be closely monitored for signs of abnormal behaviour" - and the product carries a new warning label.

So why wait a year?

Why use official clout to hide real problems with the drug?

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apc

posted on Nov, 15 2006 @ 10:43 AM

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Well, just add it to a long list of drugs that went onto the market only to be dragged through courtrooms later for dangerous side effects (Seroquel and Vioxx are recent examples). The only difference here is the widespread impact generated by the Bird Flu bru-ha-ha.

As far as GPs not having enough time, I can't really speak to that. I would hope they would be dedicated enough to know what they are prescribing. My regular physician is a doctor of Internal Medicine, and their primary focus is understanding the proper use of pharmaceuticals while making referrals to specialists rather than trying to handle everything themselves. That's one primary reason I don't like General Practitioners.