The symptoms have included convulsions, delirium or delusions, and in Japan, five deaths have been reported in children under 16 as a result of neurological or psychiatric problems. Four were fatal falls, and one was a brain infection in a patient with leukemia.
There have also been nine deaths among older teens and adults, attributed to neuropsychiatric problems or brain infections.
Of the 1,800 reports being reviewed by the FDA – collected since Tamiflu’s approval in 1999 -- 55 of them were from the U.S. The remainder was from Japan. None of the U.S. cases resulted in death.
But why did it take the FDA more than two years to get to this point?
On November 18, 2005, eight products had their safety reports reviewed by the FDA’s Pediatric Advisory Committee (PAC). Tamiflu was given special attention at this discussion.
(This safety review, by the way, is required by Section 17 of the Best Pharmaceuticals for Children Act (BPCA). BPCA mandates that all adverse event reports received during a one-year window after the drug has been approved for pediatric use must be reviewed. The Pediatric Advisory Committee (PAC) then issues recommendations on any necessary regulatory actions.)
According to the PAC Question and Answer web page, they heard several presentations on Tamiflu. The adverse event reports for Tamiflu included pediatric deaths, serious skin reactions, and neuropsychiatric events.
If there were 1,800 reports in November of 2005, what is the actual number of adverse reactions today, more than two years later? How many people, including children, have been needlessly harmed by this dangerous drug, while the FDA is doing the chicken dance in slow-motion?
See the Difference between Voluntary vs. Active Adverse Event Reporting?
One very interesting tidbit, which clearly shows the problem with the American adverse event reporting system, is the large difference between the number of Japanese and American reports (1745 vs. 55).
Yes, Japan uses far more Tamiflu than the United States. However, Japan also has different methods and requirements for adverse event reporting.
According to the Japanese Ministry of Health, Labor and Welfare, Japanese regulators require an intensive period of active adverse event reporting for 6 months after a product is approved.
So when Tamiflu was approved for influenza in Japan, Roche and its Japanese pharmaceutical affiliate actively solicited adverse event reports from hospitals and physicians in Japan. These adverse event reports included the 2003-04 flu season, which were subsequently reported to the FDA, and which are now included in their safety review.
U.S. guidelines for adverse event reporting, however, is completely voluntary, and as studies have shown, as few as 1 percent of adverse events are ever reported.
Is Tamiflu Worth the Danger?
Tamiflu (oseltamivir phosphate) is approved for treatment of uncomplicated influenza A and B in children 1 year of age or older. It is also approved for prevention of influenza in people 13 years or older.
It is part of a group of anti-influenza drugs called neuraminidase inhibitors, which work by blocking a viral enzyme that helps the influenza virus to invade cells in your respiratory tract.
Now, here’s the real kicker.
When used as directed (twice daily for 5 days) Tamiflu can ONLY reduce the duration of your influenza symptoms by 1 to 1 ½ days, according to the official data.
However, some patients with influenza are at HIGHER risk for secondary bacterial infections when on Tamiflu. Which would, well, defeat the plan of being able to jump out of bed a day sooner.
The truth is, these drugs work poorly or not at all. And, with a price tag of between $135 to $190 for a one-week prescription of Tamiflu, it’s the 21st Century version of phony snake oil.
For most people, the flu shot does not prevent illness, but actually does just the opposite -- it weakens your immune system and makes you more predisposed to the illness. They're also loaded with neurotoxic substances like mercury and aluminum.
A Personal Tamiflu Story
Dr. Lawrence G. Roberts, the authentic father of the internet, who is pictured with me above, recently sent me the following story about his run-in with Tamiflu:
“A few years ago, as I returned from Japan, I took Tamiflu on the plane as I arrived into SFO. I thought my symptoms felt like the flu and I (at that time) carried it.
“As I drove home, I was observed drifting off the road from time to time, but all I noticed was I suddenly was over too far and I corrected. Then at the exit, which was a slow right turn, I blanked out just into the turn and went straight into a tree.
“I totaled my BMW and caused some knee damage ... I realized somewhat later that the blank out was due to the Tamiflu, but not until other reports came out. Too late to argue the point. Anyway, this was a $100 K side effect caused by the drug, and there most likely have been many more that were never connected to Tamiflu.”
Just Say NO to the Flu Shot
Every use of Tamiflu does little more than line the pockets of fatcats. It certainly does not protect your health. If you follow my proven flu guidelines, however, you won't need Tamiflu or any other vaccine.