Neurotoxic Flu Drug Approved for Use on Infants
January 5th, 2013
Reader Views: 619
by Lisa Garber
Tamiflu, the antiviral drug facing international criticism for its deadly side effects, has been approved by the US Food and Drug Administration for use on infants just two weeks old.
The FDAâ€™sÂ decisionÂ comes amidstÂ international controversyÂ over Tamiflu, known generically asÂ oseltamivir. Since the drugâ€™s approval in 1999, severalÂ suicide deathsÂ and incidents of bizarre side effects have been recorded. In the UK, where use of Tamiflu was relatively low at the time of publication of aÂ 2005 article, only 41 â€śyellow cardâ€ť reports of adverse reactions were recorded, just one being agitation and two being â€śconfusional states.â€ť
In Japan, however, close to the cries of a then-imminent avian flu pandemic, 54 people with no previous discernible psychiatric or health complications were dead after taking Tamiflu in 2005.
Tamiflu-maker, Roche Holding AG, responded chillingly. â€śThese events are extremely rare in relation to the number of patients treated.â€ť
Haruhiko Nokiba, whose a 17-year old victim who committed suicide in 2004 after taking Tamiflu, says, â€śHad they issued a warning earlier, then the number of deaths could have been halved.â€ť
FDA Following the Money
A warning label about such bizarre psychiatric side effectsâ€”like the one the Japanese pharmaceutical company Chugai slapped onto Tamiflu in 2004â€”might have affected Rocheâ€™s sales, which is where the FDAâ€™s priority seems to be. This is, of course, conjectureâ€”like the kind the FDA used when approving Tamiflu for use on infants under a year old.
Because of the unlikelihood that any parents would subject an infant to controlled, randomized, placebo-controlled trials of a drug associated with psychiatric distress, the FDA made their approval decision based onÂ conjectureÂ from studies involving older children and adults.
Existing Data Encourages Caution
What this conjecture fails to take into consideration, however, is an infantâ€™s significantly greater vulnerability to drugs. Their lesser developed blood-brain barriers and detoxification mechanisms make them less capable as adults of keeping chemicals out of their developing brains and bodies.
As a neuraminidase inhibitor, Tamiflu blocks the principle enzyme in a flu virus that allows it to enter through the membrane of the host cell. Because mammals have four variations (that we know of so far) of neuraminidase enzymes, known as sialidase homologs, a drugÂ like TamifluÂ that targets these neuraminidases is likely very imprecise. These enzymes are crucial for neurological health, so â€ścross reactivityâ€ť associated with Tamiflu may be to blame for many things, like anÂ increased risk of birth defectsÂ in offspring of pregnant women given Tamiflu.
In fact, existing data rather than conjecture should have turned the FDA away from this approval. According to a study published inÂ The Pediatric Infectious Disease Journal, the majority (54 percent) of evaluable infants treated with Tamiflu experienced complications. â€śThe most serious of [these complications] were meningitis in 1 infant (1 percent), pneumonia in 9 (6 percent), and [ear infection] in 2 (1 percent).â€ť
Another study, published in theÂ International Journal of Vaccine Risk and Safety in Medicine, tracked down 119 reports of Tamiflu-induced death, 38 of which were of sudden deterioration within 12 hours of prescription. â€śThese findings are consistent with sudden deaths observed in a series of animal toxicity studies, several reported case series and the results of prospective cohort studies.â€ť
The FDA Doesnâ€™t Care About You
This is just another blight on the FDAâ€™s pock-marked, industry-linked record. In other examples, the FDA openly endorses and is pushing for the expansion of GMOs in our food supply and environment, most famously GM corn and wheat, but alsoÂ GM salmon. In efforts to squelch the GMO labeling movement in early 2012, the government alsoÂ erased 1 million signaturesÂ from the â€śJust Label Itâ€ť campaign.
They have even set their sights on labelingÂ walnuts as drugsÂ for their coveted omega 3 content and banning vitamin B6 from stores in favor of pharmaceutical company BioStratumâ€™s prescription drug using Pyrodoxamine, a natural form of vitamin B6. Forces within our own governmentâ€”selected by people they then do nothing to care forâ€”are turning natureâ€™s bountiful resources into purchasable and often unaffordable products.
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