On December 21, 2012, the FDA expanded use of the anti-viral drug oseltamivir, known by the brand name Tamiflu, to children as young as two weeks old.
Crazy?
Absolutely.
Surprising?
Not in the slightest.
While shocking, this recent move is yet another demonstration of the FDA’s unrelenting spiral to complete and utter lunacy in its decision making.
How the FDA could approve a drug like Tamiflu for children so young when it is already under scrutiny in Japan for a possible link to suicide and other abnormal behavior in children is totally incomprehensible.
As recently as April 2012, the FDA even recognized that oseltamivir, the active ingredient in Tamiflu, was associated with “abnormal behavior, delirium, including symptoms such as hallucinations, agitation, anxiety, altered level of consciousness, confusion, nightmares, delusions” as possible side effects of pediatric patients taking the drug.
The most compelling reason which calls into question the FDA’s approval of Tamiflu for infants is a 2010 study published in the The Pediatric Infectious Disease Journal which found that off label use of Tamiflu in babies resulted in 84 of the 157 infants (average age 6.3 months) experiencing complications from the medication the most serious being meningitis (1%), pneumonia (6%), and otitis media (1%).
No Safety Studies on Tamiflu for Babies
There are certainly no controlled, randomized, placebo-controlled trials on the safety of Tamiflu for babies as testing on babies is obviously considered unethical – so what possible evidence could the FDA have used for this unfathomable decision?
Did the FDA just extrapolate data from previous studies on Tamiflu use in adults and older children to justify the decision? Is this possible despite the fact that infants have not yet developed a blood-brain barrier that is able to keep a chemical out of the brain, which grows at its most rapid rate the first year of life? In addition, a baby’s detoxification mechanisms are also inadequately developed to remove a chemical out of the body quickly enough to prevent damage.
Neither of these biological facts were obviously considered in the decision. Babies were simply assumed to handle the drug in a similar manner to adults or adolescents!
It is abundantly clear in the rendering of this decision that the FDA was only attempting to please Roche, the manufacturer of the active chemical ingredient in Tamiflu, whose shareholders are undoubtedly extremely concerned about the December 15, 2010 report from the World Health Organization (WHO) that viral resistance to Tamiflu is growing.
The FDA was not in any way attempting to protect the public or help save babies’ lives from the flu by expanding Tamiflu to infants. Rather, it seems quite apparent that the move is an attempt to boost Roche’s short-term profits from the drug before expanding viral resistance renders Tamiflu ineffective and it becomes yet another Blockbuster drug relegated to the Big Pharma dustbin.
Didn’t know that your tax dollars are being used to pay the salaries of Federal bureaucrats who frequently operate as de facto corporate employees rendering decisions solely to benefit the bottom line of private companies? Welcome to the Brave New World of Corporate Socialism.
Sarah, The Healthy Home Economist
Sources: Tamiflu Side Effect Concerns Grow After Japan Deaths
FDA Approves Neurotoxic Drug for Infants Less Than One
FDA Expands Tamiflu’s Use to Treat Children Younger Than 1 Year
Scary.
Its all about greed and illegal payoffs as kids did you remember all the disclaimers and warnings on meds? That’s when people actually cared about each other and the gov. did their jobs
Beyond comprehension. It’s hard to believe that humans are behind decisions like this. Yes, I know the FDA is a big, monstrous, essentially useless protector of corporate profit, but still…PEOPLE make these decisions. Can’t quite get my head around it. They have to sleep at night, right?
🙁
Disgusting. Truly, the FDA has ceased to provide anything of value to the world and needs to be dissolved for the betterment of society. Not only is Tamiflu associated with terrifying side effects and virus mutation, but even its own website boasts only a 30 hour reduction in flu symptoms. Compare that (surely exaggerated estimate) to the 3 to 4 DAY reduction in flu that elderberry extract has been clinically proven to accomplish–with no side effects, and for about 1/10th the price of a Tamiflu prescription! Natural solutions are far, far more effective and safe. Of course there is no multi billion dollar industry built around natural flu remedies so we don’t hear much about them.
I think our MD”S could be our allies if they weren’t so indoctrinated in the status quo. Then big pharma would really be in trouble. I think it is on us to educate them if they are willing to listen.
This stuff made me a paranoid crazy person for three days when I took it as an adult. I couldn’t leave the house -and even the cat scared me!! NO WAY would I give it to my helpless children who could not reason away the symptoms.
I have the utmost respect and admiration for MDs who buck the system and refuse to go along with the FDA and CDC insanity. They are really risking their careers and licenses by doing so. If you find one who thinks for himself/herself, they are KEEPER.
Boo!
How long before people start fighting back in numbers?