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
we gave my son tamiflu when he was just over 2 years old and i still regret it. i didn’t take the time to research it as i was scared and he had the swine flu. he totally had the hallucinations and was clutzy and hurt himself while on it. i hope there are no long-term effects!
Research D-lenolate (eastpark) as an alternative to prescribed flu remedies and shots. All Natural viral and bacterial fighter. It is olive leaf extract and very effective.
While I completely agree that this drug should NOT be given to infants or even young children, I don’t like the idea of using a study that shows complications of pneumonia, ear infections, and meningitis as substantiation. These symptoms are very likely something that would occur in infants who are either misdiagnosed in the first place, or would occur as a secondary infection, such as middle ear issues. A psychiatrist told me recently that studies have to show ALL symptoms or so-called side effects–i.e., anything that the subject feels is reported during the study. So if they took tylenol and got heartburn (most likely due to poor diet anyway), the study would show a percentage of side effects being heartburn. So, in conclusion, I don’t think studies are a good way to gauge good or bad science. Because we know that lots of studies are biased in that the drug companies are sponsoring them in the first place!
IMHO that is not socialism it is a cor·poc·ra·cy (kôr-pkr-s)
n. pl. cor·poc·ra·cies
1. A society dominated politically and economically by large corporations.
And I think it is a natural outcome of letting capitalism with a Capital C run amok. Money is more valuable to the society than the social good.
The FDA cares only about making money for the big corporations. Giving such a powerful drug to babies is insane. Giving this drug to anyone seems like a very bad idea, given the comments above.
Much better to build up your immune system with real food. As for babies, the milk of a healthy mother will protect them from all kinds of illness.
What else is new? My daily “flu shots” include eating the best foods I can find and the rest of the components of my health program. Why bother with this toxic garbage when natural ways exist to prevent the flu, like tonic herbs, among countless others? As an example, astragalus will prevent the flu and improve the overall health of a person short term and long term.
I remember being shocked years ago when hearing about France’s own Phen-Phen disaster.
There were pharmacists refusing to fill doctor’s prescriptions for it: some of their clients eventually needed DOUBLE TRANSPLANTS.
At the end of this news report, the voiceover said, “And at this minute the FDA is approving this drug”.
oh dear!
🙁
A few years ago, my kids were exposed to H1N1. My son tested positive for type A flu (we opted to not test for H1N1). Pediatrician said to let it run it’s course. He would only consider Tamiflu for my daughter because she has asthma, but in general, he did not like giving Tamiflu to kids.