HSI e-Alert - Seven Year Itch

[Guest guest]

" HSI - Jenny Thompson " <hsiresearch

HSI e-Alert - Seven Year Itch

Tue, 21 Nov 2006 12:10:08 -0500

 

 

 

Dear Member,

 

Like romance, pharmaceuticals can be risky.

 

When the FDA approves a drug, it's sort of like the agency sets up

U.S. consumers on a blind date. At that point, we know some of the

basics about the drug, but those basics are nothing compared to what

we'll know in a few years, after additional studies are completed and

adverse events are reported.

 

In 1999 we went out on our " first date " with Tamiflu, a drug designed

to reduce flu symptoms. Tamiflu doesn't prevent the flu, but when

administered quickly at the outset, it may cut the duration of flu

symptoms by a day or so.

 

Now, seven years later, something peculiar is happening to some of the

youngest patients who take Tamiflu. And no one knows why.

 

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Shock to the system

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A 2005 FDA safety review identified disturbing adverse events

associated with Tamiflu use in children under the age of 16. According

to the FDA, " These adverse event reports were primarily related to

unusual neurologic or psychiatric events such as delirium,

hallucinations, confusion, abnormal behavior, convulsions, and

encephalitis. "

 

Most of those events were reported in Japan, where Tamiflu use is

about four times greater than in the U.S. A dozen deaths among

pediatric patients were also associated with Tamiflu use (although no

evidence directly blames the drug for those deaths).

 

Here's where it gets mysterious. Between 1999 and 2005, 126 adverse

events were reported. But between the summer of 2005 and the summer of

2006, 103 new adverse reports were filed. Health officials are baffled

by this sudden spike.

 

The FDA is now considering a change in Tamiflu labeling that would

include new warnings for parents to closely monitor children who take

the drug. Tamiflu sold in Japan already carries a warning about

potential " abnormal behavior " in pediatric use.

 

So it's time for a little " water cooler " regulation. While the FDA

jumps through the bureaucratic hoops of committees and advisory

panels, the rest of us can go ahead right now and let friends and

family know that kids taking Tamiflu may be at risk.

 

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Back up the Tamiflu truck

-----------

 

In an Associated Press article about the unexplained adverse events in

children, this sentence stood out: " Tamiflu is one of the few drugs

believed effective in treating bird flu. "

 

Well...not exactly.

 

The U.S. government would certainly like for everyone to believe that

a round of Tamiflu might prevent the predicted dire effects of avian

flu. According to a March 2006 report in USA Today, the federal

government has already purchased about 17 million Tamiflu treatments,

with plans to eventually purchase more than 700 million treatments.

But does the evidence really support this wild buying spree?

 

In an e-Alert I sent you last January, I told you about a 2005 New

England Journal of Medicine (NEJM) article with details about two

Vietnamese patients with avian flu who were treated with Tamiflu

shortly after symptoms were identified. Both patients died. But they

didn't die because Tamiflu was ineffective. They died because the

virus quickly developed resistance to Tamiflu.

 

Writing in NEJM, Anne Moscona, M.D., a Cornell University medical

professor, noted that the misuse of Tamiflu stockpiles may promote

resistance, lessening the usefulness of the drug. She concluded that

personal stockpiling should be strongly discouraged.

 

According to ABC News, a representative of Roche Laboratories, Inc.

(the maker of Tamiflu) reacted to the NEJM report with a news briefing

about eight avian flu patients who were treated with the drug. Four of

the patients showed a drop in viral levels and survived. The other

four patients died.

 

Obviously, the Roche rep offered this as evidence that Tamiflu is

effective against the virus. He didn't happen to mention, however,

that among the approximately 120 people who have contracted avian flu

over the past two years, about half have survived - a perfect mirror

image of his eight case studies.

 

There is zero scientific evidence that Tamiflu would be effective in

treating cases of the avian flu. Zero.

 

 

 

*****************************

 

....and another thing

 

Do you snack between meals? No problem with that, as long as you make

the right choices and don't pack in junky calories. In fact, a new

study from Perdue University shows that one particular type of snack

may actually be beneficial.

 

Enter the almond.

 

Researchers recruited 20 overweight women and asked them to add 300

calories worth of almonds to their diets each day for ten weeks. The

subjects' diets were monitored throughout. At the conclusion of the

study, researchers found no changes in total calorie intake, body

weight, body fat, or body mass index.

 

The Perdue team concluded that the additional calories from the

almonds helped to curb hunger, displacing other calories in the

subjects' diets. So instead of increasing caloric intake, they were

actually getting about the same amount of calories - while also

ensuring a good intake of the almond's natural nutrients, such as

vitamin E, calcium, magnesium (which helps your body absorb calcium),

and flavonoid antioxidants.

 

To Your Good Health,

 

Jenny Thompson

 

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