Tag Archives: fda

congressional hearings re: FDA/Avandia

Not that I think it will help or change things, but…it’s about time our congresscritters started looking into the FDA and how it’s become nothing more than a strong-arm of bigPharma. So in the NYTimes today I found this little tidbit:

Diabetes Drug Still Has Heart Risks, Doctors Warn

By STEPHANIE SAUL and GARDINER HARRIS
Published: June 6, 2007

A medical study intended to demonstrate the heart safety of a well-known diabetes treatment seems, instead, to have added to the controversy over the drug.

Its manufacturer, GlaxoSmithKline, says preliminary results of the clinical trial provide reassurance that the drug, Avandia, an oral medication for Type 2 diabetes that has been used by an estimated seven million people worldwide, does not raise the risk of a heart attack or death from cardiovascular disease.

Influential doctors said that the data published online yesterday in a major medical journal did nothing to ease their concerns about the heart risks. The doctors raised their concerns in three editorials accompanying the Avandia study in The New England Journal of Medicine.

Questions about the safety of Avandia and how regulators have dealt with its risks are to be the subject of a Congressional hearing today. The data could intensify criticism, expected at the hearing, that the Food and Drug Administration should have warned about the potential heart risks years ago.

A supervisor in the drug safety office at the agency said in an interview yesterday that she was rebuked last year after calling for a stronger warning label on Avandia and a competing drug, Actos.

The supervisor, Dr. Rosemary Johann-Liang, said that in March 2006 she approved a recommendation from a safety reviewer at the agency that the drugs be required to carry the strongest warning, a so-called black box warning, because they posed a risk of unusual swelling that could lead to heart failure.

But after officials at the agency who dealt more closely with Glaxo complained, Dr. Johann-Liang said she was ordered to retract her approval of the warning, lost her power to approve such assessments and no longer supervised reviews of the safety of Avandia and Actos.

“This was a very careful review that came to an inescapable conclusion,” Dr. Johann-Liang said in the interview. “They decided to act like the review never happened and punish me for approving it.”

Read the whole story at
http://www.nytimes.com/2007/06/06/health/06fda.html?_r=1&th=&adxnnl=1&oref=slogin&emc=th&adxnnlx=1181134860-BHv1wITY10vDpptff/AJHg

I’ll be interested in the outcome of this one since it’s actually looking at what the FDA is doing. I doubt (due to my jaded nature) that much will happen, but every little inkling of truth holds some hope that we can eventually loosen the strangle hold that pharmaceutical companies have on the FDA, and how they exploit illness for profit.


make them stop!!!!

global warming:

the scientific community came out in one, dire voice proclaiming that global warming is a FACT, is OUR FAULT, and must be addressed within the next 10 years or we will have no way out.

and the bush admin said it refuses to make energy cuts mandatory.

cervical cancer:

a short while ago, we found out that cervical cancer is caused by human papilloma virus, which is sexually transmitted. now, Texas wants to FORCE sixth grade girls to be vaccinated against this virus.

EXCUSE ME but NO!
this vaccine was fast-tracked through approval. do YOU really trust the FDA and Merck to insure the safety of this vaccine given their track record (i.e., vioxx)? but more importantly, do you really think the government has the right to force women to be vaccinated from something that MEN carry?

methinks Merck is trying to recoup their losses and they are using our cervixes to fix their bottom line.

*ahem*

i think it’s time to give full voice to RAGE AGAINST THIS MACHINE! especially us women. we are not Merck’s guinea pigs and our children’s world should not be destroyed by short-sighted, immoral government slaves to oil.


but the question is…

do we trust them?

The FDA has approved the use of bacteriophages (viruses) as a food additive to be used on processed meats (lunch meats, etc.) as a way to kill listeria. There are also trials being done to develop viruses to kill e-coli and other bacteria that routinely contaminate meat products. Now, it’s not that I think that science shouldn’t be looking at these sorts of things, but I have grave concerns about FDA approvals being truly what they are touted to be (i.e., “safe” for humans and other animals).

Here’s the part that worries me…

Consumers will not be aware which meat and poultry products have been treated with the spray, Mr. Zajac said. The Department of Agriculture will regulate the actual use of the product.

and WHY aren’t we (consumers) going to be made aware that the meat being bought (consumed) is treated with this “additive”?

Now, this part is just plain laughable.

“The F.D.A. is applying one of the toughest food-safety standards which they have to find this is safe,” said Caroline Smith DeWaal, director of food safety for the Center for Science in the Public Interest, a consumer advocacy group. “They couldn’t approve this product if they had questions about its safety.”

This from the agency that approved vioxx.

Read the entire article here:
http://www.nytimes.com/2006/08/19/us/19viruses.html?_r=1&oref=slogin


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