HealingDeva.com

[Terri R.]

Health Care Advocates, Providers and FDA Debate FDA Safety Issues After Senate Hearing
22 Nov 2004

"Health care advocates, providers and FDA officials over the weekend 'sparred' over alleged problems with the FDA prescription drug safety review process and the safety of five medications currently on the market, after an FDA safety reviewer on Thursday testified before the Senate Finance Committee that the agency is "virtually incapable of protecting America," the Baltimore Sun reports (Kohn/Bor, Baltimore Sun, 11/20).

Graham Testimony
At a hearing on the recent voluntary withdrawal of Vioxx, a COX-2 inhibitor manufactured by Merck, David Graham, associate director of drug safety in the FDA Office of Drug Safety, on Thursday testified that the company should have withdrawn the medication from the market years earlier and criticized agency actions related to the medication. He also said that FDA "as currently configured, is incapable of protecting America against another Vioxx" because of ties between agency reviewers and the pharmaceutical industry. Graham said that, based on data from studies conducted by Merck, between 88,000 and 139,000 U.S. residents have experienced heart attacks or strokes as a result of Vioxx.

He added that as many as 40% of those patients, or about 55,000, died as a result of Vioxx. Graham said that when he raised questions about the safety of Vioxx with other FDA officials, he was asked not to express his concerns or revise his conclusions.

In addition, according to Graham, five prescription drugs currently on the market present significant safety risks to consumers."

READ FULL ARTICLE:
http://www.medicalnewstoday.com/medicalnews.php?newsid=16729

[Cathi_R]

you know I had to read this one....I can't believe the audacity of the drug companies!

>>the COX-2 inhibitor Bextra, manufactured by Pfizer, which he said presents cardiovascular risks similar to those of Vioxx; <<

been on this for 2 years now....tho not regularly except for a period of about 6 months when i actually couldn't function without it. I stopped about 3 months ago....seemed when I took it I would have very frequent palpatations....and I already have enough problems with my heart....don't need to add to them. I thank God/Goddess I listened to my body!

>>Pfizer spokesperson Mariann Caprino said that studies indicate Bextra is safe when used for approved indications and that Pfizer remains "committed to conducting long-term studies" of the medication. <<

so who wants to be the guinea pig while they run their 'studies'???
Not me!!!

>>Galson added that the five medications Graham cited as unsafe "are currently approved as safe and effective"<<

ummm....excuse me? didn't they say the same thing about vioxx at one time? along with a very long list of other meds that have had to be pulled!

[BlueRose]

Hey Ms Cathi {{{{{{{{{{{Cathi}}}}}}}}}}}}}

Certainly glad you listened to your body & quit taking the Vioxx, we wouldn't have wanted you to become one of those latter statistics.

How are you doing, by the way? I love our new forum, it just seems like people are a bit more busy to hang around these days, maybe it's just a phase & we'll start coming back together soon.

Meanwhile.....sending ya some Reiki.....reach up & grab a bit, ok?

Blueie