Did you have a question?

From: computernewby (somewhereovethe_at_rainbow.com)
Date: 11/23/04 

Date: Tue, 23 Nov 2004 10:19:32 -0800

This looks like a statement to me with absolutely no effort put forth is
this post besides a cut and paste of somebody else's article. Was there a
purpose in posting this here..probably not dickhead.

"JOE" <qwertyy@fz.be> wrote in message
news:no3qp0lodckmv6khls4ud8bon0m7q4gsj2@4ax.com...
> November 18, 2004
> F.D.A. Called 'Defenseless' Against Unsafe Drugs
> By THE ASSOCIATED PRESS
>
> WASHINGTON (AP) -- The American public is "virtually defenseless" if
> another medication such as Vioxx proves to be unsafe after it is
> approved for sale, a government drug safety reviewer told a
> congressional committee Thursday.
>
> "I would argue that the FDA as currently configured is incapable of
> protecting America against another Vioxx," said David Graham, who
> warned that the arthritis drug had been linked to an increased risk of
> heart attack and stroke.
>
> He told the Senate Finance Committee that there were at least five
> other drugs on the market today that should be looked at seriously to
> see whether they should remain there. He cited the acne drug Accutane,
> the weight loss drug Meridia, the anti-cholesterol drug Crestor, the
> pain reliever Bextra, and the asthma drug Serevent.
>
> AstraZeneca Pharmaceuticals, maker of Crestor, said it was confident
> that the drug was safe. "To date, the FDA has not given us any
> indication of a major concern regarding Crestor," said spokeswoman
> Emily Denney.
>
> Tim Lindberg, a spokesman for Abbott Laboratories, said "science
> continues to support the safe use of Meridia to treat obesity, the
> leading health epidemic in the U.S."
>
> Carolyn Glynn, spokeswoman for Roche Pharmaceuticals, maker of
> Accutane, said that "it's important to point out that this drug is
> reserved for a very very serious indication, that it does carry risks
> and that its very important for physicians, patients, pharmacists to
> monitor, to conform to all of the risk programs because this drug is
> extremely beneficial as long as its used safely and appropriately."
>
> GlaxoSmithKline, maker of Serevent, issued a statement saying that it
> "stands firmly behind" the product, "which is safe and effective when
> used appropriately and in accordance with labeling and treatment
> guidelines."
>
> Representatives of Pfizer, the manufacturer of Bextra, were not
> immediately available for comment.
>
> Another FDA official, Dr. Sandra Kweder, said that she did not agree
> with Graham's assessment with the risk posed by the five drugs singled
> out by Graham.
>
> She said "there is no magic formula" to determine the drugs that pose
> the most pressing safety concerns. She said there are thousands of
> drugs on the market, each one carrying risks and benefits. "That is
> clearly Dr. Graham's opinion" regarding the five drugs, she said,
> denying that the FDA intimidates scientists whose opinions differ with
> superiors.
>
> She was asked whether her office, the Office of New Drugs, is an
> impediment to enforcing concerns about drug safety. "You know, sir,
> that is not the FDA I know.
>
> Vioxx's maker, Merck & Co. pulled the drug from the market on Sept. 30
> after a study indicated the popular painkiller doubled the risk of
> heart attacks and stroke when taken for longer than 18 months.
>
> Raymond V. Gilmartin, the company president, said in prepared
> testimony that Merck acted within four days of learning about the
> risk.
>
> "Given the availability of alternative therapies and the questions
> raised by the data withdrawing Vioxx was consistent with an ethic that
> has driven Merck actions and decisions for more than 100 years," he
> said.
>
> Gilmartin also said the company was surprised by the cardiovascular
> risk because it differed from past clinical trials. "My wife was a
> user of Vioxx until the day we withdrew it from the marketplace," he
> said.
>
> The Food and Drug Administration has defended its actions regarding
> Vioxx. In a statement issued late Wednesday, the agency cited its
> "well-documented and long-standing commitment to openness and
> transparency in its review of marketed drugs."
>
> However, Sen. Charles Grassley, R-Iowa, who chaired the hearing,
> suggested that an independent board of drug safety might be needed to
> ensure the safety of medications after they're approved for the
> market.
>
> "Consumers should not have to second-guess the safety of what's in
> their medicine cabinet," he said.
>
> Graham told the committee that research indicated that Vioxx caused up
> to 160,000 heart attacks and strokes.
>
> "If we were talking about Florida or Pennsylvania, 1 percent of the
> entire state population would have been affected," he said. "I'm sorry
> to say Sen. Grassley, but 67 percent of the citizens of Des Moines
> would be affected and, what's worse -- the entire population of every
> other city in the state of Iowa."
>
> Graham said his research helped to coax the FDA to withdraw a number
> of drugs including Fen-phen, a weight loss drug, Lotronex, Baycol and
> Rezulin. "During my career I have recommended the market withdrawal of
> 12 drugs," he said. "Only two of these remain on the market today."
>
> At the same time, though, he questioned the agency's commitment to
> removing unsafe drugs from the market, since it would call into
> question their earlier approval.
>
> Sen. Jeff Bingaman, D-New Mexico, said the problem was within the
> FDA's own culture.
>
> "The culture within the FDA, being one where the pharmaceutical
> industry, which the FDA is supposed to regulate, is seen by the FDA as
> its client instead," he said.
>
> He called on President Bush to appoint a new head for the agency.
> Lester Crawford has been acting commissioner of the agency.
>
> In the FDA statement, Crawford said the FDA initiated and paid for
> reviews of Vioxx and antidepressants after those drugs had hit the
> market. "That is evidence the system is working," Crawford said.
>
> Critics contend the agency ignored risks in both instances, then
> intimidated its own reviewers when they pointed to safety concerns.
>
> In October, the FDA ordered that all antidepressants carry warnings
> that they "increase the risk of suicidal thinking and behavior" in
> children who take them.
>
> The FDA's statement disturbed lawyer Andy Birchfield, who is
> evaluating thousands of potential cases against Merck on behalf of
> injured patients.
>
> "How can they see that type of problem and look back and say 'We did
> everything right'?" Birchfield said. "When they're not willing to
> recognize mistakes, we have no hope for them voluntarily taking
> measures to correct the situation."
>
> Crawford's statement did not mention Graham by name, but suggested
> that the reviewer was a maverick who did not follow agency protocol.
>
> Graham was lead author on a research project that studied the records
> of almost 1.4 million Kaiser Permanente patients, including 40,405
> treated with Pfizer's Celebrex and 26,748 treated with Vioxx. The
> study found that high doses of Vioxx tripled risks of heart attacks
> and sudden cardiac death.
>
> Vioxx was responsible for an additional 27,785 deaths from heart
> ailments from 1999 to 2003, Graham concluded.
>
> He has told congressional investigators that superiors pressured him
> to soften his conclusions.
>
> Crawford said in his statement that the reviewer "voluntarily chose to
> revise his conclusions, and he did so, in his own words, "without
> compromising my deeply held convictions."'
>
> ^------
>

Quantcast