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Re. Merck pulls Vioxx citing risk of stroke, heart attack

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  • #16
    'Just Business...

    Originally posted by pprescot
    And the beat goes on ...

    "What's good for General Motors id good for the country."
    LOL, pprescot! Great line!

    Actually, I was thinking about that issue while doing chores today. My thoughts were right along that line, but somehow the Godfather got mixed into it, something about "nothing personal" and "it's just business."

    Originally posted by pprescot
    And Eisenhower only warned us about the military-industrial complex.
    'Also interesting that Eisenhower, who was a General, warned us about the military-industrial complex. He must not have seen his caveat as a conflict of interest (what would the military do about it, anyway--pull his retirement?)

    Speaking of conflicts of interest:

    February 1, 2004:

    CSPI Urges Removal of FDA Panelists on SSRIs

    The Food and Drug Administration (FDA) has been urged to remove three of 11 scientists on one of its advisory boards evaluating the link between serotonin reuptake inhibitors (SSRIs) and suicide in youths because they have been paid consultants for the companies that make the drugs under investigation.

    Center for Science in the Public Interest http://www.cspinet.org/new/200402012.html

    and,

    September 25, 2004, from the British Medical Journal:

    Dr Breggin told the BMJ that a black box warning is not the strongest warning available to the FDA. "They could say the drugs are contraindicated. But the panellists, with their deep ties to industry, would never do that," he said. According to an FDA spokesperson, Jason Brodsky, 10 of the panellists received waivers because of financial conflicts of interest. sic

    British Medical Journal
    BMJ 2004;329:702 (25 September), doi:10.1136/bmj.329.7468.702

    I hope poor Jason Brodsky wasn't retaliated against for telling the BMJ about those panelists. You saw what happened to Mosholder.

    I wonder whatever happened to free speech...?
    The truth will set you free. But first, it will piss you off.--Gloria Steinem

    Comment


    • #17
      Arthritis drug recall sparks criticism of FDA

      Arthritis drug recall sparks criticism of FDA

      Last Updated: 2004-10-04 16:05:34 -0400 (Reuters Health)
      By Lisa Richwine

      WASHINGTON (Reuters) - U.S. drug safety regulators are coming under fire for their response to years of suspicions, confirmed last week, that arthritis drug Vioxx increased the risks of heart attacks and strokes.

      Merck & Co. Inc.'s withdrawal of Vioxx Thursday raised inevitable questions about whether the prescription drug taken by millions should have come off pharmacy shelves sooner, or at least carried stronger warnings.

      Amid "mounting evidence over five years that this drug had cardiovascular risks, the (Food and Drug Administration) settled for almost a minimal amount of action, a small change in the product labeling," said Thomas Moore, a health policy analyst at George Washington University.

      The FDA should have given "a more prominent and clear warning," Moore said.

      Dr. Eric Topol, a cardiologist who warned about heart risks from Vioxx in 2001, charged the FDA with "considerable failings" in its handling of the case.

      From the drug's approval in 1999 until its withdrawal, the FDA "could have exerted more effect on Merck's progress with Vioxx," said Topol, head of cardiovascular medicine at the Cleveland Clinic.


      The agency could have requested a one-year study in people at highest risk for heart problems, or advised doctors against prescribing Vioxx to anyone with heart disease, Topol said.

      The criticism follows recent charges that the FDA was slow to react to another risk -- a link between pediatric antidepressant use and suicidal behavior. Concerns arose in May 2003, but only last month did FDA officials conclude there was a link between the drugs and suicide attempts by kids.

      The FDA was "concerned and aware of the potential for cardiovascular effects with (Vioxx) for quite a few years," acknowledged Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research.

      The risk was not fully clear until last week when Merck announced a three-year study of 2,600 patients showed those who took Vioxx were more likely to suffer heart attacks and strokes than others who took a placebo, FDA officials said.

      Galson said the FDA acted appropriately by ordering Merck to add information in 2002 about a study in 2000 that showed an elevated cardiovascular risk for Vioxx patients compared with others who took the generic painkiller naproxen.

      The FDA also was watching reports of heart attacks and strokes in Vioxx users after the drug was being sold. Because those conditions are so widespread it was "almost impossible" to determine which were caused by the drug, Galson said.

      Some cardiologists defended the FDA's handling of Vioxx. "The information before this was so sketchy," said Dr. Robert Bonow, chief of cardiology at Northwestern University.

      The FDA review system is not designed to catch all serious risks before drugs hit the market. Less common problems only show up after a medicine is sold widely. FDA officials say they are working to improve monitoring of side effects once drugs are on the market.

      But Moore said the Vioxx case illustrated a breakdown of the drug safety system because long-term safety studies were not done after the cardiac risk first was suspected.

      "The result of this is literally millions of people wake up one morning and discover they were taking a drug that did more harm than good," Moore said.

      Copyright 2004 Reuters Limited.
      The truth will set you free. But first, it will piss you off.--Gloria Steinem

      Comment


      • #18
        When patient's are ahead of doctors - we look dumb.

        When patient's are ahead of doctors - we look dumb.

        http://www.worstpills.org/public/vioxx.cfm

        check out the date April, 2001.

        I was a resident when the Vioxx vs Naproxen trial came out showing more heart failure with Vioxx than Naproxen. In one of the rare pharma sponsored events I was subjected to - I ask the Merck rep why would I prescribe vioxx when naproxen might be safer ? The rep and the "doctor expert" (cough) said that Vioxx "wasn't bad for the heart" Naproxen was protective ! I said, "OH", never prescribed vioxx and have used Naproxen quite a bit.

        http://www.worstpills.org is published by http://www.citizen.org . They frequently have many good ideas. To be on record in April 2001 saying no to vioxx sure makes them look good today.

        Comment


        • #19
          FDA Official Alleges Pressure to Suppress Vioxx Findings

          washingtonpost.com
          FDA Official Alleges Pressure to Suppress Vioxx Findings

          By Marc Kaufman
          Washington Post Staff Writer
          Friday, October 8, 2004; Page A23

          A Food and Drug Administration official who sought to estimate the harm done to patients by side effects of the painkiller Vioxx said yesterday that his supervisors tried to suppress his conclusions, according to Sen. Charles Grassley (R-Iowa).

          Grassley said in a news release that David Graham, associate science director of the Office of Drug Safety, told him that agency officials "ostracized" him and subjected him to "veiled threats" as he tried to have his study cleared for publication. When a top FDA official suggested "watering down" the report, Graham responded in an e-mail: "I've gone about as far as I can without compromising my deeply-held conclusions about this safety question."

          Graham gave Grassley a copy of an e-mail in which another top official wrote that Merck & Co., which made Vioxx, "needs to know before it becomes public so they can be prepared for extensive media attention that this will likely provoke." Merck decided to pull Vioxx from the market last week after a major clinical trial, unrelated to the FDA review, indicated the drug was causing an increased risk of heart attacks and strokes.

          Steven Galson, acting director of the FDA's drug center, called Graham's accusations, as relayed by Grassley, "baloney." He said that Graham's study was going through the same review process used for all major drug-safety issues, and that the agency was frustrated by Graham's inability to produce the data he promised. "There was no battle because there was no data," Galson said. "We were waiting all summer, but he missed his deadline."

          Graham's analysis was based on a review of 1.4 million Kaiser Permanente patients given Vioxx or one of its competitors, Celebrex. In a limited presentation at a conference in France this summer, Graham said the data showed that more than 27,000 heart attacks and sudden cardiac deaths would have been avoided if the patients had used Celebrex rather than Vioxx.

          Grassley, who as chairman of the Senate Finance Committee has initiated a series of reviews of controversial FDA decisions, said: "It seems that while Merck was taking a fresh look at its clinical data in search of trouble, the Food and Drug Administration was challenging its own researcher. Merck knew it had trouble on its hands and took action. At the same time, instead of acting as a public watchdog, the Food and Drug Administration was busy challenging its own expert and calling his work 'scientific rumor.' "

          Just after Merck announced that it would recall Vioxx, Galson said in a teleconference that the FDA had received only an abstract of Graham's work and was awaiting the data and full report.

          In a statement yesterday, the FDA said that after discussing his abstract with agency officials, "it was Dr. Graham's decision to revise the abstract. . . . He transmitted his completed report to his agency supervisors on September 30. The standard agency review process for this type of report is a more rigorous scientific peer review."

          Grassley, however, likened Graham's experience to that of another FDA scientist, Andrew D. Mosholder, who had conflicts with his superiors this year over antidepressants and suicide in young people.

          2004 The Washington Post Company
          The truth will set you free. But first, it will piss you off.--Gloria Steinem

          Comment


          • #20
            As I previously mentioned the safety of Vioxx was questioned as early as 2000, little more than a year after it hit the market. Vioxx vs naprosyn appeared to increase the risk of MI. Merck's response (heavily pushed) - it wasn't that V. was dangerous but that nap. was protective.

            The FDA could have called for further trials but didn't. It's business bias is becoming more apparent with each passing year. Wonder if any FDA folks from 1999-2003 now work for Merck?
            Growing old is mandantory, Growing up is optional.

            Comment


            • #21
              I wish it was absurd

              Originally posted by pprescot
              ...Wonder if any FDA folks from 1999-2003 now work for Merck?
              pprescot, I wish I could find your statement absurd...
              The truth will set you free. But first, it will piss you off.--Gloria Steinem

              Comment


              • #22
                Where the Money Is: The Best-Selling Drugs in U.S.

                washingtonpost.com
                A List of the Best-Selling Drugs in U.S.


                The Associated Press
                Thursday, September 30, 2004; 2:55 PM

                The top selling drugs in the United States in 2003, their annual sales, what it treats and its manufacturer. The 2003 data is the most recent audited figures available.

                1. Lipitor, $6.8 billion, cholesterol, Pfizer Inc.

                2. Zocor, $4.4 billion, cholesterol, Merck & Co.

                3. Prevacid, $4.0 billion, heartburn, TAP Pharmaceutical Products Inc.

                4. Procrit, $3.3 billion, anemia, Johnson & Johnson

                5. Zyprexa, $3.2 billion, mental illness, Eli Lilly & Co.

                6. Epogen, $3.1 billion, anemia, Amgen Inc.

                7. Nexium, $3.1 billion, heartburn, Merck & Co.

                8. Zoloft, $2.9 billion, depression, Pfizer Inc.


                9. Celebrex, $2.6 billion, arthritis, Pfizer Inc.


                10. Neurontin, $2.4 billion, epilepsy, Pfizer Inc.

                11. Advair Diskus, $2.3 billion, asthma, GlaxoSmithKline PLC

                12. Plavix, $2.2 billion, blood clots, Bristol-Myers Squibb Co.

                13. Norvasc, $2.2 billion, high blood pressure, Pfizer Inc.

                14. Effexor XR, $2.1 billion, depression, Wyeth

                15. Pravachol, $2.0 billion, cholesterol, Bristol-Myers Squibb Co.

                16. Risperdal, $2.0 billion, mental illness, Johnson & Johnson

                17. Oxycontin, $1.9 billion, pain, Perdue Pharma

                18. Fosamax, $1.8 billion, osteoporosis, Merck & Co.

                19. Protonix, $1.8 billion, gastrointestinal reflux disease, Wyeth

                20. Vioxx, $1.8 billion, arthritis, Merck & Co.

                ---

                Source: IMS Health
                The truth will set you free. But first, it will piss you off.--Gloria Steinem

                Comment


                • #23
                  Discussion of rofecoxib data at rheumatology meeting, new data on etoricoxib - panel discussion with Merck, FDA, researchers. Interesting comments.
                  http://www.theheart.org/viewArticle....maryKey=631501

                  Pfizer warns of Bextra risk in CABG patients, plans new study of Celebrex as cardioprotectant in OA patients - while one apparently may increase MI risk after CABG, the other is being tested to assess cardioprotection
                  http://www.theheart.org/viewArticle....maryKey=630662

                  And the beat goes on ... few studies of COX2s have gone beyond 18 months which was where Vioxx got in trouble. So who knows if effect is a class effect?
                  Growing old is mandantory, Growing up is optional.

                  Comment


                  • #24
                    Zoloft must sell a LOT more than Zyprexa - but the latter is much more expensive, isn't it?

                    Otherwise - how could Zyprexa be the best selling Psych drug?


                    [thinking about the increase in 'Bipolar'...thinking about Zyprexa...computing...chicken...egg...]
                    who by fire.

                    Comment


                    • #25
                      The bextra hubbub was concerning docs using it for post op pain in CABG patients (reduce risk of bleeding, but sticky platelets) . ..

                      try this link http://www.rheumatology.org/annual/p...on_annouce.asp
                      The FDA has not evaluated my safety or efficacy...

                      Comment


                      • #26
                        Originally posted by kid@heart
                        washingtonpost.com
                        A List of the Best-Selling Drugs in U.S.

                        4. Procrit, $3.3 billion, anemia, Johnson & Johnson

                        6. Epogen, $3.1 billion, anemia, Amgen Inc.
                        Whoa. Is there really that much pathological anemia?
                        Did-a-chick? Dum-a-chum? Dad-a-cham? Ded-a-check?

                        Comment


                        • #27
                          I suspect renal failure and chemo add a lot

                          Comment


                          • #28
                            "The $800 Million Dollar Pill" - I forget the author.

                            Has a great chapter on the development of Epogen, how it cost the company almost nothing since it was developed on gov. grants at a university, and how the price was deliberately set in the stratosphere "to generate money to support further bioengineered drug development," which hasn't panned out at all. Congress was "talked into" the high price - most is used in dialysis patients, which of course is totally gov. paid. And the # of pts on dialysis has skyrocketed.

                            Your tax dollars at work. The company originally set the price a lot lower.
                            Growing old is mandantory, Growing up is optional.

                            Comment


                            • #29
                              Originally posted by Kursk
                              I suspect renal failure and chemo add a lot
                              Not to mention Armstrong's six Tour de France victories!

                              BTW, Kursk, is that HAL you've got watching you/us?
                              ..........over
                              All said .............. a large GRAIN

                              Comment


                              • #30
                                Why yes Dave it is Hal. Would you like to play a game of chess? It is nice to be working with you again.

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