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

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  • #46
    Originally posted by pprescot
    Me thinks Merck is in deep trouble...
    Hooo, boy...what a mess.
    The truth will set you free. But first, it will piss you off.--Gloria Steinem

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    • #47
      More trouble for Merck

      London, UK - An independent meta-analysis of clinical trial data with rofecoxib (Vioxx, Merck & Co) published by the Lancet online November 5, 2004 [1] shows that a doubling of the risk of MI with the drug could be seen by 2000, and the researchers suggest that the drug could and should have been withdrawn then4 years before it was taken off the market....

      Fatal or nonfatal myocardial infarction was the primary end point, and 64 events were found: 52 in the rofecoxib groups vs 12 in the control groups (combined relative risk 2.24, 95% CI 1.24-4.02), with little evidence of between-trial heterogeneity.

      Cumulative meta-analysis showed that an increased risk of MI became evident in 2000; at that point, 14 247 patients had been randomized and 44 events had occurred. At the end of 2000, with 52 MIs in 20 742 patients, the relative risk was 2.30 (95% CI 1.22-4.33, p=0.01). "The effect was both substantial and unlikely to be a chance finding," the authors write.
      Growing old is mandantory, Growing up is optional.

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      • #48
        What to do...

        'Pretty depressing news, PPrescot.

        I think it will take some doing for pharmaceutical companies and the FDA to win back the confidence of many of us. I am under the impression some of us remain confident in the checks and balances currently in place, and those proposed, such as making studies public on the Web.

        Personally, I would like to abandon these issues now and return to "business as usual". I think I could if I worked with adults, from whom I could gain informed consent, caution "let the buyer (prescribee) beware" and go home with a clear conscience. But caring for kids who are wards of the state, for whom truly informed consent is an elusive commodity, leaves me with an intractible superego that won't let me sleep over FDA fiascos and antidepressant mischief. I can't speak for you, pprescot, but wonder if kids are the reason you and I continue to express dismay over these issues even as the controversy wanes.

        'Not sure what to do about it. I read someplace (can't vouch for this but it sounds plausible) that Canada does not approve a number of US drugs (depo provera e.g.) because they consider the side effects more serious than does the US. Maybe listening to the views of other countries can give us a clearer view so we can sort things out.

        Then there are the studies. The other day I spoke to a doc who uses primrose oil for menstrual cramps in kids, rather than ibuprofen. She says primrose oil is a "natural prostaglandin inhibitor without the GI side effects of ibuprofen." It sounds good, but I don't know a thing about primrose oil...is it safe? Who will invest in studies of such "natural" approaches? If, say, leafy green vegetables compete successfully with statins and without side effects, who will tell the public? Who will advertise leafy green vegetables on TV?

        It seems I post more questions than answers these days...

        Ann
        The truth will set you free. But first, it will piss you off.--Gloria Steinem

        Comment


        • #49
          Originally posted by kid@heart
          The other day I spoke to a doc who uses primrose oil for menstrual cramps in kids, rather than ibuprofen. She says primrose oil is a "natural prostaglandin inhibitor without the GI side effects of ibuprofen."
          Evening Primrose Oil is a mixture of ALA (alpha-linolenic acid, an omega-3) and GLA (gamma-linolenic acid, an essential omega-6 fatty acid manufactured by the body from the essential fatty acid linoleic acid).

          GLA may be useful in diseases that involve inflammation. Appears to help in ~ 50% of women with cyclic myalgia, for example, and may help with other PMS symptoms.

          As you mentioned in another thread, the American diet is deficient in omega-3 FAs and contains too much omega-6 FAs. In this case it is the omega-6 GLA that appears to be antiinflammatory, and using EPO at least adds some omega-3 to the diet.

          About the only side effects are GI - stomach upset, diarrhea, although those with a seizure disorder or on blood thinners or hemophiliacs may have problems, and use should be stopped before surgery.

          EPO is a pretty good source of GLA with products varying from 45 to ~ 100 mg per capsule. Borage oil is even higher, generally > 200 mg. Dosage for cyclic mastalgia is 200-400 mg per day usually in 2 divided doses.

          And, as always with OTC supplements, you may or may not actually get what's on the label.
          Growing old is mandantory, Growing up is optional.

          Comment


          • #50
            Originally posted by pprescot
            Appears to help in ~ 50% of women with cyclic myalgia, for example, and may help with other PMS symptoms.

            Ooops! Should be "... cyclic mastalgia..." I need to learn to type - some day.
            Growing old is mandantory, Growing up is optional.

            Comment


            • #51
              Thanks, Pprescot!
              The truth will set you free. But first, it will piss you off.--Gloria Steinem

              Comment


              • #52
                Originally posted by airforcedoc
                PhArMa Scams
                1. Posicor
                2. Rezulin
                3. Rotavirus vaccine
                4. Baycol
                5. Duract
                6. Vioxx
                Dont forget Paxil for kids.

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                • #53
                  Going Generic + ES = "new and improved" (ahem... the FDA is useless)

                  Originally posted by airforcedoc
                  Here's a few:
                  1. Prozac Weekly to replace Prozac
                  2. Paxil CR to replace Paxil
                  3. Clarinex to replce Claritin
                  4. Augmentin XR to replace Augmentin
                  5. Glucophage XR to replce Glucophage
                  6. Avandamet to replace Glucophege and Avandia
                  7. Biaxin XL to replace Biaxin
                  8. Tri-Pak/Z-pak
                  9. Wellbutrin XL/Wellbutrin SR
                  10. Sarafem
                  11. Zyban

                  The latest scam....

                  http://www.healthfinder.gov/news/new...p?docID=518795

                  eszopliclone for zopiclone.

                  Do Single Stereoisomer Drugs Provide Value?
                  http://ti.ubc.ca/pages/letter45.htm

                  Summary: No.

                  Why does the FDA allow such lame products ?

                  Still Nexium free,

                  Comment


                  • #54
                    I thought the FDA had cracked down after lexapro/celexa and required testing of both stereoisomers...
                    The FDA has not evaluated my safety or efficacy...

                    Comment


                    • #55
                      FDA Misconduct

                      BMJ 2004;329:1255 (27 November), doi:10.1136/bmj.329.7477.1255-a

                      News

                      Public interest group accuses FDA of trying to discredit whistleblower

                      Jeanne Lenzer
                      New York

                      A public interest group that aims to protect whistleblowers claimed last week that an attempt had been made by a member of staff at the Food and Drug Administration to discredit Dr David Graham, the FDA executive who testified to the US Senate committee on 18 November.

                      Dr Graham, associate director in the FDA's Office of Drug Safety, had carried out a study with Kaiser Permanente of northern California that looked at the cardiovascular risks in patients taking rofecoxib (Vioxx). He had submitted the results of the study to the Lancet. Dr Graham withdrew the study, however, after getting a warning from his supervisor.

                      The FDA issued a statement after the Senate hearing last week, claiming that Dr Graham had failed to adhere to agency protocol when he submitted his data to the Lancet.

                      When the BMJ inquired about the FDA's statement and the possible publication of the rofecoxib study in the Lancet, Dr Graham referred the BMJ to his attorney, Tom Devine, for comment.

                      Mr Devine, legal director of the Government Accountability Project—a public interest group based in Washington, DC, that helps whistleblowers in order to promote governmental and corporate accountability—said Dr Graham, fearing for his job, had sought the group's help in connection with the rofecoxib study about a month ago.

                      The group's decision on whether to provide legal counsel for Dr Graham was delayed after it received another request for aid from someone claiming to be an anonymous whistleblower at the FDA who was being "bullied" by Dr Graham. The anonymous caller also said that Dr Graham's study could reflect scientific misconduct.

                      After some investigation the project found out that the "anonymous" charges actually came from FDA management, which, according to Mr Devine, had "full control" over Dr Graham.

                      "We made demands to call whichever side was bluffing," said Mr Devine. "The FDA flunked every test of credibility, while Dr Graham passed all of them. The FDA was employing a classic law of whistleblower reprisal—the smokescreen syndrome—which shifts the spotlight from the message to the messenger.

                      "The agency attempted to discredit Dr Graham rather than provide any scientific evidence contradicting his conclusions."

                      What can be done? What should be done?
                      The truth will set you free. But first, it will piss you off.--Gloria Steinem

                      Comment


                      • #56
                        Add "MER-29" to the list, above. What a tragedy that one was for patients and the fools at the FDA.

                        Comment


                        • #57
                          Not too surprised that whistle blowers are silenced. The political climate is now slanted toward Big Business. To quote TIME regarding prescription drug prices, "Instead of looking for ways to control U.S. prices, the Bush administration is now pressuring other countries to ease regulations so that their prices can rise to U.S. levels."
                          Growing old is mandantory, Growing up is optional.

                          Comment


                          • #58
                            Originally posted by pprescot
                            To quote TIME regarding prescription drug prices, "Instead of looking for ways to control U.S. prices, the Bush administration is now pressuring other countries to ease regulations so that their prices can rise to U.S. levels."
                            So here is yet another problem...

                            I raise concerns re: the whistleblower aspect of the FDA, as it jeopardizes any objectivity we can hope to garner as drugs are approved and disseminated.

                            And it threatens US credibility at home and abroad. The article I posted, for example, comes from the British Medical Journal, and not an American source.

                            These are among reasons I ask what, if anything, can be done.

                            In a recent Senate hearing in which the CEO of Merck testified I understand recommendations were made that the FDA Drug Approval and Drug Safety sections be separated, and an independent entity oversee the drug approval section.

                            For me this raises the question: Have similar models been applied to other government agencies branches of government, and shown effective?
                            The truth will set you free. But first, it will piss you off.--Gloria Steinem

                            Comment


                            • #59
                              "Kill as few patients as possible" said a famous internet primary care provider.

                              http://www.hc-sc.gc.ca/hpfb-dgpsa/tp...ra2_hpc_e.html

                              December 10, 2004

                              Subject: BEXTRA* (valdecoxib) tablets
                              - Cardiovascular Risks and Serious Skin Reactions

                              Serious Skin Reactions

                              Serious skin reactions (e.g. Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, and Erythema Multiforme) have been reported in patients using BEXTRA. Some of these cases have resulted in death.

                              cardiovascular/thromboembolic events

                              CONTRAINDICATIONS:

                              BEXTRA has NOT been approved for use in any peri- and/or post-operative setting and should not be used for any unauthorized indication.
                              BEXTRA is CONTRAINDICATED for the treatment of pain post-coronary artery bypass surgery (CABG), as the use of BEXTRA in such patients in this setting has led to an increased incidence of cardiovascular/thromboembolic events, deep surgical infections or sternal wound complications.

                              COX2s are dying. Or at least patients are.
                              "Kill as few patients as possible" is the first thing I can think of.

                              Comment


                              • #60
                                Now this. What's a rheumatologist to do.

                                http://money.cnn.com/2004/12/17/news...ex.htm?cnn=yes
                                The FDA has not evaluated my safety or efficacy...

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