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

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

    I really think that Pharma's business practices need to be looked at ASAP. This wave of drugs being launched with great buzz and fanfare only to be pulled out several years later, with suspicious timing (i.e. either just when the balance of profit vs. lawsuits generated losses starts tipping and/or, even more egregiously, just before a drug is just about to go generic) is, IMHO, so...BLATANT.

    Can someone give me a couple of examples of REALLY USEFUL and SAFE "revolutionary" new drugs launched within the last 20 years that we can really thank Pharma for? That you feel have really IMPROVED patients' quality of life, and morbidity.

    OK, I know, personally I am grateful that my patients have access to Risperdal, for example, as an alternative to Haldol, or, worse, to the old Thorazine. Or that I have Remeron and Effexor at hand rather than TCA's. And some of the new anti-HIV drugs have helped patients keep the infection at bay far longer and better than one could have imagined 20 yrs. ago. I want to hear other people bring up drugs that they really find helpful and safe. And please, don't say Viagra! I'm just trying to find some redemptive value in the Pharma R&D here, before I give up and convert to Scientology, or worse!

    I saw this article from 2000 http://www.mercola.com/2000/jun/24/p...l_industry.htm

  • #2
    Now lets not get crazy.
    The differences in events were not apparent until after 18 months of use. I think that the coxibs have been helpful in toto.

    That said, the prilosec-nexium; celexa-lexapro; oflox-levoquin slight of hand is pure profitering.

    As health care companies, ethics should rule the roost: make a profit IF you are helping. Primum non nocere should apply to them as well.

    I guess we'll just keep trudging along, choosing the best statistical risk/benefit ratios for our patients.
    The FDA has not evaluated my safety or efficacy...

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    • #3
      Originally posted by Scroggie
      As health care companies, ethics should rule the roost: make a profit IF you are helping. Primum non nocere should apply to them as well.
      That's the whole point. I fear that this principle is not really taken into consideration by the Pharma companies. Corporations do not take "oaths". They are just in the business of making profits.

      Comment


      • #4
        >>> They are just in the business of making profits.

        That's not totally bad... seems like us docs now are in a business to NOT make any profits, or work ourselves to death just to make a meager living. At least the pharmaceutical industry knows how to survive and have been able to hold off the Medicare/HMO/PPO industry enough to reap some rewards! Cudos to them...

        Al

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        • #5
          Originally posted by Anon_3b215c
          I really think that Pharma's business practices need to be looked at ASAP. This wave of drugs being launched with great buzz and fanfare only to be pulled out several years later...
          Ummm...might this call the FDA's practices into question?

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

          Comment


          • #6
            Its also important to remember that small differences take a long time to become statistically and clinically apparent.
            From what i've been able to gleen, this was a 2600 person study with 7 placebo events and 15 vioxx events, statistically signficant only after 18 months.
            No data that I could find on ASA use (allowed in the trial) or other CVD. Must not have been signficant or they would've tried to squirm out of it.
            If anything, it shows that the system does work *when* problems are found.
            The FDA has not evaluated my safety or efficacy...

            Comment


            • #7
              Vioxx was released in 1999. One year later the FDAs post-marketing surveillance team issued a long paper re: possible cardiac events/MIs with Vioxx. So why did it take 4 years to get more info?
              Growing old is mandantory, Growing up is optional.

              Comment


              • #8
                The first paper was a flawed metaanalysis that compared patients with rheumatoid arthritis (known CAD risk) versus healthy physicians. A second metananlysis showed a much smaller risk, and seemed to show a slight cardioprotective advantage for naproxn (the comparator). Remember these are real small differences in large studies I'll attach an analysis I did of the earlier data.
                Attached Files
                The FDA has not evaluated my safety or efficacy...

                Comment


                • #9
                  Noteworthy Pharmaceutical Achievements

                  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

                  Comment


                  • #10
                    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
                    Air-f-doc, aren't some of these are simply efforts by pharmaceuticals to get round expiring patents?
                    Bigdoc

                    Comment


                    • #11
                      I think airforcedoc's response was with tongue held firmly in cheek. However, I am a fan of Diflucan IV over the old amphoterrible, and I think the quinolones once had a nice niche before they became so overprescribed.

                      Comment


                      • #12
                        Noteworthy Withdrawls

                        Here's a few that I seem to remember:
                        1. Posicor
                        2. Rezulin
                        3. Rotavirus vaccine
                        4. Baycol
                        5. Duract
                        6. Vioxx

                        The lawyers are already casting their nets.
                        Here's a website I found:
                        http://www.vioxx-side-effects.com/

                        I once had heard someone say that all drugs should only cost 5 dollars a month like they do in New Zealand. I bet that is the reason why you don't see many new drugs being developed in New Zealand. People want drug companies to keep doing research and developing new drugs but then they don't want to pay more than a nominal amount for the cost of the drugs. I think that people need to understand that if pharmaceutical companies can't make a fair profit on drug research and development, then the research and development efforts of these companies will likely decrease. There's no free lunch.

                        Comment


                        • #13
                          Add to the list Zomax and Propulsid

                          Comment


                          • #14
                            Questioning FDA Practices

                            September 24, 2004 Washington Post (Page A08):

                            FDA Told Its Analyst to Censor Data on Antidepressants
                            By Shankar Vedantam

                            "A Food and Drug Administration medical officer was told by top agency officials to delete material on the risks of antidepressant drugs from records he was submitting to Congress and then to conceal the deletions, according to documents released yesterday at a hearing on Capitol Hill.

                            A bipartisan House panel said the FDA also repeatedly prevented Andrew D. Mosholder from disclosing his conclusions that the medications increase the risk of suicidal thoughts and behavior among children, potentially delaying the issuance of a public warning. During the day-long hearing, legislators repeatedly accused the agency of obfuscating the risks, slowing action and subjecting Mosholder to harassment…

                            …After revelations that Mosholder was asked not to present his findings at a public forum in February led to an outcry, the agency's internal investigative arm told Mosholder he might be subject to disciplinary action, the documents showed...”

                            July 21, 2004 Washington Post
                            “A high-profile congressional hearing into the safety of antidepressant medicines was abruptly canceled Sunday afternoon by a House committee whose chairman is weighing a top job at a trade group representing the biotech and pharmaceutical industries…James Greenwood (R-Pa.) is said to be considering the presidency of the Biotechnology Industry Organization…”

                            September 16, 2004, www.fda.gov:
                            “FDA Statement on Recommendations of the Psychopharmacologic Drugs and Pediatric Advisory Committees

                            The Food and Drug Administration (FDA) generally supports the recommendations that were recently made to the agency by the Psychopharmacologic Drugs and Pediatric Advisory Committees regarding reports of an increased risk of suicidality (suicidal thoughts and actions) associated with the use of certain antidepressants in pediatric patients. FDA has begun working expeditiously to adopt new labeling to enhance the warnings associated with the use of antidepressants and to bolster the information provided to patients when these drugs are dispensed.
                            In summary, the members of the advisory committees: …

                            • …reached a split decision (15-yes, 8-no) regarding recommending a "black-box" warning related to an increased risk for suicidality in pediatric patients for all antidepressant drugs;
                            • endorsed a patient information sheet ("Medication Guide") for this class of drugs to be provided to the patient or their caregiver with every prescription…” Source http://www.fda.gov/bbs/topics/news/2004/NEW01116.html

                            Things that make you say "hmmmmm..."
                            The truth will set you free. But first, it will piss you off.--Gloria Steinem

                            Comment


                            • #15
                              And the beat goes on ...

                              "What's good for General Motors id good for the country."

                              And Eisenhower only warned us about the military-industrial complex.
                              Growing old is mandantory, Growing up is optional.

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