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

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  • Guest's Avatar
    Guest started a topic Re. Merck pulls Vioxx citing risk of stroke, heart attack

    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

  • byke32
    replied
    http://www.nytimes.com/2005/02/25/politics/25fda.html

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  • Guest's Avatar
    Guest replied
    NO medicine is 100% safe -- all work by poisoning some aspect of physiology.

    It's a question of taking the good with the bad. ASA wouldn't pass current scrutiny, but it's here. Cox-2's have a role. But let's be honest about it with ourselves and our patients. Save them for pain patients who don't get relief with other agents.

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  • byke32
    replied
    http://www.reuters.com/newsArticle.j...toryID=7678828
    a sad day for the FDA...but a good day for Merck and lawyers.

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  • kid@heart
    replied
    EMRhelp quotes Dr. Richard Horton, editor of The Lancet, as saying:

    "The compromised integrity of medicine's knowledge base should be a serious concern to politicians and public alike. It is surprising and disappointing that this danger does not seem a serious priority within medicine itself."

    This is a wonderful quote, EMRhelp--thank you. That Dr. Horton presents this in his evidence to a meeting of Parliament tells us the issues raised are not only US issues, but part of a imultinational struggle to balance public health and safety with free enterprise.

    These companies have incredible wealth, and power to match. The wealth alone is greater than most governments have at their disposal. Bill Gates has more money than the Queen of England, yet his fortune is about 1/10th of that held by the pharmaceutical industry. In the US, the Food and Drug Administration oversees industries representing about 1/4 of the US gross national product!

    When industries are wealthier than governments, finding and reaching a balancepoint that provides adequate profits for companies and benefits the public simultaneously is challenging, to say the least.

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  • Guest's Avatar
    Guest replied
    EBM doesnt matter when their is no E

    wow kid@heart, great article.

    Here is a Snippet from Dr Richard Horton, editor of The Lancet.

    Q517 Chairman: Thank you very much. Can I begin by asking Dr Horton a question arising from your evidence - and we are grateful for the evidence which was interesting evidence - where you concluded, if I can quote from your last paragraph: "Modern medicine needs a dynamic, innovative, and robust pharmaceutical industry. But it is also the case that the for-profit motive of the pharmaceutical sector clashes with the public health values of NHS clinical care and independent scientific research." You go on to say: "The compromised integrity of medicine's knowledge base should be a serious concern to politicians and public alike. It is surprising and disappointing that this danger does not seem a serious priority within medicine itself."

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  • kid@heart
    replied
    Counterpoint to my previous post:

    You may read a rebuttal from the Association of the British Pharmaceutical Industry to testimony heard by the UK parliament (document dated 1/13/05) at:

    http://www.abpi.org.uk/information/i..._positions.asp

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  • kid@heart
    replied
    Lancet Editor Richard Horton Testifies

    Originally posted by bioisnonsense
    Well, he was, so it turned out, completely delerious.

    Still...the nerve!!!

    Those uppity delirium patients...sheesh.

    By the way, I managed to get a complete transcript of a meeting in the UK last month. Dr. Richard Horton, editor of the Lancet, testified to Parliament regarding the journal's experiences with pharmaceutical companies.

    He mentions ghostwriting by pharmaceutical companies; lucrative offers to purchase reprints of published articles that translate to millions in additional revenues to journals as a way of promoting paper acceptance; journal publishing employed as the marketing arm of pharmaceutical companies; and more.

    Its a long one, so you may wish to skim. You can find the UNCORRECTED TRANSCRIPT OF ORAL EVIDENCE at:

    http://www.publications.parliament.u...iii/uc4202.htm

    At this meeting Dr. Horton testifies:

    “…We are a member of the International Committee for Medical Journal Editors which has a very detailed list of guidelines about the way research should be reported which we can appeal to. The Committee on Publication Ethics, which is a UK Committee, does exactly the same. It is a forum which has a list of guidance about the reporting of research and it is also a place where we can take difficulties that we have encountered as editors and place that before colleagues to work out a way forward...”

    I wonder, does the US have such a committee?

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  • bioisnonsense
    replied
    Originally posted by kid@heart

    Could these be our next "vioxx"s?
    Yesterday I went in to see a patient in the general hospital. After I introduced myself, he asked: Do you work for Pfizer?



    He then asked me who I was going to sue. Well, he was, so it turned out, completely delerious.

    Still...the nerve!!!

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  • kid@heart
    replied
    "In response to questioning, [associate director in the FDA's Office of Drug Safety] Dr Graham indicated that five other drugs currently on the market may be endangering patients, including another cyclo-oxygenase-2 inhibitor, valdecoxib (Bextra; made by Pfizer), the weight loss drug sibutramine (sold as Reductil in Britain and Meridia in the United States), the lipid lowering drug rosuvastatin (Crestor; made by AstraZeneca), the acne drug isotretinoin (Roaccutane; Roche), and the asthma drug salmeterol (Serevent; A&H)."

    BMJ 2004;329:1253 (27 November), doi:10.1136/bmj.329.7477.1253

    Could these be our next "vioxx"s?

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  • mel
    replied
    Originally posted by EMRhelp.org
    Hilarious!!!

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  • Guest's Avatar
    Guest replied
    http://nofreelunch.org/

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  • Guest's Avatar
    Guest replied
    NSAID wrap up

    Studies show that COX2s are not safer in terms of the most important marker: Total Serious Adverse Events. Within 6 months launch of Celecoxib it was obvious that they caused GI bleeds as well.

    Mass Marketing and selective publishing of Pharma designed and run studies made patients and doctors alike believe COX2 inhibitors are better than prvevious NSAIDS.

    A really smart group - BANDOLIER - summed it up for me. The most important clinical question is not switching high risk of GI problem patients from non-selective COX2s to COX2s but to realize a high risk GI bleed patient is always a high risk patient.

    Selective COX-2 inhibitors: Are they safer NSAIDs?
    http://ti.ubc.ca/pages/letter39.htm
    - this is an excellent article that people should have read 3 years ago.

    Is there any relationship between COX2 selectiveness and GI toxicity ?
    http://ti.ubc.ca/images/39.GIF (NO).

    Are Coxibs better than other NSAIDS in the treatment of OA and RA?
    http://homepages.trevecca.edu/pa2b/Master's%20Projects/Group%203/Walker-%20.ppt

    Cox-2 roundup from the Bandolier folks (one of the best online journals)
    http://www.jr2.ox.ac.uk/bandolier/band75/b75-2.html

    NSAIDS and adverse events
    http://www.jr2.ox.ac.uk/bandolier/bo...nsae/nsae.html

    What's the bottom line? (regarding NSAIDs)
    This focus has been on some of the bad things that can happen with oral NSAIDs. It is worth remembering that NSAIDs are excellent analgesics and anti-inflammatories, and bring huge benefits to many people who need them. But the gastrointestinal consequences of long-term NSAID use are not negligible. A US study [17] puts the human impact of NSAID-related gastrointestinal deaths into perspective: the rate is higher than that found from cervical cancer, asthma or malignant melanoma.

    My oh My I hope I dont get my father's rheumatoid arthritis.

    Not to muddy the waters but Acetaminophen (aka Tylenol, Paracetamol) may also impair renal function.
    - http://diabetes.about.com/od/newswir...minophen04.htm
    I remember it hit the airwaves in the Summer. I dont know how to integrate this into clincial practice.

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  • Phillip
    replied
    As of today, adios Celebrex (and Bextra).

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  • kid@heart
    replied
    A Vote of (Un)Confidence

    Bulletin brought to you by Cassandra, Prophetess of Doom (aka C-POD):

    December 17, 2004

    Oversight Is Lacking, F.D.A. Scientists Say

    By THE ASSOCIATED PRESS

    ASHINGTON, Dec. 16 (AP) - About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency's monitoring of the safety of prescription drugs now being sold, according to an internal survey.

    Also, more than one-third of those scientists have some doubts about the process for approving new drugs, the survey found.

    Complete results of the survey, conducted by the Health and Human Services Office of Inspector General, were released only after an advocacy group filed a Freedom of Information Act request. The release comes in the wake of safety concerns forcing removal from the market of Vioxx, an arthritis drug, and Congressional testimony by an agency scientist that the F.D.A. mishandled safety concerns about other drugs.

    The survey sought the opinions of about 400 agency scientists about the process of evaluating and approving prescription drugs. A majority said they were "completely confident" or "mostly confident" about decisions concerning the safety and efficacy of drugs approved for sale. But 31 percent were only "somewhat confident" and 5 percent had no confidence in the safety decisions.

    About 66 percent of those surveyed said they were not at all confident or somewhat confident that the F.D.A. adequately monitors the safety of drugs once they are on the market.

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