1-1banner
 
medpundit
 

 
Commentary on medical news by a practicing physician.
 

 
Google
  • Epocrates MedSearch Drug Lookup




  • MASTER BLOGS





    "When many cures are offered for a disease, it means the disease is not curable" -Anton Chekhov




    ''Once you tell people there's a cure for something, the more likely they are to pressure doctors to prescribe it.''
    -Robert Ehrlich, drug advertising executive.




    "Opinions are like sphincters, everyone has one." - Chris Rangel



    email: medpundit-at-ameritech.net

    or if that doesn't work try:

    medpundit-at-en.com



    Medpundit RSS


    Quirky Museums and Fun Stuff


    Who is medpundit?


    Tech Central Station Columns



    Book Reviews:
    Read the Review

    Read the Review

    Read the Review

    More Reviews

    Second Hand Book Reviews

    Review


    Medical Blogs

    rangelMD

    DB's Medical Rants

    Family Medicine Notes

    Grunt Doc

    richard[WINTERS]

    code:theWebSocket

    Psychscape

    Code Blog: Tales of a Nurse

    Feet First

    Tales of Hoffman

    The Eyes Have It

    medmusings

    SOAP Notes

    Obels

    Cut-to -Cure

    Black Triangle

    CodeBlueBlog

    Medlogs

    Kevin, M.D

    The Lingual Nerve

    Galen's Log

    EchoJournal

    Shrinkette

    Doctor Mental

    Blogborygmi

    JournalClub

    Finestkind Clinic and Fish Market

    The Examining Room of Dr. Charles

    Chronicles of a Medical Mad House

    .PARALLEL UNIVERSES.

    SoundPractice

    Medgadget
    Health Facts and Fears

    Health Policy Blogs

    The Health Care Blog

    HealthLawProf Blog

    Facts & Fears

    Personal Favorites

    The Glittering Eye

    Day by Day

    BioEdge

    The Business Word Inc.

    Point of Law

    In the Pipeline

    Cronaca

    Tim Blair

    Jane Galt

    The Truth Laid Bear

    Jim Miller

    No Watermelons Allowed

    Winds of Change

    Science Blog

    A Chequer-Board of Night and Days

    Arts & Letters Daily

    Tech Central Station

    Blogcritics

    Overlawyered.com

    Quackwatch

    Junkscience

    The Skeptic's Dictionary



    Recommended Reading

    The Doctor Stories by William Carlos Williams


    Pox Americana: The Great Smallpox Epidemic of 1775-82 by Elizabeth Fenn


    Intoxicated by My Illness by Anatole Broyard


    Raising the Dead by Richard Selzer


    Autobiography of a Face by Lucy Grealy


    The Man Who Mistook His Wife for a Hat by Oliver Sacks


    The Sea and Poison by Shusaku Endo


    A Midwife's Tale by Laurel Thatcher Ulrich




    MEDICAL LINKS

    familydoctor.org

    American Academy of Pediatrics

    General Health Info

    Travel Advice from the CDC

    NIH Medical Library Info

     



    button

    Sunday, December 11, 2005

    Much Ado: The New England Journal of Medicine sprung a surprise on Merck, maker of Vioxx and defendant in many lawsuits over it, at the end of the week. The Journal published an "Expression of Concern" over the way data was submitted/not submitted when this paper was accepted for publication. The journal editors say they had to go over all of the original submission data when they were depositioned by lawyers for the plaintiff in the latest and most current Vioxx trial. In that data, they found a disk they hadn't looked at before, which included editing changes to a table that included the number of heart attacks suffered by Vioxx users compared to Naprosyn users. Three heart attacks among Vioxx users had been edited out of the table.

    Merck says they weren't included because they occured after the cut-off period for follow-up of the trial. The editor of The New England Journal told Forbes "We're not buying into that".

    But, in the original article, published five years ago, the authors acknowledge exactly that:

    When the data showing a reduction in the rate of myocardial infarction in the naproxen group became available after the completion of this trial, Merck, the manufacturer of rofecoxib, notified all investigators in ongoing studies of a change in the exclusion criteria to allow patients to use low-dose aspirin.

    Those words are from the original article, written five years ago, before the Vioxx trials, before the deposition, before the New England Journal's suprise late-week editorial. It appears, in this case, that Merck and its researchers are telling the truth.

    The table in question never appeared in the original study. The study itself was concerned entirely with the rate of gastrointestinal bleeding in people who used Vioxx for rheumatoid arthritis, in doses higher than normal. The information about heart attacks is one small paragraph, almost an aside, and as I mentioned, it not only points out that there were more heart attacks after the trials completion, but that Vioxx users had more heart attacks even during the study's run. And, as Derek Lowe points out, three missing heart attacks don't appreciably change the risk.

    One of Derek's commentors says that the missing data only changes things for the "innumerate." He's right. Unfortunately, we physicians are largely innumerate - even those of us who hold editorial positions at influential medical journals.
     

    posted by Sydney on 12/11/2005 12:08:00 PM 2 comments

    2 Comments:

    Don't you think that the NEJM is just "covering its behind" to prevent it from being drawn into the spree of lawsuits should Merck declare bankruptcy? The lawyers are looking for all possible "deep pockets" including the Massachusetts Medical Society and the NEJM. This is just basic risk management.

    By Anonymous Anonymous, at 5:58 PM  

    Yes, I suspect you may be right. They certainly seem to have been scared witless by their deposition. And wouldn't it be likely a plaintiff's lawyer would insinuate that they, too, might be culpable?

    By Blogger Sydney, at 10:30 PM  

    Post a Comment

    This page is powered by Blogger, the easy way to update your web site.

    Main Page

    Ads

    Home   |   Archives

    Copyright 2006