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

    Wednesday, June 15, 2005

    Race Based Medicine: The FDA is considering approval for a drug designed solely for African-Americans with heart failure. Or, more accurately, a drug marketed solely for African-Americans. The drug is BiDil, a combination of isosorbide and hydralzaine, both of which are already available as cheap generics - albeit as separate pills.

    The basis of the drug's claim to improve survival in African-Americans with congestive heart failure is this study from last year. It's important to note what the study did not show. It did not show that the benefits of this therapy was limited to African-Americans. Everyone in the study, whether they took placebo or the drug, was African-American. For all anyone knows it could work equally well in Asians or Caucasians or Hispanics.
    Even worse, the study was designed to give an inherent advantage to the treatment group over the placebo group, which was, on average, six years older. That might not seem like much of an age difference, but in someone with heart disease, the difference between 59 and 65 can make a world of difference in both survival and quality of life; a point underlined by the fact that more of the placebo group had Class IV heart disease (meaning their symptoms were worse to begin with.) [Note: I am becoming dyslexic. The subjects were controlled for age, but the point about the sicker heart failure categories still holds)

    There are other reasons to be suspicious of the study and its findings, as this editorial from the New England Journal pointed out:

    NitroMed's race-specific strategy promises another large business benefit. Two years ago, NitroMed obtained a second patent, this one based on the use of the formulation in blacks. This patent, the first ever granted to a preexisting drug for a new, race-specific use, pushes back potential market entry by generic sellers of the fixed-dose combination from 2007 to 2020. Less than a month later, NitroMed went public, raising $66 million (even though isosorbide dinitrate and hydralazine are available separately in generic formulations, making it possible to closely approximate NitroMed's combination at a cost of about 44 cents per dose).

    Thus, the emergence of the combination treatment as a race-specific drug was driven in large measure by regulatory and market incentives. It remains unknown whether these two drugs in combination with an ACE inhibitor improve survival among patients with heart failure in general (or among patients in other racial groups) beyond the improvement achieved by ACE inhibition alone. But a treatment for all patients with heart failure, regardless of race, could not have extended NitroMed's intellectual property protection by 13 years.


    Take the new medication with a large grain of salt. And if you absolutely must try it, why not use the generic alternatives? It isn't that much harder to take two pills instead of one.
     

    posted by Sydney on 6/15/2005 08:45:00 AM 0 comments

    0 Comments:

    Post a Comment

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

    Main Page

    Ads

    Home   |   Archives

    Copyright 2006