Covering the drug industry by qoe36584

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									It is big business…..
   ….but don’t forget the people
   Drug companies
   Regulatory authorities
   Doctors
   Patient groups
   Lobbyists
   Insurance companies
   Media outlets
   Politicians
   They create lots of jobs and spend money on
    research and development. What is the
    breakdown of their expenses?
   To figure this out, you have to read what they
    tell investors.
   The largest meltdown in pharmaceutical
    history
   A story of death, suffering, greed, misplaced
    faith and misrepresentation
   The entrails of the controversy provide clues
    for journalists looking for ways to improve
    their coverage of the pharmaceutical industry
   Several months after the Health Canada
    advisory committee meeting, a substandard
    warning goes out to doctors that is only aimed
    at people at high risk for heart disease. This,
    despite the fact that the clinical trial that
    sounded the alarm – the VIGOR study –
    excluded people at high risk of heart attack.
   Dear doctor letters are also problematic
    because companies routinely bury the lead.
    This came to light during the coroner jury
    investigation into the death of Vanessa Young.
   With Vioxx, there was a trade off: lesson your
    risk of stomach bleeding, increase your risk of
    heart attack.
   The risk of heart attack may have been small in
    relative terms, but the given the number of
    people taking the drug, and given their profile,
    you had what FDA whistleblower David
    Graham called a public health disaster.
   I know there was tremendous pressure on the
    FDA … to approve these drugs without
    delay… Merck was spending $16 million per
    month advertising Vioxx… An absolutely
    massive campaign and the same is true for
    Celebrex.
                       -- John Wallace, member of the FDA
                             committee that approved Vioxx
   Just because the company sells its product as a
    miracle cure, doesn’t mean it is so.
   There are very few miracles and it has been a
    number of years since any company has
    produced a blockbuster drug.
   Check with the regulatory authorities such as
    the Food and Drug Administration
   Check the concerns expressed during the
    approval process against claims being made by
    the company publicly.
   Read medical journals.
   Identify researchers who are critical of the drug
    industry and the drug regulation scheme.
   Look for databases that track events such as
    adverse drug reactions and drug approvals.
   Read what the companies say about
    themselves.
   Pay attention to court documents because.
    pharmaceutical companies are very litigious.
   Talk to former regulators.
   If a doctor is singing the drug’s praises, ask
    about his connection to the company or the
    drug.
   If the drug is being peddled as a new
    breakthrough, find out if it has ever been
    marketed for a different purpose.
   If the drug is being hailed as a breakthrough,
    find out if government agencies are willing to
    list the drug and therefore pay for it.
   Has the company ever had any run-ins with
    the regulatory authorities for sins such as false
    advertising?
   Is the company being sued?
   What has been written about the company in
    other media outlets, especially any
    investigative pieces that may have been done?
   How much does it spend on marketing
    compared to research and development?
   What’s the buzz on listservs and discussion
    groups?
   Adverse reaction databases
   Warning letters
   Coroner investigations
   Internal regulatory authority reports
   Minutes or summaries of advisory committee meetings
   Medical journals
   Clinical trial information
   Doctors
   Researchers
   Victims/advocates
   The companies themselves: websites, public
    appearances, financial statements
   Don’t forget the people who take these drugs.
   Be vigilant and use experts to help decipher the
    jargon.
   Develop contacts in different countries.
   Find out what insurance companies are willing
    to pay for.
If the drug sounds too good to be true:
             it probably is
   http://http-server.carleton.ca/~dmckie/
   To obtain the PowerPoint presentation, please
    go to the link entitled IRE Miami
   You should save it to your desktop before
    opening the file.

								
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