Covering the drug industry

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Covering the drug industry

• It is big business..

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Covering the drug industry

• .but dont forget the people

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Vanessa
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Martha
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Jamie
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L.C.
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Wilma
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THE PLAYERS

• Drug companies
• Regulatory authorities
• Doctors
• Patient groups
• Lobbyists
• Insurance companies
• Media outlets
• Politicians

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The 2007 Fortune 500
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The 2008 Fortune 500
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They spend money

• 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.

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Johnson Johnsons 10-Q
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Johnson Johnsons 10-Q
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Johnson Johnsons 10-Q
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Johnson Johnsons 10-Q
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FDA warning letters
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The adverse drug reactions
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DATA SOURCES
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THE VIOXX RECALL A VALUABLE LESSON

• 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

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THE IMPOSSIBLE LANGUAGE OF DEAR DOCTOR LETTERS

• 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.

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WHATS AT STAKE PUBLIC HEALTH

• 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.

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Whats at stake? Money

• 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

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Listservs and whistleblowers
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Listservs and whistleblowers
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Court documents
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Court documents
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DONT TAKE THE CLAIMS AT FACE VALUE

• Just because the company sells its product as a
  miracle cure, doesnt 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.

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DONT TAKE THE CLAIMS AT FACE VALUE

• 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.

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WATCH OUT FOR THE PEDDLERS

• If a doctor is singing the drugs 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.

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BACKGROUND THE COMPANY

• 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?
• Whats the buzz on listservs and discussion
  groups?

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Sources for journalists

• 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

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THE MORAL OF THE STORY

• Dont 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.

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THE MORAL OF THE STORY

• If the drug sounds too good to be true it
  probably is

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My syllabus

• 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.