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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