Prescription Drug Safety – Blog by Chris E

WSIC hosted a compelling evening of talk last Monday, welcoming special guest, and Conservative MP, Terence Young.

Terence spoke to us about prescription drug safety, a subject that hit him far too close to home. In 2000, Terence´s 15-year-old daughter, Vanessa, died after being prescribed the Johnson & Johnson drug, Prepulsid. Since then, he has researched the industry in-depth, and advocated for both a more transparent drug-approval process and plain-language labeling. As he explained to us, the Americans have far clearer labels than us, because they´re more willing to sue.

A seasoned public speaker, Terence told his story quickly. But the audience encouraged him to keep going. Soon the discussion turned to the `legalese´ found on drug labels. He warned us to watch for terms like “narrow therapeutic index,” “potential association with behavior changes including self-harm,” and other euphemisms that obscure the real danger of these drugs. Blunter language, like “this drug can lead to suicidal impulses would allow users to better weigh their risks.

Terence noted that while a mere 27 drugs have been taken off Canadian shelves since 1997, this is no indication that our drug approval process is a good one. Most of those drugs are taken off the market `voluntarily´ by the drug companies themselves.  Terence explains that many countries lack sufficient budgets to run their own approval process and depends on the FDA for safety information.  Voluntary market withdraw prevents the drug from being stricken off `approved´ lists from abroad.  With no Independent Drug Agency (IDA) in this country, Health Canada is called upon to police itself, potentially critiquing its own approval of drugs-a conflict of interest Terence suggests would not be allowed in other industries. An IDA, if developed, would not be responsible for approving new drugs-but it would be an independent body supervising Health Canada´s decisions.

There was a lot of audience response, as usual with these events. Terence contended that partial results received in drug trials should be published right alongside the most positive results (negating the appearance of a flawless drug); researchers in the audience argued that sometimes, a non-result is just that. It remains unpublished because it has no scientific merit. Dr. Paul Sandor, of CAMH, pointed out that drugs are often held back because their safety cannot be proven.

Terence also expressed concern over the pharmaceutical industry´s enormous expenditures on marketing, its willingness to `repurpose´ less-effective drugs to capitalize on their side effects (e.g. Viagara), and its sponsorship of medical journals. All food for thought, and the discussion could have lasted much later into the night, had we the time.

Terence Young is the founder and Chair of Drug Safety Canada, a research and public advocacy organization based in Oakville. He is author of Death by Prescription. []

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