Safety first

You’ve heard me say before how the over-prescribing (and mis-prescribing) of pharmaceutical medications is a leading cause of death in the United States. Well, it seems things are worse off than anyone could have imagined–at least if our neighbors to the North are any indication.

According to a new study out of Canada, serious safety issues were found in 25% of all newly approved drugs between 1995 and 2010.

Researchers looked at 434 new drugs approved in Canada between January 1, 1995, and December 31, 2010. Approximately three quarters (74.4%) underwent standard review and one quarter (25.6%) underwent priority review. (The US Food and Drug Administration has a process similar to Canada’s “priority-review,” known as an “Expedited Drug Development Pathway.”)

Overall, 23.7% of the drugs approved during the 15-year span had a post-approval safety issue. Drugs that underwent standard review accounted for 20% of the serious safety issues. But a whopping 34.2% of the products that underwent priority review ended up having serious safety concerns.

Certain drugs are given priority review because pharmaceutical companies convince the regulatory agencies that they may have potential for important clinical problems. But this study shows that rushing the approval process may cause more harm than good.

Monitoring drug safety is a major public health issue. The regulators in Canada and those at the FDA (whose track record is just as dismal as the one uncovered in this new Canadian study) are making scientific judgment calls that may affect the health of hundreds of thousands of patients within months after a drug launch. So isn’t it time we required them to start taking their job just a bit more seriously?

In any other industry, there would be a massive public outcry if 25% of what your company produced turned out to be seriously defective. Especially if those defects could potentially kill people. Yet, most Americans are content to sit idly by while these jokers have the last laugh in their corporate jets and beach houses.

When is this all going to end?

Luckily, you’ve come to the right place. Stick with my New Hamptons Health Miracle, and the detailed advice I offer in my monthly Logical Health Alternatives newsletter. It’s the best way to make sure you never become a guinea pig for Big Pharma–or a victim of the FDA’s shoddy drug approval process.

“Omega-3 fatty acids, oxidative stress, and leukocyte telomere length: A randomized controlled trial,” Brain, Behavior, and Immunity 2012; epub ahead of print 9/23