Bextra and Procurement – Be Very Afraid

You have a choice: eat Nutrient Rich and greatly increase your chances for a healthy life, or eat the standard American diet and take drugs to combat the results. Aside from the obvious difference between prevention and treatment, there’s another problem with drugs that is making the news more and more: nasty side effects.

Today the FDA told Pfizer to take its painkiller Bextra off the market because of dangerous side effects. They’re leaving other so-called cox-2 inhibitors on the market for now, despite similar side effects. And, it turns out, OTC (over the counter) drugs like ipubrofen (Advil) and naproxen (Aleve). A page on the FDA website lists the drugs you should be worried about on this account.

How could this happen, you ask? Doesn’t the FDA have to approve drugs before they can be offered to the public? Don’t the drug companies test their own drugs for safety?

Yes, and…

The drug companies themselves don’t do most of the testing of their drugs. They outsource the function to Clinical Research Organizations (CROs). The CROs find the patients, run the clinical trials, and report on the risks and benefits of the drugs in various populations. On the basis of these studies, drugs are approved or not by the FDA.

Drug companies make a lot of money by getting their drugs to market as quickly as possible. If they patent a drug and it takes five years of testing to get that drug to market, they’ve lost five years of whopping, competition-free profits. So naturally they push to complete these studies as quicly as possible.

The CROs are pushed for speed, and to keep the study costs down. This double pressure sometimes means that the longer-term safety reviews are done sloppily or not at all.

The pharmaceutical industry, in general, views hiring CROs like you might purchase toilet paper – what’s the cheapest brand that won’t chafe my butt? Their outsourcing model is not strategic; rather, it’s called “procurement.”

A procurement model is a recipe for the kinds of tragedies we’ve seen when unsafe drugs make their way to market on a turbo-charged conveyer belt driven by market interests.

Again, this may make you mad or sad, but here’s one thing I hope it makes you do: Eat Nutrient Rich, and escape the pharma trap!

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