FDA’s “Hear No Evil” Policy

by William Campbell Douglass II, MD
Daily Dose

Dr. William Campbell Douglas has been one of my personal favorites for a number of years. He tells it like he sees it, and always has interesting things to say. The article below is reprint of one of Dr. Douglas’ newsletters, with it’s advertising left in. Our website has no affiliation with any of the ads or products promoted, but I wanted to pass on the info from Dr. Douglas. It’s worth taking the time to read – Dennis.

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The Confidence Game, part two

As shocking as it is to discover (as you did in part one of this essay) that more than a third of the FDA’s scientists lack confidence in the safety and effectiveness of the drugs they approve for sale, how does this little factoid make you feel: Two-thirds of the Food and Drug Administration’s scientists perceive significant shortcomings in their agency’s monitoring of prescription medications once they hit the market.

Yes, you read that right – a 2001 government survey (the same one I referenced in the last Daily Dose) revealed that 66%, roughly two out of three, of the FDA’s front-line research scientists were either “not at all confident” or only “somewhat confident” in the agency’s practices with regard to monitoring a drug’s safety once past the approval process. And remember, this survey is SEVERAL YEARS OLD…

Imagine what those numbers would be like today, in the wake of the current heart-risk fiasco (and cover-up) involving Vioxx, Celebrex and other Cox-2 Inhibitors or the antidepressant-suicide scandal. And these are just a few of the higher-profile examples – there are dozens more that never make the mainstream’s headlines.

I’ve written about this before – specifically, the fact that for all practical purposes, there are only two ways the FDA finds out about the dangerous side effects of any drugs: One, the voluntary (not mandatory) reporting of them from the miniscule percentage of conscientious doctors out there who are willing to admit their own
culpability for prescribing these medicines. And two, from lawsuits filed by citizens injured by the drugs (or in many cases, their next of kin).

There is one other way, of course: The diligent reporting of the selfless and benevolent DRUG COMPANIES THEMSELVES. How often does this happen? Only when the dollars and cents of it add up, which is very rarely. Just about the only time it happens is when a drug’s effects are so disastrous that a public admission of
culpability saves the manufacturer more money in lawsuits or lost sales because of a public image crisis that they make in profits on the drug. In this case (like Merck with Vioxx), they’ll issue a statement purely for damage control reasons.

According to the piece, the FDA learns of only about 10% of the adverse effects of any given prescription medication once it hits the market. When you consider this, it’s easier to comprehend how the Cox-2/heart and antidepressant/suicide scandals (and umpteen others) can make it into the headlines before the clueless FDA sounds the alarm.

I didn’t say it was EXCUSABLE, just comprehendible.

Yet as you’ll discover in part three of this mini-expose, excuse this appalling ignorance we do – like we’ve got blinders on (or like we’re medicated)…

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One from the “too little, too late” file

Now that arthritis mega-drug Vioxx has been pulled from the market after being linked to tens of thousands of deaths and heart attacks – Dr. Graham (the heroic whistle-blower I cited in the last Dose) estimates the number to be as high as 140,000 – a lot of media and independent scientific attention is being leveled at others in the Cox-2 inhibitors class of drugs, namely Celebrex and Bextra…

And gallantly putting its finger to the wind and detecting a second wave of the painkiller storm, the bold and decisive Food and Drug Administration is now calling for a review of all prevention studies applicable to this family of medications.

Hummphh. Shouldn’t they have done that before APPROVING the drugs – before more American were harmed by them than were killed or wounded in the entire Korean War?

According to a recent Associated Press article, the FDA will convene this month to thoroughly study all available data on these medications, plus other painkillers shown to carry heart risks by the National Institutes of Health. They’ve also issued an advisory to physicians urging them to use caution before prescribing these drugs in the meantime.

Some might see this as an appropriate measure – a shining example of a government regulatory agency protecting us from further harm. But I see it for what it really is: An exercise in damage control. A PR campaign to get in front of an approaching scandal.

It’s a shame that so many have to die or be stricken with heart attacks or strokes before even this kind of lame-duck measure is taken, but an even bigger shame is the message this sends to the drug companies…

Unless the drug you’re making kills or maims 100,000 people or more, you can keep selling it, and nobody’s the wiser.

Always sounding the warning BEFORE the storm,

William Campbell Douglass II, MD

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