Testing the FDA's Confidence

Testing the FDA’s Confidence

Are You Gambling Your Life on a 1 in 3 Shot?

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The Confidence Game, part one

Would you get behind the wheel of a car after you found out that a third of the manufacturer’s employees were less than fully confident in the safety of the vehicles they built? Not likely.

How would you feel about going to a hospital where only 2 out of 3 staffers – doctors included – thought they were giving the safest possible care? Bet you’d be looking for an alternative treatment pretty quickly

Now, how do you feel about taking prescription drugs now that you know this:

More than one out of three of the Food and Drug Administration’s research scientists have less than 50% confidence about the safety and effectiveness of the drugs they approve.

According to a recent Associated Press article, a survey conducted by the Inspector General of the Office of Health and Human Services within the hallowed halls of the FDA between 2001 and 2003 revealed this shocking fact by extrapolating the results from a pool of 400 respondents – ALL of them scientists whose job it is to make sure that the prescription drugs we’re taking for everything under the sun are 100% safe!

The survey’s questions featured 4 possible responses: “Completely confident” and “mostly confident” on the upper half of the scale, while “somewhat confident” and “not confident” anchored the lower half.

The results showed that a full 36% percent of these FDA insiders – more than one third – felt either “somewhat confident” or “not confident” in the safety and/or efficacy of the drugs they were approving. Beyond this, the survey concluded that 58% of these scientists felt that the time period allocated for pre-approval reviews of prescription drugs was inadequate for thorough safety evaluation.

Even scarier, a full 18% of respondents had felt PRESSURED to approve a drug even though they had concerns about its safety, while 21% characterized their work environment as allowing for very limited (if any) scientific dissent. Another study conducted by the Public Citizen’s Health Research group in 2001 yielded similar conclusions.

Think something’s rotten in Denmark? Keep reading

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A latter-day Joan of Narc

Perhaps you’ve heard of Dr. David Graham. He’s the 20-year veteran FDA scientist who was one of the earliest and most vocal critics of the Vioxx arthritis drug – specifically the increased risk of heart attacks and stroke among those taking it for more than 18 months, or those taking a higher-than-normal dose.

Well, not only did his testimony before the Senate in the wake of the scandal help assure the killer drug’s permanent removal from the market (plus spurred the scrutiny of other soon-to-fall Cox-2 inhibitors), it also reinforced a disconcerting finding of the Health and Human Services survey discussed above:

That FDA scientists involved in evaluating and approving new drugs face major heat from the agency’s high muckety-mucks.

According to an article in last month’s Washington Post online, Graham claimed that scientists who dissented about a prospective drug’s safety or effectiveness sometimes faced pressure and intimidation from FDA officials – especially if the drug in question were on the newly-established six-month fast track to “priority” approval.

Consequently, the charismatic researcher said, conscientious dissenters within the agency were often “unable” to keep some unsafe drugs from reaching the market!

Now maybe I’m an idealist, but shouldn’t everyone involved in the process of approving a new drug for public consumption be completely confident in its safety and effectiveness BEFORE doctors start prescribing it? So how could they be powerless to stop the release of a killer drug? I mean, what are our tax dollars funding a bloated bureaucracy like the FDA for, if not the safest possible foods and drugs. Isn’t that the purpose of government agencies (not just the FDA, but the FAA, OSHA, and about a million others) – to give us citizens as close as possible a guarantee of safety?

Ostensibly, yes. But the harsh reality is that the bulk of a drug’s practical, real-world testing happens AFTER a medication is released for public consumption – using unsuspecting patients (maybe you?) as subjects.

I’ll tell you more in part two of this series, next Daily Dose

Dissenting while I’m lamenting,

William Campbell Douglass II, MD