The Confidence Game, part three

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Daily Dose

 

Friday February 04, 2005

 

 

 

The Confidence Game, part three

 

In the first two installments of this three-part essay, we've examined

the shocking survey administered to FDA scientists by the Inspector

General of the government's Office of Health and Human Services. In

it, we discovered that a third of them lack confidence in the overall

safety and effectiveness of the drugs they approve, while more than

two-thirds lack confidence in the agency's ability to keep tabs on the

side effects of these drugs once they've hit the market.

 

But what about patients' confidence in prescription drugs? Are we - an

entire nation of consumers pelted every day by slick, prime-time drug

ads and prescription slips from our doctors - confident in the safety

and efficacy of drugs approved by the FDA, even if their own

scientists aren't?

 

By and large, yes we are.

 

According to another Associated Press article, a recent poll conducted

by a leading public affairs agency indicated that over 80% of American

consumers are at least somewhat confident that the drugs they're

taking are safe - and that the FDA is doing its job in fine fashion.

 

What's really mind-boggling is that this poll was taken AFTER the

recent arthritis drug/heart risk scandal that has made headlines and

newscast for weeks nationwide. This snafu resulted in mega-drug Vioxx

being pulled from the market. Competitors Celebrex and Bextra (all

Cox-2 Inhibitors) may soon follow, if the negative evidence about

these medications continues to prove similar to Vioxx.

 

All this begs the question: WHY are people so confident in

prescription drugs despite the constant bombardment of negative drug

news in the media recently, or the side effects of drugs they may be

taking themselves (over 75% of those polled were currently taking

prescription drugs of one type or another)?

 

The answer points to two things: The power of marketing to falsely

inspire hope and the power of doctors to influence decisions we make

for our health. Remember, the vast bulk of mainstream MDs buy into the

promises and skewed " research " of drug companies hook, line and sinker

- largely because of the perks, junkets, freebies, and seductive sales

personnel the drug giants ply them with.

 

Why am I talking about all of this in 3 consecutive Daily Doses? Keep

reading...

 

 

 

To see change, a sea change

 

The fact that the end users (see also: victims) of prescription drugs

believe in their safety and efficacy at far greater rates than their

makers points to only one possible conclusion: A grand and

far-reaching deception by both the drug makers and the regulatory

entity our government has established to protect us. Some, like me,

would call this a conspiracy.

 

This condition also points to the need for major, sweeping reforms of

the entire system by which drugs are envisioned, tested, brought to

market, and evaluated. For starters, we need immediate and radical

reform of:

 

* THE FDA's DRUG APPROVAL PROCESS - It needs to be longer and more

intensive, totally insulated from the influence of drug companies,

completely independent of drug revenues for its funding, and 100%

accountable to its findings under penalty of both law and lawsuit.

* POST-MARKET SAFETY MONITORING - It should be mandatory for not

only doctors to report side effects and adverse events, but drug

companies as well. They should ALL be required to post this

information on a publicly accessible database which the FDA should

oversee and maintain.

* DRUG MARKETING - Drug ads should be required to reference actual

study data that's verifiable via the aforementioned database, not just

a quick list of possible side effects. People should be informed of

not only the safety downsides, but hard data on exactly how effective

the medicines they're taking really are.

* PHYSICIAN " EDUCATION " EFFORTS - Drug companies should be held to

the same standard as lobbyists (in theory, anyway): No freebies,

tchotchkes, trips to Vegas, fancy dinner events, or unsolicited staff

visits to clinics, hospitals or medical schools. Also, only purely

unbiased seminars with all pertinent data and dissenting opinions

should be allowed, with no expenses paid by the drug makers.

 

This would be a good start. But will it ever happen? I doubt it. Why?

Because the status-quo system fosters billions of dollars in profits

for not just the drug makers, but also the government and its agencies

(read FDA) through corporate taxes and sales taxes on drugs. It'll

take an extraordinary amount of pressure and a real change in the

political climate for them to give up this river of money...

 

So we'd best get started, lest we be victimized by this system before

we can change it.

 

Conspiring to win your confidence - with sense, not dollars,

 

William Campbell Douglass II, MD

 

 

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