Decision by (biased) committee -- after committee...

[Guest guest]

" WC Douglass " <realhealth

Daily Dose - Decision by (biased) committee -- after committee...

Tue, 13 Jun 2006 07:15:00 -0400

 

 

 

The FDA's ADHDilemma

 

In the last Daily Dose, I relayed to you the sobering picture of the

side effects of treating the made-by-medicine " disease " of ADHD, as

painted by the first-ever national analysis of these treatments by the

CDC.

 

In a nutshell, they found that ADHD drugs spurred over 3,000 ER visits

per year, over 600 hospital admissions, over 600 stomach-pumpings,

over 400 heart-related hospitalizations -- plus a whole raft of other

symptoms ranging from stroke and cardiac problems to rashes, abdominal

pain, and muscle weakness...

 

Which all begs the question: What's the FDA going to do about it?

 

The short answer: Not enough.

 

According to the Associated Press article part 1 of this essay was

based on, despite the urging of some doctors to require a stringent

" black box " warning on ADHD drugs (like Ritalin and Aderall), the FDA

is hedging toward other " solutions " to the problem...

 

This, despite the fact that its own Safety Advisory Panel voted 8-7 in

favor of this most-stringent warning when it convened this past

February to hash out the matter. Remember, this was BEFORE the CDC

report came out. But judging from things I've read recently, the

publication of this report seems unlikely to change the agency's

stance on what safety procedures are warranted for these drugs.

 

Currently, the approach they're talking about most (details on this

below) would be to add a more complete mention of the drug's risks to

the top of the printed insert that comes with the drug -- you know,

that little folded-up piece of paper with all the legalese and medical

jargon on it. The one with the print so fine it makes a prenuptial

agreement seem like a billboard.

 

In other words, the one NOBODY READS.

 

This approach would be a clean win for Big Pharma -- and a major blow

to the youth of our nation, the main targets of the drug-marketing

campaign that nowadays passes for medicine. It seems the FDA has

conveniently forgotten about how Canada's equivalent to the FDA yanked

Aderall from the market for 6 months last year following a rash of 20

sudden fatalities and a dozen or more strokes among both kids and

adults on the drug. Keep reading...

 

**********************************

 

In late March of this year, before the CDC issued its frightening

report on the effects of ADHD drugs, a second FDA concluded that the

prior panel's recommendation to include the " black box " warning was an

excessive measure relative to the drugs' risks.

 

Now there's a shocker.

 

I just got finished proving to you a few days ago ( " Buying the

Pharma " ) that these panels are greatly influenced by a river of

pharmaceutical industry lucre. Beyond this, it appears as though the

FDA simply convenes advisory panel after advisory panel until it gets

the recommendation it wants from the " experts " it assembles (read: Big

Pharma ringers).

 

According to an AP story from March 23 -- the day after this latest

panel rendered its limp-wristed recommendations -- the FDA's Director

of Medical Policy went on record saying the organization would likely

follow them. Of course it will, now that it and its drug-maker cronies

got the answer they want...

 

But it'll be VERY interesting to see if the FDA changes its tune in

the aftermath of this CDC report. So far, even the most outspoken

mouthpieces have been mum. If doesn't get its act together and force

the black-box warning on ADHD drugs, it'll be just one more example of

how the FDA is nothing more than the handmaiden of Big Pharma.

 

I'll keep you posted.

 

Watch-dogging the ringers and dishing out the zingers,

 

William Campbell Douglass II, M.D.