RADAR Detector

[Guest guest]

" HSI - Jenny Thompson " <HSIResearch

HSI e-Alert - RADAR Detector

Mon, 16 May 2005 06:59:00 -0400

HSI e-Alert - RADAR Detector

 

Health Sciences Institute e-Alert

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May 16, 2005

 

Dear Reader,

 

Out with the new...in with the old.

 

A large majority of consumers would prefer to take a drug that's been

on the market for 10 years or more before trying a newer drug,

according to a recent survey conducted by Medco Health Solutions.

 

You have to wonder; would that same survey have had a completely

different outcome five years ago, or even one year ago? In the past

few months we've seen some best selling drugs crash and burn amid

safety concerns, while major drug companies and the FDA have taken hit

after hit in the mainstream media.

 

And now, at exactly the time the FDA could use a complete image

makeover, agency executives have made an astonishing decision that

would be no less surprising than if FDA acting commissioner Lester

Crawford called a press conference, drew a gun, and actually shot

himself in the foot.

 

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Hit and miss

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What's the primary job of the FDA? To insure food and drug safety,

right? And how is that done? In the case of drugs, FDA executives rely

on drug companies and doctors to report adverse reactions. This

information is compiled in an FDA database. But gathering the

information is only the first step. In some cases it takes several

years to analyze the data in order to recognize and respond to a

proven adverse reaction.

 

Under this system drug companies are basically being asked to police

themselves. (That would be like asking Tony Soprano to, pretty please,

not have anybody " whacked. " ) But relying on reports of adverse

reactions from doctors is also undependable. M.D.s are expected to

report adverse reactions on a voluntary basis. But the process is time

consuming and in some cases doctors may fear that investigations will

draw malpractice suits.

 

By some estimates more than 90 percent of all adverse reactions go

unreported. And yet, according the Chicago Tribune, the FDA receives

as many as 400,000 yearly reports of adverse reactions, and the worst

of these reactions account for about 100,000 deaths each year.

 

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RADAR network

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Five years ago, Northwestern University researcher Charles L. Bennett,

M.D., Ph.D., began building a better radar to detect adverse reactions

to drugs. In fact, he called his project RADAR: Research for Adverse

Drug Events and Reports.

 

Dr. Bennett's process is fairly simple. Twenty-five doctors from five

U.S. cities report their observations of potential adverse reactions,

with special interest paid to the most serious reactions that could be

fatal. When reports come in they're then sent out to a larger group of

researchers who begin to hunt for other reports. The FDA

post-marketing database is one of the sources used for additional

reporting.

 

To date, 16 different drugs and medical devices have been linked to

adverse reactions that are potentially fatal. RADAR has identified

severe adverse reactions in nearly 1,700 patients, and 10 percent of

those patients died of complications associated with the reactions.

 

So has the FDA embraced Dr. Bennett's RADAR? If you guessed " no " to

that question, you're on the right track. But even hardened cynics

might be surprised at what happened next.

 

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The big dog bites

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One of the drugs that RADAR examined was Plavix, a popular

clot-prevention drug. According to the Chicago Tribune, Dr. Bennett's

researchers reported that in rare cases Plavix may trigger a

" catastrophic collapse of the blood system. " At Dr. Bennett's urging

the FDA added a warning to the drug packaging.

 

Dr. Bennett followed up the Plavix research with a study that compared

how four years of adverse reactions to Plavix were tracked by the FDA,

Bristol-Myers Squibb (BMS, the makers of Plavix) and the RADAR team.

As reported in the February 2004 issue of the journal Stroke, Dr.

Bennett scored RADAR's effectiveness at 92 to 100 percent, while BMS

scored between 8 to 58 percent and the FDA scored zero to 23 percent.

Dr. Bennett gave the FDA a failing grade.

 

The FDA's response? Apparently, someone at the agency was not very

pleased. The Tribune reports that FDA officials reacted to the Stroke

study by terminating Dr. Bennett's access to the agency's database.

 

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The 16 to watch

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Earlier this month the Journal of the American Medical Association

published the RADAR conclusions of Dr. Bennett and his colleagues. The

study included a list of these 16 drugs and medical devices that have

produced adverse effects: Zolendronate, Amiodarone, Epoetin,

Thalidomide, Gerncitabine, Ticiopidine, Gerntuzumab, Clopidogrel,

Nevirapine, Flutamide, Sirolimus-eluting cardiac stent, rHu-MGDF (for

thrombocytopenia), Bicalutamide, Enoxaparin, rHu-MGDF (for lymphomas),

Paclitaxel-eluting cardiac stent.

 

If you're currently using any of these drugs or devices, or if you

know someone who is, it would be wise to talk to your doctor about the

potential risks. But make sure he's not relying on the FDA's data.

 

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....and another thing

 

Time travel is bad for your health.

 

That's my theory, anyway. I'm guessing that all future attempts to

travel back and forth through time will turn out to have dire side

effects. Otherwise folks from the future would be as common as reality

TV show contestants.

 

The adverse side effect problem might also explain why no time

travelers showed up at the Massachusetts Institute of Technology Time

Traveler Convention last week. But you can't say the MIT

conventioneers didn't give it their best effort when it came to

publicizing the event.

 

Imagining that all the kinks of time travel might not be worked out

for perhaps thousands of years, they proposed ways to publish

convention details in " enduring forms. " In other words, they weren't

just trying to get a good turnout - they wanted to make time travelers

from the far off future aware of their convention in hopes that so

many of them might show up it would become a " Woodstock-like event

that defines humanity forever. "

 

I wonder if they planned ahead to provide parking for 500,000 time

machines.

 

So how do you send an invitation to someone many centuries in the

future? Not with a web site. Sooner or later the Internet will be an

outmoded curiosity. The convention planners' suggestions: " Write the

details down on a piece of acid-free paper, and slip them into obscure

books in academic libraries! Carve them into a clay tablet! "

 

If anyone actually tried these methods, they didn't seem to work. But

here's a thought: Maybe someone carved a clay tablet, but when the

time travelers didn't show up, destroyed the tablet after the

convention because it obviously hadn't gotten the message through, but

maybe the reason it didn't get through was because the tablet was

destroyed, so if the tablet hadn't been destroyed...

 

I'm getting dizzy just thinking about it. A perfect example of how

time travel can create health problems.

 

To Your Good Health,

 

Jenny Thompson

Health Sciences Institute

 

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Sources:

 

" Americans Prefer 'Safer' Older Drugs " Reuters Health, 5/6/05,

reutershealth.com

" The Research on Adverse Drug Events and Reports (RADAR) Project "

Journal of the American Medical Association, Vol. 293, No. 17, 5/4/05,

jama.ama-assn.org

" RADAR Detects Sometimes-Deadly Drug Reactions " Elizabeth Weise, USA

Today, 5/3/05, usatoday.com

" FDA Cut Off Critic's Access to Drug Database " Ronald Kotulak, Chicago

Tribune, 2/20/05, chicagotribune.com " We Need Your Help For the Time

Traveler Convention " Massachusetts Institute of Technology, 5/7/05,

web.mit.edu

 

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