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HSI e-Alert - Law & Disorder

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September 25, 2008

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Dear Reader,

If this e-Alert were a police procedural show, in today's opening scene

Enbrel would be brought into the homicide department for questioning. And some

hard-as-nails veteran detective would say something like, " This guy's got a rap

sheet a mile long. "

Enbrel? Ring a bell? For longtime e-Alert readers it probably rings

half-a-dozen bells.

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Drawing the line

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Enbrel is in a class of drugs known as TNF-alpha blockers. These drugs

(which include Remicade, Cimzia, and Humira) inhibit the body's natural immune

response in order to treat immune system dysfunctions such as rheumatoid

arthritis, psoriasis, and Crohn's disease.

But the risk here is obvious: When you solve a problem by suppressing the

immune system, you open the door to a wide variety of infections.

Which brings us to Enbrel's rap sheet of potential adverse reactions:

a.. Tuberculosis

b.. Bacterial sepsis

c.. Nervous system disorders

d.. Congestive heart failure

e.. Cancer

Year after year, one study after another has revealed exactly how

dangerous this drug really is. And of course, the FDA long ago required a " black

box " warning for Enbrel and other TNF-alpha blockers.

Riiiight. The dreaded black box. In Drug World, the black box is

considered a big deal. But what is it really? Get out a black-ink pen and draw a

rectangle. How does that look? Pretty forbidding? No. Pretty lame. When you

consider that many patients have died due to adverse reactions from these drugs,

a thin black line is literally the very LEAST the FDA can do.

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Another warning.another drug.another warning

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Earlier this month, the FDA announced yet another new warning for Enbrel

and other TNF-ab drugs.

To the rap sheet we can now add a lethal fungal infection called

histoplasmosis.

I have to admit, I'm impressed by the way the FDA initially acted on this

one. Apparently someone at the agency followed up on a single case of the fungal

infection and found evidence that TNF-ab drugs may have been linked to 45 deaths

in patients who developed the infection.

And can you guess where this is going? Yep: another black box warning.

Now you might think that at some point the FDA would throw in the towel

and say, " You know what? This stuff actually kills people. We better take it off

the market. " But three of the four TNF-ab drugs make more than $1 billion per

year. And if you're raking in that kind of crazy money, your drug doesn't get

pulled unless it's killing nearly everyone who takes it.

So the FDA is going in another direction.

According to the Associated Press, the agency advises doctors to consider

" aggressive use " of antifungal drugs in patients who develop flu-like symptoms

associated with the infection. And what's wrong with THIS picture? One FDA

official told the AP that antifungal drugs also have dangerous side effects.

He added that if a patient develops a fungal infection, doctors " should

consider " stopping treatment with Enbrel and other TNF-ab drugs.

Don't STOP treatment! Geez, don't do anything rash! But, you know,

consider it.

Rheumatoid arthritis patients might consider other directions as well.

In the e-Alert " Liquid Gold " (11/16/05), I told you about a study that

demonstrated how four teaspoons of extra virgin olive oil taken daily for 12

weeks reduced pain and morning stiffness among RA patients.

And in the e-Alert " Burning Down the House " (3/25/03), I told you about a

supplement called Wobenzyme, which contains a blend of pancreatic enzymes that

reduce RA symptoms by lowering abnormally high levels of antibodies (produced by

an overactive immune system) that prompt RA inflammation.

Talk to your doctor before treating rheumatoid arthritis with Wobenzyme or

olive oil.

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