Re: Off label usage of medicine

From: David Rind (drind_at_caregroup.harvard.edu)
Date: 01/20/05 

Date: Wed, 19 Jan 2005 19:25:02 -0500

zwalanga@yahoo.com wrote:
> :"And sometimes, even when there is only weak evidence and no FDA
> approval...etc..."
>
> It brings a tear to one's eye it does David. Your dedication to
> democracy. Have you thought of writing ad copy me boyo?

No, but I have had to make decisions about giving patients drugs for
potentially fatal illnesses on too little information. Sometimes later
information showed the decision to have been right and other times
wrong. I remember begging drug companies for protease inhibitors well
before they were approved by the FDA. I'm not sure why you think it's
shilling for the drug companies to recognize that such decisions have to
be made.

>
> http://www.citizen.org/eletter/articles/neurontin.htm
> Zee
>
> {and what was that David, about 27 "if's"?}

I honestly have no clue what you mean by that last sentence. As to the
prior URL, the Public Citizen letter is deceptive in that it implies
that there is no evidence that Neurontin works for any of these 11
indications. That is just untrue. As an example (sticking with diabetic
neuropathy):

------------------------------
TI - Gabapentin for the symptomatic treatment of painful neuropathy in
patients with diabetes mellitus: a randomized controlled trial.
AU - Backonja M; Beydoun A; Edwards KR; Schwartz SL; Fonseca V; Hes M;
LaMoreaux L; Garofalo E
SO - JAMA 1998 Dec 2;280(21):1831-6.

CONTEXT: Pain is the most disturbing symptom of diabetic peripheral
neuropathy. As many as 45% of patients with diabetes mellitus develop
peripheral neuropathies. OBJECTIVE: To evaluate the effect of gabapentin
monotherapy on pain associated with diabetic peripheral neuropathy.
DESIGN: Randomized, double-blind, placebo-controlled, 8-week trial
conducted between July 1996 and March 1997. SETTING: Outpatient clinics
at 20 sites. PATIENTS: The 165 patients enrolled had a 1- to 5-year
history of pain attributed to diabetic neuropathy and a minimum 40-mm
pain score on the Short-Form McGill Pain Questionnaire visual analogue
scale. INTERVENTION: Gabapentin (titrated from 900 to 3600 mg/d or
maximum tolerated dosage) or placebo. MAIN OUTCOME MEASURES: The primary
efficacy measure was daily pain severity as measured on an 11-point
Likert scale (0, no pain; 10, worst possible pain). Secondary measures
included sleep interference scores, the Short-Form McGill Pain
Questionnaire scores, Patient Global Impression of Change and Clinical
Global Impression of Change, the Short Form-36 Quality of Life
Questionnaire scores, and the Profile of Mood States results. RESULTS:
Eighty-four patients received gabapentin and 70 (83%) completed the
study; 81 received placebo and 65 (80%) completed the study. By
intent-to-treat analysis, gabapentin-treated patients' mean daily pain
score at the study end point (baseline, 6.4; end point, 3.9; n = 82) was
significantly lower (P<.001) compared with the placebo-treated patients'
end-point score (baseline, 6.5; end point, 5.1; n = 80). All secondary
outcome measures of pain were significantly better in the gabapentin
group than in the placebo group. Additional statistically significant
differences favoring gabapentin treatment were observed in measures of
quality of life (Short Form-36 Quality of Life Questionnaire and Profile
of Mood States). Adverse events experienced significantly more
frequently in the gabapentin group were dizziness (20 [24%] in the
gabapentin group vs 4 [4.9%] in the control group; P<.001) and
somnolence (19 [23%] in the gabapentin group vs 5 [6%] in the control
group; P = .003). Confusion was also more frequent in the gabapentin
group (7 [8%] vs 1 [1.2%]; P = .06). CONCLUSION: Gabapentin monotherapy
appears to be efficacious for the treatment of pain and sleep
interference associated with diabetic peripheral neuropathy and exhibits
positive effects on mood and quality of life.
----------------------

Pretending that data like these don't exist just because it wasn't
worthwhile for the manufacturer to apply to the FDA for an added
indication is just silly. Neurontin may not be worth its side effects
when used for diabetic neuropathy, but there is good evidence that it
relieves pain. 

-- 
David Rind
drind@caregroup.harvard.edu

Relevant Pages

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