Re: Off label usage of medicine

zwalanga_at_yahoo.com
Date: 01/20/05 

Date: 19 Jan 2005 17:42:11 -0800

David Rind wrote:
> 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

Now I do not know what you are saying. I want to see all indications
approved, formally. I do not think the FDA or Health Canada should be
allowing off-label use at all. But if a drug can be used off-label then
I want to see regulations about when and why not. Enforced. Wouldn't
that eliminate a lot of risk, which by the way is all for me, your
patient? I think everything is way too lax as is, and that is why we
are in such trouble. Am I being too simplistic in thinking not enough
safeguards are in place, and those that are in place are being ignored;
again, to my detriment?

What do you mean "may not be worth its side effects" but relieves pain?
Why would Neurontin be worth anything to me, if to relieve pain I risk
something else, and no one knows why or what, until several thousand of
us are injured trying to find out why or what?

Zee

Relevant Pages

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