Rilutek - Lavon

[Guest guest]

Good evening, Lavon.

From the Fall 1997 issue of PLS Newsletter (Volume 13, Number 3):

Mac, PhD., contributed an article on clinical trials of

Riluzole (Rilutek). After full trials, including placebo-controlled,

double-blinded, the results were statistically significant, so it was

concluded that Riluzole prolonged survival, but questions were raised

because the prolonged survival for patients taking Riluzole was

greater for those with bulbar onset ALS than for limb onset ALS. That

should not have been the case if both froms are the same disease.

A second trial was accomplished using nearly 1,000 patients in several

countries. The results of the second trial were discussed at a major

ALS conference in the US in November 1996. The following points

were the most controversial:

It was concluded that the trial showed an increase in survival, yet

there was no effect on any of the usual measures of the rate of

progression of the disease such as progressive muscular weakness.

The very small differences in survival between experimental and

control groups. (Recent newspaper article stated that difference to be

about three months). Finally, the regional differences in surviving

patients, e.g. patients in France, the home of Rhone Poulenc (the

company who developed the drug) survived " better " than those in the

US.

The conference ended with some researchers and physicians feeling

that Riluzole was a breakthrough and major step in treating ALS.

Others suggested that the main reason that the drug was released as a

treatment was that it was the first drug which even might be useful in

treating ALS, after years of unsuccessful trials of many other drugs.

One veteran researcher considered the drug to be a victory for the

maker, rather than for ALS patients, calling it " the triumph of money

and politics over science. "

I understand that the drug is very expensive.

Additional information is available on both the ALS and PLS websites.

Don