Some corrections on earlier information I added to the E-drug message on
tenidap:
Tenidap was registered in Netherlands in 1994 (and in Italy last year), but it
is NOT on the market.
Tenidap was registered in Netherlands under the brandname ENABLEX. But to really
get on the market, Pfizer had to convince our health Ministry that it was a
totally new drug. Otherwise, it would be put as an ordinary drug in one of the
existing classifications, and only be allowed a low price. Our Ministry did not
allow tenidap to be classified as a new category; in response, Pfizer refused to
market the product.
There was even a small scandal, written up in the NRC (leading newspaper) on 13
February 96:
Dr. Leo Offerhaus, clinical pharmacologist, wrote that Pfizer (in a bid to get
recognition for a special category for tenidap) had participated and won a
special price of our national pharmaceutical industry association (NEFARMA) for
the "most innovative drug in 1994". However, the jury for this price consisted
of some industry, but also some cicil servants of the Ministry of Health, drug
registration department (including its chairman!).
Dr. Offerhaus stated that there are very few publicly available trials of
tenidap; therefore, the members of the jury could only have allocated the price
based on information provided by the manufacturer, or by knowledge they had from
the confidential drug application for tenidap. Civil servants must , however,
keep that information secret. The Ministry of Health seems to have issued stiff
warnings after this incident.
Dr. Offerhaus ends his article by quoting from the few trials that nearly all
longterm patients on tenidap had protein in their urine. He suggested that
ENABLEX could become a DISABLEX...
sources: SCRIP No 2127, 10 May 1996, p 22
NRC, 13 February 1996 (in dutch)
Wilbert Bannenberg