Hi Folks:
   I'm new to the list. I'll introduce myself and my reason for being
on the list at a later date, but for now, here is a news article from
earlier this year that might be of interest to some on the list...

Dwight Weideman ([log in to unmask])


DAILY CAMERA

NEUROLOGIST SUES SISTER COMPANY OF SYNTEX

THE SUIT CLAIMS BREACH OF CONTRACT BY HOFFMAN-LA ROCHE.



Tuesday, January 7, 1997

Section: BPLUS
Page: 6D

By Tom Locke Camera Business Writer

A Denver neurologist has filed a lawsuit against Hoffman-La Roche Inc., a
sister company of Boulder-based Syntex Chemicals Inc., claiming that her
contract services were terminated after reporting adverse drug side-effects
that Hoffman-La Roche allegedly didn't want reported.

The lawsuit, transferred from Denver District Court to U.S. District Court
in Denver, asks for unspecified damages for breach of contract, emotional
distress, and interference in contractual relations between the
neurologist, Dr. Margaret Hoehn, and her patients.

Those 36 patients, some of whom were from Boulder County, were involved in
phase-three clinical trials, under Hoehn's supervision, for a
Hoffman-La Roche drug called Tolcapone.

Boulder-based Syntex Chemicals Inc. and Hoffman-La Roche are both owned by
Basel, Switzerland-based Roche Holdings Ltd., a pharmaceutical
company with 60,000 employees worldwide. Syntex was once asked by
Hoffman-La Roche to work on a new way of processing Tolcapone, but it
declined and has not been involved in the drug at all, said Karen
Sandstead, communications manager at Syntex.

With the completion of its

phase-three trials, Hoffman La Roche filed a new drug applica tion for
Tolcapone last June and hopes to get approval for it from the Food and Drug
Administration in 1997, said Darien Wilson, assistant director of public
affairs for Nutley, N.J.-based Hoffman-La Roche.

Wilson was not familiar with the details of the Hoehn lawsuit. However, she
said, "It's not our position to just terminate someone and have them not
report adverse effects."

But the lawsuit claims that, beginning in June 1994, Hoffman-La Roche
agents began pressuring Hoehn to deviate from FDA standards in reporting
adverse reactions from Tolcapone. According to the lawsuit, Hoffman-La
Roche took the stance that Hoehn should only report the reactions if they
were severe enough to move a patient between categories of severity, such
as from "mild" to "moderate" or from "moderate" to "severe."

That stance was contrary to FDA standards, says the lawsuit, and Hoehn kept
reporting the side effects of the drug and was terminated on Oct. 4,
1994. While no reason for the termination was given to Hoehn, the lawsuit
claims that an Oct. 31 letter made it clear that the termination was due to
Hoehn's side-effects reports.

Hoffman-La Roche's Wilson agreed with Hoehn's assertion that all adverse
reactions caused by a tested drug - not just those that move patients
between categories - should be reported in drug trials.

It's not that Hoehn believes Tolcapone adverse reactions are dangerous. In
fact, she favors FDA approval for release of the drug. "In certain
patients, it does a lot of good," she said.

Nevertheless, she has been involved in clinical trials since 1967, she
said, and never had a pharmaceutical company question her decisions. "This was
a real shock to me," she said.

Hoehn explained that Parkinson's disease is due to a deficien cy in the
brain of a chemical called dopamine. Without sufficient dopamine, people can
suffer the Parkinson's symptoms of tremors, rigidity, slowness and loss of
balance. Sinemet, a dopamine-like synthetic drug, reduces the Parkinson's
symptoms but can cause side effects such as abnormal involuntary movements.
Tolcapone works to boost Sinemet, making it last longer and
increasing its potency. But with some patients it also increased side
effects such as involuntary movements.

It was that increase in unwanted side effects from Tolcapone that Hoehn was
reporting before Hoffman La-Roche terminated the contracts for her
supervision of the clinical trials, says the lawsuit.

The abrupt end of the trials caused consternation among her patients, said
Hoehn, because they feared there was something quite harmful in the drug
they were testing. Hoehn said she persuaded Hoffman-La Roche to allow some
of her patients to continue the trials under the supervision of other
doctors.

Hoehn said she thought about reporting the situation to the FDA, but on the
advice of others she decided not to.

"I really thought it should be reported," she said. "You can't suppress
adverse events in a drug trial."