 |
 |
Hi Folks: I found this article on the Web.... 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." _____________________________________________________________________ Sent by RocketMail. Get your free e-mail at http://www.rocketmail.com