While the FDA's Dr. Curtis Wright says that drug companies are known to perform investigations overseas because they've grown frustrated with the long U.S. approval process, few academics pursue such projects. Adds Stanley Glick, the ibogaine researcher at Albany College of Medicine: "I don't know of anyone else who's done anything like this. In one sense, I admire her for doing it. In another sense, I think she's crazy. She's taking a significant risk in terms of her credibility in the scientific establishment. She's taking a risk by working in a country that's not bound by our laws, and this could affect her ability to get funding in this country." (On the other hand, one high-ranking NIDA official contends that data from the St. Kitts project might actually prompt the agency to reconsider a grant application from Mash.)
In December 1996 Mash filed a federal lawsuit against Lotsof and NDA International, alleging that he failed to complete an application for a noribogaine patent as he was obliged to do, and that he had taken credit for inventing "noribogaine plus," an ibogaine-related concept for the combined use of two substances that Mash claims her team discovered in 1994. Instead he obtained his own patent for noribogaine plus in January 1997.
Those two actions, she contends in her lawsuit, invalidate Lotsof's agreements with the University of Miami and will deprive her, her colleagues, and the university of their share of any profits from the development of both noribogaine and noribogaine plus.
James Gale, a Miami attorney who specializes in patent law, says it is highly unusual for such a lawsuit to be filed, since Mash was never a party to the contract between Lotsof and the university. Nor can Mash ever gain the rights to noribogaine plus, even if she successfully challenges Lotsof's patent, he says. Under federal laws, a patent can be corrected only if it was erroneously filed -- not if a person alleges willful deceit.
Lotsof's New York City attorney, Michael Ronemus, contends that Mash simply wants to control the drug's use and production. "Dr. Mash clearly wants that contract revoked so that she can do her own thing, so she can do what she is not permitted to do," he says. "I think [Mash's] lawsuit was nothing more than an effort to get out of [UM's] contract [with Lotsof]."
Lotsof says he was so infuriated by Mash's work on St. Kitts and her lawsuit that he decided he too should take legal action. But it wasn't until last month that he finally filed his own lawsuit in New York, accusing the University of Miami of allowing its investigator, Mash, to violate its agreements with him when she set up her own treatment center and when she obtained patents for discoveries she made while studying the process he invented. (This past April Mash and a colleague at the University of Minnesota obtained a patent for a new class of ibogaine-related compounds.) "Howard had worked on this for a number of years," Ronemus says. "He's cited in nearly everybody's research, and Mash is not. Mash appropriated what [the university was] entrusted with."
Chris Dudley, a university spokesman, would not comment on either lawsuit. Mash says that her department chairman is aware of the work she's doing offshore but stresses that the university is not involved. Geller, who is acting as Mash's attorney, says: "I don't believe in trying cases in the press. I will say that Mr. Lotsof's suit is totally without merit and is nothing but an attempt to divert attention from his own wrongful acts.