Aug. 30, 2016
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| Actor Michael J. Fox's star power has built the Parkinson's charity he started into a fundraising juggernaut.
A crucial clinical trial of the most promising new treatment for Parkinson’s disease in decades might be delayed because of a feud between a key scientist and the influential Michael J. Fox Foundation.
The prominent foundation — the richest nonprofit seeking to cure the crippling neurological disorder — initially wanted to collaborate on a study with the Georgetown University researcher. His preliminary findings last year had buoyed patients’ hopes for the first Parkinson’s medicine that might reverse some of their debilitating symptoms.
The trial was supposed to begin in October, but Fox and the Georgetown team had a bitter falling out, and it’s unclear whether Georgetown will be able to obtain the medicine from its manufacturer so that the study can proceed. Fox, meanwhile, is moving forward on its own, and has established a separate group to study the same drug. That trial won’t start until about a year from now — a long wait for millions of Parkinson’s patients worldwide.
“We thought it was a scientific discussion, but (the foundation) had alternate motives,” Dr. Charbel Moussa, the Georgetown scientist, told STAT. Fox engaged in “a premeditated attempt to cut us out,” he said. “Some people think they are the owners of the conversation, the owners of the scientific debate, the owners of Parkinson’s research.”
Todd Sherer, chief executive of Fox, denied Moussa’s accusations. “We acted in good faith” to reach an agreement with Georgetown, he said, noting that the foundation has a long record of “credibility and authority” in its collaborations with hundreds of researchers.
STAT learned of the dispute from members of the Parkinson’s research community, and subsequently examined published scientific papers and emails and research proposals that passed between Georgetown, Fox, and the foundation’s collaborators.
Conflicts over credit and control of research are far from rare in the chase for medical breakthroughs. But rarely do such fights — with high stakes for professional stature, organizational prestige, and fundraising — erupt into public view.
The trial offers Moussa, a little-known scientist, a chance to vault into the top ranks of researchers, while Fox and its collaborators could reinforce their standing and tap into a bonanza of donations from wealthy philanthropists and worried patients.
The episode also highlights the tension between scientists and foundations that are no longer content simply to dole out money. Following the lead of the colossal Bill & Melinda Gates Foundation, major medical research philanthropies increasingly seek to coordinate or manage studies, or control details of how they are done — vexing many grant recipients.
In this case, the clash involves nilotinib, a cancer drug tested by Moussa and his colleagues in 12 Parkinson’s patients — many of whom described substantial relief from symptoms such as shuffling gait and cognitive decline. Although the trial was small, the results announced last year thrilled doctors and patients who have waited decades for a glimmer of success.
Soon after, Moussa said, the foundation, started by actor and Parkinson’s patient Michael J. Fox, approached him about funding his next steps. Moussa said he already had separate funding, and approval from the US Food and Drug Administration and a university research review board to conduct a Phase 2 trial — a larger test of the drug’s safety and effectiveness — at Georgetown. He hoped that Fox would underwrite costs for other test locations, which would give the results more credibility.
Discussions between the sides lasted about six months, during which Fox officials reviewed and asked for changes in the Georgetown study design. Moussa disagreed with some requests involving verification of concepts he said had been demonstrated in the initial study. The modifications would “delay us for one year, and this was not good for patients,” Moussa said.
Dr. Charbel Moussa, in his laboratory at Georgetown University, is investigating a new treatment for Parkinson’s disease.
The talks fell apart when Brian Fiske, the foundation’s senior vice president for research, told Novartis, nilotinib’s maker, that Fox disavowed the Georgetown project.
“Whether they [Novartis] will continue to review your proposal is of course up to Novartis, but we made it clear that this was submitted without our knowledge or commitment to support,” he wrote to Moussa in a June 17 email provided to STAT by the Georgetown scientist.
Moussa said he hopes Novartis eventually will donate the drug — valued at several million dollars — for the proposed 75-patient trial. He said Fiske’s intervention seemed designed to sabotage his proposal.
Soon after, Fox announced its own Phase 2 trial. Sherer said he encouraged Novartis to supply nilotinib to all researchers — including his foundation and its partners from two other nonprofits.
Novartis spokeswoman Julie Masow would say only that the company “is in discussions with Georgetown about the possibility of supporting this study.”
https://www.statnews.com/2016/08/30/parkinsons-study-fox-foundation-feud/?
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