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Nov. 4 — The uncertain political climate caused by the upcoming presidential election hasn’t derailed the momentum of the cancer “moonshot,” the White House’s lead on the initiative said Nov. 4.
“I’ve been in Washington since 1985, and I have never been associated with a program that has more bipartisan support and more excitement from the average citizen than the moonshot,” Greg Simon said at a biopharmaceutical conference. “That’s irreplaceable, and that has to be sustained.”
Simon, who is the executive director of the initiative led by Vice President Joe Biden to double the rate of progress in cancer research and treatments in five years, discussed the future of one of President Barack Obama’s final major health initiatives four days before the Nov. 8 election.
Democratic nominee Hillary Clinton endorsed the cancer moonshot in August and said she wanted Biden to continue his work in some capacity. “I haven’t heard anything from the Trump campaign at all,” Simon said. But a pharmaceutical executive is serving as chief of staff for New Jersey Gov. Chris Christie (R), who is the chairman of Republican nominee Donald Trump’s transition team, he noted. Christie tapped Celgene Corp. executive Richard Bagger, whom Simon said he knew because they worked together at Pfizer.
“That’s just a serendipitous thing,” he said.
Simon said he was meeting later that day with representatives of the 20 federal agencies in the task force to discuss how to carry the moonshot forward in any administration.
Simon also outlined a plan to break down barriers to data sharing—one of the primary goals he has repeated numerous times since his appointment to head the cancer moonshot task force in March.
“Our medical research system is just an extensive insider trading system,” he said at the Biopharma Congress II: Election Impact on Biopharma in 2017. “If you look at health research as a market, you can’t have a market when you don’t have data transparency and real time reporting of what’s going on,” he said.
He called for leaders to change incentives across the research system that make scientists reluctant to share their data. Some steps already have been made, he said, pointing to a new requirement at the National Cancer Institute, part of the National Institutes of Health, stating that any cancer center that wants to be part of the NCI’s cancer care network must agree to share its data as a condition of receiving the agency’s millions of dollars. He also wants peer reviewed journals to open up databases immediately upon publication, “or NIH is going to revoke certain moonshot money to require that.”
“Clinical trials are supposed to be for the good of society, which is why you’re supposed to share the information,” Simon said. “If you don’t share the information, it’s really unethical to put a person into a trial if the information gained by using that human being isn’t shared.”
Richard Pazdur, acting director of the FDA Oncology Center of Excellence, also said there could be changes among the drug and device industry to promote data sharing and share control groups. He said he listened to a presentation from an investigator who had five ongoing clinical trials studying the same type of renal cell cancer. While the study drugs were from different companies, they all had the same control groups.
“The clinical trial enterprise is not the property of a drug company. It is a national treasure that we have,” Pazdur said. “We have to use that treasure in a judicious way.”
FDA Commissioner Robert M. Califf said during a later session at the same conference those reward systems that don’t give incentives for data sharing have also been a major barrier in the agency’s move to incorporate more real-world evidence into the regulatory approval decisions of new medical products.
“The main limiting factor is purely cultural,” Califf said. “There’s overblown protectiveness that needs to be solved.
Simon echoed Califf’s thoughts. “Our attitude about sharing needs to catch up with our ability to share. We can move information all over the world in a nanosecond—only if we push the button.”
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More information on the Biopharma Congress is at http://www.focr.org/events/biopharma-congress-ii-election-impact-biopharma-2017.
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
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