ASHINGTON — At a national cancer summit Wednesday, Vice President Joe Biden threatened to cut funds to medical research institutions that don’t report their clinical trial results in a timely manner.
“Under the law, it says you must report. If you don’t report, the law says you shouldn’t get funding,” Biden said, citing a STAT investigation that found widespread reporting lapses.
“I’m going to find out if it’s true” that the research centers aren’t reporting the results, Biden said — “and if it’s true, I’m going to cut funding. That’s a promise.”
Biden’s remarks came at the start of a daylong cancer summit at Howard University, in which government officials, medical researchers, industry officials, patient advocates, and others gathered to discuss how to make faster progress in the fight against cancer.
Dr. Francis Collins, the director of the National Institutes of Health, later told reporters that a proposed rule — soon to become a final rule — should help by giving the agency more “clout” to crack down on institutions, not just individual investigators, when clinical trial data isn’t reported.
“That final rule is close to appearing,” he said. When it does, “we can basically say to Harvard, ‘Sorry, we’re not giving you any dollars until this principal investigator who ran a clinical trial deposits the data.’”
He also said the Food and Drug Administration will have the ability to impose $10,000-a-day fines on companies it regulates if they don’t comply with the reporting law.
Lawmakers and independent experts applauded the vice president’s attention to clinical trial data.
“I appreciate that Vice President Biden used the bully pulpit of his position to draw attention to this issue,” Senator Chuck Grassley (R-Iowa) said later in the day, adding that he has previously tried to address the problem. “I hope the Vice President’s speech pushes NIH into doing everything possible to bring about the timely reporting of research results for patient and doctor benefit. … Sometimes enforcement is necessary to get results.”
“We cannot optimally advance health care innovation — the discovery and development of new cures and therapies — without clinical trial transparency,” said Jennifer Miller, a New York University medical ethicist. “We need to learn from the lessons of the people who went before us,” for both positive results and failures. “It is also essential to protecting the patients and healthy volunteers in the clinical trial process.”
Miller’s own research has shown that only about two-thirds of results from human trials of approved drugs are made public. For drugs yet to be approved or rejected by the Food and Drug Administration, very little trial information is available, she said.
“The only point of funding a trial is to get the results, it’s mind-blowing that funders tolerate results being withheld. …(M)aking funding contingent on actually sharing your results, and ideally your data, is vital. If NIH can lead on this, then other non-governmental funders will hopefully follow,” said Dr. Ben Goldacre, a fellow at the University of Oxford and cofounder of The Compare Project and Alltrials.net, which advocates for disclosure of clinical research.
Goldacre has shown that a lack of transparency in trial reporting also has led to frequent discrepancies between the outcome measures specified by researchers at the start of a study, and those they ultimately report. That kind of cherry-picking of results can mislead doctors and patients.
“It’s only by … holding individuals accountable, that we can improve behavior,” he said.
At the summit, participants held closed-door workshops to discuss new ways to work together on issues like how to improve all levels of care for cancer patients, how to use data more effectively, and how to get more cancer patients to participate in clinical trials.
It was the centerpiece of a series of more than 250 local gatherings around the country, with their own discussions about the future of cancer research.
The national summit had a feel-good quality to it, with speakers praising Biden’s cancer effort and audience members sitting around tables with placards advertising the summit’s hashtag: “#CanServe.”
But Biden became visibly angry at times as he talked about the breakdowns he has seen — including the lapses in clinical trial reporting, as well as the steep rises in the cost of cancer drugs. He said he had learned of one drug — which he didn’t identify — that started out at $26,000 a year, and is now $100,000 a year.
“Tell me, tell me, tell me — what is the justification for that?” Biden demanded.
“Quite frankly, we have to change the culture” that allows such rapid price increases, Biden said, calling the cost of some cancer drugs “astronomical.”
The STAT investigation found that many research institutions, including well-known centers like Stanford University and Memorial Sloan Kettering Cancer Center, haven’t reported their clinical trial results as required under federal law — and the federal government hasn’t imposed any fines or withheld research grants, even though it has the authority to do so.
By law, the results of many human trials must be reported to ClinicalTrials.gov, a website operated by NIH. Four of the top 10 recipients of NIH funding failed to report results or reported after required deadlines at least 95 percent of the time since reporting became mandatory in 2008, STAT found. Even NIH’s own staff scientists didn’t report results as required by law three-quarters of the time. Such failures can prevent doctors, patients, and researchers from understanding key data on the safety and efficacy of drugs and medical devices.
Some of the institutions have improved their reporting practices since the STAT investigation appeared in December, according to the institutions. In February, NIH officials reported that in December and January they saw a 25 percent rise in new submissions of trial results compared to the prior year.
Biden promised to help find ways to get the federal government “out of the way,” but insisted that medical researchers and the rest of the community have to do more to overcome problems like the inability to share electronic medical records more easily.
“The impediment isn’t the lack of gray matter genius and ingenuity. … It’s all this stuff that gets in the way,” Biden said. “We have to figure out how to get out of the way, and you guys have to figure out how to get in each other’s way more,” he said, alluding to the need for more collaboration among researchers.
The vice president talked of the death of his son, Beau, at age 46 from brain cancer — which Biden identified as a stage 4 glioblastoma. He said Beau was treated in three different hospitals before his death, praised his MD Anderson doctors as “great tutors,” and added that, “If there are any angels in heaven, they’re all nurses.”
He said the cancer effort was about “honoring Beau,” but added that “this isn’t about him. It’s not about any one person. It’s about us.”
The Howard University audience also heard from Carol Burnett — one of the most popular comedians in the history of television — who choked up as she talked about her daughter Carrie Hamilton, who died of cancer while still in her 30s.
“Today is remarkable for many reasons, not the least of which is hope,” Burnett said, fighting back tears. “To a cancer patient … hope means everything.”
A full transcript of Biden’s comments on the reporting issue:
“There was a report in STAT news that although NIH funding for cancer trials requires the results of that data be reported instantly, the number of institutions that receive the most funding don’t report back to NIH in a timely fashion — sometimes a year or more. NIH scientists themselves, 75 percent of the time are late, or don’t report their results. That’s the study. It may be wrong and I hope the experts here will tell me that’s incorrect, but under the law, it says you must report. If you don’t report, the law says you shouldn’t get any funding. Doc, I’m going to find out if it’s true and if it’s true, I’m going to cut funding. That’s a promise.”