Academic scientists who ignore legal requirements to publicly report clinical trial results often have received large payments from drug companies involved in the studies, a STAT review of federal data found.
Such financial ties raise the specter of commercial interests overriding researchers’ ethical and legal responsibilities. But weaknesses in a federal law mandating reporting of clinical trial data have made it hard to assess how drug company ties to academic researchers contribute to their frequent failure to disclose study results.
STAT reported this week that nearly all universities, academic medical centers, and drug companies routinely fail to report the results of trials involving human subjects within legal time limits — or at all. Many prominent institutions have flouted the law on 95 percent to 100 percent of their trials, including many funded by corporations.
“I wouldn’t accuse anybody of selling their opinion or their reporting behavior to a drug company,” said Dr. John Abramson, a health policy lecturer at Harvard Medical School and an advocate for greater openness of trial results.
But he worries about academic researchers’ divided loyalties. “What is the responsibility of experts who receive funds from drug companies to the public at large, as opposed to their responsibilities to the drug companies who are paying them?” he said.
In 2013 and 2014, pharma companies paid US doctors $6.5 billion for research and for travel, consulting, and speaking fees, according to the federal Centers for Medicare and Medicaid Services OpenPayments website. Another $1.8 billion went to teaching hospitals, and doctors held $1.6 billion in ownership or investment stakes in drug firms.
Dr. Steven Goodman, a Stanford University professor who leads a center that plans to monitor government statistics on clinical trial reporting, said, however, that reporting lapses often have innocent causes, such as lack of familiarity with the process.
“It’s not all malfeasance or scandal,” Goodman said. “There’s ignorance, difficulty, maybe honest efforts that are improperly applied.”
In 2007, Congress mandated that researchers report the results of many human experiments of drugs and medical devices to the website ClinicalTrials.gov, administered by the National Institutes of Health. They were concerned that scientists who conduct industry-funded studies were often induced by financial ties or restrictive language in research agreements to withhold the findings — especially negative results.
“I’ve heard from some scientists that they can’t disclose the findings of their studies because the data belongs to the manufacturer,” Senator Charles Grassley, an Iowa Republican who was a key advocate for the law, said before it passed. “(A)nd those results don’t always see the light of day. But scientists need access to all of the evidence to conduct a full and independent review of a product’s safety.”
The law requires that “principal investigators” — the lead researchers on a study — be named in ClinicalTrials.gov. But a STAT analysis of trials required to report results to the database shows that no name was provided for more than 30 percent — nearly 2,800 studies.
Clinical trial reporting lapses visualized
STAT examined data reporting for all institutions – federal agencies, universities, hospitals, nonprofits, and corporations – required to report results to ClinicalTrials.gov for at least 20 human experiments since 2008. This visualization shows the first comparative analysis of their performance. Among the groups, just two companies provided trial results within the legal deadline more than half the time. Most – including the National Institutes of Health, which oversees the reporting system – violated the law the vast majority of the time.
Percentage of clinical trials by entity that have late or no results:
Some of the missing investigators were likely staff scientists for pharma or medical device companies, but the number is unclear from the database.
In addition, investigators at universities and other nonprofits are not obligated to provide the details of their information-sharing agreements with companies — including restrictions on what they can say about the research — until they actually post results to ClinicalTrials.gov.
Those factors make it hard to draw firm conclusions about whether influence by pharma companies is a large factor in the widespread failure by researchers to comply with reporting requirements.
Individual cases show why critics remain concerned about those financial links.
Dr. E. Steve Woodle, a transplant surgeon at the University of Cincinnati, failed to submit results by Sept. 10 (when STAT downloaded the ClinicalTrials.gov database) on four trials of drugs to prevent organ rejection.
Some of the results were published in medical journals, and Woodle said in an interview that his studies all had favorable outcomes. After being contacted by STAT, he said he quickly submitted his required results to ClinicalTrials.gov. The data for one study have now been posted — more than four years late. The other results have not yet appeared on ClinicalTrials.gov, pending the normal NIH quality-control review.
Woodle said he started the data-entry process months earlier and blamed cumbersome NIH procedures for his tardiness. ClinicalTrials.gov data entry costs him $25,000 to $50,000 per trial and is an “unfunded mandate,” he said. NIH estimates that it takes, on average, much less time — about 40 hours — to enter trial data.
In 2013 and 2014, Woodle earned more than $131,000 from drug firms for speeches, consulting, and travel, plus about $4 million for research — by far the most overall funding for any US transplant doctor — according to the OpenPayments website. The money included payments from Sanofi (SNY) and Millennium Pharmaceuticals, firms involved in three of his four tardy trials, including one completed in 2013 with results due in 2014.
He said the payments had no effect on his filing of results and were unrelated to the trials in question.
A Louisville, Ky., dermatologist has the dubious distinction of leading the two most-overdue trials registered with ClinicalTrials.gov — nearly seven years. Dr. Joseph Fowler Jr. received more than $800,000 from drug companies in 2013 and 2014, including $14,000 in speaking and consulting fees from Valeant, parent company of Coria Laboratories, which sponsored both studies of drugs for skin ailments. Through a representative, he declined to comment.