Spotlight: Falsified and misreported data on the rise?
Last week, an appeals court affirmed the 57-month prison sentence for a former Iowa State University researcher who falsified the results of an HIV vaccine experiment. Also last week, a GlaxoSmithKline (GSK) biostatistician who blew the whistle on significant flaws with Nicoderm studies claims to have been fired as a result.
It was a big week for shining a spotlight on the misreporting of data in biopharma.
The researcher in Iowa, Don-Pyou Han, must repay more than $7 million to the National Institutes of Health (NIH), in addition to nearly five years of jail time.
In the meantime, the former GSK biostatistician who filed a lawsuit in Morris County Superior Court in New Jersey over his termination says that when he brought signifiant mistakes to his superior’s attention, he was told, “I am free to decide, say or write whatever I want. I’m not going to listen to you.”
What exactly happens after misreported data like this comes to light? What takes place downstream of information that doesn’t reflect the reality of a study?
The first step, when misreporting is confirmed, is retraction of the scientific paper that initially made public the now-troublesome results, said Ivan Oransky, co-founder of five-year-old Retraction Watch, an organization that draws attention to papers retracted from scientific journals.
Disturbingly, though, many retractions go unnoticed, and some researchers build their studies on information from the retracted paper, citing it in their research. Mistakes of this nature spread like a virus, said Oransky.
Retraction Watch draws readers to the 10 most highly cited retracted papers. A number of these papers were cited hundreds of times after their retraction simply because other researchers never saw that the authors had admitted the data contained significant errors.
The good news is that most retractions take place in the preclincal space, well before a compound or device has made it into clinical trials, said Oransky.
“At the end of the day, we can all be more skeptical of pharma because they have financial interest in study results, but they are also heavily, heavily regulated, and clinical trials are very expensive,” he said. “You’re far less likely to see misreporting in research funded by pharma.”
In 2010, the FDA proposed a change to its rule on the reporting of information regarding falsification of data, placing more of the onus on the sponsor.
“Although our own inspections sometimes uncover falsification of data, sponsors of studies are responsible for ensuring the integrity of study data and are in a better position to discover possible falsification,” wrote the FDA in the proposed rule amendment.
Why change the rule now? The agency said an FDA working group identified much ambiguity in the current regulations. Impactful changes include: possible falsification of data must be reported; the amount and type of information sponsors must report when a study and/or an investigator’s participation in a study has terminated; the company that falsified data must be reported; and the timeliness of filing a report must be documented.
That, and falsification of data is on the rise, said the FDA.
“The FDA’s proposal to amend the regulations has its origins in events that occurred in the mid- to late-1990s, when complaints to the FDA ... revealed some particularly egregious cases of falsification of data by clinical investigators,” wrote the agency. “For example, in one case, an investigator falsified data that extended across studies in 91 applications submitted to the FDA by 47 different sponsors.”
While the Iowa researcher who falsified HIV trial data goes to jail and tries to figure out how to repay in excess of $7 million to the NIH, eyes are on the GSK Nicoderm whistleblower case.
The FDA proposal to amend regulations is a step toward rectifying processes, but companies need to be more vigilant for the problem to be solved on an acceptable level.
Suz Redfearn is an award-winning journalist and former senior staff writer for ClinPage.com. Her articles have appeared in numerous publications, including the Atlantic.com, the Washington Post, Slate, Salon, Politico, Men's Health, MedPage Today and Physicians Practice. Suz holds a degree in print journalism from Loyola University in New Orleans and has been a medical writer since 1990, focusing on clinical research since 2007. Email firstname.lastname@example.org.
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