A trio of federal prosecutors this week dissected trends they are seeing in health care fraud, but were cautious during a panel discussion about moving too far from traditional enforcement.
Fraud in medical research is an emerging theme, the Assistant U.S. Attorneys said, prompting concerns about patient care.
“The intersection between the commercial world and the research world and the translation of these research ideas into marketing messages or the influence of the commercial silo on the type of research that is done and not done… is, I think, really important for patient safety,” said Susan Winkler, a prosecutor with the Massachusetts U.S. Attorney’s office.
Winkler said research fraud cases exploit a weak point where the commercial and research industries connect. “It’s a big learning curve for the department to get to that particular area — it’s not easy,” she said.
But rooting out medical research fraud is necessary for “patient care, because we want evidence-based medicine,” she said.
“We want our doctors… to rely on evidence that is real and true and accurate and not partial or affected in some way by a money interest behind it,” she said Monday.
Winkler spoke Monday along with fellow Assistant U.S. Attorneys Marilyn May, of the Eastern District of Pennsylvania; and Maureen Ruane, of the District of New Jersey. They were part of a panel at the 13th Annual Pharmaceutical Regulatory and Compliance Congress for corporate compliance officers, held in Washington, D.C.
Winkler pointed to the government’s massive settlement with GlaxoKlineSmith, which agreed in July to pay $3 billion to resolve a range of fraud allegations, including unlawful promotion of certain drugs, failure to report safety data and false price reporting. Following the announcement, GSK put in place a number of procedures to bolster transparency in its research publications. Winkler lauded GSK’s efforts, and told the compliance officers in the audience that such practices are worth looking into for their own companies.
May added that the emerging trends shouldn’t deter prosecutors or compliance officers from staying focused on typical fraud in the health care industry, including price fixing, off-label marketing and kickback schemes.
“Despite all your efforts,” May to the compliance officers, “we’re still seeing the same kinds of cases. Seeing an upswing of research fraud… doesn’t mean cases we’ve been working on for the past 10 or 12 years aren’t still coming in.”