The Obama administration recently made it clear that it will require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment under the new health care law — see the New York Times. Large numbers of American doctors receive payments from drug and device companies every year —  sometimes amounting to hundreds of thousands or millions of dollars — and the new standards will hopefully have a deterrent effect on these financial conflicts of interest.

However, the new disclosure standards only apply to products covered by Medicare and Medicaid. And federal law does not prohibit doctors from accepting such largesse; it only mandates that the companies disclose the payments to the federal government, which will then post the payment data on a publicly available website. Hence, doctors in the private sector can continue to take what some call “kickbacks” in exchange for promoting drugs and medical devices at conferences and in medical journal articles.

This may explain why researchers have recently called for both stricter enforcement of anti-kickback statutes already on the books and for the passage of federal legislation that would prohibit such kickbacks to doctors in the private sector. In a recent overview article in the Journal of Law, Medicine and Ethics, Mark Rodwin, a professor of law at Suffolk University, notes that the U.S. (unlike France, for instance) only prohibits kickbacks — in the form of gifts, speaking and consulting fees, entertainment and travel reimbursement — for publicly employed doctors, not for the majority of U.S. physicians working in the private sector. So Rodwin, who is also an Edmund J. Safra Fellow at Harvard University, urges Congress to ban such kickbacks to all physicians.

Most physicians object to what he calls “abnormal corruption: explicit kickback payments” for prescribing or purchasing drugs, he notes. Yet many accept what he calls “normal corruption: influence through gifts and financial support.”

Not only should Congress ban kickbacks for all doctors, Rodwin argues, but the U.S. (along with France and other countries) should create an alternative to pharmaceutical industry funding for professional medical activities. He suggests that policy makers tax drug companies and other commercial interests that support continued medical education (CME) activities and then have an independent government or quasi-government agency distribute those funds for such activities. As Rodwin explains:

“When consumers and public authorities pay these expenses directly, they eliminate a major source of dangerous conflicts of interest that compromise medical practice.”

Consumers, after all, are already paying for the huge investment drug and device companies make to influence physicians — in the form of high drug prices. So why not use this approach to keep drug and device companies at arms’ length from medical education? Are you listening, Congress?

In the meantime, federal and state officials could do much more to deter what Rodwin calls “institutional corruption” by enforcing anti-kickback and false claims laws that are already in the books. In an article published Tuesday in PLoS Medicine, three researchers argue that physicians who attach their names to journal articles ghost-written by medical contractors working for the drug industry may be legally liable under these existing statutes.

They argue that prominent physicians or key opinion leaders who are paid speaking and consulting fees by drug companies and then attach their names to ghost-written articles that tout company products could be named as co-conspirators in a False Claims Act (whistleblower) lawsuit, along with the manufacturer. Physicians could also be charged with receiving kickbacks in exchange for appending their names to ghost-written articles, under the current anti-kickback statute. Right now, guest authors are rarely named as defendants in either personal injury lawsuits or government cases alleging the illegal marketing of off-label drugs.

As I mentioned earlier, both of these statutes only apply to drugs that are covered by Medicare and Medicaid, but since most new drugs are covered by these government programs, that would encompass the vast majority of physicians who attach their names to articles ghost-written at the behest of drug companies.

As the PLoS Medicine authors argue, merely attaching the names of KOLs to such lawsuits would create a powerful deterrent against an unethical but still widespread practice in medicine — ghostwriting. So why the heck not?

 

 

 

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