When TAP Pharmaceutical Products Inc.'s national account executive Janice Swirski offered Joseph Gerstein, MD, an administrator with Tufts Health Plan, a $40,000 “unrestricted educational grant” to put TAP's drug Lupron on Tufts' formulary — she picked the wrong doctor for a bribe. For years, Gerstein has written newsletters deriding pharma marketing practices. But TAP had gone too far. Gerstein reported the incident to federal prosecutors, and helped them build a case that resulted in the largest health care fraud settlement in U.S. history — $875 million, according to the Boston Globe. (Though it settled in October, Lake Forest, Ill.-based TAP denied many of the government's allegations.) Six TAP top managers were also indicted by a federal grand jury for allegedly offering doctors kickbacks and bribes.

The case is the most dramatic example of the recent government crackdown on illegal pharmaceutical marketing tactics. While the TAP case was prosecuted under federal anti-kickback laws, which apply to drugs and devices reimbursed by government programs such as Medicare and Medicaid, it nevertheless has ramifications for the entire medical community, including physicians and CME providers, as well as drug companies.

To help the medical community understand the implications of the TAP case and the intensifying government scrutiny of pharma practices, the Health Care Compliance Association held an audioconference in December. Presenters included federal prosecutors, and pharma company representatives, who clarified they were speaking for themselves, not on behalf of their clients or employers. They stressed that the case is a wake-up call for the industry. “We already knew we couldn't bribe doctors to prescribe, offer phony grants as rewards, or pay for doctors' attendance at conferences based on their volume of prescribing,” said Ann Lewis, senior corporate counsel, Pfizer Inc., New York. “Regardless of whether the TAP allegations are true, we learned nothing we didn't already know. But we can expect closer scrutiny of actions from the government and potential whistle-blowers.”

CME providers who have complained long and loud about the unethical practices of some reps should applaud the presenters' recommendations:

  • Just Say No — Physicians and pharma reps need ongoing training in ethical and legal guidelines regarding inducements such as gifts and grants;

  • Adhere to AMA Rules — All players should abide by the American Medical Association's ethical guidelines on gifts to physicians;

  • Fund Bona Fide, Not Bogus, Programs — Pharma firms should pay for legitimate educational programs or physician consulting services — not use funding to bribe or reward doctors;

  • Get the Good Housekeeping Seal — Pharma-funded educational events that are accredited by the CME community may be at lower risk for investigation.

CME — Not a Shield for Improper Inducements

While pharma support of education is valid and CME accreditation affords programs a certain prima facie legitimacy, you cannot use CME as a shield against improper inducements, said Lewis, in an interview after the conference. “It is in the interests of CME providers to adhere to the highest standards. Nothing makes a CME provider look more legitimate than a refusal to be a mouthpiece for a company. CME providers who are willing to ‘wink-wink, nod-nod’ with companies in terms of program content debase the entire field of activity.” She advises organizations to disclose funding sources, even for promotional activities, just as the Accreditation Council for CME stipulates that providers disclose commercial support of accredited programs.

Dine ‘n’ Dash Raises Red Flags

As for promotional activities, prosecutors said they are looking for a “culture to defraud,” rather than isolated cases of misconduct. “It's not illegal to hope for sales. It's illegal to pay for them,” said Jim Sheehan, assistant U.S. attorney, eastern district of Pennsylvania. “The sales rep who brings pizza to the [medical] staff is not someone you want to haul off to the grand jury. That goes under the category of hope. But a corporate culture that allows dine 'n' dash events, and gas 'n' go, can lead to problems. Once you feed [physicians], and give them gas for their cars, it can be hard for sales reps to distinguish between that and the next thing the doctor asks for, such as a dinner and a $250 consulting fee just for showing up. Where do you draw the line as an organization? Guidelines have to be very clear.” Added Lewis, “We need to create buy-in to the anti-kickback laws and an enthusiastically law-abiding sales force.”

Crackdown Continues

The Office of the Inspector General is developing a voluntary guidance for pharmaceutical companies, which will be ready for comment in the spring. Speakers stressed that the government has made enforcement of pharmaceutical industry regulation its top priority, and they expect the scrutiny to last for the next three to five years.