A number of the pharmaceutical companies who have made payments to University of Georgia Health Center physicians have settled multi-million dollar lawsuits with the Justice Department in recent years for crimes involving illegal drug marketing and payments to physicians.
The University Heath Center was not involved in any of the lawsuits and there is no evidence of any wrongdoing on the part of UHC employees.
These criminal cases are relevant, however, because they reveal a pattern of deliberate efforts on the part of many pharmaceutical companies to either bribe or mislead physicians into prescribing their medications.
In 2008, agreed to an over four million dollar settlement with the United States Justice Department to resolve allegations they marketed their drug Ambilify for off-label uses. Between 2005-2008, the Justice Department cited Otsuka for knowingly promoting Ambilify for pediatric use and dementia-related psychosis. Otsuka allegedly directed its sales force to specifically target child psychiatrists, pediatric specialists, and physicians and encouraged providers to prescribe Ambilify for pediatric patients. According to the Justice Department, “because of the potential market benefit, the long term care sales force promoted Ambilify off-label for the treatment of dementia-related psychosis.”
In 2015, W agreed to plead guilty to a felony charge of health care fraud. The $109 million settlement was part of a larger global settlement totaling $125 million for its illegal marketing of seven drugs, including the birth control Loestrin. Warner Chilcott admitted to the felony act of paying kickbacks to physicians throughout the United States to encourage them to prescribe their drugs. The government reported that the company’s management- including the former President W. Carl Reichel who plead guilty to one count of conspiracy to provide kickbacks to physicians – directed its sales teams to pay “remunerations” to physicians who would prescribe Warner Chilcott drugs.
The Justice Department cited the company for hosting fake “Medical Education Events” that proved to only be opportunities to pay physicians in the form of meals, dinners, and lunches at expensive restaurants in order to induce prescribing practices and gain competitive advantage.
The case did not outlaw payments for “food and beverage”, the most common payment to UHC physicians, within the industry all together. Rather, the courts have affirmed that meals, like many other forms of non-cash remunerations, could be considered illegal kickbacks depending on the circumstances.
In 2010, the company Allergan Inc. was forced to pay a $600 million dollar settlement for off-label marketing of their drug Botox. They “doubled the size of [their] reimbursement team
to assist doctors in obtaining payment for off-label Botox® injections,” according to the Justice Department. They engaged in other illegal marketing practices such pressuring doctors to make diagnosis for cervical dystonia (a diagnosis they focused their off-label scheming on) despite the absence of any clinical signs of cervical dystonia. Allergan held professional workshops and dinners for physicians to encourage off-label prescribing, paid doctors to be on “advisory boards” that focused on off-label uses, and enacted hotlines and reimbursement offices to help physicians get reimbursement from insurance for off-label prescriptions in order to encourage the practice.
Sanofi US agreed to a $109 million settlement with the Justice Department in 2012 over violations of the Anti-Kickback Statue of the False Claims Act. Sanofi allegedly gave physicians free units of the drug Hyalgan to persuade them to prescribe the drug to patients.
These court cases, and others like it, should give physicians pause even when they’re receiving legal payments from pharmaceutical companies, according to Dr. Banja.
“Let’s face it, that [pharmaceutical representative] is profoundly conflicted,” said Dr. Banja, “for the obvious reason, that they want to sell their drugs as much as possible.”
By: Amy Libby