In a new article in the Journal of the American Medical Association, Diana Mason and Tony Yang discuss a $24 Million settlement paid by the pharmaceutical company AbbVie after a whistleblower complaint led to an investigation of their use of “nurse ambassadors” programs. Many pharmaceutical companies offer such programs that assist patients in using difficult to administer drugs. The lawsuit leading to the settlement alleged that nurse ambassadors are marketers disguised as caregivers.
“Nurse ambassador programs in part aim to ensure that patients continue the use of costly medications and have provided incentives to physicians and other clinicians to prescribe the medication,” Mason and Yang write.
While this settlement did involve some changes of practice to address the kickbacks to physicians and clinicians, the authors argue that the changes are not enough, and the settlement ultimately serves to normalize the use of harmful nurse ambassador programs. Many pharmaceutical companies continue to use nurse ambassador programs despite the ethical concerns raised by this lawsuit and others like it.
A number of authors have pointed to industry corruption involving pharmaceutical companies and the detriment it causes to the medical fields. Academics have criticized industry influence on research and scholarship as corrupting.
Industry funding of evaluations of its own products creates conflicts of interest so pervasive that some authors have argued that it calls into question the reliability of unbiased evidence as a whole. This same corruption has led some physicians to go so far as to say evidence-based medicine is no longer useful.
Research has found that industry payments to physicians likely change prescribing practices, lead to increased costs for programs such as Medicare, and expose patients to more dangerous, less efficacious drugs. This research suggests that these payments are a direct threat to patient care. The nurse ambassador programs have similarly offered payments to physicians in the form of cash, meals, trips, patient referrals, free management software, and assistance with insurance forms.
Another corrupt pharmaceutical company practice involves identifying physicians as “key opinion leaders” and publishing research in those physicians’ names that exaggerates the benefits and ignores the risks of industry products. The whistleblower complaint that occasioned AbbVie’s $24 million settlement made similar complaints that nurse ambassadors were encouraged to present unbalanced information about industry products to patients.
In 2018 one of the nurses working as a nurse ambassador alleged that AbbVie was using kickbacks to increase the number of prescriptions written for a dangerous tumor necrosis factor blocking drug called Adalimumab. The whistleblower also said the nurses were presented as an extension of the doctor’s office while acting as marketers for the drug. The complaint noted this corruption was so pronounced that the program alone caused patient’s insurance rates to increase.
The authors note that the product being promoted also presents serious safety risks:
“Adalimumab is a tumor necrosis factor (TNF) blocker that suppresses the immune system and has a ‘black box warning’ because of potential adverse effects of serious infections and cancer. At the cost of more than $7000 per month, the complaint noted that Humira had ‘single-handedly caused ratepayers in California to spend more money on insurance.’”
The settlement resulted in AbbVie paying $24 million to the state of California and admitting no wrongdoing. In addition to the cash settlement, AbbVie agreed to change some of the more egregious practices in the nurse ambassador program. They are no longer able to describe the nurse ambassadors as an extension of the doctor’s office.
In addition, nurse ambassadors must inform the patients that they are employed by the company selling them the drug, not the doctor’s office responsible for their care. They must provide patients with a United States Food and Drug Administration-approved medication guide, including the drug’s risks. Nurse ambassadors must be trained not to have patient-specific discussions with physicians, and their compensation can no longer be tied to patient adherence to the company’s product.
Mason and Yang see many problems with the settlement and believe it does not address the core problem with these programs: using trusted healthcare professionals to manipulate patients into using costlier, less effective, more dangerous drugs. While the settlement provisions seem to address some of the issues with kickbacks, the authors argue that these programs are still allowed to give physicians gifts in the form of costly nursing services performed by the nurse ambassadors.
Additionally, the settlement does not describe exactly how the nurse ambassador’s relationship to the parent company should be disclosed and expects each patient to understand the implications of nurses being paid by drug manufacturers. When this article was published, the webpage dedicated to AbbVie’s nurse ambassador program did not directly acknowledge that the nurses are hired and paid by the pharmaceutical company.
The authors do acknowledge some benefits of this program. It has the potential to reduce costs for patients while offering personalized care. These programs could also reduce administrative costs for physicians. However, they argue:
“The ultimate costs are transferred to private insurers, government programs, and taxpayers. When adverse effects begin to outweigh the benefits of the medication or the drug is not affordable, patients must decide whether to continue taking the drug or lose the personalized nursing care.”
Mason and Yang argue that the settlement paid by AbbVie does not do enough to dissuade pharmaceutical companies from using manipulative practices that put patient health at risk. Instead, it serves to normalize such underhanded practices by allowing them to continue mostly unchanged.
Yang YT, Mason DJ. Problematic Promotion of Medications by Nurse Ambassadors—Legal and Ethical Issues. JAMA. 2021;325(4):345–346. doi:10.1001/JAMA.2020.24509 (Link)