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)
They call themselves “Fierce Pharma” for a reason. It’s a shame how much big Pharma has corrupted the medical literature, thus the entire medical industry.
And now the doctors and nurses are being called “heroes,” as we’re living through – possibly the biggest medical / pharmaceutical industrial complex hoax in world history – except the hoax that’s been propagated against all of Western civilization, by the psychiatric industry, for decades, or maybe even centuries?
Six years ago I was a beneficiary of an AbbVie ‘compassionate treatment program’ that got me access to the over A$100,000 worth of pills needed to cure my hep C. The drugs were yet to be listed on Australia’s Pharmaceutical Benefit Scheme (PBS) and there was no way I could afford them. My liver was in the process of turning to wood and it’s unlikely I would have survived until they were listed.
So do you think I’m grateful to AbbVie?
No fucking way!.
The so called ‘compassionate’ program was really a marketing exercise akin to a seeding trial, designed to turn doctors, nurses and patients into partisans for the drug. Several drug companies had hit the market with 2nd generation treatments for hep C at the same time and based on precedent it seemed unlikely more than one of them would receive PBS listing. The idea was that medicos who’d gained experience on the ‘compassionate’ programs would lobby the government to ensure AbbVie’s was the treatment that won. Their pills would then monopolise the Australian market with the taxpayer footing the ridiculous bill.
In the end the PBS listed all the new treatments, but with the proviso that after a certain number of full price prescriptions the Australian government would receive a substantial discount on subsequent ones (around an 80% reduction I’m told).
The lesson for US readers is that government funded health programs are in a much better position to negotiate deals with extortionate drug manufacturers than consumers or private health funds.
The lesson for everyone is that we should stop fining drug companies a fraction of the profits they make from illegal and unethical marketing practices and nationalise the lot of them. Or better yet, internationalise them.