Fourteen-year-old Carson Domey recently injected himself with his Crohn’s disease medication for the first time. But he didn’t quite position the injector properly, so some of the clear liquid accidentally leaked down his leg.
His mom, Michelle, was outwardly reassuring but silently freaking out. She normally pays just $23 in monthly copays for Carson’s four allotted doses of Humira. Without insurance, a replacement dose would cost about $2,500.
While waiting for a callback from her son’s doctor, she phoned a nurse made available to her by AbbVie (ABBV), the drug company that makes Humira. With a few phone calls, the nurse arranged for a new dose to be sent free of charge to their home in Bellingham, Mass.
To Domey, the nurse was a godsend.
But to detractors, the nurse — and others like her, who are often known as “nurse educators” — blur the line between caregiver and marketer, raising ethical questions for both the nurses who deliver the care and the companies that pay their salaries.
In lawsuits filed over the past year against several of the largest drug makers, whistleblowers have raised questions about whether the use of nursing staffs — which AbbVie called nurse ambassadors — is medically appropriate or a multimillion-dollar violation of public trust.
The lawsuits contend the companies hired third-party contractors to deploy nurses — sometimes by phone, sometimes in patient’s homes — to ensure that prescriptions were refilled. The drug makers also allegedly provided kickbacks to physicians in the form of free insurance processing assistance, medical practice management software, and marketing assistance to persuade them to prescribe their drugs.
“This is marketing laundered through your doctor,” said Adriane Fugh-Berman, a professor at Georgetown University Medical Center in Washington, who runs PharmedOut, a project that examines the influence drug makers have on the practice of medicine.
On one hand, the nurses teach patients how to use complicated medications, work to resolve drug-related problems, and help with insurance paperwork — all of which Domey and other Humira patients may appreciate. But they also keep patients taking the world’s best-selling medication, even if another drug would work just as well, Fugh-Berman said.
Among detractors, that has earned the practice the term “white coat marketing.”
“You’re providing services to a patient so that patient will be motivated to stay on a drug which may not be the best drug for them and may not be the most cost-effective drug,” Fugh-Berman said. “That’s what the purpose is.”
In addition to AbbVie’s use of nurse ambassadors, the lawsuits also cite Eli Lilly’s use of nurse educators for its insulin drugs to treat diabetes; Gilead Sciences (GILD) for its HIV and hepatitis C drugs; Bayer (BAYRY) for its cancer and multiple sclerosis drugs; Amgen (AMGN) for cancer-related treatments; and AstraZeneca (AZN) for three medicines, including the Brilinta blood thinner.
The companies have defended their practices, saying nurses provide a benefit to patients and doctors. AbbVie, for instance, has contended its program complies with state and federal laws, and does not interfere in relationships between patients and doctors. Spokesmen for Bayer and Lilly said the claims are without merit and denied the allegations.
The other drug makers either declined to comment or did not reply to questions.
Until recently, the issues raised in the lawsuits gained little notice.
But that changed last month, when California Insurance Commissioner Dave Jones filed a lawsuit that largely mirrored allegations made by a former AbbVie nurse educator, Lazaro Suarez, in whistleblower lawsuits that he filed earlier this year in a California state court and in a federal court in Illinois in 2015.
“The company used nurse ambassadors to interfere with the communication between patient and doctor, in order to keep patients on its drug. And private insurers paid out $1.2 billion in claims,” Jones said in an interview. He declined to say whether his department is probing other drug makers, but maintained that his office conducted a separate investigation to verify the whistleblower allegations.
The heightened interest threatens to engulf the pharmaceutical industry in yet another scandal over marketing practices. More than a decade ago, nearly every large drug maker paid hefty fines and reached settlements with the federal government for marketing medicines that were not approved by regulators for particular uses. The practice is known as off-label marketing.
More recently, federal prosecutors have actively pursued alleged kickbacks paid by drug makers to physicians in order to encourage prescribing. These accusations, which often involve speaking or consulting fees, are also mentioned in the latest round of lawsuits. But allegations over the improper use of nurses may pose an entirely new set of challenges for drug makers.
“This is the biggest topic in compliance circles, by far,” said Manny Tzavlakis, a managing partner at Helio Health Group, which advises drug makers on regulatory issues. “You’re seeing patients becoming more of the center of commercial programs now. And this is the new area where the government can take on the industry.”
Whether other state regulators will file lawsuits is unclear. Jones noted few states have laws that allow officials to pursue health care fraud against commercial insurers. Tzavlakis, however, pointed out that there are signs government officials beyond California might be taking an interest.
Both Sanofi (SNY) and Biogen (BIIB) have received notices from the federal government seeking information about clinical educator programs. And an upcoming industry conference devoted exclusively to nurse educator programs lists U.S. attorneys from Newark, N.J., and Philadelphia as speakers.
So far, though, the federal government has not gotten directly involved in any of the whistleblower lawsuits. Under federal law, the Justice Department can join a lawsuit, although it usually does not do so unless there is a good chance the case will succeed.
David Schumacher, a former deputy chief of the health care fraud unit in the U.S. attorney’s office in Boston, said there are long-standing concerns about white coat marketing.
“If you’re a nurse who can gain access [to the patient] and use professional bona fides to cloak the real objective — to promote the drug — that relationship is of concern, if it’s coercive and can lead to overuse or inappropriate use of a drug,” said Schumacher, now a partner at the Hooper, Lundy & Bookman law firm. “That type of arrangement is going to be very closely scrutinized.”
“But the nature of the content of the interaction matters a lot,” he added. “Is it purely a clinical discussion or more for marketing reasons? There are other factors they look at, such as who does the person report to — a medical officer or a sales manager? If it’s a sales manager, it may be considered evidence that the person is there to drive sales.”
“This is adding a kind of dark layer to our whole system, because we don’t really know what they’re doing. Essentially, the companies are creating their own internal, closed health care system.”
Elissa Ladd, Massachusetts General Hospital Institute of Health Professions
The AbbVie lawsuit, filed by a former nurse ambassador, accuses the company of getting its nurses to assume functions typically performed by the doctor’s office, such as discussing a patient’s health status, and working with patients to enable payment of the drug.
This “offers tremendous value and time-saving to physicians and incentivizes them to prescribe Humira, and also has the effect of diluting the doctor-patient relationship,” the lawsuit stated. “Further, the direct patient contact between AbbVie … and the patients enables the ongoing gathering of patient information — and provides a slanted and improper forum for discussion of Humira’s side effects.”
Before the nurse ambassador program, the lawsuit charges, many doctors didn’t prescribe Humira because it required so much patient support and paperwork.
“The Ambassadors step in to take over these functions and thus relieve the initial barrier to the sale,” according to the lawsuit. “Tellingly, the sales representatives tell doctors to ‘think of [the Ambassador] as an extension of your office.’ This plants the seed for doctors to muddy the role of the Ambassador in descriptions to patients.”
These nurses in these programs operate outside the normal medical system and are accountable to a company rather than a patient or doctor, said Elissa Ladd, an associate professor of nursing at the MGH Institute of Health Professions in Boston.
“This is adding a kind of dark layer to our whole system, because we don’t really know what they’re doing,” Ladd said. “Essentially, the companies are creating their own internal, closed health care system.”
But it’s easy to see why nurses would want jobs like these, she said: They don’t involve night and weekend work or lifting patients. They pay well. And nurses love playing the role of educator.
“I don’t think they’re in on the scheme,” said Ladd, adding that she believes the companies are intentionally deceiving these nurses about their true role.
Rae Merlo, an AbbVie ambassador nurse until recently in the San Francisco Bay area, said she and others in the program were “very much aware of what the guardrails were and we never gave the impression we were promoting the drug in any way.”
“It was reiterated over and over that we were never to give medical advice and refer patients back to health care providers if there were any problems or complaints with the drug,” she said. “There were 400 nurses in the program by the time I left. What is the likelihood AbbVie would find 400 nurses who would agree to go against the ethical training we learned in nursing school?”
As for the whistleblower, “if this person’s experience was, indeed, that he was instructed to advise his patients not to communicate with health care provider … either he didn’t understand instructions or reported to a rogue manager.”
Fugh-Berman said she sees these jobs as unethical, and believes nurses — the most-trusted professionals in America — shouldn’t be taking them, no matter how good they seem on the surface. “You are betraying your profession,” she said.
But what if, at the end of the day, patients feel the service as been helpful?
Brooke Nisenbaum, a community health worker in Phoenix who has Crohn’s, said she used a nurse ambassador for her Humira and loved the at-home visit, the personalized training, and the nurse’s responsiveness to her many questions. Her nurse ambassador also helped her sign up for a copay assistance program and got her six free doses of the drug to get her started.
She didn’t feel pressured to start the drug her doctor had prescribed or continue on it, and did not experience any side effects or problems.
“They’re really helpful,” she said of the nurse ambassadors.
Similarly, Domey, Carson’s mom, said she hasn’t felt deceived at all by the nurse ambassador program. She understands that the nurses are not her son’s caregivers or part of his medical team — but she appreciates the tips, such as how to keep Humira cold when the family travels.
She doesn’t feel pressured to continue Carson on the drug; he’s taking it because it’s effective, she said. He hasn’t needed to go to the hospital for the three years he’s been on Humira, and hasn’t noticed any significant side effects.
“Right now,” she said, “this is what’s working.”