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Opinion

Grandstanding AGs sue to stop drugmaker's work to insure patients take medicine properly

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Opinion,Op-Eds,FDA,Class-action lawsuits,Pharmaceutical Industry

Patient adherence to instructions on prescription drugs is a problem of behemoth proportions.

According to a report conducted by the New England Healthcare Institute, not taking medications as prescribed leads to poorer health, more frequent hospitalization, a higher risk of death and as much as $290 billion annually in increased medical costs.

There isn’t any one way to solve the problem. Education? Sure, but that only gets you so far. Apps and other social media interventions? Yes. Phone call reminders from physicians and pharmacists? Absolutely. But, alas, there is no one magic bullet.

As any health care provider will tell you, the fact that actually taking a medication as prescribed is in a patient's best interest does not lead to a patient doing what is in his best interest.

And, to make matters worse, there isn’t any single overriding reason why patients are noncompliant.

Pharmacy programs seem to be the best way forward, and there's hard data to back that up. Case in point: the successful Appointment Based Model program being used at Thrifty White, a Midwestern chain of pharmacies. (For more information on the Thrifty White program, see the article "Adherence and persistence associated with an appointment-based medication synchronization program" from the December edition of the Journal of the American Pharmacists Association.)

But what about programs for medicines that are sold via specialty pharmacy because of regulatory restrictions?

The use of specialty pharmacies to support patients with complex medical conditions is an effective, well-established practice to help ensure patients comply with their physician-directed treatment plan.

One example is Exjade, a treatment option for patients with serious blood disorders who have chronic iron overload due to blood transfusions.

Chronic iron overload is potentially life-threatening, and does not always have symptoms that are recognizable until serious complications occur.

To drive compliance, Novartis — the developer and marketer of Exjade — developed a plan to drive compliance by incentivizing the specialty pharmacy BioScrip to develop and implement aggressive patient communications programs. And, yes, “incentivize” means “paying them to do it.”

According to Novartis, they “worked with BioScrip to ensure it had the information needed to reach out to patients. BioScrip reached out to patients using its own protocols to provide education, counseling and information about proper administration of the medicine and to fulfill prescriptions that have been prescribed by a patient's treating physician.”

And the programs worked. Patients were more compliant, and that’s a good thing, right? Not so fast.

New York recently filed a joint complaint with eight other states alleging that the Novartis program amounted to “kickbacks” paid, per New York State Attorney General Eric Schneiderman, to “promote Exjade drug to treat excessive iron in the blood."

"This arrangement between Novartis and BioScrip was dangerous for patients and is against the law," Schneiderman said.

"Our lawsuit against Novartis and our agreement with BioScrip send a clear message: Drug companies cannot pay pharmacies to promote drugs directly to patients."

But is working to drive patient compliance “promotion?” Is educating a patient on the urgency of compliance “dangerous?”

What message is being sent by Schneiderman?

Whether or not the Novartis program is against the law is a legal question to be argued in court, but on the face of it, the lawsuit sounds like an ill-considered shakedown with significant unintended public health consequences.

"The company disputes the allegations made by the Attorney General for the State of New York related to Novartis Pharmaceutical Company's (NPC) interactions with specialty pharmacy BioScrip and intends to defend itself in this litigation," said André Wyss, NPC president.

This is an important issue. Hopefully, Wyss’ resolve remains firm.

Peter J. Pitts is a former Food and Drug Administration associate commissioner and is now president of the Center for Medicine in the Public Interest.
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