Three Strikes and They’re Out?
Last Wednesday patients and doctors welcomed a third win in the courts upholding state laws that limit pharmaceutical company interference with good prescribing. Judge Lynch on the U.S. Court of Appeals in Boston (First Circuit) handed down the ruling on Maine’s 2007 “data mining” law banning the use or sale of records showing which drugs health care practitioners have prescribed to their patients. The Maine law is nearly identical to laws in New Hampshire and Vermont that have also survived challenges by industry.
Prescription data mining, described in more detail here, is the business of health information organizations, such as IMS Health, Verispan and Wolters Kluwer. These companies purchase records from pharmacies containing prescription information (but not patient identities), combine them with practitioner profiles purchased from the American Medical Association and sell complete practitioner prescribing profiles to pharmaceutical companies. These profiles let marketers know exactly which drugs individual practitioners are prescribing so they can tailor their promotional messages to them. Maine’s law allows health care practitioners to “opt-out” of releasing their prescribing data for marketing purposes at each instance of licensure or re-licensure. The AMA has its own “opt-out” system, but few doctors even know about the program. Furthermore, it still allows drug companies to buy the disapproving physician’s prescribing profile, only requiring they refrain from sharing the individual-level prescribing data directly with the sales reps.
It’s clear that showing up in an office to pitch a new drug armed with the doctor’s complete prescribing history creates an unlevel playing field, making the interaction less about education and more about sales objectives. It’s not a surprise that most prescribers are not aware that their prescribing data is for sale. It’s even less surprising that drug reps are reluctant to inform prescribers that they have access to this information.
Solutions and Appeals
In 2006, New Hampshire passed the first-in-the-nation law completely banning the sale and use of prescriber-identifiable prescription data for marketing purposes. Representative Cindy Rosenwald—whom we’ve interviewed on related privacy issues before—pushed the legislation through the state assembly in 2006 as a measure to bolster public health and curb rising drug costs due to industry marketing.
Health information companies challenged the New Hampshire law shortly after it was enacted. A U.S. district court in New Hampshire overturned the law in April 2007 on the grounds that the use of such data by health information companies, pharmacies, and drug companies constitutes commercial speech; the law, they asserted, restricted that speech. New Hampshire Attorney General Kelly Ayotte appealed the decision and took the case to the United States Court of Appeals for the First Circuit. Community Catalyst and other consumer, professional and medical organizations presented arguments supporting the law in an amicus brief filed by, Sean Flynn of American University’s Washington College of Law
In late 2008, the First Circuit solidified the first in a series of major wins for prescription privacy advocates, upholding the New Hampshire law and affirming its constitutionality. The Court found that the law regulates conduct rather than speech, so does not infringe on First Amendment rights. It ruled that the state can regulate this practice since it affects public health and costs of care. Last year, the Supreme Court refused to hear a further appeal of the New Hampshire law filed by the plaintiffs (IMS and Verispan).
In 2007, Vermont legislators had passed a similar law banning the use of prescriber-identifiable data, except in cases where a health care practitioner “opts-in,” agreeing to release their prescribing records to marketers.
The Federal District Court in Vermont upheld the law on grounds that it would protect public health and contain drug costs, but the ruling was again appealed by health information organizations. Shortly after the Supreme Court refused to hear an appeal of the New Hampshire law, the Court of Appeals for the Second Circuit denied a request to grant an injunction of Vermont’s law, allowing the law to go into effect last July. We and others supported the law in an amicus brief. The Court is still considering the appeal and a decision is expected soon.
Where We Stand
For those keeping score, we now have three variations of data mining laws in three states. We’ve got the total ban, the “opt-in” and the “opt-out.” Each of the states has also been given the go-ahead to implement its law, though we’re still waiting for the outcome of the final appeal on the Vermont statute.
The First Circuit ruling is another win for prescription privacy and public health advocates. But the ruling may be most significant because there isn’t really anything remarkable about it. It feels like we’ve been here before, heard many of the same arguments and had similar results. Even though these three laws differ slightly in how they go about it, they all have the same intent: to limit drug reps’ access to prescriber-identifiable data. The legal and public health arguments for limiting data mining are clear, and that’s been shown time and again. Last week’s ruling in Maine cited many of the same findings from Vermont and New Hampshire decisions: the statute is constitutional, does not infringe on free speech guarantees, stands to protect public health and will save public dollars.
Maybe this was strike three. Or maybe the final appeals court ruling on Vermont’s law will be strike three. Sooner or later it will come and advocates can focus on developing programs and systems that use prescription information to improve patient care, rather than simply defending against its use for marketing practices that drive up costs. With the passage of the new health law, we need smart strategies like these to make the health care system more sustainable while improving quality.
— Ian Reynolds, program associate