IMS Health Inc. operates in the shadows of the healthcare industry, gathering data that drug makers can use to sell medications more effectively. The data, however, are taken from the prescriptions that doctors write for their patients. That information is at the heart of a dispute over how far states can go to protect privacy ― a dispute that has reached the Supreme Court, and one that could broaden the reach of the 1st Amendment in troubling ways.

IMS and a handful of market research competitors pay pharmacists for the details contained in prescriptions, including the name of the doctor and the patient, the drug prescribed and the dosage. They compile that information into databases that track individual doctors’ prescribing habits, replacing patients’ names with “de-identified” numbers. Such databases can be valuable to the public, potentially helping to enforce drug laws, find patterns in the spread of disease and spot variations in how medications are used. But the main use ― and the one that pays for the databases ― is to help pharmaceutical companies persuade physicians to prescribe more of their products.

That’s one of the reasons states across the country have proposed or enacted regulations governing prescription data mining. Drug makers hire legions of sales representatives to pitch physicians in person about new products and new applications for older medications. They pay market researchers millions of dollars for information on individual doctors’ prescriptions because it helps them find sick people (chronically sick people in particular) who could be treated with their drugs or who are taking their competitors’ medications.

Some doctors object to the disclosure of such arguably private information to drug company sales forces. And some consumer advocates argue persuasively that the marketing inevitably leads physicians to prescribe drugs too frequently, and to prescribe the newer and more expensive drugs that pharmaceutical companies hawk most aggressively. These drugs may have been approved by the Food and Drug Administration, but that doesn’t mean they’re necessarily the best choice for the patient; the FDA doesn’t compare the effectiveness of new drugs against existing therapies.

In light of these concerns, Maine, New Hampshire and Vermont each adopted laws restricting the release of information on individual physicians’ prescriptions. IMS, other market researchers and drug manufacturers challenged those laws in federal court, claiming that their 1st Amendment rights were violated. The plaintiffs contended that the information provided by market researchers to drug companies and from drug companies to physicians was a form of “speech” that the states could regulate only if there was a compelling state interest and only if they used the least restrictive means to do so. There was no evidence that drug marketing harmed physicians or patients, they argued, so there was no compelling state interest in limiting speech.

The U.S. 1st Circuit Court of Appeals upheld the strictures in New Hampshire (and later, Maine) but the 2nd Circuit overturned the law in Vermont. The divergent rulings reflected a split between the courts over whether regulating the sale of such data amounted to a restraint on speech. The 1st Circuit held that New Hampshire’s law restricted market research companies’ conduct ― namely, their ability to aggregate and transfer information for drug-marketing purposes ― not their speech. The 2nd Circuit held that Vermont restricted speech by data miners and pharmaceutical companies, but did so without demonstrating a compelling state interest.

This month the Supreme Court agreed to consider Vermont’s appeal, and we hope the justices will be guided by the dissent written by 2nd Circuit Judge Debra Ann Livingston. As Livingston noted, pharmacies obtain sensitive information about doctors and prescriptions only because the state orders them to gather it for law enforcement reasons. Otherwise, doctors and patients might insist that the data be kept confidential. That information is every bit as sensitive as a hospital chart or a doctor’s notes, and should be subject to equally effective protection.

Just because IMS doesn’t supply patients’ names to drug companies, that doesn’t mean they can’t be tracked individually. According to Meredith Jacob of the American University Washington College of Law, the databases assign unique numbers to pharmacies’ customers that can be used to follow their prescriptions over time, helping drug makers spot the patients most likely to be customers for their new drugs and market those medicines to their physicians.

What’s worse, the data about prescriptions could conceivably be combined with other records to reveal some patients’ names. That’s because “de-identified” data may provide clues that enable it to be matched against names in other databases. In one example of this technique cited in a brief by the Electronic Privacy Information Center, a researcher was able to use public records to name more than a third of the supposedly anonymized victims in Chicago’s homicide database.

Drug makers should be able to market their products, but their 1st Amendment rights shouldn’t guarantee them access to sensitive data that wouldn’t exist but for the government’s requirement that doctors and patients disclose it. Many of the public health and safety benefits cited by defenders of prescription data mining can be obtained without revealing prescribers’ names to drug company sales reps. If states want to give doctors and their patients more protection against marketers gaining access to that information, they should be able to do so.

(Los Angeles Times, Jan. 31)