Advertisement

SKIP ADVERTISEMENT

A Fight Over How Drugs Are Pitched

Before pharmaceutical company marketers call on a doctor, they do their homework. These salespeople typically pore over electronic profiles bought from data brokers, dossiers that detail the brands and amounts of drugs a particular doctor has prescribed. It is a marketing practice that some health care professionals have come to hate.

“It’s very powerful data and it’s easy to understand why drug companies want it,” said Dr. Norman S. Ward, a family physician in Burlington, Vt. “If they know the prescribing patterns of physicians, it could be very powerful information in trying to sway their behavior — like, why are you prescribing a lot of my competitor’s drug and not mine?”

Marketing to doctors using prescription records bearing their names is an increasingly contentious practice, with three states, Maine, New Hampshire and Vermont, in the vanguard of enacting laws to limit the uses of a doctor’s prescription records for marketing.

On Tuesday, the Supreme Court will hear arguments in a case, Sorrell v. IMS Health, that tests whether Vermont’s prescription confidentiality law violates the free speech protections of the First Amendment.

The case is being closely watched not only by drug makers and data collection firms, but also by health regulators, doctors and consumer advocates who say the decision will have profound implications for doctors’ control over their prescription histories, and for information privacy, medical decision-making and health care costs.

Vermont’s attorney general, William H. Sorrell, petitioned the court to review the case after three leading data collection firms including IMS Health, a health information company, and the Pharmaceutical Research and Manufacturers of America, a drug industry trade group, challenged the state statute. Although the federal district court in Vermont originally upheld the law, an appellate court reversed the decision last November.

The federal government, the attorneys general of several dozen states, AARP, professional medical associations, privacy groups and the New England Journal of Medicine have filed briefs in support of Vermont’s law. The National Association of Chain Drugstores, the Association of National Advertisers and news organizations like Bloomberg and The Associated Press have filed briefs aligning themselves with the data firms.

The concern over marketing based on doctor-specific prescription records revolves around the argument that it makes commercial use of private health treatment decisions — initiated in nonpublic consultations between doctor and patient, and completed in government-regulated transactions with pharmacists.

The data has become more available because pharmacies, which are required by law to collect and maintain detailed files about each prescription filled, can sell records containing a doctor’s name and address, along with the amount of the drug prescribed, to data brokers. (The records are shorn of patient names and certain other personal details covered by the Health Insurance Portability and Accountability Act, known as H.I.P.A.A., the federal legislation governing a patient’s privacy.) Data brokers in turn aggregate the records for use in medical research and marketing.

Drug makers spent about $6.3 billion on marketing visits to doctors in 2009, the last year that such figures were available, according to IMS Health. Access to a doctor’s prescription history, drug makers say, helps ensure that information about the latest prescription drug options quickly reaches specialists who treat particular conditions.

But some federal regulators and medical societies argue that drug makers are simply mining the data to identify and go after the doctors who would be most likely to prescribe the latest, most expensive brand-name medicines — driving up health care costs and exposing patients to newer drugs whose side effects may not yet be fully known.

Vermont enacted its prescription confidentiality law with the idea that drug makers do not have an inherent right to a doctor’s identifiable prescription information for use in marketing because the data originated in highly government-regulated, nonpublic health care transactions, said Mr. Sorrell, the Vermont attorney general.

“Does ‘Ajax Incorporated’ have a constitutional unfettered right to the data for commercial purposes,” Mr. Sorrell said, “or is it legitimate to give the doctor who is writing the prescription a say over whether that information should be used for marketing?”

Although the state law does not inhibit pharmaceutical sales representatives from marketing to doctors in their offices, he said, it does give doctors the right to consent before their prescribing information may be sold and used for marketing. If a doctor does not agree, he said, pharmacies must remove or encrypt the doctor’s name, just as they do for patients, before they sell this type of record for promotional use.

Even if the Supreme Court were to find that the law infringes on free speech, Mr. Sorrell added, the justices could still uphold the law on the grounds that the state has a legitimate interest in containing the higher medical costs and safety risks that can be associated with the newest drugs.

But industry representatives contend that Vermont should not be allowed to cherry-pick certain approved uses for the records in question while restricting those that conflict with what the law’s opponents say is the state’s apparent agenda: promoting less expensive generic drugs in an effort to lower health care costs.

Vermont allows those records to be used in research and by law enforcement, said Thomas C. Goldstein, a lawyer representing IMS Health. Moreover, he said, drug makers are allowed to buy the very same records so they can identify doctors whose patients might be good candidates for clinical trials or communicate drug safety updates.

“The one exception is that drug companies cannot use the data to combat the insurers’ and the state’s messages about their products,” Mr. Goldstein argued.

He added that pharmacies obtain the information through business transactions that are no different than any other, making the physician records no more private than stock quotes or commodity prices.

“It’s all data,” he said, “and it’s all protected by the First Amendment.”

Moreover, such laws reduce the ability of drug makers to quickly communicate with specialists about new drugs for rare diseases, a situation that could make it prohibitive for, say, a small biotechnology company with a tiny sales force to market a breakthrough medication, said Randy Frankel, the vice president for external affairs at IMS Health.

“Without the data, you might visit 1,000 physicians to identify the 10 whose patients might most benefit,” Mr. Frankel said. “With the data, you would go to the 10.”

But some consumer advocates say the real issue in the case is the confidentiality of information that people submit in government-regulated transactions that they would not otherwise make public.

“If the court is not going to protect personal and confidential health records,” said Wells Wilkinson, a staff lawyer at Community Catalyst, a nonprofit group that filed a brief in support of Vermont, “how could any consumer transaction be protected?”

A version of this article appears in print on  , Section B, Page 1 of the New York edition with the headline: A Fight Over How Drugs Are Pitched. Order Reprints | Today’s Paper | Subscribe

Advertisement

SKIP ADVERTISEMENT