Supreme Court Overturns Ban on Prescription Data Mining

Mark Crane

June 23, 2011

June 23, 2011 — The US Supreme Court today overturned a Vermont law that banned the use of physician prescription drug records for marketing purposes, ruling for free-speech rights over medical privacy concerns.

By a 6 to 3 vote, the nation's high court struck down a 2007 law that prohibited the practice of data mining: the sale, transmission, or use of prescriber-identifiable information for marketing a prescription drug without the prescribing physician's consent.

Data-mining companies that collect and sell such information — IMS Health, Verispan, and Source Healthcare Analytics, a unit of Dutch publisher Wolters Kluwer — had challenged the law.

The justices upheld a ruling by a US appeals court that the Vermont Prescription Confidentiality Law infringed on commercial free-speech rights in violation of the First Amendment of the US Constitution.

Vermont, Maine, and New Hampshire are the only states to have adopted such laws, although similar measures have been proposed in about 25 states in the last 3 years.

Pharmaceutical manufacturers spend nearly $8 billion annually on marketing efforts to physicians and use data about physicians' prescribing habits to better inform their drug salespeople when they visit physician offices to market certain products, according to legal briefs filed in the case Sorrell v. IMS Healthcare.

"Speech in aid of pharmaceutical a form of expression protected by the Free Speech Clause of the First Amendment," Justice Anthony Kennedy wrote in the court's majority opinion.

Vermont said its law was aimed at protecting the privacy of physicians and their prescribing practices and at bringing costs down through promotion of cheaper generic drugs, which are not marketed as heavily as brand-name drugs. The Obama administration supported the state law.

Companies that collect the data have said the information about physicians' prescribing patterns can be used to help monitor safety issues of new medications, to reduce costs, and for research purposes such as studying treatment outcomes.

Vermont pharmacies must collect prescription drug information, including the prescribing physician's name and address; the name, dose, and quantity of the medication; the date and place where the prescription was filled; and the patient's age and sex. The law bars pharmacies from disclosing the data and gives prescribing physicians the right to consent before any information is sold or used in marketing.

Attorneys for the pharmaceutical companies argued the law discriminated against them, making it harder to get their message to physicians. They argued the law unfairly favored views espoused by the state and insurance companies that favor generic drugs.

Justice Kennedy agreed and said the law imposed burdens on protected free-speech expression.

"The state may not burden the speech of others in order to tilt public debate in a preferred direction," Kennedy said in the 25-page opinion, regardless of how laudable the goals of lowering health costs and protecting public health.

"Vermont seeks to achieve those objectives through the indirect means of restraining certain speech by certain speakers — i.e., by diminishing detailers' ability to influence prescription decisions," he wrote. "Those who seek to censor free expression often assert that disfavored speech has adverse effects. But 'the fear that people would make bad decisions if given truthful information' cannot justify content-based burdens on speech."

Justices Stephen Breyer, Ruth Bader Ginsburg, and Elena Kagan dissented. Breyer called the law a lawful governmental effort to regulate a commercial enterprise.

Professional groups, including the American College of Physicians, have historically opposed the use of physician prescribing data for marketing purposes.

"While the American Medical Association [AMA] supports the appropriate disclosure of prescriber data, the AMA firmly believes that every physician has the unequivocal right to decide whether his or her individual prescribing data is shielded from pharmaceutical detailers," the organization said in a statement.

The AMA created the Physician Data Restriction Program, which enables physicians to "opt out" of such disclosure while still allowing their data to be available for academic and governmental research.

Physicians overwhelmingly oppose data mining and consider it a violation of their privacy, according to a recent poll of 740 physicians by MDLinx.

When asked whether they would proactively "opt in" to a system that would collect their prescribing records, 81% of physicians answered "no," with 19% stating they would. When asked whether they considered the collection of their prescribing history a violation of their privacy, 65.3% answered "yes." When asked about their overall opinion of the practice, only 3% of physicians said they supported it, with 65.3% saying they were against it. The remainder stated they did not care about the issue. "Pharmaceutical companies have been monitoring our prescription writing for years," said one responding physician. "The insurance companies already watch us and the government already watches us."

Some physicians who stated they were against the practice expressed specific patient privacy concerns. "In a small town, especially with patients who have a rare condition, it would be easy to find out what medication which patients are taking," said one respondent. "I only have one patient with multiple sclerosis, her meds would be easy to find out."


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