Drug info firms target prescriber data laws

Doctors do not have a privacy right to their prescription-writing habits, data-collection firms say as they sue in Vermont and Maine.

By — Posted Oct. 1, 2007

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After landing a first-round federal court victory against a 2006 New Hampshire prescriber privacy law, data-gathering firms are targeting similar laws set to take effect next year in Maine and Vermont.

Legislators in those two states, wary of a similar legal upset, shied away from a New Hampshire-style ban on any marketing use of prescriber data. Instead, they crafted legislation allowing physicians and other prescribers to choose whether drugmakers can access their prescription data.

In Maine, doctors could opt out of data sharing; in Vermont, they could opt in.

But prescription-data-collection firms IMS Health Inc., Verispan LLC and Source Healthcare Analytics Inc. filed federal lawsuits in late August challenging the new laws. The complaints argue that they violate the U.S. Constitution's First and 14th Amendments as well as the Commerce Clause.

"The problem with the Maine and Vermont laws is that they create an entirely new and unprecedented privacy right for physicians in their professional conduct," IMS spokesman Randy Frankel said. "Improving our health care system depends on access to more information, not less."

The U.S. District Court of New Hampshire ruled last spring that the state's prescriber privacy law infringes on constitutionally protected commercial speech rights. The court also concluded that physicians do not have a privacy right in their prescribing habits. In August, New Hampshire Attorney General Kelly Ayotte appealed the decision to the 1st U.S. Circuit Court of Appeals. A ruling is not expected before next year.

IMS and other data-collection firms crunch prescription records purchased from pharmacy chains and doctor information secured from the American Medical Association's Physician Masterfile and others like it. Data-gathering firms sell the results to drugmakers, who in turn use the data to hone their detailing efforts.

The state medical societies in New Hampshire, Vermont and Maine backed their states' prescriber privacy legislation. Many politicians and academics argue that detailers' access to the data gives them great leverage in persuading doctors to prescribe newer and costlier drugs that are not more effective.

State societies want laws upheld

Steve Larose, a spokesman for the Vermont Medical Society, said physicians are hoping that the state's law will withstand court challenges because it lets doctors choose how their information will be used.

"Physicians should have the right, and do have the right, to privacy for their prescribing patterns," Larose said.

Gordon H. Smith, executive vice president of the Maine Medical Assn., agreed. "We're disappointed that IMS has brought this lawsuit in Maine," Smith said. "It's not the same law as New Hampshire's -- it's not a ban."

Ben Schaefer, MD, is a Bangor, Maine, cardiologist who wants to control how his prescribing data are used.

"I want my prescription information to be protected from commercial exploitation," Dr. Schaefer said in a statement released by the Prescription Project, a pressure group that supports legislation aimed at reducing physician conflicts of interest.

At press time, neither the Vermont Medical Society nor the Maine Medical Assn. had decided whether to file amicus curiae briefs in the cases. The attorneys general in those states announced they would fight to uphold their laws in court.

Along with a number of other groups, the New Hampshire Medical Society has filed two friend-of-the-court briefs in the litigation over the Granite State's prescriber privacy law.

The counsel of record on those briefs is Sean M. Flynn, adjunct law professor at American University's Washington College of Law and associate director of the school's Program on Information Justice and Intellectual Property.

"The New Hampshire district court decision is doomed to fail," Flynn said. But even if it withstands appeal, he added, the Maine and Vermont statutes address some of the court's concerns. For example, both laws more explicitly address the public policy findings that serve as the basis for the data-sharing restrictions.

"The Maine and Vermont laws are more narrowly and specifically tailored to the interests of doctors and the confidentiality of records," Flynn said.

But University of California, Los Angeles, law professor Eugene Volokh said that allowing doctors to opt in or out of data sharing should not stand up to constitutional scrutiny. If such a legal approach to speech prevailed, Volokh said, then individuals could "put themselves on the no-write-about list" for newspapers.

On the national front

Shortly before New Hampshire's law was enacted last year, the AMA announced its Physician Data Restriction Program. By enrolling in the program, physicians can keep their prescribing information out of the hands of drug reps and their direct supervisors.

Physicians also can use the program to lodge complaints about inappropriate drug rep behavior. As of early September, more than 9,300 doctors were enrolled.

More information is available at the Physician Prescribing Data Information Center's site (link).

The AMA is concerned that restricting prescription data sharing could impede medical research, drug recalls and clinical trials, but a spokesman said the Association is officially neutral on prescriber privacy laws. The AMA has no plans to file briefs in the litigation in Maine, New Hampshire or Vermont.

In January, the AMA partnered with IMS Health to offer physicians a free quarterly online continuing medical education newsletter called Therapeutic Insights (link).

Each issue covers a different condition and includes data on the prevailing national and state prescribing patterns in the treatment of the condition. Physicians can sign up for the program online.

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Physician control

May 2006: American Medical Association unveils its Physician Data Restriction Program, which lets doctors opt out of having their prescribing information shared with detailers.

June 2006: New Hampshire becomes the first state to ban drugmakers, data-collection firms and pharmaceutical benefit managers from selling or using prescriber data for marketing purposes. The New Hampshire Medical Society supports the law.

July 2006: Prescription-data-gathering firms challenge the New Hampshire law in federal district court, arguing it unconstitutionally infringes on commercial free-speech rights.

April: Court rules that physicians do not have a right to keep prescribing data secret.

June: Vermont and Maine pass prescribing data laws. In Vermont, doctors can opt in to data sharing; in Maine they can opt out. The Vermont Medical Society and Maine Medical Assn. support their states' respective laws, set to take effect Jan. 1, 2008.

August: New Hampshire appeals the lower-court ruling to the 1st U.S. Circuit Court of Appeals. Data-collection firms challenge the Maine and Vermont laws in federal courts.

Sources: Court filings, news accounts

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External links

Therapeutic Insights (link)

Physician Prescribing Data Information Center (link)

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