Later this month, the Supreme Court will hear IMS v. Sorrell, about the right of Vermont and other states to restrict a practice called data-mining – the collection and sale of doctors’ prescribing histories that drug companies then buy and use in marketing to MDs and other prescribers. Vermont’s law banning this practice was struck down in the Second Circuit Court of Appeals, after the First Circuit upheld similar laws. (Both New Hampshire and Maine have standing laws, and Massachusetts is considering a bill this year supported by consumers and the state medical society that would do the same.)

Prescription data-mining is a multi-million dollar business for companies that buy prescription records from pharmacies and physician lists from the American Medical Association, and then match these to produce profiles that they sell to drug companies.  The companies then arm their drug reps with this information to market their drugs to individual prescribers. (Way more about that in the PostScript archives)

Why did the court strike the law? The drug industry trade group PhRMA and the ‘data-mining’ companies, like IMS, who sell this information argued that it was ‘speech’ protected by the First Amendment.

Speech? Are your purchases on Netflix speech?  This seems like a stretch.

The First Amendment protects some kinds of speech more than others, based on the whether the speech has political or cultural value, whether it relates to business and commerce, or whether its part of an otherwise criminal act. The most protected speech is the set of public exchanges that create a thriving free marketplace of ideas – political, social, and economic – which are essential to a vibrant democracy. For instance, the government cannot pass laws preventing the news media from lying. The answer to any lies or untruths in this are is the free flow of opposing ideas – more speech.

However, in the commercial sphere, the government has broader authority to protect people from being deceived or misled. So consumer protections laws can ensure that when a company runs an ad, they have to honor that ad, and not use it to lure customers in for other deals. But since 1976, the Supreme Court ruled that the First Amendment also protects truthful commercial speech from excessive government regulation, because the vibrancy of the marketplace of ideas in a democracy is affected by the free flow of information in the marketplace of goods and services.

That means the First Amendment allows someone affected by a government regulation to ask a court to make the government prove that the government’s regulation of commercial speech ‘directly advances’ a ‘substantial’ state interest, and that the government restriction of speech is not more extensive than necessary to achieve the government’s interest. Lawyers call this “intermediate scrutiny.”

Despite the fact that the First Court of Appeals upheld similar laws in New Hampshire and Maine, the Second Circuit was not convinced that the law banning the use of this data directly advanced the substantial interest of the state (which it acknowledged) in promoting public health and reducing health care costs.

But in its appeal, Vermont maintains that banning the non-consensual sale and use of these doctors prescribing records is “a modest step that protects the traditional confidentiality of the doctor-patient relationship.” Indeed, the state says, it’s not a pharmacy’s free speech right to sell a prescriber’s info that it obtained solely because federal law requires pharmacies to collect that prescriber data in order to dispense prescriptions. (DOJ concurs with this position.) These are undeniably private medical records, the state appealed, and their privacy should be protected as the Court has for other medical records and information.

We have long supported the efforts of Vermont and other states to ban or restrict the sale and use of prescriber data for marketing purposes, since it violates the privacy of the prescriber-patient relationship without conferring any medical (or other) benefit on either party. (The legislation only bans use of this data for marketing, not for legitimate research or quality improvement planning.)  Indeed, in all the hearings and subsequent court cases since New Hampshire passed its first-in-nation data-mining law, no benefit has been established other than that conferred on companies’ marketing campaigns, which are much more effective when a rep knows how much of a competitor’s cholesterol med a doc prescribed last week.

In preparation for the case, Community Catalyst and its Prescription Access Litigation (PAL) project along with more than 32 groups and 35 states (plus DC!) filed amici curiae in support of Vermont’s law. The U.S. Dept. of Justice also weighed in to back the state law.

Drawing on PAL’s experience from several lawsuits, Community Catalyst joined with Health Care for All and AFSCME District Council 37 to highlight how this data-mined prescriber information was used to perpetuate illegal industry promotion. Numerous documents from several lawsuits have shown that data-mined information is an integral part of the drug industry success in its illegal promotion of unapproved uses of prescription drugs like Neurontin, Zyprexa, and Bextra. This illegal promotion not only put consumers at greater risk, it also cost consumers and insurers billions of dollars for ineffective and inappropriate drug treatments.

Don’t want to wade through all those other legal briefs yourself? Don’t worry, we did! In the next week we will be blogging a sort of viewer’s guide that summarizes key points and quotes from other amici, including state medical societies, lawmakers, the New England Journal of Medicine, and major consumer groups. Check back in next week for those.

–Wells Wilkinson, Community Catalyst and Kate Petersen, PostScript blogger