The Supreme Court heard oral arguments yesterday in the prescription data-mining case IMS v. Sorrell, and there’s a whole passel of news stories:

Washington Post

New York Times

Los Angeles Times

Christian Science Monitor

Reports indicate the judges were skeptical of Vermont’s position that preventing companies from buying doctors records from pharmacies – importantly, without the doctors’ consent—was not, in fact, limiting commercial speech.

Two important points that sort of rush by in the Post story. The Post quotes IMS attorney Thomas Goldstein: “If the message is accurate . . . the drug companies can go make their pitch,” Goldstein said. “Vermont can come along and make the opposite pitch. Terrific. So can insurance companies.”

But the accuracy of the message is squarely in question, and at the center of Vermont’s concern. The message is accurate…ly geared to sell drugs. Like all salespeople, those being given doctors’ prescribing data are not obligated to provide complete, accurate pictures about a given therapy class. They are obligated by their job description to sell more of their drug than the next guy.

In some cases “accurate” has been interpreted so broadly that companies promote their drug for uses beyond their approved indication. While physicians should be free to make those prescribing choices within the individual patient-physician relationships, sales-fueled marketing of such uses “off-label” can be dangerous to patients and is therefore illegal. And as we discussed last week, pharmaceutical companies have gotten in big multi-billion dollar trouble with that one. The flagrant scope of this shrugging off of the law and patient safety in favor of profit-motive is one thing Community Catalyst asked the Court to consider as it weighed Vermont’s case for restricting sale of prescriber-identifiable info.

The Post article also says:
“IMS Health and other companies that collect data from pharmacies say it helps law enforcement and public health officials by locating areas where certain illnesses are concentrated and to identify doctors who overprescribe certain drugs, such as narcotics.”

This elides some really important matters at the heart of the case.

Not being in the room, it’s hard to know what exactly was said, but let’s be clear: Drug companies are not spending millions of dollars on this data each year to turn around and share epidemiologic trends with public health officials. One, because spotting disease trends does not require prescriber-identifiable data—knowing the incidence diabetes type II in Stowe, VT is unrelated to knowing which doctors in Stowe prescribe how much tolazamide vs. rosiglitazone. And that’s an important difference, because it’s that second kind of info IMS is making its money selling.  Moreover, Vermont’s law specifically exempts legitimate research and public health uses of the data from its law.

Secondly, neither the pharmaceutical industry nor health-data companies like IMS are in business to out overprescribers. Not their job, and not in their interest. Claiming otherwise before the Court should be a non-starter.

Kate Petersen, PostScript blogger

In the third part of our Supreme Court prescription data-mining review (here’s Part 1 and Part 2) we look at the amicus briefs filed by groups of major physician organizations that represent hundreds of thousands of US physicians and a prominent medical journal.

Since it’s physicians whose prescribing data and identity are being sold to marketers, their interests stand at the heart of this case. Their statements to the Supreme Court demonstrate their powerful consensus that Vermont’s data-mining law protects against harmful intrusion into their clinical decision-making and the foundation of their profession: the confidentiality of the patient-physician relationship.

Vermont Medical Society, New Hampshire Medical Society, Maine Medical Association, Medical Association of Georgia, American Academy of Family Physicians, American Academy of Pediatrics (pdf)

In a brief submitted by groups who represent more than 170,000 physicians nationally, the Vermont Medical Society and other physician groups told the Court that data mining with Prescriber Identifiable (PI) data violates medical privacy, one of the “central tenets” of the patient-physician relationship.

They argue that because the data in question belongs to a physician and patient it is private data, not public, and does not qualify as commercial speech. But they go on to build a case that even it were commercial speech, the Prescriber Confidentiality Law substantially advances state interest by closing gaps in medical privacy and protecting the patient-physician relationship from intrusion by sales people, who tend to promote newer, less-tested and more expensive brand name drugs.

The law also protects public health, they say, and lowers health care costs that come with the intrusion of salespeople into the medical decision-making—salespeople whose “goals are wholly unrelated to the best clinical treatment for any specific patient.” Studies and millions of marketing dollars have shown that drug company detailing influence the prescribing of newer less-tested, more expensive brand-name drugs when proven lower-cost alternatives exist.

In its decision, they say, the Second Circuit ignored the existing framework of state and federal privacy laws—Vermont’s Prescriber Confidentiality Law fills in those gaps that have allowed data-miners to buy and sell confidential prescriber data.

Other notable quotes:

–With unrestricted access to otherwise confidential data, pharmaceutical companies have been able to insert themselves as a third party in the physician-patient relationship in a way that would not be possible without access to PI data. The intrusion on this private relationship is harmful because it calls into question the treatment choices made by physicians and therefore injures the integrity of the physician-patient relationship.

–The law takes appropriately narrow steps to close an unintended loophole in the State’s regulatory system, thereby closing the back door through which data miners buy access to the private patient-physician relationship.

–When salespeople use the prescriptions a physician writes for his or her patients as a basis to “tailor” their pitches, they are actively seeking to exploit confidential treatment information to gain influence and press their advantage over the physician’s subsequent treatment decisions.

New England Journal of Medicine, Massachusetts Medical Society, National Physicians Alliance, and American Medical Students Association (pdf)

By using prescriber-identifiable data without consent of either patient or physician, these groups argue, drug companies and data miners essentially force the doctor and her patients to speak against their will. It detooths HIPAA and other laws that aim to protect private medical info from commercial exploitation, they say, and the Court should not apply advertising cases to what is essentially a medical privacy law. By matching detailed info about a patient’s conditions and treatment, the practice exploits patients and their medical history to publication and exploitation—exploitation the Vermont law seeks to prohibit.

They write:

This case isn’t fundamentally an issue of commercial speech; our view as medical publishers, physicians and medical students is that data miners have wrongfully converted private health information for commercial purposes without consent. Data miners should not have a First Amendment right to use or sell private health information.

The First Amendment does not protect data theft, and the drug companies buying this data without doctors’ consent would not suggest that the First Amendment protects the sale and use of their trade secrets without consent.

Furthermore, the amici write, Vermont’s action only empowers physicians to choose privacy—a choice all physicians should have.

“In a world where privacy is daily being eroded by technological advances,” they write, “Vermont may deem it prudent to slow the dissemination of certain data in order to avoid similar breaches. Federal law has specifically permitted just such a move.”

Other notable quotes:

–One key error in the Court of Appeals below was the failure to appreciate this difference between unauthorized access and subsequent publication. Publishers certainly have First Amendment rights, but not if the data was taken without consent, violating privacy, confidentiality, or intellectual property laws.

–Leave these complex matters of science and health policy in the hands of those best suited to make the decision – the prescribing physicians who are able to discuss these issues with their patients. Let the individual physician decide whether data mining is detrimental or helpful. The First Amendment does not require unconsented disclosure of prescriber-identifiable medical records.

–Kate Petersen, PostScript blogger

As part of our multi-blog review of friend-of-the-court briefs submitted to the U.S. Supreme Court in the prescription data-mining case IMS v. Sorrell, today we look at the amicus briefs filed by major consumer groups and policymakers in favor of Vermont’s law.

Brief of AARP and the National Legislative Association on Prescription Drug Prices (pdf)

AARP and the National Legislative Association on Prescription Drug Prices (NLARx) filed a brief noting how the Vermont law helps protect patient privacy, safeguards the doctor-patient relationship from undue industry influence and misleading marketing, and helps reduce unnecessary and inappropriate prescribing driven by marketing. They note that “the data-mining companies do not meaningfully de-identify the records at all” but only “encrypt the name of the patient . . . [using] an individual identifier to ‘track the patient over time.’”

A recent Wall Street Journal article revealed that TV advertising companies have started to use such so-called de-identified patient data concerning prescription drug purchases to profile discrete individuals for more effective TV advertising. These alarming threats to personal privacy should signal to the Court that protecting the privacy of personal health information is increasingly more important in the data-rich, computer-driven world today. And they offer a compelling argument — that even if data-mined information is commercial speech, this type of private health information, which is never publicly disclosed into the commercial marketplace, is a type of commercial speech that warrants a lower level of protection by the First Amendment.

“The Vermont law directly advances its interest in protecting against disclosure of records containing the most personal of information as well as its interest in protecting individual autonomy in decision making on important personal matters,” said Sean Flynn of American University’s Washington College of Law and counsel to AARP and NLARx in a statement. “Protecting the confidentiality of records advances important goals of our health system, including combating undue influence of in-person pharmaceutical marketing that raises costs and damages public health interests.”

Brief of Public Citizen, The Center for Science in the Public Interest, Consumer Action, Public Good, U.S. PIRG and New Hampshire PIRG (pdf)

These groups argue that if the Second Circuit’s ruling were to stand, it would jeopardize a slew of federal and state consumer-protection laws around privacy of information such as financial data, emails, and health and education records, and would unleash a landslide of litigation from companies who would profit from selling private consumer data the law now requires them to protect.

“The information being sold, highly detailed prescribing data, belongs to a doctor just as other private data such as bank and health records do,” they maintain.

“Such information is confidential under state law, and drug companies have no more right to access it than they have to access a doctor’s private bank records,” they write. They worry that the Second Circuit’s holding would give advertisers First Amendment cover “to surreptitiously track the websites that users visit and sell that data, complete with identifying information, for a profit.” They also point out that the Court has before acknowledged states’ need for “broad latitude” in experimenting with ways to protect their citizens’ privacy.

Notable quotes:

“Laws limiting certain uses of private information reflect the common-sense judgment of federal and state governments that consumers who supply their private information for a specific purpose—such as applying for a driver’s license or a credit card—do not expect that information to be sold to mass marketers.

“That problem is essentially the one that Vermont sought to address here—doctors writing private prescriptions for their patients do not expect that information to come back to them in the form of drug-company marketing efforts. Because [such data-mining laws] do not restrict what anyone can say or to whom they can say it, federal and state governments should be free to make such judgments with the same ‘broad latitude’ that the Court has given to other essentially economic regulations.”

–Kate Petersen, PostScript blogger