By law, pharmacies are required to collect certain data about the prescriptions they fill including the prescriber’s name and address; the name, dosage, and quantity of the drug prescribed; the date and location where it was filled; and the patient’s age and gender. Pharmacies sell this data to data-mining companies (like IMS Health, Verispan, and Source Healthcare Analytics) who aggregate the data to reveal physician prescribing patterns. They then sell this information to pharmaceutical companies who use it to solicit physicians (also known as “detailing”). (See my post – The Costs of Living – Part 2 where I discuss these solicitation practices and their effects on pharmaceutical prices). Pharmaceutical companies say they need the PI for their “detailing” efforts so that they can focus marketing messages for individual prescribers, direct scientific and safety messages to physicians, track disease progress, and conduct post-marketing surveillance among other marketing endeavors.
In 2007, Vermont passed a law that prohibits selling prescriber-identifiable data for marketing or promoting a prescription drug unless the prescriber consents. The state’s legislative intent was to protect the privacy of doctors and the information about patient’s prescriptions, reduce health care costs by encouraging prescription of generic drugs, and to protect public health.
Vermont’s law is virtually a “do not call” registry for doctors. Remember when telemarketers would call your house every night, interrupting dinner and family time? They got your information by the same chain that these data-miners use to get physician information. For instance, a retailer might ask for your phone number and then sell your information to companies who sort it by demographics such as race, income, household size and spending habits. These companies, like IMS Health, would in turn sell it to telemarketing businesses who could contact you at home. We were all relieved when the Do Not Call Registry started. Vermont’s law does the same thing, but instead of opting-out (by putting your name on a registry), each doctor has to opt-in to allow his or her information to be used for marketing purposes thus protecting that doctor’s confidential information.
While this is a case about privacy and access to information, it somehow got turned on its head and now (erroneously in my opinion) centers around freedom of speech and the First Amendment. The U.S. Court of Appeals for the Second Circuit struck down Vermont’s law last November citing that it is a restriction on commercial speech that does not directly advance Vermont’s state interests. I would join Judge Livingston in her dissent of the Appellate Court’s ruling.
The majority argues that the data collected and sold by data-miners and used by pharmaceutical companies is protected speech citing a previous opinion that “even dry information, devoid of advocacy, political relevance, or artistic expression” may be protected by the First Amendment. (The case sited was about computer programs constructed from code.) But as Judge Livingston points out, the information is not protected unless it actually “advances the values served by the First Amendment” such as the pursuit of truth, the achievement of social stability, the exposure and deterrence of abuses of authority, personal autonomy, and the functioning of democracy. As she points out, the information is just a product, “not distinguishable from the data miners’ perspective to widgets.” Information exchange is not automatically protected by the First Amendment, it may be if the information “advances the values served by the First Amendment,” but not if it is simply a product.
As I said, this case is wrapped up in the First Amendment when really it’s a case about privacy and whether we can restrict access to confidential information. The Supreme Court has already ruled that the First Amendment “does not carry with it the unrestrained right to gather information.” Thus, just because the information is there does not mean that anyone and everyone should have access to it. In this case, access is particularly important because it’s not that these companies are collecting, selling and using information, but that the information is confidential. But for the laws requiring the data to be collected by the pharmacies, this information would not exist in pharmacy databases. As the Justice Department states, “To be sure, the information here is in private hands rather than the government’s possession, but it came into those hands as a result of the pharmacies’ participation in a closed regulatory system for the safe dispensing of prescription drugs.” As such, this confidential information does not automatically become subject to public access when entered into a pharmacy database and therefore should not be given out except for the limited purposes of law enforcement, medical research, time-sensitive safety information, and claims processing by insurance companies.
Judge Livingston correctly finds that the Vermont law restricts the dissemination of confidential information and not the marketing messages from pharmaceutical “detailers.” The majority, she points out, “begins its analysis at the end of the sequence of events” whereas the law “starts at the beginning, and seeks to cut off the flow of PI data at its source.” In other words, the statute restricts the access to and use of this confidential information by the data-mining and pharmaceutical companies, not the messages they pursue once in possession of the information. The only speech that should be protected here is the marketing messages. The gathering, selling, aggregating, and reselling of confidential information is not in itself speech but rather a process using information as a product (which we already noted is not speech).
Let’s also be clear here, restricting access to this information not only protects the privacy of physicians, but patients themselves. While a patient’s name is encrypted when the information is sold, the patient’s use of a drug can still be tracked and associated with the prescriber, payment source (i.e. insurance company) and pharmacy. In other words, your confidential health information is being sold as a commodity so pharmaceutical companies can solicit (I choose solicit instead of detail, which I find to be a ridiculous description of their activities) doctors and encourage them to write prescriptions that cost more money and whose safety may not yet be wholly known because they may not have been on the market for very long. The pharmaceutical companies are not beneficently educating doctors about the life-saving effects of their products, nor are they following up to see if the patients taking their medications are experiencing side effects, and they certainly aren’t providing fair and accurate information. They are in the business of SALES and that’s all. The fact that these companies compensate their solicitors based on the prescriptions written by the doctors they meet with is further proof of that they aren’t worried as much about the message as they are about making a sale and increasing their product margin.
I could go on about the Second Circuit Court of Appeals decision in this case including their ridiculous suggestions for “less restrictive” measures Vermont could consider (which are actually more restrictive) and their incorrect finding that the state does not have an interest in medical privacy. I could discuss Vermont’s accurate conclusion that these practices drive up the costs of medications and interfere with the doctor-patient relationship. Needless to say, I think the Appellate Court here got it wrong. The Vermont law, like similar laws in New Hampshire and Maine, should be upheld. The President, 35 states, the Justice Department, the New England Journal of Medicine, AARP, other medical organizations, and groups specializing in e-commerce would agree with me. (a list of amicus curie briefs and other documents can be found at SCOTUSblog.com)
However, I am disheartened to hear the reports that the Supreme Court justices have serious doubts about the Vermont law. Justice Antonin Scalia said that for a doctor to avoid unwanted solicitation by a pharmaceutical rep, “he can do [it] by saying: I don’t want to talk to you.” Justice Ruth Bader Ginsburg questioned whether it was appropriate to promote sales of generic medications over brand-name drugs. Justice John Roberts said the law “censor[s] what [doctors] can hear to make sure they don’t have full information, so they will do what you want them to do when it comes to prescribing drugs.” And Justice Anthony Kennedy asked, “what you’re saying is the state can prohibit the most efficient form of speech.”
Still, Justice Sonia Sotomayor understood that this is NOT about restricting speech, it is about restricting access to confidential information, agreeing that the law is analogous to the “do not call” laws.
The point is – marketing messages will still be touted by pharmaceutical companies and their representatives. They can, and before the age of massive databases have, done this for decades without needing to target specific doctors or “tailor” their messages. Their speech therefore is NOT limited, restricted, or censored in any way. What is restricted is access to personally identifiable information of both physicians and patients – information meant to be collected for safety purposes but are now used to increase the bottom lines of pharmacies, data-miners, and pharmaceutical companies to the detriment of public health and against our understanding of the right to privacy.
The Supreme Court decision should come out in late June/July.
 IMS Health, Inc. v. Sorrell, 630 F. 3d 263.
 Vt. Stat. Ann. tit. 18, §4631 (a) & (d).
 Universal City Studios, Inc. v. Corely, 273 F. 3d at 446.
 CFTC v. Vartuli, 228 F. 3d 94, 111.
 Zemel v. Rusk, 381 U.S. 1, 17.
 See IMS Health Inc. v. Ayotte, 490 F. Supp. 2d 163; IMS Health Corp. v. Rowe, 532 F. Supp. 2d 153.