Last month, the US Supreme Court struck down a highly controversial Vermont law that restricted the sale of prescription drug info identifying prescribers and patients for commercial marketing purposes. The practice is known as data mining and has been growing for the past two decades, ever since data was gathered by market research firms. However, data mining went to the court for review over heated arguments about free speech, health care costs and information privacy (back story). We spoke with Sharon Treat, a Maine legislator, who also heads the National Legislative Association on Prescription Drug Prices, about the implications and the likelihood that Vermont and two other New England states with similar statutes – Maine and New Hampshire – can rewrite their laws to survive fresh challenges…

Pharmalot: Which aspect of the decision surprised or disappointed you in particular?
Treat: The Supreme Court claimed the Vermont law targeted data miners unfairly. But I think the decision ignored a lot of evidence. On one hand, the majority said Vermont could have crafted its law more narrowly and gone down a different route. But the fact is the Vermont statute is already narrowly crafted. They also complained that the law forbids sale of data with exceptions. But the sort of exceptions contained in the Vermont law are the same kinds that you see in HIPAA. For example, using the data so you can fill prescriptions and process payments for them. It seems like they missed a lot of the point.

Pharmalot: And what about the issue of commercial speech?
Treat: This is private information. To call it speech, in my view, is a stretch. It’s not published in articles. It’s not used in advertising. It’s used to create proprietary profiles of doctors and other prescribers, which is then sold to the pharmaceutical industry to help them figure out their marketing campaigns. The information is not what most people would consider to be speech, in the past, from a legal sense.

The most concerning aspect of the decision is applying heighted level of scrutiny to a commercial activity, and it’s hard to call that activity speech. It’s the first time the Supreme Court has used this standard of review for a commercial speech case. And that has serious implications, because if you go through the dissent, (Justice Stephen) Breyer does a good job of parsing what disappointed me with the majority opinion. Breyer points out that regulations, by their very nature, are aimed at particular activities and that’s the nature of the beast. But the bottom line is that it’s commercial in nature. This is first time the court gave state law this heightened level of scrutiny, which makes it harder to sustain regulation.

Pharmalot: So what do you think the implications are?
Treat: It’s not just relating to pharmaceutical policy. Is it really a retrenchment in terms of what state governments can do in terms of regulating a wide range of industry practice. Although do provide some language that looks like it might be helpful in rewriting of state statutes, but it also seems to be inconsistent. It’s going to be difficult to sustain laws (in other states) as they’re currently written based on the Supreme Court decision. And I think it’s very likely that states that have been considering similar laws in past legislative sessions - and there have been several – will not move forward and enact proposals into law. There was already a delayed, chilling effect with a case pending before the Supreme Court and I would think most states now would be extremely reluctant to go forward without a positive role model, such as one of these states coming back with a revised version that would pass muster..

Pharmalot: What impact might this have on consumers and prescribers?
Treat: Some of this comes down to a factual question, which is to what extent does private payment data get out into this commercial world? We know it gets out in the so-called identified format. There is evidence out there that names can get pretty easily re-attached to this data. Tracking numbers get attached so that profiles can get re-created. If you believe that evidence, you’d say patients in the three states that had the laws will be left unprotected in terms of their privacy. Certainly, the privacy of the prescribers is definitely compromised by this decision, such as information on how much a particular doctor prescribes a particular drug.

It’s very much tied in with a whole system that targets doctors for payments and recruitment in what are basically marketing programs – and not focused on what is the most appropriate drug. …It’s part of an overall system of payments and marketing and conflicts, which we’ve seen over the years. The Supreme Court has made it much harder to tackle those concerns. And I think the Supreme Court did not appreciate the importance of the Vermont’s legislature’s interest in protecting public health. It did not see the public health connection. And I think it’s pretty strongly there.

Pharmalot: You mentioned efforts to rewrite existing law. Do you think this will happen?
Treat: Well, I see no reason to broadcast a strategy to the pharmaceutical industry when it’s hard enough to get anything passed with their lobbying clout and fundraising abilities. What I can tell you is that I think there are some opportunities. We talked about language in the Supreme Court decision about a more narrowly crafted approach by adopting HIPAA. They’ve laid that out. Vermont is in a unique situation with its Green Mountain care – there may be an opportunity to put language in the contracts. Contractual restrictions would not face the same First Amendment options. The program is not implemented yet, but could roll this into the contracts. Whether they’ll go forward with that, I don’t know. …Will be it appropriate to get this going in again in a different guise, I don’t know. But of all the states, the political will exists in Vermont.

In New Hampshire, the (data mining) law was passed with strong Republican and Democratic support. And you have a very strong privacy ethic in that state. I think there’s a possibility for bipartisan support. Maine is in a whole different place. There’s a Republican governor and Republican legislature and they’ve tried to roll back several laws that were designed to create limits for industry (see this). And there are ties to industry, so it’s the least likely state where we would expect to see something going forward..