Last week, Maine’s governor signed LD719 into law, repealing a series of pharma transparency laws including one that required drug companies to report certain marketing costs, including meals and gifts to physicians. I talked with Maine representative and director of the National Legislative Association on Prescription Drug Prices Sharon Treat (D-Hallowell) to find out what this repeal means for her state, the wider transparency landscape, and what we might expect next.

PS: There’s been a lot of action on the state front again at the end of this budget season. Massachusetts protected its gifts ban from some aggressive repeal threats, and now Maine has repealed its disclosure law. Maine’s move doesn’t seem to reflect a bigger consensus. What do you see happening at the state level?

ST: The new Republican governor and majority in the Maine Legislature have together now repealed not only the state’s gift disclosure law, but nearly every progressive prescription drug policy we have, including our pharmacy benefit manager (PBM) law, and pricing transparency.  This is not surprising as there are very close ties between the pharmaceutical industry and the Republican party in Maine. None of these laws were easy to pass in the legislature even when Democrats had the majority, because the drug industry is very powerful when it comes to influencing politicians.

I don’t think the repeals reflect a change in what the public thinks.  In fact, I doubt if most Maine people have any idea what’s been repealed.  This session a lot of attention was focused on proposed repeals of many of our environmental laws, and in that case the public uproar stopped the rollbacks from going forward.  In the case of the pharmaceutical laws, there aren’t strong consumer advocacy groups in the state that have taken up these issues, partly because so many other social policies are on the chopping block at the same time.

PS: There’s a lot of talk about state Medicaid budgets these days. Why is disclosure an important piece of the cost equation, to your mind?

ST: Maine’s gift and advertising disclosure law was enacted originally because legislators wanted to know how much was being spent by the pharmaceutical companies on promotional activities, since the industry claimed that drug prices had to be high in order to support their R & D activities.

The information gathered showed that advertising and promotion outspent R & D.  It helped make the public case for reducing high drug prices.  Then, as the data was collected, more public attention was paid to conflicts of interest and the role of gifts and payments in driving prescribing of the highest priced branded drugs.  It helped open peoples’ eyes to larger issues of safety and appropriateness of prescribing.

Maine also had a law, also just repealed,  that directly collects drug price data from the pharmaceutical companies and requires a person with authority to certify the truth of this data. This independently collected information was a direct help to the state in negotiating very favorable rebates and limiting pricing fraud under the Medicaid “best price” requirement (nationally major drug pricing fraud cases are common).  Maine gets a return on average of about 50 percent of its Medicaid drug spend back in rebates, and having this check on drug company pricing reports has helped avoid fraud and keep our Medicaid prescription drug budget in line, with minimal increases over the years.

PS: Your colleague, physician Linda Sanborn, also supported the Maine transparency law, and state physician groups have supported similar bills and laws elsewhere. Have you heard from Maine physicians on the repeal, and next steps?

ST: Dr. Sanborn spoke eloquently in the floor debate about the need to have public disclosure of the clinical trials data- another law that was repealed.

Fortunately, federal laws will eventually pick up the slack on both the clinical trials database and reporting on gifts and payments, but the Legislature’s majority did not support even linking our state website to the federal databases.  All of the Democrats on the Health and Human Resources Committee strongly supported these laws and spoke to the issues.

The physician groups were most active trying to prevent the repeal of the academic detailing program, which they are now very involved with implementing.  Although the funding was reduced, this program did stay alive in part because of their advocacy.

In terms of next steps, it would be foolish to try to reverse these repeals with the current Legislature and governor.  If Maine people want a different result (and understand what has happened) then they will elect different people the next time around.

I was actually shocked that so many legislators who ran for office on platforms of preventing fraud and abuse passed two laws that repealed effective anti-fraud laws– the PBM law repeal and the pricing disclosure law. These repeals will hike the costs of the Medicaid program (as confirmed by the Legislature’s fiscal office in the fiscal note on the legislation).

PS: Transparency of industry marketing relationships with prescribers isn’t going away. Taking the long view, what can we expect next?

ST: I think we will see a more active media in Maine looking into the federal doctor payment databases and the financial links between big pharma and Maine politicians.  I expect that there will be more awareness going forward about these conflicts of interest.  My hope is that this awareness will once again lead to taking action with public support and a more receptive legislature and governor.

–Interviewed by Kate Petersen, PostScript blogger

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

by Ann Woloson, Executive Director, Prescription Policy Choices

Who’s lurking in the shadows of our kid’s computer screen? Marketers, that’s who, including drug companies offering free gifts in exchange for personal information, which in turn, is used for marketing purposes.

Many adults might be surprised and offended to know their personal information, which most assume is private, is frequently being used in such ways.  Now young teens and older children are being targeted via the internet by a whole host of marketers, including pharmaceutical companies.

As a policy maker and a parent, I’m concerned about drug companies reaching out to kids over the internet under the guise of providing information.  Free gifts are offered in exchange for names, addresses, date of birth, and other personal information; which is unknowingly used, shared or sold for marketing purposes.

My concern is not about limiting access to information, especially information kids want about health care they may need.  My concern is over what drug companies do with information they collect from teens. It will be used to market specific drugs to kids–products that might not be necessary or not as safe or effective as others on the market.

While federal law offers some protection to kids under age 13, older children are not protected. A law to help prevent predatory marketing was passed unanimously in Maine last spring.  Its intent was to prevent the retrieval of personal health care-related information from kids that would in turn be used for marketing purposes.  Testimony regarding the proposed law described drug company pop-ups and other ads that lure kids to websites offering free gifts (music downloads, backpacks, coolers, art supplies, lunch boxes, etc), coupons and free samples, in exchange for their personal information.

The law was challenged in court by a number of plaintiffs, including web companies, universities, and newspapers, who were concerned about free speech rights. Colleges were concerned they wouldn’t be able to market programs to students. Newspapers worried they could not report on sports events or kids who make the honor roll.  While drug companies are not named in the challenge, they were represented and provided comment at a legislative committee meeting in Maine where the law was reviewed.

Previous legal cases have established that public speech and commercial speech are provided different protections, especially when states have an interest in protecting the health, safety and welfare of children.

However, it appears, that Maine’s final predatory marketing law may pose unintended problems even though it was amended to address real privacy concerns. For that reason, it’s likely to be repealed and reintroduced with changes allowing legitimate activity, while providing privacy protections teens need to prevent the use of their personal information for unintended purposes.  There needs to be a balance between the right to access information for legitimate purposes, and the right to safeguard and protect the privacy of our children’s personal information.

PostScript is a group blog, and a forum for many different opinions on prescription drug issues. The views expressed do not necessarily reflect those of Community Catalyst or of other PostScript authors.