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

While physicians may be more wary of marketing relationships with industry, a new national survey of nurse practitioners shows that the group, who outnumber family docs, still has extensive ties with the industry and holds favorable views toward marketing tactics such as drug samples, sponsored lunches and dinners, and industry-backed continuing medical education. Considering nurses’ expanding role as primary prescribers in the U.S. health care system and the way the Sunshine provisions in the health reform law require reporting of only physician payments, these data may presage a turn in the industry’s promotional efforts away from physicians and toward nurses.

In the survey of nurse practitioners, “Under the Radar,” conducted in 2007-2008 by Elissa Ladd et al and published in the latest issue of the American Journal of Managed Care, 96 percent of respondents reported having regular interaction with the pharmaceutical industry, and the same number attended an industry-sponsored CME program over the prior five years. Forty-nine percent of nurse practitioners reported that they regularly attended pharma-backed lunches or dinners in the previous six months, and 48 percent said they’d be more likely to prescribe a drug that was highlighted at such a lunch or dinner event.

While the nurses’ survey does not give us trends, it does suggest an openness to industry marketing that may be waning, if slightly, among physicians. In a widely-cited 2004 survey by Eric Campbell et al in the New England Journal of Medicine, 94 percent of physicians reported having a relationship with the pharmaceutical industry. According to a November 2010 follow-up survey in the Archives of Internal Medicine by the same authors, fewer physicians (about 84 percent) reported relationships with pharmaceutical companies and involvement in all domains—samples, gifts, payments, and reimbursement—had decreased over the previous five years. Still lots of ties, but less of them.

Take samples. The number of physicians accepting samples went from 78 percent in 2004 to 64 percent in 2009; that reduced percentage nearly matches the proportion of nurses—66 percent—who reported taking samples between 2007-2008. So while we can’t see trends in the nursing data, we can surmise that policies around physician-industry relationships, coupled with nursing’s favorable attitudes toward promotional activities and its growing prominence (there are now more prescribing nurses in the U.S. than family physicians) could push both exposure and marketing attention toward the nurses’ corner.

If there is a salt-grain alert, it could be that the nurse survey represented a much smaller pool of respondents (263) than the 2009 AIM physician follow-up (1,891). And as they were independently designed and conducted, the surveys are necessarily snapshots, and not designed for perfect comparison.

Still, a few general lessons are worth noting here. While the spotlight has been trained on physician-industry relations in the last six years, the fact that prescribing nurses still hold a very positive attitude toward and active engagement with pharma marketing is an important signal for the nursing profession and those concerned with the influence of marketing to look more closely at the industry’s interaction with prescribing nurses.

State and federal policymakers moving to curb the influence of marketing on prescribing should keep in mind the implications of a group of prescribers whose numbers and prescribing power in the health care industry is growing, but whose involvement with the industry has largely flown “under the radar,” and make sure that policies don’t make a loophole of the nursing profession, and undercut the regulations that seek to protect the integrity of the patient-prescriber relationship.

–Kate Petersen, PostScript blogger

PhRMA announces changes to marketing code

The main trade association of the drug industry, Pharmaceutical Researchers and Manufacturers of America, announced today it is revising its voluntary code ‘Interactions with Healthcare Professionals’ to ban small gifts such as pens, mugs, stethoscopes, and impose bigger suggested limits on support for travel, Continuing Medical Education, and consultants. [For you seeing-is-believing types, check the revised code out here.]

According to the New York Times, the new code “provides no definite limits on the millions of dollars spent on speaking and consulting arrangements that drug makers have forged with tens of thousands of doctors. Nor does it ban the routine provision of office breakfasts and lunches, or the occasional invitation to educational dinners at fancy restaurants.”

Though the industry’s Code till now has been unenforceable and vague, the announcement of the change, a day after the UK drugmakers association adopted new provisions, may change the game for state lawmakers considering a ban on gifts to physicians. Such a ban is currently under review by Massachusetts state lawmakers, and is already on the books in Minnesota.

“A voluntary restriction on the small gifts used by pharmaceutical companies to curry favor with doctors is a step in the right direction, ” said Rob Restuccia in a Prescription Project statement on the Code revisions, and added that the change “is an important complement to efforts by state and federal policymakers to limit industry marketing.”

And it’s time to get your own pens, docs, says the droller Wall Street Journal Health Blog.

Salesforce in the Green Mountain state grows

Pharmalot’s Ed Silverman sums up the latest numbers from Vermont’s pharma payment disclosure law: “A total of 84 drugmakers spent more than $3 million dollars in Vermont in fiscal 2007 to influence sales, a 33 percent increase over the previous year and a 42 percent jump from two years ago, according to a report issued by the state’s attorney general.”  Four out of the five of the top marketed drugs in the Green Mountain State are used to treat ADHD or depression, according to the report.

Acronym Soup

This Inside Higher Ed article looks at the path toward greater federal regulation of conflicts of interest among academic researchers, some pending legislation on the Hill that might change the laws around financial disclosure of those funded by NIH grants, and some of the milestones (and Senators) that got us here.

From the glad-someone-caught-it dept.

Howard Brody over at the Hooked blog spotted this exchange between former NEJM editor Marcia Angell and the Manhattan Institute’s Benjamin Zycher in the pages of the Wall Street Journal. When Mr. Zycher opinioned in the Journal that Big Pharma is an indispensable piece of the research machine, Dr. Angell cries foul on industry credit-taking for what she writes is often publicly-funded university research that gets licensed (and profits) later.

It’s a slugfest, and Brody is the best sort of bystander, polite but not deferent, someone who knows a ball from a strike before the umpire moves, and doesn’t spill nachos on your feet in the fourth.

AMSA applause

And a few RxP allies at the American Medical Student Association got a tip of the hat and a little cash to boot for their notable work in AMSA’s PharmFree program, in the form of The Medical Letter-AMSA PharmFree Scholarships. Congratulations Jonas, Gabe, and Lekshmi.

Keep on keepin’ on – the Lipitor bump

And in a predictable industry find, the good folks who bring you Lipitor found in a study published in the July issue of Current Medical Research and Opinion – surprise! – patients are more likely to stay on Lipitor than its competitor class of  (cheaper) simvastatins. The text: good news for patients and doctors, because medicine adherence is key to managing disease. The subtext: good news for Lipitor, because once you’re on it, you stay on it, even though recent studies dispute its artery-clearing powers against a placebo.

We’re waiting for someone to do an adherence study comparing a drug and nothing-at-all. PostScript bets it’s easier for folks to remember to take the pill you don’t have to.

This, of course, is only a hypothesis.

In case you thought Canadians were less conflicted:

A University of Toronto publication reports that Dr. Claire Bombardier has just been named to a new rheumatology research chair in the Faculty of Medicine.

Who is Bombardier? She was the lead author of VIGOR. That’s the famous Vioxx study in the New England Journal of Medicine — the one in which the authors removed information describing the number of heart attacks in the Vioxx group two days before publication.  There were 17 heart attacks among Vioxx patients and 4 among patients taking the control drug (old, inexpensive generic naproxen). Merck, the study sponsor, continues to defend itself in court.

But, hey, there’s no need to worry any more about ties between Dr. Bombardier and Merck. Her new position is funded by a $1.5 million grant — from Pfizer.
Reference: U Toronto Medicine (March 2008)