The state of Vermont’s annual report on industry payments to doctors shows that payments in that state have gone down significantly: total number of expenditures went down 80 percent from 2008 levels, when manufacturers reported the most payments. In 2009, the state strengthened its law to ban meals and most gifts (including gifts that PhRMA swore off in its own 2008 Code). This year’s report suggests those restrictions had a big effect on how drug companies spent their money in Vermont.

This report—and proposed amendments to the law to accommodate industry requests—has got people talking again about how disclosure and gift bans can work together, and whether the downturn in payments to Vermont docs suggests the problem is going away.

It’s like that Jake Gyllenhaal movie, right: All that pharma-rep coziness was way back in the 90s?

Well, no. Far from having gone away, there’s evidence that the problem of pharma conflicts of interest and their impact on clinical care may be getting bigger. Pharma now tops all industries, including defense, in total fraud payments paid under the False Claims Acts. And of the 150+ pharmaceutical company settlements—that’s $19.8 billion in penalties between 1991 and 2010—three quarters of both the settlements and penalties have occurred since 2006. (Check out Public Citizen’s great report on this.)

More? The two largest criminal fines in U.S. history were imposed on two drug companies in 2009 for off-label promotion, and in 2010 alone, at least five companies paid settlements of at least $100M due to marketing a product off label, paying illegal kickbacks or making misleading claims about a product. Eight of the ten largest settlements with the federal government in FY2010 were over drugs.

And despite recently endorsing conflict-free guideline writing committees, more than half of those writing clinical guidelines for the American College of Cardiology through 2008 reported financial ties to the drug industry, a 2011 study found.

But isn’t all that money for innovation and research collaboration?

Vermont’s data suggests it’s not. Before the state asked for the proverbial check on drug company wine-and-dines, meals were in some sense the main course in industry-MD relationships in VT, representing about 30 percent of the total spent by companies on docs in  2009 and accounting for 87 percent of payments that year.

Some industry voices suggest that the updates and modifications Vermont has made to the law since 2008 signal vacillation—one blog even went so far as to say it showed that lawmakers “had little idea of what they were doing when they first created the law” and weren’t accounting for stakeholders.

That’s not true, or fair. Especially since some of this year’s proposed updates grow directly from industry asks, including an exemption for market-research payments.

The legislative process is built to flex and accommodate changing realities and lessons learned, and Vermont’s gifts and disclosure laws is a great example of that, and how public disclosure can signal gaps and needs in the law.Seeing that the majority of payments were going to feeding MDs and prescribers – costs with dubious patient benefits but that get passed onto patients – helped Vermont target its law while protecting the legitimate sort of academic-industry relationships that are critical to good medical innovation. The number of companies disclosing to Vermont went down in tandem with the meals ban, and if companies left because the best thing they had to offer in Vermont was lunch, well, from a public health standpoint, that’s okay.

With the industry’s “market and let’s see what works” approach of off-label marketing alive and well, Vermont and academic medical centers across the country have provided a sensible counter-approach of evolving regulation that seeks to protect patients.

Such responsiveness makes for good lawmaking in the interest of the public health, and transparency paved the way for that lesson-based learning.  We don’t know what lessons we’ll learn from Sunshine, and that’s exactly why we need it.

–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

Data-mania!

Eighteen states considered restrictions on commercial use of prescriber data this year, according to this Associated Press story.  But a pending decision in the 1st Circuit Court of Appeals (IMS v. Ayotte) about the legality of the first-in-nation New Hampshire data mining ban has largely frozen the issue, which is earning attention at the federal level, as well.  In the spring, Sen. Herb Kohl (D-WI)  made some inquiries into the American Medical Association’s sale of its prescriber profiles for hefty sums each year.

“We have no privacy issues here,” IMS vice president Randy Frankel told the AP, but many physicians and their advocates (RxP among them) say it goes beyond politesse, and that pharma reps who know covertly doctors’ prescribing patterns are invading the doctor-patient relationship by often pitching the most expensive, least-proven drugs.

Read the RxP fact sheet on data mining here.

Speaking of places where there are privacy issues, this Des Moines Register says that no one has been prosecuted for violating the federal patient privacy law known as HIPAA, the Health Insurance Portability and Accountability Act, even though “38,000 Americans, including 267 in Iowa, have complained of HIPAA violations to the federal Office for Civil Rights” since enforcement began in 2003.  According to the Register, “[m]ore than half of those complaints nationally have been disposed of with no investigation. Until last year, no one nationally ever was prosecuted for violating HIPAA.”

And then there were two

Though we saw numbers like this earlier this year, now there are Just Two, so here’s a pre-convention update: Going by campaign contributions, Pharma is hedging for Obama, and in a big way. According to a Center for Responsive Politics study, first reported by Bloomberg, presumptive Democratic presidential nominee Sen. Barack Obama (Ill.) has received three times as much pharma moula as presumptive Republican nominee John McCain (Ariz.).

Check it out at The Scientist Blog.

Vioxx papers reveal marketing roots

In a paper published in the Annals of Internal Medicine this week, researchers found evidence in the Vioxx documents that the ADVANTAGE trial was drummed up entirely by the Merck marketing department.

According to the paper:

The trial emerged from the marketing division with a marketing objective; Merck’s marketing division collected, analyzed, and disseminated both the scientific and the marketing data; and Merck did not reveal the marketing purposes of the trial to participants, physician-investigators, and institutional review board members.

For those of us who read Melody Petersen’s book, Our Daily Meds, such news isn’t as surprising as it ought to be, but all the same, we’re glad to see this truth vs. advertising getting into the medical literature.

Now you CMAP, now you don’t

The Dallas Morning News reports that the Children’s Medication Algorithm Project, a preferred drug program for psychiatric medications in Texas, has been halted as part of an ongoing investigation by that state’s Attorney General.  TMAP, the adult precursor, triggered a suit alleging undue pharmaceutical company influence on the selection of the drugs.

According to News, “[a]t least four of CMAP’s key developers – all affiliated with the University of Texas system, and all of them published child psychiatry experts – have received research funding from drug companies, or have been consultants and speakers for several different pharmaceutical firms.”

“In our country, there’s been a switch from taking care of people to focusing on big corporate money,” Rep. Juan Escobar told the News.  According to the News, Rep. Escobar proposed unsuccessful legislation in Texas last year that “would have banned researchers or government employees funded by the pharmaceutical industry from designing state psychiatric drug protocols.”

Hat tip to Pharmalot.

Deja – vu all over again

Harry and Louise are back, and they’re having some second thoughts about healthcare. Check out the story in the Detroit Free-Press here.

Yesterday, the Wall Street Journal Health Blog talked with JAMA editor-in-chief Cathy D’Angelis about this editorial, which breathed a big sigh of peer-review relief at a judge’s decision to stop Pfizer from getting its hands on some confidential journal documents.

In continuing court cases over adverse cardiac events skipped over in ads for its pain drugs Celebrex and Bextra, Pfizer subpoenaed from JAMA and sister publication Annals of Internal Medicine all documents relating to the drugs – including the internal comments, correspondence, and profiles of peer reviewers, among the most guarded of guarded documents in academia. Earlier this month, a district court judge ruled denied the motion to compel subpoena, effectively shutting the door on Pfizer’s attempt to get into the proverbial back room of medical journal peer review.

This is good news to D’Angelis. One of the reasons the peer-review process works, she said, is that reviewers trust the anonymity and confidentiality of the process, and handing over such revealing into the internal workings of the process would not only give a pharmaceutical giant a super-inside look at how scientific papers are vetted and published at two major medical journals, but would harm participation in the process itself.

“You’re asking people to put their reputation on the line, to spend their time, their expertise and their effort for nothing,” D’Angelis told the Healthblog. “Why should they do it if they fear there’s going to be some retribution?”