Boston Globe coverage of the progress of the Massachusetts health cost containment and quality bill, which was debated in the House yesterday, runneth over –

The gist

The letters

Lisa Kaplan Howe, Health Care for All

Brian Hurley, American Medical Student Association

The outcome

Now the omnibus bill (56 sections!) goes to conference, where the Sen. President’s version including a complete gift ban, disclosure and academic detailing should keep things interesting.

Singing the PhRMA Code Blues

This week, the head of a Kaiser Permanente’s physician network, the largest of its kind in the U.S., spoke out against the revised PhRMA code in the pages of the San Francisco Chronicle, calling it “nothing more than window dressing,” and “a weak, transparent move by an industry that is pretending to take strong action.”

Dr. Pearl, CEO and executive director of The Permanente Medical Group, a 6000-physician network that serves 3.3 million patients in northern California and abides its own pharmfree code, said that instead of relying on the profit-driven drug industry to police itself, physicians must collectively take responsibility for limiting the influence of pharmaceutical marketing on the medicine they practice, writing that “we cannot abdicate our responsibility as professionals – whose duty is to put patients’ interest first – by relying on the industry that benefits from those inducements to self-regulate.”

Rx realignment

Times of London columnist Carl Mortished says that in a convergence unseen in ElectionLand in recent years, both presumptive U.S. presidential candidates have angled to take on big Pharma: Obama has talked about allowing Medicare to negotiate drug prices, and both he and McCain have been seen stumping drug reimportation, which has had banana-peel traction under the current administration.

Though the Times online headline, “Barack Obama and John McCain go to war with Big Pharma” probably overstates things a bit, the article takes a good look at how U.S. politics may feed and shape bigger Western pharma trends.

Legislative affairs

As part of his continuing inquiry into medical conflicts of interest and financial ties to the pharmaceutical industry, Sen. Chuck Grassley (R-IA) has asked the American Psychiatric Association to submit to him its financial statements, citing concern that the degree of support the specialty society receives from commercial interests is causing field-wide bias.

Here’s coverage in the New York Times, and an opinion piece in the Boston Globe by former New England Journal of Medicine editor Dr. Arnold S. Relman discussing the proper source of incentives in academic research.

And in the San Francisco Chronicle, Dr. Lawrence Diller, a UCSF-affiliated pediatrician writes:

“The Fortune 500 drug companies, by their sheer economic clout, have become the single most dominant influence in our health care system. The ambiguities of children’s mental health and illness make child psychiatry the most vulnerable branch of medicine open to such influence.”

Maple Leaf Rag

The Canadians have found us! Proof in the pages of this month’s Canadian Medical Association Journal.  Thanks, Canada. We’ll watch hockey this year, promise.

And these last two are from the Wall Street Journal Healthblog. The first told us more than we knew about PhRMA chief Billy Tauzin and his history on the Hill, and the second – well, though the Healthblog wasn’t first to pick it up, we liked the desk-cowering image: Turns out injury-by-spacecraft has its own diagnostic code.

Lends a whole new meaning to Universal health care.

Shahram Ahari, a former Eli Lilly sales rep, is in Boston this week talking to medical students at Tufts, Harvard, and Mass General Hospital about how reps make the sale to physicians — and how the future docs can resist the pitch.   He speaks here to Jim Braude of NECN about the rules of engagement for pharma’s sales force.

Ahari, now at the University of California-San Francisco School of Pharmacy, has testified recently before Congress on the Physician Payments Sunshine Act and federal academic detailing initiative.

According to a recent post at Pharma Marketing Blog, online CME has taken a toll on the standard powerpoint and folding chair affairs.  Continuing medical education (CME), which are the credits required for a physician to maintain her medical license, comes in many forms: hospital grand rounds, symposia at annual meetings, correspondence courses offered through universities, medical associations, and journals, or online courses among them. Blogger John Mack did the numbers on the Accreditation Council for Continuing Medical Education annual trends and found that pharmaceutical investment in traditional CME has leveled off, and doctors are doing more and more CME online—a trend that Mack argues allows less opportunity for ‘collateral marketing,’ by which he must mean handouts, tchotchkes, and location, location, location.

But though these data show traditional pamphlet and slideshow courses may be on the wane, the same isn’t true of pharma’s influence.  Just look at the web ads above Mack’s blog post:
“7th Annual ePharma Summit” for “Pharma-marketing in the Web 2.0 World” at the Ritz-Carlton in Philly, www.freecme.com, www.cmedownload.com. And it’s anyone’s guess how many more online CME brokers advertise on this page and others like it. 

Mack argues that “pharma’s return on online CME investment may be much less than for live events such as symposia at medical conferences,” but don’t be so sure.  As with online shopping—or online anything—the nature of the web makes it easier to pass something off as something else: in this case, to hide sources, support, and credentials, at less cost to those doing the fleecing.

Though in broad strokes, Big Pharma’s trickling R&D pipeline, shrinking profit margins and multi-front regulatory war make it look like a lumbering and antiquated machine, the industry in other ways moves with the deftness of a biological organism, adapting to and manipulating a quickly changing environment in real time.

The number of third-party CME companies proliferating in the brochures of annual meetings and online medical journals are evidence of the latter. 

Take the CME shop featured in Dr. Daniel Carlat’s blog post this week: a company that will provide ‘independent content validation’ for your industry CME courses. Responding to a heightened regulatory atmosphere, the service on offer, “CME Peer Review,” pledges to verify the science and “truthiness” of your CME—via a pool of other industry-backed experts.  Dr. Carlat, who has made it his mission to expose industry-backed CME—a challenge not for lack of material, but for its myriad disguises and tendency to shapeshift—flips through the materials with equal parts incredulity and admiration of the deft corporate evolution on display.  

But for every Superbacteria that crops up, the world uses more hand sanitizer: as pharmaceutical companies get more sophisticated in their methods of influencing CME, so too do those who are calling for the profession to take back the textbooks…and the seminars, and web curricula, and annual meeting symposia.

Recently, PostScript talked with a physician who regularly attends the CME series at University of California San Francisco. Last month, a course called “Marketing Medicines: Critical Skills for Physicians” caught her eye.  The course is supported through the Consumer and Prescriber Grant Program that grew out of the $430 million Neurontin off-labeling marketing settlement in 2004.  The UCSF course is just one of a series of projects intended to re-educate doctors and prescribers about the influence of pharmaceutical companies on medical practice; Dr. Jerry Avorn’s academic detailing work in Pennsylvania and Elissa Ladd’s nurse education program at MGH are others familiar to the Prescription Project.

As universities, government leaders and payers tighten their belts and restrict physician gifts and inducements from pharmaceutical companies, less overt influencing—i.e. marketing disguised as education—will undoubtedly become the locus for more and more industry attention. 

And as industry adapts to an increasingly aware medical community and skeptical public, count on the ways it gets its message into docs’ homework pile to multiply.

The Center for Knowledge Management at the University of California San Francisco wants to expand its Drug Industry Document Archive, an online storehouse for pharmaceutical industry documents.  When the Prescription Project, which supports increased disclosure of pharma-related info, got wind of the possible archive expansion, we wanted to find out more.

PostScript talked with Kim Klausner, who manages the Legacy Tobacco Digital Library at UCSF and is looking to expand DIDA.  She said the idea for DIDA grew out of the Legacy Tobacco Digital Library, a rich repository of documents turned over by the tobacco industry during its settlement with state Attorneys General in the late 1990s.

The Legacy library, which contains more than 40 million pages of corporate and court documents from the tobacco settlements, has proved a valuable asset to investigators, reporters, attorneys and public advocates as they continue to expose tobacco industry misdeeds against public health and trust. 

Established with help from a charitable gift in 2005, DIDA currently includes some 1,000 searchable documents, primarily court materials from the 2004 Neurontin case, in which a division of Warner-Lambert (now Pfizer) settled with the U.S. government for $430 million on charges of illegal marketing for off-label use.  The archive also contains documents related to Merck and the Vioxx suits. 

In a post-Vioxx world, many like Klausner believe that internal documents from pharmaceutical companies and the court cases brought against them could be of commensurate value to those interested in increasing drug safety and opening Big Pharma’s playbook to the public. 

PS: Do you think there are historical moments when archives such as the ones at DIDA are more necessary than others? What characterizes such a moment? Is this one of them?

KK: Since the mid-19th century, when national corporations started to develop, muckraking journalists, Congressional committees, and advocacy groups have tried to obtain information about corporate misdeeds in a variety of ways. But it was the confluence of two factors that exponentially increased the public’s ability to discover how an industry contributes to the degradation of the public’s health.  In 1998 the tobacco industry, in order to settle lawsuits by 26 state Attorneys General, agreed to make available to the public millions of documents from their files.  By 2000, digital technology had developed to a point that the University of California, San Francisco Library was able to take these memos, reports, correspondence, videos and more and put them in a searchable database on the Internet for all to see.  And, in 2006 we were able to make the text of the documents themselves fully searchable. 

Advocates for pharmaceutical industry reform will have the opportunity to learn about a wide variety of companies, drugs and issues because plaintiff attorneys in lawsuits against pharma companies can ask the courts to make the documents that have been submitted to them available to the public.  When that happens we’ll add the documents to DIDA. 

So, long story short, it’s always been necessary for advocates to have information about what corporations are doing but now it’s possible to a greater extent than it was before.

PS: At this juncture in the Information Age, it seems DIDA and the Legacy library are each part of a larger trend of information aggregation. Still, concerns about the consequences of too much information—data mining, wiretapping, corporate and government monitoring—have spread; for instance, in 2002 librarians became privacy advocates when the government invoked the Patriot Act to search library records. 

Are they flip sides of the coin, two ways that information abundance is used, sometimes to counteract one another? And must we take one with the other? Or is there good and bad information collection, and how do we parse that out in a public way?

KK: For the most part, technology is ethically neutral. But there are moral implications for the way that people use technology.  So, I don’t think that the aggregation of information is in itself a bad thing.  However, it can be used in a myriad of ways along the good – evil spectrum.  Yes, the public needs to be ever vigilant that the government and corporations don’t use data in a way that is harmful to people.

PS: What lessons did you take from the LTDL, and were there any that came as a surprise to you?

KK: I’m not sure I’ve learned any lessons from LTDL, but I have learned a lot about how the tobacco industry operates — how the companies manipulate scientific research and public opinion, how they’ve spent a great deal of money creating materials to convince their own employees that it’s okay to work for them, how they’ve pursued their legal strategies, and how tenacious they are in marketing their “nicotine-delivery devices” internationally, among other issues.

Sadly, none of this was surprising to me.  But it has been really interesting to watch videos and read documents that the companies never thought would see the light of day.