A bill, introduced today in both House and Senate, would have the federal government go head-to-head with the pharmaceutical industry’s 100-thousand-or-so sales reps.

The Independent Drug Education and Outreach Act of 2008 provides grants for the creation of unbiased educational materials for doctors. And another set of grants funds pharmacists and nurses to take that good information to the doctors in their offices.

Office calls work. That’s why they are the preferred sales tactic of industry. So it makes sense that governments and others who actually foot the cost of prescription drugs should adopt the same tactic, albeit with the goal of encouraging the use of the best, safest, most cost-effective drugs.

This idea, sometimes called “academic detailing” has been around for at least 20 years. Programs are well established in other countries and in several states. Australia and Pennsylvania have model programs. Kaiser Permanente has its own long-established initiative. The evidence shows that such programs not only improve patient outcomes, they also produce net savings – by one estimate two dollars is saved for every dollar invested. See our related Senate testimony here.

But it is also important to note that these programs are not mainly about cost savings; they are about providing good information. Sometimes that even means encouraging more use of pharmaceuticals. And doctors who have a chance to participate generally appreciate having a source of information they can trust.

IDEA is being sponsored in the Senate by Sen. Herb Kohl (D-WI), Sen. Edward Kennedy (D-MA), Sen. Richard Durbin (D-IL) and Sen. Robert Casey (D-PA), and in the House by Rep. Henry Waxman (D-CA) and Rep. Frank Pallone (D-NJ). Both the Prescription Project and the National Coalition for Appropriate Prescribing support passage of this bill.

The IDEA Act allows for public payors and non-profits – those free of pharmaceutical industry funding – to apply for grants. That means a new potential source of funding for state programs, such as the one Massachusetts is likely to pass today [tune in tomorrow for more on that]. The Congressional Budget Office should score this bill. The House and Senate should pass it quickly. We have neither time nor money to waste.

Pharmalot reports that the Pharmaceutical Researchers and Manufacturers of America surveyed 501 physicians and found that only 11 percent of doctors said that info from sales reps greatly influences their prescribing decisions.  

While it looks like bad news to some, PostScript read it as a convenient companion piece to the industry’s Code revisions that were enacted two weeks ago.  Why?  Because it underscores PhRMA’s contention that doctors are not swayed by pens, pads, gifts and now, the salespeople who bear them.

Not clear on the difference between the old and new voluntary codes? Check out the Prescription Project fact sheet comparing the two.

The Center for Science in the Public Interest has developed a model disclosure policy that it’s encouraging medical journals to adopt uniformly, according to the Scientist blog. The Center’s Integrity in Science director Merrill Goozner is in discussion with the Committee on Publication Ethics, a journal cohort, and said that three journals have already adopted the guidelines.

In this op-ed in the Providence Journal, Gregory Fritz, a child psychiatrist at Brown University in Rhode Island, says that the influence of pharmaceutical marketing may be most egregious at medical society meetings, where seminars funded by pharmaceutical companies “feature excellent speakers, little redundancy, current data, professionally made slides and handouts and terrific free food,” making those without pharma backing, which often feature behavioral therapy and health-services solutions, seem “dowdy” in comparison.

“The insidious aspect is that a newcomer to the field would easily conclude that the excitement and future of psychiatry is only in psychopharmacology,” Fritz writes. “This imbalance in prestige and financial rewards between the pharmacologic and psychosocial components constitutes a major factor behind the trend for many psychiatrists to become only prescription writers.”

And here’s an interesting tidbit – Pharmalot says a new study funded by the Robert Wood Johnson foundation and published in the Journal of General Internal Medicine this week found that some medical bloggers are promoting medical products in their web writing (11 percent).  According to lead author Tara Lagu, a recent poll found that nearly a third of medical bloggers surveyed had been approached by a company to promote a product – and the JGIM paper found product promotion in 31 of the 271 blogs analyzed. 

Seems getting a doc-blogger to mention your drug or medical device is the 2.0 answer to earlier product placement ploys like the cereal boxes in Jerry Seinfeld’s kitchen.

PharmaExec says it’s ‘win-one/lose-one’ for drugmakers as the cost and quality bill passed out of the Massachusetts House last week without the gift ban but with a data-mining provision. Details will be worked out between the Senate and House version by the end of next week. 

And in an interview at PsychCentral, Massachusetts psychiatrist and CME watchdog Daniel Carlat talks with John Grohol about why he doesn’t see drup reps any more but still takes samples, and how the blogosphere has changed his mission to stem industry influence on medical education. 

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.

Today’s blog comes to us courtesy of RxP data-master Ian Reynolds.

Yesterday, just as PhRMA was announcing revisions to strengthen its voluntary Code on Interactions with Health Care Professionals, the Vermont attorney general was putting out a report of his own: Pharmaceutical Marketing Disclosures: Report of Vermont Attorney General William H. Sorrell on Payments to Physicians. The report documents numerous instances in which the industry violated its own voluntary Code through the provision of gifts and payments to Vermont health care providers.

“As this report demonstrates, the Payment Disclosure Law in Vermont provides useful information regarding pharmaceutical manufacturer’s distribution of money within the Vermont medical community to market pharmaceuticals,” said Sorrell.

Some of the more “useful” pieces we found:

• 84 pharmaceutical manufacturers reported spending $3,138,794 in Vermont on fees, travel expenses, and other direct payments to Vermont physicians, hospitals, universities and others for the purpose of marketing their products
• a 33% increase over reported expenditures for similar expenses in FY 06
• a 42% increase over reported expenditures for similar expenses in FY 05
• An average value of $1,348 of payments from pharmaceutical companies per recipient
• Vermont Secretary of State and the Medical Practice Board currently list 5,154 persons as licensed health care providers, and 2,328 of them received payments over $25 last year from pharmaceutical companies

Who is getting all these payments?
The top 100 recipients received a total of $2,127,325 in FY 07, or 68% of the total payments. And these top 100 payment recipients were spread out over 25 different areas of medical specialty (self reported), although we’re not sure we could have named all those specialties before reading the report.  We are sure that while pharma may be spending the big bucks on promoting certain drugs, they are still managing to make it into the offices of every kind of provider, from gastroenterologists and family practice types to physician assistants and nurse practitioners.

What are they paying for?
Are Vermonters really a bunch of depressed diabetics with serious concentration issues whose doctors have no idea how to treat them? We doubt it. But here comes pharma to the rescue! Five of the ten most heavily promoted products were mental health drugs, two for ADHD and three for depression.  Two more of the top ten are for treating diabetes.

“Cash or check” payments have been going up as a percentage of overall payments, while the percentage of “food” payments has remained relatively steady.  Speakers fees (52% of the $3,138,794 total) went up as a proportion of overall payments as well.  Speakers fees are basically payments for physicians to give “educational” talks.  Dr. Carlat’s piece, ‘Dr. Drug Rep’ in the New York Times Magazine, details the practice well and explains how he used to get $500-$750 for a one-hour “lunch and learn” promoting Effexor to his fellow psychiatrists.  That’s a lot of coin.

Playing the game
Pharma got tricky and Vermont got tough.  Individual payment information from Vermont may not be publicly disclosed if the manufacturer specifies that it is a trade secret.  As one might expect, companies had been declaring more and more of their payments trade secrets every year since the law was put on the books.  The Vermont attorney general probably suspected that the pharmaceuticals sales business hadn’t changed so much each year since 2002 that more payments should constitute trade secrets, so they took action.  For the 2007 reports, they required that companies specify exactly which information about the payment makes it a trade secret.  Turns out all those payments weren’t so top secret after all: There was a 22% decline in trade secret declaration for 2007.

What to do
It’s clear that pharma’s marketing model is changing.  The catered office lunches seem to be here to stay, but physicians are being paid to “educate” each other more through speakers bureaus than ever.  The fact that the top 100 recipients received an average of $56,944.00 is significant.  These doctors are seriously supplementing their incomes with drug company money.  It would be nice to have full public disclosure via a website like Minnesota does to see what services exactly these top 100 doctors are providing.  Are they doing 100 lunch and learns per year? Research for those drug companies? what?

It’s no surprise that PhRMA’s freshly revised Code does not address the fastest growing types of payments to physicians—speaking and consulting fees—or in-office meals.  With this in mind, it is imperative that states considering gifts legislation remember that banning the small items like pens is important, but full public disclosure of other payments is also critical.

Is your physician in the top 100?

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.

Our Fellow coalitioneers over at Health Care for All have a good post on the Massachusetts pharma gift ban as we await word on whether House lawmakers will include the section in its recommended version of the health care cost containment bill being finalized now.  Check it out here. 

This week, Pfizer announced that it will stop funding physician continuing medical education through medical education and communication companies (MECCs), effective immediately. According to the company’s press release, the move is meant to curb conflicts of interest engendered by industry funded CME. The drug giant says it will continue to provide CME through academic medical centers and professional medical societies.

For more, check out:

Pharmalot

WSJ Health Blog

Kaiser Daily Health Policy Report

The Denver Post reports this week that a new set of conflict of interest guidelines being proposed at the University of Colorado would curb industry influence on faculty and students there in a major way, but that it’s raised the hair on the backs of some faculty members.

Richard Krugman, dean of the CU School of Medicine, said the guidelines will bolster the medical professionalism the public deserves.

“I chafe at lots of federal and state regulation,” Dr. Krugman told the Post, “but the reality is, we have to have guidelines and policies and regulations.”

And though this story comes out every year (see last year’s version), the economic downturn, and the astro-price of fuel and food make this Pharmalot story about gianormous FDA bonuses seem especially egregious this year.

On Wednesday, The Boston Globe looked closely at how Sen. Ted Kennedy is convening health care leaders from Massachusetts in discussions that may yield the blueprints for a universal health care plan.  Among those in attendance were Community Catalyst Director Rob Restuccia and former director of Health Care For All, John McDonough, who is now chairing Sen. Kennedy’s health initiative. 

We hope prescription reform is one of the pieces of the health care cost puzzle that gets talked about as national health care plans are shaped, and so do the writers of this opinion piece in the Syracuse Post-Standard, who include AARP New York director Lois Aronstein and the Center for Medical Consumer’s Art Levin.

At it Aggie-an: The University of California - Davis student newspaper, The California Aggie, picked up the story about the medical schools’ top mark on the AMSA Scorecard.

Here are two mega-articles in the Philadelphia Inquirer that center around a lawsuit filed after a hip replacement patient wasn’t told about her doctor’s financial ties to the maker of the implant. 
(For the CliffsNotes version, check out the Wall Street Journal Healthblog entry.)

The Chronicle of Higher Education says Sen. Chuck Grassley’s conflict of interest disclosure hunt – which has so far trawled up undisclosed millions taken by three Harvard psychiatrists and the incoming president of the American Psychiatric Association at Stanford – is far from over. 

Two belated pick ups from the blogosphere that are worth a read:

University of Maryland professor and blogger Steven Salzberg’s post on the ubiquity of Pfizer-funded trials for its own smoking-cessation drug Chantix in the literature is exhaustive and damning.  PostScript felt a twinge of fellow-feeling for Salzberg, whose search for authorship affiliations and disclosures was steered by the capricious winds of e-journal privileges, just like our searches are.

And a blog tip to Mike Barr at Shillfactor, a site devoted to illuminating financial conflict in the world of AIDS research and treatment.  Check out his blog and encyclopedic list of people with conflicts running the show.

We’re late out of the gate on this one, but the numbers still bear mentioning – a report from the Center for Public Integrity out last month showed that the pharmaceutical industry’s been getting its money’s worth on K Street. Good news for the industry, because those expenditures totaled $168 million in 2007, up 32 percent in a year.  Bad news for those concerned that pharma’s influence on the Hill and on its own regulation is already too big.

In the win column for the industry in 2007: the reauthorization of the Prescription Drug User Fee Act, and a blocked bill that would have permitted drug reimportation.

The eye-opening stat for PostScript? “More than $6.8 million of the $14.4 million the pharmaceutical and health product industry gave in contributions went to members of three committees that regulate the industry: the House Committee on Energy and Commerce, House Committee on Ways and Means, and Senate Committee on Health, Education, and Labor.”

And while some may still hold out hopes of Karl Rove’s ‘permanent majority’, this report made it clear that pharma isn’t among them – support for candidates by party has swung widely since the Dems’ 2006 takeover, and for the first time in history, Democratic candidates received more funding from the industry than Republicans did.