A couple of weeks ago, GlaxoSmithKline Chief Chris Viehbacher tried out the bully pulpit on Massachusetts lawmakers considering a gift ban for physicians.  Too early to tell, but it may have done more harm than good.  So now pharma companies are trying a different tactic – have the caterers plead their case for them.

The caterers who make all those physician lunches certainly have a horse in this race – Kevin Abt, Founder of RestaurantstoYou.com, a corporate catering service in Stoughton, Mass., estimates that pharmaceutical reps drop $40 million on food in for docs in the state every year. Hardly chump change.  And because of this, he’s asking Massachusetts representatives to strike meals from the list of gifts that would be banned under proposed bill S.B. 2660.

We know that pharma has long found ways to get what it wants by talking through others – physicians, say, or advisors for the FDA. But a tip to the letter-writers of the world: if you don’t want to look like you were put up to something, don’t parrot information you probably couldn’t get doing your job. 

The petitioner from RestaurantstoYou moves quickly from entreating to indignant: “How could we think “the most educated people in the world, Doctors, could be manipulated by the offer of a ham sandwich and chips from a pharmaceutical or medical device company sales agent?  Instead, the opposite is true. Doctors routinely ask these reps to go do more research for them, at no cost to the doctor, so that they can have additional information for their individual analysis that they will use to make decisions regarding their patients.”

Abt knows this because he says to better understand his clients, he has watched from the back of the room in admiration as the reps performed their lunch and learns. Fine.

But if you are the one making the sandwiches, do you really want to sound like you are reading off the same talking points as the state policy director for the PhRMA trade association? PostScript has been to enough hearings to know those talking points when we hear them. Sales reps with no background in science are providing valuable information about drugs that physicians can’t get anywhere else? And pasta salad.

Yep. 

No doubt: $40 M is a lot of money to spend on food every year – but if that number tells Massachusetts lawmakers anything, it’s the sheer scale of investment these companies have made in wooing physicians, evidence that it’s probably time for the marketing machine is to be reined in.

If nothing else, it’s intriguing to see pharma moving the mouths of both Ivy League physicians who are recruited to speakers bureaus where they use marketers’ slides to pitch their drugs for them, and those of the blue collar catering drivers from Stoughton: “The food we deliver is wholesome and delicious, but it is not flashy or expensive.”  We have to hand it to them: The chemical pushers have become deft chameleon puppeteers.

But in another sense, pharma has found authentic common ground with the simple ham sandwich makers of the world – they’ve got mouths to feed, starting with the shareholders.

Reading the fine print

Glad we read the Boston Globe this week, where we stumbled across this great opinion piece by internal medicine resident Dr. Michael Hochman, who says that recent revelations about pharmaceutical companies ability to bury unfavorable studies (or just write better ones themselves) have got him and his colleagues at the Cambridge Health Alliance thinking twice about the sizeable chunk of industry-funded research in the medical literature.

“One of the more experienced doctors I work with, for example, told me that he no longer views industry-funded research as an unbiased source of information but rather treats these studies like advertisements for pharmaceutical products,” Hochman writes.

Though he says he’s encouraged by recent changes to limit marketing influence on good medicine, such as the Journal of the American Medical Association’s pledge to exorcise itself of ghostwriters, and Boston University School of Medicine’s recent introduction of strong policies that ban industry gifts and payments, he will “rely less heavily on studies funded by pharmaceutical companies when making decisions about my patients. And when I do read industry-funded studies, I will use the skeptical mindset I developed during my medical training not only to evaluate the study methods but also to consider the motives of the researchers involved.”

After the Wire, Under the Arch: med school policies in perspective

The Baltimore Sun ran this comprehensive article on the AAMC recommendations and the state of pharmaceutical conflict-of-interest work at the state, federal, and academic medical center level.  According to the Sun, “The Johns Hopkins University and the University of Maryland allow doctors and researchers to accept gifts that have “educational value” and to earn money for company-sponsored speeches. Officials at both schools say the policies are under discussion and might be tightened in response to the new AAMC guidelines.”

Here’s another good omnibus article in the St. Louis Post-Dispatch on the state of industry influence on academic medicine – and the effect of the AMSA Pharmfree Scorecard last year.

According to the Post-Dispatch, after the scorecard came out “Washington University adopted a policy to ban representatives from interacting with students without faculty supervision. Among other rules, representatives are barred from bringing food on campus.”

A second year medical school put it this way: “By the time I’m done, I’ll have paid a couple hundred thousand dollars for my medical education,” she told the Post-Dispatch.  “I think I’ll be well-qualified enough to educate myself.”

And the accompanying editorial says that it’s no coincidence that “Americans spent $216 billion on prescription drugs in 2006, an increase of nearly 80 percent over the $121 billion spent in 2000.

“The simple truth is that when drug and medical device makers offer a free lunch, the rest of us pay the bill.”

American College of Physicians mag looks at COI policies

Here’s a great look at what AMCs are doing about industry influence from a professional perspective.  The ACP Hospitalist talks with RxP and a whole starting line-up worth of adminstrators who have taken their organizations pharm free, including BUSM’s Dr. David Coleman, University of Pittsburgh Medical Center associate dean Dr. Barbara Barnes, and SMDC Health System’s Dr. Kenneth Irons, who took the out-of-sight-out-of-mind approach offshore, orchestrating the shipment of all his clinics’ pharma gizmos to Cameroon earlier this year.

In Heinz sight

And for anyone who doubts that pharmaceuticals have gotten away from the science in favor of lifestyle marketing campaigns run by brand-savvy MBAs, we bring you this nugget, courtesy of the WSJ Health Blog.

When we heard this ‘Marketplace’ story about the economics of a box-office flop, we couldn’t help but think it all sounded a bit familiar.  Referring to the current kids film Speedracer, ‘Marketplace’ anchor Kai Ryssdal reported that, “Warner Bros. put $100 million into making it, then another $150 million marketing it. Total box office so far? Less than $30 million.”

Hmm.  Sounds like a problem the pharmaceutical industry has had too, of late. Though the numbers differ, it’s widely believed that pharma marketing budgets outstripped R&D spending awhile ago, resulting in a rash of combination and me-too blockbuster drugs that cost much less to invent than they do to push.

But back to the Speedracer fable. A big chunk of that $150M marketing budget? Happy meal toys. We know that pharma already has that routine in the bag. According to the ‘Marketplace’ story, Warner Bros. spent $80 million in ‘promotional partnerships’ for the film. Those, too, are a core strategy of pharma’s marketing arm – drugmakers sponsor everything from celebrity golf tournaments to 10K races, and underwrite medical society annual meetings and patient advocacy groups.  Payments to doctors could even count as promotional partnerships at the individual level.

A consumer retail consultant on the show said that hope was not lost for the Speedracer campaign – foreign markets and DVD sales might help recoup some of the loss.  For me-too and new drugs that don’t perform on the market as projected, there are always foreign markets – for instance, the ceilingless seller’s market for anti-retrovirals in emerging nations, or the DVD release-like molecular tweaks companies make to extend patent exclusivity.

Though the show ended with a clever line tugged from the Speedracer script – “It’s getting ugly out there” –’Marketplace’ didn’t have to say that maybe one of the lessons for the studio was to reallocate funds next time toward making a better movie, one that would sell itself once the lights went down.

So long, samples

The Carolinas HealthCare System is nearly halfway through its first year of zero free drug samples, reports the Charlotte Observer.  Dr. William Sugg, the medical director of the 600-member CHS physician network, told the Observer that though some of the physicians are “violently opposed” to the new rule, the system made the change out of concerns over both safety and the marketing influence. 

“If it wasn’t influencing prescribing habits, why would they be doing it?” Sugg said of sample hand-outs.

The Trees for the forest: Stanford paper praises policies

And it’s a pat on the back for Stanford Medical School, which the Stanford Daily editors say “has beaten the AAMC to the punch” with its 2006 conflict of interest policy.  Well, that’s one way of looking at it – it’s possible, though,  that movement toward strong conflict of interest policies by early adopters like Stanford helped create momentum that influenced the AAMC task force findings.  

According to the editorial, a working group at Stanford is now looking at industry involvment in continuing medical education.

Tech-ethics in AAMC guidelines

Though there was a flurry of coverage on the new AAMC guidelines, which prescribe a ban on all industry gifts, this week Modern Healthcare zeroed in on a different part of the recommendations that discussed healthcare IT – electronic medical records and e-detailing, for example. From the Reader’s reading of things, seems like the recommendation in question amounts to: technology is medical education is important – let’s talk about it more.

State savvy

The USA Today opinion blog says that the states with gift bans and disclosure laws have the right idea when it comes to pharmaceutical generosity toward MDs.  “While each of the state programs has its flaws,” the editors write, “the forced transparency is a sensible first step toward curbing abuses.”

Speaking of transparency…

The Physician Payments Sunshine Act has undergone some changes in the Senate as members prepare to attach it to this year’s Medicare bill.  Eli Lilly has come out in support of the amended version, in which the reporting threshold was raised from $25 to $500, the start date moved back from 2008 to 2011, and which would, if passed, preempt existing state disclosure laws beginning in January 2010. 

Read coverage in the Indianapolis Star and The Hill for more.

And for the weirdest idiom tweak of the week, this DigitalJournal.com article on the co-opting of news by drug marketers takes the grain of cake:

“When health care experts appear on 24/7 news stations to promote the latest gastric bypass surgery, viewers should take their announcements with a large bear-hug of salt.”

We first read about Congressman Steve Kagen’s insurance status on the Wall Street Journal Health Blog, which pointed to this article in the Scientific American. Apparently, Rep. Kagen, a Wisconsin physician who joined the U.S. House of Representatives last year, got funny looks from the human resources department when he turned down the congressional health care plan. “I’ll respectfully decline until you can make that same offer for all of my constituents,” he told SciAm of the conversation.

The article comes now that Kagen has paired his insurance abstinence with a bill – the No Discrimination in Health Insurance Act – which would require insurers to disclose rates and make it illegal to refuse coverage for pre-existing conditions.  Kagen’s proposal isn’t a comprehensive measure, but it’s also cost-neutral.

And that’s just one guy’s strategy –- okay, a guy who gets to vote on declarations of war and budget appropriations — but there are others.  There is the McCain un-Strategy, the Democratic candidates’ proposals, and Ron Wyden’s Healthy Americans Act, which has captured the attention of a bunch of folks on the Hill, and the hearts of an eager army of health bloggers.  And then there are the states, where some say the lion’s share of coverage and reform work is happening.

Consumer Voices for Coverage is one such effort to coordinate those state-level efforts among health care consumer advocates and ensure consumers have a voice in the health care debate.  Being steered by RxP parent group Community Catalyst and funded by a grant from the Robert Wood Johnson Foundation, CVC is a 12-state initiative based on the idea that consumer coalitions can move states at the tipping point of health reform by sharing resources, strategies, and experience. As this Health Affairs paper demonstrates, efforts vary widely among states, and budgetary constraints that don’t bind the feds – say, balancing the budget each year – limit the scope and practicality of cost-positive solutions in the states. And there are many states where health reform isn’t even close.  So attention to the coverage deficit at the federal level – whether it’s Kagen’s version or Wyden’s – is a good thing, and will most certainly move the needle.
 
Some HealthBlog commenteers point out that if Kagen does fall ill, he’ll probably get customary free care from a fellow physician – and that even un-physicians are eligible for free care, which contributes to higher rates for the insured.

Then again, no one said Kagen’s refusing insurance would solve the coverage crisis in America. But in a choice-happy climate, it’s good to see someone choosing solidarity with the people he represents.

The unconventional thank you note: GSK exec demonstrates

Yesterday Chris Viehbacher, head of GlaxoSmithKline’s U.S. Division, sent a wouldn’t-it-be-a-shame note to legislators considering a Massachusetts bill that would ban pharmaceutical vendors from giving gifts to physicians.  In the letter, Viehbacher expressed his displeasure at the prospective law and reminded them of Glaxo’s recent job creation in the Bay State. Considering that the same legislators have proposed $1B to help boost the state’s biotech cluster, we wonder just how much Viehbacher wants before he’d be content ditching the bribes to physicians and sticking to the science.

Here’s the original story in the Boston Herald, and today’s follow-up, which includes interviews with two legislators who weren’t amused. We were, though, to read that state Sen. Mark Montigny (D-New Bedford) called the letter ‘baloney.’

Speaking of the Boston broadsheets, Pharmalot says supporters of physician/industry relations have enjoyed some column inches lately on the op-ed pages of the Herald and Globe. Chief of medicine at Mass General Hospital Dennis Ausiello, M.D. coauthored both, in which he calls for “more, not less, interaction between academic physician scientists and their counterparts in industry, engagement that should occur at every stage of the drug development process.”

When last we checked, that engagement was happening at every stage of the process – and look how good Vytorin turned out.

We’d like to hear from you

Today, Big Pharma goes to the Hill, but not for lobbying (ok, well maybe for that too.) The House and Energy Oversight and Investigations subcommittee will be hearing from Pfizer, Johnson & Johnson, Merck, and Schering-Plough about direct-to-consumer advertising.

The baby in the bathwater, and Texaco treats at school:

A doc–off over AAMC recommendations

Over at MSNBC, Art Caplan Ph.D., a renowned bioethicist at University of Pennsylvania squares off against Cornell surgeon Edward Craig M.D. M.P.H.  about why the new AAMC recommendations are a good thing – or not.

Caplan writes:

Business has no business selling or promoting in the middle of classrooms or other academic settings. Academic medical centers, if they want to teach their students how best to think about the medicines they prescribe and to retain the trust of the American people about evaluating them objectively, should do everything they can to keep the marketing, sales pitches, promotions and bribes — large and small — away from campus.

Craig, however, says that the prescribed ban, which includes things as big as foreign travel and as small as pens, lacks subtlety, and insults hungry doctors.  “When was the last time you were bribed by a piece of pizza or a logo pen with five days worth of ink?” Craig writes.

Ah, the old if-it-were-you argument.  More than a few fables and aphorisms have been written to warn us against that reasoning, but perhaps Jane Austen did it best in her novel, Persuasion: “How quick come the reasons for approving what we like!”

(And we like the pens a lot.)

Airing on the side of secrecy

Slate.com reported on some undisclosed industry relationships on the airwaves.  Neither the hosts nor the medical experts interviewed during a program on the depression meds SSRIs announced the experts’ consultant and advisory capacities for makers of the drugs.  More here.

When it comes to conflict of interest among new members of the DSM-V committee, the glass is half empty or half full, depending how you look at it. The Diagnostic and Statistical Manual for Mental Disorders is the encyclopedia of treatment guidelines put out by the American Psychiatric Association once every so often (the last one was in 2000).

According to the Integrity in Science watch (from Center for Science in the Public Interest), it’s half full – of conflict.  To be more precise, 14 of 28 committee members have some financial conflict with the pharmaceutical industry – ranging from the Conflicted to the Whoa (“William Carpenter, Jr., director of Maryland Psychiatric Research Center at the University of Maryland, who over the past last five years worked as a consultant for 13 drug companies, including Pfizer, Eli Lilly, Wyeth, Merck, Astra Zeneca, and Bristol-Myers Squibb.”)

As they say, it’s all about perspective.  Perhaps for APA President Carolyn Robinowitz, this means the committee is emptier of conflict than before – after all, among the 170 DSM-IV creators, 56 percent had conflicts.

But when Robinowitz pledged to make “every effort” to eliminate conflict in its development in the news release about the DSM-V workgroup, seems the folks at CSPI were underwhelmed – as we were – by a straight-down-the-middle 50 percent.

A few weeks ago, we posted on the curious persistence – and size — of propaganda for Vytorin, the combo cholesterol drug that’s efficacy went the way of its clinical trial results – into thin air – after a panel of cardiologists rendered its cholesterol-lowering powers null and void at the American College of Cardiologists meeting in March.

But Gary Giorgio, MD, a doctor of emergency medicine in Akron, Ohio, said it better than we could have in this letter to the editor of the Akron Beacon-Journal, which ran two full-page Vytorin ads like the ones we saw in the Globe.

“The ads follow fast and furious on the heels of a study published in the New England Journal of Medicine that showed no benefit of the combination drug in reducing plaque,” Giorgio wrote.

“Given these facts, why would any intelligent physician prescribe this medication? Is it because industry-tainted guidelines keep pushing for lower and lower cholesterol targets despite a lack of evidence that this is beneficial? Is it because pharmaceutical giants Merck and Schering-Plough, which stand to make billions more dollars if patients are switched to or kept on Vytorin, have duped physicians and their patients? You be the judge.

“If you’re taking Vytorin, maybe, as the ad suggests, you should be talking more to your physician.”

Feds Put AMA on the Hot Seat

This week, Senators Herb Kohl (D-WI) and Richard Durbin (D-IL) sent a letter to the American Medical Association requesting information about its prescriber data opt-out program. According to the BNA Health Care Daily Report, “the letter asked for information related to the AMA’s Physician Data Restriction Program (PDRP), which allows doctors to protect their prescribing information. The letter also requested information regarding the type of outreach the AMA conducts to physicians to educate them about the program, the number of physicians who currently participate, and how the AMA ensures that pharmaceutical companies are appropriately responding to and adhering to the program.”

“To say the least, we are troubled by any attempt to persuade physicians to prescribe a drug for any reason other than the patient’s condition and the drug’s effectiveness in treating it,” said Kohl and Durbin in a statement this week. “Without question, it is very important for physicians to be able to protect the privacy of their prescriber numbers and prescribing patterns.”

What’s it all about? In a (hyphenated) word, data-mining. While the sale of the Masterfile brings home a bundle for the AMA annually ($44.5 million in 2005), the AMA’s opt-out program doesn’t have quite the same cache —few physicians know about it, and even less have opted-out. Some who’ve done it say it’s a rigmarole, and one which must be done every three years to stay “opted-out.” Even then, an opted-out doc’s prescribing data can still be sold – the purchasers must only agree not to share it with individual sales reps. We’re glad to see it’s getting some attention on the Hill.

And this just in, from the On the Dotted Line Dept...

If you haven’t already, check out RxP’s consumer petition for the Physician Payments Sunshine Act, a national disclosure bill backed by the National Coalition for Appropriate Prescribing and gathering steam among members of Congress (including Sen. Kohl, who co-sponsors with Sen. Chuck Grassley.)

For more on the Sunshine Act, go here.

And if you’ve already signed up, thank you.