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.

The Association of American Medical Colleges released a set of recommendations this week urging its 129 North American member medical schools to ban all industry gifts to faculty, staff and students, as well as to prohibit ghostwriting arrangements and industry-funded meals and travel.

The recommendations, the result of a two-year task force process on industry funding of medical education, align closely with those of the Prescription Project.

“Most medical schools do not have strong conflict-of-interest policies,” RxP director Rob Restuccia told the New York Times, “and this report will change that.” 

Read the Times editorial here, which calls for the policies to be immediately adopted and in some cases, strengthened.

For medical schools writing or revising conflict-of-interest policies, the Prescription Project has developed toolkits describing best practices and practical considerations. Check them out at the RxP website.

The Prescription Project, National Physicians Alliance, Prescription Access Litigation (PAL) and US PIRG have submitted public comments opposing an FDA Draft Guidance that would allow drug companies and their salespeople to distribute reprints of medical journal articles discussing off-label uses to physicians.

The groups outline numerous reasons why the distribution of reprints by pharmaceutical representatives does not facilitate evidence-based decision making and could jeopardize patient safety and public health. They urge the FDA not to issue the Draft Guidance in its current form and to hold public hearings on industry marketing of products for off-label purposes.

Off-label prescribing, the prescribing of drugs for non-FDA approved purposes, is legal. However, the marketing of drugs by pharmaceutical companies for off-label purposes is not legal. Currently, pharmaceutical companies can provide medical journal articles discussing off-label uses to physicians only if the physician asks for the information. The FDA guidance would loosen that restriction.

A whole lot of bloggers have taken on last week’s ghostwriting study in JAMA. Here are a few of our faves:

National Physician’s Alliance, the RxP partner group of physicians to which JAMA author Joseph Ross belongs, has this analysis of the latest chapter in the Vioxx saga.

Here’s NPA member Howard Brody’s take at the Hooked blog.

And in other blogs:

Daniel Carlat at the Carlat Psychiatry Blog compares the Pentagon’s use of thought-leaders (in this exhaustive New York Times investigative report) with Pharma’s strategy to push its message through ‘hired gun’ physicians.

Researcher and watchdog Aubrey Blumsohn has built a Scientific Misconduct Wiki to pair with his Scientific Misconduct blog.  Blumsohn writes:

Hopefully this will form the seed of a peer reviewed online journal devoted to Scientific Integrity. For the moment, it will serve as a non-collaborative repository for reports and academic analysis of the integrity scandal involving Procter and Gamble and the drug Actonel (including the serious implications of the failed but rather sad attempts at coverup and delay by ‘regulators.’”

And here’s a real time example of a university enforcing its policy of financial disclosure for physicians.  Pharmagossip and Pharmalot posted on a story in The Cincinnati Enquirer that the University of Cincinnati has a closer eye on psychiatry professor Melissa Delbello these days after big discrepancies in the size of her paycheck from AstraZeneca came to light.  The letter from Sen. Grassley probably helped things along, but it’s good to see an academic medical center acting on its conflict of interest policies.

Ghostwriters…

The big story from the Pharm Country this week is ghostwriting, in the wake of reports that some of the papers published about Vioxx were penned by Merck but attributed to physician authors.  If you haven’t seen the story, you need not look very far — it’s everywhere.  The Baltimore Sun and CNN here, plus some more in an earlier blog post.

Sen. Chuck Grassley (R-IA), sponsor of the Physician Payments Sunshine Act, wasted no time writing Merck a letter.

As FDA deadline approaches, so do lobbyists

And as the deadline for public comment on the FDA’s proposal to loosen restrictions on off-label marketing materials, pharma lobbyists descend on Washington.  The story is in the Wall Street Journal.  The approaching guidance would allow pharmaceutical salespeople to distribute journal articles about off-label uses of their drugs to doctors – but this review of Neurontin off-label use (spoiler alert: it’s dismal) is a good case study in why some worry about the legalization of such off-label promotion. 

Massachusetts Senate cost control bill moves to House

In Massachusetts, the state Senate has passed a comprehensive cost-control bill that includes a gifts ban and academic detailing provision.  Now it moves on to the House. 

But not before veteran pharma champion and biotech director Thomas Stossel MD of Harvard Medical School and co-writer and Harvard doc Dennis Ausiello MD got their word on the gift ban in.

“We believe that the best approach to optimize cost effectiveness of product prescribing is to promote more, not less, interaction among all stakeholders involved in health-care delivery, including company marketing reps,” Stossel and Ausiello wrote in the Boston Herald. 

Hmm.  A call for more interaction among all stakeholders + a state shortage of primary care docs = Perhaps the reps could see patients themselves, to help the docs out?

We thought we were just poking fun, till we saw this post on Pharmalot – it’s almost happening! In Australia, medical practices have started to ask pharmaceutical companies to help with payroll for their staff.   A total pigs-on-the-runway moment for PostScript.

Pharmalot and the HealthBlog are really good about pointing out relevant ties to industry that may color the opinion columns and letters of pharma’s more prolific defenders like Stossel, which is good, because it seems the original publisher of those pieces rarely get disclosure of his industry ties right on the first try….

The Vytorin Connections

Part of Schering-Plough’s clean-up team for the Vytorin mess is on the board of the New York chapter of the American Heart Association,  as is one of S-P’s compliance officials, reports Pharmalot.  While consumer groups like the AHA taking funding from pharmaceutical companies is nothing new, Pharmalot says there are an awful lot of dots to connect in this picture.

On the street where you live

All politics are local, and now so are drug ads, like this Zyrtec pull-away flyer.  Streetcorner DTC? From what we know about the size of pharma’s marketing budget, we’d say this is cutting more than a few street corners.
 

Using court documents from lawsuits over Merck’s Vioxx, a study in this week’s Journal of the American Medical Association found that Merck often wrote first drafts or commissioned for-profit ghostwriters to write academic articles on the pain drug, then paid academic thought leaders for claiming primary authorship. Half the time, those doctors did not disclose that payment in publication, and often the corporate ghostwriter was not listed among authors at all. 

In a companion editorial, JAMA editor-in-chief and RxP advisory board member Catherine D’Angelis M.D. decries the practice, writing, “it is clear that at least some of the authors played little direct roles in the study or review, yet still allowed themselves to be named as authors.”  The lead author of the paper, Dr. Joseph Ross of Mount Sinai School of Medicine in New York, is a member of the National Physicians Alliance, a partner of the Prescription Project.

Read more in the Washington Post, the Boston Globe, and the New York Times.

One of the beauty’s of the American marketplace is this: If you can buy ad-space, you can sell your wares, even when those wares have been proved a sham. This week’s proof? Vytorin.  Clinical trials of the combo-cholesterol drug, which were subject to a little data-magic last year, have come up way short in the cholesterol-lowering and plaque-dissolving departments for which it was sold.  But aggressive marketing of the drug, which got the official snake-oil verdict by an expert panel of cardiologists at the American College of Cardiologists conference two weeks ago, steams ahead.  This week, Merck and Schering-Plough, the drug companies that teamed up to bring us Vytorin, ran a double-sided full-page ad touting the drug in a number of top newspaper dailies in the country, including the Boston Globe and the Los Angeles Times.

Another beauty of the American marketplace is this: Bad news doesn’t go unnoticed.  News of Vytorin’s dismal trial results triggered a stock price plummet and ensuing crisis at Schering-Plough, the New Jersey Star-Ledger reported Sunday. In the aftermath of the ACC conference, Schering-Plough announced it would eliminate 5,000 jobs as part of a cost-cutting strategy, the development of which was apparently a Zen-like experience for CEO Fred Hassan, who told the Star-Ledger:

“It’s really very refreshing and energizing to see people just come together and in a very good way,” he said. “We had the whole team there working together.”

Hmmmm. That kumbiya-like description of how well the S-P management team worked together to plan cutbacks may not have been the best story to relay through New Jersey’s top news outlet. We’re pretty sure that the 5,000 Schering-Plough employees – mostly New Jerseyites - whose jobs are on the chopping block, not to mention the five million people who shelled out for Vytorin last year, are feeling anything but refreshed and energized today.