Last week the Association of American Medical Colleges and three other university associations took aim at the NIH’s proposed rule to tighten disclosure and reporting requirements, departing from their initial support of tightened regs last summer.

Like the AAMC and Association of American Universities (AAU), who joined AAMC in its comments, we voiced our support for reform and suggested ways to strengthen reporting and transparency when the NIH solicited public comment last summer on ways to shore up rules aimed at promoting objectivity in research.

This May, the Institutes issued a proposed rule with many strong reforms (you can read about that here on PostScript.) The rule was amended and the comment period extended after it came to light that an National Institutes for Mental Health director Thomas Insel had recommended psychiatrist Charles Nemeroff for a job at University of Miami, despite Nemeroff’s failure to report large sums he received from GlaxoSmithKline while working on an NIH–backed grant on a GSK drug. That violated NIH rules and led to his resignation from Emory University, but Insel apparently assured Miami administrators that Nemeroff would be eligible for NIH funds at a different university. (Carlat Psychiatry Blog and Pharmalot have the backstory.)

In its newest comments, AAMC asks for reporting exclusions that would significantly weaken the proposal.  As currently written, NIH would exempt disclosures only for seminars at institutes of higher ed and government agencies. AAMC suggests exempting all speaking gigs, lectures and seminars at academic teaching hospitals, medical centers, research institutes affiliated with an institute of higher education, and other non-profits involved in research.

They also suggest that travel funds be exempted from reporting requirements, as well as any funding for CME presentations that meet ACCME standards. However, in this compliance-savvy climate, most industry-backed CME presentations in which NIH investigators participate are ACCME accredited – and such accreditation does not eliminate inherent bias in such programs.

Unfortunately, those are pretty big slices of the pie. A lot of research-related dollars are flowing through third parties at this point—including the non-profits and other third parties that AAMC asks to be exempted. Most patient organizations and professional medical associations are non-profits, and the grants money they receive is often passed on to individuals for fellowships, participation in research symposia, or education. As you can see on Pfizer and Lilly’s websites, most grant recipients from the two drug companies listed here are non-profits, and many of those grants seem to be for these research-related purposes.  
Just because they are issued through a non-profit does not mean these funds cannot somehow influence how an investigator conducts his research.

The AAMC and its cosigners also suggest that NIH should rely first on investigators to decide what to report, based on their judgment of the relatedness of a financial interest to their research.

Well, this is how much of this started – Sen. Grassley and others found that investigators, who decide under current regs what they do and don’t report to their institution, weren’t reporting some pretty big industry payments related to their research. See Nemeroff, Schatzberg, Biederman, et al. In most cases, the medical schools that AAMC represents were the ones to get the bad press and in hot water for these omissions. The NIH proposed rule change would help protect these institutions by taking the evaluative reporting decision away from the investigator. With the Sunshine Act providing a national database of company payments to physicians and teaching hospitals, we don’t want institutions that are accountable to NIH to be caught out if they aren’t aware of a payment to an investigator that shows up in the Sunshine database.

The AAMC also proposes that if undisclosed conduct is discovered, an investigation could be waived.  But we support NIH’s proposed mandatory investigation if someone fails to report a Financial Conflict of Interest (FCOI). The new regs were proposed and will be implemented for good reason. There is no current mechanism for NIH or an institution to judge whether an investigator failed to report a FCOI “in bad faith” or whether the unreported interest affected research. Unless you investigate, there is almost no way to uncover intentional and problematic non-disclosures. We can’t count on whistleblowers to enforce this.

Worryingly, the groups frame their comments by calling into question the very need for the reforms.

There is a paucity of evidence that the disclosure and management of financial conflicts of interest affect objectivity and integrity. In the absence of such evidence, onerous regulations are not only unwarranted, but could create a glut of policies that increase activity without adding protections and at the same time erode the trust between the regulators and those being regulated.

We think this is a tough claim to make, since the rule was proposed and amended in large part because of Congressional investigations and media stories that revealed millions of dollars of undisclosed industry funds in the hands of publicly-funded researchers.

While there may be no study yet that links disclosure of FCOIs to research integrity, there is increasing evidence of bias in research and disclosure is one step we can take to try to reduce this bias.

–Kate Petersen and Ian Reynolds, PostScript

MedPac approves disclosure recs

Last week, the Medicare Payment Advisory Commission approved recommendations that would require pharmaceutical and medical device companies to disclose payments to clinicians, academic medical centers, continuing medical education programs, and other health care entities in a public database.

We discussed the recommendations and their potential influence on the next Congress last week here.

Medical school mashup

Conflicts of interest in academic-industry relations were the hot topic at the annual meeting of Association of American Medical Colleges last week, said Stanford School of Medicine Dean Phillip Pizzo in his Dean’s newsletter last week.

Speaking of academic-industry relations, Emory University has announced that it has formed an ethics panel to look into its management of researcher conflicts of interest. The move comes after a Senate Finance Committee investigation into the extra-curricular and undisclosed industry payments of Dr. Charles Nemeroff led to his stepping down as chair of Emory’s psychiatry department last month.

Check out RxP director Rob Restuccia’s op-ed on why greater transparency like the kind the Finance Committee is seeking is essential for good medicine, and find out more about the new Emory ethics panel here.

Hunting caps

Based on the GlaxoSmithKline’s recent comment that it will be capping industry payments at $150,000 per doctor per year in line with the industry’s current standards, Ed Silverman at Pharmalot went on an epistolary hunt to see exactly what those industry norms were. Many of the responses he received from companies suggested they were looking at current practices, and referenced compliance with the revised PhRMA code which, incidentally, is silent on caps on payments to doctors.

Papers weigh in on pre-emption

And thought it seems forever ago, it was just last week: Before there was Election Hubbub, there were opening arguments in the Supreme Court’s hearing of Wyeth v. Levine, the preemption case that will determine whether consumers can file suits over FDA-approved drugs in state courts. Here are opposing editorials from the Boston Globe and Wall Street Journal – we’re sure they won’t be the last – and the Kaiser Daily Health Policy Report provides a good soup-to-nuts.

Subcommittee refutes FDA safety finding

In a follow-up to a story we touched on last month, Integrity in Science Watch reported that the FDA subcommittee assigned to look at the FDA’s prior ruling on bisphenol-A “blasted the agency for declaring the plasticizer safe, saying the agency used unacceptable criteria for selecting studies to inform its deliberations.” Some groups had been concerned with a possible conflict of the subcommittee chair, who received a large undisclosed gift for his University of Michigan research lab from a Michigan-based plastic maker.

Despite the subcommittee report, the FDA issued a statement saying it stands behind its position that BPA is still safe for water bottles everywhere.

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.

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.”

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.

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.

It’s a week of catch up at PostScript – here’s a little link-love before the weekend hits:

A great opinion column appeared in yesterday’s Eugene Register-Guard. The author Gail Hacker M.D., medical director at Lane Community College Health Clinic, does an eloquent job of explaining why drug samples aren’t a solution for her and her underserved patients – and why she feels it’s incumbent on her fellow physicians to turn back pharma’s advances, not the other way around. She writes:

Physicians can afford office supplies and food. Physicians can read journals to get unbiased updates on medications. And if physicians choose to get medical information from a representative of a pharmaceutical company, they can certainly do so without being fed.

Former drug rep talks to docs to Beantown

As we posted earlier this week, former Eli Lilly rep Shahram Ahari was in town talking to medical students and trainees at Boston University, Harvard, Tufts, and Mass General Hospital.  Joe Shortsleeve of WBZ-TV reported on one of his talks and legislation in Massachusetts that would ban gifts to doctors. Watch here.

Congressional clips

Cleveland Plain-Dealer columnist Diane Suchetka takes a look at the proposed federal academic detailing initiative in Congress right now, and talks about the bill with RxP member Allan Coukell, who testified about the practice before the Senate this month.

Coukell also spoke with Pharma Executive about the Physician Payments Sunshine Act, which has been introduced in both houses of Congress.

Business Journal features chief of UMass

John O’Brien, president and CEO of UMass Memorial Medical Center in Worcester, penned this column in the Worcester Business Journal about the process his medical center used to build new, top-tier confict-of-interest policies.

Aussies, AMSA, and Academe

Pharmalot’s been busy, as usual. Here are some recent posts that caught our eye:

Australian Rx is spending big bucks on doctors, too 

AMSA’s how-to on holding pharm-free meetings and conferences

Two MIT researchers’ big idea for restructuring the drug pipeline

Lit review: a false positive?

UC Davis Professor of Medicine Michael Wilkes has this caveat emptor in the Sacramento Bee for those trying to make sense of recent study that found antidepressants little better than placebos in most cases.  Wilkes reads the PLoS Medicine paper as both a case study and cautionary tale about how much we – patients, doctors, even journal editors -  can trust ‘the literature’ in a scientific culture where pharmaceutical companies own the studies and the data they produce.

“Even the process of getting research published in a major medical journal is subject to bias,” Wilkes writes.  “For example, in one recent report, 8 percent of research with a negative result was published in medical journals, compared with 97 percent of research with a positive result.”

This education brought to you by Merck: OK with IOM?

This article from Medical Marketing & Media says the Institute on Medicine is halfway through its slate of meetings on commercial funding of CME, and reports that attitudes on the committee against industry CME may be thawing, but warns that “conflict hawks” like the Josiah Macy Foundation and the Association of American Medical Colleges could still change the status quo.

A new study in the Journal of the American Medical Association found that academic medical centers have been slow – or slower than hoped – in addressing institutional conflicts of interest (ICOI) in a formal way. The gist – of 125 medical schools surveyed in 2006, 86 responded, and only 30 of those had a policy to address ICOI, which include things such as royalties, equity holdings, or other financial stakes held by researchers or institutional officials. The authors are researchers at Massachusetts General Hospital and the Association of American Medical Colleges.

In this accompanying editorial, Dr. David Rothman (who heads up the Institute on Medicine as a Profession and is the associate director of the Prescription Project), says no one should be shocked that academic medical centers are fertile ground for institutional COI – indeed, we made them that way with Bayh-Dole, and the FDA’s Critical Path Initiative, which encourage academic-industry collaboration on pharmaceuticals and whose “unintended consequences have been to blur the distinctions between academic and commercial entities, and to make ICOI much more pervasive.”

When it comes to narrative oomph, individual conflicts of interest often seem to pack a little more punch, because it’s about one physician or prescriber taking a personal check, making a decision to go to dinner with the drug reps, or to accept a consulting job, or to travel attend an out-of-town conference on industry’s dime.  Royalties, equity, IRB firewalls – it all sounds a little, well, cold. 

But Rothman rightly reminds us that institutional COI can have equally pernicious effects – lethal ones, even, as in the case of Jessie Gelsinger, who died in 1999 from participating in experimental gene-therapy trial and the University of Pennsylvania.  As Rothman points out, no one knows whether Gelsinger would have survived if Penn and the principal investigator conducting the research didn’t have big claims to any patents and profits that came out of the therapy.  But, as the bioethicists say much better than we can, it sure didn’t look good.

With a finger in the air, Rothman feels the winds of regulation a-blowin’, perhaps a little stronger than the winds of institutional change are.  Let’s face it, neither Congress nor university medical centers sport a Jack-be-nimble, Jack-be-quick reputation. But we’re glad that he also singles out a handful of medical centers that have bucked the image of the institution as a slow-moving giant.

There also seems to be a vacuum in professional society leadership, a sector that could provide positive leadership for institutions out ahead of government regulation or the policy-from-scratch approach some schools have taken.  Instead, Rothman finds that “neither the Association of American Universities nor the Association of American Medical Colleges has issued a model policy.” 

So now we wait – for other institutions to address conflicts of interest, for the AAMC to release its much-expected new conflict of interest policies this spring, and for the day when medical journals, who get all that ad revenue, let us read the important articles for free.