The American Medical Student Association released its 2013 PharmFree Scorecard this month, continuing to pressure and encourage medical schools to improve their policies on conflicts of interest and interactions with industry. These policies have impacts on students’ medical education, the future of the medical profession and the care physicians provide. As patients we should be able to trust that decisions about our care are based on science and our best interests, not the marketing strategies of the pharmaceutical industry.

Now in its sixth year, the AMSA Scorecard rates U.S. Medical Schools on 11 key model polices that institutions should implement to reduce inappropriate interactions between the industry and medical school faculty and students. In the 2013 Scorecard, fully 115 (73 percent) of the 158 U.S. medical schools now receive an aggregate grade of A or B for their policies, compared with 102 last year and just 45 in 2009.

Dr. Elizabeth Wiley, AMSA national president, praised the progress made: “The PharmFree Scorecard is a successful, evolving tool which assesses the policies of academic medical centers and medical schools… With all of the compelling data about how marketing influences even the best-intentioned physicians, it is gratifying to see that medical schools are taking the necessary steps toward practicing evidence-based medicine, which translates into better patient care.”

The Scorecard analyzes and scores gifts and meals from industry to doctors, paid promotional speaking for industry, acceptance of free drug samples, interaction with sales representatives and industry-funded education. Ninety-seven percent of all eligible medical institutions sent their policies to AMSA for analysis this year, up from 92 percent in 2009, a striking confirmation of its significance for medical school leadership.

Dr. Maurice Clifton, Sr. Associate Dean for Academic Affairs at the new Commonwealth Medical School in Scranton, PA, told Community Catalyst that “The scorecard was an essential tool that helped us develop a comprehensive policy to ensure appropriate interactions between students, faculty and industry in the academic clinical setting.”

Commonwealth Medical School, which welcomed its first class in the 2009-2010 academic year, received an aggregate “A” grade, with the highest scores possible on 10 of the 11 model policies. In March, Commonwealth MS joined other Pennsylvania medical schools and academic medical centers in a meeting convened by Community Catalyst to discuss best practices and strategies to implement the policies that the Scorecard measures.

Highlights of the 2013 AMSA Scorecard:

• 93 schools (59 percent) now have model polices prohibiting all gifts and on-site meals, up from 19 (12 percent).
• 79 schools (50 percent) have a curriculum on conflicts of interest, up from 12 (8 percent) in 2008.
• Schools with model policies on speaking arrangements have grown tremendously; 44 (28 percent) schools ban or severely restrict participation in speaker bureaus compared to 31 (20 percent) in 2011-2 and only 4 (2.5 percent) in 2008.
• Only 41 schools (26 percent) have a model policy in terms of disclosure, requiring personnel to disclose past and present financial ties with industry (e.g., consulting and speaking agreements, research grants) on a publicly-available website and disclosing these relationships to patients.
• Policies restricting industry support for Continuing Medical Education are now in place in only 28 schools (18 percent), but this is nearly double the number of schools in 2010.
• Access by pharmaceutical sales representatives remains a major challenge, with only four schools (2.5 percent) prohibiting sales reps from meeting with faculty and trainees regardless of location, or prohibiting sales reps from marketing their products.

A webcast of a live discussion of the AMSA Scorecard release can be found here. This National Grand Rounds was organized by the National Physicians Alliance, and includes a description of the updated methodology for the 2014 Scorecard for medical schools, as well as the new Scorecard for teaching hospitals, which were designed by AMSA and the Pew Charitable Trusts.

Community Catalyst is also producing “A Policy Manual for Academic Medical Centers and Medical Schools,” with Toolkits on the policies rated by the AMSA Scorecard – you can download the the first one, on medical school curricula on conflict of interest, here.

The 2013 AMSA PharmFree Scorecard, the NPA National Grand Rounds and the Community Catalyst Policy Manual are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin. Partners in the PACME project are AMSA, Community Catalyst, the National Physician’s Alliance, and the Pew Charitable Trusts. For more information, contact Marcia Hams, at mhams (at) communitycatalyst (dot) org.

Marcia Hams, Director of Prescription Access and Quality, Community Catalyst

This week, I talked by email with physician and researcher Dr. Joseph Ross about the importance of using unique identifiers in pharma disclosure data, and other ways to take the guess work out of the Physician Payments Sunshine database.

PS: Last week, a commentary in JAMA (Carpenter/Joffe) suggested that unique investigator identifiers should be used in the Physician Payments Sunshine database to make the data most usable, accurate, and suitable for cross-reference with other databases.

You’ve spent a lot of time with data collected under similar disclosure laws in Minnesota and Vermont. From your point of view as a researcher, what aspects of an identifier are important or helpful to looking at these data?

JR: From our experience examining the data in Minnesota and Vermont, I can only say that some unique identifier is necessary. Neither the Minnesota or Vermont data that we used included a unique identifier, just the name of a physician, clinician, or hospital/clinic that accepted the payment from the pharmaceutical company.

We found that trying to determine exactly who accepted which payment was virtually impossible, because one could not be sure whether a “Dan Smith” in Minneapolis was the same or a different “Dan Smith” in St. Paul, for example. Without a unique identifier, doing research to examine which physicians or clinicians are accepting payments can only be done in the aggregate, not at the individual level.

However, what is most interesting about Carpenter and Joffe’s proposal is not the unique identifier in itself, but the development of an identifier that could be used across databases, linking payment disclosure data, to grant applicants, to manuscript submissions and publications, to service on NIH or FDA committees. I could imagine this identifier being an expanded use of the NPI (national provider identifier), or another number, but it would certainly make identifying potential conflicts of interest far simpler.

PS: One of the reasons these authors suggest a unique identifier is to capture payments made to non-physician investigators. Did you deal with this issue in your work with the Minnesota and Vermont data?

JR: Yes, examining the data in Minnesota and Vermont, there were a substantial number of payments made to non-physicians, although these clinicians were not necessarily investigators. I agree that if the PPSA is broadened to include payments made to non-physicians, an alternative identifier to the NPI might be necessary. NPIs are required by all health care providers, including non-physicians who bill insurance companies or write prescriptions. But some non-physicians who receive payments from industry may not fall into this category.

However, to me, the real issue is a shortcoming of the PPSA, which requires companies to include physicians’ NPIs in their annual submissions, but prevents these numbers from being made publicly available.

PS: Why is that a problem?

JR: This is a problem because, as it stands, the payment disclosure data cannot be confidently attributed to an individual without using the NPI as a unique identifier. Our prior experience suggests that individual physicians will appear in the disclosure data multiple times, potentially with different spellings of their names, different practice addresses and so forth. It becomes a bit of guess work to determine if a payment to Daniel Smith from Lilly in September should be combined with the payment to Dan Smith from Lilly in April.

PS: In your 2007 JAMA article, you wrote about difficulty you had obtaining the Vermont/Minnesota data, and the poor quality of the information once you received it. Out of this experience, what should some of the priorities be in developing Sunshine systems and payment categories to produce a meaningful public disclosure scheme?

JR: Well, we’re still more than two years away from seeing how the PPSA plays out in practice. The legislation was fairly specific in terms of what information is to be collected.

Of all the categories pre-specified, the “nature” of the payment is most subject to interpretation.

My hope is that they interpret it as specifically as possible, so that, for instance, its disclosed when a payment is for a) speaking at a ACCME accredited educational event, b) speaking at a non-ACCME accredited educational event, c) attending a ACCME accredited educational event, or d) attending a non-ACCME accredited educational event. If the “nature” of a payment is disclosed vaguely, all four of those activities could be listed under the umbrella of “education.”

Otherwise, I agree with the Carpenter/Joffe commentary: Something needs to be done to ensure that a unique identifier is required for disclosure by companies and made available to the public. Without this, these payments may be misattributed, particularly within larger markets, limiting the effectiveness of this law within those communities.

Joseph S. Ross, MD, MHS, is an Assistant Professor in the Section of General Internal Medicine at the Yale University School of Medicine in New Haven, CT. He holds a medical degree from the Albert Einstein College of Medicine, Bronx, NY, and completed his post-graduate training in primary care internal medicine at Montefiore Medical Center in Bronx. As a fellow in the Robert Wood Johnson Clinical Scholars program at Yale University, Dr. Ross earned a Master’s degree in health sciences research. Using health services research methods, Dr. Ross’s research focuses on examining factors which affect the use or delivery of recommended ambulatory care services for older adults and other vulnerable populations, evaluating the impact of state and federal policies on the delivery of appropriate and higher quality care, and issues related to conflicts of interest, medical professionalism, and drug safety.

Interviewed by Kate Petersen, PostScript blogger

Sunshine’s getting closer, and we’re not talking sandals and patio seating.

With complete rules scheduled to be out this October, the Centers for Medicare and Medicaid (CMS) are spending the summer writing the whos, whats and whens of the Physician Payment Sunshine provisions, which will require drug and device companies to publicly report payments to doctors and teaching hospitals. And since the devil’s in the details, consumers and industry are weighing in with CMS on how to make Sunshine a source of light, not just heat.

On a recent open door call with the agency, industry and consumers weighed in on aspects they think are important to consider as it builds the Sunshine regulations and system. Representatives from Community Catalyst, Health Care for All (Massachusetts), Minnesota Prescription Coalition and the National Physicians Alliance joined representatives of BIO and PhRMA on the call.

Here are some of the key issues we heard (and were underscored by follow-up letters PhRMA and BIO published this week.)

Payment categories
Categories of reported payments should be adequately detailed, clearly defined and discrete: payment for meals, travel, gifts and entertainment should be reported in separate categories, rather than lumped into broader catch all categories, or collapsed into research or education. This will prevent double-counting, make data comparable across companies and provide more accurate and comprehensive info for researchers and consumers.

In its letter, PhRMA proposes collapsing some payment categories: “some meals and travel could be reported as expenses associated with consulting activities, rather than individual line items.” But CMS should be careful, as collapsing categories could make the data less useful and might assign marketing-based payments –dinner at a nice restaurant, sports tickets—the false legitimacy of bona fide research payments.

Other things it’s important to define:

• Payments reported as “research” should meet the standards, in existing federal law, for systematic investigations, which does not include, for instance, marketing research;
• Payments reported as ‘education’ should refer to participation in an accredited CME program;
• “Consulting” should hew to the definition of bona fide services established in a number of widely accepted industry codes (AdvaMed, PhRMA) and include a written contract, deliverables and clinical research protocol;
• Community Catalyst emphasized that the name of the drug associated with each payment should include both the common name (in addition to the technical name) so consumers will recognize drugs they may be taking.

The Vermont disclosure database and Massachusetts’ databases, though not perfect, provide useful examples for CMS in structuring these definitions and categories.

Accuracy
All parties on the call agreed that industry and CMS should work together to make sure the data is as accurate as possible. Establishing detailed unambiguous guidelines and reporting forms as well as opportunities to correct data will help with that. So would coming up with a list of all potential recipients and assigning unique identifiers, industry and consumers said. Consumer groups also want to see aggressive enforcement to ensure accuracy and full participation by companies.

Speaking of all potential recipients, we’re baffled by a number that keeps coming up. Both on the call and in its letter to CMS, PhRMA cited a mid-size company that estimated it would have to report more than 1 million transactions with 300,000 physicians in the first year of Sunshine. Considering that there are a total of about 660,000 in the whole US (BLS), we are both impressed by the reach of that mid-size company and wide-eyed at its marketing budget. Unless they’re going pen by pen (which the law precludes), that’s a lot of dinners. Or research.

The point they’re making is—we think—is the burden of all this data. A million anything is hard to keep track of! But Vermont’s disclosure law provides some evidence that companies are already managing these data well, because though it is a small state, the Attorney General’s office in Vermont manages to collect comprehensive data from 141 manufacturers of pharmaceuticals, biologics and medical devices. And unless they aren’t complying, this means the companies are managing to get it to them. All that’s good news.

Background info
So why do we need Sunshine? That’s an important question to answer on the Sunshine website, we think, so that consumers and other visitors have both context and rationale to frame what – let’s face it—is going to be a lot of numbers.

The risks associated with financial conflicts of interest are inherent in academic-industry relations, but gone unacknowledged, such COIs have the potential to bias patient care and prescribing. The Institute of Medicine has done excellent work framing the rationale for financial transparency.

Both PhRMA and BIO made a point of asking that the Sunshine website describe the benefits of academic-industry collaboration to patient care; we think such commentary, if included, must be counterweighed with evidence of the risks of financial marketing relationships on clinical care.  Both aspects of the relationship are explored in the IOM research, and its process has included all stakeholders.

So what’s next?

CMS has an open comment period this spring and summer with a goal of having completed regulations up by October 1, 2011 so that companies can begin collecting data in 2012.  The first year data is set to be published by CMS September 30, 2013.

More about Sunshine? Check out the Sunshine Act Guide.

–Kate Petersen, PostScript blogger

The 2010 American Medical Student Association (AMSA) Scorecard is out today, and for the first time since the student group began assessing conflict-of-interest policies four years ago, one half of all U.S. medical schools received an A or B (78 out 152).

That’s up from approximately one in three schools last year, and just 20 percent in that range just two years ago, suggesting that we really are engaged in a nationwide project to figure out what the proper role of the industry in  medical education should be.

About one-fifth of medical schools improved their scores over last year, the same improvement rate as we saw in 2009 over the previous year’s Scorecard. We think that’s really good. Let’s remember that these are giant, slow-moving academic institutions – not exactly the hares of the system-change race. That makes such steady and significant shifts even more impressive.

As for “most improved” candidates for the we-wish-it-existed AMSA Scorecard Yearbook, Tufts University would have to be up there, moving from D to an A and to the top of the class this year among medical schools in Massachusetts, as would University of South Dakota Sanford School of Medicine and Des Moines College of Osteopathic Medicine, who also jumped from Ds to As in a year.

We should point out here that the room between A and B is somewhat complex. The scorecard is composed of 11 domains:
-acceptance of gifts and meals from industry;
-consulting relationships;
-speaking relationships;
-disclosure of financial conflicts;
-pharmaceutical samples;
-individuals with financial conflicts participating in university purchasing decisions;
-financial support for educational events (on- and off-campus);
-industry support for scholarships and trainee funds;
-access of industry sales personnel to medical school or hospital personnel;
-and inclusion of education about conflict of interest within the academic curriculum.

Each year, AMSA asks all medical schools, early and often, for their policies in each of these domains and then using methodology developed with the help of the Pew Prescription Project, independent blinded assessors evaluate the policy out of a possible three points.

The needle’s been harder to move in certain domains than in others.

Unsurprisingly, very few—10 percent of schools—got a perfect score on their on-campus continuing medical education policy. Drug company sponsorship of grand rounds and other on campus co-hosted educational activities is a big money maker for medical schools, and can give a company talk the imprimatur it craves. The Accreditation Council for Continuing Medical Education gets this, and its policy recommendations have lagged behind many rule-making bodies and medical groups on decoupling industry-physician marketing relationships.

More surprisingly, perhaps, even fewer schools – just two – got a perfect score on limiting access to sales reps. A score of “3″ on industry access, according to AMSA’s scorecard site, is given to policies in which “pharmaceutical and device representatives are not allowed to meet with faculty regardless of location, or are not permitted to market their products anywhere inside the medical center and associated clinics and offices. (Exceptions may be made for non-marketing purposes, such as training on devices or equipment.)”

Schools that limit faculty and student interaction with sales reps, or where sales reps can go, but do not ban them, received a 2.

Still, the fact that no more than two schools banned sales reps outright is surprising to us because:

A) allowing sales reps on campus seems like the easiest, clearest example of letting industry inappropriately infiltrate your medical school. It’s in the name: they are there to sell stuff. Cutting out sales reps doesn’t get into questions of patient access to drugs or doctor access to education programs.

B)There are just less of them than two years ago. The last half of this decade hasn’t been a good one for sales reps, as pharma companies with trickling pipelines have slashed traditional marketing budgets in favor of … well, doctor-to-doctor CME, for one, and online campaigns. It seems that this would make it even easier for schools to put together great policies to keep the sales reps at bay. Maybe people need pens more than we thought.

For more, visit the 2010 scorecard at http://amsascorecard.org or check out the Pew Prescription Project resources on marketing and conflicts of interest.

–Kate Petersen, PostScript blogger

Three headlines that caught our eye over the weekend:

FDA report suggests it’s not quite time for J&J to cut the ribbon on its brand-recovery campaign. The New York Times looks at the most recent inspection report the agency filed on J&J’s troubled Puerto Rico plant, which documents “distribution of drugs that failed quality requirements, a failure to identify product defects during routine testing, failure to detect incorrect expiration dates on drug labels, failure to adequately investigate product problems, failure to follow laboratory controls and inadequate training of lab staff.” The report goes through early November; earlier this month, more manufacturing problems led the company to make another huge wholesale recall of more than 9 million bottles of liquid Tylenol, 4 million packages of Benadryl, as well as Motrin and Rolaids products.

As concerns of nationwide counterfeiting problems grow, India commissions a feasibility study on a federal computerized distribution system to better track drugs through the supply chain. In addition to this survey of stakeholders, India’s drug regulatory agency, DCGI, is also encouraging smaller drug companies to use national subsidies to help with set-up costs of a barcoding system. “Both developments tie in with recent initiatives by the Indian government to try to improve the transparency of India’s pharmaceutical sector – a critical supplier of essential generic medicines for countries around the world – and shake off its image as a hub for counterfeit and substandard drugs,” Securing Pharma writes.

And American Medical News, the online news arm of the American Medical Association, sees a significant drop in doctors’ financial ties to drugmakers. Using follow-up survey data on commercial CME, meals, and samples in a recent Annals of Internal Medicine article, the AMN suggests the last five years have seen a sea-change in the way industry markets to doctors (or conversely, the way doctors accept industry’s advances.)

But though there may be a trend here, recent payment data from Massachusetts’ disclosure law and aggregators like PharmaShine and ProPublica suggest that hundreds of millions of dollars are still going from industry marketing budgets to physicians’ pockets each year.

The future federal sunshine law, as well as state and other AMC public disclosure regs (which barely got a paragraph here) are key: not only as potential driving factors in the trends that AMN is pointing to, but as sources of data that suggest the drop off of physician-industry coziness may not be quite as simple as the AMN suggests.

The article also gives a lot of space to the voluntary PhRMA conduct code and AMA’s own code, both of which are relatively weak and unenforceable compared to many academic medical center policies, and which were, chronologically, responses to pressure for system reform rather than drivers of such change, as the AMN article implies.

–Kate Petersen, PostScript blogger

Having revealed that more than 250 physicians with serious sanctions against their medical licenses are on the speaking circuit of some of the nation’s top drug companies, ProPublica and a series of news outlets around the country have put the question to the companies: When it comes to speakers bureaus, who’s keeping the gate?

One company said that they had a previous plan for gatekeeping.  So what happened to it?

These are not nitpicky violations we’re talking about—a CME credit here or there, unpaid dues. One doctor listed in the ProPublica database, Kenneth Fisher, is paid by GlaxoSmithKline and two other companies despite having been on probation for nine years in the state of Arizona for a series of serious misconduct charges, including sexually violating HIV patients.

This is the sort of thing that makes landlords do background checks. And if landlords can do them, why not drug companies spending millions to have certain doctors talk about their finely-tuned brands?

“Let’s be honest, they do a lot of very complicated things very well,” Hastings Center bioethicist Josephine Johnston told ProPublica. “These are the people who have figured out how to get prescription data for individual doctors so they can send drug reps to target particular doctors in particular ways.”

Good point. Data-mining isn’t exactly a simple (or transparent) marketing strategy, but the industry has it down, spending millions each year to buy individual prescriber records and pairing them with prescribers’ names so that they can tell how much Lipitor Dr. Doe is writing, and how many more scrips she’s likely to write (more on data-mining here). But complicated things in service of marketing that works, and complicated things that might make effective marketing harder are two different matters (although one wonders if there aren’t easily 250+ blemish-free docs willing to step in to fill vacancies on the speaking circuit).

Perhaps the failure to do background checks—the casualness it conveys—underscores just how big these marketing budgets are. That the $7.1 million these seven companies gave the sanctioned docs in the last two years isn’t enough to inspire thorough background checks suggests the sums don’t make industry’s reputation radar. Pharma has been cutting sales rep jobs for awhile now, but let’s not mistake that for cutting marketing spending—doctor-to-doctor talks work, and they are still going strong: The ProPublica aggregator totaled up $282 million in speaking fees from seven companies between 2009 and 2010.  And there are more than 70 drug companies in marketing in the U.S., meaning there’s potentially a lot more money on the table that we will learn of when state disclosure laws and the federal Sunshine laws kick into effect.

None of the seven companies whose payment data was reported offered an official to speak with ProPublica (a sign as a reporter that you’re on to something). But among the general statements they did make, we couldn’t help our jaw from dropping a little as we read the range of reasons companies gave for not doing background checks on their speakers:

Pfizer and Glaxo noted that some of the physicians listed no longer speak for them.

Pfizer also noted that none of its doctors had been banned from participating in federal health programs.

Merck & Co. said it had “previously initiated” plans to conduct more frequent background checks and “is exploring additional capabilities.” The firm would not be more specific.

Johnson & Johnson, Glaxo and Cephalon each said that they are always looking for ways to enhance their selection of speakers.

In an e-mail, Glaxo spokesman Kevin Colgan added that disciplinary actions alone shouldn’t be the basis for excluding a potential speaker or consultant.”

Glaxo and Lilly each made payments to more than 100 of the 292 sanctioned docs ProPublica identified.

After reading about Dr. Fisher’s record, we’d be interested to see the criteria GSK does use to exclude a potential speaker or consultant.

–Kate Petersen, PostScript blogger

Are the muckrakers moving more slowly than their subjects in the medical field when it comes to pharmaceutical conflicts of interest? That’s one way to look at two recent stories that indicate that the press establishment may be increasingly confronted with the same questions that it’s been pressing physician and medical groups to answer for years.

Eyebrows were raised recently over the news that Pfizer endowed $80,000 worth of fellowships through the National Press Foundation for 15 journalists to attend a four-day conference on cancer in October. According to Pharmalot, this is the second year of the conference.

On her blog at Politics Daily, Alison Fairbrother asks: Just how big a conflict is this?

Well, plenty of people (journalists included) readily answered: Big. Pfizer makes a handful of incredibly expensive cancer drugs. (Probably not on the conference program is Forbes columnist Robert Langreth’s “Why Pfizer can’t cure cancer.”) There is now wide consensus that industry-backed education for doctors (CME) creates the potential for bias, and many medical schools, specialty societies and physicians groups have moved accordingly, restricting ways that industry can support CME or banning such support entirely, as the University of Michigan did earlier this year.

This week, in fact, a Harvard neurologist launched an industry-free CME company that will draw on expertise of non-conflicted Harvard physicians to create the curriculum modules. It’s encouraging to see the move toward industry-free continuing medical education move beyond regulation and back into the private market.

And as for the journalists? A Pfizer spokesman told Pharmalot this:  “With the 24/7 news cycle now, my concern continues to be the ability of journalists to have enough time to understand the material and have the knowledge to do the analytic work they need to do. I can complain or be part of the solution. We believe we’re doing this the right way.”

That’s not surprising. And it sounds a whole lot like the pharma industry’s pitch for detailing and CME sponsorship: How else, they say, are busy doctors going to get this information?

Well, there are beginning to be more alternatives for doctors. And we would posit that that’s precisely journalists’ job: to figure out the right unbiased way to get the information, also known as reporting. That’s what they are: professional information-getters.

But as newsrooms cut and cut further, they will be scanning ever-wider circles for someone willing to foot the bill, as Gary Schwitzer of Health News Review told Pharmalot and Fairbrother.  And pharmaceutical companies are great at footing the bill, especially when the ROI looks good.

And when you have the President of the National Press Foundation saying things like this—“I evolved a way of using a strict set of guidelines which basically say we’ll take money from anybody as long as they follow certain rules”—how could pharmaceutical companies not see an open door? They have whole divisions devoted to following rules.

Arguably, awareness of the potentially problematic financial ties between physicians and industry has never been higher, and the new federal Physician Payments Sunshine law will further illuminate the scope and prevalence of those ties. It’s perhaps ironic, then, that the industry that played such a big role in raising that awareness may be next to confront its own vulnerability to Rx influence.

–Kate Petersen, PostScript blogger

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

Yesterday, Harvard Medical School announced strict conflict-of-interest rules that limit ties between its 11,000 faculty members and pharmaceutical and medical device makers, making it one of a growing number of medical schools across the country to address concerns about the influence of industry marketing on the education, training and practice of physicians.

Highlights of the new policy, which will be phased in by January 1, 2011, include:

• prohibiting all personal gifts, travel or meals from industry
• banning participation on speakers bureaus (company-controlled talks)
• capping at $10,000 annually per company the amount faculty can earn from a company whose technology or product they are investigating in clinical research
• requiring Harvard to post on its website faculty member financial interests in, or payments from, pharmaceutical and medical device companies
• prohibiting companies from sponsoring specific Harvard-run CME courses for physicians, unless more than one company sponsors the course and no one company funds more than 50 percent
• requiring industry exhibits and programs to be held at a separate time and place from Harvard CME courses

As one of the world’s most prestigious medical education and research institutions, Harvard’s decision to strengthen its rules is a powerful acknowledgement of the impact of aggressive industry marketing on medicine. It also sends a strong signal to other institutions that have yet to address industry’s presence on medical campuses. It is also a reminder to the Massachusetts legislature, which is debating efforts to repeal the state’s ban on industry gifting to prescribers, that the medical profession is increasingly embracing the need for these restrictions and ethical standards.

When the Prescription Project formed in 2007 with a goal of eliminating conflicts of interest at academic medical centers, conventional wisdom had it that change at Harvard and its affiliated hospitals would not come easily. After Boston University and UMass Memorial Medical Center released strong policies in 2007 and 2008 respectively, the Project convened all of the Boston-based academic medical centers with the hopes of building momentum for change at all of the Massachusetts-based schools and teaching hospitals.

Harvard’s new policy buttresses similar guidelines issued last year by Partners Healthcare, which employs thousands of Harvard physicians and operates two of Harvard’s teaching hospitals – Mass General and Brigham & Women’s.

As a number of other top institutions around the country – Stanford, University of Pittsburgh, University of California Davis – released new COI policies in 2008 and 2009, attention continued to focus on Harvard. A series of unflattering media exposés on Harvard physicians’ ties to industry, followed by a Congressional investigation by Senator Charles Grassley (R-Iowa) into whether the physicians had violated federal conflict-of-interest payments for failure to disclose large drug company payments, raised questions about the school’s policy and helped thrust the issue into the national spotlight.

In June of 2008, the American Medical Student Association (AMSA) released its Pharmfree Scorecard developed in partnership with the Pew Prescription Project. Harvard received an “F” score due to its failure to submit its policy. The score garnered unwanted media attention from several major national news outlets.

In addition to creating external pressure on Harvard, AMSA began to work internally to push for reform and signs of progress were beginning to surface. When the Harvard University Faculty of Medicine Committee on Conflicts of Interest and Commitment convened in late 2008, AMSA members from Harvard Medical School and across New England asked for involvement in the policy drafting process, increased transparency, mandatory lecturer disclosure and a reasonable timeline for drafting and implementation.

Last year, Harvard submitted policies to AMSA and received a “B” score on the 2009 Pharmfree Scorecard.

“Harvard’s policy represents an important milestone because many institutions look to Harvard to set an example,” said Chris Manz, Pharmfree Director at AMSA.  “While the policy revision has room for improvement, it sends the message that academic medical centers can responsibly collaborate with industry while also preserving the integrity of the medical practice, and we’re proud that PharmFree students played an integral role in its development”

In some areas, Harvard’s new rules may set standards for other schools, particularly in the area of faculty earnings from industry. The rules cap at $10,000 the amount Harvard faculty can earn from a company whose technology or product they are investigating in clinical research.

Despite that, the new rules on continuing medical education (CME) do not go as far as those at schools like UMass and Stanford, which the Project has cited as model policies. Nevertheless, it will be interesting to see how the CME policies impact Pri-Med, the Boston-based annual physicians conference that features Harvard lecturers and has been a carnival of industry marketing. The new rules propose a “firewall” between Harvard and the companies that use these events to market their wares in every spot imaginable, including, apparently, the bathrooms, which will no longer be allowed.

Overall, these are strong policies that will be hugely influential.

– Kathy Melley, Director of Communications

New proposed rules from the NIH yesterday on preventing conflicts of interest in biomedical research improve public disclosure but leave the decision about what constitutes a financial conflict with an investigator’s institution. The rule lines up with much of Community Catalyst and Pew Prescription Project’s recommendation to the agency in July 2009. The Institutes are again seeking public comment for 60 days.

The proposed rules require investigators – that is, anyone involved with the design, conduct or reporting of publicly-funded research – to disclose to their institution all payments greater than $5000. Those payments include consulting, honoraria, speaking or travel funds, or paid authorship. The institution – commonly an academic medical center or university—must then determine what is a potential conflict and report those payments and a management plan to the NIH.

This is a shift from the current rules, which require an investigator to disclose payments to her institution only if she believes it conflicts with her research – a system, it seems, that left too much room for interpretation. News reports have documented millions of drug company dollars that went to investigators running trials on drugs made by those companies. (GoozNews has about a complete a list of news clips as one could want.)

The proposed rule also requires each institution seeking NIH funding to establish a publicly accessible website on which it would post its conflict of interest policy and all financial conflicts of interest held by investigators, updated at least annually. This is a great step toward better transparency that is meaningful to patients and consumers, as it will provide an important crosscheck to the Sunshine database and other disclosure websites for assessing conflicts and compliance.

We’d still like to see payments below $5000 be disclosed to institutions – the number is arbitrary, and studies suggest gifts and payments much lower than that can create bias.  Though the NIH cited concern over administrative burden, many institutions and companies have already begun requiring disclosure at a much lower threshold, suggesting it’s important, and doable.

And the big increments that NIH set for public disclosure on the websites (less than $20,000, less than $50,000, less than $100,000 or more than $250,000) leave too much guesswork. There is a difference between a $250K relationship and one in the millions, but the public won’t be able to see that if the proposed rule stands as is.

The nature of academic-industry relations has changed dramatically in recent years, and it’s encouraging to see that the NIH rules get that—and account for it. For instance, the NIH addressed the shift in industry-backed CME by making explicit that payments for lectures, seminars, and speaking gigs sponsored by non-profits are not exempt from disclosure, acknowledging that for-profit companies often create non-profit arms to fund talks and execute programming. And they added “paid authorship” and “travel reimbursement” to the list of examples of payments to acknowledge industry’s heavy reliance on speakers’ bureaus, backing researchers to attend or present at conferences, and ghostwriting – or soliciting an academic to sign an article that was not written by her/him in full:

With regard to “paid authorship”, in particular, although there should be little question that receipt of payment from an entity in exchange for the drafting of a publication constitutes payment for services, we believe it is important to reference this form of payment specifically in the regulations.

Read more about our original comments to the NIH here, or read the proposed rule at the Federal Register.

–Kate Petersen, PostScript blogger