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

Yesterday, the American Medical Student Association (AMSA) released their 2011-2012 PharmFree Scorecard, now in its fifth iteration. The Scorecard evaluates conflict-of-interest policies at the 152 medical schools in the U.S. and Puerto Rico, as well as a number of affiliated academic medical centers. With growing consumer and government scrutiny of the relationships between doctors and pharmaceutical companies (see, e.g., ProPublica’s series Dollars for Docs and the Physician Payment Sunshine Act), the Scorecard takes a unique look at how well professional standards are being introduced to the next generation of doctors. We don’t doubt the importance of education about pharmaceutical interventions and treatments, but it is also important to learn to question the veracity of information presented at industry-funded events, and understand the pharmaceutical marketing machine before a doctor begins her practice.

The Scorecard assesses policies that seek to reduce drug industry influence on the educational and clinical environment in which physicians do their training—including bans or limits on industry provision of gifts, meals speaker’s bureaus and samples; on industry influence on medical education and drug purchases by hospitals; on drug reps’ access to clinical areas; and, disclosure of industry relationships. This year’s grades demonstrate that medical schools are taking important measures to control the interaction between students or faculty and the pharmaceutical industry. Twenty-eight schools received an A (28 percent), 74 schools received a B (49 percent), 15 schools received a C (10 percent), and 13 schools received a D (9 percent). That leaves 9 schools with an F, and 15 “In Progress” schools. Despite progress overall, challenges remain, especially with policies on disclosure of financial ties with industry, samples, and access by sales representatives.

There are 102 schools with As or Bs (two-thirds!), up from 79 in 2010 and 45 in 2009. Four schools significantly improved their scores and went from F grades last year to B grades – gold star! These schools are University of Texas Health Center at Houston, University of South Carolina, Howard University, and Morehouse School of Medicine. Five other schools improved by two letter grades or more: Eastern Virginia Medical School, University of Arizona College of Medicine, Midwestern University – AZCOM Arizona College of Osteopathic Medicine and CCOM (Chicago), University at Buffalo, and OU-COM Ohio University – College of Osteopathic Medicine. And although other schools made this particular improvement, it is nice to see that Harvard Medical School has improved from a B to an A. (Recall that in 2008 they started with a great big F.) Kudos to the leadership (and student activists) who helped Harvard institute some of the strongest policies in the country, including a ban on speakers’ bureaus and a strong gift, disclosure and samples policy.

“It’s gratifying to see the improvement of medical school grades on the AMSA scorecard. This reflects the importance that medical schools are placing on the highest principles of professionalism. The policies that medical schools adopt set the tone for the culture of the institution that instills the values of professionalism in the medical students, residents, and fellows who train there.”

Stephen R. Smith, M.D., M.P.H.
Professor Emeritus and Former Associate Dean for Medical Education
Warren Alpert Medical School of Brown University

We’ve come a long way since Brennan, Rothman and company published their seminal article in 2006 on conflicts of interest in academic medical centers and their impact on medical professionalism. To put those recommendations into practice, the Prescription Project was launched in 2007 at Community Catalyst, funded by Pew Charitable Trusts. In 2008, The Association of Academic Medical Centers (AAMC) stepped up with strong standards. For the last five years the AMSA Scorecard has served to keep everyone’s feet to the fire—while measuring steady progress and pointing to barriers that must still be overcome.

To look up any school and see all the details on what’s behind each grade, please visit http://www.amsascorecard.org/

Community Catalyst, AMSA, Pew Charitable Trusts and the National Physicians Alliance have now begun a new three year collaboration, The Partnership to Advance Conflict-Free Medical Education to address these issues at medical schools and AMCs. The initiative is 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.

–  Anna Dunbar-Hester,  Program Coordinator
Prescription Access & Quality

‪Pressure’s building on the Office of Management and Budget to give a status update after Nature blog reported earlier this week that OMB may have tossed a rule proposed by NIH last year that would tighten conflict of interest reporting rules for biomedical researchers and institutions. Yesterday, Sen. Charles Grassley wrote to the Administration asking for documents related to the decision, and saying to rollback the rule “flies in the face” of its own transparency promise (hat tip Pharmalot).‬

‪In the spirit of disclosure, we supported the NIH rule in public comments with the Pew Prescription Project last year, and defended it here when university associations took aim at it late last summer. Despite progress among academic medical centers in tightening individual conflict policies, many AMCs still do not publicly disclose faculty ties to drug companies, and schools and investigators are left making the call if and what to report.

Meanwhile, media reports and industry-based disclosures like the Propublica ‘Dollars for Docs’ database show that millions of dollars are still moving from drug company to doctors’ hands. When those doctors are also doing tax-payer funded research that guides clinical practice and prescribing, we think the NIH–and the public–should know.‬

‪I talked to Dr. Sidney Wolfe of Public Citizen yesterday about the rule, the flap around conflict of interest at FDA, and just how hard it is to find an unconflicted expert around here.‬

‪‪PS: Many academic medical centers have strengthened or implemented better disclosure policies recently. And we have the Physician Payments Sunshine Act coming down the line. So why was this NIH rule needed? Where does its rollback leave us?‬‬

‪SW: Just think about the Dollars for Docs. Before a website like that (which only has data from the eight companies that currently disclose) you needed to go to each of the eight companies’ websites, instead of being able to get all of the information on a  specific doctor at one place. Instead of having to write to every academic medical center, [the NIH rule] would put it in a user-friendly place subject to analysis.  ‬

‪And academic medicine revolted against it. They don’t want this, they don’t want medical students to easily out find what’s going on. Because if you are a med student, you may have a different view of your instructor who’s positive toward a therapy if you find out he or she is getting a considerable amount of money from the company who makes it.‬

‪There’s little doubt as to why the academy pushed against this rule. They don’t want people to believe members of their faculty have a bias. Of course, many still have to disclose it, but now it requires leafing through papers, or waiting for a FOIA request.‬

‪PS: What happened? Is this about budget woes, or pressure from industry and the universities?‬

‪SW: Nothing has happened yet.  But from what [Nature reporter] Meredith Wadman reported, it certainly pushes away from what should have been now been finalized.‬

‪No one is disputing there is a big glitch in this process. I doubt whether out of a clear blue sky, [OMB's] Cass Sunstein says, ‬Oh, that is not a good idea‪. I assume he read the letters, and he may be just more ideologically attune to academic medicine and those trying to fend off what was originally proposed by the government 15 months ago.‬

‪PS: Conflict of interest rules at FDA are also in the news after Commissioner Hamburg said at a Public Citizen meeting this week said that limiting financial conflicts has made it hard to fill advisory boards. But Health News Review and Project on Government Oversight offer lists of independent experts, and say the rule is not to blame.  Is this a real problem? ‬

‪SW: There’s no doubt that it’s more difficult to find someone without a conflict, but it’s obviously very important to do so, because these decisions are best made by people who don’t have a conflict of interest. The advisory committee I serve on, the Drug Safety and Risk Management Advisory Committee, had some empty slots, but the slots have all been filled now.

I don’t think there have been any committees that have not met because of unfilled slots.  One could argue that having tougher conflict laws and missing two or three people on a committee actually makes the decision-making better. This decision-making is too important to be polluted with a conflict of interest. ‬

‪There are two questions, and it’s not clear which Commissioner Hamburg was referring to.‬

‪Question A: Does someone get put on a committee or not?‬

and Question B is: Even if they are on a committee, should this person be recused from a given meeting? Someone with a conflict can also be given a “waiver,” but this happens much less than it used to six, eight, 10 years ago. ‬

‪PS: NIH has rules around advisors’ conflicts, too. To be an NIH reviewer, one must receive less than $10,000 from an involved company per year, as I understand it. Do you know if NIH has similar vacancies, or problems finding unconflicted experts? ‬

‪SW: NIH reviewers pretty much have a final say, whereas we are just advisors to the FDA. I doubt seriously that NIH will tell you that they have a very difficult time finding enough reviewers. And if it’s a little more difficult, remember, the whole purpose is to be as unfettered as possible. So it’s worth the extra effort.‬

interviewed by Kate Petersen, PostScript blogger

Late last summer, the Association of American Medical Colleges attempted at the eleventh hour to significantly weaken proposed rules to tighten up conflict of interest policies for NIH-funded biomedical research.

Now the rule, which would require institutions to collect and report more information about their investigators’ financial ties to drug and device companies, is facing threats from another corner, as OMB trawls the regulation fountain for small savings.

But looking to detooth or block conflict of interest regs isn’t the answer. We know from ProPublica‘s review of company payments and other recent reports that big dollars from pharmaceutical companies are still flowing into the hands of clinicians, who are often also publicly-funded researchers.  And we know from a series of Senate and media investigations that the current honor system of requiring researchers to report conflicts with the drug industry is broken in big ways.

The new rule would help fix that by creating common protocols and measurements, helping to ensure all NIH-funded institutions are reporting and managing COIs in the same basic way.

The AAMC and AAU’s earlier attempt to weaken the NIH proposal illustrates the difficulty an association that represents so many institutions can have setting a high bar, and there’s sometimes a tendency to recede to the lowest common denominator.

Indeed, many academic medical centers have been very proactive in taking steps to better manage the potential financial conflicts of their faculty. But the Senate’s investigation revealed many medical schools were guilty of lax oversight, and this would help them avoid similar problems in the future.

Recent sanctions of some high profile researchers at the center of the conflict of interest storm, including a prominent group of Harvard psychiatrists, remind us why NIH proposed the new rule in the first place, and of the potential costs of not changing them.

Harvard psychiatrist Joseph Biederman contributed to a 40-fold increase in pediatric bipolar diagnoses between 1994-2003, running NIH-funded research even as he was on the payroll of the companies whose drugs he was studying – netting $1.6 million from the drug industry from 2000-2007 alone. He urged one company to fund a Harvard research center “to move forward [its] commercial goals.”

The explosion of pediatric bipolar treatment is a part of a larger rise of mental health diagnosis and treatment. One in 10 Americans over age six now take an anti-depressant, and the newer class of atypical antipsychotics—about which relatively little is known—is now the top-selling drug class in America.

So how much has this high-stakes blurring of the line between research and marketing cost us?

In its assessment of the new rule, HHS estimates that it will take an institution one hour to review an investigator’s conflict, and two hours a year for an investigator to adhere to the reporting rules. It estimates only an incremental cost for institutions to post the information to a public website, since all of them already have such websites.

So how much is it worth to us to make sure that future leading-edge clinical science–which guides so much medical practice in this country–is done with transparency and objectivity? How much is it worth to improve a system that has clearly been ineffective in ensuring that taxpayer-funded pharmaceutical research is about good science, not good marketing opportunities?

The Administration would do well to calculate all this before watering down important reforms needed to ensure responsible use of taxpayer funds.

–Kate Petersen, PostScript blogger

When it comes to pharma meals, MA medical centers have already spoken

In its aggressive push to repeal the state’s gifts and meal ban, the Massachusetts restaurant industry (and pharma, the presumptive cooks in the kitchen behind this lobbying blitz) are hoping legislators will think the issue of doctors and drug companies is still, well, on the table. Since Bay State restaurant numbers don’t seem to have suffered from the law, these groups are betting that lawmakers will be willing to open the old and fundamental question: Should prescribers who are responsible for their patients’ best interests be letting pharma pay their way for meals, liquor and other perks?

But the question’s closed: Academic medical centers in Massachusetts have spoken loudly, and they’ve said that physicians and drug companies should work together at the lab bench, not the dinner table (or the bar). They’ve done this by developing and strengthening policies around industry marketing over the last four years, many of which set the bar nationally for rethinking conflicts of interest in the clinical setting, while protecting innovation.

UMass, Boston Medical Center, Tufts and Harvard Medical School have all demonstrated national leadership and done big work in setting ground rules to keep pharma’s marketing dollars out of doctors’ training, practice, and professional development. The American Medical Student Association scorecard, which evaluated conflict policies at all U.S. medical schools, recognized this leadership with top grades.   Specifically, all of these institutions received perfect “3s” on gifts and meals, meaning that “all gifts and on-site meals funded by industry are prohibited, regardless of nature or value.”

So, if Massachusetts’ flagship medical centers have done this, why all this hubbub over at the State House?

In 2008, lawmakers heard the message from these clinical centers about keeping medicine separate from marketing, and they realized that what’s good for patients and providers at UMass or Harvard is good for patients and providers outside the academic medical centers—on the Cape, or in Waltham, or Deerfield. Tchotchke-free waiting rooms and unbiased clinical care should be the norm everywhere in the state, and that could only be addressed by a state law. And so they passed a law limiting the kinds of gifts and meals drug and device companies could give docs—including the ‘educational’ wine-and-dines at some of the state’s priciest restaurants.

This wasn’t radical: This was the next step on ground cleared by AMCs and the industry itself (whose own code of conduct Massachusetts used as a template for its law).

The drive to preserve this law will be decided in the next few weeks.  The House voted to repeal the gift ban, but the Senate Ways and Means budget, released yesterday, does not include mention of repeal. Senate President Therese Murray championed passage originally as part of the effort to eliminate unnecessary health care spending, including that driven by drug company marketing.  And as for that claim that these meals are necessary educational opportunities for docs: What caliber of education do we really believe happens in the function rooms of Boston’s finest restaurants over a $40 cut of Kobe sirloin and a few bottles of a nice reserve cab?  (Dr. Carlat talks menus here.) Remember, the law doesn’t prevent companies from catering a legitimate program in the hospital, but that wouldn’t include liquor and elaborate meals.

So as the debate heats up again, let’s remember that we’ve already had this one—and physician leaders have said clearly that gifts, food and booze don’t have a place in the medicine being practiced our prestigious academic institutions.  We hope these leaders will take the opportunity to remind the public in the coming weeks why they took a stand for reforming the relationships between the industry and physicians, and why their new institutional policies and the Massachusetts gifts and disclosure law are important to upholding the state’s reputation for clinical excellence and medical education.

–Kate Petersen, PostScript blogger

The state of Vermont’s annual report on industry payments to doctors shows that payments in that state have gone down significantly: total number of expenditures went down 80 percent from 2008 levels, when manufacturers reported the most payments. In 2009, the state strengthened its law to ban meals and most gifts (including gifts that PhRMA swore off in its own 2008 Code). This year’s report suggests those restrictions had a big effect on how drug companies spent their money in Vermont.

This report—and proposed amendments to the law to accommodate industry requests—has got people talking again about how disclosure and gift bans can work together, and whether the downturn in payments to Vermont docs suggests the problem is going away.

It’s like that Jake Gyllenhaal movie, right: All that pharma-rep coziness was way back in the 90s?

Well, no. Far from having gone away, there’s evidence that the problem of pharma conflicts of interest and their impact on clinical care may be getting bigger. Pharma now tops all industries, including defense, in total fraud payments paid under the False Claims Acts. And of the 150+ pharmaceutical company settlements—that’s $19.8 billion in penalties between 1991 and 2010—three quarters of both the settlements and penalties have occurred since 2006. (Check out Public Citizen’s great report on this.)

More? The two largest criminal fines in U.S. history were imposed on two drug companies in 2009 for off-label promotion, and in 2010 alone, at least five companies paid settlements of at least $100M due to marketing a product off label, paying illegal kickbacks or making misleading claims about a product. Eight of the ten largest settlements with the federal government in FY2010 were over drugs.

And despite recently endorsing conflict-free guideline writing committees, more than half of those writing clinical guidelines for the American College of Cardiology through 2008 reported financial ties to the drug industry, a 2011 study found.

But isn’t all that money for innovation and research collaboration?

Vermont’s data suggests it’s not. Before the state asked for the proverbial check on drug company wine-and-dines, meals were in some sense the main course in industry-MD relationships in VT, representing about 30 percent of the total spent by companies on docs in  2009 and accounting for 87 percent of payments that year.

Some industry voices suggest that the updates and modifications Vermont has made to the law since 2008 signal vacillation—one blog even went so far as to say it showed that lawmakers “had little idea of what they were doing when they first created the law” and weren’t accounting for stakeholders.

That’s not true, or fair. Especially since some of this year’s proposed updates grow directly from industry asks, including an exemption for market-research payments.

The legislative process is built to flex and accommodate changing realities and lessons learned, and Vermont’s gifts and disclosure laws is a great example of that, and how public disclosure can signal gaps and needs in the law.Seeing that the majority of payments were going to feeding MDs and prescribers – costs with dubious patient benefits but that get passed onto patients – helped Vermont target its law while protecting the legitimate sort of academic-industry relationships that are critical to good medical innovation. The number of companies disclosing to Vermont went down in tandem with the meals ban, and if companies left because the best thing they had to offer in Vermont was lunch, well, from a public health standpoint, that’s okay.

With the industry’s “market and let’s see what works” approach of off-label marketing alive and well, Vermont and academic medical centers across the country have provided a sensible counter-approach of evolving regulation that seeks to protect patients.

Such responsiveness makes for good lawmaking in the interest of the public health, and transparency paved the way for that lesson-based learning.  We don’t know what lessons we’ll learn from Sunshine, and that’s exactly why we need it.

–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

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

Using public reports from seven drug companies about their payments to doctors, a wide-ranging investigative report by ProPublica revealed this week that tens of thousands of U.S. doctors and health practitioners were paid over $250 million by pharmaceutical companies since 2009, much of it to give promotional talks for the companies. Among them, ProPublica found that hundreds have been cited for serious sanctions and misconduct, lack expertise such as publications or even board certification, or are in violation of their medical institution’s or hospital’s conflict-of-interest policies.

This report, in cooperation with the Boston Globe, the Chicago Tribune, NPR, PBS Nightly Business Report and Consumer Reports, suggests that when it comes to selecting opinion leaders, drug companies have often created their own from sheer volume of talks a doctor is hired for. The report also suggests a eye-opening failure to perform due diligence in investigating the records of those speaking to other physicians about their products. ProPublica reports:

A review of physician licensing records in the 15 most-populous states and three others found sanctions against more than 250 speakers, including some of the highest paid. Their misconduct included inappropriately prescribing drugs, providing poor care or having sex with patients. Some of the doctors had even lost their licenses.

More than 40 have received FDA warnings for research misconduct, lost hospital privileges or been convicted of crimes. And at least 20 more have had two or more malpractice judgments or settlements. This accounting is by no means complete; many state regulators don’t post these actions on their web sites.

Only two of the seven companies said they looked routinely into state licensing boards before hiring doctors to speak for them.

These frightening findings—made possible by the fraction of payment data currently available from companies–remind us that complete and mandatory disclosure of payments made to doctors is a critical crosscheck for consumers who want to know whether their doctor has been paid by industry, and for public and private payers and institutions interested in the compliance of health practitioners with state or institutional policies. ProPublica collected the data from the seven companies that publicly report some physician payments—AstraZeneca, Cephalon, GlaxoSmithKline, Eli Lilly, Johnson & Johnson, Merck and Pfizer—in a database that consumers and medical school compliance officers can use to make these searches.

That’s a good thing, but these companies represent just over a third of prescription drug sales in the U.S.; extrapolating, significantly more money trading hands isn’t being captured. That’s why the Physician Payments Sunshine law, which will require all U.S. drug, device and biotech companies to disclose all payments over $10 to physicians beginning in 2013, is so critical to completing the picture.

Despite the hundreds of millions of dollars that doctors are being paid to give drug talks—many making the equivalent of a second salary to do so—a survey done by Consumer Reports as part of the series suggests that consumers are clearly fed up and understand the dangers of bias that attend marketing relationships between industry and physicians: Nearly three-quarters of Americans are concerned that taking pharma money affects patient care, and more than two-thirds think that their doctor should tell them if he or she has been paid by a company whose drug they plan to prescribe.

The survey underscores a 2008 Pew Prescription Project consumer survey (pdf) that showed the public was similarly concerned that being paid to talk about a company’s drug could bias their health provider.  In the absence of professionwide self-regulation by physicians, many of whom continue to take these large sums, medical schools, hospitals, and states have stepped forward, creating new policies and regulations that put distance between doctors and drug marketing departments.

The American Medical Student Association Scorecard, which assesses the conflict-of-interest policies of every U.S. medical school each year, is a powerful tool that consumers and administrators can use alongside ProPublica’s database to check compliance of their doctor with his or her school’s policy, and to get ideas for how some medical centers have gone about strengthening their policies.

One example is Harvard Medical School’s new policy banning faculty from doing industry speaking gigs, which goes into effect early next year. Using the 2009-2010 data, the Boston Globe found that nearly half of the $6.3 million paid to Massachusetts physicians went to those affiliated with Harvard, and several doctors told the Globe they had stopped the speaking arrangements in order to comply with Harvard’s new rules.

But the Globe story also showed that just having a rule or strong policy isn’t enough. The Globe found that numerous clinicians whose Massachusetts hospitals had rules against giving promotional talks, including Beth Israel Deaconess Medical Center and Boston Medical Center, continued to perform such talks for drug companies.  These institutional policies and state laws need diligent and rigorous enforcement.  Having good intra-institutional compliance structures and information-sharing among medical schools about implementation are key to the success of these policies. Disclosure tools like Sunshine database, when it is complete, and others like ProPublica will reveal health providers who violate these rules.

One final point: the fact that the news outlets here found so much misconduct connected to drug company money in the incomplete records they have suggests there may be much more that remains undiscovered. Rigorous enforcement of existing policies and laws, and comprehensive disclosure from good work like ProPublica’s database and the future Sunshine Act, have never been more important in making sure that patients are getting the best medicine from their doctors, and that physicians are getting the best unbiased information about drugs.

Find the full series and searchable database at: http://www.propublica.org/topic/dollars-for-doctor

–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