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

Consumer advocates, doctors, employers and leaders in Congress alike have all written letters this month urging the Centers for Medicare & Medicaid Services (CMS) to implement the Physician Payment Sunshine Act (PPSA), making drug industry payments to doctors public and transparent. Passed into law as part of the Affordable Care Act (ACA) in 2010, the PPSA requires manufacturers of drugs, medical devices and biologics to report payments they make to doctors and teaching hospitals to the Department of Health and Human Services (HHS), which must disclose these payments in a publicly available, searchable online database.

While Congress intended for CMS to have final rules in place back in January 2012, the agency faced understandable obstacles to that goal. When CMS published its proposed rule on November 15, 2011, it received an unprecedented flood of stakeholder comments, forcing it to push back all associated deadlines so it would have time to take all of the input into consideration. During the first half of 2012, CMS also faced uncertainty on whether the ACA would be ruled unconstitutional, taking the PPSA down with it. However, any larger questions about the ACA were settled in June, and instead of issuing a second draft of its guidance in July, CMS sat on its hands all summer. The agency promised rules by the end of 2012, which would allow companies to collect data January 1, 2013 and disclose all financial relationships with doctors to the public by September 1 of this year. Bloomberg News reports that CMS spokesperson Brian Cook has promised the regulations “soon.” Yet, the agency refrains from saying when we can expect final regulations and begin bringing transparency to doctors’ conflicts of interest.

Due to the ongoing delay, patients remain in the dark about whether their doctors are accepting lavish dinners or travel from drugmakers, and whether those relationships may be affecting their patient care. In his letter to White House Chief of Staff Jacob Lew, PPSA co-author Sen. Charles Grassley (R-IA) pointed out that CMS won’t be able to collect data on time, now that the statutory deadline is 15 months past due. “At best, the public may miss an entire year’s worth of data collection—perhaps more,” he noted. “This is unacceptable.”

On January 14, Community Catalyst organized 18 consumer, patient and labor organizations in urging the Obama Administration to issue the final rules. Others weighing in on the delay include medical student and physician advocates, a number of high-profile doctors, Senator Grassley and Rep. Sharon Treat (D-ME). Even drug and device manufacturers have been calling on CMS to publish the final rules, in order to gain clarity.

While all sides agree the rules should be out soon, how quickly the rules are put in place may be controversial. Patients want this information as soon as possible, but industry is on record asking for as long as half a year. Such an additional delay is unacceptable for two reasons. First, nearly all the drug and device manufacturers have been reporting their payments under state law requirements in Vermont, Massachusetts and Minnesota for years. Secondly, nearly half the biggest drug manufacturers have been tracking and reporting payments to the federal government under settlement of criminal and civil prosecutions for illegal marketing.

Unfortunately, even after CMS issues PPSA rules, consumers will still have to wait until April 1, 2014 for the first public disclosures, a full year later than originally planned by Congress. We cannot wait any longer.

– Khadijah M. Britton, JD, Program Associate, Prescription Access and Quality

Yesterday, DPH issued temporary regulations that, unless changed, will gut the state’s drug and device marketing regulations, which were proudly heralded in 2008 as a step toward curbing drug industry marketing abuses and addressing spiraling health care costs. In a shocking capitulation to industry, the DPH regulations go even further than the amendments passed this summer by the legislature, which had weakened the ban on industry providing lavish meals to physicians. DPH would allow drug, device and biotech companies to pay for physician meals outside clinical settings, with no restrictions on the cost of the meals.

A DPH staffer acknowledged that the administration’s Mass Life Sciences Center was consulted about the language— companies meeting down the street at the BioPharm America 2012 Conference must be thrilled. Pharma’s lobbyist, Marjorie Powell, was quoted in the Globe on Thursday,, saying “the Massachusetts law was placing unnecessary restrictions on the industry as it tries to work with health care providers” and she reported meeting with DPH employees who were drafting the regulations. Yet DPH refused to meet with consumer advocates in the Massachusetts Prescription Reform Coalition, nor incorporate any of our written recommendations.

This summer, the Massachusetts legislature repealed the component of the gifts and disclosure law that prohibits pharmaceutical and device companies from giving gifts to Massachusetts doctors, nurses, and other health care providers. The amendment made it legal for the industry to provide “modest meals and refreshments” off-site, at restaurants and other facilities “conducive to informational communication.” DPH was then required to define these terms but it failed to do a credible job, allowing “modest” to simply mean “similar to what a health care practitioner might purchase when dining at his or her own expense.” If that isn’t bad enough, public health experts at the DPH also decided not to address the issue of industry paying for wine or alcohol. Can this possibly be reasonable, given the law’s requirement that payment for meals and refreshments be allowed only in a venue “conducive to informational communication?”

HCFA reports that at yesterday’s Public Health Council meeting to review and approve the regulations “a number of Council members were openly skeptical. One member asked about alcohol. The DPH staffer explained that they saw rationale in the law for barring alcohol. Another Council member asked how the restrictions would be enforced. Self-reporting was the answer. How would DPH know whether the ‘educational’ sessions were truly educational? The DPH replied that it would be up to the drug manufacturer to make its own decisions.”

The gifts ban and disclosure law was an early reform aimed not only at protecting patients but also reducing health care costs—an important goal for sustaining our near-universal coverage in Massachusetts. Numerous peer-reviewed studies show that marketing tactics such as providing meals and gifts influence prescribers to select the latest, most expensive drugs when generics or other lower-cost, equally effective alternatives are available.

Although the gift ban is backed up by sound policy rationales and studies, the politics have been challenging. The pharmaceutical industry teamed up with the restaurant industry and lobbied hard to withdraw the gift ban in 2009, 2010 and 201l. But now they have nearly succeeded in undermining the law, gaining far more concessions from the Patrick administration in these regulations than the legislature allowed.

The DPH regulations would end all disclosure requirements, which under the law apply not just to physicians but to all providers. The DPH regulations dismantle this system as well as the $2,000/company annual fee that supports it. The pretext is the upcoming implementation of the Physician Payments Sunshine Act in Obamacare, which requires industry to report all payments to physicians and teaching hospitals. But the MA law includes disclosure of payments to all providers, including nurse practitioners and physicians’ assistants, key primary care providers in MA who are increasingly the target of industry marketing. Such disclosures are not preempted by the federal law.

Fortunately, Massachusetts medical schools and medical centers have enacted their own policies to shield physicians, researchers, physicians-in-training and other staff from the influence of inappropriate marketing. They have instituted bans on gifts, meals, inappropriate consulting and other marketing, basing their policies on a strong commitment to medical professionalism and good patient care. These institutions acknowledge that relationships with pharmaceutical, device and biotech companies are essential for research and innovation—we all agree with the Mass Life Sciences Center on that. However, these institutions are also committed to erecting firewalls that protect patient care and medical education from industry influence. But they cannot regulate physicians that are not in their systems—the Massachusetts law bridged that gap by creating a blanket policy for all providers.

We call on patients, consumer advocates, legislators, physicians and other providers to join us in reversing the DPH emergency regulations and maintaining the letter and spirit of this important law.

–Marcia Hams, Director of Prescription Access and Quality

– Anna Dunbar-Hester, Policy Analyst

This blog was made possible by a grant from the Attorney General Consumer and Prescriber Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin.

Community Catalyst and 18 other consumer, patient safety and labor groups weighed in last week in support of (with important “friendly amendments”) draft regulations issued by the Centers for Medicare and Medicaid Services (CMS) requiring that the drug, biologics and medical device industries publicly report all payments to physicians and teaching hospitals. See here and here. As a result, all of these industry payments will be displayed on a publicly available website, where the information can be viewed by patients, or downloaded and studied.

Over 300 organizations submitted comments on these “sunshine” provisions of the health reform law. That’s a surprising number of comments, given that the provision doesn’t affect a patient’s right to benefits, or set up a new program or regulate insurance. The provision simply requires transparency in virtually all drug and device industry payments to physicians and to the teaching hospitals that train doctors or host biomedical research. Such transparency is critical for patients and the health care system, because it can expose industry marketing that undermines good prescribing, trust in doctors and affordable care. As Senator Chuck Grassley, who long championed the bill with Senator Herb Kohl, said in 2009, “Transparency fosters accountability, and the public has a right to know about financial relationships. Patients rely on their doctors’ advice. Taxpayers spend billions every year on prescription drugs and medical devices through Medicare and Medicaid. They also fund tens of billions of dollars of medical research each year, and the doctors conducting that research have a big influence on the practice of medicine.”

This transparency program was slated to go into effect on January 1 of this year, but the Department of Health and Human Services and CMS have been behind on issuing the rules. All 18 consumer and labor groups urged that this transparency be started as soon as possible after the final rule is issued. There’s no legitimate reason to delay further, because the nation’s biggest drug makers have already been reporting their payments as a result of federal investigations or settlements of possible illegal kick-backs paid to doctors. And nearly all of these manufacturers have been reporting these payments to the States of Vermont, Minnesota and Massachusetts, under state transparency laws.

The proposed rules address many complicated issues. For instance, how any payment to a doctor is labeled, as a ‘gift’ or ‘consulting fee’ or a payment for ‘research,’ etc. We urged CMS to adopt clear-cut, non-overlapping definitions to ensure that all the information is accurate, understandable to the public, and not open to manipulation. We also applauded a number of CMS proposals to improve the public’s ability to understand what payments are for, such as separating ‘lump sum’ payments into smaller units. This will help prevent industry from trying to bury inappropriate payments for lavish meals or travel to fancy resorts within a larger payment for ‘education’ or ‘research.’

We also applauded CMS efforts to prevent loopholes, by including all drug and device manufacturers, regardless of whether their products are manufactured overseas, and by including payments made to doctors through third parties, where appropriate. Plugging these potential large loopholes is essential to real transparency.

Under the statute, research payments must be reported but can be delayed for four years to protect industry from competition during product development. However, we urged CMS to narrow the definitions so that payments related to research on new uses (such as ‘off-label’ uses) of drugs, biologicals and invasive implanted devises are not delayed. Numerous federal investigations and prosecutions have exposed the illegal promotion of unapproved, or ‘off-label,’ uses of drugs and devices, fostered in part by inappropriate industry ties to physicians. This has resulted in widespread harm to consumers. For instance, the illegal ‘off-label’ promotion of the epilepsy drug Neurontin resulted in 90 percent of its prescriptions being for unapproved uses. Promotion of unproven medical devices is also increasingly a problem. As a result, we asked CMS to require that payments related to ‘research’ on products that are actively being prescribed not be subject to any delay.

Finally, CMS proposed to require CEOs to personally attest to the accuracy of their company reports. We heartily agree with this requirement—accountability should be the bottom line for any company that produces the drugs that patients ingest or the devices implanted in a patient’s body.

– Marcia Hams, Director of Prescription Access and Quality, Community Catalyst
– Wells Wilkinson, Staff Attorney, Community Catalyst

For more see this post.

Last week, Maine’s governor signed LD719 into law, repealing a series of pharma transparency laws including one that required drug companies to report certain marketing costs, including meals and gifts to physicians. I talked with Maine representative and director of the National Legislative Association on Prescription Drug Prices Sharon Treat (D-Hallowell) to find out what this repeal means for her state, the wider transparency landscape, and what we might expect next.

PS: There’s been a lot of action on the state front again at the end of this budget season. Massachusetts protected its gifts ban from some aggressive repeal threats, and now Maine has repealed its disclosure law. Maine’s move doesn’t seem to reflect a bigger consensus. What do you see happening at the state level?

ST: The new Republican governor and majority in the Maine Legislature have together now repealed not only the state’s gift disclosure law, but nearly every progressive prescription drug policy we have, including our pharmacy benefit manager (PBM) law, and pricing transparency.  This is not surprising as there are very close ties between the pharmaceutical industry and the Republican party in Maine. None of these laws were easy to pass in the legislature even when Democrats had the majority, because the drug industry is very powerful when it comes to influencing politicians.

I don’t think the repeals reflect a change in what the public thinks.  In fact, I doubt if most Maine people have any idea what’s been repealed.  This session a lot of attention was focused on proposed repeals of many of our environmental laws, and in that case the public uproar stopped the rollbacks from going forward.  In the case of the pharmaceutical laws, there aren’t strong consumer advocacy groups in the state that have taken up these issues, partly because so many other social policies are on the chopping block at the same time.

PS: There’s a lot of talk about state Medicaid budgets these days. Why is disclosure an important piece of the cost equation, to your mind?

ST: Maine’s gift and advertising disclosure law was enacted originally because legislators wanted to know how much was being spent by the pharmaceutical companies on promotional activities, since the industry claimed that drug prices had to be high in order to support their R & D activities.

The information gathered showed that advertising and promotion outspent R & D.  It helped make the public case for reducing high drug prices.  Then, as the data was collected, more public attention was paid to conflicts of interest and the role of gifts and payments in driving prescribing of the highest priced branded drugs.  It helped open peoples’ eyes to larger issues of safety and appropriateness of prescribing.

Maine also had a law, also just repealed,  that directly collects drug price data from the pharmaceutical companies and requires a person with authority to certify the truth of this data. This independently collected information was a direct help to the state in negotiating very favorable rebates and limiting pricing fraud under the Medicaid “best price” requirement (nationally major drug pricing fraud cases are common).  Maine gets a return on average of about 50 percent of its Medicaid drug spend back in rebates, and having this check on drug company pricing reports has helped avoid fraud and keep our Medicaid prescription drug budget in line, with minimal increases over the years.

PS: Your colleague, physician Linda Sanborn, also supported the Maine transparency law, and state physician groups have supported similar bills and laws elsewhere. Have you heard from Maine physicians on the repeal, and next steps?

ST: Dr. Sanborn spoke eloquently in the floor debate about the need to have public disclosure of the clinical trials data- another law that was repealed.

Fortunately, federal laws will eventually pick up the slack on both the clinical trials database and reporting on gifts and payments, but the Legislature’s majority did not support even linking our state website to the federal databases.  All of the Democrats on the Health and Human Resources Committee strongly supported these laws and spoke to the issues.

The physician groups were most active trying to prevent the repeal of the academic detailing program, which they are now very involved with implementing.  Although the funding was reduced, this program did stay alive in part because of their advocacy.

In terms of next steps, it would be foolish to try to reverse these repeals with the current Legislature and governor.  If Maine people want a different result (and understand what has happened) then they will elect different people the next time around.

I was actually shocked that so many legislators who ran for office on platforms of preventing fraud and abuse passed two laws that repealed effective anti-fraud laws– the PBM law repeal and the pricing disclosure law. These repeals will hike the costs of the Medicaid program (as confirmed by the Legislature’s fiscal office in the fiscal note on the legislation).

PS: Transparency of industry marketing relationships with prescribers isn’t going away. Taking the long view, what can we expect next?

ST: I think we will see a more active media in Maine looking into the federal doctor payment databases and the financial links between big pharma and Maine politicians.  I expect that there will be more awareness going forward about these conflicts of interest.  My hope is that this awareness will once again lead to taking action with public support and a more receptive legislature and governor.

–Interviewed by Kate Petersen, PostScript blogger

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

This Pharma With a Chance of Meatballs site is making the rounds, and it’s a great illustration of the issues on the Massachusetts gift ban we touched on yesterday.

(The site’s author clearly has a knack for story-booking policy issues. We can’t help wondering what an animated version of academic detailing or the Physician Payments Sunshine Act would look like…)

–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

As you may have read by now, the Massachusetts House has voted to repeal a chunk of its first-in-nation gift and meal ban, spurred on by cries from the state restaurant lobby. The law, which bans drug companies from treating Bay State physicians to some gifts and restaurant meals, aims to check the potential for conflict of interest inherent whenever pharma picks up the tab.

No matter that state numbers show restaurant revenues are up nearly 10 percent over last year (see here), or that drug companies are moving their operations into town (see here and here and here). Or that despite the ban, new state payment data suggests drug companies didn’t seem to lose face time with Massachusetts docs – companies paid individual docs $16.4 million in the last half of 2009 alone.

“The only thing that’s being hurt is the ability of the drug industry to market their high-priced drugs by wining and dining doctors at our expense,’’ Health Care for All’s Brian Rosman told the Boston Globe.

But a concerted push by the Massachusetts restaurant industry seems to have swayed House lawmakers, who, by a wide margin, voted last week to repeal the part of the law that prevents drug, device and biotech companies from footing physicians’ bill at restaurants. (Companies are still permitted to bring docs lunch in their offices for “educational” presentations.)

An editorial in the Globe yesterday says the legislature shouldn’t chip away at the law. It’s not just that such meals are medically unnecessary. “But there’s also an unsavory conflict of interest in doctors being feted by drug companies and then turning around and prescribing the companies’ drugs to their patients. Are the prescriptions really necessary? Are the drugs really the most effective treatment?”

Many doctors insist their professional judgment cannot be bought with fancy meals. But if wining and dining didn’t work, the drug industry wouldn’t spend $6 billion a year on direct marketing to physicians. The Legislature should send the repeal amendment and similar attempts to weaken the gift ban back to the kitchen.

In characteristic color, Newburyport psychiatrist and blogger Daniel Carlat agrees.

Yes, commoners escape workplace demands by going home at 5 or by taking a stroll through a park during lunch. But doctors need raw oysters and wine after a hard day of work—plenty of it, free, and with fawning pharmaceutical reps complimenting them on their knowledge of vintages.

Hopefully the State Senate will realize that Massachusetts doctors have stronger ethical compasses than Massachusetts politicians, who since 2009 have been barred from receiving anything of value from lobbyists. Lawmakers are, indeed, vulnerable to inappropriate influence from meals and other gifts. But physicians would never prescribe more Abilify after enjoying a steak dinner funded by Bristol-Myers Squibb. After all, they’re doctors!

The Massachusetts Senate is due to vote on its budget later this month. For more on industry-physician interactions visit Community Catalyst’s resource page and the Physician Payments Sunshine guide.

–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