I stopped by the Expo floor and couldn’t help but notice the decline in the number of industry exhibitors. We had similar declines in our exhibitors last year, which causes me to think this is representative of the new nature of our relationships with industry. Our relationships with industry are becoming increasingly sparse, which some would argue is how it should be. Or they would argue that the relationships shouldn’t exist at all.

That’s not the College’s view, though. We believe that although there must be firewall for relationships with industry, done correctly, they can be positive and constructive relationships. These relationships shouldn’t be seen as inherently bad, they just must be effectively and ethically managed, and breaches in ethics should NOT be tolerated.

The ACC handles our relationships by creating a firewall between the funding and the program it supports. The funding is solicited for specific new or ongoing programs/initiatives. The money is dedicated exclusively to an objective – but the industry supporter has no say in how the funds are used for the program/initiative. By using this process, the ACC can still get the valuable financial support it needs to continue to make available quality programming and education.

The College has taken a leadership role in this debate, building consensus on the issue among medical professional societies. (For more on ACC’s stance on relationships with industry, see a post from ACC.09.) We must continue to move toward responsible, transparent relationships that will allow us to maintain quality education and research in cardiovascular medicine.

What do you think?

 

I'm sure you all saw the headlines early this month related to the Department of Justice settlement with Pfizer over their past off-label promotions of Bextra and other drugs. The settlement will cost the company a record-breaking $2.3 billion ($1 billion in civil settlements and a $1.3 billion criminal penalty related to Bextra).

Bextra was approved for treatment of arthritis and menstrual pain, but Pfizer allegedly promoted it in doses and for uses not approved by the FDA, putting patients at risk of serious cardiovascular complications including heart attack and stroke. Pfizer voluntarily withdrew Bextra from the market in 2005.

Of course, Pfizer isn’t the only company that has been involved in off label promotions. And we physician are also involved in how off label uses occur, and in relationships with industry that are under increased scrutiny in these regards. Off label usage of pharmaceuticals is often how new therapeutic advances occur and it’s not evil. But, if we had more comparative effectiveness research and dollars (and we soon will) available to research off label use, we could more rapidly advance therapeutics of newer agents and protect patient safety as well.

*** Image from Flickr (DawnVGilmorePhotography). *** 

Chair Herb Kohl and the Senate Special Committee on Aging held a hearing last week on industry funding of continuing medical education (CME). Predictably, most of the witnesses opposed industry funding, including ACC Past President Steve Nissen, M.D., M.A.C.C. Dr. Nissen and other witnesses called for a strong firewall between the sales and marketing divisions of organizations offering CME and the educational divisions that develop the CME.

Of course, this “firewall” is already reality at the ACC, where there is a firm separation between our corporate relations and fundraising teams and our education division. The College has been a vocal advocate of responsible, transparent relationships with industry.

But, the College leadership differs from our respected Past President in that we believe eliminating industry funding for CME could be a serious blow to medical education in this country -- and ultimately to quality care. Steve’s arguments are compelling however, in terms of how often breaches of ethics have occurred (to the consternation of ethical physicians and industry participants in the CME process). What is important from the College’s point of view is that conflicts can be effectively and ethically managed -- and that breaches in ethics need NOT be tolerated.

The College has taken a leadership role in this debate, building consensus on the issue among medical professional societies and drafting a straw man proposal on conducting responsible, ethical relations with industry. The ACC remains committed to working with members of the house of medicine to protect access to the very best continuing medical education and -- most importantly -- to defend the interests of cardiovascular patients.

*** Image from Flickr (DawnVGilmorePhotography). ***

ACC President Fred Bove's responsible rebuttal of the recent JAMA editorial on relationships with industry got a lot of play outside cardiology this week. The Policy and Medicine Web site, for example, cited Fred as “taking JAMA to task for calling for an end of all industry relationships with physicians and medical societies.”

Meanwhile, Sen. Chuck Grassley (R-Iowa) is continuing his personal quest to let the sunshine in by asking eight medical journals to describe their policies on ghostwriting of articles about drugs and devices. We are glad that JACC is notably not among the following journals receiving Sen. Grassley’s concerned inquiry for information:

• American Journal of Medicine
• Annals of Internal Medicine
• Annual Review of Medicine
• Archives of Internal Medicine
• Nature Medicine
• Journal of the American Medical Association (JAMA)
• New England Journal of Medicine (NEJM)

*** Sen. Grassley. Photo from Wikimedia Commons. ***

I've talked pretty extensively over the past couple of weeks on this blog about ACC’s position on conflicts of interest and relationships with industry. In a response released yesterday, the ACC again outlined its "stringent approach to ensuring responsible, transparent relationships, in which industry support has no influence on educational content, quality measures or scientific research.”

Institute of Medicine Report
We also signed on to a joint statement with several other medical societies responding to the April 28 Institute of Medicine report on the topic. On Tuesday, I interviewed current ACC President Fred Bove, M.D., Ph.D., F.A.C.C., on the report. He said, “The report made it very clear that there’s a value in working with industry ... We can’t divorce things, one from the other; but rather, we must come up with the proper solutions for transparency, with review processes that prevent bias ...” Check the video below for the full interview.  I was also interviewed by MedPage Today on the report.

The College is committed to responsible and transparent relationships with industry. While the potential for abuse is there, by following responsible, ethical, and transparent policies, industry support can produce positive patient and societal benefits, including much-needed funding for research, evidence-based quality improvement and unbiased medical education.

The Accreditation Council for Continuing Medical Education (ACCME) will not take any action to end the commercial support of accredited CME, according to a report from their March board meeting. The report underscores ACCME's belief that its Standards for Commercial Support and associated ACCME policies "support the development of independent continuing medical education that is free from commercial bias and does not result in an inclination by professionals to direct care that is unwarranted or unnecessary."

The report notes that the ACCME will consider creating a new designation for CME that is free of commercial support, as well as an independent, nonprofit granting entity to accept unconditional and unrestricted donations from all U.S. sources to distribute to ACCME-accredited organizations for development of CME.

UPDATE: The ACC has released this statement on our committment to comparative effectiveness, in response to a recent Bloomberg article on a new coalition called the Partnership for Improving Patient Care, an organization formed to promote comparative effectiveness and comparative effectiveness research (see yesterday's post on the subject "Clinical and Cost Effectiveness: The Bloomberg Boo Boo). It states:

We must develop much-needed randomized clinical trial data to fill many research gaps in the current environment. CE and CER provide a critical means to address these data and research inadequacies. Without a multi-billion dollar ongoing commitment to comparative effectiveness through federal funding, many unanswered vital clinical questions could persist for decades. This is unacceptable.

The College fully understands that cost effectiveness also is important to society and to health care reform and that it is an important parallel process to clinical effectiveness. If we are to distribute scarce resources fairly to the most important scientific and clinical priorities and to all patients regardless of income, we must determine cost effectiveness of care options, once the science is clear, and recognize that marginal increases in clinical effectiveness with very large price tags will not be affordable in a sustainable health system.

It concludes: "There’s no conspiracy here. ACC’s participation in PIPC is consistent with our principles, policies, commitment to ethics and appropriate relationships with industry."

Bloomberg News this week reported a damning story on a new organization called the Partnership for Improving Patient Care (PIPC). PIPC is a benign and positive new coalition (about 4 months old), which industry folks have decided to participate in.

The Bloomberg story suggests PIPC is nothing more than a front for big PhRMA, and actually opposes comparative effectiveness. Wrong. ACC joined PIPC about two months ago (for a nominal membership fee) to be part of a very broad constituency of consumer groups, professional societies and others who believe that comparative clinical effectiveness is a critical priority in health care reform, as well as a process that must be determined in a scientific, unbiased and pure fashion -- and thus not mixed up with cost effectiveness as the hidden goal -- in order to have the respect and trust of physicians and patients.

Other members of this partnership include the American Association of People with Disabilities, American Academy of Nursing, the American Association of Neurological Surgeons, the Association of Clinical Research Organizations, Easter Seals, the National Alliance for Hispanic Health, the AIDS Institute and many more. Some pharmaceutical companies, device manufacturers and related coalitions have recently also joined to support the aforementioned goals. That shouldn’t be surprising. More...

AstraZeneca CEO David Brennan has been elected to chair the PhRMA Board of Directors for 2009-2010. Brennan espouses a patient-centric approach to health care reform. He advocates more communication between PhRMA members and health care practitioners, as well as innovation and outcomes-based care. In his chairman’s address at the PhRMA annual meeting, he encouraged PhRMA members to —

1. Promote quality care for all – with an emphasis on outcomes.
2. Embrace a system that supports a doctor/patient relationship and emphasizes prevention and personal responsibility.
3. Bring about co-pay reform that gives patients real access to the best medicines and treatments.
4. Work toward policies that promote continuous medical innovation.
5. Advocate for strengthening the FDA so that they can do a more timely and consistent job.

It’s a pretty positive overall agenda to come out of PhRMA. I like Brennan.

Relationship with Industry
Speaking of the currently controversial topic of professional relationships with industry, David Shaywitz and Thomas Stossel, M.D., last week published an editorial in the Wall Street Journal discussing the value of working with industry to create useful therapies. A little balance is a good thing.

*** Photo of David Brennen from AstraZeneca Web site. ***

I did an unhealthy red-eye and 24 hour total stay in Paris this week to make a keynote presentation on our vision for health IT and on how registries could greatly improve quality here in the US and internationally at an invitation-only meeting organized by Sanofi and others in Paris.

Europe and other countries are behind our progress in these regards. I imparted a lot and also learned a great deal from other presenters, including about the growing interest of consumer groups in our activities, and about the growing interest in improving medication adherence everywhere. Some of the best results in that latter category seem related to pilots where health insurers pay for the outpatient drugs 100% if adherence is measured and tracked. 

Everybody, however, interprets the recent JAMA article on relationships with industry as potentially spoiling any genuine partnerships that might otherwise develop to improve patient care via registries and professional societies.

Merck and other companies are also hard at work on researching how to improve adherence. We have learned a lot from their sharing of their research, along with ideas from the Veterans Association, MedCo, and others -- who like us, know that in addition to improved prevention strategies, adherence has to be a critical priority if we intend to reduce morbidity significantly in the near future. This will important in preventing readmissions as well.

*** Image from Flickr (macwagen). *** 

Much has been made last week of relationships with industry. During ACC.09, reporters and other stakeholders took note that the ACC had decided not to pursue industry sponsorship of lanyards, portfolio bags and other high-value items (these would have produced nearly half a million dollars of revenue for the College). We did this in order to avoid the “NASCAR effect” of attendees as walking billboards and to visually reaffirm our commitment to responsibility and transparency in our partnerships with industry. But that doesn’t mean that well managed relationships with industry don't have real value for patients and society.

The ACC believes in responsibility and transparency in its relationships with industry, and we have taken many steps to eliminate historic practices that became acceptable to us (and are still in place with many other societies).

BUT we also believe partnerships with industry are absolutely critical to maintaining scientific progress in cardiology and other specialties. Right now, public funding for research and medical education is scarce. Cardiologists already pay for 90-95% of their own educational costs. Our attendees have to pay for everything on their own. Plus, leaving one’s office to attend a meeting like this in itself costs a lot of money in lost income! Digital education is valuable, but does not substitute for real discourse -- and folks would not go online and spend four 8-10 hour days staying up with what we presented.

Industry’s participation in our Exposition Hall (which is totally separated from any connection to educational programs or content), and some industry sponsored non-specific educational grants subsidize the meeting costs and therefore allow for reduced registration charges to the meeting (already over $800 or more for attendees). Also they create the ability to offer simulation, live cases, and innovative educational venues that attract people out of their offices to LEARN -- venues we could not otherwise afford to produce. More...

Reps. Henry Waxman (D-Calif.) and Bart Stupak (D-Mich.) are again pressing Schering-Plough Corp. and Merck & Co. for huge amounts of information about clinical trials related to Vytorin. They’re also continuing to question other professional societies about relationships with industry (RWI). It’s tough.

I’m glad we came through our encounters with these committees early and swimmingly, but we are not relaxing our efforts at increasing RWI transparency and high integrity in avoiding and disclosing. In fact, we are about to post all conflicts and RWI issues of individual ACC Board Trustees and State Chapter Governors on our Web site (by the time of the Annual Scientific Session in March), along with our existing full posting of all grants and industry funding, journal advertising, etc., to the College itself. This will be much appreciated by Congress, Institute of Medicine and others.  

*** Image from Flickr (macwagen). ***

Sens. Grassley and Kohl have on Thursday introduced the Physician Payments Sunshine Act as promised. As not promised, a lot of our proposed amendments aren’t in there. It really isn’t traumatic, because there’s plenty of time for amendments, but here’s what they’ve done:

• They require pretty much ALL pharma and device manufacturers to report on gifts, payments, contributions, and even samples to physicians.
• At this time everything that exceeds $100 has to be reported.  I’m thinking that will get amended out in favor of a higher threshold.
• They also did not require that all the companies report to one common public Web site. Instead, at least in this version as I read it, each company reports on its own Web site. This makes it a lot less threatening because no one is going to take the time to look at all the infinite number of Web sites that will be up. I would suspect other members of Congress will want to see a common public site, but maybe that poses budgetary problems in these tight times for Congress. That said, other entities (like the Center for Science in the Public Interest) might fund a common site.
• It preempts less-demanding state laws, but allows more-demanding state laws to prevail.
• One of the reporting categories is the specialty of the physician. [For more details, see Policy and Medicine's post about it]

We should still support these Sunshine efforts. They will offset public distrust of those exceptions among professionals and companies who exercise bad judgment in their relationships with industry. We’ll work on adding some amendments that make this whole thing a bit more reasonable as it moves forward.

The Food and Drug Administration (FDA) has finalized guidelines for pharmaceutical companies to be further able promote off label uses for drugs to physicians, and particularly through peer-reviewed medical journals. The new guidelines are provoking criticism from some sectors that the FDA is allowing companies to promote products to doctors even if the uses have not been rigorously vetted.

It general this seems a practical thing for FDA to do to me, given the numbers of off-label uses in practice, but with discretion when adverse risks are not well known or documented. Maybe this could allow for more responsible educational venues around off-label uses, given that the funding to research these uses is in short supply now, and will likely be until Bank of America, Citibank, and average taxpayers like you and me are back on our collective feet. This will be an early challenge for the next FDA Commissioner -- haven’t heard anymore about where that decision is this week, except that there are three prominent cardiologists alleged to be close contenders now.

Canada’s medical schools this week endorsed a report from the Association of American Medical Colleges calling for medical schools and teaching hospitals to prohibit industry gifts and services and to curtail the involvement of industry in educational activities.

The head of the Association of Faculties of Medicine of Canada says endorsing the report, "Industry Funding of Medical Education," ensures that industry support of education does not lead to real or perceived conflicts of interest.

We walk a fine line with our partners in industry. The ACC, of course, has strict policies in place to ensure industry never influences our educational content, and we’re incredibly transparent about our funding. On the other hand, without industry support, we — and other CME providers — could not offer the quality education our members trust.