Sen. Grassley (R-Iowa) has asked 33 professional and disease-oriented organizations (Derm, Ophthalmology, Urology, Ortho, Neuros, AHA, etc) for information about the financial backing they get from the pharmaceutical, medical device and insurance industries as part of his effort to ensure transparency in medical associations’ relationships with industry.

The ACC has been asked to participate in an American Association of Medical Society Executives (AAMSE) conference call with leaders from those 33 groups to share our own experience responding to Sen. Grassley’s requests. The ACC has been a leader in transparency in our relationships with industry, publicly posting all our funding sources on our Web site and spearheading the development of standard guidelines for medical societies’ relationships with industry.

Congress is entirely focused on transparency and full disclosure. Along with the Dept. of Justice, the Office of the Inspector General (OIG), they are not asking that there be no industry funding of CME, expos, journal ads, grants, etc. We in the profession are doing that to ourselves in some instances, apparently feeling we cannot manage such relationships. We can. And these inquiries need not be feared. More clear transparency is needed.

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

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). *** 

There were some exciting late-breaking clinical trials presented here today and yesterday, and ACC leaders were widely quoted in the media on the implications of what was discussed. 

I took a little time out yesterday from the international scene to hold a panel with the American Heart Association to examine AHA and ACC’s vision for the future of U.S. health care. The panel featured me, Fred Bove, Clyde Yancy and Robert Califf.  Part of the purpose was to help cardiologists and CV professionals understand better the differences and areas of collaboration between AHA and ACC. We focused on the positives, which are numerous, rather than on areas on competition. As I’ve said before, the future of health care should be rewarding for continuous outcome improvement and providing patient-centered care.

The ACC has a health care reform campaign, called Quality First, which, like the name suggests, advocates for payment incentives for quality care, along with increasing the focus on patient value (which we define as transparent, high quality, cost-effective, continuous care), better coordination across sources and site of care and emphasizing professionalism to increase partnerships with patients. Reform would also provide universal coverage through an expansion of public and private programs. (You can read more about Quality First and specific examples of how to make it a reality in ACC’s “Blueprint for Reform.”)

Of course, making sure all of this is included in health care reform is quite a tall order, which is why the ACC is working with lawmakers and the White House to make sure that they know what we feel is best and how best to achieve it. We’ll know soon enough if we’ve left an impact.

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. ***

Earlier today, CMS updated its Hospital Compare Web site to include data about 30-day hospital readmission rates for acute myocardial infarction, heart failure and pneumonia. The site already provides information about 30-day mortality measures for the same groups. The site is intended both as a resource to patients – who can search by hospital to find out how their hospital compares to other hospitals – and to hospitals looking to improve their performance.

Making this data publicly available is a positive first step toward improving quality, simply in that it lets hospitals know how they’re doing. The way our current health care system is structured, it’s completely possible that they have no idea – which means there is no incentive to improve. However, given the dire straights our health system is in, we all need to take part in reducing costs to make the system viable in the long-term. In the CV world, ACC data show that reducing high-cost heart failure readmissions by 20 percent could save $265 million. That kind of savings is nothing to laugh at.

What You Can Do
First, start by reviewing the data. Once you’ve done that, ACT. The ACC is encouraging hospitals to enroll in our new Hospital to Home (H2H) initiative, which aims to reduce cardiovascular readmissions by 20 percent by 2012 by improving the transition from hospital to “home.” This is a lofty goal, but by providing evidenced-based strategies for reducing readmissions along with technical assistance to implement the strategies, we can make the reduction a reality.

Other Considerations
Although we value the opportunity for improvement Hospital Compare offers, it’s equally important that the data used is both fair and valid – and that our response as a community always places the best interests of the patients in the forefront of our efforts. The ACC will work with CMS and others to use the release of this data to strengthen the Medicare program and help ensure that Medicare beneficiaries receive high-quality CV care. Because at the end of the day, high-quality CV care for patients is the most important goal.

Additional Coverage:

• Baylor hospital leads way to lower heart failure readmission rates. USA Today.
  
  
• 'Double failure' at USA's hospitals. USA Today. 

*** Image from Flickr (jypsygen). ***

The ACC/AHA Task Force (TF) on Practice Guidelines (GL) convened in Chicago last week to continue its meticulous examination of the process and methodologies for guideline development. This important group, under the leadership of Dr. Alice Jacobs, is committed to rigorous scientific and ethical standards, near-continuous analysis of new studies to keep guidelines current and relevant, and easy accessibility by users. We’ve asked this beleaguered TF to “turbocharge” the GL process to try to keep up with the ever increasing progression of science. (Gird your loins folks, because the National Academy of Sciences says that in the next decade the total body of human science, accumulated from the dawn of humanity to now, will increase by at least 4-7 fold! I know that sounds absurd--unless you’re a Terminator fan who wants to let the machine doctors do their thing for whatever they will be paid then.) 

The point is, how can we keep up? The GLs in the future will be done by benevolent automation I assume. But today, we rely on dedicated volunteers who are already working hard in their day jobs. Asking them to turbocharge is not easy.

Let’s slip back from this transgression from the ‘singularity’ (sentient machine future) to a reality we’re more comfortable with: 54% adherence to GLs and pressure from outsiders (like the IOM) to consider GLs produced by professional societies as perhaps too biased to recognize. We need to be on our toes here. This must remain our AHA-ACC turf.

Our TF rose to the challenge of an uncertain future in my view. We had already decided that those persons with industry conflicts, no matter how dominant in the science of a particular issue, cannot a chair a GL committee, and cannot be panel members without broad disclosure and compelling reason. In the future such individuals may serve only as consultants or testifiers, with no voting privileges, I suspect. We are tightening this up.

In recognition of the critical significance of comparative effectiveness research, members agreed to consider cost and cost-effectiveness whenever relevant and possible in future guidelines. This would not have been considered even 5 years ago. They considered changes to the recommendation language to convey incremental value in comparisons and suggested the addition of health economists and statisticians to the team of contributors. Again, a bold move.  

This month’s post comes to us from past president of ACC’s Virginia Chapter, John Brush, Jr., M.D., F.A.C.C. In addition to serving three years as Chapter president, Dr. Brush practices at Cardiology Consultants, Ltd., in Norfolk, Va., and is an Assistant Professor of Clinical Internal Medicine at Eastern Virginia Medical School. He also has been a leader in quality improvement, assisting ACC efforts with “Door-to-Balloon: An Alliance for Quality” and the IC³ Program, and as a member of ACC’s Clinical Quality Committee.

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In the current health care reform debate, there has been considerable discussion about comparative effectiveness. This method of evaluation could provide valuable information on the relative value of competing drugs, devices and treatment strategies, which in turn could improve outcomes, efficiency and satisfaction. Critics are concerned, however, that comparative effectiveness could be used to deny coverage, squelch innovation and ration care. Because of these concerns, some stakeholders forcefully argue that comparative effectiveness evaluations should be totally devoid of cost considerations.

But how can you compare competing treatments and ignore costs? To use heart failure as an example, could you really compare the relative effectiveness of ACE inhibitors and left ventricular assist devices and ignore the wide difference in costs between the two treatments? And isn’t the public’s desire to gain “more bang for the buck” what’s driving health care reform in the first place?

The Case for Cost Effectiveness
Cost effectiveness research is difficult and has recognized limitations. Yet no method of research is perfect or definitive. Although cost effectiveness research has some limitations, we should not reject the useful information that it provides for comparative effectiveness analysis.

There is a compelling need to contain costs in order to extend health care coverage universally in America.  Comparative effectiveness research will give policy makers important information that will help set priorities for spending.  As with clinical practice guidelines, comparative effectiveness analysis should inform, but not dictate clinical decisions.  Personalized decision-making for individual patients should always trump broad policy recommendations.

Comparative + Cost Effectiveness
Comparative effectiveness research and analysis will require a disciplined approach.  Comparative effectiveness research should be a transparent scientific process, absolutely free of economic influence.  Advisory boards that oversee this research and analyze the results should be shielded from undue political influence.  For years, NIH has distributed billions of dollars in funding, using established methods that are generally respected as fair and non-biased.  Similar independence and discipline can be established for overseeing comparative effectiveness research and analysis. 

Comparative effectiveness research using cost considerations should be a two-stage process.  The first stage should pertain to relative clinical effectiveness and the second stage should deal with costs.  For competing treatments with similar clinical effectiveness, no further cost effectiveness research is needed because direct cost comparisons would be simple.  But in comparisons where one treatment is more effective, careful analysis of costs will be necessary to estimate the monetary value of the increased effectiveness.

Constructing a Firewall against Undue Influence
To maintain the integrity of this process, and to shield the process from political and financial influence, a firewall should be constructed between comparative effectiveness evaluation and insurance coverage decisions.  The funding level for coverage is a political or a business issue, not a scientific issue.  The funding level for Medicare is up to Congress, and, ultimately, to taxpayers.  The funding level for private health plans is up to the purchasers and benefit design managers.

Comparative effectiveness analysis can be separated from coverage decisions by borrowing the method used in the process of grant funding:  

• When judging grants, the judges evaluate the grants based on the scientific merit of the grant, without consideration of whether the grant will actually receive funding.
• Grants are graded on a relative scale.
• Top grants that fall within the funding range receive a grant.

Is that rationing?  Perhaps so, but this explicit method of determining coverage seems more rational than the current method for rationing where we deny care to nearly 50 million Americans because they lack employer-based insurance or don’t meet the criteria for Medicare or Medicaid.

The device and pharmaceutical industry is predictably worried about comparative effectiveness.  Undoubtedly, comparative effectiveness would provide pressure on pricing, which is generally lacking when providers and patients pass on costs to third party payers. Transparent comparative effectiveness would give consumers of health care an opportunity to shop for greater value, which will help contain overall costs. 

We Can’t Have it All
This is the unfortunate truth: the growth in health care spending is unsustainable and is making health care unaffordable for average Americans.  In health care, we can have nearly anything we want – we just can’t have everything we want.  Because of escalating costs and limited funding, we need mechanisms to differentiate medical treatments with high value and those with little incremental value.  Without a method to objectively analyze the relative value of treatments, the costs of medical care will continue to rise to unaffordable levels.

-- John E. Brush, Jr., M.D., F.A.C.C.

* Dr. Brush’s post is part of a monthly series of guest posts by ACC leadership. Check back next month to see which ACC leader is sharing his or her thoughts on health care reform!

*** Image from morgueFile (jdurham). ***

 

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.

On Friday, the Centers for Medicare and Medicaid Services (CMS) released to all U.S. hospitals their performance on six key measures, in preparation for public announcement of these measures this summer.  The measures: 30-day mortality and 30-day readmissions for heart failure; acute myocardial infarction; and community-acquired pneumonia.

Hospital to Home
"Hospital to Home" -- a new partnership between the ACC and Institute for Healthcare Improvement -- is moving along swiftly, as a way to help our members reduce CV hospital readmissions. CV hospital readmissions are currently at 25% of discharges within 30 days. 

Though our Hospital to Home (H2H) project, we aim to reduce 30-day all-cause readmissions for heart failure and AMI by 20% nationally by December 2012.  The project will officially launch when the CMS measures are publicly released this summer.  Watch the video below for more info.

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...

It’s amazing how fast things are moving in DC right now on both the system reform and the stimulus implementation fronts. There are hearings, major Congressional and White House briefings, press events, and high level policy meetings every day. ACC participated last week, for example, in:

The IOM, in partnership with AARP, and the ABIM Foundation sponsored an invitation-only meeting on physician payment reform. The chiefs of staff of key Senate and House health committees were there to receive feedback. I was there for ACC, and shared our views on how payment reform (linked to quality improvement) can reach out to practices NOT in large integrated systems through our proposed voluntary “quality first networks” and the IC3 program. This is increasingly received with excitement, and nicely dovetails with the Brookings Institution proposal for “Accountable Care Organizations” (ACOs) of physicians and patients linked together around risk sharing quality improvement strategies.

Senate Health, Education, Labor and Pensions Committee had a private invitation-only briefing on the current status of their joint drafting of the Senator Kennedy-sponsored health reform bill. They are making progress and wanted to share the outlines of the still-being-brainstormed concept. They reiterated that a “single payer” concept was not a politically viable option. HELP believes reform will pass this year, even if it takes several years to finance full implementation. ACC was invited, and I had a chance to share our quality improvement ideas there as well.

Senate Finance Committee held an invitational briefing on their proposal, being coordinated with the HELP proposal, and Sens. Baucus and Grassley are still optimistic reform will pass this year. We are giving feedback on all issues they are covering. The Senate’s goal is to have a bill drafted by June. ACC was there.

The National Coalition on Health Care (NCHC): this largest of the health reform coalitions met last week, and Drs. Weaver and Bove represented us with the major labor, employer, consumer group, and pension plan members.

Drs. Weaver, Bove, Brindis, and I met with influential House member Chris VanHollen (D-Md.) to discuss his sponsoring of  a “quality first” ACC Medicare pilot project proposal. There is growing interest in this kind of pilot.

House Ways and Means: held an invitational briefing on the status of their ideas about reform. WAM is holding roundtable informal hearings with members and guests from April to May, with the goal of a committee markup on health care reform legislation in June. Their focus this week was on coverage and affordability, much of which focused on the pros and cons of adding a public plan to compete with private health insurance. Health Subcommittee Chair Henry Waxman (D-Calif.) strongly supports this idea, which will be a deal killer for House Republicans as what they view to be a path toward single payer. WAM leaders Waxman, Charles Rangel (D-N.Y.) and George Miller (D-Calif.) sent a letter to President Obama committing to a bipartisan effort to pass health care reform before the August recess. ACC was there. 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). ***