This post was authored by James Fasules, MD, FACC, senior vice president of Advocacy for the ACC.

Just when you thought you’d learned enough healthcare acronyms to understand what we should care about as cardiologists, they add another one. This time, it’s the UFAs – the User Fee Acts, the quick way insiders refer to the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee Act (MDUFA) and the new generic drug and biologic user fee programs. Collectively, these programs help to fund the congressionally-mandated mission of the Food and Drug Administration, which is necessary given the dichotomy between what is expected of the FDA and what Congress appropriates for the FDA to achieve those expectations. The first of the programs, PDUFA, came out of the HIV-AIDS crisis when it became clear that the FDA did not have the necessary resources to review new drug applications quickly enough. Industry pays certain fees to have their applications reviewed. In exchange, the FDA commits to reviewing and coming to decisions (approval or otherwise) within certain timeframes.

The programs, created by Congress, sunset every five years, and it is up to Congress to decide whether to reauthorize the program. Thus, without Congressional action, PDUFA and MDUFA are set to expire on Sept. 30. To put it in perspective, funding from the PDUFA program is so important to the Agency today that approximately 2,000 staff reviewers will lose their jobs in the event that PDUFA is not reauthorized and the application review process will come to a grinding halt. Because of differences between the two programs and the two industries, the expiration of MDUFA would lead to the loss of between 200 and 300 jobs for device reviewers.

So why should cardiologists care? After all, if it’s just about approvals for devices and drugs, shouldn’t that be industry’s problem?  Well, if you think the FDA is slow at reviewing applications now, imagine how slowing things would move without all of those individuals reviewing the applications. New devices and pharmaceuticals would take even longer to get to market and even fewer patients would have access to them. Just think about how much further behind Europe we would be. It’s not just about TAVR; it’s about all of the new interventions that have been developed in recent years and have helped to reduce mortality resulting from cardiovascular disease.

Over the last two years, ACC’s Advocacy team has been meeting with members of Congress and their staff on these issues, as well as agency officials, industry representatives, consumer groups and public health advocates. Additionally, the ACC is working with a number of physician organizations to promote the passage of the UFAs, as well as legislation pertaining to related issues.

Recently, both the House and Senate overwhelmingly passed their respective versions of bills reauthorizing the UFAs.  Over the next month, Committee staff from both chambers will work together to iron out differences between both House and Senate bills before voting on final legislation and sending to the president for his signature.  It’s an exciting time to be an UFA!

It’s been a while since we’ve heard about the Physician Payments Sunshine Act, (read previous blog posts here and here) but this week the Centers for Medicare & Medicaid Services (CMS) released the long-awaited proposed regulations.  A requirement of the Affordable Care Act, the Sunshine Act requires drug and medical device companies to publicly report their payments to physicians.

CMS had missed their deadline of October 1, but after some pressure and criticism from lawmakers and industry, the agency released the rules just in time for the holidays. Since the rules are late, data collection will not begin until the final regulations are issued.

The ACC has a stringent position on conflicts of interest and relationships with industry, and while we strongly support transparency in physician and physician organization relationships with industry, we believe that it is critical this information be placed into the proper context, and made publicly available in a format understandable by the average consumer.

The College will be submitting comments on these proposed regulations to make sure the Sunshine Act process is as transparent and accurate as possible. View the comments submitted to CMS earlier this year here. For more information, visit www.cardiosource.org/Advocacy.

Larry Dean, president of SCAI, and I just sent out an e-mail to our memberships regarding a series of articles that have appeared in the mainstream press about overuse of stents and the opportunity this offers for professional associations like the ACC & SCAI to take a proactive approach to quality issues. Please see the full text below, and leave your comments at the end of the article.

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The American College of Cardiology (ACC) and the Society for Cardiovascular Angiography and Interventions (SCAI) are deeply disturbed by findings in a new U.S. Senate Finance Committee report concerning the ongoing investigation into alleged inappropriate use of percutaneous coronary intervention (PCI) and overutilization of stents at St. Joseph Medical Center, in Towson, MD. While the ACC and SCAI cannot comment on the merits of ongoing investigations, the use of inappropriate or unnecessary procedures is intolerable and a violation of both organizations strict codes of ethics (.pdf) as well as the Hippocratic Oath.

Over the last several months the Maryland Chapter of the ACC and SCAI, working closely with the national ACC, have been proactively addressing the issues raised by these allegations. ACC and SCAI representatives have met with state policymakers and have, at the request of Maryland officials, drafted comprehensive legislation that would require accreditation for all state hospitals performing PCIs.

Meanwhile, the overarching issue of quality and appropriate use of medical procedures is not just confined to the state of Maryland and the use of stents. In fact the Senate Finance report has generated national media coverage in the New York Times, Wall Street Journal and other papers. The investigations and subsequent media coverage provide an opportunity for professional societies like the ACC and SCAI to take the lead locally, regionally and nationally to ensure patients receive the right care at the right time.

Collectively, these developments underscore the need for internal peer-review that is clear, rigorous and objective. A standardized internal process must be followed by independent external oversight performed by an external body, such as the Accreditation for Cardiovascular Excellence (ACE) program. ACE has an independent governing board, allowing for removal of any perceived or real conflicts of interest in oversight of hospital and physician quality performance. ACE accreditation criteria also calls for use of registries like the National Cardiovascular Data Registry (NCDR) and adherence to appropriate use criteria -- both of which are already widely accepted and respected by professional and regulatory communities nationwide.

In addition, quality tools produced by both the ACC and SCAI can provide states, payers and purchasers of care with critical, transparent metrics with which to evaluate quality of care, especially as the health care community adopts a National Quality Strategy and shifts from a fee-for-service reimbursement model to one more focused on outcomes-based care and commensurate reimbursement.

The ACC and SCAI have the knowledge base and expertise as cardiovascular leaders to advise and implement such programs. The efforts under way in Maryland to address quality and appropriate care have far-reaching implications. Addressing them proactively will allow the field of cardiology to remain ahead of the curve and avoid future allegations like those outlined by the Senate Finance Committee. Working together we can ensure our patients receive high quality and effective cardiovascular care delivery driven by physician oversight and leadership.

The ACC Foundation and the American Heart Association yesterday released a joint clinical alert on clopidogrel (Plavix). The alert is intended to help CV professionals make sense of a recent FDA black box warning for the drug saying that some patients’ genetic makeup can affect their response and put them at risk for serious adverse events.

Two to 14 percent of patients are “poor metabolizers” of clopidogrel and do not benefit fully from it, according to FDA analysis. Information about the specific genetic variation that might affect clopidogrel metabolism – and thus, lead to suboptimal clinical responses – is increasing, but there still isn’t sufficient evidence available to develop specific recommendations related to genetic testing in patients. Many questions remain about how and when to use genetic tests for clopidogrel candidates, which tests to use, as well as whether tests will be reimbursed.

The new ACCF/AHA report reviews the backdrop for the black box warning, including the multiple unknown factors that can influence individual patient outcomes. Its recommendations for practice are as follows:

1. Adherence to existing evidence-based guidelines from ACC, AHA or other professional societies for using antiplatelet therapies should remain the foundation of care. If clopidogrel is prescribed, health care providers should help ensure that patients take it as prescribed.
   
   
2. Clinicians must be aware that in certain patients with either acute or chronic coronary artery disease, genetic variability in response to clopidogrel can affect its inhibition of platelet function.
   
   
3. Careful clinical judgment, including weighing the risks and benefits, is needed in considering all therapies. The new boxed warning points out that for clopidogrel, if there is a lack of efficacy, the consequences can potentially result in fatal outcomes.
   
   
4. Results from ongoing clinical trials in large groups of patients will provide more information about the predictive value of genetic testing and better inform the role genotyping might play in personalizing medicine and optimizing outcomes.
   
   
5. Genetic testing to determine if a patient is a “poor metabolizer” may be considered before starting clopidogrel therapy in patients believed to be at moderate or high risk for poor outcomes (e.g., patients undergoing elective high-risk PCI procedures).
   
   
6. Using alternative antiplatelet therapies or altering the dosing of clopidogrel may be reasonable options in patients who experience an adverse event while taking clopidogrel and have been taking the drug as prescribed.

These recommendations are intended to help guide health care providers in devising the best treatment plan for each patient. That said, care providers of course should continue to use careful clinical judgment in each patient.

Relationships With Industry

An interesting side note to this document is that it was the first major clinical document to be produced under a new set of ACC principles for relationships with industry for the development of clinical documents.  Of the many things discussed in the document, one principle outlined is that the chair of the writing committee and greater than 50% of its members must have no relevant relationships with industry.

For the clopidogrel document, only two out of the five authors have relevant relationships with industry that needed to be disclosed.  ACC Vice President and writing committee Chair David Holmes, M.D., F.A.C.C., did not. Being 2/3 of the way free of relationship represents a vast improvement over both our previous clinical documents and our new RWI guidelines. It’s important to the ACC that it be able to offer unbiased clinical documents. It’s not that we think that cardiologists who accept money from drug companies are biased  (we believe that the RWI can provide value when such relationships are ethically structured) , it’s just that we feel strongly in the importance of transparency and maintaining rigorous levels of relationship-free writing committee members helps us to do this.

I’ll be talking more about relationships with industry in the coming weeks, but I’m interested to hear what you think now. Should clinical document writing committees exclude physicians because they accept industry funding or is there an acceptable level of relationships within a writing committee?

UPDATE (7/1): Watch a CVN video with writing committee chair and ACC Vice President David Holmes, M.D., F.A.C.C., explaining the alert.

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.

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)

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.