Renewed Efforts to Reduce Industry Funding of CMEs

Last week’s Journal of the American Medical Association (JAMA) reported on the challenges that certain medical schools and medical centers across the country are facing as they decrease or eliminate industry funding of their continuing medical education (CME) programs.  These institutions have shown concern over the potential conflicts of interest when pharmaceutical and medical device companies fund educational programs which could bias future prescribers/customers toward their targeted products.  The adoption of industry-free CMEs could help filter out any potential marketing messages, and leave behind a balanced and evidence-based perspective.  After all, as the New York Times has reported, there are over 700 accredited CME providers in the United States and CME spending hovers around $2.5 billion per year, nearly half of which is paid by pharmaceutical and medical device companies.

Last year, three medical schools declined industry support for their CMEs: the University of Missouri-Kansas City School of Medicine, Nova Southeastern University College of Osteopathic Medicine, and Touro University Nevada College of Osteopathic Medicine.  This past June, the University of Michigan Medical School (UMMS) announced an actual policy change, effective January 1, 2011, whereby the school will no longer accept industry funds, which presently comprise almost 45% of its total CME funding.  UMMS believes contributions from various departments will help offset this sizable loss, as will higher CME registration fees and “less glamorous venues.”  UMMS is the first medical school to introduce such a policy and does so noting “we should take pride in our position as a national leader on this issue.”

This is all well and good, but in light of the enormous industry contributions, the $64,000 question really becomes: “Is Industry-free CME a Sustainable Model?“  And that’s exactly what speakers and attendees asked at the June 25, 2010, PharmedOut Conference entitled “Prescription for Conflict: Should Industry Fund Continuing Medical Education.” The conference was held at Georgetown University (PharmedOut is a Georgetown University Medical Center project funded by the Attorney General Consumer and Prescriber Education grant program.  Its team of physicians and academics lecture on the physician-pharma relationship, and provide access to online and industry-free CMEs).  Dr. Robert Wittes, Physician-in-Chief at Sloan-Kettering’s Memorial Hospital for Cancer and Allied Disease (”Memorial Hospital”), told his colleagues during the Conference that:

[t]here is life in CME after you do something like this.  But you have to be willing to prioritize the activity, such as putting institutional funds toward the balance [previously covered by commercial funds] and/or charge registration fees for CME activities that involve outside physicians.

Memorial Hospital stopped accepting industry money for its CMEs in 2007.  Dr. Wittes acknowledged that “[w]e don’t have these things in hotels in mid-Manhattan anymore; we have them on our own premises.”  Yet he cautioned against any institution from completely severing ties with the industry because there are positive interactions which can result in improved products and commercial science.

For further reading, check out Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy’s whitepaper on “Drug and Device Promotion: Charting a Course for Policy Reform.”  The Center makes several recommendations for overhauling the CME funding mechanism.  It also points out that accountants, lawyers, and other professions pay for their continuing education programs.   Be sure to check out Michael Ricciardelli’s post on industry funding of CMEs for nurse practitioners and Kate Greenwood’s post on ACCME Standards for Commercial Support too.

Nurses, Prescriptions and Pharma Influence– Under the Radar?

Very interesting point made over at Gary Schwitzer’s Health News Review Blog regarding Industry funding of Continuing Medical Education (CME) for Nurse Practitioners (if you’ve never visited Mr. Schwitzer’s blog you should, he is informative, well written and generally brief).

Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy issued a White Paper last year, “Drug and Device Promotion: Charting a Course for Policy Reform,” which called for a cessation of industry funding of CME. The Center noted:

Reforming Funding for Continuing Medical Education (CME). Most states require physicians to undertake continuing medical education to maintain their medical license. The drug and device industry currently funds over half of the accredited CME courses available to physicians. The Center recommends that industry funding for continuing medical education should be phased out, and replaced by an educational process driven by physicians.

And that

• Ninety-four percent of physicians have some kind of financial relationship with industry, as reported in a major recent national study.

• Commercial support for accredited CME, nearly all of it from drug and device manufacturers, grew from $302 million in 1998 to $1.2 billion in 2006.

But what about nurse practitioners? Schwitzer, who attended the recent Georgetown Conference, “Prescription for Conflict: Should Industry Fund Continuing Medical Education?” noted that:

There are more nurse practitioners (147,000) than there are family physicians (100,000) in the US.

These advance practice nurse professionals can write prescriptions, and it’s estimated that the average nurse practitioner writes more than 6,000 a year.

And about 70-80% of those nurses who regularly attended lunch or dinner “continuing education” events sponsored by drug companies said they were more likely to prescribe the drugs that were highlighted in the lunch.

The presenter was nurse-researcher Elissa Ladd, PhD, RN, Asst. Clinical Professor, Massachusetts General Hospital Institute of Health Professions, who says the possible pharma influence on nurse-prescribers has largely flown “under the radar.”

A little quick and basic math will give us some inkling of just how much flies under that radar. We’ll use the minimum figure in all estimates. So…

147,000 Nurse Practioners each writing 6,000 prescriptions per year = 882,000,000 prescriptions. Yes, that’s 882 million prescriptions per year– conservatively estimated.

“More likely to prescribe the drugs that were highlighted in the lunch” we can estimate at 51%. We wind up with a potentially influenced 449,820,000 prescriptions. Again, conservatively estimated.

So now the only question is just what percentage or how many Nurse Practitioners “regularly attended lunch or dinner ‘continuing education’ events sponsored by drug companies?”

With a total pool of over 882 million prescriptions per year available– at least 450 million of them potentially swayed over lunch–my guess is that Pharma’s answer would be “As many as possible.”

Medical Education & Health Reform

[Ed. note: As noted in the post above, we are very pleased to welcome Associate Dean & Professor of Law Kathleen M. Boozang, J.D., LL.M., to Health Reform Watch today.]

The news has been much absorbed by the “scandals” associated with physician conflicts of interest arising out of their relationships with the pharmaceutical and medical device industries. Concerns include the potential biases created by industry funding of continuing medical education, the impact on patient care of physician activities as paid industry consultants and promotional speakers, as well as the impact on the integrity and patient safety of industry-funded research.  Analogous issues emerge from industry funding of medical schools themselves.

A pervasive conception of systemic health care reform would provide the opportunity to address many of these problems.  Academic medicine’s drive for money arises not only from the amount of uncompensated care they provide to the under- and uninsured, but from the structural flaws of the funding mechanisms for medical education and research in the United States.  According to the June MedPac Report on medical education,  it is unclear how much it actually costs to train new physicians, partly because of the multiplicity of funding sources.  While it could be that the funding is sufficient, medical school faculty and deans nonetheless find themselves under tremendous pressure to raise money from government grants, industry relationships, and clinical practice to support themselves. This pressure increases as constrained state budgets contribute less to public universities. Income from physician practice plans is leveling off as academic medical centers become unappealing participants in managed care plans — they too frequently focus insufficiently on primary care, and managed care increasingly balks at contributing to the costs of medical education which are built into academic hospital rates. Further, many academic medical centers are less nimble and efficient than the multi-practice plans and surgi-centers pervasive in many communities.

While greed and poor judgment are certainly factors driving some physicians’ relationships with industry, academic medicine’s over-reliance on “alternative revenue” streams can also be explained by the irrationality of the extraordinarily complex mechanisms for funding medical education and research. More frustrating is Medicare is spending $9 Billion annually to new train physicians to function in a health care system that is hopefully short-lived in its current form.  Meaningful healthcare reform will rest on reform of the delivery and finance systems — new health care professionals must be educated to perform in this reformed environment, which should involve increased collaboration between physicians and allied healthcare professionals; treatment of patients outside of the hospital; and knowledge of comparative effectiveness of alternative therapeutic options.

Health care reform should condition future financing of medical education on the absence of collaborations that create conflicts of interest that threaten the integrity of the medical profession.  It should also jumpstart radical reform of the content, methodology and quality of educating medical students, residents, and physicians, who are the linchpin to changing how we deliver healthcare.  The plan for systemic reform should compel a reconceptualization and expansion of allied health care professionals’ roles in health care delivery to address cost, access, quality, and error avoidance.  Finally, the vision for the future should commit to resolving the inequities in the health care status of all who live in the United States, an issue whose solution is inextricably linked to producing a sufficient number and variety of health care providers available in every part of the country who have a broader conception of health care, with the knowledge and skills to achieve the goals of health for all.

The Life Cycle of Objectionable Drug Marketing Practices

[This is a guest post by Nathan Cortez, assistant professor of law at the Dedman School of Law at Southern Methodist University. Cortez has published in the peer-reviewed Food and Drug Law Journal and teaches international health, pharmaceutical and administrative law. I've learned a lot from his work, and I'm happy he's agreed to let me post this here.]

By Nathan Cortez

The pharmaceutical industry spends some serious coin on sales and marketing-anywhere between $30 billion and $57 billion per year. And this money funds much more than the ubiquitous ad campaigns to which we’ve grown accustomed (sing along if you know the “Viva Viagra” jingle). Over the years, sales and marketing departments have conjured up increasingly creative marketing practices of questionable legality. For example, drug companies have funded “research” and “educational” grants of questionable validity, sponsored continuing medical education (CME), paid ghost writers to generate favorable journal articles, provided free gifts, meals, and entertainment to prescribers, paid prescribers as speakers, consultants, or preceptors, and even hired former college cheerleaders to gain access to prescribers. Most of these practices have been condemned, and many have been prosecuted, resulting in billions in settlements for federal and state governments. The pharmaceutical industry can’t even give away free drugs without being punished.

Last Monday, the New York Times highlighted yet another objectionable drug marketing practice: targeting medical schools. As the article explains, drug companies have long had ties to medical schools and their students by funding endowed chairs, faculty prizes, research grants, capital improvements, and even volunteering employees to teach classes. Students get showered with enough free pizza and trinkets to think that they might already have prescribing privileges. More recently, the Times reports that the faculty at Harvard Medical School has come under fire for its ties to drug companies that hire faculty as speakers, consultants, or even board members. More than 200 Harvard Med students have objected, leading the school to convene a 19-member panel to reevaluate the school’s conflict-of-interest policies (meanwhile, the University of Minnesota Medical School is loosening them).

In the “Life Cycle of Objectionable Drug Marketing Practices,” we’re currently at the “media coverage and public outrage” phase. Gradually, most of the practices listed in the initial paragraph have either disappeared or have lost their allure. Media coverage and public outrage is quickly followed by government outrage (possibly even Congressional hearings) and promises of self-regulation by the drug companies to preempt more stringent regulation. Self-regulatory efforts like the PhRMA Code and the AMA Ethical Guidelines provide some bright-line standards for complying with ridiculously broad laws like the federal anti-kickback statute and its complicated safe harbors. If companies still don’t get the hint, the government simply tells drug companies what not to do.

And if none of these events ends the Life Cycle of the Objectionable Drug Marketing Practice, litigation usually does. Pretty much every major pharmaceutical company has settled a Corporate Integrity Agreement with the government for violating federal drug marketing laws-the latest being a staggering $1.4 billion settlement paid by Eli Lilly to settle claims that it illegally marketed its anti-psychotic drug Zyprexa. By settling, companies thus avoid the “death penalty”–being excluded from Medicare and Medicaid.

Although the drug companies never die, the practices usually do, precipitated by an avalanche of government investigations, whistleblower suits, shareholder suits, and even marginally-related product liability suits. Federal and state lawmakers also pile on. In the last few years, nine states have enacted (and dozens have considered) pharmaceutical marketing laws, requiring disclosures of marketing payments made by drug companies to potential prescribers, in addition to caps on payments, disclosure of sales representative activities, and other prohibitions. Indeed, the Senate Finance Committee is currently considering a federal bill that would explicity preempt state laws.

Thus, the Objectionable Drug Marketing Practice dies a violent death. It can rest in peace, but the sales and marketing departments can’t. Because they have to find new ways to drive market share.

Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy Releases White Paper Recommending Reform of Drug and Device Promotion

Seton Hall University School of Law’s Center for Health & Pharmaceutical Law & Policy has called for broad reforms in the marketing of drugs and devices. In a whitepaper, entitled, “Drug and Device Promotion: Charting a Course for Policy Reform,” the Center proposes legal and policy changes to address conflicts of interest in the relationship of medicine and industry. “The time is right for reform in the marketing of drugs and devices to doctors,” said Center Executive Director Tracy Miller. “Conflicts of interest have become pervasive in medical practice. Reform is needed to ensure that patients’ interests are at the heart of medical education, practice, and research,” she said.

The Center recommends: (1) making payments by drug and device companies to doctors transparent, with public disclosure by industry and physicians of their financial relationships; (2) adopting federal legislation to ban gifts, meals and other benefits provided to doctors as part of the current marketing model; (3) setting new policies to give FDA the authority to require studies of safety and efficacy of drugs and devices used off-label; and (4) undertaking a fundamental change in funding for continuing medical education to end industry support.

Moving to Transparency. The Center recommends that payments by drug and device companies to doctors should be publicly disclosed. “Transparency is critical to shore up public trust in physicians and the collaboration of industry and medicine,” said Tracy Miller. Transparency would also foster better practices by doctors and industry, advance government oversight, and provide information to the press and public. Pending federal legislation, the Physician Payments Sunshine Act, would require industry to disclose payments to doctors.

The Center supports this approach. It also recommends that states undertake disclosure by doctors, and decide how information about physician financial relationships with industry could best be shared with patients. Law Professor Kathleen Boozang adds that, “If doctors had to disclose payments from industry it would prompt them to examine their practices through the eyes of their patients and peers.”

Banning Gifts, Meals, Perks. The Center proposes adoption of federal legislation to ban the use of gifts, meals, and other perks to promote drugs and devices. The states have taken the lead to date–Massachusetts, California, Minnesota, and the District of Columbia have passed laws to limit or ban gifts and meals that are now routine in marketing practices. Concluding that industry self-regulation is not sufficient, the Center calls for national legislation to create uniform practices by industry and physicians. As urged by Professor Boozang, “the benefits of drugs and devices should drive promotion and physicians’ decision to prescribe, not a marketing model that depends on gifts and meals.”

Promoting Scientific Study of Off-Label Uses. The Center proposes that national policy should be redesigned to assure that physicians, patients and government have reliable information to make informed choices about off-label medications. Estimates suggest that as many as 40% of all prescriptions are for off-label uses. The FDA has recently issued guidelines to promote integrity and accuracy in medical articles that drug and device companies give to doctors. The Center urges that this policy guidance, while useful, does not go far enough to provide crucial information about the safety and efficacy of drugs and devices prescribed by doctors for uses other than those approved by the FDA.

The Center proposes giving FDA the authority to mandate scientific studies for off-label medications and devices that have high sales volumes or large profits but lack needed evidence of efficacy or safety. This would protect the interests of patients and advance sound choices about the risks, benefits, and economic value of off-label uses.

Reforming Funding for Continuing Medical Education (CME). Most states require physicians to undertake continuing medical education to maintain their medical license. The drug and device industry currently funds over half of the accredited CME courses available to physicians. The Center recommends that industry funding for continuing medical education should be phased out, and replaced by an educational process driven by physicians. As stated by Tracy Miller, “Physicians need to retake control of their professional education. CME should focus on doctors as professionals caring for the whole patient, not just as prescribers of drugs and devices.” While the transition to new funding occurs, the Center recommends that speakers at CME events should disclose more information about their financial interests, and physicians who are paid to promote drugs and devices should not speak at CME events about those products.

Factual Background for the Recommendations

• Ninety-four percent of physicians have some kind of financial relationship with industry, as reported in a major recent national study.

• Five states–Maine, Massachusetts, Minnesota, Vermont and West Virginia– have required industry to disclose financial relationships with physicians.

• As shown by a recent Congressional investigation of payments by industry to prominent psychiatrists, even at universities with strong disclosure policies, practices have not kept pace, leaving the public in the dark about financial ties between physicians and industry.

• Medications are widely used off-label, especially in certain fields such as psychiatry, pediatrics, and oncology. A recent study found that 73% of off-label uses lack evidence of efficacy.

• Commercial support for accredited CME, nearly all of it from drug and device manufacturers, grew from $302 million in 1998 to $1.2 billion in 2006.

Read Whitepaper here.