Life Science Compliance Update

March 02, 2012

Physician Payment Sunshine: USA Today Editorial Author Still Hiding in the Shadows vs. Stell bringing Sunlight to Sunshine

Flashlight
Now that the comment period for the Physician Payment Sunshine Act (Section 6002 of the Affordable Care Act) has closed, various news media have begun discussing and examining the potential impact this legislation and regulations will have on healthcare stakeholders.  

Unfortunately, these media have decided to focus on selling stories and headlines about “potential conflicts of interest,” instead of telling the true and balanced story behind physician-industry collaboration.  For example, a recent editorial from an unnamed author in USA Today, claimed—without providing any evidence (since none exists)—that “small-bore favors such as free samples, promotional trinkets, tickets to sporting events, and deli trays delivered to the office have evolved into practices that look more like outright bribes.” 

These kinds of claims are outright wrong and unethical.  They are nothing more than smoke and mirrors to promote an anti-industry agenda to support some peoples academic careers and livelihoods.  

The reality is, the kind of practices described above are practically non-existent, illegal, and banned by PhRMA and AdvaMed codes.  In fact, the USA Today article’s only mention of evidence of this activity came from a 2007 article.  And that article itself likely collected data from prior years.  So in its duty to report fair and balanced information, the USA Today failed by using old data and not even attempting to discuss the current state of industry.  

The article claims that while “the drug industry stopped paying for some restaurant meals and distributing trivial gifts such as mugs, pens and the like,” items like vacations thinly disguised as educational seminars and fees — kept flowing.  But this is absolutely incorrect.  ACCME and AMA rules ban such meetings for accredited educational programs, and while promotional programs may still exist, these have been restricted severely as well.  The “good old days,” as the author would like to believe still exist, are long gone. 

Consequently, the article then moves on to discuss the Physician Payment Sunshine Act, which requires pharmaceutical and medical device manufacturers to report and submit all payments they make over $10 to physicians and teaching hospitals.  The author’s viewpoint is that, “Physicians and medical schools are still fighting to limit the law's reach.” 

The article notes that, “Doctors insist that industry payments lead to valuable innovations, not to conflicts of interest.”  And the author admits that this is “sometimes true.”  But instead of delving into the lifesaving breakthroughs, treatments, and technologies that have come from physician-industry collaboration, the article and author does what mainstream media do best: dramatize reality to sell papers and sensationalize news, leaving the hardworking physicians and patients to suffer from their publishing and editorial greed.  

The article references “investigations” that have “turned up evidence of payments that could compromise patient care, drive up medical costs and weaken drug safety.” 

We do not condone the past behaviors of companies, executives, or employees who have engaged in deceptive, immoral and unethical behaviors.  Those individuals and parties who have defrauded our government and harmed patients deserve to be prosecuted to the fullest extent the law allows.  These investigations, however, are rare instances, and involve a tremendously small amount of individuals.  

The overwhelming majority of individual physicians who are consulting, researching, and educating physicians are ethical physicians.  They would not deceive or harm patients for a pen or pizza or for that matter $10,000.  These physicians, as we have quoted many times, work with industry to advance medicine, to teach their peers, to interact and learn from other experts, and to ensure better patient care.  

However, USA Today could care less about the lifesaving treatments and medical devices that industry and physicians are creating every day.  The author sensationalizes and stigmatizes physician-industry collaboration without even considering or mentioning the value these relationships provide.  There is no mention of how American lifespan has increased tremendously, how cancer and heart disease death rates have dropped significantly, and how medicines and treatments are reducing the incidence and costs of chronic diseases such as diabetes, hypertension, and asthma.  

The only thing the author even says is the following: “some paid collaborations between doctors and industry yield important medical discoveries.”  Hardly a journalistic attempt considering the significant emphasis and research the author put on the opposing view.

Instead, the article focuses on the few cases where investigations have showed that the proper firewalls and safeguards were not used or in place, which allowed the “potential for conflict” to appear.  

Opposing View 

Lance K. Stell offered the opposing view to the above editorial.  Of course, USA Today gave Stell half as many words to respond to the “majority view” noted above. 

Dr. Stell, who teaches medical ethics at Davidson College and at Carolinas Medical Center, noted that, Supporters of the Physician Payments Sunshine Act fail to take into account how expensive sunshine" would be.  He recognized how, “Requiring drug and medical device manufacturers to publicly report virtually every payment they make to physicians, physician groups and teaching hospitals will end up costing far more than the $224 million estimated for just the first year of compliance.” 

As Stell noted, however, “The biggest cost will be the valuable, socially useful physician-industry collaborations that simply won't occur.” 

In 2007, the measure's original sponsors, Sens. Chuck Grassley, R-Iowa, and Herb Kohl, D-Wis., argued that shedding light on industry payments to physicians would be good for the system. The Pew Prescription Project, alarmed by findings that more than 90% of physicians receive payments of some kind from the pharmaceutical industry, opined that patients deserve to know whether their doctors are on the take. 

“Sunshine supporters always affirm that many financial relationships between medicine and industry are necessary and beneficial. However, the measure's title implies that such relationships need detoxification by exposure to "sunshine," the best disinfectant.”

Stell asserted that, “The new law stigmatizes payments and deters accepting them. But it's utopian to suppose that doctors will give their time and effort for free to do socially useful research and peer education.”  In fact, many physicians won't want to be enshrined in this hall of shame. 

Instead, Sunshine will just make physicians “require higher payments to provide what even "sunshine" supporters agree is valuable work. How much higher? That depends on how our most talented and innovative physicians price their time and how much compensation they'll charge for loss of anonymity and insinuations of corruption that a sunshine listing implies.” 

Ultimately, Stell noted that supporters of the Sunshine Act “foresee only benefit devoid of risk. But they've done no credible cost/benefit estimate. Reporting errors, misattribution and mistaken shaming will occur.” 

What is most problematic about this, as Stell points out, “the government candidly acknowledges that it has no empirical basis for estimating the frequency of improper payments, the likelihood that reporting will reduce them, or the likely effects on reducing the costs of medical care.” 

Conclusion 

As CMS begins going through the hundreds of comments stakeholders submitted on the proposed Sunshine regulations, the media will continue to press on about the potential impact of publishing physician payments.  It is important to remember in reading articles about physician-industry collaboration that many of the articles and journalists covering these topics will only take the viewpoint that industry is bad and payments for collaboration are inherently wrong.  

We encourage readers to do their own research, to ask their own doctors and healthcare providers about the important value industry provides to them, whether through education, research, new products and treatments, and grants.  While transparency and sunshine is important for patients and consumers, it is also important to know the context of these relationships and payments.  Patients should be skeptical about reading articles that stigmatize a few bad apples to generalize an entire profession of healthcare providers who are overwhelming ethical and practice medicine to improve patient health and advance science. 

March 12, 2010

Continuing Education Reform: Are We Throwing the Baby Out With the Bathwater?

Recent evaluations of professional societies and accredited continuing medical education (CME) providers have “further questioned the legitimacy of industry physicians and biomedical scientists providing scientific information or participating in educational program planning.” These evaluations have “deemed that such participation is in violation of ACCME guidelines,” according to a recent article in Clinical Pharmacology & Therapeutics titled Continuing Education Reform: Are We Throwing the Baby Out With the Bathwater?

Specifically, the article looked at the practices of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), who underwent a CME review in 2009. As a result of that review, the Society will no longer be in a position to provide CME and continuing pharmacy education (CPE) after the 2010 Annual Meeting. Accordingly, the article goes on to explain why such a decision was made, and how it affects the overall understanding of continuing education (CE).

 

Continuing Education

 

As we have written many times, CE or CME “is the process by which health professionals keep current with the latest knowledge and advances in health care.” Without CME, doctors and patients would continue to suffer from old and new diseases and symptoms, and be forced to choose outdated treatments, devices and medicines to help with their disorders and illnesses. Over the past few decades, the collaboration of industry and physicians who provide CME has resulted in numerous breakthroughs in patient care. Despite the obvious benefits gained from these relationships, the claim that “there are major flaws in the way CE is conducted, financed, regulated, and evaluated” raises serious concerns.

 

Such a claim is misguided, and to suggest that the numerous providers, researchers, physicians and accredited CME providers are “not optimally prepared to provide the highest quality of care to patients or to meet public expectations for quality and safety” is problematic.

 

As the authors trace the history of CME, they note its importance for addressing the issue of improperly trained practitioners (prior to World War I), and its use for helping well-trained physicians keep current with advancing knowledge (after World War II). It was shortly after this time that the pharmaceutical industry became involved with CME, and “professional product representatives were an important resource for providing physicians with new information.” Consequently, the present “construct of using CME to improve performance began in the late 1970s, when CME was suggested to be a continuous process based in practice settings.”

 

Over the years, criticism has gained momentum about the interactions industry has with CME, and as a result, a process of regulation “began largely as a method for the American Medical Association and state medical societies to monitor the pharmaceutical industry’s influence on physician education.” Another result from this regulation was that “CME increasingly became provided by a combination of specialty societies, state and local medical organizations, and pharmaceutical companies,” and not just one singular source.

 

In the arena of continuing pharmacy education (CPE), the landscape is a bit different, with “approximately 43% of CE programs for pharmacists receiving commercial support.” Such “high levels of support” have resulted in some to assert that CPE “are dependent on industry to assist them in covering administrative, educational, and non-educational expenses.” As a result, the “most recent iteration of these regulations from the Accreditation Council for Pharmacy Education assert that “the provider must plan all CPE activities independent of commercial interest.”

 

The result of such regulations have “systematically stripped CE programs of content that is necessary to ensure education and performance improvement of practitioners.” Consequently, CE programs have also suffered from these kinds of regulations because their goals have “been grossly misplaced such that the passive participation of professionals who must demonstrate evidence of CE to maintain certification/licensure is fostered more than the actual delivery of information amenable to translation into working knowledge.”

 

Industry Support

 

Criticisms that industry support biases or conflicts CME programs are unwarranted because the current CME “system has integrated sources of financial support, accreditation mechanisms, and CE methods in such a way that it is nearly impossible to analyze any of them independently.” In other words, critics cannot just point the fingers at industry because “CE funding comes from numerous sources.”

 

For example, “health professionals themselves, employers, commercial entities, and, to a much smaller extent, the government” all fund CE programs. “In 2007, physicians paid 42% ($1.05 billion) of the total $2.54 billion spent on CME, which resulted in approximately $1,400 per year of out-of-pocket costs per physician.” Such investments prove how “many organizations and employers see CE as an important investment in staff development and thus provide financial support for at least a portion of CE costs.”

 

What critics and opponents are not happy with is the reality of a glooming economy over the past year or two, and an economic crisis that saw rapidly “shrinking resources and increasing costs associated with both providing and obtaining CE credits.” As a result, while the need for CME only continues to grow as more patients fill our hospitals and more diseases are found, “continuing professional education within the health-care arena is quickly becoming a non-sustainable venture.” So then, as the authors ask: what could happen if commercial funding was totally withdrawn and no subsidies were provided by other sources?

 

On average, physicians would have to invest approximately $3,500 annually to continue to attend the same types of CME activities that are currently offered, with similar figures for nurses, pharmacists, etc. Of course these numbers don’t account for travel, lodging, and other associated expenses.

 

Potential for Conflict

 

Just because there is a “potential for conflict” does not mean there are conflicts within industry funded CME. Although countless efforts to develop safeguards meant to ensure that CME providers are free from conflicts of interest have been developed, “widespread skepticism remains about the intentions of entities that provide CME.”

 

This kind of worrying is misguided because CME providers need to “appropriately support the real costs (e.g., travel and lodging expenses, modest honoraria to compensate for effort in developing content of CE presentation) associated with the development of unbiased, high-quality CE.” Supporting these legitimate and legal costs is essential for medical education and pharmaceutical companies to “be able to retain the services of true experts capable of providing current and credible educational programs.”

 

Accordingly, “the considerable progress that has been made in the past 5 years toward protecting educational content from potentially corrupting influences and promotional intent, rigid, industry-wide adherence to current guidelines can eliminate commercial bias.” Examples of these protections include detailed regulations from ACCME to “ensure that commercial well interests are kept separate from learning activities and course content.”

 

“The regulations require CME providers to disclose conflicts of interest and resolve relevant financial relationships with any commercial interest among those in a position to control CME content. They also require that CME providers give a balanced view of therapeutic options and, with respect to education in clinical pharmacology and therapeutics, that any description of off-label drug use be disclosed as such, and that use of proprietary (trade) names for drugs be avoided.” These example clearly demonstrate that eliminating industry support is and overreaction, and would only hurt patients and doctors.

 

Moreover, the process for CME providers to become accredited also eliminates the potential for bias and conflict significantly because companies must be evaluated annually by the accrediting body with associated annual fees that increase each year. This “institution of processes enables continuous quality improvement (most of which introduce progressively increasing allocation of resources to ensure compliance), and continuing contact between the accrediting body and providers.” In fact, both ACCME and the ACPE adopted new accreditation policies and standards that went into effect in January 2009. These new policies require that “no employees of a commercial interest can serve as planners or speakers in any accredited CME activities if the content relates to the “business lines and products of its employer.”

 

Conclusion

 

With a growing population, and increasing number of elderly and sick, America needs “a workforce of competent health professionals” that can use and learn the best health-care practices that effectively cure and prevent disease and promote well-being. In order to achieve this success, an “integrated system of CE is an important contributing factor to knowledge and performance deficiencies that occur at individual and systemic levels in the United States,” one which includes industry support.

 

Today, it’s not just about short-term profits because companies are “funding programs that have the most impact on physician performance.” This kind of industry support provides immense value for all involved. Any attempts to “ban industry contribution from CE in a manner that lacks insight and careful planning is sure to be detrimental to academic medicine and, ultimately, to patients.”

 

Ultimately, “discounting legitimate and high-quality science and not offering it as part of CE because it originates from industry is not necessarily a good plan with the potential of disastrous long-term consequences.

 

Likewise, to imply that scientist’s present biased material merely because they are employed by industry is inaccurate and ill thought out.” As the author of this article correctly asserts, “some of health care’s greatest contributions have originated from industry-sponsored science,” and to eliminate them now would be detrimental to patients.

March 09, 2010

Nature Editorial: Building Bridges not Barriers

An editorial in Nature used the recent appointment of William Chin as a perfect example of why “industry talent should be welcomed into academia, not seen as a corrupting influence.” In his new role as executive dean for research at Harvard Medical School, Dr. Chin, who was a top executive at the pharmaceutical giant Eli Lilly, will use his experience to create new treatments that will help numerous patients and help educate thousands of doctors.

 

Particularly interesting about Dr. Chin is that he spent 25 years at Harvard and its affiliated hospitals before moving to Eli Lilly 11 years ago. Critics believe that moving between companies and academia creates a conflict that taints the academic enterprise. Such opponents use the few examples that exist academic researchers' failed (mostly did not understand because of complex and different rules) to disclose their industry income.

 

As the editorial correctly asserts, such critics are misguided, and have “have conflated the very existence of industry–academia collaborations with failure to disclose those links.” In fact, critics need to be more mindful of the ongoing efforts of pharmaceutical companies, ACCME, and other health care providers who are constantly updating codes of ethics to increase transparency. As a result of such endeavors, those against industry and academic collaboration must abandon the view that “any and all cooperation between industry and academics is inherently suspect.”

 

Such a perspective “has created a poisonous atmosphere that has driven some young investigators to take up other careers,” which means less treatments and studies will be done that could help cure diseases today and in the future. One example the authors noted of such a stigmatized atmosphere took place last week, “Robert Califf, vice-chancellor for clinical research at Duke University Medical Center in Durham, North Carolina, told a conference at NIH headquarters in Bethesda, Maryland, about a recent meeting where the leaders of major academic medical centers were afraid to sit in the same room with industry leaders — with the goal of enhancing understanding and cooperation — for fear of an outcry either in Congress or the media.”

 

This kind of fear undermines the true value and significance of industry-academic collaboration: helping patients find new treatments through clinical studies, research and development. The reality is, appointments such as Dr. Chin’s and meetings with industry and academia “are not only appropriate, but essential for strengthening university research and for bridging the gap between lab and clinic — a gap that has bred a justifiable public impatience for cures at the advent of the century of biology.”

 

Like many physicians and researchers who have worked in/with industry and academia, Dr. Chin “has both a physician's appreciation of illness and an enviable scientific pedigree.” In fact, any significant, ethical or legal worries about his work with industry are nonexistent as “the chairs of the medical school's basic-science departments endorsed his hiring unanimously.”

 

The experience physicians like Dr. Chin gain allow researchers and physicians to find and connect laboratory discoveries to human disease. Discovering such connections gives doctors “the kind of management experience and insights into discovery and translation that can be got only in industry.” More importantly, having worked inside and with industry for so long, Dr. Chin and others with similar experience will use their knowledge “to inform their efforts to guide a medical school's scientific interactions with industry, in the drive to meet critical medical needs.”

 

To exclude people like Dr. Chin from working in academia would truly hurt patients, and physicians seeking highly needed training and experience with industry, and not just free lunches. In addition, Harvard is not the only example, as the University of California, San Francisco (UCSF), last year named Susan Desmond-Hellmann, previously president of product development at biotech company Genentech, as its chancellor. Using her experience over the past six months since taking over, UCSF announced last week “collaboration with Genentech aimed at generating small-molecule drug candidates, a step that has proven a major obstacle in drug discovery.”

 

Ultimately, critics “fail to understand that industry–academia cooperation is essential if we are to speed the medical progress that everyone seeks.” Evidence of this progress will likely be seen in the coming years from the works of Dr. Chin and Ms. Desmond-Hellmann.  Accordingly, critics of such collaboration must reevaluate their oppositions to consider what society will benefit from more: less interaction and experience with industry or more partnerships, such as those that have led to reducing heart disease, increasing cancer survival rates, and fighting HIV.

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