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25 posts from October 2010

October 29, 2010

CME Crossroads: A Survey of Continuing Medical Education Analysis, Criticism, Research and Policy Proposals

Trial Results Presentation 
Over the past several years, numerous reports and proposals from professional organizations, federal agencies, academic medical centers, medical journals, and states have sought to change the nature of the continuing medical education (CME) enterprise and its stakeholders.

A recent report from Global Education Group entitled “CME Crossroads: A Survey of Continuing Medical Education Analysis, Criticism, Research and Policy Proposals,” analyzed these proposals. The paper was peer reviewed by more than 20 CME professionals representing all key stakeholders, including representatives of the Accreditation Council of Continuing Medical Education (ACCME), American Medical Association (AMA), professional societies, medical education companies, hospitals, academic centers, and grant funding organizations.

The CME Crossroads is a survey of key CME articles, policy papers, consensus documents, and opinions between 2005 and 2010. During the past six months, the authors reviewed more than 100 studies and documents and were able to identify four “CME Policy and Scrutiny Trends” represented in the literature. Those trends include:

-       Incorporate adult learning principles/expertise into CME

-       Produce Better CME Outcomes

-       Heighten CME Regulation/Enforcement

-       Address Conflicts of Interest

After identifying these trends and providing information to clarify the analysis of CME, the paper concludes with several recommendations to positively shape future debate and CME analysis.

According to the authors of CME Crossroads, the survey of reports and committees created a “perfect storm of criticism, analyses, and policy proposals between 2005 and 2010.” The literature called for everything from a restructuring of the CME system to regulatory and accreditation en­forcement reform, to elimination of commercial support representing more than 50% of the fund­ing for CME activities. The CME Crossraods report asserts that much of the discussion and analysis within the reviewed reports “has been charged with emotions, peppered with anecdotal information, and plagued by confusion.” This finding is particularly problematic given the fact that many reports share the initiative of changing CME, and more specifically removing commercial support.

Although the damage to the CME enter­prise these reports have created is difficult to assess, there are concerning trends found in the ACCME Annual Report data. Specifically, when comparing the recently published 2009 annual report to that from 2007, the number of accredited providers of CME fell by 174.

During this same period, the ACCME reported equally troubling data on the number of certified CME activities. The number of CME activities decreased by 17,941 (-15.8%) between 2007 and 2009. Despite claims that CME funding was “approaching $3 billion” in 2008, actual ACCME report data show that it decreased to a total of less than $2.2 billion, of which 39% ($856 million) was comprised of industry grant funding to support CME activities. Despite the rally cry for al­ternative funding, the 29.3% decrease in industry grant funding was not offset by government or other sources.

The direct decrease not only in funding, but the number of CME providers and activities is disturbing, especially for physicians and patients. It is more shocking given the fact that we are adding 30 million more people to our health system, which means we will need more doctors and health care providers to educate, and more CME.

The interest in CME issues and policies however has surged. In the last five years, the authors found more than 100 articles published on assessing and sharing educational outcomes for CME activities and curricular initiatives and a peer-reviewed journal devoted solely to continuing education out­comes analysis has been published since 2006.

Significant changes in the CME enterprise have also taken place over this time frame, including the development of a “Certified CME Professional” (CCMEP) exam and designation in 2008. Further, the ACCME produced updated criteria for assessing all accredited CME providers in 2006, followed by 2007 policy updates and several calls for comment regarding regulatory proposals between 2008 and 2010, including those focusing on the Standards for Com­mercial Support, a rapid response system to address non-compliance, and blueprints for a future CME monitoring and compliance enforcement mechanism.

Given all of the changes and current activities, the authors assert that the CME enterprise “has reached a crossroads.” As a result, the authors examine the available evidence and provide clarification of the analysis, criticism, research, and policy proposals regarding CME. From their analysis, the authors concluded that the “literature surveyed demonstrated clear trends in criticism and a clear reaction from the CME enterprise. It included genuine evidence-based debate as well as unproven CME accusations.”

As a result, the authors recognized that despite the “rational and irrational concerns” in CME, “many stakeholders that comprise the CME enterprise have taken significant steps toward quality improvement.” Accordingly, the authors noted that the “challenge lies within the CME community to speak with one voice when defin­ing certified CME.”

The authors recommend that the CME enterprise needs “to communicate clearly to groups outside of the CME industry exactly what the CME enterprise is, and perhaps more important, what it is not.” In doing so, they acknowledged that CME providers must emphasize their movement toward quality, which will continue to improve healthcare through physician per­formance improvement.

Next week we will provide a summary of the trends found in the Global Education report, as well as their responses and recommendations.

October 28, 2010

How Conflict of Interest Rules Endanger Medical Progress and Cures: Effects on Pharmaceutical and Device Marketing

Collaboratoin 

Conflict of interest regulations are also adversely affecting the relationship between physicians and industry by limiting the use of marketing, consulting, and education in the pharmaceutical industry. As Richard A. Epstein, a visiting scholar at the Manhattan Institute, explained in his report on How Conflict-of-Interest Rules Endanger Medical Progress and Cures, “strict conflict of interest regulations on promotion and marketing “will increase the cost of getting a new drug to market and thus delay its effective use.”

Our previous articles discussed the origin of Epstein’s report and the initial discussion of conflict of interest (COI) regulations in government and academia. This article will discuss Epstein’s analysis of COI regulations in drug and device marketing.

COI Regulations in Drug and Device Marketing

The clear problem COI regulations aimed at reducing drug and device marketing is that when “a company is not able to market the drugs, they cannot afford to make them.” Epstein points out that marketing is necessary because new drugs are complex chemical products that require a close understanding, and because research and development often involve the creation of new products. Epstein recognizes however, that the creation of new products, however successful, “will produce enduring social gains only if the producers of pharmaceutical products and medical devices can sell these products in the broader market.”

Marketing is also an important function because it ensures that “people in the profession are aware that a new drug has made its way through to the marketplace.”

Consequently, Epstein maintains that sending out representatives from the company or from medical practice to explain what their complications might be, and how they should be addressed, is clearly appropriate. Company representatives are making public statements about these products. If cases arise where such interactions are unethical, the company could easily suffer substantial exposure to tort liability or regulatory sanctions, which has happened for several companies over the past few years.

Additionally, companies are not marketing products and devices to “naïve audiences.” Companies speak to “physicians who face their own reputational and liability risks when they prescribe drugs. In most of these sessions, physician questioning plays a prominent role, and there is little reason to think that companies will push risk-making claims that could lead to improper uses giving rise to serious tort liability.”

Everyone involved in the debate of COI regulations understands that making drugs give “rise to life-and-death questions.” If companies and agencies do not protect patients through clinical trials, tests, or post-market surveys, people die. However, as Epstein points out, enacting stringent COI policies can “stifle the marketing and promotion of new drugs that outperform their rivals, and their tardy arrival could spell death or serious injury to the people who cannot obtain the desired relief from existing drugs.”  Therefore, he recognizes the need for COI policies to take into account both chances for error.

As Epstein explains further, errors from delaying drugs because of stringent COI policies are also social issues that can have long-term effects. While the public attempts to justify such restrictions by crying “better safe than sorry,” Epstein notes that this “image does not carry over to issues of pharmaceutical research, where regulations routinely deny even prudent individuals and firms a “safe harbor,” where they can collaborate without fear of sanction.”

The problem that arises is that people with dangerous conditions for which there are no known acceptable therapies and treatments suffer because strict COI policies impose obstacles “in the path of new drug marketing and development.” Such obstacles are significant because they affect the “speed with which needed new products get to the market.” For example, patients depend on the institutional arrangements that guide drugs from initial conception to ultimate commercialization. Since the relevant processes to get a drug from discovery into production is never “in the control of a single individual, let alone a single firm,” policies that hinder such relationships and collaboration “prevent sick people from getting much needed treatment in timely fashion.”

Moreover, product development is also dependent on “developing close connections among all individuals in the production cycle so that the insights learned at one stage can be made available to people working at either a previous or subsequent stage,” and that information is reliable.  However, the “adoption of aggressive conflict-of-interest regulation can exert deleterious effects on both aspects of information transfer” (speed and reliability). As a result, Epstein notes that these policies have “placed unnecessary bumps in the road to sound product development and commercialization.”

He uses the example of the so-called Pharmaceutical and Medical Device Manufacturer Conduct Act, which is now in effect in Massachusetts, to show a policy that is having a deleterious effect on information transfers between industry and physicians. The law tries to impose on companies a fair code of conduct. The problem with this law is that the legislature made no real inquiry into how marketing and industry meetings work for conveying information to physicians, which is evident by the ambiguous and confusing language of the legislation.  Another weakness of the code is that it cuts “so deeply into customary ways of doing business, despite the absence of evidence of systematic abuse.”

Conclusion 

Epstein’s approach to COIs is that there should be trade-offs, not moral absolutes.  He asserts that we should accept COIs “as a necessary part of doing business and manage to the point that the last dollar spent in seeking to prevent error generates the same return as the last dollar spent on any other phase of medical research.”

Nevertheless, as Epstein thoroughly describes, “the current conflict rules that are ordered by such key organizations as the NIH, the FDA, and various medical schools and medical societies have passed the point of good sense and have entered an area where we can predict serious difficulties.” These policies have made it harder for industry to help researchers and to exchange information. Although “it is perfectly appropriate to devote more resources to the monitoring of conflicts of interest,” Epstein recognizes that “a few incidents of misbehavior should not lead to a total reorientation of attitudes and policies.”

In the end, “severe and broad conflict-of-interest regimes sweep before them even highly regarded, well-motivated professionals, denying society the benefits of the knowledge they possess.” The restrictive policies that these individuals and agencies have enacted are unnecessary because such conflicts can “be managed through a judicious combination of disclosure and oversight.”  

Since 1945, “we have had the benefit of these collaborations without having seen any sign of the systematic abuse that could justify the tough bans that have been put into place today.” By continuing to create and uphold intrusive and unwise policies and injunctions on physician-industry collaboration, agencies are only “throwing sand into the gears of progress at every stage of the drug production cycle, from basic research through final sale.”

Continuing down this path will only hurt patients and future generations. As such, agencies and institutions should seriously consider Epstein’s recommendations before it is too late for patients.

October 27, 2010

How Conflict of Interest Rules Endanger Medical Progress and Cures: Institutions and Academia

Harvard Quad 
 
As we mentioned earlier this week, Richard A. Epstein, a visiting scholar at the Manhattan Institute, examined “How Conflict-of-Interest Rules Endanger Medical Progress and Cures.” The published report was part of the Manhattan Institute’s “Project FDA,” which is a committee of physician-scientists, economists, medical ethicists, and policy experts, which examines the current framework and direction of federal and state regulation to help promote the development of a robust medical innovation pipeline. 

Epstein organizes his report into five separate parts. Part I introduces readers to a definition of conflicts of interest (COI). Part II looks at the nature of COI regulations in general. Part III discusses COI in government work. Part IV analyzes COI regulations in university-industry collaboration. Part V discusses conflict of interest (COI) regulations in drug and device marketing. This article will discuss Epstein’s analysis of COI regulations in general, and more specifically in government work and university-industry collaboration.

Definition of COI

There is no universal definition of what constitutes a conflict of interest. Having different understandings of what signifies a “conflict of interest” is one of the problems with COI regulations. Since institutions, agencies, journals, academic medical centers, and professional organizations all use different definitions the meaning of COI varies. Epstein uses the example of the COI policy from Harvard Medical School, which states that  "A Faculty Member is considered to have a conflict of interest when he/she, any of his/her Family, or any Associated Entity possesses a Financial Interest in an activity which involves his/her responsibilities as a member of the Faculty of Medicine.”

COI Regulations

COI regulation is typically used “before something improper occurs or when sanctions are triggered by the occurrence of some wrongful action (i.e. fudging data).” While regulations that operate prior to the commission of any wrongdoing help prevent “messy scandals,” Epstein points out that they can also impose heavy costs on research projects and development, which result in delay of medical care and denial of medical care. Delay in care can lead to loss of life, and significant time delays for getting products into each stage of drug design, testing, and commercialization.

Epstein asserts that a better way to go about COI regulation is to let the pre and post policies work together in a synergistic fashion. He explains that this approach often “requires a system of using a set of widely circulated and highly publicized announcements to warn individuals of the adverse consequences of conflicts of interest, should they materialize.” Instead of listing all the possible COIs, he notes that “it is better to follow a simple program calling for the release of all experimental data and the disclosure of all funding sources.” Similar to how product warnings have a few clear cautions on the label, but a comprehensive list in the FDA package insert, Epstein states that “simple remedies for complex processes should never be disparaged when they actually alter behavior for the better.”

He also recognizes that strict COI policies, which force disclosures of financial COIs, has markedly diminished the “willingness of governing authorities to issue waivers” for government or institutional researchers. This has the impact of “fewer good people to sit on these committees” and leads to their exclusion from participation in key projects. Such policies run “the high cost of impeding or even stopping the orderly transfer of information among experts at all points in any complex distribution system.”

While disqualification is proper in certain instances, Epstein acknowledges that a total ban on particular persons “should be invoked only when alternative modes of communication and investigation are abundant and secure.” Instead, he asserted that where “only imperfect substitutes are available, continued participation in a given venture should be encouraged, subject to various forms of cooperation, supervision, and oversight by persons who do not labor under the same direct conflict of interest.”

For Epstein, this analysis shows that the new trend of COI regulations “pushes in the wrong direction at key stages of the drug-production cycle.” He recognizes that the “contemporary one-two punch—adopt a broad definition of a conflict of interest, and then impose stiff sanctions for a violation of the conflict-of-interest rules—can block the easy flow of information needed at every stage in the drug-development process.”

COI in Government Work

COI regulations in government agencies such as the NIH and FDA are beginning to block those very channels needed for an easy flow of information needed at every stage in the drug-development process. In Epstein’s detailed analysis of the historical progression of COI policies at the NIH, what is important to take away is that although incidents of serious lapses in judgment have occurred, they “do not suggest a serious institutional breakdown in the applicable scientific norms.” He also notes that incidents involving senior scientists not filing required forms do not suggest “a need for new rules to plug the gap.” Instead, Epstein asserts that these events “suggest only that the rules already on the books should be diligently enforced. Problems with NIH policies include:

Senior scientists and family members having to divest holdings in private companies, making recruitment difficult and would delay treatment and important decisions about products and research.

Encouraging NIH employees to advance science and stay on the cutting edge of research, but not allowing them to interact with scientists in industry, whose applied research could be expedited by contact with the NIH’s basic scientists.

The Office of Technology places heavy barriers in the path of fruitful collaborations between basic scientists and their counterparts in private industry based on the “risk” of some conflict of interest.

A clear bias against industry by preventing NIH scientists from engaging in public health activities and genuine teaching opportunities such as vaccine programs or speaking with a company’s research group.

The clear problem with government policies is that “strict separation that prevents conflicts of interest also prevents cooperation” and collaboration. Institutions depend on collaboration to “encourage scientific interactions that facilitate the cross-pollination of ideas with outside scientists.” As Epstein points out, NIH regulations that go overboard in an effort to hinder such cooperation are unnecessary since “many of these potential exchanges do not pose the slightest risk of inappropriate influence.”

Similarly, the COI policies at the FDA also “tend to eliminate the most valuable advisory committee members” due to the risk of COI. The 49 FDA Advisory Committees are essential for every stage of drug development as well because they review key submissions of the various drug companies. However, FDA’s recent change to more stringent COI policies are causing significant problems for the agency given that over 200 seats on the 49 Advisory Committees are vacant. Not only is this troublesome for the sake of speed and reliability for companies to have their products considered, but the new FDA policies used misguided reasoning.

FDA tightened its COI policies in “response to academic warnings of runaway conflicts of interest.” Policy changes at academic medical centers (AMCs) sprung from the Wazana study, which did not use patient outcomes. Moreover, Epstein noted that claims made in the Wazana study about “differences in apparent patterns of behavior is a far cry from presenting evidence of any newly found dangers in physician care.” Moreover, a study in JAMA showed that the impact of COI on meetings was modest, which means adjustments to practices should be modest.

Given the obvious problems of COI policies in government, Epstein asserted that a “wholesale revision of the basic NIH policy is needed.” He recognized that it “is critical that the NIH treat collaboration as the main objective and conflicts of interest simply as an important side constraint.” In addition, NIH should seek not only to “remove barriers to cooperation but to open additional possibilities to it by sponsoring workshops and conferences that bring together scientists from government and universities to work together on joint projects whenever possible.”

With respect to the FDA, Epstein acknowledged the need for policies to enable the agency to fill seats, instead of placing additional obstacles in the path of that objective.  He warned that with stricter rules, “the likely result of this will be to narrow the pool of qualified applicants, which will lead to “additional delay, weaker committees, and more dubious decisions.

University COI

Universities have also handled the COI policy problem in a counterproductive manner. Academic scientists address scientific problems until a “proof of principle” is established; then private firms take over the task of commercialization. In the process of taking over commercialization of a product, private firms and “individuals who developed the basic theory often realize that academic scientists are in the best position to aid in its rapid and effective commercialization.” As Epstein explains, that is “why it is commonplace today for many basic scientists in universities to work on outside ventures of a commercial nature, in which they take an ownership or a patent position.”

Recently enacted policies by academic medical centers (AMCs) hinder this relationship by preventing those individuals who know about the field of research from providing valuable information to industry. As Epstein asserts, “to impose an absolute ban on these collaborations would be to force major scientists to take up residence in one camp or the other, in ways that could impoverish both.”

Industry-academic collaboration should be championed, not prohibited. Epstein asks why it is bad that Bayh-Dole does direct research to commercial ends. The reality is, “a project that produces commercial gains benefits individuals, often desperately sick individuals, outside the academic community. Indirectly, it generates tax revenues for the government, some of which can be used to fund further research, and it offers proof that individuals outside the tight circle of academia have gained from the research, for they purchase only those products and services whose value to them exceeds their costs.”

As a result, Epstein recognizes that showing “these tangible benefits could easily affect public support for basic research. Tangible inventions and therapies enable people to see what their tax dollars have bought. If we adopted that view, we would quickly dismiss the universal, if unsubstantiated, fear that the successful commercialization of basic research will sap the public’s confidence in the entire academic enterprise.” This kind of public support is crucial as many “universities today are short on resources to conduct basic research.” Accordingly, Epstein asserts that a proper balance of industry-academic collaboration is needed because blocking out industry support “is deadly to scientific advancement.”

Accordingly, Epstein’s analysis of government and university COI policies makes a clear case for why agencies, institutions, and academic medical centers should not adopt strict COI policies. As Epstein asserts, the government or a private body should not adopt the “ban-first, think-later approach because it could effectively block all formal and informal means of communication” between researchers and industry.

What institutions and policymakers at agencies should take away from Epstein’s recommendations is the need to reassess COI regulations. Extreme responses through strict regulation are not justified from rare exceptions and modest mistakes. The most important tasks that government agencies and AMCs must now address is the need to put collaboration and innovation with industry first, and management of COI second, so that barriers to information are removed and successful progress that our country has enjoyed in medicine the past decade can continue unhindered.  

There is no widespread abuse of COI in AMCs or the government, at least not in medicine or scientific research. Instead, there is a natural tendency and desire among industry, physicians, and researchers to seek out the best sources of information to ensure the continued advancement of health and wellness in Americans.

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