JAMA Forum: Tackling the Ebola Epidemic

Lawrence Gostin, JD

Lawrence Gostin, JD

The Ebola virus epidemic in West Africa is now out of control, but it shouldn’t have come to this. Ebola virus disease (EVD) is a preventable disease, but the current epidemic is challenging efforts to contain it. Previous outbreaks that have occurred since the virus was first detected in 1976 have been confined to rural areas. This time, EVD has reached the urban landscape, with people and animals congregating together. Extensive travel across land borders and by air is furthering its spread.

Why Ebola Is Out of Control

The most affected countries—Guinea, Liberia, and Sierra Leone (with recent spread to Nigeria, which currently has a dozen cases)—are ranked lowest in global development and do not have the basic infrastructure to contain the Ebola epidemic. Even with international help, it will take at least 6 months to bring the crisis under control, according to Médecins Sans Frontières/Doctors Without Borders. For now, Ebola is spreading unchecked because of such factors as fragile health systems in resource-poor countries, cultural practices, and deep-seated distrust.

Broken Health Systems

Being treated or working in a hospital in affected states is hazardous. Health professionals are the most susceptible: they typically care for infected patients without personal protective equipment and infection controls; they lack training in differential diagnosis of and treatment for EVD; and they are underpaid. Patients, too, perceive that hospitals in the affected countries are unsafe places that offer little effective treatment. Consequently, patients with Ebola-type symptoms stay away, and those who need treatment for myriad health problems—from AIDS and malaria to cancer and heart disease—remain untreated in the community.

The persistence of traditional burial and other cultural practices in West Africa also make it more difficult to contain Ebola. Loved ones come in close contact with the deceased, including ritual touching and bathing. Burial practices create the conditions for transmitting EVD, which then can be spread throughout the community. Another practice, consuming bush meat, which might include animals that are reservoirs for Ebola virus, is a traditional source of food, especially for poor Africans, providing life-sustaining protein. Women, as the traditional caregivers, are more likely to contract the virus than men.

Further challenging attempts to contain the spread of Ebola are common misperceptions, such as the belief that aid workers from medical groups were spreading the disease. Public education has been neglected and governments have curtailed accurate news reporting about the crisis. Epidemic control requires trust and an informed public, so risk communication is fundamental to controlling Ebola’s spread.

Ethical Issues

Also related to the issue of trust has been the use of scarce experimental therapies. More than 20 Ebola outbreaks have erupted in sub-Saharan Africa, yet the world was unprepared for the current tragedy, with no licensed vaccines or treatments. (This lack of readiness would not have surprised Albert Camus. As he wrote in The Plague, “Everybody knows that pestilences have a way of recurring in the world; yet somehow we find it hard to believe in ones that crash down on our heads.”)

An experimental drug called ZMapp, which has neither been proven effective nor tested for safety in humans, was available in scarce amounts and was administered to 2 US aid workers and, reportedly, to a Spanish priest. The last remaining doses have now been delivered to West Africa, but the initial perceived preference given to white foreign workers fueled a sense of injustice. Although selecting who should get the untested treatment is an agonizing choice, it’s my opinion that priority should be given to African health workers, who die of Ebola in far greater numbers than do foreign workers. In any case, it is vital that allocation decisions be made fairly and transparently. The decision to treat the foreign workers was made behind closed doors without community consultation. Going forward, high-resource countries should create public-private partnerships to ramp up development and rigorous evaluation of vaccines and treatments.

Militarization of a Disease

Adding to the distrust that hinders attempts to control the epidemic is local populations’ fear not only of Ebola but also of the militarization of the disease. Countries have erected cordons sanitaires (guarded lines preventing anyone from leaving), but are using ancient methods to enforce the quarantine. In West African hot spots, armed troops have established blockades, closed roads, and banned travel beyond the guarded perimeter.

As a result, the populace is finding it hard to obtain food and other basic necessities. Targeted travel restrictions may be necessary, but there is a smarter way to go about them, through humane care and incentives. Governments should provide people with nourishing food, health care, and psychosocial support. Transmission hot zones can’t be ignored, but neither can the needs and human rights of communities.

What Can Be Done Now? A “Health Systems Fund”

Fragile health systems are at the root of the problem, and bolstering them is a key to fighting Ebola and preventing another uncontrolled outbreak. Affected countries are unprepared for Ebola’s complexities; they are unable to provide all their people basic health services, much less the requirements of an Ebola response, including full body protective gear, specially trained health workers, isolation units, and advanced laboratory capacity with higher biosafety capabilities. Building strong health systems would rebuild the most basic community asset: trust. Looking ahead, the international community should mobilize to provide sustainable funding scalable to needs.

This crisis represents a manifest failing of the international community, particularly its wealthier members, which ought to have been generous in supporting surveillance and response capacities obligatory under the International Health Regulations (IHR). The World Health Organization (WHO), the World Bank, and the United States Agency for International Development, among others, have made notable pledges of support. But what the region needs now is an assurance that these funds will be ample and sustainable.

To address this need, I propose an emergency, and then an enduring, “Health Systems Fund” administered by WHO (with participation of local governments and civil society) and supported by high-resource countries. Considering the funding needs, an immediate (emergency) down payment of $200 million is needed for the affected countries and their at-risk neighbors. The money should be spent to strengthen health systems. Building on recent pledges of support, these additional funds could reward and motivate frontline health workers, ensure humane conditions in communities subjected to cordon sanitaire, and establish surveillance and response preparedness.

This fund would be surprisingly affordable, with this initial installment of funding representing only 1% of international health assistance. Growing the fund over time into a multibillion dollar funding channel for lower-income countries would finally make it possible to mobilize the resources envisioned in the IHR, as well as the growing global commitments to universal health coverage. Eventually, the fund might be merged with the Global Fund to Fight AIDS, Tuberculosis and Malaria into a new Global Fund for Health.

It is in all states’ interests to contain health hazards that may eventually travel to their shores. But beyond self-interest are the imperatives of health and social justice: a humanitarian response that would actually work, now and for the long term.

 ***

About the author: Lawrence O. Gostin, JD, is University Professor and Faculty Director, O’Neill Institute for National and Global Health Law, Georgetown University Law Center, and Director of the World Health Organization Collaborating Center on Public Health Law and Human Rights. His most recent book is Global Health Law (Harvard University Press).

About The JAMA Forum: JAMA has assembled a team of leading scholars, including health economists, health policy experts, and legal scholars, to provide expert commentary and insight into news that involves the intersection of health policy and politics, economics, and the law. Each JAMA Forum entry expresses the opinions of the author but does not necessarily reflect the views or opinions of JAMA, the editorial staff, or the American Medical Association. More information is available here and here.

 

 

JAMA Forum: We Are the 98%

Andrew Bindman, MD

Andrew Bindman, MD

The Occupy Movement against social and economic inequality popularized the slogan, “We are the 99%”—a phrase highlighting the enormous income disparity in the United States between the top 1% of earners and the other 99%. The 1% of highest income earners, defined in 2011 as an adjusted income of more than $389 000, includes many physicians, but it also turns out that physicians have their own version of “payment inequality.” And this payment inequality, particularly when it is done with public dollars, has important social implications.

Medicare’s first-ever public release of physician payments in April revealed that 2% of physicians accounted for approximately a quarter (23.6%) of the $63.9 billion total Medicare payments to physicians in 2012. The largest portion ($3.3 billion) was paid to the 2995 ophthalmologists who received average Medicare payments of more than $1.1 million dollars each that year. Several other specialties were disproportionately represented among the 2% highest earners, including hematologists-oncologists, cardiologists, radiation oncologists, and dermatologists.

Medicare comprises about 20% of most physicians’ revenue, which varies by specialty and individual practice. Medicare payments are not equivalent to net income, as some portion would typically be used to cover office expenses. Some cases of high payments, for example, may involve physicians who specialize in procedures that require expensive drugs or medical devices, and a substantial portion of Medicare payments for those procedures may ultimately end in the pockets of drug companies or device makers. But it is reasonable to assume there’s often a strong correlation between payment and net income.

Raising Questions

The extraordinary size of the Medicare payments to a small number of physicians raises questions about the legitimacy of this reimbursement and whether all the care that was provided was appropriate. One also has to wonder whether the Medicare population is best served by investing 23.6% of its physician resources in 2% of the physicians and whether concentrating so much of Medicare’s physician payments in specialty areas such as ophthalmology and dermatology is the best way to derive value in this publicly financed program.

Primary care might offer a better return on investment, but the payment differential between primary care and specialty care prevents many students from choosing this career path. The more than $15 billion paid to the 16 485 of highest-paid physicians in Medicare would have entirely erased Medicare’s portion of the pay differential with specialists for the more than 160 000 primary care physicians participating in the program.

Some physicians might wonder if it is their place to question the amount Medicare pays their colleagues, but they need to realize that they have a shared interest in how Medicare’s payments are distributed. Because Medicare’s Sustainable Growth Rate (SGR) formula used to set physician payments establishes a fixed pool of resources for this purpose, the disproportionately high payments to 2% of physicians come at a cost to the other 98%. A payment amount beyond the fixed pool established by the SGR formula triggers an across-the-board payment cut. Congress has always passed legislation to prevent payment cuts from occurring, but it is a source of recurring tension in the physician community.

Physician organizations frustrated by the uncertainty in Medicare payment have lobbied Congress to replace the SGR with a more dependable revenue stream. Congress seemed poised to do this prior to the end of March this year, but it failed when Republicans and Democrats could not agree on a source of savings in the budget to offset the increased amount it would require to pay physicians.

After seeing the distribution of Medicare payments to physicians, one has to wonder whether the recurrent showdowns between physicians and Congress regarding the SGR is mainly for the benefit of the highest paid 2% of physicians. It’s not possible to examine trends in physician payments based on the data released by Medicare, but if payments to physicians parallel what is observed in our society at large, the largest growth in Medicare spending over time is most likely among those who are also among the highest paid. Perhaps the SGR problem could have been fixed some time ago had the medical community overseen the distribution of payments by Medicare and recognized that the amount paid to the 2% in 2012 was 50% greater than the amount needed to patch the SGR shortfall for that year.

The medical profession should have an interest in ensuring that physician resources are used to maximize benefits for the population. But when the American Medical Association (AMA) spent 35 years in court fighting the release of Medicare physician payment records, it may have put the interests of the highly paid 2% ahead of the other 98%.

Before releasing the information on physician payments, the Centers for Medicare and Medicaid Services requested public input about taking this action. Among the dozens of public comments from professional organizations, there was a mix of opinions among physician organizations that were concerned about physicians’ privacy, the data’s accuracy, and the public’s ability to understand it. But none stated an interest to work with Medicare to help identify physicians whose billing practices might be threatening the reputation of the profession and undermining the capacity of the overwhelming majority of physicians to meet the health challenges of the Medicare population.

Collective Actions Needed

Although lawyers inside and outside of the government line up to identify whether the information contained in the Medicare physician payment database reflects fraudulent billing by those who are several standard deviations beyond the average provider, physicians who are committed to their patients, to upholding the integrity of the profession, and to restoring the public’s trust in our ability to self-regulate and behave in a socially responsible manner might pursue a series of collective actions through their professional organizations in response to these data.

First, the physician community should establish standards and methods for regularly reviewing physician practice patterns. A high level of payment by itself is not proof that a physician has done anything wrong. But there needs to be a means to identify physicians who derive excessive payments for care of questionable value so that corrective action can be taken to conserve resources and protect patients from unnecessary care.

Second, the profession should encourage payers aside from Medicare to be similarly transparent with their physician payment data. This would eliminate the secrecy that can allow a minority of physicians to abuse different payment systems.

Third, the profession should examine the role that the American Medical Association /Specialty Society Relative Value Scale Update Committee (RUC)  in setting the prices Medicare pays physicians. The RUC wields enormous power, and it has been criticized for its part in creating an imbalance in payments among different specialties. Given the physicians who are among the highest earners in Medicare are so disproportionately concentrated in just a few specialties, it is reasonable to question whether the RUC is serving the broad interests of all physicians or only a select minority.

Finally, the profession should reflect on whether the fee-for-service system continues to be the best way to meet the interests of both physicians and patients. It should do all it can to support the development of payment models that reward physicians for their hard work and for using health care’s limited resources in the most effective and efficient ways.

***

About the author: Andrew Bindman, MD, is Professor of Medicine, Health Policy, Epidemiology and Biostatistics at University of California San Francisco (UCSF). He is the founder and Director of the University of California Medicaid Research Institute, a multicampus research program that supports the translation of research into policy.

About The JAMA Forum: JAMA has assembled a team of leading scholars, including health economists, health policy experts, and legal scholars, to provide expert commentary and insight into news that involves the intersection of health policy and politics, economics, and the law. Each JAMA Forum entry expresses the opinions of the author but does not necessarily reflect the views or opinions of JAMA, the editorial staff, or the American Medical Association. More information is available here and here.

 

JAMA Forum: On Medicine and Money

Eli Adashi, MD, MS

Eli Adashi, MD, MS

US consumers have always had limited information about how physicians and other health care professionals practice medicine. Now, however, the April 9 release by the Centers for Medicare and Medicaid Services (CMS) of data on medical services and procedures provided to Medicare beneficiaries will help fill that gap “by offering insight into the Medicare portion of a physician’s practice,” said Health and Human Services Secretary Kathleen Sebelius in an accompanying statement. The newly released data, she added, will “afford researchers, policy makers and the public a new window into health care spending and physician practice patterns.”

All told, the newly released CMS data set provides information about more than 880 000 health care professionals who received $77 billion in Medicare payments in fiscal year 2012 for 6000 different types of services and procedures under the Medicare Part B Fee-For-Service program. Additional data releases may well follow before too long, with an eye towards enhancing transparency.

“Data transparency is a key aspect of the transformation of the health care delivery system,” said CMS Administrator Marilyn Tavenner. In addition to the new information about clinicians, CMS made hospital charge data available last May, thereby apprising consumers of the wide-ranging hospital costs for common inpatient and outpatient services.

 

Medicare Millionaires

As might have been anticipated, much of the media coverage of the release of the CMS data focused attention on health care professionals dubbed “Medicare millionaires” and their practice patterns. Tantalizing as such details might be, more profound issues were being sidestepped. In particular, little has been said with respect to the uncomfortable relationship between medicine and money.

This is an unfortunate state of affairs, because the ethical and moral challenges associated with the juxtaposition of medicine and money are highly deserving of our attention. A clear-eyed recognition of this age-old subject and of the all-too-common frailty of human nature were articulated as early as the 12th century by Moses Maimonides, the philosopher and physician, in the Prayer of Maimonides: “Do not allow thirst for profit, ambition for renown and admiration to interfere with my profession . . . .”

But there are no easy answers to this conunundrum.

Many see the pairing of money and medicine as a nonissue, and instead view it as capitalism at its best, with medicine being just another market in which competition reigns supreme. For proponents of this point of view, health care professionals might be seen as operatives in a retail business, wherein the volume of sales (of health services) carries the day, creating a vibrant health care market that sparks the scientific innovations upon which we have all come to depend. They see the business model of medicine as no different than that of any other field of pursuit, naturally rooted in foundational libertarian principles. Viewed in this light, the intersection of medicine and money is as American as apple pie. Exemplified by the time-honored “private practice” of medicine, this all-out embrace of the business principles of a market economy remains undiminished—if increasingly untenable.

 

No Fail-Safe Firewall

But there’s a potential flaw in this line of reasoning: the presumption of a fail-safe firewall between financial considerations and clinical decision making. Sadly, that may not always be the case.

Indeed, Congress has frequently seen fit to shield consumers from untoward practices. Examples of this include the Stark Law (which prohibits clinicians from “self-referring” a Medicare or Medicaid patient for services), the Emergency Medical Treatment & Labor Act (which ensures public access to emergency services regardless of ability to pay), and the Affordable Care Act (which expanded requirements for physician-owned hospitals).

Moreover, as recently as February 26, according to the annual Health Care Fraud and Abuse Control (HCFAC) Program report, the US government “recovered a record-breaking $4.3 billion in taxpayer dollars in Fiscal Year 2013 from individuals and companies who attempted to defraud federal health programs.” In that same year, 718 defendants were convicted of health care fraud–related crimes. Defendants who were charged and sentenced are facing an average of 52 months in prison. Regrettably, many of those involved were physicians, nurses, and other licensed medical professionals.

Clearly, opinions vary widely as to the ethical and moral wisdom of mixing medicine with money. Some would favor a lightly regulated, self-policing field, wherein unfettered entrepreneurship and Medicare millionaires are bound to thrive. According to this outlook, infractions perpetrated by a select few do not warrant the imposition of blanket, heavy-handed oversight.

But those who consider medicine and money to constitute a volatile mix may express preference for another model, such as a national health care system buttressed by a single governmental payer, in which value rather than volume of services determine provider compensation. Under this system, Medicare millionaires are unlikely to flourish.

Will the push for transparency into health care spending and how clinicians practice medicine foster change that addresses the intersection of medicine and money?

***

About the author: Eli Y. Adashi, MD, MS (Eli_Adashi@brown.edu) is a professor of medical science and a former dean of medicine and biological sciences at the Warren Alpert Medical School of Brown University in Providence, Rhode Island. A member of the Institute of Medicine, the Association of American Physicians, and the American Association for the Advancement of Science, Dr Adashi has focused his writing on domestic and global health policy at the nexus of medicine, law, ethics, and social justice. A former Franklin fellow, Dr Adashi served as a senior advisor on Global Women’s Health to the Secretary of State office of Global Women’s Issues during the first term of the Obama Administration.

About The JAMA Forum: JAMA has assembled a team of leading scholars, including health economists, health policy experts, and legal scholars, to provide expert commentary and insight into news that involves the intersection of health policy and politics, economics, and the law. Each JAMA Forum entry expresses the opinions of the author but does not necessarily reflect the views or opinions of JAMA, the editorial staff, or the American Medical Association. More information is available here and here.

 

 

Author Insights: Leaders at Academic Centers Often on Drug Company Boards

Walid F. Gellad, MD, MPH, of the University of Pittsburgh and staff physician at the Pittsburgh VA Medical Center and colleagues, found many leaders at academic medical centers are paid to serve on pharmaceutical company boards. Image: iStock.com/graffoto8

Walid F. Gellad, MD, MPH, of the University of Pittsburgh and colleagues, found many leaders at academic medical centers are paid to serve on pharmaceutical company boards. Image: iStock.com/graffoto8

Many leaders at academic medical centers are doing double duty, serving on the boards of pharmaceutical companies and being paid handsomely for it, finds an analysis published in JAMA today.

Nearly half of the top 50 pharmaceutical companies worldwide have leaders from top academic medical centers on their boards. Of the 17 US drug companies, 16 count academic center leaders. These individuals, who included 2 university presidents, 6 deans, 6 hospital system executives, and 7 department chairs or directors. The average compensation they received for board service was $312 564. By comparison, the average dean of medicine earns $445 781, and the average associate dean at a medical school makes $196 212, according to a 2012-2013 survey by the College and University Professional Association for Human Resources.

Walid F. Gellad, MD, MPH, assistant professor of medicine at the University of Pittsburgh and staff physician at the Pittsburgh VA Medical Center, discussed the study’s findings with news@JAMA:

news@JAMA: Why did you and your colleagues decide to do this study?

Dr Gellad: There’s a lot of interest in identifying potential conflicts of interest in medicine. There is the Physician Payment Sunshine Act, which reveals payments companies make to physicians. The issue is of great interest to medical trainees, especially because there are limits on receiving free pens or lunches. The issue of dual leadership at academic centers and on corporate boards has received less attention.

news@JAMA: Do you think this is a new phenomenon?

Dr Gellad: I don’t think it is new at all. One study in 2007 in JAMA looked at the corporate relationships of department chairs.

news@JAMA: Were you surprised by the number of administrators serving on pharmaceutical company boards?

Dr Gellad: Yes. There are different grades of leadership represented. They are not all deans or chief executives, but all have some leadership role. This is about individuals holding dual leadership responsibilities at academic and pharmaceutical companies.

news@JAMA: What about the magnitude of the compensation?

Dr Gellad: I think it is pretty standard for someone who serves on a corporate board. This is from public data. It also includes stock and charitable donations made on behalf of these individuals. These numbers are striking when the salaries of most academic center leaders are not that much higher than what they are receiving for serving on a corporate board. It is way greater than the average salary of most people in the country.

news@JAMA: What do you think can or should be done?

Dr Gellad: Our hope is that this paper gets people to ask that question. It’s up to university ethicists and other university leaders to decide what should happen. We need to understand the risks and benefits of these relationships. I think a lot of people are not aware these relationships exist.

news@JAMA: Is there anything you’d like to add?

Dr Gellad: We wanted to make clear in putting this together that we wanted this study to focus not on individuals but on the topic.

Author Insights: Rapid Drug Approvals Leave Many Safety Questions Unanswered

An analysis by Thomas J. Moore, AB (above), a senior scientist at the Institute for Safe Medication Practices, and Curt Furberg, MD, PhD, of the Wake Forest School of Medicine in Winston-Salem, North Carolina, found that studies used for expedited drug approvals are so small they may be unable to answer key safety questions.

An analysis by Thomas J. Moore, AB (above), a senior scientist at the Institute for Safe Medication Practices, and Curt Furberg, MD, PhD, of the Wake Forest School of Medicine in Winston-Salem, North Carolina, found that studies used for expedited drug approvals are so small they may be unable to answer key safety questions.

The US Food and Drug Administration (FDA) has created fast-track approval processes to speed certain drugs to market, but an analysis of these expedited approvals finds they often leave important safety questions unanswered. The analysis was published today in JAMA Internal Medicine.

To help expedite approval of drugs, the FDA has created processes that waive some of the requirements that are part of a standard drug approval. These expedited reviews, popular with industry and patient groups, are used for drugs that the FDA determines represent “a significant therapeutic advance” or that fill unmet needs. The Obama administration has also proposed additional ways to speed the pace of drug approval.

But an analysis of the differences between standard and fast-track reviews by Thomas J. Moore, AB, a senior scientist at the Institute for Safe Medication Practices (ISMP) in Alexandria, Virginia, and Curt Furberg, MD, PhD, of the Wake Forest School of Medicine in Winston-Salem, North Carolina, found that although fast-track approvals may shave about 2½ years off approval time, they also provide less information about the safety and efficacy of the drugs.

Moore and Furberg examined 20 drugs approved by the FDA in 2008, including 8 that received expedited reviews and 12 that received standard reviews, finding that the expedited drugs took a median of 5.1 years of clinical development to reach approval compared with 7.5 years for the drugs undergoing standard approval. But the expedited drugs were tested on far fewer patients—a median of 104 patients, compared with a median of 580 patients for the standard review drugs. Safety problems emerged after approval for drugs in both categories, but many safety questions that might have been resolved by postmarketing studies by the FDA remain unanswered, as less than one-third of 85 such studies had been completed by 2013.

Moore discussed the implications of the study’s findings with news@JAMA.

news@JAMA: Why did you decide to do this study?

Thomas Moore: The question this study was trying to address is: are novel drugs today tested enough? We found that many questions are left unanswered.

news@JAMA: What kinds of questions are going unanswered with the expedited reviews?

Thomas Moore: As trials get smaller or shorter, you know less about critical issues, like whether there is target organ toxicity, whether certain subpopulations develop adverse events, what the contraindications are, and how the response differs between women and men. The more you look, the more problems you identify.

news@JAMA: How long does it take to get these answers after approval?

Thomas Moore: For novel treatments, the drugs are developed and approved very quickly, in about 5 years. But answers to unanswered safety questions come slowly after approval. Two studies, one by ISMP and one by the FDA, have found that significant safety warnings emerge at a median of 11 years after approval. We are approving drugs quickly, but we are taking a very long time to address the questions we left on the table.

news@JAMA: What implications do your findings have for proposals to further speed the approval process?

Thomas Moore: The FDA is advancing several proposals that would further reduce the amount of preapproval testing. Is this movement in the wrong direction? This is an issue for the medical community to debate and think about. Physicians and patients need to think about whether we want drugs quicker or whether we want more study so we know how to use them wisely.

news@JAMA: What do you think physicians and patients should know about drugs that have undergone expedited approval?

Thomas Moore: Physicians need to be aware when they use novel drugs approved under expedited review the safety information available is much more limited than for other drugs they use. That means they should use these drugs with more caution and extra vigilance.

What patients need to realize is that even experienced physicians can’t always tell if a drug is working. We have one really good tool to assess drug effectiveness and safety: randomized controlled clinical trials. The sad story we have witnessed is that often patients want new drugs and are willing to take risks to get them, but then hundreds of thousands of dollars may be spent on the drug before we realize it doesn’t work or patients [are harmed]. Patients need to be aware of the importance of clinical testing so they can benefit from drugs and reduce their chance of getting hurt.

The wise and safe use of drugs requires clinical testing.

Updated Rules for Clinical Research Strengthen Patient Protections

Ramin W. Parsa-Parsi, MD, MPH, of the German Medical Association, said changes in the World Medical Association’s revised Declaration of Helsinki are intended to bolster protection for participants in research involving humans while still promoting quality research.

Ramin W. Parsa-Parsi, MD, MPH, of the German Medical Association, said changes in the World Medical Association’s revised Declaration of Helsinki are intended to bolster protection for participants in research involving humans while still promoting quality research.

The rights and interests of patients must always trump medical researchers’ drive to generate knowledge, according to updated guidelines for the ethical conduct of clinical research from the World Medical Association (WMA).

The WMA’s Declaration of Helsinki has set the worldwide standard for ethics in research involving humans for nearly 50 years. First drafted in 1964, the declaration is used by researchers, funders, ethics oversight bodies, and research participants to assess whether clinical research is hewing to appropriate ethical standards. One notable exception is the US Food and Drug Administration’s decision in 2009 to follow a different standard, a move that some speculated may be linked to the declaration’s guidance that the best possible treatment be used instead of placebos.

The updated version is designed to be more easily accessible, grouping recommendations by subject matter, with specific sections dedicated to informed consent, the use of placebos, and the conduct of research on vulnerable groups. It also includes several revisions aimed at strengthening protections for research subjects.

In a video interview, Heikki Pälve, MD, PhD, chief executive officer of the Finnish Medical Association, explained that the most important recommendation is number 8, which says, “While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.”

Pälve said that putting patient rights first is crucial to ensuring the future of clinical research by protecting the public’s trust in the enterprise. For the first time, the declaration requires that participants who are harmed in the course of research be compensated and provided with appropriate treatment. The declaration also requires researchers to share the overall study results with participants. Ramin W. Parsa-Parsi, MD, MPH, of the German Medical Association, who also participated in the interview said, “We believe that this revised document achieves a good balance between strengthing safeguards for patients while promoting good quality research.”

Several changes were also made to protect the interests of research participants in resource-poor countries, which are increasingly used as sites for clinical trial research. In a Viewpoint accompanying the declaration in JAMA, Paul Ndebele, PhD, of the Medical Research Council of Zimbabwe, said the revised declaration addresses some of the ethical issues specific to studies conducted in middle- and low-income countries. For example, it requires that researchers provide for ongoing access to effective interventions and care after trial completion.

But some questioned whether the revised declaration went too far in protecting patients. A second JAMA Viewpoint, by Joseph Millum, PhD, and colleagues, argues that the document doesn’t provide for situations when it might be appropriate to forego informed consent or where very broad consent may be given for use of biomedical samples. The Viewpoint also questions whether the guideline is too restrictive about exposing patients to risk in the context of clinical research: “The declaration’s lack of clear and consistent guidance regarding when net risks are acceptable creates unnecessary confusion and fuels the unfounded concern that all medical research is inherently exploitative.”

Report Identifies Problems With National Database of Physician Misdeeds

Some reports of physician misbehavior may not show up in searches of a national database used by hospitals and others making decisions about hiring or disciplinary actions. Image to come: Ivan Ivanov/iStockphoto.com

Some reports of physician misbehavior may not show up in searches of a national database used by hospitals and others making decisions about hiring or disciplinary actions. Image: Ivan Ivanov/iStockphoto.com

A national database that helps hospitals and state medical boards identify physicians who have had a history of disciplinary actions and malpractice payouts may have flaws that let some reports go unnoticed, according to a report by Public Citizen, a civic watchdog organization.

By law, the National Practitioner Data Bank (NPDB), which is maintained by the Health Resources and Services Administration, collects information on all medical liability settlements, medical license revocations, and disciplinary actions against physicians by state medical boards, hospitals, and professional societies. Hospitals, state medical boards, and other health care organizations consult the NPDB for information on physicians that may be relevant in hiring decisions or disciplinary actions. But users may get incomplete information when they query the database, the report found.

Specifically, reports submitted to the database by the Department of Health and Human Services’ Office of Inspector General (OIG) that have information that the OIG has prohibited a physician from participating in federal health programs may have errors that cause the reports to slip by unnoticed, according to Public Citizen. Such holes in the data could lead to serious repercussions for hospitals, which may fined if they employ or contract with an clinician who has been excluded from providing services to Medicare or Medicaid patients. According to the report, an analysis by NPDB staff found that only 47% of the 8845 OIG reports submitted to the database from 1990 through 2012 had been disclosed to users of the database, compared with 71% of reports from medical boards and 85% of reports from hospitals. Public Citizen found errors in OIG exclusion reports, such as incorrect information about which state had licensed the physician or a lack of identifying information.

The OIG in May recommended that hospitals and other users of the NPDB directly search OIG’s exclusion database. The Centers for Medicare & Medicaid Services maintains its own Medicare Exclusion Database, in part because of previous difficulties with the OIG reports. But Public Citizen argues that OIG should improve its reports to the NPDB so that users don’t have to consult multiple databases.

“Making OIG exclusion reports more accessible to users of the NPDB would improve patient safety and program integrity in the health care industry by ensuring that the serious provider problems that caused the exclusion in the first place are known to potential employers such as hospitals or HMOs and to medical boards when they do background checks on these individuals,” said Sidney M. Wolfe, MD, director of Public Citizen’s Health Research Group, in a statement.

The OIG will begin using National Provider Identification Numbers to help improve the usability of its reports, a step that has been recommended by Public Citizen. But the OIG will provide the numbers only for reports made after 2009, which according to Public Citizen represents about 16% of the total exclusion reports.