Financial Conflicts of Interest and the NIH
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《新英格兰医药杂志》
The National Institutes of Health (NIH) is widely regarded as the world's premier biomedical research institution. The doubling of the NIH budget over the past decade reflects the trust that the American people place in this federal government agency and its employees, as well as the importance of its work. Recently, however, this confidence has been called into question by a report in the Los Angeles Times about consulting payments from pharmaceutical companies to high-ranking NIH officials.1
According to Dr. Elias A. Zerhouni, the director of the NIH, to date there is "no evidence that patients were harmed or that decisions were influenced by compensated outside activities" or that employees have failed to disclose their financial arrangements to their supervisors and the agency's ethics officers.2 Although the details of specific instances are still being evaluated, Zerhouni has announced immediate steps "to maintain the public trust." These include a review of all instances in which NIH employees have received compensation from nongovernmental sources for outside activities such as consulting since January 1, 1999. They also include the creation of a new NIH ethics advisory committee to advise on the management of conflicts of interest and to ensure that "activities involving acceptance of compensation from outside sources receive uniform oversight," the appointment of a "Blue Ribbon Panel" of outside experts to fully and independently review all ethics policies and practices at the NIH and to recommend changes within 90 days, and a review of financial disclosure requirements for NIH personnel. The review is expected to lead to increased public financial disclosure.
In an interview in early January, Zerhouni said: "What is being portrayed in the press is not the reality, but that doesn't mean that we couldn't do a better job of managing the conflict issues." The controversy "still leaves the question of perception of inappropriate conflict-of-interest management and whether or not we pass the smell test in terms of perception. It is important for me to address that."
The definitions of the proper relationships between the NIH and industry, like other academic–industrial relationships in the life sciences, continue to be very contentious.3 Collaborations between the federal government and industry can substantially benefit the nation's health and economy, as Congress recognized in the Bayh–Dole Act of 1980 and the Federal Technology Transfer Act of 1986. Both the Clinton and the Bush administrations have encouraged close working relations between government and industry, at the NIH and elsewhere.
Technology-transfer activities at the NIH have increased along with the institutes' budget. The NIH has about 275 cooperative research and development agreements with industry. These public–private partnerships facilitate the commercialization of scientific knowledge and technology developed in federal laboratories. The NIH Office of Technology Transfer administers more than 1500 active licenses, as well as patents and patent applications. Forms of technology from research conducted at the NIH have been licensed as part of the development of prescription drugs and vaccines approved by the Food and Drug Administration, including treatments for human immunodeficiency virus infection, parasitic infections, and cancers. Collaborations, however, can raise questions about whether researchers are placing a higher priority on the needs of their industry collaborators or their personal financial well-being than on the safety of research subjects and the integrity and openness of the research environment.3
One of the reasons physicians and the public might be concerned about the financial ties of NIH employees, particularly senior scientists and the leaders of its 27 institutes and centers, is that these ties may affect their decisions in setting the institutes' priorities, in designing clinical trials, and in providing expert advice. In addition, the salaries of federal scientists are a sensitive topic. A federal scientist who makes $200,000 a year is paid more than the Vice President, the justices of the Supreme Court, or members of Congress.1 The same scientist, however, might be able to earn considerably more if he or she worked for a university or for industry. The ability of NIH researchers to supplement their incomes through outside activities with relatively few restrictions may make it easier for the institutes to attract top scientists.
The majority of the NIH budget supports the extramural program, whose researchers are affiliated with universities, medical centers, and nonprofit and for-profit research facilities. The controversy does not concern these scientists, but rather the 17,000 people who are direct NIH employees. Most of these employees are part of the intramural program — research and training conducted by federal scientists at NIH facilities — and the administration of the institutes. A decade ago, the outside activities of NIH employees were restricted much more stringently than they are today (see Table). For example, employees were prohibited from consulting or lecturing for outside organizations that had business dealings with their laboratory or branch. They were also prohibited from accepting stock or stock options as payment for outside activities. They could earn no more than $25,000 a year from any single outside source and no more than $50,000 from all sources combined. High-ranking officials, such as the NIH director, associate and deputy directors, and institute and center directors, had even further restrictions; because of "their national prominence and professional achievement," they were limited to outside activities such as writing and editing.
Table. NIH Policies Regarding the Outside Activities of Employees.
The institutes' policies changed in 1995, when Dr. Harold Varmus was the NIH director. At the time, Varmus was seeking to revitalize the institutes and to respond to charges that the science in the intramural program had become inferior to the science in the extramural program. Varmus is credited with improving the NIH, recruiting and retaining top scientists, and helping to convince Congress to double the NIH budget.
The Office of Government Ethics is a small agency within the executive branch with the responsibility of preventing conflicts of interest on the part of government employees. In 1991, the office audited the NIH ethics program and found several deficiencies. As a result, the NIH developed new procedures and more restrictive guidelines. In 1995, as part of a follow-up audit, the Office of Government Ethics found that that the NIH had a "strong ethics program which is working well on a decentralized basis," according to a memo Varmus wrote at the time. In fact, a number of policies that the NIH had implemented at the office's request were now "more restrictive" than the standards of conduct for the executive branch that the office had established after the first audit.
Varmus had a choice: he could change the NIH policies regarding outside activities to conform to the executive-branch standards, as recommended by the Office of Government Ethics, or he could prepare new regulations containing the more restrictive policies and seek the office's approval for an exception. He changed the NIH policies. An attachment to Varmus's memo noted that "fewer restrictions may serve as a recruitment and retention incentive" for high-level scientists. Among other changes (see Table), the new guidelines struck down the bans on the acceptance of honoraria and stock, as well as the limits on the amount of money that employees could earn from outside work and the time they could devote to such work (as long as it did not interfere with their work at the NIH). Employees were prohibited from engaging in activities with any outside organization with which they had direct business dealings as government employees, but they were allowed to work with other organizations. A common set of standards was applied to all employees. Senior staff members were no longer more restricted than others, with the exception of presidential appointees such as the NIH director and the director of the National Cancer Institute, who were subject to more stringent limitations. All outside activities still had to be disclosed to supervisors and the agency's ethics officers, and prior approval was required. Although these changes were known within the NIH, the reaction to the recent reports in the media suggests that they may not have been widely appreciated by the broader research community and the public.
Varmus remained concerned about the NIH ethics program and questioned whether it was working effectively so that employees were "informed of the proper requirements and that only appropriate activities being approved," according to a 1999 memo in which he reminded senior staff members and institute and center directors of the responsibilities of NIH employees to abide by federal laws and regulations. "I am deeply concerned about public reaction to real and perceived conflicts of interest in outside activities performed by NIH employees," he wrote. "All employees are viewed as representatives of the NIH, and as such they must conduct themselves in the highest ethical manner."
There have also been separate changes in the procedures that govern the completion of financial disclosure reports by many senior NIH employees. The NIH has a variety of mechanisms by which scientists are hired and payment plans. As part of its efforts to recruit and retain top-quality researchers, the NIH, under Varmus, made extensive use of a payment plan with a very wide salary range. This plan made it easier for leading scientists to be paid higher salaries. According to a 1998 advisory opinion from the Office of Government Ethics, the low end of the salary range for the employee's pay plan, not the employee's actual salary, should be used to determine the type of financial disclosure form that should be filed. As a result of the shift in payment plans, more highly paid NIH employees were required to file confidential "form 450" financial disclosures. These confidential disclosures are reviewed within the institutes but are not made public. Fewer highly paid employees were required to file "form 278" financial disclosures, which are available for public review. Given the ethics-office opinion, NIH officials have said that changing the rules to increase the frequency of public financial disclosures for highly paid employees would have required legislation, which they did not seek. In 2003, the employees who filed public financial disclosures were those whose salary range began at $102,168 or higher.
In the Los Angeles Times,1 David Willman reported consulting payments from pharmaceutical companies to ranking NIH officials ranging from tens of thousands to hundreds of thousands of dollars, cumulative over a period of years. These officials included the director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the director of the NIH's Clinical Center, the former scientific director of the National Human Genome Research Institute, and the former director of the Division of Diabetes, Endocrinology, and Metabolic Diseases at the National Institute of Diabetes and Digestive and Kidney Diseases. Willman reported that outside payments to NIH scientists are increasingly not publicly disclosed, because of the changes in reporting requirements. Of 2259 NIH employees making more than $102,168 a year, 127 — only about 6 percent — are filing disclosure forms that are available to the public, according to Willman. From 1997 to 2002, the number of NIH employees filing public disclosure forms decreased by about 64 percent. Scientists named in the articles have disputed some of the allegations. They have said that their outside activities were authorized in advance by NIH officials and their income properly reported on the required financial disclosure forms. Many have also cited the benefits of their collaborations with industry for their work at the NIH and for society.
What is the best policy on financial conflicts of interest for NIH employees? Zerhouni has stated that he is committed to "the necessary steps to ensure that we eliminate real and apparent conflicts of interest."2 Within the next several months, there will probably be Congressional hearings, as well as new policies and more specifics about exactly what the NIH plans to do. Among the questions that Zerhouni is considering is whether the NIH should have limits on outside activities for its employees that are more restrictive than those for the rest of the executive branch. This is the same question that Varmus faced in 1995. A second question is whether the policy regarding the outside activities of senior scientists and ranking officials should differ from that used for other employees. "My viewpoint is very simple," Zerhouni said. There should be "a separation of oversight and conflict management. You can't have individuals that have a direct fiduciary relationship also having a conflicting relationship." A third is whether all financial disclosure reports for highly paid NIH employees should be available for public review. "Transparency — full light on any relationship — is one of the best protections against any real or perceived conflict of interest," said Zerhouni. "How you accomplish that is first on the agenda. I have my own ideas, but I want independent people to advise me on whether you go to full public disclosure for everybody or you select the relationships that require that disclosure."
References
Willman D. Stealth merger: drug companies and government research. Los Angeles Times. December 7, 2003:A1.
Zerhouni EA. Letter to the Honorable W.J. "Billy" Tauzin, Chairman, Commitee on Energy and Commerce, House of Representatives. Bethesda, Md.: National Institutes of Health, December 23, 2003.
Blumenthal D. Academic-industrial relationships in the life sciences. N Engl J Med 2003;349:2452-2459.(Robert Steinbrook, M.D.)
According to Dr. Elias A. Zerhouni, the director of the NIH, to date there is "no evidence that patients were harmed or that decisions were influenced by compensated outside activities" or that employees have failed to disclose their financial arrangements to their supervisors and the agency's ethics officers.2 Although the details of specific instances are still being evaluated, Zerhouni has announced immediate steps "to maintain the public trust." These include a review of all instances in which NIH employees have received compensation from nongovernmental sources for outside activities such as consulting since January 1, 1999. They also include the creation of a new NIH ethics advisory committee to advise on the management of conflicts of interest and to ensure that "activities involving acceptance of compensation from outside sources receive uniform oversight," the appointment of a "Blue Ribbon Panel" of outside experts to fully and independently review all ethics policies and practices at the NIH and to recommend changes within 90 days, and a review of financial disclosure requirements for NIH personnel. The review is expected to lead to increased public financial disclosure.
In an interview in early January, Zerhouni said: "What is being portrayed in the press is not the reality, but that doesn't mean that we couldn't do a better job of managing the conflict issues." The controversy "still leaves the question of perception of inappropriate conflict-of-interest management and whether or not we pass the smell test in terms of perception. It is important for me to address that."
The definitions of the proper relationships between the NIH and industry, like other academic–industrial relationships in the life sciences, continue to be very contentious.3 Collaborations between the federal government and industry can substantially benefit the nation's health and economy, as Congress recognized in the Bayh–Dole Act of 1980 and the Federal Technology Transfer Act of 1986. Both the Clinton and the Bush administrations have encouraged close working relations between government and industry, at the NIH and elsewhere.
Technology-transfer activities at the NIH have increased along with the institutes' budget. The NIH has about 275 cooperative research and development agreements with industry. These public–private partnerships facilitate the commercialization of scientific knowledge and technology developed in federal laboratories. The NIH Office of Technology Transfer administers more than 1500 active licenses, as well as patents and patent applications. Forms of technology from research conducted at the NIH have been licensed as part of the development of prescription drugs and vaccines approved by the Food and Drug Administration, including treatments for human immunodeficiency virus infection, parasitic infections, and cancers. Collaborations, however, can raise questions about whether researchers are placing a higher priority on the needs of their industry collaborators or their personal financial well-being than on the safety of research subjects and the integrity and openness of the research environment.3
One of the reasons physicians and the public might be concerned about the financial ties of NIH employees, particularly senior scientists and the leaders of its 27 institutes and centers, is that these ties may affect their decisions in setting the institutes' priorities, in designing clinical trials, and in providing expert advice. In addition, the salaries of federal scientists are a sensitive topic. A federal scientist who makes $200,000 a year is paid more than the Vice President, the justices of the Supreme Court, or members of Congress.1 The same scientist, however, might be able to earn considerably more if he or she worked for a university or for industry. The ability of NIH researchers to supplement their incomes through outside activities with relatively few restrictions may make it easier for the institutes to attract top scientists.
The majority of the NIH budget supports the extramural program, whose researchers are affiliated with universities, medical centers, and nonprofit and for-profit research facilities. The controversy does not concern these scientists, but rather the 17,000 people who are direct NIH employees. Most of these employees are part of the intramural program — research and training conducted by federal scientists at NIH facilities — and the administration of the institutes. A decade ago, the outside activities of NIH employees were restricted much more stringently than they are today (see Table). For example, employees were prohibited from consulting or lecturing for outside organizations that had business dealings with their laboratory or branch. They were also prohibited from accepting stock or stock options as payment for outside activities. They could earn no more than $25,000 a year from any single outside source and no more than $50,000 from all sources combined. High-ranking officials, such as the NIH director, associate and deputy directors, and institute and center directors, had even further restrictions; because of "their national prominence and professional achievement," they were limited to outside activities such as writing and editing.
Table. NIH Policies Regarding the Outside Activities of Employees.
The institutes' policies changed in 1995, when Dr. Harold Varmus was the NIH director. At the time, Varmus was seeking to revitalize the institutes and to respond to charges that the science in the intramural program had become inferior to the science in the extramural program. Varmus is credited with improving the NIH, recruiting and retaining top scientists, and helping to convince Congress to double the NIH budget.
The Office of Government Ethics is a small agency within the executive branch with the responsibility of preventing conflicts of interest on the part of government employees. In 1991, the office audited the NIH ethics program and found several deficiencies. As a result, the NIH developed new procedures and more restrictive guidelines. In 1995, as part of a follow-up audit, the Office of Government Ethics found that that the NIH had a "strong ethics program which is working well on a decentralized basis," according to a memo Varmus wrote at the time. In fact, a number of policies that the NIH had implemented at the office's request were now "more restrictive" than the standards of conduct for the executive branch that the office had established after the first audit.
Varmus had a choice: he could change the NIH policies regarding outside activities to conform to the executive-branch standards, as recommended by the Office of Government Ethics, or he could prepare new regulations containing the more restrictive policies and seek the office's approval for an exception. He changed the NIH policies. An attachment to Varmus's memo noted that "fewer restrictions may serve as a recruitment and retention incentive" for high-level scientists. Among other changes (see Table), the new guidelines struck down the bans on the acceptance of honoraria and stock, as well as the limits on the amount of money that employees could earn from outside work and the time they could devote to such work (as long as it did not interfere with their work at the NIH). Employees were prohibited from engaging in activities with any outside organization with which they had direct business dealings as government employees, but they were allowed to work with other organizations. A common set of standards was applied to all employees. Senior staff members were no longer more restricted than others, with the exception of presidential appointees such as the NIH director and the director of the National Cancer Institute, who were subject to more stringent limitations. All outside activities still had to be disclosed to supervisors and the agency's ethics officers, and prior approval was required. Although these changes were known within the NIH, the reaction to the recent reports in the media suggests that they may not have been widely appreciated by the broader research community and the public.
Varmus remained concerned about the NIH ethics program and questioned whether it was working effectively so that employees were "informed of the proper requirements and that only appropriate activities being approved," according to a 1999 memo in which he reminded senior staff members and institute and center directors of the responsibilities of NIH employees to abide by federal laws and regulations. "I am deeply concerned about public reaction to real and perceived conflicts of interest in outside activities performed by NIH employees," he wrote. "All employees are viewed as representatives of the NIH, and as such they must conduct themselves in the highest ethical manner."
There have also been separate changes in the procedures that govern the completion of financial disclosure reports by many senior NIH employees. The NIH has a variety of mechanisms by which scientists are hired and payment plans. As part of its efforts to recruit and retain top-quality researchers, the NIH, under Varmus, made extensive use of a payment plan with a very wide salary range. This plan made it easier for leading scientists to be paid higher salaries. According to a 1998 advisory opinion from the Office of Government Ethics, the low end of the salary range for the employee's pay plan, not the employee's actual salary, should be used to determine the type of financial disclosure form that should be filed. As a result of the shift in payment plans, more highly paid NIH employees were required to file confidential "form 450" financial disclosures. These confidential disclosures are reviewed within the institutes but are not made public. Fewer highly paid employees were required to file "form 278" financial disclosures, which are available for public review. Given the ethics-office opinion, NIH officials have said that changing the rules to increase the frequency of public financial disclosures for highly paid employees would have required legislation, which they did not seek. In 2003, the employees who filed public financial disclosures were those whose salary range began at $102,168 or higher.
In the Los Angeles Times,1 David Willman reported consulting payments from pharmaceutical companies to ranking NIH officials ranging from tens of thousands to hundreds of thousands of dollars, cumulative over a period of years. These officials included the director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the director of the NIH's Clinical Center, the former scientific director of the National Human Genome Research Institute, and the former director of the Division of Diabetes, Endocrinology, and Metabolic Diseases at the National Institute of Diabetes and Digestive and Kidney Diseases. Willman reported that outside payments to NIH scientists are increasingly not publicly disclosed, because of the changes in reporting requirements. Of 2259 NIH employees making more than $102,168 a year, 127 — only about 6 percent — are filing disclosure forms that are available to the public, according to Willman. From 1997 to 2002, the number of NIH employees filing public disclosure forms decreased by about 64 percent. Scientists named in the articles have disputed some of the allegations. They have said that their outside activities were authorized in advance by NIH officials and their income properly reported on the required financial disclosure forms. Many have also cited the benefits of their collaborations with industry for their work at the NIH and for society.
What is the best policy on financial conflicts of interest for NIH employees? Zerhouni has stated that he is committed to "the necessary steps to ensure that we eliminate real and apparent conflicts of interest."2 Within the next several months, there will probably be Congressional hearings, as well as new policies and more specifics about exactly what the NIH plans to do. Among the questions that Zerhouni is considering is whether the NIH should have limits on outside activities for its employees that are more restrictive than those for the rest of the executive branch. This is the same question that Varmus faced in 1995. A second question is whether the policy regarding the outside activities of senior scientists and ranking officials should differ from that used for other employees. "My viewpoint is very simple," Zerhouni said. There should be "a separation of oversight and conflict management. You can't have individuals that have a direct fiduciary relationship also having a conflicting relationship." A third is whether all financial disclosure reports for highly paid NIH employees should be available for public review. "Transparency — full light on any relationship — is one of the best protections against any real or perceived conflict of interest," said Zerhouni. "How you accomplish that is first on the agenda. I have my own ideas, but I want independent people to advise me on whether you go to full public disclosure for everybody or you select the relationships that require that disclosure."
References
Willman D. Stealth merger: drug companies and government research. Los Angeles Times. December 7, 2003:A1.
Zerhouni EA. Letter to the Honorable W.J. "Billy" Tauzin, Chairman, Commitee on Energy and Commerce, House of Representatives. Bethesda, Md.: National Institutes of Health, December 23, 2003.
Blumenthal D. Academic-industrial relationships in the life sciences. N Engl J Med 2003;349:2452-2459.(Robert Steinbrook, M.D.)