According to the New York Times, declining public trust in the safety of new drugs combined with soon to expire patents of current blockbusters are posing a challenge to large pharmaceutical companies.
The American public believes strongly that electronic medical records can make the difference between life and death in emergencies, new research being released today shows. Nearly three out of four Americans (72%) say they favor the establishment of a nationwide electronic information exchange that would allow a patient's health information to be shared with authorized individuals quickly, privately, and securely via the Internet. However, ensuring patient privacy and control over their own records is essential to full consumer acceptance of such an exchange. More than three out of four Americans (79%) say making sure their records could be shared only after they provide permission is a priority.
The survey results will be presented Oct. 11 at the first national conference to focus on the needs and concerns of consumers, including privacy, in the rapidly growing field of health information technology. Conference organizers also will present seven consumer and patient principles, which have been endorsed by a wide range of consumer, business, and other organizations involved in health care. The principles are designed to protect privacy and ensure that personal health information is used appropriately in health information exchange. Sponsored by the Markle Foundation, the Robert Wood Johnson Foundation (RWJF), and the Agency for Healthcare Research and Quality (AHRQ), the conference will focus on advances in personal health technology and the core principles for creating a health information environment in which consumers can use information technology to participate more fully in managing their health and health care. More than 700 individuals registered to take part in the conference, including consumer advocates, business leaders, entrepreneurs, medical professionals, and government officials.
"Americans use digital information technology to manage their finances, pay bills, book flights, and customize the music they listen to, and our research shows they now want to use health information technology to get the best care possible for themselves and be better able to manage their own health," said Zo� Baird, president of the Markle Foundation, which funded the research. "People realize that if they or those they love are in an accident or disaster, having their medical records available at a moment's notice through secure, electronic information exchange could mean the difference between life and death."
"We are on the cusp of a technological revolution in health care, as more personal digital health products are developed, and consumers in the 'iPod generation' are more receptive to using them," said David Lansky, senior director of the health program at the Markle Foundation. "Each device that is developed should meet consumers' needs for privacy and security, as should the entire nationwide health information environment in which consumers and health professionals will be using these digital tools. That is why these new patient and consumer principles are being proposed."
The number and types of personal digital health technologies is growing rapidly, and a bipartisan group of national leaders is keenly interested in how information technology can transform health care. Business leaders, including Andy Grove of Intel, and national leaders, including President Bush, Senate Majority Leader Bill Frist (R-Tenn.), Sen. Hillary Clinton (D-N.Y.), Rep. Nancy Johnson (R-Conn.), Rep. Patrick Kennedy (D-R.I.), and former House Speaker Newt Gingrich, are advocating the use of information technology to improve the quality of health care, reduce medical errors, and increase efficiency. President Bush has called for all Americans to have an electronic personal health record within 10 years.
The survey released at today's conference shows that four in five Americans (80%) believe that if physicians kept electronic medical records on their patients, health care quality would improve and medical errors would be reduced, because authorized doctors would be able to retrieve a patient's medical history in a matter of seconds. An equal number (81%) believe that the ability of researchers to review millions of records anonymously to determine best treatment practices would help all doctors improve the quality of medical care.
Despite these high levels of support for health information technology, keeping electronic medical information private and secure remains a top concern for consumers. Today's research shows that people are much more likely to support online medical records if they have control over their own information and safeguards to protect privacy are in place. Public Opinion Strategies, Alexandria, VA, conducted the survey Sept. 20-22, 2005. The survey of 800 adults has a margin of error of +/- 3.46 percent. According to the poll:
Individuals want to review who has seen their medical information.
Eighty-one percent of respondents say reviewing who has had access to their personal health information is a "top" or "high" priority.
Patients want to be asked before their information is shared.
Seventy-nine percent of respondents say it is a "top" or "high" priority that their medical information be shared electronically only with their permission.
Consumers want the identity of anyone who sees their records to be carefully confirmed.
Ninety-one percent of respondents say carefully confirming the identity of anyone using the system to prevent unauthorized access or cases of mistaken identify is a "top" or "high" priority.
The public does not want employers to have access to workers' health information.
Sixty-eight percent of respondents say it is a "top" or "high" priority that employers not have access to secure health information networks.
A separate study, conducted by Public Opinion Strategies on Sept. 28-Oct. 2, 2005, (800 adults; margin of error +/- 3.46%) showed that consumers would use their own secure, online "personal health record" account to better manage their health care. Nearly seven out of 10 respondents (69%) said they would use this online service to check for mistakes in their medical records, as well as to check and refill prescriptions (68%). Nearly six in 10 respondents said they would like to get medical results over the Internet (58%) or conduct secure and private email communications with their doctors (57%). Taken together, these results show a strong interest among consumers in using health information technology to more fully participate in their own health care.
The new consumer and patient principles to guide the development of online health information exchange were developed by the Personal Health Technology Council, a group of 44 leading consumer and privacy advocates, medical professionals, informatics experts, payers, technologists, federal policymakers, bio-ethicists, and researchers. The group believes these principles should guide developments in the private and public sectors, including several pieces of legislation that have already been introduced in Congress and would increase the use of electronic health records within any new nationwide health information exchange.
The seven patient and consumer principles endorsed by the Personal Health Technology Council are:
1. Individuals should be able to access their health and medical data conveniently and affordably.
2. Individuals should be able to authorize when and with whom their health data are shared. Individuals should be able to refuse to make their health data available for sharing by opting out of nationwide information exchange.
3. Individuals should be able to designate someone else, such as a loved one, to have access to and exercise control over how their records are shared.
4. Individuals should receive easily understood information about all the ways that their health data may be used or shared.
5. Individuals should be able to review which entities have had access to their personal health data.
6. Electronic health data exchanges must protect the integrity, security, privacy, and confidentiality of an individual's information.
7. Independent bodies, accountable to the public, should oversee local and nationwide electronic health data exchanges. No single stakeholder group should dominate these oversight bodies, and consumer representatives selected by their peers should participate as full voting members.
"When all Americans have the ability to review their own medical records online, we then will begin to see a health care system that reduces disparities in medical care, and increases the quality of care for all Americans," said John R. Lumpkin, M.D., M.P.H., senior vice president and the director of the Health Care Group for RWJF. "People want to take advantage of health information technology, but they need to trust that the new information environment respects their privacy and ensures the security of their information. Therefore, the new health information technologies that are being created, as well as the health information environment itself, must focus on consumers' concerns about privacy, security, and personal control."
"Consumers have clearly understood how electronic records can improve quality of care, and the recent experience of lost medical records in hurricane Katrina has made this lesson even more vivid," said AHRQ Director Carolyn Clancy, M.D. "But access and control for the patient must be built in from the beginning. Under HHS Secretary Mike Leavitt's leadership, AHRQ will help lay the groundwork for privacy and security as an integral part of building the technical foundation for electronic health records."
To view today's research, read the draft consumer principles, or locate information on today's conference, go to www.phrconference.org or www.markle.org
Recent initiatives appear to have created renewed interest for young physicians to pursue research careers, according to a study in the September 21 issue of JAMA, a theme issue on medical research.
Results of the study were presented today at a JAMA media briefing on medical research.
Physician-scientists, defined as individuals with a medical degree who perform medical research as their primary professional activity, have contributed much to the preeminent position of the U.S. in medical science, according to background information in the article. The unique perspective that physician-scientists bring to the medical research workforce is that their scientific questions arise at the bedside and in the clinic. Despite this perspective, the pipeline of physician-scientists has had a serious problem, first described more than a generation ago: the physician-scientist population in the U.S. is smaller and older than it was 25 years ago. These and other trends have led some observers to conclude that the physician-scientist is a threatened species. A variety of factors were thought to contribute to this problem, including increasing indebtedness of medical school graduates caused by rapidly rising medical school tuition costs.
Several National Institutes of Health (NIH)-sponsored groups, private foundations, and national organizations called for new initiatives and award programs aimed at revitalizing the physician-scientist career path. These initiatives were begun between 1998 and 2002.
These initiatives included NIH career development awards for young physicians being trained to carry out clinical research, awards for established clinical investigators, awards for academic institutions with programs supporting clinical research training and infrastructure, and a series of competitive loan repayment programs (LRPs) for young physician-scientists with significant debt.
The private not-for-profit sector created new awards for young and established physician-scientists and an increasing number of research-intensive medical schools and hospitals (where most physician-scientists work) have constructed multifaceted programs aimed at encouraging medical students to become involved with research before and after receiving their M.D. degree and at protecting the research time of young physician-scientists during their junior faculty appointments.
Timothy J. Ley, M.D., of the Washington University School of Medicine, St Louis, and Leon E. Rosenberg, M.D., of Princeton University, Princeton, N.J., conducted a study to attempt to define the effects that these budgetary and institutional initiatives have had on the physician-scientist career path. The authors determined trends using data obtained from the NIH, the American Medical Association, the Association of American Medical Colleges, and other sources.
The researchers found that the number of physician-scientists in the United States has been in a steady state for the past decade, but funded physician-scientists are significantly older than they were 2 decades ago. "However, the study of early career markers over the past 7 to 10 years has demonstrated increasing interest in research careers by medical students, steady growth of the M.D.-Ph.D. pool, and a new burst of activity in the 'late bloomer' pool of M.D.s (individuals who choose research careers in medical school or in residency training), fueled by loan repayment programs that were created by the NIH in 2002. Several recent trends for more established physician-scientists have also suggested improvement."
Concerning applications for NIH research project grants (RPGs), first-time M.D. applicants, whose numbers hovered at 750 to 800 between 1995 and 1999, have slowly increased recently, reaching a total of 995 in 2003. First-time RPG applicants with M.D.-Ph.D. degrees have steadily increased, from 133 in 1970 to 600 in 2003.
"New programs recently initiated by the NIH and private foundations are beginning to have a positive impact on the decisions of young physicians to pursue research careers. To maintain this trend, strong funding commitments will be required beyond the entry level. If these commitments are sustained, we are cautiously optimistic that they will result in an increase in the population of physician-scientists in the United States in the near future," the authors conclude.
To maintain their effectiveness for conducting medical research, academic medical centers must face critical issues such as constrained funding sources, scientific integrity, recruiting physician-scientists, and the increasing costs of research, according to an article in the September 21 issue of JAMA, a theme issue on medical research.
Lead author Jordan J. Cohen, M.D., of the Association of American Medical Colleges (AAMC), Washington, D.C., presented the article today at a JAMA media briefing on medical research.
Dr. Cohen and co-author Elisa K. Siegel, A.B., of the AAMC, examined the status of medical research at academic medical centers.
"The present era offers more promise for progress in medical research than ever before. Contemporary science has deciphered the human genome, discovered some of the potential of stem cells, and unleashed the power of information technologies. Any one of these three historic scientific achievements would have the potential to effect a fundamental transformation in medicine; their confluence has created unprecedented opportunity for spectacular breakthroughs in human health."
The authors write that despite this promise for progress, many challenges await medical research:
� The need to manage high (and often unreasonable) public expectations for lifesaving discoveries.
� The need to maintain public trust despite the suspicions aroused by financial conflicts of interest.
� The need to sustain the cultural norms of academe while partnering with industry to promote technology transfer.
� The obstacles to recruiting and retaining physician-scientists to pursue translational research.
� The widening gap between the costs of research and available funding sources.
� The unfunded mandates with which investigators and institutions must comply.
� The need to transform an academic reward structure built to encourage individual scientists to pursue their own ideas into one that fosters teams of collaborating investigators to pursue "big science".
Promoting Public Understanding
"Having raised expectations with tantalizing promises of scientific breakthroughs, the research community has an obligation to help the public understand the process of medical research and the often uneven and incremental pace of progress that characterizes most medical discoveries," the authors write. "Academic medical centers, as sources of much of the advances in medicine, have a special role to play in managing the public's expectations and can do so by ensuring that public communications about their research developments are tempered with realistic assessments of their practical impact."
Managing Financial Conflicts of Interest
Financial conflicts of interest on the part of investigators and their institutions have the potential both to undermine the integrity of the scientific process and to compromise the safe conduct of human research. "According to a 2004 AAMC survey, the academic medicine community has made substantial progress in moving beyond the minimum requirements prescribed by federal regulations to strengthen the safeguards against conflicts of interest in human research. However, this survey also revealed that the academic medicine community still has more work to do to establish a uniformly robust set of policies and procedures. . Sustaining public trust in the medical research enterprise will, at minimum, require continued efforts to identify and address ways to improve the protection of human research subjects and to buttress the management of financial conflicts of interest."
Maintaining Academic Values
According to the authors, examples of the potentially damaging effects of academic-industry relationships include real or perceived pressures to relax scientific standards, inducements to become advocates (or shills) for industry, suppression of nonoptimal research results, incomplete or misleading descriptions and interpretations of trial results, and premature termination of clinical trials. "Academic medical centers and their industry partners must be willing to adopt more uniform, more robust, and more transparent standards governing their relationships if the mutual benefits of those relationships are to be sustained."
Sustaining Research Funding
In recent years, the growth of federal funding for medical research has decreased, with the NIH's budget growing by less than the rate of inflation. Compounding this restrictive fiscal climate are the increasing costs of modern science and of complying with the ever-increasing burden of government regulations.
"The White House Office of Science and Technology Policy and Office of Management and Budget have undertaken a cross-agency initiative to identify more efficient business models and to streamline agency requirements for federally sponsored research, giving rise to some hope that the federal government will at least partially restore the balance of responsibility that formerly characterized the historic federal-academic partnership in the country's research enterprise. If some relief is not forthcoming, some institutions may find it impossible to sustain their sponsored research programs."
"Academic medical centers face many difficult challenges in pursuing their research mission, and the interconnectedness of those challenges magnifies the difficulty. The ability to nurture and sustain a vibrant clinical research workforce in the future is heavily dependent on the ability to shift the academic culture and reward system away from the traditional paradigm focused on the individual investigator in favor of one that is more collaborative, team-based, and interdisciplinary," the authors write.
"The ability to sustain financial support for medical research in the face of constrained federal and state budgets is heavily dependent on managing unrealistic public expectations and on maintaining public trust. The ability to benefit optimally from the growing relationships with industry is heavily dependent on remaining true to fundamental academic values, including the safety of human subjects research, the integrity of the scientific process, and the free exchange of research results. The degree to which medical schools and teaching hospitals are successful in meeting these challenges will determine the degree to which the historic promise of modern medical science will be realized," the authors conclude.
From 1994 to 2003, total funding for biomedical research in the U.S. doubled to $94.3 billion, with industry providing 57 percent of the funding and the National Institutes of Health providing 28 percent, according to a study in the September 21 issue of JAMA, a theme issue on medical research.
Lead author Hamilton Moses III, M.D., of the Alerion Institute, North Garden, Va., presented the findings of the study today at a JAMA media briefing on medical research.
Few comprehensive analyses of the sources of financial support of biomedical research and uses of these funds have been available, according to background information in the article. This results in inadequate information on which to base investment decisions and can create a barrier to judging the value of research to society. Previous articles have examined specific sectors, but few have done so comprehensively.
Dr. Moses and colleagues conducted a study to determine the level and trend from 1994 to 2004 of basic, translational (the application of knowledge of basic science research to clinical care), and clinical U.S. biomedical research support from the major sponsors of this research: (1) federal government, (2) state and local governments, (3) private not-for-profit entities including foundations, and (4) industry. The researchers compiled publicly available data for federal, state, and local governments; foundations; charities; universities; and industry. Proprietary (by subscription but openly available) databases were used to supplement public sources.
The researchers found that biomedical research funding increased from $37.1 billion in 1994 to $94.3 billion in 2003 and doubled when adjusted for inflation. Principal research sponsors in 2003 were industry (57 percent) and the National Institutes of Health (28 percent). Relative proportions from all public and private sources did not change. Industry sponsorship of clinical trials increased from $4.0 to $14.2 billion (in real terms) while federal proportions devoted to basic and applied research were unchanged.
The United States spent an estimated 5.6 percent of its total health expenditures on biomedical research, more than any other country, but less than 0.1 percent for health services research. >From an economic perspective, biotechnology and medical device companies were most productive, as measured by new diagnostic and therapeutic devices per dollar of research and development cost. Productivity declined for new pharmaceuticals.
The NIH is by far the largest federal funder of biomedical research. Adjusted for inflation, NIH obligations nearly doubled (in 2003 dollars) from $13.4 billion in 1994 to $26.4 billion in 2003. Private support for biomedical research, adjusted for inflation, increased 36 percent from $1.8 billion in 1994 to $2.5 billion in 2003 (in 2003 dollars). Private support for biomedical research comes primarily from foundations, voluntary health organizations, and the free-standing research institutes.
Industry funding from pharmaceutical, biotechnology, and medical device firms increased 102 percent from $26.8 billion in 1994 to an inflation-adjusted $54.1 billion in 2003 (in 2003 dollars). The growth rate (inflation adjusted) for the medical device sector (264 percent) exceeded that for either the pharmaceutical (89 percent) or biotechnology (98 percent) sectors. The proportion of biomedical research support coming from industry sources remained relatively constant and was 56 percent for 1994 and 58 percent for 2003.
The federal government and foundations spent $1.4 billion on health policy and health services research in 2002. Federal funding for health services research came primarily from the NIH ($787 million in fiscal year 2002) and the Agency for Healthcare Research and Quality ($299 million in fiscal year 2002). The sum of federal and foundation spending for health services research in 2002 was an estimated 1.5 percent of biomedical research funding.
"The doubling over a decade of total spending by U.S. public and private research sponsors in real, inflation-adjusted, terms should be reassuring to those who fear that financial sponsorship for research is not paralleling scientific opportunity. It is also reassuring that spending on health and biomedical science research by companies and government is not following reductions in research and development in other industries or reduced support for other areas of science. By comparison, the low proportion of spending on health services research is especially notable, since it is the main tool available to evaluate the clinical benefit of technology," the authors write.
"Barriers to the discovery of new drugs have received much attention over the past decade. Despite the doubling of biomedical research funding and the shift toward clinical research by pharmaceutical companies, the number of new molecular entities approved by the FDA has fallen. For example, from 1994 to 1997, the number of new molecular entities approved averaged 35.5 per year. From 2001 to 2004, the number of new molecular entities averaged 23.3 per year. As a consequence, pharmaceutical productivity decreased over the last 10 years, and it is lagging that of the biotechnology and device sectors," the researchers write.
"We believe a major factor in decreasing productivity stems from pharmaceutical companies' frequent determination that compounds approvable from a regulatory standpoint are not worth bringing to the market because the intensity of competition is so high that it is not worth challenging existing drugs that are safe and effective. This highlights the need to invest in clinical areas with few effective treatments and for which novel mechanisms or entirely new classes of drugs are possible. The willingness of biotechnology companies to do this may, in part, account for their greater relative productivity."
"For all sponsors, the challenge is patience. Biomedical research is an inherently high risk and lengthy process. It would be helpful to remind those making financial decisions that the promise of earlier advances in the basic understanding of physiology in the 1920s and 1930s, or of biochemistry and microbiology in the 1940s, 1950s, and 1960s, took decades to unfold."
"Enhancing research productivity and evaluation of benefit are pressing challenges, requiring (1) more effective translation of basic scientific knowledge to clinical application; (2) critical appraisal of rapidly moving scientific areas to guide investment where clinical need is greatest, not only where commercial opportunity is currently perceived; and (3) more specific information about sources and uses of research funds than is generally available to allow informed investment decisions. Responsibility falls on industry, government, and foundations to bring these changes about with a longer-term view of research value," the authors conclude.
A comprehensive study by the Medical Group Management Association (MGMA) Center for Research and the University of Minnesota School of Public Health has captured the current state of adoption of electronic health records (EHR) by U.S. medical group practices. More than 3,300 medical group practices participated in the Assessing Adoption of Health Information Technology project, which was funded by the federal Agency for Healthcare Research and Quality (AHRQ). The study reports current rates of EHR adoption, which EHR features are more frequently used, barriers to adopting an EHR and how users rated the benefits of having adopted an EHR.
Smaller Practices Report Lower Adoption Rates
The research shows that just 14.1 percent of all medical group practices use an EHR, and just 11.5 percent indicated that an EHR was fully implemented for all physicians and at all practice locations. More significantly, the research shows that only 12.5 percent of medical group practices with five or fewer full-time-equivalent physicians (FTE) have adopted an EHR. The adoption rate increased with the size of practice; groups with six to 10 FTE physicians reported a 15.2 percent adoption rate, groups with 11-20 FTE physicians reported an 18.9 percent adoption rate, and groups of 20 or more FTE physicians had a 19.5 percent adoption rate.
Other data reveals that 12.7 percent of groups were in the process of implementing an EHR; 14.2 percent said implementation is planned in the next year; and 19.8 percent said implementation was planned in 13-24 months. The remaining 41.8 percent have no immediate plans for EHR adoption. Among those with no immediate plans for implementation, the difference between large and small groups is striking�47.8 percent of practices with five or fewer FTE physicians compared with only 20.7 percent of practices with 21 or more physicians.
"Obviously, rates are low across the spectrum of all group sizes, but smaller groups face more challenges in adopting these technologies and progress more slowly than their larger counterparts," said Terry Hammons, MD, senior vice president, research and information, MGMA Center for Research, and co-author of the study. "For widespread adoption of EHRs to be successful, more work needs to be done, and small to medium size medical group practices will need more help than they are getting now."
Contributing researchers from the University of Minnesota School of Public Health Bryan E. Dowd, Ph.D., professor and director of Graduate Studies, Division of Health Services Research, Policy, and John E. Kralewski, Ph.D., professor, Division of Health Services Research and Policy, note that while some practices report important efficiency gains from their EHRs, there is widespread dissatisfaction with the design and performance of these technologies.
Nationally Representative Sample Surveyed
With funding from AHRQ, MGMA Practice Management Resources Director David N. Gans, FACMPE, Kralewski, Hammons and Dowd surveyed a nationally representative sample of medical group practices to assess their current use of information technology. They conducted the survey in January and February 2005. MGMA members made up 25 percent of the sample.
"This survey provides a guidepost for where we should focus our efforts to move the adoption of state-of-the-art electronic health record systems," said AHRQ Director Carolyn M. Clancy, M.D. "Adoption of these EHR systems is an important means to an end in our efforts to improve the quality of health care in America."
Findings of the research are also highlighted in the September/October edition of Health Affairs in "Medical Groups' Adoption of Electronic Health Records and Information Systems" written by Gans, Kralewski, Hammons and Dowd.
EHR Capabilities Vary
The report provides insight into which EHR capabilities are actually used, as not every EHR has all functions and not every medical group fully uses the capabilities of its EHR system. More than 97 percent of the respondents with an EHR reported that their system had functions for patient medications, prescriptions, patient demographic and visit/encounter notes. Less than 65 percent reported the EHR provided drug formulary information or clinical guidelines and protocols. Equally important was that only 83.1 percent of respondents said their EHR was integrated with their practice billing system.
"System integration is a highly important function of the EHR," Gans said. "Integration with the practice billing system facilitates cost savings by eliminating the manual entry of billing information, improving charge capture and improving documentation in the medical record of billed services."
Cost a Barrier to Adoption
Despite State and federal efforts to encourage adoption of these technologies, group practices cited "lack of capital resources to invest in EHR" as the top barrier to adoption. Also, University of Minnesota researchers noted, an important barrier to adoption is that practices are not convinced EHRs will improve their performance. The return on investment in terms of cost and quality are not yet evident, according to Kralewski.
The research indicates that the average purchase and implementation cost of an EHR was $32,606 per FTE physician. Maintenance costs were an additional $1,500 per physician per month. Not surprising was the finding that smaller practices had the highest per-physician implementation cost at $37,204. The study also found that the average cost for EHR implementation was about 25 percent more than initial vendor estimates.
Denying earlier reports that the federal government's effort to supply doctors with a free version of the VISA computer records system had been put indefinitely on hold, Officials from the Centers for Medicare & Medicaid services said this project remains on track, according to Healthcare IT News.
A federal Department of Health and Human Services project to distribute a free version of VISTA, the electronic records management software used by the Department of Veterans Affairs, is indefinitely on hold, according to Government Health IT.
Designing hospitals so they are pleasing reportedly reduces medical errors, patient stays, and even patient falls, according to the Daytonal Beach News.
Yet another cancer center apparently has economic development potential for its host community, as Sacramento reportedly stands to benefit from research conducted at the U C Davis Cancer Center, MSNBC reports.