Keynote address
by
Mark B. McClellan, M.D., Ph.D.
Commissioner of Food and Drugs
for
Health Services and Outcomes
Research Conference
Houston, Texas
November 25, 2002

Good morning, and thank you, Ambassador Djerejian, for your leadership and for the Baker Institute here at Rice University.

I want to begin with an apology for false advertising. As you may know, this is an important issue for FDA. When you extended to me the honor of speaking at this fine event, you were expecting someone in a different position - and accordingly, perhaps a somewhat different focus of my remarks. Either that, or you have a lot better foresight than I do.

Since then, there has been a change. A little over a week ago, Vice President Cheney swore me into the most important job I have ever had, the Commissioner of the Food and Drug Administration. A day later, I participated in my inaugural event, the groundbreaking of a major new building in the FDA's future campus near Washington. A part of FDA's much needed efforts to consolidate its facilities, the construction is emblematic of the agency's efforts to adapt and respond to the challenges of the 21st century.

And now, just over a week later, I want to thank you all for giving me the chance to come back to my roots to deliver my first address away from Washington. As a fourth-generation Texan, I cherish some of my earliest memories of our family life right here in Houston. Some 20 years ago, I had my first experience in biomedical research right down the road at the M.D. Anderson Cancer Institute. That experience in Houston's world-class medical center and at Rice University has stayed with me ever since.

And while I'm proud to be one of the many Texans serving in Washington, I have to say: nothing beats coming back. One reason for that is Houston's leadership in health care and, increasingly, health policy. Much of the credit goes to the emphasis placed by Baker Institute -- and reflected in this conference -- on bringing together academic experts, policy makers, and community leaders to find comprehensive, community-based approaches to improving health. The same must be said for programs and research activities related to improving health outcomes at Rice University, University of Houston Medical School, Baylor Medical School, and the affiliated hospitals.

There is a great need for these efforts. Today, more than ever, Texas needs creative leadership in health policy: 24% of Texans are uninsured, and the rates are highest among persons with lower incomes and, especially, Hispanic-Americans and African-Americans. Many parts of the state are medically underserved - for example, 158 counties have no obstetricians/gynecologists. A high incidence of neural tube defects and tuberculosis provides evidence of too-frequent failures to take steps to prevent diseases.

Those of you who are dedicated to satisfying these health needs share the same goal with us at the FDA: we are all looking for new opportunities to better protect and promote the health of our nation. That's the top priority of the FDA, and it is a top priority of our President and of Secretary of the Department of Health and Human Services Thomas G. Thompson.

Today, at the Institute of Medicine, Secretary Thompson is discussing a broad range of new ideas including "demonstration programs" to develop and test better ways of improving our health care system and our health. The Institute recently recommended such demonstration programs as vehicles for, for example, carrying out overdue and badly needed medical liability reforms, providing health insurance credits to enable all Americans to get truly helpful, up-to-date health insurance coverage, and to introduce new, patient-oriented initiatives to prevent the complications of chronic diseases, or prevent these diseases altogether.

Thanks to your leadership and dedication to the cause of better health, I can't think of a more fitting place to test these ideas than the Houston region.

At the FDA, in our Federal government, and here in Houston, the challenges for improving the health of our nation have never been greater -- but the opportunities have never been greater, either.

In the FDA's purview there are more health care products than ever, and they are being used by more people. As one example, it is estimated that our pharmacists will fill by the end of this year 3.1 million prescriptions; that's 60 percent more than ten years ago.

Manufacturers everywhere are increasingly presenting their new pharmaceuticals for FDA's review and approval: 60 percent of the world's drugs are introduced first in the United States. And R&D pipelines hold the promise of dramatically advanced treatments, thanks to breakthroughs in genomics, proteomics, nanotechnologies, and other biomedical sciences. In the years ahead, we can look forward to more sophisticated, individualized, and effective treatments. This is a good thing.

As an agency that is responsible for the safety of 80 percent of our nation's food supply, we are also involved in ensuring the safety of many new types of food. And since the terrorist attacks last year, we are taking steps to protect all food that reaches our consumers against the threat of bioterrorism. Our special emphasis is on the security of our food imports, which are rising by as much as 21 percent a year.

We have a major opportunity to help people improve their health by providing them with the up-to-date information they need to choose a healthy way to live. There is compelling evidence that behavioral choices and other non-medical factors have a much larger impact on the overall health of our population than medical care. For example, obesity and excessive weight -- which affect 60% of Americans, one-sixth of whom are teenagers -- are important contributors to many chronic diseases, and those factors are not likely to change much unless and until many people opt for healthier diets and life styles. Responding to our consumers' interest in learning more about the ways to improve their health, is another great opportunity and an important mission for all of us.
Last but far from the least, we are all confronted with one of the most dismal -- because it is unnecessary -- public health shortcomings reflected in the 1998 estimate of the Institute of Medicine that many thousands of Americans die each year in hospitals alone because of preventable medical errors. In Secretary Thompson's words, this is a human tragedy and a shocking result of a failure to realize many of the potential benefits of modern medical treatments.

We have huge opportunities for improving health by preventing medical errors and providing higher-quality care - getting the right treatment to the right patient at the right time.

I believe that at the FDA, we can help meet these challenges and realize these opportunities by focusing on four priorities:

(1) We have to make sure that we have a strong, science-based FDA. We must work to ensure that our rules and our decisions are firmly anchored in the latest science; that they are fair; that they are dynamic; that they are focused on public health risks; that they are cost-effective; and above all, that they are responsive to the changing circumstances we face.

We need to adjust our policies, methods and practices to the increasing volume, variety and complexity of products in our purview, as well as to the new threats -- such as bioterrorism -- to their safety. We have to broaden the application of the science of risk management, by making a committed, constant and consistent effort to find ways to reduce health risks and increase health benefits to the public as efficiently as possible.
We are already advancing changes that will help us meet these criteria. For example, our agency has developed a detailed plan for an overhaul of the practices on which the FDA as well as manufacturers rely to ensure that pharmaceutical products are safe, effective, and of the highest quality. These requirements have not been modified for about 25 years, and they need to be brought abreast of technological advances that are affecting drug production. The new rules will encourage manufacturing innovation while continuing to assure the highest drug quality.

I am also interested in new areas of research, including innovative statistical methods and outcomes research, to help us find better ways to improve health outcomes, which is another reason why I will be very interested in the results of this conference.

(2) Since last September, we have become acutely conscious of the threats of terrorism to our homeland. We must make our country more secure, by protecting the public's health against a potential terrorist attack. The FDA has tackled this critical task with vigor. For example, our Center for drugs last year took the initiative of clarifying that the antibiotics doxycycline and penicillin G procaine are approved for use in treating all forms of anthrax infections. The clarification included explicit dosing recommendations based on FDA's review of scientific literature and data from a supplemental animal study.

Our Center for biologics continues to work closely with industry and other government agencies in an effort to assure adequate supply of products for immunization against anthrax, botulinum, smallpox and other substances that might be used by terrorists. And our Center for medical devices has contributed to the development of methodology for the detection of biological agents with bioterrorism potential, and helped develop a guidance on the use of potassium iodide to reduce the risk of thyroid cancer in radiation emergencies.

Following the attacks, Congress has reinforced FDA's counter-terrorism program with a special appropriation of $153 million. Much of this new funding is being used to protect our consumers against intentionally contaminated food imports -- products on which we depend for 34 percent of our fresh produce and most of our seafood. The added funds have enabled us to hire more than 800 new employees who are being trained and assigned to our field offices from coast to coast and to many of the nation's ports of entry, including here in Texas. And thanks to the recently adopted Public Health Security and Bioterrorism Preparedness and Response Act, we have been provided with new authorities that will help make our counter-terrorism program more effective.

(3) A third top FDA priority is to help consumers get reliable, widely available, helpful and effective information about the products our agency regulates. The FDA is helping advance this critical knowledge in many ways: for example, our agency has introduced nutrition labeling on practically all packaged food that encourages shoppers to select low-fat, high-fiber products; the FDA requires the distribution of drug leaflets with filled prescriptions; it has helped develop more legible and understandable labeling for OTC products; and it has conducted a nation-wide campaign to teach the principles of proper use of drugs.

But consumers today want still more and better information, and much more remains to be done. I believe that almost all consumers want to know the latest scientific findings about the health effects of foods and nutritional supplements. They want to be sure that the ads and commercials for medical products, foods, and dietary supplements are truthful and not misleading. They want the labeling of both prescription and OTC pharmaceuticals to be helpful and in keeping with the latest science. In these and other areas of product information, the FDA is committed to be of help.

(4) Last but far from the least, it is one of our Administration's, our agency's, and my own top priorities to reduce preventable adverse health events. I left this very important priority last, because it bears on the theme of this conference - health outcomes research - and because it is the subject on which I want to focus my remarks.
I must emphasize that the need to counter adverse events applies not only to medical care, but also to food consumption. Foodborne outbreaks, according to a 1999 survey by the Centers of Disease Control and Prevention (CDC), cause annually 325,000 hospitalizations, 5,000 deaths, and economic damage of up to $23 billion. In addition to food contaminants, inadvertently consumed allergens result in thousands of avoidable emergency room visits. These are important issues to address as well. But today, I want to focus on improving health outcomes through better detection and prevention of adverse medical events.

The statistics on the prevalence of avoidable health complications that often involve the use of FDA-regulated products presents a huge challenge for our agency and for all of us. Medical errors are estimated to rank as the eighth leading cause of death in the United States, and misuse of pharmaceuticals is associated with thousands of deaths and about 3 million hospital admissions a year. In 2000, the economic cost of drug-associated errors alone was estimated to reach over $75 billion a year. Even if we only succeed to eliminate 10% of these errors, think about the resulting improvement of the lives of hundreds of thousands of Americans and Texans, and about the greatly reduced burden for the national and Texas health care systems.

The FDA does a great deal to improve health outcomes as part of its core mission to protect and promote the public health. Our agency works to ensure the safety and effectiveness of new medications and medical devices by helping guide their development, evaluating the results of clinical trials, and monitoring the performance of the approved products after they reach the market. The human and economic benefits of these medical products can be enormous. To mention just one example: the massive reduction in the death rate from heart attacks in the last couple of decades was in part made possible by new treatments approved by our agency, which included such breakthrough products as ACE inhibitors, so-called "clot-busting" drugs, and stents that have reduced the need for risky and costly surgeries.

Yet too often, highly valuable treatments are associated with adverse events. Virtually all medical therapies have side effects, and it is important for these side effects to be well understood so that we can be sure that the benefits of the products we approve outweigh their risks. But preventable adverse events are a different health hazard: they are avoidable medical complications that need not, and -- health professionals generally agree -- should not occur. The FDA has done, and continues to be doing, a great deal to help health professionals avoid adverse events.

For example, the FDA has developed and is improving a system of voluntary reporting of adverse events associated with the use of agency-approved products. The agency's MedWatch program receives each year about 25,000 adverse event and medical product problem reports, mostly from health care professionals and consumers. The MedWatch data are entered into the database of FDA's Adverse Events Reporting System, which also receives 270,000 reports of similar nature from manufacturers. The manufacturers' reports, which must be filed periodically with the FDA, are based on information provided by physicians and other health care providers.

Another important FDA program is the Vaccine Adverse Events Reporting System (VAERS). VAERS received more than 14,000 reports of adverse reactions in fiscal year 2002, most of which were volunteered by health care providers, patients and their parents.

To ensure the safety of the blood supply, our Center for biological products requires all blood banks to promptly report fatalities connected with blood transfusions and donations. In addition, the Center operates a Web-based voluntary reporting system for rapid identification of supply shortages affecting blood, blood components and reagents. Our Center for food is developing and testing a system for improved reporting of adverse events associated with the consumption of food, including dietary supplements, as well as cosmetics.

The vast amount of information about adverse medical outcomes that reaches our agency is analyzed, and if necessary, followed up with requests for additional information and epidemiological studies to determine the need for further action. It is a system that provides many valuable insights, but that has also limitations stemming from its largely voluntary nature and, in some areas, lack of "real time" reporting. We are working to improve the quality and comprehensiveness of this information, and to make it easier for health professionals and consumers to report adverse events to a single 800 number. But despite the FDA's past efforts, we suspect that, for reasons ranging from the chore of filling out a case report to concerns about potential liability, these systems do not capture the full spectrum of serious adverse events.

I am confident that we can do much better in this arena with the help of the new tools that are now available to modernize a 21st century health system. Many of these technologies and devices parallel the capabilities of modern electronic information and communication systems that in numerous ways have become part of our lives. Used comprehensively and on a nation-wide scale, information technology (IT) would form the backbone of an interoperative Health Information Infrastructure (HII), a system capable of rapidly and securely transmitting significant health-related data to institutions and public health professionals who need them to ensure better care for patients.

It is my priority for the FDA to support and use these new tools of health information technology and their incorporation in HII, and thereby open new opportunities for advancing our mission of promoting the public health.

The potential health benefits of an effective use of today's IT are great. For example, IT can help professionals monitor the patient's progress and deliver a health care that "gets it right." Many of the new, complex treatments inherently have a higher potential for toxicity, and their use requires careful monitoring for liver, kidney and other toxicities, as well as for interactions with the patient's co-morbid conditions and other medical treatments. IT could provide significant assistance in this area. The technology could also aid in the sophisticated monitoring and support required by many seriously ill patients who have undergone complex and sometimes lifesaving surgical procedures.

With wider use of IT we could also earlier recognize -- and therefore, take action to counter -- adverse side effects that had not emerged during the drug's clinical studies. As I have mentioned, today's system for tracking complications associated with drugs, devices, and biologicals depends largely upon spontaneous and voluntary reporting that is not always as fast and full as it should be. As a result, unexpected side effects may go undetected for too long, complicating and delaying the recognition of their association with particular treatments in particular kinds of patients. An automatic HII could help to rapidly detect the toxicity and side effects of new drugs and identify patient characteristics associated with low toxicity. The findings, passed on to the manufacturer and the FDA, would trigger labeling changes and other actions to improve the products' positive health effects.

Such nationwide sentinel health information system would also strengthen the public health protection by quickly identifying bioterror attacks, infectious disease outbreaks, and other threats to the health of consumers. The system could also provide each patient with a more reliable and complete medical record, that would be patient-controlled, portable, and help make sure that the health professionals have accurate and up-to-date information on the patient's circumstances.

HII could also provide better information on treatment options and their quality, and thus help guide patients' decisions about which treatments are right for them. Moreover, through these and other clinical improvements, the sentinel systems could realize large efficiency gains. Many reputable experts think that if these IT technologies were fully adopted and used effectively, health care costs could be reduced by 25 percent or more.

Many other IT benefits have been widely noted. Information technologies are already boosting the efficiency in health care administration and billing. But the promise IT holds for improving the quality and safety of medical care is far from being realized. As Secretary Thompson recently observed, the level of information technology in some hospitals is higher in the cafeterias than on the patient floors.

There are important reasons, why.

Essentially, for many organizations it doesn't make business sense, or simply isn't feasible, to adopt up-to-date systems that can significantly improve health care quality and safety. The Administration has explored the reasons for this state of affairs with health care professionals, experts, and HII advocates, and we've been working to remove them.

These are some of the key barriers to a national health-information network, as we have found them:

One of the major obstacles to creating high-quality health IT systems is the absence of standards.

Standards are the building blocks and the foundation upon which innovative health information technology can be based, and they are essential to communications interoperability -- the ability to share electronic information meaningfully among healthcare and public health personnel who have a need for access. Recognizing this basic necessity, the Administration is supporting the key goal of effective interoperability standards in many ways.

For example, the Department of Health and Humans Services (DHHS) is well into the process of implementing the administrative simplification provisions of the Health Insurance Portability and Accountability Act (HIPAA). The primary focus of this law is to create standards supporting common administrative transactions in health care -- such as claims payment, insurance enrollment, eligibility confirmation, etc. HIPAA activities involve a national collaborative process through which health care industry, providers and standards development organizations seek to identify and adopt standards.

While cumbersome at times, this inclusive process is probably the best way to obtain broad acceptance of criteria that can get the job done. The Administration is hard at work to issue the remaining standards required by the act and to ensure their successful implementation. The HIPAA benchmarks and their accompanying framework can serve as the foundation for broader progress in standards for health information systems.

There are other government components at work on this matter. The CDC's National Electronic Disease Surveillance System (NEDSS) is focusing on the development of information standards for more complete and comprehensive integration of public health reporting systems. The National Institutes of Health (NIH) is expanding the Unified Medical Language System (UMLS), with a Metathesaurus to improve its ability create and retrieve computer-based patient records.

And the FDA is doing its part, by working -- as I've mentioned -- on a rule that will create standards for bar coding on all drugs and biologic products. The code would contain certain information about the product, such as its National Drug Code Number. When used in conjunction with bar-code scanners and electronic patient order entry systems, the system would help protect a patient from getting the wrong treatment, and would make it easier for health care providers to collect information on the drug-related complications and adverse events. Bar-coding standards might also be extended to medical devices, with similar benefits.

Another important barrier to effective health information systems is the need to gain patients' confidence in the security and confidentiality of their medical records. People will understandably not allow their medical information to be stored and used electronically by their health providers without strong privacy and confidentiality protections. The final rule on medical data privacy, released by DHHS this summer, helps provide this assurance -- while still allowing relevant information to be used for quality improvement efforts.
Still another obstacle to be overcome is the health providers' concern about liability. Physicians and other providers will not place badly-needed information about medical complications in these data systems unless they are confident that their report will not be used against them. "Risk management" programs in hospitals are too often about managing litigation risk, not patient risk. In that respect, our medical liability system is exerting a real drag on healthcare quality improvement.

As the President has noted, something is wrong when doctors who try to get together to find ways to identify and avoid complications and improve the quality of care have that information turned against them in a lawsuit. Current liability protections for peer review do not reliably extend across institutions that wish to pool data to evaluate quality improvements, and in some states they may not even protect data within hospitals. Without such protections, health information systems are likely to miss a lot of vital information.

Fortunately, bipartisan legislation is making its way through Congress that would provide these essential protections. The provisions would not take away any existing opportunities to obtain medical record data for the purposes of litigation, or remove any existing reporting requirements; they would only protect new quality and safety improvement programs, based on the analysis of existing data for patterns. This is a critical step for improving quality. The most important short-term legislative priority for improving health IT is getting this legislation through Congress. In the Congress that just ended, this legislation passed two House committees with broad bipartisan support, and there is strong bipartisan interest in the Senate as well. Hopefully, it will not be much longer in coming - but we need your help to get it enacted.

Lack of information, understanding and experience regarding health IT can also serve as a barrier to its use. More research, demonstration, and evaluation programs are needed to better understand how such health-enhancing systems can be implemented effectively. Here are some examples of current efforts to meet this need:

• In fiscal year 2002, Agency for Health Research and Quality (AHRQ) funded over $18 million in health information technology and standards projects, including $5.4 million to support clinical informatics applications for patient safety. The agency has funded studies that have helped produce evidence on the benefits of health IT programs such as computerized patient order entry and has supported collaborations by health care organizations to improve quality of care.
• The CDC recently provided $1.2 million to fund a pilot program for a standardized, integrated early-warning system for terrorism-related illness outbreaks. Appropriately, CDC's assistance is focused on building on existing health IT systems, rather than on the traditional use of a separate process through phone or other "active" reporting to state public health offices. This can be a model for other public health early-warning systems.
• The Veteran's Administration (VA) has long been in leader in this field, researching and implementing a variety of innovative health information systems.
• Medicare's Quality Improvement Organizations support information-based efforts by health care groups to eliminate errors and improve quality.

The Administration expects to continue effective research and to support these and other activities in the coming years.

Perhaps the most important obstacle to a health-information network is the fact that financial incentives in health care generally are not aligned with quality improvement. Health care organizations and providers should be rewarded for high-quality care. Payments based at least in part on quality would reward providers who do it right the first time and avoid complications, and would create needed incentives for the adoption of effective QI and patient safety programs.

Ideally, a health IT system would provide the best possible data on benefits, risks, and costs of alternative treatments, and particularly the impact of different treatments and provider choices on the outcomes that patients care about. In that ideal system, any health care provider that did not as a matter of course adopt effective health IT systems would unavoidably lose revenues and lose business.

As many of you know too well, there are many obstacles to the creation and use of data on health outcomes for guiding treatment choices. One of difficulties, which I've mentioned, is simply the lack of the necessary data in real time. Another problem is that the use of risk adjustment and other statistical techniques are usually required to create valid measures, but patients are not randomized to treatments or to health care providers. Therefore, care must be taken that outcome measures and any other quality measures are valid.

The good news is that the Administration is working on improving the availability and quality of this information. For example, the Administration has supported the nursing home quality initiative in Medicare and its participation in efforts sponsored by the National Quality Forum and other groups to promote incentives for providers of high-quality care. AHRQ and, to some extent, the NIH are also sponsoring research on innovative statistical methods for developing valid outcome measures from observational data.

Finally, this discussion would not be complete without mentioning the Administration's efforts to promote improvements in health information systems through focused direct financial support for providers. There are many examples of these activities. For instance, of the $26.7 million recently allocated to the small rural hospital grant program, $14.8 million is intended to help finance HII at 1,450 rural hospitals. The funding will provide $10,000 grants for improving quality and patient safety through greater investments in information systems.

Another example is the Administration's support for a health information network to strengthen bioterrorism preparedness. In addition to the CDC programs mentioned earlier, the Centers has been augmenting it's Health Alert Network (HAN) by distributing since 1999 almost $90 million in HAN-related grants to States. In addition, the President's budget for the current fiscal year provides $518 million for hospital preparedness and infrastructure to enhance the ability of our hospital system to handle a biological or chemical attack. Much of this funding, and the FY 2002 funds already released, have been and will be used to upgrade the IT infrastructures of hospitals.

All of these programs make a valuable contribution toward the creation of a functional health information infrastructure, but the best way to advance this critical project, as I have suggested, is by removing the barriers in its way and creating incentives for adopting cost-saving improvements to provide high quality care.

I am well aware that the ideal of implementing health information systems that would realize the great potential for avoiding adverse medical events is a difficult objective. But it is a vision for the future of health care that is worth all of our efforts. Last year's report on the HII by the National Committee on Vital Health Statistics describes a vision for electronic sharing of appropriate information and knowledge in a confidential and secure manner to help support the best possible health decisions. It points out that ready access to relevant, reliable information and secure modes of communications would enable consumers, patients, health care providers and public health professionals to address health concerns far more effectively than is now possible.

This vision is now within reach: As a result of Federal policy developments and technological progress, most of the technological hurdles to an effective health information exchange have been overcome. Not only has the Internet made possible greater connectivity and interoperability given predetermined standards, but technology has also allowed for innovative ways to protect privacy.

The public is becoming increasingly aware of the need for quality and value in health care purchasing, and our people understand that IT is an integral part of providing both.

Health care providers, once considered a brake on the diffusion of HII, have in fact shown a willingness to change when quality and efficiency are enhanced by technology. In addition, payors are increasingly under pressure to provide value, and hence have been encouraging the adoption of technology.

We are at a crossroads. We talk about an ideal world in which electronic medical records, computerized order entry, bar-coding, and accurate, up-to-date information on the risks and benefits of treatment are ubiquitous in the healthcare system.

The challenge is, how do we get there from here?

Some have lamented that we face a "chicken and egg" problem. A health provider won't adopt effective health information systems until it pays to do so, and that won't happen until many health care providers have effective IT.

I consider it more a choice between two cycles, one of which is vicious and the other one virtuous. If we take no effective steps to address the underlying obstacles -- if we do not work to improve data quality, and if we talk only about the high cost of implementing often unproven technologies -- then we won't move forward. Many providers will continue to believe that measures of quality of care are invalid and can be gamed, and that there is no real "business case" for health IT improvement.

On the other hand, every time we take a step to remove an obstacle to an effective health information systems, and every time we improve the health measures -- including adverse event measures -- that can be derived from medical information systems, we improve the ability of patients and doctors to make informed decisions. We improve the payoff to investing in effective health information systems.

This in turn strengthens the environment for effective health IT investment, which makes possible further benefits from still more investments, thereby creating the virtuous cycle. There are powerful technologies, including sentinel systems for error detection and systems that allow for improved order entry. They are available today, and they would benefit immediately from continued improvements in the investment environment for effective health IT.

Every step in the right direction, however incremental, helps, and deserves our full attention.

In my new post, I look forward to supporting FDA's efforts to fulfill its important role in this process, and to help secure the benefits of a robust 21st century health care system.

I am glad to report that the FDA has already taken innovative steps toward this goal. For example, our Vaccine Adverse Event Reporting System is shared with CDC and includes participation by large health plans. The Centers for Education and Research on Therapeutics (CERTs), which was authorized by the FDA Modernization Act and is administered through grants from AHRQ, is helping collect information on safe and effective use of FDA-approved medications. And we see the most promising emergence of increasingly sophisticated electronic databases that make possible public-private collaboration in learning more about the ways to improve the safety of medical treatments.

One of bright spots is MedSun, FDA's pilot program for devices that requires rapid adverse event reporting on medical devices by a group of hospitals and nursing homes. The system advances the public's health by giving FDA quicker and more detailed information, without identifying involved individuals, on potential problems with health care products in actual medical practice. This is a rapidly growing network that also provides health care organizations with a fast feedback about lessons learned by the FDA.

There are many other efforts, not all of them governmental, to realize the HII potential. One example is the Health Legacy Partnership, is an impressive program of AHRQ and the Joseph H. Kanter Family Foundation. This partnership, with assistance from FDA and others, supports work toward three key goals: improving healthcare decision-making through IT and print media; advancing the development of a national outcomes database; and standardizing outcomes data necessary for the database. As part of this effort, the FDA is involved in a "Marconi" project that will demonstrate a standards-based electronic model of data transmission and exchange, involving key producers and consumers data. In this demonstration, important drug-safety information collected at a hospital can automatically be sent to the FDA.

There are still other ways that this approach can help improve the safety of medical treatments at lower cost than current methods. For example, FDA could be automatically informed about the occurrence of positive pregnancy tests for patients on Accutane. This would help us determine the effectiveness of labeling and other educational efforts to prevent adverse events related to this product. As another example, automatic reports of lab tests could indicate the frequency of serious hepatic abnormalities in patients on drugs with hypothesized liver toxicity. Initiatives like these may be included in the "Marconi" demonstration project to evaluate whether the exchange of clinical data can improve safety.

And the future holds still more promise. Imagine bar-coded medical treatments helping hospitals ensure that patients receive the right dose of the right drug and automatically providing up-to-date, useful electronic labeling information on potential problems for doctors. Imagine a system more quickly identifying an association of a drug with a serious problem in actual practice, such as a liver failure. Imagine patients who, with the help of bar-coding, could receive from the pharmacist up-to-date drug information designed for their individual need and circumstances.

These and other great strides are part of a vision of what can be accomplished if all of us in government, the health professions, academia and industry continue to work toward better health information systems -- and more generally, toward a health care system that helps patients and health professionals make better decisions supported by safer and more effective medical treatments.

Thank you for your commitment, as reflected in this outstanding conference, to a better future for our health care system and better health for Texans and all Americans. I look forward to working with you to achieve this important goal.