Hatch, Brown Sound Alarm on Super Bugs

Statement

Hatch, Brown Sound Alarm on Super Bugs

Today Sen. Orrin G. Hatch (R-Utah) joined with Sen. Sherrod Brown (D-Ohio) to introduce
the Strategies to Address Antimicrobial Resistance Act (S. 2313). The following are Hatch's remarks upon introduction.

Mr. President, as recent events in neighboring Virginia have made all too clear, this country faces a number of troubling questions about whether we are prepared to address the growing problem of drug-resistant, bacterial infections. Indeed, while recent media reports have raised the visibility of this issue, infectious disease doctors have been sounding the alarm for years.
Now, Senator Brown and I are sounding the alarm as well.
Data from the Centers for Disease Control and Prevention show that resistant strains of infections have spread rapidly. This alarming trend continues to grow and treatment options are sorely lacking.
Senator Brown and I have collaborated to develop legislation that takes a science-based approach to this problem. This legislation, the Strategies to Address Antimicrobial Resistance Act (or "STAAR Act" S. 2313), should be seen as a measure to catalyze a greater government focus on a frightening, growing, public health problem which should be of concern to each and every one of us in this Nation.
One of the things that Senator Brown and I have found in our considerable study of this issue is that there is not adequate infrastructure developed within the government to collect the data, to coordinate the research, and to conduct the surveillance necessary to stop drug-resistant infections in their tracks.
We believe that jump-starting a greater, stronger, organizational focus at the Department of Health and Human Services will help our government and our scientists develop an infrastructure that can grow as science develops.
At the same time, we make perfectly clear that our bill is not the sole answer to the complex, vexing problem of antibiotic resistance. At a minimum we need better testing, better hospital controls, better medications, and better funding to support these efforts, particularly the work of the Centers for Disease Control and Prevention.
The Infectious Diseases Society of America, the Institute of Medicine, the Resources for the Future, the Centers for Disease Control, and many others have been sounding the alarm about the growing threat from resistant microorganisms.
Congress must listen.
In fact, it its seminal report, "Bad Bugs, No Drugs", the Infectious Diseases Society (or IDSA) said:
"Drug-resistant bacterial infections kill tens of thousands of Americans every year and a growing number of individuals are succumbing to community-acquired infections. An epidemic may harm millions. Unless Congress and the Administration move with urgency to address these infections now, there is a very good chance that U.S. patients will suffer greatly in the future."
Indeed, the seminal IDSA report points out a number of compelling facts.
As the report notes, infections caused by resistant bacteria can strike anyone, young and old, rich or poor, healthy or ill. However, the problem of antibiotic resistance is especially acute for patients with compromised immune systems, such as persons living with HIV/AIDS.
The scope of the problem is equally of note. As IDSA has calculated, about two million people acquire bacterial infections in U.S. hospitals each year - and as many as 90,000 die as a result. More and more, public health experts are finding infections developed in the home or community as well. Infections in both settings are increasing, and the resultant drug resistance shows no sign of lessening.
This is a costly problem, costly for patients, for society, and potentially threatening to our global security.
And, in fact, health care providers are running out of treatments as the resistance problem grows.
Nobel Laureate Joshua Lederberg said it well: "We are running out of bullets for dealing with a number of (bacterial) infections. Patients are dying because we no longer in many cases have antibiotics that work."
Indeed, last week, noted Utah infectious disease expert Dr. Andy Pavia told me about a 14 year-old boy he had treated who had bone, muscle and lung infections from MRSA, an aggressive, difficult to treat, form of staph that has spread rapidly within communities. Half of the children he sees with severe MRSA infections acquired their infection at home.
This young man, Dr. Pavia relates, was forced to undergo multiple surgeries and six weeks of intravenous antibiotics. MRSA infections are steadily increasing in Utah, as well as across all other states.
Fortunately, that young man is on the road to recovery. But the statistics indicate it is just as likely that he would not be.
We are not only talking about MRSA. Dr. Pavia also cites the real crisis growing with resistant gram-negative bacteria, which he calls the "Rodney Dangerfield of the infectious disease world" - in other words, "it don't get no respect."
We are also seeing increases in extensively-drug resistant (XDR) tuberculosis. And, there are numerous reports of soldiers returning home from Iraq with Acinetobactor - a resistant infection that is especially difficult to treat and the only option is a very toxic antibiotic.
Senator Brown and I have worked on this issue for many months, starting with our collaboration on provisions in the Food and Drug Act Amendments recently signed into law by the President. We are also working with our colleagues in the House, foremost among them Utah Congressman Jim Matheson, author of the House STAAR Act.
Our conclusion is that the solutions to this problem are manifold, but they must start with a stronger government effort. That is the genesis of the STAAR Act.
Let me review briefly what our legislation does.
The bill makes a series of congressional findings which lay out the problem and the need to address it.
In particular, we note that while the advent of the antibiotic era has saved millions of lives and allowed for incredible medical progress, the increased use and overuse of antimicrobial drugs have correlated with an increase in the rates of antimicrobial resistance.
An important component to this problem is the fact that scientific evidence suggests the source of antimicrobial resistance in people is not only the overuse of human drugs, but also it may be from food-producing animals which are exposed to antimicrobial drugs.
As scientists have found, nearly 70 percent of hospital-acquired bacterial infections in the U.S. are resistant to at least one drug; in some cases, the rate is much higher. In fact, each year nearly two million people contract bacterial infections in the hospital, and it is estimated that 90,000 of them die from the infections.
There seem to be no recent data on the costs associated with this problem, but a 1995 report by the office of Technology Assessment found that six different antimicrobial-resistant strains of bacteria accounted for $1.3 billion in nationwide hospital costs - almost $1.9 billion in 2006 dollars!
Here is how our bill attempts to address the problems I have just laid out.
First, the bill establishes a new Office of Antimicrobial Resistance in the Department of Health and Human Services. That Office will work with the Task force to issue biennial updates to the Public Health Action Plan to Combat Antimicrobial Resistance, including enhanced plans for addressing the problem here and abroad. As appropriate, the Office's Director will establish benchmarks for achieving the plan's goals, assess patterns of antimicrobial resistance emergence and their impact on clinical outcomes, determine how antimicrobial products are being used in humans, animals and plants, and recommend where additional federally-supported studies may be beneficial.
Second, we renew the Antimicrobial Resistance Task Force authorized in section 319E of the Public Health Service Act. The Task Force, whose authorization lapsed last year, is comprised of representatives from the following Federal agencies and offices, plus any others the Secretary deems necessary: the new Office of Antimicrobial Resistance established in the bill; the Assistant Secretary of Preparedness and Response; the Centers for Disease Control; the Food and Drug Administration; the National Institutes of Health; the Agency for Healthcare Research and Quality; the Centers for Medicare & Medicaid Services; the Health Resources and Services Administration; the Environmental Protection Agency; and the Departments of Agriculture, Education, Defense, Veterans Affairs, Homeland Security, and State.
Mr. President, it is important to note that Senator Brown and I gave careful consideration to the location of this new Office.
We considered locating it at the CDC, the Office of the Assistant Secretary for Health (OASH), and in the Office of the Secretary (OS). There are benefits and drawbacks to each. Indeed, had OASH its previous organizational structure, that is, line authority over the Public Health Service agencies, that decision would have been easy. But since a change was made many years ago to devolve most of the OASH functions to the separate PHS agencies, OASH was not the natural locus for the new Office, we decided. Our final conclusion was that it was most appropriate to locate the new office in OS, both for reasons of prominence and flexibility.
Third, S. _____ establishes a Public Health Antimicrobial Advisory Board, a panel of outside experts who will advise the Secretary on ways to encourage an adequate supply of antimicrobial products that are both safe and effective; help determine what research priorities should be, what data and surveillance are necessary to be collected, and assess how the Action Plan can be updated and strengthened.
It is very important to Senator Brown, if I may speak for him, and to me that our measure be seen as a collaborative effort that draws on the strengths of existing organizations and catalyzes their efforts for greater good.
So, fourth, our bill requires the Secretary - working through the new Office, the CDC and the NIH, in consultation with other appropriate agencies - to develop a antimicrobial resistance strategic research plan that strengthens existing epidemiological, interventional, clinical, behavioral, translational and basic research efforts to advance our understanding of the emergence of resistance and how best to address it.
Fifth, the bill authorizes establishment of at least 10 Antimicrobial Resistance Clinical Research and Public Health Network sites, geographically dispersed across the United States. The sites will monitor the emergence of resistant pathogens in individuals, study the epidemiology of such pathogens and evaluate the efficacy of interventions, and study problems associated with antimicrobial use. In addition, we are asking the network to assess the feasibility, cost-effectiveness, and appropriateness of surveillance and screening programs in differing health care and institutional settings, such as schools, and evaluate current treatment protocols and make appropriate recommendations on best practices for treating drug resistant infections. It is my hope the network will be able to take into account successful models for surveillance and screening such as inpatient programs of the Veterans Health Administration, work done in states such as Illinois, New York and the Utah Aware program, and experience overseas in countries such as the Netherlands, Denmark and Finland. Our bill authorizes $45 million for these networks in FY 2008, $65 million next year, and $120 million in FY 2010.
Finally, Mr. President, I would like to speak about data collection activities in S. 2313.
It has become obvious to me that there is a pressing need for better surveillance of antibiotic resistance and better data collection that is shared both within states and across states. From my long work on public health issues, it is equally clear to me that there is a need for the government to give guidance - guidance, not a mandate - on uniform ways in which those data should be collected so that all of the agencies are talking the same talk, so speak.
Our bill asks the Office of Antimicrobial Research to work with the Task Force and member agencies to develop those uniform standards for data collection. In drafting S. 2313, Senator Brown and I were very sensitive to the jurisdictional needs of other Committees. At the same time, it is clear that any serious effort to address antimicrobial resistance must be spread across the many agencies of government, each of which has a role to play in our collaborative effort. It is for that reason that our bill asks the Office and Task Force to work with the other agencies, some of which do not fall within the jurisdiction of the HELP Committee. If this language needs to be strengthened as consideration of S. 2313 progresses, it is our hope to work with the other committees which have an interest in the bill.
A second issue related to data collection is the fact that there is a pressing need for epidemiologists and other public health experts to begin to see data showing how many antibiotics are being distributed and used by patients so that they can evaluate the amount of resistance that is emerging. In writing our bill, we were sensitive to the need to provide scientists with these data, while at the same time working to make any new reporting provisions the least burdensome possible, while protecting both the national security and propriety aspects of those data. For that reason, our bill builds on current reporting to the FDA of pharmaceutical distribution data. Those data are currently submitted by manufacturers on the anniversary date of the product's approval. Our bill would move that reporting date to 60 days after the beginning of each calendar year, thus allowing epidemiologists to compare data from year to year. Our second concern, that of potentially harmful release of data, was addressed in the following way. Our bill precludes the release of data which are proprietary in nature and whose release could have the perverse result of providing a disincentive to antibiotic development. This strong section, section 7 of the bill, also precludes release of data which could be harmful to our national defense.
In closing, I wish to commend S. 2313 to my colleagues and ask for their serious consideration of this measure. For those who doubt the need for this legislation, if there are any doubters among us, I ask the following questions:
Where do we begin to get serious to address this concern?
Where do we begin to recognize that it will take literally years to develop an effective response?
What are we doing to develop the collaboration across agencies to assure the American public we are developing an action plan to combat the problem?
It is our hope that STAAR Act will begin to catalyze that response.
That is the motive behind our introduction of this legislation.
We look forward to working with our colleagues on the Health, Education, Labor and Pensions Committee as consideration of this legislation begins and we remain available to our colleagues to answer any questions or concerns they may have about this legislation.

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