30 April 2010

Antibiotic Resistance and the Threat to Public Health – Wednesday, 28 April 2010 13:02

The Subcommittee on Health held a hearing entitled “Antibiotic Resistance and the Threat to Public Health” on Wednesday, April 28, 2010. The hearing explored the phenomenon of antibiotic resistance and the effects it has on human health.

Witnesses

• Thomas Frieden, M.D., M.P.H., Director, Centers for Disease Control and Prevention
• Anthony Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases

Documents

• Opening Statement of Chairman Waxman (as prepared)
• Briefing Memo

Testimony

• Testimony of Thomas Frieden
• Testimony of Anthony Fauci

The Subcommittee on Health held a hearing entitled “Antibiotic Resistance and the Threat to Public Health” on Wednesday, April 28, 2010. The hearing explored the phenomenon of antibiotic resistance and the effects it has on human health.

Witnesses

• Thomas Frieden, M.D., M.P.H., Director, Centers for Disease Control and Prevention
• Anthony Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases

Documents

• Opening Statement of Chairman Waxman (as prepared)
• Briefing Memo

Testimony

• Testimony of Thomas Frieden
• Testimony of Anthony Fauci

Video

WMV
Download or Stream

REP. PALLONE: The hearing of the subcommittee is called to order. Today, we’re having a hearing on antibiotic resistance and the threat to public health. And I will first recognize myself for an opening statement.

This is a very serious public health concern and I know it’s an issue of great interest to many members of the House of Representatives. Antibiotics are among the most impactful medical innovations of the 20th century. Though first discovered in the late 1920s, antibiotics became part of routine treatment to combat bacterial infections in the 1940s and were one of the main contributors in the decline of infectious diseases. Illness that had been widespread and often fatal prior to the development of antibiotics were suddenly curable with the administration of these new wonder drugs. In fact, the CDC list control over infectious disease is one of their top 10 great public health achievements of the last century and mentions antimicrobial as crucial to that accomplishment.

Bacteria, we know, are living organisms, and as such they can and will mutate with time to be able to resist the drugs that have been developed to combat them. And we now find ourselves in a situation where our triumph over infectious diseases is in jeopardy.

More and more bacteria are proving to be resistant to the antibiotics currently on the market. Unfortunately, these resistant diseases are among the most predominant illnesses in the population, including respiratory diseases, such as pneumonia, food related diseases, including E. coli and salmonella, and hospital acquired infections, such as methicillin resistant staphylococcus aureus, okay, more commonly known as MRSA.

And I should point out, however, that MRSA in particular is now migrating out of the health care setting and can also be found in the community, posing a new threat to Americans. Newspapers across the nation report on the danger and prevalence of these bacteria. In my state of New Jersey, we had a number of schools closed a few years ago after children were diagnosed with MRSA. Some were even hospitalized for weeks. And I’m sure everyone here remembers the scare we’ve had not long in the House of Representatives, when MRSA was found in the House staff gym.

The consequences of these antibiotic resistant bacteria are dangerous, expensive, and at times deadly. In 2005, the CDC estimated that roughly 94,000 Americans contracted MRSA and over 18,000 died as a result of that disease, including young and otherwise healthy patients. And many in the medical community believe that MRSA might not be as big of a threat as some of the other antibiotic resistant diseases as fortunately there still are some drugs that can treat MRSA.

For other diseases like acinetobacter, there are very few options. As articles in the press have highlighted, acinetobacter was a particular concern among the wounded troops in Iraq. Thirty five percent of those infections responded to only one antibiotic on the market today and 4 percent were resistant to all our current drugs.

It’s pretty horrifying to me to think that our soldiers can survive a war only to them succumb to a bacterial infection we’re powerless to treat.

In treating these highly resistant infections, physicians often have to prescribe more expensive, older, and less commonly used antibiotics that can cause serious side effects, including nerve and kidney damage. Patients up hospitalized for longer periods of time and often suffer recurring infections that s them back to the doctor time and again. And not surprisingly, these illnesses t to be very expensive, not to mention the threat they pose to all who come in contact with these patients. And that’s why this hearing is important today.

I’m very eager to hear from our witnesses about the problem we’re experiencing with antibiotic resistant bacteria, but also about the work they’re doing to address these problems. And I know both of you are engaged in some very exciting research that will hopefully help us tackle antibiotic resistance in the most effective way possible.

I want to welcome you both to the committee, apologize for the fact that we had to start so late. I know one or both of you mentioned catching a plane. I don’t know what the situation is with that. But for now I’ll recognize our ranking member, Mr. Shimkus, for an opening statement.

REP. JOHN SHIMKUS (R-IL): Thank you, Mr. Chairman.

Antimicrobial drugs are effective, often life saving tool when used correctly. We know that microbes, including bacteria, can quickly evolve and become resistant to drugs. And resistance is already a concern in our communities, particularly in the hospital setting, where numerous deaths occur each year as a result of a resistance.

I’m glad we have our panel before us and the CDC and NIH here today to discuss the role the federal government has played, particularly with the U.S. Interagency Task Force on Antibiotic Resistance. I look forward to hearing more on the progress made and what we might expect from the task force’s update action plan expected to be released later this year.

I’ve always believed that a crucial component in this fight is providing industry an incentive and regulatory framework that encourages the development of more antimicrobial drugs.

Many manufacturers have turned away from the R&D of new antimicrobials because of increased incentives to develop drugs in other therapeutic areas and the uncertainty of the marketplace.

As members of this committee wish you work hard to break down the barriers, encouraging the marketplace incentives like exted patent exclusivity for new antibiotics and the economic incentives, such as an R&D tax credit.

Unfortunately, I believe that the $27 billion tax on the drug industry and the health reform law will have a negative effective and only serve as stifle and not encourage more development of antibiotic drugs. Perhaps that isn’t the case, but this is a very good example of why we must hold hearings on the new health reform law. Last week, I raised issues we already knew were problems — preexisting conditions coverage for children, individuals who don’t qualify for the not new high risk pools, families being forced into Medicaid, premiums going to rise on average of $2,100 for those in the individual market, and being able to drop coverage and avoid penalties after three months and one day. And this week, we already have new questions. The majority repeatedly said health care sping would decrease. The president even pledged the American people cost would go down, not up, as a result of health reform.

(continues)

Yet, CMS released a report by actuary Rick Foster last week, saying national health care expectations — expitures will increase by $311 billion, making health care 21 percent of the GDP. Should be believe the CMS actuary expert or the majority and their bill, now law?

Are the $575.1 billion in custom Medicare unrealistic and unsustainable as the reporter claims? Will the cuts drive 15 percent of hospitals in the red and force them to close their doors? How would this jeopardize access to care for seniors? What does the hospital community say about this? Are 50 percent of seniors really going to lose the Medicare Advantage plans? Can 14 million low wage working Americans have their employer insurance dropped, forcing them into Medicaid? How will the state Medicaid plans handle these new populations and costs?

These are the questions being raised and the real concerns and fears coming from the public. This committee and this Congress cannot just bury our head in the sand and pret these problems don’t exist in this massive health reform law.

Chairman Pallone, I asked before and I hope we — and Chairman Waxman’s here, I hope we have hearings on the implementation of this law and address some of these problems that we should start moving to fix before they actually become problems — and I’ve identified quite a few of them. And with that, Mr. Chairman, I yield back my time.

REP. PALLONE: Thank you. Chairman Waxman is recognized for an opening statement.

REP. HARRY WAXMAN (D-CA): Thank you very much, Mr. Chairman.

We need to debate the health care bill and review its implementation, but we ought to be able to chew gum and walk at the same time because it’s not going to make much difference if you have health insurance or not if you’re going to die from something that could have been prevented from an antibiotic. And we’re seeing more and more antibiotic resistance.

The revolution of antibiotics, starting with penicillin in 1927, has been a major accomplishment in the health care world and has led to many people surviving things that in the past might have cost them their lives. Before we had antibiotics, common skin infections could turn fatal. Childbirth could be a death sentence for both mother and baby. And superficial wounds could deteriorate rapidly, often resulting in amputation.

Antibiotics changed all that. And with the discovery of these medicines, doctors could readily treat infections and literally, save lives. The modern age of medicine was launched.

Some 80 years later, this medical miracle is still saving lives. And without antibiotics, many of today’s cancer protocols would be nearly impossible to use because the immune system, when it becomes compromised by the treatments would quickly lead people to die from opportunistic infections without antibiotics.

So in brief, we cannot do 21st century medicine without antibiotics, whether you like the provisions of the health care bill or not. We need to have antibiotics available and, shockingly, experts — which I understand is supposed to be the reason for this hearing — are telling us that we are on the precipice of losing the power of many of today’s antibiotics. As a greater number of bacteria become more resistant to them — for reasons we will explore this afternoon — antibiotics, in turn, become less effective, making infections far more hazardous to health.

This is not exaggeration or hyperbole or even the stuff of some hypothetical computer model. This is not propaganda, which we hear a lot about in these committee sessions, when people are campaigning for the November election and not looking at the issues that we have to deal with. Too many Americans have already succumbed to our inability to treat infections and the numbers are staggering.

Today, we’ll learn about the impact of antibiotic resistance on human health from two of the nation’s leading experts on infectious diseases, Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, and Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at NIH.

As we do, I hope we can start to understand and appreciate the severity of the problem we face and together, work toward a public- private plan of attack.

I don’t know what we need to do. Obviously research, that’s our default and most important answer to any problem like this, but it’s going to take a strong, multifaceted yet coordinated strategy to get the job done. I think we have to think about things that have not been on the aga for a while because of the pressure from some of the special interests. What is the impact of using antibiotics without a medical need when it’s applied to large numbers of animals? Is this resulting in more drug resistant antibiotics? What will it take to get the pharmaceutical companies to do more work in this area?

I met with a group yesterday who told me they need this, they need that, and they need the other thing. But they don’t want to work on antibiotics because it’s not profitable enough. Well, let’s look at that problem. Let’s look at whatever it’s going to take and keep our eye on the objective. We cannot afford to live in a world where antibiotics don’t work anymore. And I think that the numbers are just so staggering. Ninety thousand Americans die each year of deadly hospital-acquired infections, which are predominantly caused by antibiotic resistant bugs. Over 18,000 Americans, including healthy young people, die annually from methicillin-resistant staphylococcus aureus, also known as MRSA. We’ve seen soldiers defeat deadly enemies in Iraq, only to return home with an epidemic of deadly antibiotic resistant acinetobacter.

And we need more hearings so we can say these words correctly. (Laughter.) Because these are infections that we want to stop with antibiotics.

Thank you very much, Mr. Chairman. I look forward to the testimony.

REP. PALLONE: Thank you, Chairman Waxman.

The gentleman from Kentucky, Mr. Whitfield.

REP. ED WHITFIELD (R-KY): Mr. Chairman, thank you very much.

We look forward to this very important hearing and certainly appreciate our two witnesses being here today.

I would, however, like to reiterate the importance and necessity, in my view, of holding hearings regarding the implementation of this massive and far reaching change to our health delivery system.

As Chairman Waxman noted about hospital infections, according to the Centers for Disease Control, two million people acquire bacterial infections in hospitals each year. And of that, around 90,000 people die because of these infections.

And according to the information given to me, 70 percent of the hospital acquired infections are caused by bacteria that are resistant to at least one of the drugs most commonly used to treat them.

I also do believe that we must explore incentives and other options to encourage pharmaceutical companies to continue their research and coming up with new medicines to deal with this problem.

I look forward to the testimony of our witnesses today and yield back the balance of my time.

REP. PALLONE: Thank you.

The gentlewoman from the Virgin Islands, Ms. Christensen.

DEL. DONNA CHRISTENSEN (D-VI): Thank you, Chairman Pallone.

And thank you Dr. Fauci and Dr. Frieden for being here. And it’s good to see you again. The hard facts and data about the prevalence of antimicrobial resistance are nothing short of astounding. Because of repeated and widespread improper antibiotic use, almost every type of bacteria become stronger and less responsive to antibiotic treatment.

Between 5 and 10 percent of all hospital patients, that’s roughly two million people, will develop an infection.

(continues)

And 90,000 of these patients die. This tr is related to the fact that more than 70 percent of bacteria that cause these infections are resistant to at least one of the antibiotics most commonly used to treat them. Though the full economic impact is difficult to determine, the estimated costs are somewhere in the vicinity of $5 billion every year.

But what it’s also so disturbing is that because of this resistance, we’re facing the prospect of reverting to times in health care where we were only able to offer a hand to hold. Not only might antibiotics be priced out of reach, but we may see cases where there are none that are effective in a given infection and that’s unacceptable.

As a physician, I know the pressures that we are always under to prescribe antibiotics. I made it a point not to use them until unless I thought they were indicated either for my patients or my family. And I thank GW and Howard for that.

As I see it, the resistance horse is out of the barn. The only way to contain it is to fence it in by the national institute developing the vaccines, as they did in the macaques, which had a good result for spurring the development of new antibiotics, and by the CDC campaign that have been directed at providers, including hospitals and the public, especially including the public. None are easy, but have to become a priority because this country and the world cannot revert to the dark days of medicine.

So thank you Chairman Pallone and Ranking Member Shimkus for holding this hearing. Dr. Fauci and Dr. Frieden, I look forward to your testimony and the discussion. I yield back.

REP. PALLONE: Thank you.

Gentleman from Pennsylvania, Mr. Pitts.

REP. JOSEPH PITTS (R-PA): Thank you, Mr. Chairman.

Antimicrobial drugs have saved countless lives over the last half century and enhanced the quality of life for many more people.

Unfortunately, we are observing a growing amount of bacterial resistance to antibiotics and many infectious diseases are becoming increasingly difficult to treat as a result. There’re multiple reasons for microbes becoming drug resistant, including inappropriate use by physicians, inadequate diagnostics, hospital use, and agricultural use.

I was pleased to see that in the majority’s memo for this hearing, they noted that, quote, “the National Institute of Allergy and Infectious Diseases acknowledges there is debate about the public health impact,” quote, of antimicrobial use in animal agriculture, particularly in animal feed. Because I believe that the legitimate and judicious use of antibiotics in animal agriculture has been unfairly attacked and demonized in recent years. FDA puts these drugs through a rigorous approval process with many newer antibiotics having been extensively reviewed, specifically to assess any risk to humans as a result of drug resistance. Treatment, prevention, control, and growth promotion, feed efficiency are all FDA approved uses for antibiotics.

FDA also conducts post-approval monitoring and multiple public and private surveillance systems monitor for any sign of antibiotic resistance.

While every possible cause of antibiotic resistance should be studied and explored, I would hope that this series of hearings would focus more on areas where the science has told us there is cause for concern. And that is not the antibiotic use in animals.

I look forward to hearing from our witnesses and I thank you, Mr. Chairman, for scheduling this hearing.

REP. PALLONE: Thank you.

Chairman Dingell?

REP. JOHN DINGELL (D-MI): All right. Thank you. I have a splid statement. I know everybody will benefit by reading it. I ask unanimous consent to insert into the record. Thank you, Mr. Chairman.

REP. PALLONE: Without objection, so ordered.

Gentleman from Texas, Mr. Burgess.

REP. MICHAEL BURGESS (R-TX): Thank you, Mr. Chairman. And due to the high octane witnesses we have, I’m going to wave an opening statement, submit for the record, and reserve time for questions.

REP. PALLONE: Without objection, so ordered. And — or did you have a statement — you just said — REP. BURGESS: Submit it for the record.

REP. PALLONE: — submit it for the record. Let me say all the statements will be submitted for the record. Thank you, Mr.

Burgess. The gentlewoman from Illinois, Ms. Schakowsky.

REP. JAN SCHAKOWSKY (D-IL): I’ll put my full statement on the record, but I do have a couple of comments. In my home state, the Illinois Department of Health has stated that in just four years the incidence of MRSA has increased 57 percent to over 10,000 cases. And as we’re going to hear from the CDC and the National Institutes of Allergy and Infectious Diseases, antibiotics become less effective as humans are increasingly and often unnecessarily exposed to them. This is going to happen when they’re overprescribed. But it also happens to other types of exposure. It’s for this reason that I find the rampant use of antibiotics for non-therapeutic purposes in livestock populations alarming.

Many factory farms give cows, chickens, and pigs antibiotics in their daily feed. They aren’t treating any known diseases.

They’re promoting growth and compensating for bad sanitation. When antibiotics are used in livestock populations, it gets into our food systems and into our water supply, using highly potent medications for this type of use continues to contribute to the increasing prevalence of antibiotic resistant infections.

I applaud my good fri, Rep. Louise Slaughter, for introducing the Preservation of Antibiotics for Medical Treatment Act, which would take needed steps to protect the effectiveness of antibiotics. I’m a co-sponsor of this legislation. And I look forward to Dr. Frieden and Dr. Fauci’s testimony on this issue. I hope you’ll address this as well. And I yield back. Thank you.

REP. PALLONE: Thank you.

Gentlewoman from Tennessee, Ms. Blackburn.

REP. MARSHA BLACKBURN (R-TN): Thank you, Mr. Chairman. And Dr. Frieden and Dr. Fauci, thank you for being with us today.

I will have to say this is a hearing that I’ve waited a long time for us to have. I first wrote you, Mr. Chairman, in October ‘07 with my concerns about MRSA and the fact that we needed to look into this. I find it astounding, when you look at the 2005 stats, that there are more people that die from MRSA caused infections than those that die from AIDS, Parkinson’s, emphysema, or homicide each year.

And I do think that this is something that has to be addressed.

I were surprised as I looked at the issue first in ‘07 to find out from our Tennessee Department of Health that there is not a national standard on a way to report MRSA issues. And that is of concern to me. It’s something I want to address with both of you as we move through the hearing.

I do have a full statement that I want to submit for the record, but I thank you for the hearing and look forward to our witnesses. REP. PALLONE: And the full statement will be entered into the record. Thank you.

Our vice chair, Ms. Lois Capps, gentlewoman from California.

REP. LOIS CAPPS (D-CA): Thank you, Chairman Pallone. I’ll be very brief, but I want to thank you for holding the hearing and thank our witnesses for coming today and for their testimony. I have to give a special thank to Dr. Fauci, who gave us a stirring commencement speech for someone named Amy Fisher, who’s now my medical health specialist on my staff. So you must have said just the right things when she graduated from Emery.

Thank you very much.

This issue of antibiotic resistance is of extreme importance to both the health and the economic well-being of all Americans.

(continues)

Resistant strains of bacteria are harder to treat, often requiring longer and more difficult courses of treatment. And the longer an individual must sp fighting an illness, the greater the loss of valuable time at work and at home with families. But there is also an economic consequence to the nation as a whole.

These infections cost the health care system through exted hospital stays, more expensive treatments and nearly $5 billion in annual cost associated with hospital acquired infections.

For many years, we have taken for granted that when we are sick, we can go to our doctor, take a week’s worth of medicine and be well again. But now we must face the facts that we need a more comprehensive approach to treating bacterial infection. Perhaps most concerning is that there are a broad range of potential causes for the antibiotic resistance that affects us today. Individual level factors, like when and what medicines the doctor prescribes and how well a patient adheres to treatment, combined with health care associated infections, agricultural antibiotic use, and the lack of new antibiotic treatments. All of these have contributed to the current state of antibiotic resistance.

I look forward to hearing our witnesses’ thoughts and how we can employ evidence-based strategies to combat antibiotic resistance and the multiple factors that contribute to it in a coordinated approach.

So thank you for being here, and I yield back.

REP. PALLONE: Thank you.

Next, gentleman from Utah, Mr. Matheson.

REP. JIM MATHESON: (D-UT): Thank you, Mr. Chairman. I have a full statement. I’ll submit it for the record. But I’d just make just one brief comment. I just want to point out that on this important issue, I have once again reintroduced in this Congress H.R.

2400, the Strategies to Address Antimicrobial Resistance Act, or the STAAR act. I believe this is a comprehensive piece of legislation to strengthen our country’s response to pathogens that are increasingly becoming resistant to antibiotics. Senators Sherrod Brown and Orrin Hatch will be introducing the companion bill in the Senate in the coming weeks. I encourage this hearing and others moving forward, and I hope that piece of legislation, the STAAR act, can be — contribute to this debate and offer opportunities for us to make progress on the issue. With that, I yield back.

REP. PALLONE: Thank you.

Gentleman from Ohio, Mr. Space.

REP. ZACHARY SPACE (D-OH): Thank you, Mr. Chairman, for holding this hearing and I’d like to thank the witnesses for their attance today. I think we have all as a nation kind of taken it for granted that the antibiotics were there. And as apparent, I’ve thought much about the consequences if they hadn’t been there. And it’s a little unnerving now to see that in combating some forms of bacteria, we can now say that the antibiotics are less effective. And the words of Chairman Waxman that this would be a very frightening world if it were a world without antibiotics ring true.

I’m very pleased that the CDC and FDA and other agencies have begun to take some basic steps to combat the problem. I think public awareness is certainly being part of it. I think that this Congress and other agencies have an obligation to advance research into the issue. My only hope is that if this Congress, this term decides to take legislative action that we do so with a sense of moderation, to the extent that that can be done. The concern always is that we may be overreaching. I don’t want to see that. So researching and developing a solution to this problem is very important, but ensuring access to antibiotics for all Americans is equally important during the process. And with that, Mr. Chairman, I yield back.

REP. PALLONE: Thank you.

Gentlewoman from Florida, Ms. Castor.

REP. KATHY CASTOR (D-FL): Thank you, Mr. Chairman, for holding this afternoon’s hearing on human resistance to antibiotic drugs. Welcome to our witnesses.

This is a critical and rather frightening issue that we must work to resolve. Particularly the findings of the recently released Agency for Health Care Research and Quality report are alarming.

Postoperative blood infections increased by 8 percent. Catheter related urinary tract infections increased by 3.6 percent. There’re more statistics like that and the number should be going down, not up.

I thought it was also disturbing that the report found that blacks, Hispanics, Asians, and Native Americans patients were less likely than whites to receive preventative antibiotics before surgery in a timely manner. So we still have those disparities in health care. And all these infections cause nearly 100,000 deaths each year, and account for up to $26 billion a year in additional costs. Many of these infections are resistant to some of the strongest antibiotics, causing some patients to be in the hospital for weeks or months.

In Florida, drug resistant MRSA infections are growing and are infecting healthy adults and children. The number of cases in Florida from outpatient facilities increased more than four times in the three-year period from 2003 to 2005.

Drug resisting gram-negative infections, different from MRSA, are also on the rise. These infections are primarily acquired in hospitals or in long term care settings. They have a high death rate and are resistant to antibiotics, usually known as the last line of defense.

According to the CDC, the antimicrobial resistance problem is a major, booming public health crisis. Researchers that I’ve heard from have highlighted to me the lack of resources coming from NIH for this particular issue. They’ve highlighted the lack of resources on the state level to detect, monitor, and control any microbial resistance in public health laboratories. Florida, like other states, does not have any technical ability to categorize resistant patterns quickly.

So gentlemen, you have your work cut out for you. We need your help in tackling this crisis. I look forward to your testimony.

Thank you, Mr. Chairman.

REP. PALLONE: Thank you. I think everyone has had a chance to give an opening statement, so we’ll now turn to our panel. We have our two witnesses today. I want to welcome you. Let me introduce. On my left, Dr. Thomas R. Frieden, who’s director of the Centers for Disease Control and Prevention, and to my right, is Dr. Anthony S.

Fauci, who’s director of the National Institute of Allergy and Infectious Diseases.

Thank you for being with us today. Sorry again you had to wait.

You know that we have five-minute opening statements that are made part of the record and you can submit additional statements or comments after we may also follow up with some written questions. So I’ll start with Dr. Frieden. Thank you.

THOMAS FRIEDEN: Thank you very much, Chairman Pallone, Chairman Emeritus Dingell, Ranking Member Shimkus, and members of the subcommittee for your interest in this topic and for holding this hearing.

As an infectious disease physician myself and having worked as a tuberculosis control officer, health commissioner, for more than 20 years I’ve seen the growing problem of drug resistance and also the potential to prevent and reverse drug resistance with effective public health action. I appreciate the opportunity to speak with you today about the public health threat of antibiotic resistance and the role that CDC plays in preventing, detecting, better understanding, and responding to the problem.

I’d like to show several slides to illustrate the problem.

The first one shows the increase in drug resistance in two different organisms, Staphylococcus aureus, resistant to penicillin, something that emerged almost immediately after penicillin became available.

Early on, tiny doses of penicillin were able to cure severe infections with staph aureus. Those resistant organisms first emerged in a hospital and then after a gap of a decade or so, in the community.

That same pattern has existed with MRSA, methicillin-resistant Staph aureus, which first emerged in hospitals in the late ’70s, early ’80s and over the past decade we’ve seen increasingly in the community.

Antibiotic resistance is an increasing public health problem.

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Resistance occurs virtually wherever antimicrobials are used. Many bacteria become resistant to more than one class or type of antibiotics and doctors and nurses are now all too often faced with treating infections with antibiotic options that are limited, or in some cases, nonexistent.

As resistance increases, both the risk of death and health care costs increase.

Addressing each antibiotic resistant pathogen requires a balanced portfolio, a multifaceted approach that would reduce inappropriate use of antibiotics, prevent the spread of resistant organisms, and develop new antibiotics for the future.

Dr. Fauci will speak about the need to continue and accelerate our efforts to develop new antibiotics, but unless we improve our monitoring and use of antibiotics through effective public health action, we will steadily lose the ability to use both current and future drugs.

The next slide shows our approach to combating antimicrobial resistance. It starts with surveillance, understanding what’s happening. Surveillance is key to assessing and monitoring the scope, magnitude, and trs of antibiotic resistance. Surveillance data can drive and direct prevention efforts and determine treatment recommations, guide new drug developments, and evaluate whether our prevention efforts are working.

We need to detect and respond, including through more effective laboratory facilities in hospital, in state and local health departments, and throughout the federal system. We need to develop and implement prevention strategies. An example of this, CDC working with the Veterans Administration hospital in Pittsburgh documented a 60 percent decline in MRSA infections. That same approach was rolled out to the VA system nationally, and then to many other health systems nationally. And although drug resistance is a growing problem, we’ve had some good news in that there has been a documented decline in MRSA nationally by about a half and of methicillin susceptible infections in hospitals by about 70 percent, according to the hospitals that we track over time in the National Health Care Safety Network. And finally, to rigorously evaluate the impact, to see what’s working and what’s not.

In my written statement, I highlighted several high priority antibiotic infections and prevention strategies and the next slide outlines some of those — MRSA, gram-negative rods, gonococcus.

Gonorrheal infections are becoming increasingly resistant in the U.S.

and around the world. Tuberculosis, where infections increase the risk of death and the cost of treatment. Generally, we work to improve antibiotic use, facilitate rapid and accurate diagnosis, improve treatment of infections — and we’ve seen significant progress in reducing inappropriate antibiotic use among pediatricians, improve infection control, and wherever possible, create and distribute vaccines, for example to prevent pneumococcal infections, a vaccine which has prevented about 10,000 deaths and saved more than $300 million in direct medical cost each year over the past decade.

We speak of the pre- antibiotic and antibiotic eras, but if we don’t improve our response to the public health problem of antibiotic resistance, we may enter a post- antibiotic world in which we will have few or no clinical interventions for some infections.

We’re working closely with our colleagues across HHS on this important issue. We very much appreciate the committee’s interest and welcome your questions.

REP. PALLONE: Thank you, Dr. Frieden.

Dr. Fauci?

ANTHONY FAUCI: Mr. Chairman, Ranking Member Shimkus, Mr.

Dingell, members of the committee, thank you for calling this hearing and thank you for giving me the opportunity to discuss with you for a couple of minutes here the role of the biomedical research eavor in the comprehensive strategy to address antimicrobial resistance.

As shown on the slide on the screen, as pointed out so well by Dr. Frieden, the strategy to address antimicrobial resistance includes surveillance, infection control, and the promotion by various means of the rational use of antimicrobials. An important component of that strategy is the biomedical research eavor fundamentally to understand the mechanisms of resistance and to do the basic and clinical research to develop the countermeasures that are needed against microbial resistance.

On the next slide is a picture of a journal in which we have published the research aga of the National Institute of Allergy and Infectious Diseases, which has three major pillars to it — basic fundamental research, clinical research, and transnational research leading to product development.

On the next slide, I want to very briefly address the issue of basic research. Fundamental to the basic research approach is the study of the microbe itself. We have been enormously put at an advantage over the last decade by the striking, if not stunning, advances in the ability to sequence and annotate the genome of microbes.

Just to give you an example, in 1996, when the first microbe Haemophilus influenza was sequenced, it took about a year and about a million dollars. In the year 2000, you can sequence a bacterium for about $50,000 and it would take about four days. Today, you can sequence a bacterium for $1 and it takes just several hours. So we have the capability right now to do sequencing — mass sequencing of microbes as they evolve into their resistant form. This gives us the opportunity of what we’re pursuing very aggressively in our research, is determine the molecular mechanisms of resistance and to use that to target both diagnostics, vaccines, but importantly, the targets for new pipelines of antimicrobials.

In addition, we study the host pathogen interaction, namely how the microbe, be it a virus or a bacteria, interacts with the host and what the body’s immune response is in the form of an immunological response.

On the next slide, we also do clinical research activities.

And as Dr. Frieden has pointed out, we focus on some of the problematic organisms, in this case obviously one that was mentioned several times already this afternoon, methicillin-resistant Staph aureus. In addition, the escape organisms, which are also prone to resistance, are on our top priority.

What do we do with clinical trials? Besides testing new drugs, we determine under certain circumstances is treatment even needed, such as in some of the infections that turn out actually to be viral infections, in which the use of antibiotics might not be appropriate.

We also need to know how much antibiotics we should use and for how long. The appropriate duration of therapy for different types of infections has still not been fully worked out. And importantly, we’re looking for new uses for older off-patent drugs. Drugs that have fallen into disuse because of the more modern antibiotics might actually be brought back into the ball game to treat multiple drug resistant microbes.

On the next slide, it’s a scheme that goes from left to right. I think this is a very important slide that I’d like to just sp a minute on because it’s the scheme of what happens when you develop products for antimicrobials, in this case those that are resistant. On the far left is what the NIH, NIAID in particular, does best and does more intensively. And that is the fundamental research to develop the concepts to, ultimately, on the far right hand side of the slide, to develop countermeasures. These could be diagnostics which are critical in the addressing antimicrobial resistance because you want to know if you’re dealing with a resistant microbe. The other is a vaccine, which some of you have mentioned, to prevent some of the infections in the first place. And then finally, the development of new antimicrobial drugs.

As you go from left to right, industry plays more and more of a role. And as we have seen, the incentive for industry to get involved in the development of new antimicrobials is not very great.

(continues)

(Laughter.) Let me depart from what I was going to do for just a moment because the whole issue of profitability — penicillin is truly a wonderful discovery and Mr. Alexander Fleming appropriately knighted by the king or the queen, appropriately honored with a statue erected by the bullfighters in Spain, but really it was an American manufacturing company — I think it was Pfizer — during the World War II that changed penicillin from kind of a parlor trick that it inhibited bacterial growth on an agar plate to one of clinical utility for thousands and indeed hundreds of thousands of people because of the ability to create a lot of it in the manufacturing process that they developed in the World War II.

You argue if there was truly a profit motive, they would have kept the numbers of doses of antibiotics low and kept the price high.

But they went with the mass production, and as a consequence, soldiers during D-Day were spared life and limb because they head readily available abundant, cheap penicillin, which you alluded to on your slide worked well until darn bacteria figured out that they could chew up that beta-lactam ring and survive quite nicely with their cell intact in spite of the penicillin.

So it’s not always a profit motive. That was a — I’m telling you stuff that you know better than I. This was a seminal event in American medicine. It fundamentally changed the way all of them — subsequently all of us were trained and practiced in the generations that followed. It truly was a life altering event.

But let’s think for just a minute — Dr. Fauci, the new molecular entities for broad spectrum antibiotics that have been introduced by the FDA in the last 10 years, do we have an idea of how many new drugs have been produced, broad spectrum antibiotics?

DR. FAUCI: New antibiotics, very few. I mean handfuls.

REP. BURGESS: I have a list of 10, does that sound right?

DR. FAUCI: That sounds about right.

REP. BURGESS: But I’ve got — my staff has gotten me about 25 pages of antibacterials that have been approved for new indications. You referenced that in your slide, new chores for old drugs that we might find. But these older drugs not necessarily helping us fight the war against resistance; they’re just an antibiotic that was found to have an indication for something else.

So the problem is if there’re only two — 10 truly new antibiotics produced in the last decade and then another document that tracks $92 million in federal research, at your institute, Dr. Fauci, in Fiscal Year ‘09 alone, on antibiotic research. Does that sound like a fair figure?

DR. FAUCI: No, actually on antimicrobial research we do about — (off mike) — research on resistance specifically we do about $200 plus.

REP. BURGESS: Okay, so my numbers were low.

DR. FAUCI: Right.

REP. BURGESS: So the taxpayers are pumping in a lot into the pipeline and we’re getting out of the other approximately the average of one new antibiotic a year? Is that the — am I making the correct — well, I would just ask a question. Do we have a problem with — sounds like we have a problem with the pipeline? So where in the pipeline is the problem? Is it the dollars we’re pumping in? Is it the research we’re putting into it? Is it the FDA? Where is the problem in the pipeline?

DR. FAUCI: Well, Mr. Burgess, the problem in the pipeline is right in the middle of that arrow that I showed in one of my slides.

And that is that the pharmaceutical companies, as much as we can do research, we can sequence now as I mentioned — I mentioned that for a reason. We can sequence 1,000 microbes for a reasonable price really, really quickly. We can pinpoint all of the different targets that could serve as a target for the development of a drug. There is not an overwhelming incentive on the part of companies to get involved in developing a new antimicrobial.

And that’s the reason why in the answer to the question of Mr. Waxman I emphasized that there’re a lot of issues that go into why we don’t have a lot more drugs for the amount of fundamental research money that we put in. But one that’s really paramount is to get the companies involved and incentivized into wanting to make them. And I don’t have the complete answer for that. We’re trying the things that I mentioned in response to Mr. Waxman’s question, but we need to do better than that. REP. BURGESS: Yes, I do not want to cut you off because I know your position in the scientific world and mine, so — and — but I need to ask you this. So market incentives, are those always dollars or are there changes we can make at the regulatory level that would help the environment?

DR. FAUCI: The FDA right now is putting a considerable effort in pushing what is referred to now as regulatory science, in other words to get them involved in developing bioassays, biomarkers, new clinical trial designs that would facilitate the development of any product, including a product that’s geared against a resistant microbe. So there is something we could do at the regulatory level.

And the FDA is really trying very hard to push that aga.

REP. BURGESS: Well, I’m going to ask Mr. Shimkus’ question because I can’t help myself. Then we put a $27 billion new tax on to the industry under the health bill, so is that likely to have a positive or negative effect on the pipeline problem that we have?

Okay, we’ll go to the next question. (Laughter.) Does your institute track how much of their research invested has translated into applications and approvals at the FDA? So what kind of data does the National Institute of Allergy and Infectious Diseases have that could be shared with this subcommittee?

DR. FAUCI: When you say information, everything we do is transparent. You can get any information that you want. But I think you were asking — REP. BURGESS: About the applications and approvals that then go over — the applications that go over to the Food and Drug Administration, and then the approval of those applications that come out at the other .

DR. FAUCI: — as a product.

REP. BURGESS: As a product.

DR. FAUCI: See, that’s a question that’s difficult if not impossible for me to answer because we don’t control the concept of product. We do fundamental research that might develop a concept that can be pushed to the preclinical. But if we were solely responsible for soup to nuts, I could give you an exact answer.

REP. BURGESS: All right.

DR. FAUCI: But we’re not. We have to point it to the pharmaceutical companies. That’s the point.

REP. BURGESS: But it just seems — the slide that one of you showed with the methicillin-resistant Staph aureus and the numbers going up and now community acquired, I think it’s a huge problem in jails. I think it’s a huge problem in dormitories and homeless shelters. It seems like the market is being created. None of the companies are interested in being the first one to cross the finish line with the silver bullet that wipes out MRSA? Where is the Paul Ehrlich of our generation?

DR. FAUCI: I would think personally that a company would be very interested in getting in it. They balance the risk for the benefit. And as I mentioned, there is a considerable risk for a company to put several hundreds of millions of dollars to develop a product. And what I would be proposing is that somehow we in the federal government help alleviate that risk by doing some of the things that I mentioned we can do, but we’re not the only player in this.

REP. BURGESS: Let me just ask you a quick question of hospital acquired infection.

DR. FAUCI: No, no, no. But I’m going to try and explain that — REP. CAPPS: All right.

DR. FAUCI: — we can get away from the mixed messages by compartmentalizing it. You try as best as you to prevent the emergence of resistance by the public health measures that Dr. Frieden spoke about. REP. CAPPS: Yes.

DR. FAUCI: Unfortunately, we are in a position where there are resistant microbes out there that we are up to the last line of defense with one and at the most two antibiotics that are useful. So there is a clear need to fill — to feed into the pipeline for antimicrobials. So I look at it as not a mixed message. We need to do two things simultaneously.

REP. CAPPS: Great.

DR. FAUCI: We need to put the lid on the evolution and the development antimicrobial resistance and then we’ve got to have a pipeline of drugs that take them. So the message is we’ve got to get more antibiotics, but we’ve got to prevent further evolution of resistance.

REP. CAPPS: Do you have a public message that you’re putting out for the public on ways to not go and keep asking your doctor for something for a sore throat and so forth — that kind of thing. Is that being done?

DR. FAUCI: Definitely, yeah.

REP. CAPPS: Like, PSAs and so forth.

DR. FAUCI: Yes.

REP. CAPPS: Okay. That’s — I’ll assume that’s happening.

And now from the other side, because I want to get at the concern that has been raised about, you know — I appreciate the history of the story of the development of penicillin. But pharmacology, pharmaceutical companies are very much working from more of a profit motive today than perhaps they were when some of these initial antibiotics came onto the market just because they were out their way to be developed.

Dr. Fauci, can you elaborate on the pathway that you illustrated in your slides from basic research to private development.

I like to know how you’re collaborating with private industry in this area, which you noted isn’t necessarily the first area of private — that private industry would like to invest on. In other words, you really want some — you know, some antibiotics to fight these resistant — to fight the MRSA and other resistant diseases. How can you — how can we incentivize them to do this?

DR. FAUCI: Well, I can give you actually a concrete real- time, real life example of how we’ve done that with one particular finding since we are involved fundamentally in pursuing and supporting basic research for concept development.

REP. CAPPS: Great. DR. FAUCI: We have funded a group of investigators from several of our centers and they have found a small molecule which has the capability of inhibiting essentially any virus that has a lipid component to its envelope or its outer coating, potentially a really, really important advance. They have no — REP. CAPPS: Where did you do this? At NIH, you’ve done this?

DR. FAUCI: We funded them at a university.

REP. CAPPS: Okay, great.

DR. FAUCI: They made the discovery. So how we’re partnering with industry and biotech is that we are providing the resource reagents, the animal models, the capabilities to do a phase one clinical trial for those investigators and hooking them up with biotech companies and then ultimately pharma in order to take what was just a concept into something that might actually be a product.

And when I hope this comes to fruition of a product and if and when it does, we’re going to provide the clinical trial capabilities to test it in people to see if it works. So we’re really forming a partnership that goes right from the investigator who makes the original observation and develops the concept up through and including the translation of that through biotech and industry.

REP. CAPPS: And you have the commitment from biotech and industry to — because they see the kind of research that you’re incentivizing at the university level, if you will, and so they’re committed already, that they’ll take — DR. FAUCI: We hope that they’re committed and stay in the game. If we make — and this is the point I was making in answer to several questions — REP. CAPPS: Right.

DR. FAUCI: If we can facilitate that difficult process from concept to product by anyway we can, by making our assets available, other things beyond our control such as financial incentives, et cetera, it makes that transition from concept to product much easier.

We play an important but not an exclusive role in that. There are other components that have to come in to do that.

REP. CAPPS: Thank you very much. That’s helpful.

I have a question for you, Dr. Frieden, but I’m out of time.

So we’ll wait for the next hearing. Thank you very much.

Thank you.

REP. PALLONE: Thank you. The gentlewoman from Florida, Ms.

Castor.

REP. CASTOR: Thank you, Mr. Chairman.

I’m interested in whether or not you are able to accumulate enough data to track what is obviously a major public health issue — one that has deadly consequences for so many. When I look at the estimates, we have estimates in a number of antibiotic resistant infections and then we have estimates in the number of health-care associated infections, the CDC’s most recent data is that in the U.S.

every year, it’s about two million hospital-related infection and about 90,000 Americans die from that. Then the other one included in our materials, in America there are — anywhere about 94,000 cases of MRSA every year with 18,000 deaths from MRSA.

And doctors, do these figures sound about right for you, that is it fair from the figures to conclude that over 100,000 Americans die each year due to antibiotics resistance?

DR. FRIEDEN: Large numbers — that estimate that you gave was 90,000 which is an estimate that’s years before. As I indicated in my opening statement, there has been progress with MRSA where we’ve seen a decrease of about 50 percent in serious infections in the hospitals that participate in the National Healthcare Safety Network.

REP. CASTOR: So how is the data collected for you to compile these numbers and estimates?

DR. FRIEDEN: We have two major methods. The one that’s more widespread is the National Healthcare Safety Network that builds on really more than a decade of experience working with hospitals, working with infection control practitioners, standardizing definitions, encouraging reporting, and now we have 28 states which mandate reporting 21 of them use the NHSN infrastructure to report.

And about half of all hospitals in the United States currently are on board, including many hospitals in states that don’t require reporting publicly yet. And that reporting we expect to see expand nationally over the next couple of years.

REP. CASTOR: Why — why would states not mandate that? And why would hospitals not?

DR. FRIEDEN: It’s a recent phenomenon, so five, ten years ago no state mandated it. Again, a few states, it’s been gradually spreading. It is concerning to hospitals, they’re worried about reporting from reputational risk and the approach has been to make clear that reporting is a good thing because it helps us to identity problems and then address them.

REP. CASTOR: So with the estimates you have now, do you — knowing that there — some has not reported and some states don’t mandate it — do you extrapolate? DR. FRIEDEN: Yes, these are extrapolated from both NHSN and also a network called the ABC, which allows us to monitor antibiotic resistance to a series of core infections in our representative sample across the country.

REP. CASTOR: Should it now become a reportable disease?

DR. FRIEDEN: Certain strains of antibiotics resistant organisms are mandatorily reportable. There are some that are so common that reporting probably wouldn’t be worth the burden and sampling may be more effective. But for many organisms, reporting — mandatory reporting is something that’s recommed by the councilor state and territorial — (inaudible) — and it’s done in most or all states.

(continues)

REP. CASTOR: It sounds like we can do a lot better. What are you working on or what recommations do you have to improve reporting so that we’re able to track with adequate data?

DR. FRIEDEN: Thank you. They’re all excellent questions.

One of the things that we have done is to try to use electronic health records to extract information which then is validated by human being that would allow us to ensure that infections are reported reliably or assess the completeness of reporting. One of the things that’s essential to make that happen is electronic laboratory reporting. So when a laboratory gets a result, it s up in the medical record. If it’s a reportable condition, it s up with the authorities to — which it should be reported.

We also fundamentally we need to make better use of the information so that we implement the programs that we know work. And there’re some programs that we know can drastically reduce central line-associated infections and other hospital-associated infections and that we continue to generate knowledge so we can better prevent problems that we don’t yet have good tools to prevent, such as, community-associated methicillin-resistant staph aureu.

REP. CASTOR: Doctor, you want to comment on the data track?

Well, I wanted to say in my district back home, we have a researcher that’s working on the antibiotic resistance and he — and this is Dr.

Turro at the University of South Florida. And his research is MRSA- based and he is particularly looking at the design and development of nanoparticle-based technology for drug delivery. But he has — in his comments to me in advance of this hearing, he was right on point with what you all are saying of what happens from the basic research level and then turning that into some kind of new antibiotic — that’s a real issue and along with the lack of funding at NIH, CDC and DOD — (inaudible) — said that’s practically non-existent where you simply cannot get the private companies to take any interest.

Thank you very much.

REP. PALLONE: Thank you. Gentlemen, Mr. Shimkus wanted to ask additional question and then if anybody else does, I’ll allow it because I don’t want to have another round, but I know there’s a great deal of interest here. So recognize the gentleman from Illinois.

REP. SHIMKUS: Thank you. And I’m just — you know, we’ve talked about the CDC, NIH, FDA, USDA and then through this hearing, I remembered that the copper industry had been working with the Department of Defense to test copper as an anti — how you say it? The killer, antimicrobial killer. And so EPA has just certified deep — the Environmental Protection Agency approved the registration by the Copper Development Association for copper and copper allies to make public health claims as being antimicrobial. These claims acknowledge the fact that copper is inherently capable of killing bacteria. Have you guys done any look at that? And should you? Is that something that CDC or NIH or is this a problem? I mean, the federal government is huge and we’re doing different things but — DR. FAUCI: Well, let me try to answer it in a way. It may not be the direct answer that you’re asking for, but there’re a lot of elements that can have antimicrobial activity. The question is to get into a drug that would not be toxic. That’s the — REP. SHIMKUS: Yeah, but this is making a claim that copper being used on surfaces kills microbes. This is what — and this is — I think we’ve had terrible hours doing research in DOD through the Department of Defense. All I would say is think, you know — REP. PALLONE: You want to get back to it?

REP. SHIMKUS: That’s out there, the EPA — the EPA has said that they can make that claim.

REP. PALLONE: Right. Why don’t you ask them? Why don’t you get back to us?

REP. SHIMKUS: Okay, will do.

REP. PALLONE: All right. Ms. Capps, did you want to ask your additional question?

REP. CAPPS: (Inaudible.) But — and I don’t want to keep you because you’ve already waited most of the afternoon anyway. But my question — and it kind of ties in with before I can come up in another hearing we might have as well, I was just concerned — curious if because according to the National Antimicrobial Resistance Monitoring System data — and that is a mouthful — about 80 — at least 80 percent of meat and poultry products are tainted with some kind of antibiotic resistant bacteria, it says, a study that has been out there.

What — can I use that as a basis of fact then? Is that a fact?

DR. FRIEDEN: I’m not familiar with that specific statistic.

REP. CAPPS: Okay. Well, maybe it’s in the — we’ll make the assumptions then. This is a National Antimicrobial Resistance Monitoring System data and they did state that at least 80 percent of meat and poultry products are tainted with antibiotic resistant bacteria — tainted — I don’t know what level.

My question was that — what bacteria are we testing for in our food? Are we doing any kind of antibiotic resistant pathogens like staph, or like MRSA, methicillin-resistant staph, MRSA? Is it possible to test for any markers or any kind of fact that this might be in food products?

DR. FRIEDEN: These are all relatively easily tested for in small quantities. If you want to test large proportion of the foods obviously are logistical and financial implications. This really is territory of the FDA.

REP. CAPPS: I know, I understand that. But just from the science point of view — and you’ll have to agree that the study — (inaudible) — this is something — DR. FRIEDEN: I’m not disagreeing with you. I just don’t have the statistics.

REP. CAPPS: Right. We can just take that off the table.

But supposing something like that is true, there is science to be able to pick up markers and tests within food products. And again, I’m not suggesting that we should because I understand — and this belongs to another department. But there is concern about the spread of MRSA and whether or not it’s there and there is a possibility that some research in another department like Food and Drug Administration could do this.

DR. FRIEDEN: Yes.

REP. CAPPS: Okay.

DR. FAUCI: It’s scientifically possible. It’s a logistic issue. The FDA — REP. CAPPS: I agree. DR. FAUCI: — a very difficult to ask the FDA to test broadly — and they only have the capability and the logistic capability exacting a very small fraction.

REP. CAPPS: Exactly.

DR. FAUCI: Right.

REP. CAPPS: Thank you very much. And that completes.

REP. PALLONE: Vice, thank you.

Dr. Burgess, do I dare ask if you have another question?

(Laughter.) REP. BURGESS: Of course, you can. I just like to hear from one or both of you, just what are some of the things that you see over the horizon, just very quickly that this committee should be aware of.

Dr. Fauci, you referenced a couple of things with the genomics and being able to sequence things very rapidly. We didn’t really get into the diagnostic — the diagnostics part of this, haven’t really talked about the vaccine part of this. But just very briefly what’s over the horizon that you guys see on a daily basis that we wouldn’t be aware of?

DR. FRIEDEN: I think in terms of practice, the first thing is scale off the proper means of reducing hospital-associated infections and reducing an appropriate antibiotic use. This is something which we’ve made progress in but we could make a lot more progress in. And I have to say because there’s been a lot of discussion of antibiotics in animal feed and use for growth promotion data efficiency, that — we do not consider use to promote growth an example of judicious use of antibiotics.

I think the directions we’re going are, first, to apply the things we know well to reduce infections and I think we have a lot farther to go there. And second, to continue to generate knowledge on how we can reduce infections through programs such as hospital associated programs, electronic health records, reminder systems, control systems that will support doctors in restricting use of antibiotics and as Dr. Fauci mentioned, point of care diagnostics which are very important in helping a doctor know right there — the kid doesn’t have strep throat, you don’t have to treat him for strep throat.

(continues)

Testimony by Rep. Waxman, Henry – (D-CA) – April 28, 2010

Mr. Chairman, thank you for holding this hearing on one of the most pressing public health issues we face today – the rising tide of antibiotic resistance.

From hospitals at home to battlefields in Iraq and Afghanistan, Americans are more vulnerable than ever to infection because of the growing resistance to critical antibiotics.

Antibiotics irrevocably changed public health for the better.

From the discovery of penicillin in 1927 by Dr. Alexander Fleming, antibiotics forged a revolution in public health.

Before we had antibiotics, common skin infections could turn fatal. Childbirth could be a death sentence for both mother and baby. And a superficial wound could deteriorate rapidly, often resulting in amputation.

Antibiotics changed all that. With the discovery of these medicines, doctors could readily treat infection and literally, save lives. The modern age of medicine was launched.

Some 80 years later, this medical miracle is still saving lives. Without antibiotics, many of today’s cancer protocols would be nearly impossible to use – patients whose immune systems are severely compromised by the treatments would quickly die from opportunistic infections without these medications. Tuberculosis and other respiratory infections would be killing young and old alike. And surgeries that are now commonplace – procedures such as hip replacements or angioplasty – would be much more dangerous because of the possibility of the development of an untreatable infection. In brief, we cannot do 21st century medicine without antibiotics as an effective component within our collective medical toolkit.

Shockingly, experts tell us we are on the precipice of losing the power of many of today’s antibiotics. As greater numbers of bacteria become more resistant to them – for reasons we will explore this afternoon – antibiotics, in turn, become less effective, making infection far more hazardous to health. Indeed, public health officials are increasingly warning that the escalation in antibiotic resistance is threatening to return us to the days before Dr. Fleming’s discovery.

This is not exaggeration or hyperbole – or even the stuff of some hypothetical computer model. Too many Americans have already succumbed to our inability to treat infections. The numbers are staggering:

? Over 90,000 Americans die each year of deadly hospital-acquired infections, which are predominantly caused by antibiotic resistant bugs.

? Over 18,000 Americans, including healthy young people, die annually of methicillin-resistant staphylococcus aureus, also known as MRSA.

? We’ve seen soldiers defeat deadly enemies in Iraq, only to return home with an epidemic of deadly antibiotic-resistant acinetobacter, an infection that is extraordinarily difficult to remedy.

Today, we will learn about the impact of antibiotic resistance on human health from two of the nation’s leading experts on infectious diseases: Dr. Tom Frieden, Director of the Centers for Disease Control and Prevention, and Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at NIH.

As we do, I hope we can start to understand and appreciate the severity of the problem we face and together, work toward a public-private plan of attack. Because the status quo simply cannot be an option. To accept that as our standard of care would risk setting American medicine back to a time long gone. Instead, it will take a strong, multi-faceted, yet coordinated strategy to get the job done. I hope today’s hearing will begin to set us on that path.

I consider this to be one of the most important public health issues we confront today.

I thank the witnesses for coming today and look forward to their testimony.

Lee Ann Torrans
ltorrans@gmail.comLee Ann Torrans
ltorrans@gmail.com