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Nachreiner 1 Matthew Nachreiner Dr. Quinn Microeconomic Public Policies 8 December 2016 Pathway to Solve the Antibiotic Resistant Bacteria Problem Introduction to the Problem Figure 1 (Source: Cooper, 2011). Our efforts to address the rise of antibiotic resistant bacteria (ARBs 1 ) have been lackluster. Figure 1 illustrates the increasing level of resistance in just 3 ARBs over a thirty-year period (1980 2010) and it seems to continue to rise. If we aren’t able to halt antibiotic resistance bacteria, we will lose antibiotics as an option to cure bacterial infections. More importantly, the lack of antibiotics to address bacterial infections would render modern advances 2 such as surgery, transplants and chemotherapy unviable useless due to the threat of 1 See Appendix to see the abbreviations/acronyms spelled out. (Page 18) 2 Without effective antimicrobials for prevention and treatment of infections, medical procedures such as organ transplantation, cancer chemotherapy, diabetes management and major surgery (for example, caesarean sections or hip replacements) become very high risk” (World Health Organization).
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Antibiotics Public Policy

Feb 07, 2017

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Page 1: Antibiotics Public Policy

Nachreiner 1

Matthew Nachreiner

Dr. Quinn

Microeconomic Public Policies

8 December 2016

Pathway to Solve the Antibiotic Resistant Bacteria Problem

Introduction to the Problem

Figure 1 (Source: Cooper, 2011).

Our efforts to address the rise of antibiotic resistant bacteria (ARBs1) have been

lackluster. Figure 1 illustrates the increasing level of resistance in just 3 ARBs over a thirty-year

period (1980 – 2010) and it seems to continue to rise. If we aren’t able to halt antibiotic

resistance bacteria, we will lose antibiotics as an option to cure bacterial infections. More

importantly, the lack of antibiotics to address bacterial infections would render modern

advances2 such as surgery, transplants and chemotherapy unviable useless due to the threat of

1 See Appendix to see the abbreviations/acronyms spelled out. (Page 18) 2 “Without effective antimicrobials for prevention and treatment of infections, medical procedures such as organ

transplantation, cancer chemotherapy, diabetes management and major surgery (for example, caesarean sections or

hip replacements) become very high risk” (World Health Organization).

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infection. This is a major cause for concern as society used roughly 38 million pounds of

antibiotics in the agriculture and healthcare sector combined in 2011 (Philpott). Legislation in

antibiotics is only now starting to be passed as ARBs are relatively new surfacing over the past

60 years. 3 In 2014, the Obama Administration issued the Executive Order on Combating

Antibiotic Resistance Bacteria (CARB) and funds were allocated to the Centers for Disease

Control (CDC) to initiate action only this year. CARB hasn’t been able to implement a strategy

to tackle the core issues: 1) the lack of a protocols and tracking on antibiotic use and negative

externalities of Obamacare’s policies, 2) the widespread use of antibiotics in livestock

production (as a growth supplement) and 3) the lack of antibiotic alternatives due to absence of

research and investment over the last three decades.

Due to the lack of a permanent and cohesive protocol throughout the healthcare sector for

the use of antibiotics and prevention of ARBs, doctors have oversubscribed antibiotics and

administrators in public institutions have failed to contain this growing problem. Figure 2 shows

how ARBs are also passed from animals to humans due to the widespread use of antibiotics in

the food industry to promote growth in food-producing livestock. To solve this issue, the

pharmaceutical industry, which has significantly reduced antibiotics research evident by 4

companies left in the market in Figure 1, has to produce more drugs of increasing strength to

manage the impact of ARBs. While, developing new innovative alternatives to antibiotics. As

stated by Tom Frieden, Director of the CDC: “Every day we don’t act to better protect antibiotics

will make it harder and more expensive to address drug resistance in the future. Drug resistance

can undermine both our ability to fight infectious diseases and much of modern medicine.

3 Case Study: Timeline of an ARB. University of Chicago Medicine developed the timeline of Methicillin-resistant

Staphylococcus aureus (MRSA). General Synopsis: First Outbreak in Boston in 1968, Large Outbreak in 1981,

Epidemic in 1998.

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Patients undergoing chemotherapy for cancer, dialysis for renal failure, and increasingly

common treatments for diseases such as arthritis depend on antibiotics so common infectious

complications can be treated effectively” (Dr. Frieden 5).

Figure 2 (Source: Frieden, 2013:15).

Brief History of Antibiotics and How Bacteria Become Antibiotic-Resistant:

Antibiotics were discovered by Sir Alexander Fleming and used to treat infections or

diseases caused by bacteria. Due to their effectiveness, they have increasingly been deployed

beyond human applications such as the agriculture sector where antibiotics are deployed to keep

livestock healthy by inhibiting the growth or destroying microorganisms. Figure 3 depicts how

bacteria become resistant to antibiotics. The antibiotics kill certain strains of bacteria, the

genetics of these strains are selected against and removed from the population. Conversely, the

genetics of the strains of bacteria that survive the antibiotics are selected for and grow in

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abundance in the population. The ARBs render the original antibiotic useless and forces

scientists to produce new antibiotics capable of destroying resistant-antibiotic bacterial genes.

The overall theme of this mechanism is evolution and it has started a vicious, endless cycle.4

Figure 3 (Source: Frieden, 2013:15)

Economic Impact to Society:

In 2010, the Obama Administration addressed the impact to society of healthcare costs

with the Affordable Care Act (ACA)5. Still, the overall healthcare spending across the economy

has reached 18.2% of gross domestic product still significantly more than the Organization for

Economic Cooperation and Development (OECD) average (Sussman). ARBs are a prime

contributor to rising healthcare costs because its expensive treatment and readmission of patients.

The health and economic impact of ARBs6 estimated by CDC in the United States (2013): “At

least two million illnesses and 23,000 deaths are caused by antibiotic-resistant bacteria in the

United States alone...Antibiotic resistance adds $20 billion in excess direct health care costs,

4 Case study of an ARB Defensive Mechanism- MRSA. The following sources, RxList and Postgrad Med (Look at

References Section), go into hard science behind the defensive mechanism for MRSA. 5 The following source, United State Department of Health and Services (Look at References Section) has more

information regarding ACA. 6 For in-depth information regarding individual ARBs cost to society look at Dr. Frieden’s article that entails CDC

report about Antibiotics (Page 51-89). For example: Clostridium Difficile: Costs over $1 Billion in excess medical

per year, 14000 deaths, and 250000 hospitalizations.

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with additional costs to society for lost productivity as high as $35 billion a year.” (Dr. Frieden

11). On a microscale, there was a case study in Chicago that looked at the impact of ARBs in a

hospital setting where “the cost (of an ARB) per patient ranged from $18588-29069, increased

hospital stays by 6.4-12.7 days, attributable mortality increased by 6.5%, and societal costs were

$10.7-15.0 million” (Roberts).7 Table 1 breaks down every party that is affected by ARBs. All

the costs mentioned above are being distributed across all these parties.

Table 1 (Source: McGowan 2001:1)

Goals of National Strategy for CARB

1. Slow the Emergence of Resistant Bacteria and Prevent the Spread of Resistant Infections

2. Strengthen National One-Health Surveillance Efforts to Combat Resistance

3. Advance the Development and Use of Rapid and Innovative Diagnostic Tests for

Identification and Characterization of Resistant Bacteria

4. Accelerate Basic and Applied Research and Development for New Antibiotics, Other

Therapeutics and Vaccines

5. Improve International Collaboration and Capacities for Antibiotic Resistance Prevention,

Surveillance, Control, and Antibiotic Research and Development (CDC)

The CDC is allocating $160 million to stop ARB in 2016 and $40 million in 2017 against a

total budget of approximately $7 billion (CDC). Prominent Public Health experts agree that

ARBs threaten modern medicine, but the actions to combat them are inadequate. Mae Wu, a

7 The study also looked at the impact if they reduced the ARBs levels by 3.5% in their hospital setting. They found

that the hospital would have saved $910,812, and the societal savings for reduced mortality and lost productivity

would have been $1.8 million.

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Natural Resources Defense Council (NRDC) attorney issued the following quote, “It’s great that

the President has elevated [the problem of antibiotic resistance] to this level, and the White

House is really talking about the problem and developing a plan over the next five years about

how to do it,” she says. “But it’s disappointing that they are being so passive on one of the

largest issues – the largest use of antibiotics in this country [in agriculture]” (Parks). In addition,

Venki Ramakrishnan a Nobel prize winner from the Laboratory of Molecular Biology at the

University of Cambridge pushed for a larger governmental role: “So I think that governments

really need to get involved in the development of new antibiotics. They have to think of this as

something generally good for society, the same reason that governments fund education, roads,

police, defense and so on. This is one case where governments need to act” (Moskvitch). Second,

the stated goals of CARB8 are simply too broad to bring solutions in a timely manner. The core

problem is that we must stop, or at least slow, the rate of growth of ARBs and, most critically,

create an alternative to antibiotics. As we finally start to address this problem, we need to over-

emphasize spending and activity on Goals 1 (Slow the Emergence of Resistant Bacteria and

Prevent the Spread of Resistant Infections) and 4 (Accelerate Basic and Applied Research and

Development for New Antibiotics, Other Therapeutics and Vaccines).

Modified National Strategy

In addition to requiring stronger funding, there are three main ways to overcome ARBs

economic and health impact on society:

1) Protocol

- Make Antimicrobial Stewardship Program (ASP) a federal mandate

- Properly educate our patients on antibiotics and look into prevention strategies.

- Remove patient satisfaction rating from the physician payment system formula that was

incorporated under the ACA to increase quality of healthcare

8 For example, one of CARB’s measured outcomes was reducing “inappropriate inpatient antibiotic use for

monitored conditions/agents will be reduced by 20% from 2014 levels” (CARB 9). The CARB failed to mention

how they would be able to measure this outcome.

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2) Elimination of Antibiotic Use for Growth Promotion in Animals in Agriculture

- The Food and Drug Administration (FDA) should make “Guidance for Industry (GFI)

#152”9 law that clearly that the bans the use of medically human important antibiotics for

growth promotion in agriculture. The law should be implemented over time for the

industry to adjust, although consumers have been demanding more antibiotic free

poultry/meat over the years. Companies that have made that transition could serve as case

studies.

3) New Antibiotics, Antibiotic-Free Alternatives, and Amending Obamacare

- The markets and the government have to restructure regulatory policies and incentivize

the development of new antibiotics.

- Actively develop antibiotic-free alternatives

Protocol on the Usage, Amending Obamacare, Patient Education of Antibiotics,

Prevention:

Public health institutions such as the IDSA (Infections Diseases Society of America)

along with the Obama Administration have started to take steps to cut back the excessive usage

of antibiotics that have led to the antibiotic resistance bacteria. The CDC has estimated: “up to

50 percent of all the antibiotics prescribed for people are not needed or are not prescribed

appropriately” (Dr. Frieden 15). The most significant step is the implementation of the ASP that

wants to coordinate the entire healthcare sector (private or public) to administer proper usage of

antibiotics that maintains its effectiveness and increases efficiency within the sector (Bakken).

The ASP would rely on CDC’s core elements. The core elements involve leadership

commitment, accountability, drug expertise, action, tracking, reporting, and education. The

public health institutes need to look at hospitals that have opted into the program and learn from

them to increase the efficiencies of future programs across the country. By publishing the results

behind these case studies, government agencies would be able to push forth a proposal for a

federal mandate for ASPs across the country.

Pew Trusts analyzed case studies and came away with important guidelines for the

successful implementation of ASP’s: “Someone within the institution who strongly believes in,

9 For more information regarding this GFI, refer to the following source FDA on the references section.

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and is committed to, antibiotic stewardship. Shared responsibility for monitoring the program

and implementing new interventions” (Talkington). These characteristics motivated the hospital

to sustain their ASP, along with results that justified the costs of the program. One case study

proved that the cost savings created by the ASP outweighed the initial costs of implementing it.

St. Tammany Parish Hospital in Covington, Louisiana carried out an ASP that required

employees to complete stewardship training and the information technology manager created a

computer-assisted surveillance program that held physicians accountable for their decision

making. Physicians were aided by the installment of ASP recommendations on their medical

software prior to administering antibiotics to their patients. In addition, the hospital held weekly

meetings to discuss appropriate antibiotic selection and dosing. All their efforts culminated in

reducing daily doses per month of all antibiotics by more than 61%. Furthermore, the adjusted

total antimicrobial cost per adjusted patient-day peaked at $25.93 in October 2012 and was

reduced to an average cost of $8.32 per patient-day after ASP implementation. Since its

inception in July 2013, the ASP’s review of antimicrobial use has resulted in a total savings of

$1.3 million through December 2014. The cost savings generated by the ASP in the first year

alone more than offset the staff time devoted to ASP activities (Talkington).

The ACA aimed to improve the quality of healthcare by tying patient satisfaction into the

formula for physician payment. The Obama Administration argued that this portion of the ACA

would hold physicians accountable to their patients. For instance, Dr. Miller from the University

of Utah Hospitals & Clinics in Salt Lake City saw, “A big turnaround for our institution” in

terms of bedside manner to being attentive to basic needs. However, this creates a conflict of

interest in solving the ARB problem. Professor Hoff points out that a “provider giving a patient

an unnecessary antibiotic simply because it will earn him or her a better rating” (Wolinsky).

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Unfortunately, the patient satisfaction component of the physician payment system has

created a negative externality by incentivizing physicians to provide antibiotics to a patient

in order to get a better rating and higher pay, even though that isn’t the treatment that patient

needed.10 This leads to the oversubscription of antibiotics and in the long run economic and

health costs to society due to resistance. The next Presidential administration must take patient

satisfaction out of the formula for physician payment to avoid oversubscription of antibiotics.

In addition to the concerted effort from the public health institutions, the physicians need

to educate their patients on antibiotics and the treatment plan. A study published in Society for

Healthcare Epidemiology of America, concluded that complying with the physician’s antibiotic

treatment plan significantly reduces the spread of a particular ARB, MRSA. They looked at 223

households in southeast Pennsylvania, who contracted MRSA and were prescribed antibiotics,

founded that those who stuck to the antibiotic treatment guidance by the physician were able to

completely wipeout MRSA in 4 days faster than non-compliant households11. This study points

out the importance of antibiotic education. For example, many patients stop using antibiotics

once they start to physically and mentally feel better. However, the bacteria aren’t necessarily

eradicated and can come back if the patient fails to carry out the physician’s antibiotic schedule

completely. Furthermore, the patient’s negligence can foster a population of antibiotic-resistant

bacteria that not only renders the original antibiotic useless, but could potentially put their health

in danger (Society for Healthcare Epidemiology of America).

In addition to patient education and protocol on antibiotics, healthcare facilities can also

engage in prevention strategies. For example, the Veteran Affairs Medical Center (VAMC)

10 Hard to find data regarding this claim because the physician would be criticized by public health experts.

However, this is important to point out because in theory it incentives the physician to act against the public good. 11 4 more healthy days to a patient may make them more productive in the workforce, which leads to an increase in

income.

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wanted to prevent hospital acquired MRSA. They implemented a national initiative to prevent

MRSA. The VAMC took on a bundled approach: “screening every patient for MRSA, use of

gowns and gloves when caring for patients colonized or infected with MRSA, hand hygiene, and

an institutional culture change focusing on individual responsibility for infection control. It also

created the new position of MRSA Prevention Coordinator at each center” (Evans). After four

years of the national initiative, the VA saw a 36% decrease in MRSA infection rate (Evans).12

All hospitals can learn from the Veteran Affairs Medical Center’s case study that utilized a

prevention strategy that significantly reduced the spread of ARB diseases in a healthcare facility

setting13.

Eliminate Antibiotics for Growth Promotion for Animals

The food industry accounts for close to 80% of all antibiotic usage in the US and has

been slow to accept responsibility for their contribution to the ARB problem (ConsumerUnion).

The industry argues that the use of antibiotics on livestock only contributes to the ARB problem

in livestock-essentially it is isolated to their own community. The CDC, Food and Drug

Administration (FDA), World Health Organization (WHO), and other reputable scientific

organizations have testified that antibiotic usage in animals leads to antibiotic resistance in

humans. Dr. Thomas R. Frieden, Director of the CDC, noted that “there is strong scientific

evidence of a link between antibiotic use in food animals and antibiotic resistance in humans”

(ConsumerUnion).

12 The article didn’t give any CBA analysis of the national initiative. It is safe to assume that the benefits

outweighed the costs because the VAMC expanded the strategy to 133 long-term care facilities across the US. 13 Sherwin Williams has created a product, Paint Shield Microbicidal Interior Latex paint, that can kill ARBs that

comes into contact with the painted surfaces. This product is EPA-registered. (Look at References Section)

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Figure 2 clearly shows the ARB’s can enter humans through direct consumption of

contaminated meat and environmentally from the agriculture employees and facilities. In fact, 14

Consumer Reports tested retail poultry and found that more than ⅔ of the samples were

contaminated with more than 60% of the bacteria resistant to one or more antibiotics

(ConsumerUnion). The counterargument from industry is that people know how to thoroughly

cook poultry to avoid this threat. While this is a valid argument, we have seen 2 outbreaks

serious enough to involve the CDC - one that required that 36 million pounds of turkey15 to be

recalled (ConsumerUnion).

Given the high stakes involved in stopping ARB and strong scientific evidence showing

the links between animals and humans, we have to take stronger action to eliminate the use of

antibiotics medically important to humans for growth promotion in animals. This means that the

US government should make FDA’s GFI #152 not a recommendation that results in voluntary

cooperation by the companies, but rather a law that allows time for these companies to transition.

The argument from the agriculture and pharmaceutical community is that antibiotics are

needed to prevent disease. The GFI addresses this issue by allowing antibiotics by prescription

from a veterinarian. 16GFI #152 will not have a major impact on the agriculture industry as firms

have been in tune with consumer trends over the years. A case study done by the non-profit

organization, NRDC, looked at this phenomenon in greater detail. A Consumer Reports survey17

revealed that 86% of consumers wanted antibiotic-free meat and poultry in their local

14 White examined the impact and cases of meat that contains ARBs consumed by the population in the following

article, “The Isolation of Antibiotic-Resistant Salmonella from Retail Ground Meats”. 15 Cargill’s ground turkey contained multi-resistant salmonella that caused 77 illnesses. Bottemiller goes into more

detail about this incident in the following article, “Cargill Recalls 36 million pounds of ground turkey”. 16 In Nordrum and Whitman’s article, they estimated that Pharmaceutical companies spent at least $14.3 million

lobbying Congress in 2013 and 2014 against proposed bills against antibiotics in the agriculture industry.

Agricultural groups spent another $9.2 million on the same proposed bills. 17 The following article, “Meat on Drugs”, provides Consumer Reports Survey and takeaways from its research.

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supermarket, 60% were willing to pay at least $0.05 cents per pound more, and 40% said they

would pay $1 or more per pound. In terms of the market for these products, they found that the

sales for meats without antibiotics had grown 25% over a three-year window (2009-2012) and

have been the fastest grower in the organic industry. Sales of antibiotic-free chicken had grown

over 34% in value in 2013, with consumer spending reaching over $1 billion in 2014 which

excluded restaurants and commercial purchasing. This growing demand from consumers has

forced chicken buyers and chicken producers to alter their production lines. The two biggest

chicken producers, Tyson Chickens and Pilgrim’s Pride, along with one of the biggest chicken

buyers, Chick-fil-A, are leading the charge and represent the tipping point for the industry. A

Pilgrim’s Pride’s representative said that “We’re seeing quite a big growth in antibiotic-free

product. As consumers and the population are looking more for that, the industry needs to

follow” (NRDC). Experts have quelled the worry about the transitional costs for many

companies by pointing towards Denmark18 who phased out the routine use of antibiotics in

animal feed and found no net cost changes because money saved by not purchasing these drugs

offset any costs associated with animals growing fatter on less feed. In addition, research from

the Economic Research Service19 provides evidence that cost of these products wouldn’t result in

significantly higher costs to consumers estimating that wholesale prices of pork and poultry

would increase by less than 5 percent, and retail prices would increase by even less (NRDC).

Alternatives:

Pew Charitable Trust has conducted extensive research showing that the discovery of

new antibiotics has diminished completely in the last half century due to multiple factors. In fact,

18 Following article “Impacts of Antimicrobial Growth Promoter Termination in Denmark”, contains the Denmark

Case Study. 19 The economist, Sneeringer, has piles of research that back this claim. (Look Sneeringer under the References

Section).

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Figure 4 shows that there hasn’t been a new type of antibiotic in the past 30 years. The primary

reasons are: “scientific barriers to drug discovery, regulatory challenges, and diminishing returns

on investment have led major drug companies to scale back or abandon their antibiotic research”

(Antibiotic Resistance Project).

Figure 4 (Source: Silver, 2011)

In other words, the markets haven’t incentivized the major players in drug development to solve

the antibiotic resistance problem. Nor has the market made it enticing for healthcare investors to

put their money into anti-bacterial research versus oncology research.

The numbers behind this claim were analyzed via a cost-benefit analysis from the Office

of Health Economics in London, where they calculated the net present value (NPV) of a new

antibiotic is only about $50 million, compared to approximately $1 billion for a drug used to

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treat a neuromuscular disease” (Ventola). In addition, the pricing of new antibiotics is

economically unappealing compared to new chemotherapy treatments: “Newer antibiotics are

priced at a maximum of $1,000 to $3,000 per course, while cancer chemotherapy that costs tens

of thousands of dollars” (Ventola). The reason behind this rationale is that “to keep resistance

levels down and maintain effectiveness, doctors often hold new drugs in reserve and use them

only when needed and with limited patient populations” (Thayer). Thus, there is a reduced use of

new antibiotics limiting revenue, and then generics are introduced lowering prices as patents

expire. “Hospitals are constrained in how they reimburse for drugs, so it’s difficult to convince

doctors to look at a new therapy, especially if cheaper generics are available” (Thayer). As a

result, the cheaper generics reduce the return on investment for the original supplier.

Furthermore, “many payers expect all antibiotics to be priced similarly—even new agents that

target multidrug-resistant (MDR) pathogens”. This has led the majority of the major

pharmaceutical players to abandon the antibiotic field. Figure 5 shows that all these factors have

led to the reduction over time in antibacterial new drug application approvals that are still being

processed in Phase II and Phase III of FDA Approval20.

As a result, Pew Charitable Trust has recommended changes to regulatory policies and

providing economic incentives to promote drug development. In addition, they suggest major

agents that are involved in the problem develop plans to share information on developing a better

understanding on the science behind ARBs, innovating new solutions that deviate from

antibiotics, and tackling the basic scientific barriers impeding antibiotic discovery and

development (Antibiotic Resistance Project).

20 For more information regarding the different phases, refer to USFDA on the references section.

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Figure 5 (Source: Ventola 2015).

Over the past 2 decades, the FDA has introduced changes in clinical trials that has made

antibiotic clinical trials very challenging. Basically, the changes require large sample populations

driving higher costs making the development of antibiotics uneconomical and unattractive. In the

article, “The United States Food and Drug Administration and the End of Antibiotics”, Shlaes

and Moellering discussed how altering the requirements for trial designs can have a significant

impact on the size, and hence cost, of conducting clinical trials. Although more work in this area

needs to be done, the FDA issued guidance in 2013 that changed the required clinical trial for

acute bacterial skin and skin-structure infections. While these minor changes are encouraging,

we need to support the new limited-population antibiotic drug (LAPD)21 regulatory approval

pathway to enable smaller, less-expensive and faster clinical trials.

21 For more information regarding (LAPD), refer to Infectious Diseases Society of America under the references

section.

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In addition, we will have to consider investment and economic incentives for large

pharmaceutical companies to encourage research and development in this area. The current

CARB program relies almost exclusively on government agencies, BARDA22, FDA and others,

to develop antibiotic alternatives. We need to include private industry solutions. In January, 80

drugmakers and diagnostic companies, which included the market leaders, signed a request for

companies and government to cooperate to develop incentives for research and development of

new antibiotics (Berkrot). They proposed a new business model where profits would not be

linked to higher sales instead lump sum payments23 would be awarded to companies, or groups

of companies, that develop effective new antibiotics and antibiotic alternatives. We must have

engagement and leadership from the strongest players in the pharmaceutical industry to develop

alternatives, a group should be formed to include this structure in the CARB action plan.

The following paragraph describe a new alternative24 that has a high potential in solving

specific ARB such as MRSA or a broad range of ARBs.

A future treatment that revolves around antibacterial technology with creams has started

to surface under the tutelage of a Dutch Biotechnology Firm, Micreos Human Health B.V. They

have been recently awarded a large sum of equity to further their development of Staphefekt. The

product specifically targets S. aureus and its resistant strains such as MRSA. Additionally, the

product utilizes an enzyme called endolysins that kills off bacteria at a high rate and extremely

unlikely for an emergence of resistance to the enzyme. This alternative has long way to go before

22 BARDA (Biomedical Advanced Research and Development Authority) 23 From the article, “New Incentives Needed to Develop Antibiotics to Fight Superbugs”, a lump-sum payment

would look like what the British Government panel suggested “drug companies be offered up to $1.5 billion for

successful development of a new antibiotic”. 24 There are two interesting alternatives (Phage Therapy and ADEP) that are still in its initial stages, but have

encouraging results. For more information regarding Phage Therapy refer to Górski and ADEP refer to Herring

under the references section.

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the product can be introduced to the market, however the initial results have been promising and

gives the pharmaceutical industry and society hope that we can solve this problem (Micreos).

Final Thoughts

ARBs are a serious threat to our society and the healthcare system. Even though the US

government has been late to address this problem, it is encouraging that we are now taking steps

to address it. However, I believe the national strategy lacks funding and focus. My modified

national strategy narrows down the focus to the major components that are integral to solving

this problem in the short and long-term. Once, we are able to solve this issue in the United

States, we have to help the World conquer this problem and put into place a system that will

track and control ARBs worldwide.

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Appendix

ACA- Affordable Care Act

ARBs- Antibiotic Resistant Bacteria

ASP- Antimicrobial Stewardship Program

CARB- Combating Antibiotic Resistant Bacteria (Obama Administration Plan)

CDC- Center for Disease Control and Prevention

FDA- Federal Drug Administration

GFI- Guidance for Industry

HHS- Health and Human Services

IDSA- Infectious Diseases Society for America

LAPD- Limited Population Antibiotic Drug

MRSA- Methicillin-resistant Staphylococcus aureus

NCBI- National Center for Biotechnology Information

NRDC- Natural Resources Defense Council

OECD- Organization for Economic Cooperation and Development

USFDA- United States Food and Drug Administration

VAMC- Veteran Affairs Medical Center

WHO- World Health Organization

WSJ- Wall Street Journal

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References:

Antibiotic Prescriptions per 1000 Persons of All Ages According to State, 2010 [Model]. (2010).

Retrieved from https://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats

-2013-508.pdf#page=13

Antibiotic Resistance Project. (2016, May 11). Retrieved October 12, 2016, from The Pew

Charitable Trusts website: A Scientific Roadmap for Antibiotic Discovery

Bakken, J. S. (2016, January 4). IDSA Comments to PACCARB on Antibiotic Resistance Data

Collection. Retrieved from IDSA website:

https://www.idsociety.org/uploadedFiles/IDSA/Policy_and_Advocacy/Current_Topics_a

nd_Issues/Advancing_Product_Research_and_Development/STAAR_Act/Letters/IDSA

%20Comments%20to%20PACCARB%20on%20Antibiotic%20Resistance%20Data%20

Collection_01042016.pdf

Berkrot, Bill. "New Incentives Needed to Develop Antibiotics to Fight Superbugs." Reuters, 27

May 2016. www.reuters.com/article/us-health-superbug-antibiotics-idUSKCN0YI2MZ.

Bottemiller, Helena. "Cargill Recalls 36 Million Pounds of Ground Turkey." Food Safety News,

4 Aug. 2011. www.foodsafetynews.com/2011/08/cargill-recalls-36-million-pounds-of-

ground-turkey/#.WEh_eIWcHIV.

CARB. (2014). National Strategy For Combating Antibiotic Resistant Bacteria. WH, 37.

Retrieved from

file:///C:/Users/Matt/AppData/Local/Microsoft/Windows/INetCache/IE/ZIG9C

YW6/carb_national_strategy.pdf

Carrillo, C. L., & Abedon, S. T. (2011, April). pros and cons of phage therapy. NCBI, 1(2), 112-

114. Retrieved from

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278648/pdf/bact0102_0111.pdf

CDC. "National Strategy for Combating Antibiotic Resistant Bacteria."

www.cdc.gov/drugresistance/pdf/carb_national_strategy.pdf. Sept. 2014.

ConsumerUnion. (2016). The Overuse of Antibiotics in Food Animals Threatens Public Health.

ConsumerUnion. Retrieved from http://consumersunion.org/news/the-overuse-of-

antibiotics-in-food-animals-threatens-public-health-2/

Cooper, Matthew A., and David Shlaes. "Fix the antibiotics pipeline." Nature, 7 Apr. 2011.

www.nature.com/nature/journal/v472/n7341/full/472032a.html.

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