Category Archives: Pharmaceuticals

Vancomycin HCL Capsules for treatment for C. difficile-Associated Diarrhea (CDAD) Launched by ANI Pharmaceuticals,Inc.

ANI Pharmaceuticals, Inc. today announced the launch of Vancomycin HCl 125mg and 250mg capsules indicated for treatment of C. difficile-associated diarrhea.

The overall US market for Vancomycin HCl Capsules is approximately $113 million, per IMS Health.

Arthur S. Przybyl, President and Chief Executive Officer said, “We are pleased to announce the launch of our authorized generic to Vancocin, which replaces the authorized generic previously on the market. This is the second of four generic products we plan to launch before the end of 2015, having previously announced the launch of Oxycodone Oral Solution in October. The launch of an authorized generic for one of our acquired branded products represents an important value driver for ANI and a key component of our mature brand strategy.”

About Vancomycin HCl Capsules

Vancomycin Hydrochloride Capsules are indicated for the treatment of C. difficile-associated diarrhea (CDAD).

Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains). Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections.

About ANI

ANI Pharmaceuticals, Inc. (the “Company” or “ANI”) is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The Company’s targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products.

To read the article in its entirety click on the link below:

http://www.prnewswire.com/news-releases/ani-pharmaceuticals-announces-launch-of-vancomycin-capsules-300169652.html

Preventing Healthcare-Associated Infections (HAI’s) and the War On Superbugs

Many hospitals have made impressive strides in preventing health care-associated infections; some have seen a 70 percent reduction in the rate of bloodstream infections, thanks to safeguards such as checklists of steps to take before and during medical procedures and stepped-up hand-washing. But the problem continues to worsen. Now the White House has asked Congress for $1.2 billion to fund an effort to cut the rate of dangerous infections in half by 2020. The plan includes steps to prevent and slow the spread of infection, improve surveillance of resistant bugs, develop better diagnostic tests and new antibiotics and curb the misuse of currently available drugs – the main driver of drug resistance.

This is no fleeting crisis. Experts warn that the loss of antibiotics would roll back medical progress by 70 or 80 years. Without them, people could die of everyday dental abscesses and strep throat. Just inserting an IV could have lethal consequences. “Medical practice developed in a way that presumes the ability to treat infection in order to allow other things to be done like major surgery, cancer chemotherapy, transplants and joint replacement,” says James Johnson, senior associate director of the Infectious Disease Fellowship Program at the University of Minnesota in Minneapolis.

In terms of their power and importance, “almost nothing else in medicine comes close,” says Brad Spellberg, chief medical officer and professor of clinical medicine at the Los Angeles County and USC Medical Center. He is also the author of “Rising Plague: The Global Threat from Deadly Bacteria and Our Dwindling Arsenal to Fight Them.”

The trouble is that “any time we use antibiotics, we’re contributing to their future ineffectiveness,” Johnson says. It’s natural for an organism to eventually become resistant to that drug. And too often, bowing to the demands of patients, doctors prescribe antibiotics when they’re not needed; the drugs aren’t effective against viral illnesses.

Another problem: Because it takes time to determine precisely which organism is the culprit, doctors frequently prescribe “broad spectrum” antibiotics that work against a wide range of bacteria when a more targeted drug would do. “The consequence,” Johnson says, is that “we’re using our last-reserve antibiotics with increasing frequency.” The CDC estimates that at least 50 percent of antibiotic use in humans is unnecessary or inappropriate.

At the same time, 80 percent of antibiotics in the U.S. are used in livestock feed to prevent or control infection and promote growth, which fuels outbreaks of drug-resistant organisms such as Salmonella, E. coli and Campylobacter that spread through the environment. The end result: “There are patients in hospitals in the U.S. today suffering and dying from infections for which doctors have no antibiotics to give,” says Arjun Srinivasan, associate director for Healthcare Associated Infection Prevention Programs for the CDC. “They are completely resistant to all therapies.” Experts agree that no single intervention will solve the problem – and are exploring a number of needed solutions:

Under the president’s plan, hospitals would establish antibiotic stewardship programs to focus doctors on “prescribing the right antibiotic at the right time at the right dose for the right duration,” says Ann McIntyre, clinical associate professor in internal medicine at Nova Southeastern University and director of the infectious diseases fellowship program at Palmetto General Hospital in Florida. Only about half of hospitals currently have such programs. But the Centers for Medicare and Medicaid Services is expected to make them a requirement for eligibility for reimbursements by 2017. Typically led by a multidisciplinary team – infectious disease doctors, pharmacists, microbiologists or epidemiologists and nurses – stewardship programs involve keeping careful control over how the drugs are dispensed. They include such strategies as frequently reviewing patients’ status to make sure they still need an antibiotic, and if so, reassessing the drug, dosage and type of delivery (switching from IV to oral antibiotics, for instance, eliminates a potential source of additional infection), and restricting the use of certain broad spectrum antibiotics until an antibiotic expert weighs in. “Physicians are used to practicing for the patient in the moment and not having to think about all patients globally,” says Neil Fishman, an infectious disease specialist and chief patient safety officer at the University of Pennsylvania Health System. That, he says, has to change.

To read article in its entirety click on the link below:

http://health.usnews.com/health-news/patient-advice/articles/2015/10/14/the-new-war-on-superbugs

World Health Organization (WHO) World Antibiotic Awareness Week November 16-22

The first World Antibiotic Awareness Week will be held from 16 to 22 November 2015. The campaign aims to increase awareness of global antibiotic resistance and to encourage best practices among the general public, health workers and policy makers to avoid the further emergence and spread of antibiotic resistance.

Stop the Spread of Antibiotic Resistance and C. difficile Infections

Antibiotic-resistant germs cause more than 2 million illnesses and at least 23,000 deaths each year in the US.

Up to 70% fewer patients will get CRE over 5 years if facilities coordinate to protect patients.

Preventing infections and improving antibiotic prescribing could save 37,000 lives from drug-resistant infections over 5 years.

Problem: Germs spread between patients and across health care facilities.

Antibiotic resistance is a threat.

Nightmare germs called CRE (carbapenem-resistant Enterobacteriaceae) can cause deadly infections and have become resistant to all or nearly all antibiotics we have today. CRE spread between health care facilities like hospitals and nursing homes when appropriate actions are not taken.
MRSA (methicillin-resistant Staphylococcus aureus) infections commonly cause pneumonia and sepsis that can be deadly.
The germ Pseudomonas aeruginosa can cause HAIs, including bloodstream infections. Strains resistant to almost all antibiotics have been found in hospitalized patients.
These germs are some of the most deadly resistant germs identified as “urgent” and “serious” threats.

C. difficile infections are at historically high rates.

C. difficile (Clostridium difficile), a germ commonly found in health care facilities, can be picked up from contaminated surfaces or spread from a healthcare provider’s hands.
Most C. difficile is not resistant to antibiotics, but when a person takes antibiotics, some good germs are destroyed. Antibiotic use allows C. difficile to take over, putting patients at high risk for deadly diarrhea.

Working together is vital.

Infections and antibiotic use in one facility affect other facilities because of patient transfers.
Public health leadership is critical so that facilities are alerted to data about resistant infections, C. difficile, or outbreaks in the area, and can target effective prevention strategies.
When facilities are alerted to increased threat levels, they can improve antibiotic use and infection control actions so that patients are better protected.
National efforts to prevent infections and improve antibiotic prescribing could prevent 619,000 antibiotic-resistant and C. difficile infections over 5 years.

“Patients and their families may wonder how they can help stop the spread of infections,” says Michael Bell, M.D., deputy director of CDC’s Division of Healthcare Quality Promotion. “When receiving health care, tell your doctor if you have been hospitalized in another facility or country, wash your hands often, and always insist that everyone have clean hands before touching you.”

Antibiotic-resistant germs, those that no longer respond to the drugs designed to kill them, cause more than 2 million illnesses and at least 23,000 deaths each year in the United States. C. difficile caused close to half a million illnesses in 2011, and an estimated 15,000 deaths a year are directly attributable to C. difficile infections.

The report recommends the following coordinated, two-part approach to turn this data into action that prevents illness and saves lives:

Public health departments track and alert health care facilities to drug-resistant germ outbreaks in their area and the threat of germs coming from other facilities, and
Health care facilities work together and with public health authorities to implement shared infection control actions to stop the spread of antibiotic-resistant germs and C. difficile between facilities.

“Antibiotic resistant infections in health care settings are a growing threat in the United States, killing thousands and thousands of people each year,” said CDC Director Tom Frieden, M.D., M.P.H. “We can dramatically reduce these infections if health care facilities, nursing homes, and public health departments work together to improve antibiotic use and infection control so patients are protected.”

The promising news is that CDC modeling projects that a coordinated approach—that is, health care facilities and health departments in an area working together—could prevent up to 70 percent of life-threatening carbapenem-resistant Enterobacteriaceae (CRE) infections over five years. Additional estimates show that national infection control and antibiotic stewardship efforts led by federal agencies, health care facilities, and public health departments could prevent 619,000 antibiotic-resistant and C. difficile infections and save 37,000 lives over five years.

During the next five years, with investments, CDC’s efforts to combat C. difficile infections and antibiotic resistance under the National Strategy to Combat Antibiotic Resistant Bacteria, in collaboration with other federal partners, will enhance national capabilities for antibiotic stewardship, outbreak surveillance, and antibiotic resistance prevention. These efforts hold the potential to cut the incidence of C. difficile, health care CRE, and MRSA bloodstream infections by at least half.

The proposed State Antibiotic Resistance Prevention Programs (Protect Programs) would implement this coordinated approach. These Protect Programs would be made possible by the funding proposed in the President’s FY 2016 budget request, supporting work with health care facilities in all 50 states to detect and prevent both antibiotic-resistant germs and C. difficile infections. The FY 2016 budget would also accelerate efforts to improve antibiotic stewardship in health care facilities.

Dr. Nicholas Kartsonis Discusses Merck’s History In Infectious Disease and Their Ongoing Research Plus Some Of The Company’s Current Treatments, Including Dificid, To Address C. diff. Infections (CDI)

What’s new in the C Diff Foundation?

Let us introduce you to the first internet radio talk show dedicated to C. diff. and more……

“C. diff. Spores and More”

UPCOMING SHOW: TODAY ~ Tuesday, May 26th:

Dr. Nicholas Kartsonis; Merck Research Laboratories (MRL)

Join us today, Tuesday, May 26th, as our guest Dr. Nicholas Kartsonis , Associate Vice President of Clinical Research for Infectious Diseases for Merck Research Laboratories (MRL) and Section Head within MRL for antibiotics, antibacterials and cytomegalovirus shares his time and discusses the past, present, and future contributions of Merck Research Laboratories.

Dr. Kartsonis joined Merck Research Laboratories in February 2000 and has been actively involved in programs for new antibacterials, antifungals, anti-HIV, anti-CMV, and agents targeted against C. difficile infection. Most recently, he has led the efforts to ensure the integration of the Cubist Pharmaceuticals clinical research portfolio within Merck.

Dr. Kartsonis will provide an overview of Merck’s current efforts to address the worldwide public health crisis posed by antimicrobial resistance, as well as the company’s history in infectious disease and antimicrobial stewardship. In addition, he will talk about the company’s current treatment for C. difficile and ongoing research efforts to address C. difficile infections (CDI).

http://www.voiceamerica.com/show/2441/c-diff-spores-and-more

We invite you to join us in listening to this exciting, new internet talk show that broadcasts live every Tuesday at the following times:

Click Image Above to Listen to Archived Shows

PT 11a, MT 12p, CT 1p, ET 2 p

We are pleased to share “C. diff. Spores and More” with you because, as advocates of C. diff., we know how important this cutting-edge new weekly radio show means for our Foundation’s community worldwide.

Hard Facts: Deaths and illnesses are much higher than reports have shown. Nearly half a million Americans suffered from Clostridium difficile (C. diff.) infections in a single year according to a study released today, February 25, 2015, by the Centers for Disease Control and Prevention (CDC).

• More than 100,000 of these infections developed among residents of U.S. nursing homes.

Approximately 29,000 patients died within 30 days of the initial diagnosis of a C. diff. infection. Of these 29,000 – 15,000 deaths were estimated to be directly related to a
C. diff. infection. Therefore; C. diff. is an important cause of infectious disease death in the U.S.
Previous studies indicate that C. diff. has become the most common microbial cause of Healthcare-Associated Infections found in U.S. hospitals driving up costs to $4.8 billion each year in excess health care costs in acute care facilities alone. Approximately
two-thirds of C. diff. infections were found to be associated with an inpatient stay in a health care facility, only 24% of the total cases occurred in patients while they were hospitalized. The study also revealed that almost as many cases occurred in nursing homes as in hospitals and the remainder of individuals acquired the
Healthcare-Associated infection, C. diff., recently discharged from a health care facility.

This new study finds that 1 out of every 5 patients with the Healthcare-Associated Infection (HAI), C. diff., experience a recurrence of the infection and 1 out of every 9 patients over the age of 65 diagnosed with a HAI – C. diff. infection died within 30 days of being diagnosed. Older Americans are quite vulnerable to this life-threatening diarrhea infection. The CDC study also found that women and Caucasian individuals are at an increased risk of acquiring a C. diff. infection. The CDC Director, Dr. Tom Frieden, MD, MPH said, “C. difficile infections cause immense suffering and death for thousands of Americans each year.” “These infections can be prevented by improving antibiotic prescribing and by improving infection control in the health care system. CDC hopes to ramp up prevention of this deadly infection by supporting State Antibiotic Resistance Prevention Programs in all 50 states.”

“This does not include the number of C. diff. infections taking place and being treated in other countries.” “The CDF supports hundreds of communities by sharing the CDF mission and raising C. diff. awareness to healthcare professionals, individuals, patients, families, and communities working towards a shared goal ~ witnessing a reduction of newly diagnosed C. diff. cases by 2020 .” ” The CDF Volunteers are greatly appreciated as they create positive changes sharing their time so generously worldwide aiding in the success of our mission and raising C. diff. awareness.”

“C. diff. Spores and More” spotlights world renown topic experts, research scientists, healthcare professionals, organization representatives, C. diff. survivors, board members, and their volunteers who are all creating positive changes in the C. diff. community and more.

Through their interviews, the CDF mission will connect, educate, and empower many worldwide.

Questions received through the show page portal will be reviewed and addressed by the show’s Medical Correspondent, Dr. Fred Zar, MD, FACP, Dr. Fred Zar is a Professor of Clinical Medicine, Vice Head for Education in the Department of Medicine, and Program Director of the Internal Medicine Residency at the University of Illinois at Chicago. Over the last two decades he has been a pioneer in the study of the treatment of Clostridium difficile disease and the need to stratify patients by disease severity.

Please join us Tuesdays in listening to the educational episodes of “C. diff. Spores and More”

View the programs and radio information and access previous episodes available as a podcast by clicking on the link below:

www.voiceamerica.com/show/2441/c-diff-spores-and-more

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Service Evaluation Study Data Shows DIFICLIR [TM] fidaxomicin by Astellas Pharma EMEA Reduces Recurrence and All-Cause Mortality When Used First-Line in All Patients Diagnosed With Clostridium Difficile (CDI) Infection

Presented May 20th, 2015 at the 5th International Clostridium Difficile Symposium (ICDS) in Bled, Slovenia, the CDI Service Evaluation Study is the first and only real-world multicenter study assessing the effectiveness of current CDI treatment in NHS Secondary Care Trusts in England.[6]

“This study builds on the growing evidence that adopting fidaxomicin as first-line treatment for all patients with CDI, rather than reserving it for more severe cases, provides the best outcomes in terms of recurrence, all-cause mortality and cost effectiveness compared to older treatments - vancomycin and metronidazole”, comments Dr Simon Goldenberg, Consultant Microbiologist and Infection Control Doctor, Guy’s and St Thomas’ NHS Foundation Trust. “A previous study also showed that first-line use of fidaxomicin reduces environmental contamination compared to those treated with vancomycin or metronidazole, further demonstrating the role fidaxomicin may play in reducing the spread and incidence of CDI alongside stringent hospital hygiene protocols.”

In Europe the incidence and severity of CDI is increasing,[1],[2],[3],[4] with nearly 125,000 cases a year,[5] posing a major threat to healthcare systems and patientsData presented today from the CDI Service Evaluation study shows that the adoption pattern of treatment impacts CDI outcomes. Compared to traditional broad-spectrum antibiotics, first-line use of fidaxomicin - a targeted treatment - in all CDI patients provides the best outcomes in terms of recurrence rate, all-cause mortality and cost effectiveness, compared to use in selected patients only.[6] CDI is associated with high-mortality[7] and cost burden,[8] therefore reducing the incidence and recurrence of CDI is a priority for clinicians, payers and health authorities alike.
Over 1,450 patients were included in the analysis conducted in seven UK hospitals that introduced fidaxomicin, a narrow-spectrum antibiotic for the treatment of CDI, between July 2012 and July 2013.[6] Data collected from 177 patients treated first-line with fidaxomicin during the 12-month evaluation period were compared with those from a retrospective cohort treated with broad-spectrum antibiotics - vancomycin and metronidazole - during the previous 12-month period.[6]

In the two centres (A and B) where fidaxomicin was adopted as a first-line treatment for all patients diagnosed with CDI, a significant reduction in 28-day all-cause mortality was observed, from 18.2% to 3.1% (P<0.001) and 17.3% to 6.3% (P<0.05) respectively.[6],[9] The real-world analysis also supports clinical trial data in highlighting dramatically reduced recurrence rates: from 12.1% and 23.5% with vancomycin and metronidazole, to 3.1% in both centres with first-line fidaxomicin. For every 50 patients treated, this would result in 5 and 10 recurrences avoided in the two centres respectively.[6]

A separate study recently looked at the impact of CDI treatment on environmental contamination. The analyses showed those treated with fidaxomicin are more than 20% less likely to contaminate their environment with CDI (36.8%) compared to patients treated with metronidazole and/or vancomycin (57.6%). This significant decrease in environmental contamination may further contribute to a reduction in secondary cases of CDI.[10]

“The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) identified recurrence as the next big challenge to be met in the treatment of CDI, since it occurs in up to 25% of patients treated with current broad-spectrum therapies,” comments Professor Mark Wilcox, Professor of Medical Microbiology, Leeds Teaching Hospitals & University of Leeds. “Fidaxomicin has limited activity against the ‘good bacteria’ in the gut and so can be considered to be a targeted treatment option. Preservation of the gut microflora likely contributes to the lower rates of recurrence seen after fidaxomicin treatment of CDI compared with those associated with broader-spectrum antibiotics like vancomycin.”

A CDI recurrence has been previously estimated to add an additional £20,249 on top of an estimated £13,146 spent to treat the initial infection due to prolonged hospital stay, ICU stay, high cost drugs and the surgery necessary to tackle it.[11] An in-depth costing analysis at the two centres that adopted fidaxomicin as a first-line treatment revealed that in centre A the 5 recurrences that could be avoided for every 50 patients treated with the narrow-spectrum antibiotic would result in a cost saving of £19,490, and in centre B, for the 10 recurrences avoided, a cost saving of £121,144.[6] With nearly 125,000 cases of CDI occurring in Europe each year,[5] the potential cost saving for the treatment of this potentially fatal condition is likely to be far greater.

The cost-effectiveness of fidaxomicin has been reinforced in a recent study in France, with fidaxomicin proving to be both clinically and cost-effective compared to vancomycin.[12] The main driver of cost-effectiveness was a significant reduction in the rate of recurrence, resulting in a reduced cost of hospitalisation.[12] In the base case, fidaxomicin was cost-effective compared to vancomycin for all patients at a cost per QALY of €24,242.[12] The cost per recurrence avoided was €1,877 and cost per faecal transplant avoided was €8,967.[12]

In Europe the incidence and severity of CDI is increasing, posing a major threat to healthcare systems and patients.[1],[2],[3],[4] Information suggests that CDI results in death for 9% (2% primary cause, 7% contributory) of all diagnosed patients.[7] This suggests that CDI contributes to the death of around 27,000 people each year across Europe,[7] around five times that of MRSA associated deaths.[13]

ESCMID guidelines currently recommend DIFICLIR as a first line therapy option in CDI patients at risk of recurrence and in patients with severe and non-severe CDI.[14]

NOTES TO EDITORS

About the CDI Service Evaluation study[6]

The CDI Service Evaluation Project is the first and only real-world multicenter study assessing the effectiveness of current CDI treatment for UK patients in NHS Secondary Care Trusts in England. This evaluation looked specifically at the cost-effectiveness of fidaxomicin in clinical practice versus standard of care treatments (vancomycin and metronidazole) in seven trial centres from across the UK:

• Leeds Teaching Hospitals NHS Trust

• Guy’s and St Thomas’ NHS Foundation Trust

• County Durham & Darlington NHS Foundation Trust

• University Hospitals of Morecambe Bay - NHS Foundation Trust

• St George’s Healthcare NHS Trust

• University Hospitals of Leicester NHS Trust

• Derby Hospitals NHS Foundation Trust

The study was sponsored by Astellas Pharma Ltd.

About Clostridium difficile Infection

CDI is a recurring and preventable illness resulting from infection of the internal lining of the colon by C. difficile bacteria.[15] The bacteria produce toxins that cause inflammation of the colon, diarrhoea and, in some cases, death.[16] Patients typically develop CDI after the use of broad-spectrum antibiotics that disrupt normal bowel flora, allowing C. difficile bacteria to flourish.[17] CDI is highly infectious[18] and has surpassed MRSA as a leading cause of healthcare-acquired infection.[19] It is most common in those taking broad-spectrum antibiotics that result in the disruption of normal bowel flora,[20] and threatens those most vulnerable, including the elderly, patients who are immunocompromised or with renal impairment and those who have prolonged periods of hospitalisation.[21],[22] People in hospital with CDI are up to three times more likely to die in hospital (or within a month of infection) than those without CDI.[23],[24] Information suggests nearly 125,000 cases of CDI occur in Europe each year,[5] and that CDI results in death for 9% (2% primary cause, 7% contributory) of all diagnosed patients.[7] Recurrence of CDI occurs in up to 25% of patients within 30 days of initial treatment with current therapies.[25],[26],[27] The ESCMID has identified recurrence as being the most important problem in the treatment of CDI.[28]

About DIFICLIR (fidaxomicin)

DIFICLIR (fidaxomicin) is a first-in-class macrocyclic antibiotic targeted to kill the C. difficile bacteria[29] while sparing the ‘good’ gut bacteria,[30],[31],[32] and represents the newest development in CDI for over 20 years.[33],[34] In the largest Phase III trials in this area fidaxomicin was shown to be non-inferior in initial cure and clearly superior to current standard of care treatment - vancomycin - in achieving sustained clinical cure and addressing recurrence.[27],[35] ESCMID guidelines recommend DIFICLIR as a first line therapy option in CDI patients at risk of recurrence and in patients with severe and non-severe CDI.[14] The safety profile of DIFICLIR is based on data from 564 patients with CDI treated with fidaxomicin in Phase III studies.[33]

About Astellas Pharma EMEA

Astellas Pharma EMEA operates in 40 countries across Europe, the Middle East and Africa, and is the EMEA regional business of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. The organisation’s focus is to deliver outstanding R&D and marketing to continue growing in the world pharmaceutical market. Astellas presence in Europe also includes an R&D site and three manufacturing plants. The company employs over 4,500 people across the EMEA region. In 2013 Astellas was awarded SCRIP Pharmaceutical Company of the Year in recognition of its commercial success and pipeline development.

FOR FULL ARTICLE:

http://www.liberoquotidiano.it/news/comunicati/11791316/DIFICLIR-TM—Fidaxomicin-.html

“Superbugs” Multibillion-Dollar Global Support to Fund Antibiotic Research Is Needed

A multibillion-dollar investment into the global pharmaceuticals industry is needed to ward off the threat of drug-resistant “superbugs,” according to Jim O’Neill, the economist leading a review into antimicrobial resistance for the U.K. government.

Mr. O’Neill, best known for coining the “BRIC” acronym for Brazil, Russia, India and China while at Goldman Sachs, estimated that as much as $37 billion is needed over the next 10 years to spur the industry to develop innovative antibiotics, since there is little market incentive to do so.

Mr. O’Neill added that this sum was “modest” in comparison with the economic cost of ignoring the problem. In an earlier report, he estimated that antimicrobial resistance, or AMR, would kill 300 million people prematurely in the next 35 years if unaddressed, leaving global gross domestic product 2% to 3.5% short of what it otherwise would have been by 2050. That would mean $60 trillion to $100 trillion in lost economic output over that 35-year span.

Pharmaceutical companies largely retreated from antibiotic research during the 1990s, due to a high degree of uncertainty on the eventual market size for any novel drugs. A plentiful supply of older and cheaper antibiotics means that a novel product will be used only after other treatments have failed.
Related

Now, the pipeline of new antibiotics has dried up, so there are few new drugs to combat bacteria that have developed resistance to existing treatments. U.K. Prime Minister David Cameron, who commissioned the review in July, has said increasing drug-resistance could cast the world back into the “dark ages of medicine where treatable infections and injuries will kill once again.”

Mr. O’Neill said extra investment was needed at every stage of the antibiotic development process to “radically overhaul” the antibiotics pipeline over the next 20 years.

He proposed giving companies that already have the “highest priority antibiotics” in their pipelines a “lump-sum” payment. This would “delink” profitability from sales volumes, lowering the risk of developing a novel antibiotic as well as reducing the incentive to oversell the drug once it is on the market.

In the USA -

March 2015: Two million illnesses. 23,000 deaths. According to the Centers for Disease Control and Prevention, that’s the human toll from antibiotic-resistant “superbugs” each year in the United States. To fight the growing problem of infections that can’t be treated, the administration of President Barack Obama is implementing a five-year national action plan at a cost of $1.2 billion. Those funds, part of the President’s 2015 budget, which must still be approved by Congress, would nearly double the amount of federal money allocated to the fight. The plan calls for creating a “one-health” approach to testing and reporting superbugs around the country, as well as establishing a DNA database of resistant bacteria. New, rapid tests to detect emerging resistant bacteria will be developed. Research for new antibiotics and vaccines will accelerate. The plan calls for two new options for people, and three for animals, by 2020.

The National Action Plan for Combating Antibiotic-Resistant Bacteria

Global surveillance and cooperation is also stressed, including a global database for animals.

http://www.cnn.com/2015/03/27/health/obama-antibiotic-resistance/index.html

“Anti-microbial resistance has the potential to harm or kill anyone in the country, undermine modern medicine, to devastate our economy and to make our health care system less stable,” Dr. Tom Frieden, MD, CDC Director said. Antibiotic resistance costs $20 billion in health care spending a year, Frieden said. To combat the spread of resistant bacteria, Frieden said the CDC plans to isolate their existence in hospitals and shrink the numbers through tracking and stricter prevention methods.

http://www.usatoday.com/story/news/nation/2014/07/22/antibiotic-resistance-bacteria-drugs-cdc-lab-safety-mers-anthrax/13005415/

Dr. Arjun Srinivasan, MD, CDC Medical Epidemiologist states, “Today’s antibiotics are miracle drugs, but they are endangered,” “These new materials provide core elements and practical tools for beginning and advancing antibiotic stewardship programs.”

In July 2014 the United Sates Centers of Disease Control and Prevention (CDC) rolled out a new way every hospital in the country can track and control drug resistant bacteria. CDC already operates the National Healthcare Safety Network (NHSN), with more than 12,000 health care facilities participating. Now we are implementing a breakthrough program that will take control of drug resistance to the next level – the Antibiotic Use and Resistance (AUR) reporting module. The module is fully automated, capturing antibiotic prescriptions and drug susceptibility test results electronically. With this module, we’ll be able to create the first antibiotic prescribing index. This index will help benchmark antibiotic use across health care facilities for the first time, allowing facilities to compare their data with similar facilities. It will help facilities and local and state health departments as well as CDC to identify hot spots within a city or a region. We’ll be able to answer the questions: Which facilities are prescribing more antibiotics? How many types of resistant bacteria and fungi are they seeing? Do prescribing practices predict the number of resistant infections and outbreaks a facility will face? Ultimately with this information, we’ll be able to both improve prescribing practices and identify and stop outbreaks in a way we have never done before. This will help deploy supportive and evidence-based interventions at each facility as well as at regional levels to help stop spread among various facilities. The need for a comprehensive system to collect local, regional, and national data on antibiotic resistance is more critical than ever. The system now exists, and we need quick and widespread uptake.Rapid and full implementation of this system is supported through the proposed increase of $14 million contained in CDC’s 2015 budget request to Congress.

UK: Mr. O’Neill highlighted antibiotics that were active against bacteria where the existing drugs are already the “last line” of defense as those that could receive priority funding. He also called for a “global AMR innovation fund” of around $2 billion over five years to kick-start basic research into new antibiotics.

While Mr. O’Neill didn’t specifically call on pharmaceutical companies to foot the bill for the innovation fund, he did urge the industry to act with “enlightened self-interest” in tackling AMR, “recognizing that it has a long-term commercial imperative to having effective antibiotics, as well as a moral one.”

He said these measures, along with efforts to link up early research with companies, could bring 15 new drugs a decade to market, at least four of which would be “truly novel.”

The proposals received broad support from the industry. Severin Schwan, chief executive of Roche Holding AG , said the company was “committed to working with the AMR Review Committee and being part of this solution.” Patrick Vallance, president of pharmaceuticals research and development at GlaxoSmithKline PLC, also said he welcomed the findings of the review.

In an earlier report, Mr. O’Neill had already called for more action to make better use of existing antibiotics, such as curbing excessive use or researching whether combining old drugs could prove more effective against superbugs.

The economist is scheduled to submit his final recommendations in the summer of 2016.

C Diff Foundation

Educating and Advocating for the Prevention, Treatment and Environmental Safety of Clostridium Difficile Infections Worldwide