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Addressing the Bacterial Infection Threat That Can Complicate Covid-19 Cases

March 31, 2020
9:52 am

Dr. Julie Gerberding, former head of the Centers for Disease Control and Prevention and today an executive vice president for Merck for strategic communications, global public policy, and population health wrote an op-ed for STAT News on the high mortality rate associated with COVID-19 patients who develop a secondary bacterial infection.  She said this underscores the need for research and development into new antibiotics.  The op-ed is found below and here.

Antibiotic resistance: the hidden threat lurking behind Covid-19

By Julie L. Gerberding

March 23, 2020

The ongoing Covid-19 pandemic highlights the critical need for rapid development of vaccines and antiviral treatments to reduce the number of hospitalizations and deaths caused by this dangerous new coronavirus, SARS-CoV-2. The biopharmaceutical industry has quickly responded and at least 80 candidates are already in development. With good luck, we will eventually have some of the tools we need to fight this new global threat.

But there is an even larger threat lurking behind the current outbreak, one that is already killing hundreds of thousands of people around the world and that will complicate the care of many Covid-19 patients. It is the hidden threat from antibiotic resistance — bacteria that are not killed by standard antibiotics. Unfortunately, the pipeline of drugs to manage these deadly infections is nearly dry.

Although antibiotic resistance hasn’t gotten our attention in the same way that SARS-CoV-2 has, antibiotic-resistant bacteria present a growing global menace. In the U.S. alone, we see 2.8 million antibiotic-resistant infections each year and more than 35,000 deaths, though experts fear that the real number is much higher. The so-called superbugs that cause these infections thrive in hospitals and medical facilities, putting all patients — whether they’re getting care for a minor illness or major surgery — at risk.

The patients at greatest risk from superbugs are the ones who are already more vulnerable to illness from viral lung infections like influenza, severe acute respiratory syndrome (SARS), and Covid-19. The 2009 H1N1 influenza pandemic, for example, claimed nearly 300,000 lives around the world. Many of those deaths — between 29% and 55% — were actually caused by secondary bacterial pneumonia, according to the Centers for Disease Control and Prevention. It’s a one-two punch: A virus can weaken the body, making it easier for complex, hard-to-treat bacteria to take hold.

The new coronavirus is no exception. Already, some studies have found that 1 in 7 patients hospitalized with Covid-19 has acquired a dangerous secondary bacterial infection, and 50% of patients who have died had such infections. The challenge of antibiotic resistance could become an enormous force of additional sickness and death across our health system as the toll of coronavirus pneumonia stretches critical care units beyond their capacity.

Seventeen years ago, when I was leading the CDC, we worried about antibiotic resistance complicating the care of SARS patients. We knew then that America’s arsenal of antibiotics was not sufficient to guarantee we could manage a large outbreak of drug-resistant bacteria. Since then, these bacteria have only become more widespread, more deadly, and far more difficult to treat, yet our stable of antibiotics to manage them has barely increased. In fact, the gap between the superbug threats we face and the antibiotics we have to combat them is rapidly growing wider.

We can’t predict when or where the next pandemic-triggering virus will emerge, but we can predict that secondary bacterial infections will follow. To fight these superbugs, we desperately need new antibiotics. An important question policymakers should be asking themselves is this: Why don’t we have powerful antibiotics on hand when we need them the most?

In a perfect world, we would always have new antibiotics to fight emerging antibiotic-resistant infections, ready to use when a crisis like the Covid-19 pandemic strikes. But developing new antibiotics takes time and can cost more than $1 billion and that investment cannot be recovered by wide use of new antibiotics because they must be used as sparingly as possible to preserve their effectiveness for as long as possible.

Current hospital reimbursement systems generally discourage use of new antibiotics, even when patients clearly need them, because they are more expensive than older antibiotics. Understandably, hospitals that are already challenged to cover the rising costs of care find it hard to justify the inclusion of more expensive drugs on their formularies.

As a result of this unique market dynamic — low reimbursement and low-volume use — many of our country’s most promising antibiotic developers have gone out of business or suffered severe financial losses, including three biotechnology companies within the last year.

This market failure must be corrected as if lives depend on it because they do — as we may soon see as cases of Covid-19 increase. Reimbursement reform will both improve appropriate access to novel antibiotics and encourage private investment in the pipeline. While other proposals have been discussed, including stockpiling and further grant funding for research, these measures do not address the underlying issues.

Recognizing this need is critical, Sens. Bob Casey (D-Pa.) and Bill Cassidy (R-La.) and Reps. Danny Davis (D-Ill.) and Kenny Marchant (R-Texas) have introduced the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act, a bipartisan bill that would reform Medicare reimbursement to make it easier for hospitals to use the antibiotic that is most appropriate for a patient. Right now, there’s a strict cap on how much hospitals are reimbursed by Medicare for inpatient services, which deters use of new targeted antibiotics that might be the best course of therapy for patients with superbug infections.

Passing the DISARM Act is a first step we can take to help ensure that hospitals are not financially penalized when providing patients the lifesaving antibiotics they need. This is good for patients and will, in turn, sustain the confidence investors need to support companies developing new antibiotics. Policymakers must also create incentives, like market entry rewards and other “pull” mechanisms, that clearly signal to biopharmaceutical companies that the antibiotic pipeline merits ongoing research and development investment.

As we come together to fight today’s Covid-19 crisis, we must also look ahead to the next one. We cannot be short-sighted, and we cannot be complacent, especially about antibiotic resistance. We must put measures in place to ensure that we have the antibiotics we need — today and in the future. The time to act is now.

Julie L. Gerberding, M.D., is chief patient officer and executive vice president for strategic communications, global public policy, and population health at Merck. She was director of the CDC from 2002 to 2009.

Guest Post: The Underutilization of Prevention

March 12, 2020
11:50 am

Robert Popovian is Vice President of U.S. Government Relations at Pfizer

One of the most underutilized ways to reduce medical costs in the U.S. is health care prevention. Unfortunately, politicians choose instead to implement draconian policies such as price controls or utilization management, which focus solely on cost management without any consideration given to patient outcomes or the value of an intervention to society.

The reason policymakers promote these types of measures is twofold. One, these policies are simple to implement and two, they reach their intended results quickly by reducing budgets, whether it be hospital costs or drug expenditures. On the other hand, promotion of preventative measures are complicated and challenging to implement and are thus ignored, despite the fact that the data show that such measures lead to better patient outcomes, including improvements in quality of life and productivity.

The two examples of preventative interventions that have not only shown to reduce costs but also improve outcomes are improving immunization rates and medication adherence.

Vaccines are one of the most cost-beneficial interventions in health care. In the U.S., we have done a great job ensuring our children are protected from various communicable diseases. Vaccination rates for most serious ailments are in the 90th percentile for children. However, the same cannot be said when it comes to adults, as their vaccination rates are abysmal. For example, less than 50% of adults get a flu shot every year.  What’s even more alarming is that approximately 20% of high-risk patients (e.g., patients suffering from lung disease) receive a pneumococcal vaccine. Both measures are well below the Healthy 2020 targets set by the Office of Disease Prevention and Health Promotion (ODPHP).

One approach to encourage adult vaccination is to further expand community-based pharmacist immunization capabilities. The evidence is clear that allowing pharmacists to provide vaccinations is the lowest cost alternative for providing this essential public health service. So it is vital that we expand and harmonize state laws governing pharmacist authority to immunize and to allow pharmacists to administer all Food and Drug Administration (FDA) approved and Advisory Committee for Immunization Practices (ACIP) recommended vaccines.

The second example of a cost-saving preventative intervention is medication adherence. One of the most cost-effective ways to improve patient adherence is through pharmacist-led medication synchronization. Medication synchronization is a service that has been offered for the past several years by pharmacists to patients who take multiple chronic medications.

A pharmacist collaborating with a physician and in consultation with the patient ensures that all of the patient’s medications are refilled on the same day. Pharmacists operationalize the concept by making an appointment with a patient to pick up their prescriptions every month, or at 60 or 90 days — depending on the refill schedule — and to discuss other issues pertinent to their care, such as over-the-counter medicine usage, smoking cessation needs or vaccination requirements. Medication synchronization has not only reduced the number of trips a patient has to take to the pharmacy and lessened the administrative burden for pharmacists and physicians, but most importantly it has led to better patient medication adherence and cost savings overall.

In 2014, for example, the Centers for Medicaid and Medicare Services (CMS) decided that patients enrolled in Medicare Part D plans should have the opportunity to synchronize their medications if they choose to and if it is deemed appropriate by their pharmacist or physician, not only because it improved adherence but also because of the overall health care cost reductions. In their analysis, CMS stated, “while the estimated total 6-year cost of this rule to Part D sponsors is $0.5 million, the savings to Part D sponsors and beneficiaries is $1.8 billion.” More recently, a research article published in Health Affairs suggested that patients with cardiovascular disease whose medications were synchronized were three times more adherent with their medications leading to 9% lower hospitalization and emergency department visits.

Fortunately, most states except for California and a handful of smaller ones have taken the lead from CMS to allow all patients in need to benefit from medication synchronization. It is now up to the pharmacists to offer this service universally to their patients.

No one denies that saving health care costs is a noble cause, and everyone agrees that it is not an easy task. However, policymakers are only focusing on the side of the ledger marked “cost”.  Instead, they should be implementing policies that guide us towards the goal of disease prevention to achieve the ultimate endpoint of reducing health care costs while improving patient outcomes.