Monday, November 28, 2016

Fall Managed Care Forum 2016

On November 10-11, 2016 NAMCP Medical Directors Institute, AAMCN, and AAIHDS proudly presented the Fall Managed Care Forum in Las Vegas, NV. The forum brought together Medical Directors and Nurses from around the country to learn in the same environment. Attendees were welcome to participate in live sessions in the Business Track, Health Management Track and/or the Oncology Track to earn continuing education hours. The forum provided breakfast, lunch, breaks, and plenty of reception time for building one's career network and speaking with industry exhibitors.

New Certified Managed Care Nurses (CMCNs). Below are individuals receiving the certification from AAMCN's President, Jacquelyn Smith, RN, BSN, MA, CMCN.

 Managed Care Nurse Leader of the Year:

Clare Jarrard, RN, PhD, CMCN (center)

The award was presented to Clare by Sue Ellen Scott, RN (left) and Jane Goodeve, MSN (right).

The AAMCN Leadership Council developed the award to recognize AAMCN members who have made outstanding contributions as a leader in managed care nursing, their communities and patient advocacy. The award is given out once a year at the Fall Managed Care Forum.
Nurses Only Reception

Friday, November 4, 2016

What Is an "Average" Caseload?

Pat Stricker, RN, MEd, Senior Vice President
TCS Healthcare Technologies

How many times have we all heard (or asked) "What is the ‘average’ caseload?" Sounds like a simple question, doesn't it However, case management programs have struggled for years trying to determine realistic, standard caseloads. People are looking for "a number" that defines the average caseload, but in reality, there is no "magic" number.  

Determining standard case loads is a challenge due to a complexity of factors across diverse CM settings. In addition, rapid changes in the medical management field have added to those complexities, e.g. the integration of utilization management (UM) and disease management (DM) into case management (CM) functions, and the increase in complex, condition management strategies. Some care management applications promote standardized workflows and acuity levels that can help determine caseloads and acuity levels for a given population. However these applications usually lack evidence-based algorithms to determine distinct, accurate, and realistic caseloads. 

Literature reviews and other research findings on this topic cite caseloads that are focused on specific clinical or program areas, which make it difficult to generalize. In fall 2008, the Case Management Society of America (CMSA) and the National Association of Social Workers (NASW) published the Caseload Concept Paper to try to fill-in long standing gaps in this area. Their research found "average caseloads" ranging from two to 365!  

This graph from the Health Intelligence Network shows the average monthly caseloads reported in the 2012 Healthcare Benchmarks: Healthcare Case Management.

More recently an online nursing chat site identified caseloads ranging from 28 to 350!  

How can these ranges be so different?  The disparity is due to a variety of factors that affect the "average" caseload.  The CMSA/NASW Concept Paper provides a Caseload Matrix that defines the variables that tend to impact caseloads:
  • Business environment, model, and setting 
  • Type and location of CM program, i.e. short or long term, inpatient or outpatient, provider/hospital/payor-based 
  • CM services offered and noncase-related duties assigned to the case manager
  • Simplicity/complexity of the program, i.e. on-site, telephonic, Medicaid/Medicare, 
  • Role, expertise, and training of the case manager
  • Organizational resources/extended staff available to assist the case manager
  • Patient population, i.e. severity/acuity of the patient, complexity of the case, dual-eligibles
  • Regulatory influences
  • Paper-based vs. computerized processes/documentation
The addition of integrated care management interventions, complex condition management programs, and provider-based accountable care organizations have also added to the dynamic nature of determining what the "right" caseload is in any given situation. 

As a result of the above study, CMSA developed a free Case Load Capacity Calculator that provides rules and weights based on industry research and expertise. It can be used to calculate comparative caseload capacities across teams of case managers specific to the domain and setting in which they practice. It gathers information about the variables noted above and allows organizations to customize the tool to accommodate for differences in care delivery. CMSA has given us a great start by providing the concept paper and calculator, but we all need to work together to help define average caseloads for various types of programs. I encourage all of you to try the tool. Inputting your data will help you see how the various factors affect your caseload, as well as help contribute to the overall empirical data that is needed to determine the appropriate "average" caseload.

CMSA also continues to sponsor other initiatives to determine the "average" caseload. For the past six years, CMSA has co-sponsored the Health Information Technology (HIT) survey with TCS Healthcare Technologies (TCS), and the American Board of Quality Assurance and Utilization Review Physicians, Inc. (ABQAURP). A core objective of the bi-annual survey was to identify how HIT applications impact the case management industry. Schooner Strategies (dba Schooner Healthcare Services), which conducted the surveys, has published a series of Trend Reports analyzing the results. Trend Report #7: Caseloads, focuses on care manager caseloads and time allocation.  

The survey asked respondents to estimate how many cases they handle per week, and describe how their time is allocated between various tasks, such as direct and indirect patient communication and administrative tasks. The report includes several figures and tables that analyze:
  • Average number of cases handled each week 
  • Breakdown of caseload statistics by various provider settings
  • Care managers’ time allocation broken down by different activities 
  • Relationship between time allocation, caseload levels, and activity types
The survey questions looked at weekly caseloads, as opposed to the total number of cases that might be assigned to a care manager, to generalize the data across various settings. 26.5% of the respondents said they had 25-49 cases, 19.5% had 10-24 cases, 15% had 50-74 cases per week and 11.5% reported having over 100 cases per week. 16% indicated they did not have a routine caseload (i.e., management and administrative staff).   

Case managers working in provider settings (behavioral health facilities, home care, hospital or health systems, medical group/clinic settings, retail clinics, skilled nursing or long-term care facilities) consistently reported having an average caseload of 25-49 cases. In addition, 62% of the case managers working in a home care setting reported having less than 50 cases per week, with 22% of that group supporting one to nine cases per week. Case managers in research centers or academic medical settings (29% of the respondents) were the outliers. They only reported having one to nine cases each week.  

The survey also asked respondents to indicate how much time they spend with patients and how much was devoted to performing other duties on a weekly basis:
  • Face-to-face patient contacts (meeting directly with patients in a provider setting, home visits, community settings, or clinic venues)
  • Non face-to-face patient contacts (telephonic, electronic, and/or hardcopy correspondence)
  • Administrative support (paperwork, staff meetings, trainings)
  • Other activities
Caseload levels were also compared with activities to determine the relationships with average time allocations. The highest face-to-face contacts were found in programs where case managers have between 120 and 174 weekly cases.  These are usually in provider settings with short-term cases that require more immediate and defined tasks, such as in hospital or clinic settings, rather than in long-term, complex, telephonic case management programs.   

The survey analysis supports the premise that variations in the delivery and settings for care management have a direct impact on the size of caseloads. A full copy of Trend Report #7: Caseloads and all other Trend Reports can be found here.   
Will we ever be able to determine the average caseload? It seems unlikely that we will be able to define a specific number for an average caseload, but that doesn’t mean we should stop trying. We should continue to define caseloads for our specific programs, based on all the variables. More importantly, we need to share that data with one another so we come closer to finding that "illusive number."     

To contact Pat Stricker, email her at pstricker@tcshealthcare.comor reach her at (530) 886-1700 ext. 215.  

This article was originally published in the March 2014 edition of CMSA Today.

Monday, September 19, 2016

MACRA Impact on Medicare Patients and Clinical Professionals: What You Really Need to Know

Written by Bonnie Zickgraf, RN, BSN, CPHQ
Coauthor: Aaron Turner-Phifer 

There is sweeping new federal regulation that will impact the future role of managed care nurses and physicians in the most challenging of ways. This new law is referred to as “MACRA.”

MACRA will overwhelmingly affect pre-authorizations, clinical coding review, claim reimbursements, policy development, performance measures and coordination of care, defining new roles for Medicare providers and managed care professionals in the United States.

You don’t serve the Medicare population in your current managed care position? Not to worry.

Because of the over-arching theme of increased financial risk and variable incentive payments addressing performance in the value of care, the U.S. potentially stands to lose hundreds if not thousands of providers serving Medicare patients, which can also mold and impact the commercial health care markets.

Hoping to retire someday and sign up for Medicare? Here is some helpful information you should know as a patient and as a managed care professional. Let’s look at the history, the regulation and the impact it may have on your own physician, the provider space at large, and you as a managed care professional.

This isn’t your Granddaddy’s Medicare system anymore, so I’ve enlisted input from my colleague at URAC, Aaron Turner-Phifer, Director, Government Relations and Policy, for some basic information about MACRA first:

MACRA Basics
In a rare show of bipartisanship, Congress overwhelmingly passed the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) which replaced the much maligned sustainable growth rate (SGR). MACRA represents the latest policy meant to facilitate the transformation of America’s delivery system toward value-based care and away from fee-for-service.
To facilitate this shift MACRA creates the Quality Payment Program which is comprised of two different programs: the Merit-based Incentive Payment System (MIPS) and Alternative Payment Models (APM).
Physicians and clinicians participating in the MIPS program will receive a bonus or penalty in their overall reimbursement based on a composite score compared to others in the MIPS program. The better a physician or clinician does, the higher the bonus. The inverse is also true, the worse a physician or clinician performs compared to the field, the higher the penalty.  Beginning in 2019, the first year payment adjustments begin, the maximum payment adjustment for physicians and clinicians is four percent. This escalates to nine percent by the year 2023.
Image provided by the American College of Rheumatology
As an alternative to MIPS, physicians and clinicians can participate in the APM (Alternative Payment Model) program which excludes them from the requirements of MIPS. Physicians or clinicians in the APM program get an annual five percent lump sum bonus simply for participating beginning in 2019. APMs are defined as those that meet criteria for linking payments to quality measures, use of EHRs, and nominal risk. CMS has identified the following programs that meet this definition:
-       Track 2 and 3 Medicare Shared Savings Program ACOs
-       Next Generation ACOs, Comprehensive Primary Care Plus (CPC+), and
-       some Comprehensive ESRD Care organizations (ESCOs).
CMS released the draft rules to implement the Quality Payment Program enacted by passage of MACRA on April 27, 2016. The final rules are expected sometime in the fall but physicians and clinicians impacted by the program are encouraged to begin planning now in order to meet a potential implementation date of January 1, 2017. --- Aaron Turner-Phifer

So, as you can see, Medicare reimbursements left for physicians (that will still be accepting Medicare reimbursements after January 2017) can ultimately go up or down in 2019 as a high as 9% under one payment strategy (MIPS) or, under the APM strategy, require possible restructuring into Patient Centered Medical Homes or to join an Accountable Care Organization that may require greater financial risk by the physician or choose to participate in bundled payment models. 

Physicians will need to carefully consider all options and decide which program to participate in (or not to participate in) or whether to treat Medicare patients at all. So how will this affect you as a managed care nurse going forward?

CMS calculates the change due to MACRA will impact three-quarters of a million physicians, hospitals and other providers, especially the smaller independent practitioners. One very good article about impact to the providers can be found here: (retrieved August 22, 2016)

Interestingly enough, what is most profoundly lacking in the resources today is the impact to nurses. In November 2015, the American Nurses Association (ANA) along with eight other nationally recognized nursing associations, submitted changes and voiced concerns to CMS about the proposed rule change, including the lack of recognition of the Advanced Practice Registered Nurse (APRN) and the roles they can most adeptly provide in light of the MACRA rule changes. This letter can be found here:

For those of you working in an office or in the field as a health UM nurse or as a case manager, access to care will become paramount. Finding a suitable (or any) Medicare provider may become a bigger challenge. New patient resources will need to be gathered to address patient needs including access to timely care, transportation, transitions of care between acute, subacute and home settings and discharge planning, to coordinate the care with Medicare providers.

Underutilization will need to be identified and critically analyzed by networks and by nurses for hidden root causes such as lack of affordability to the Medicare patient, or lack of available providers or delays in care coordination. Providers under MIPs payment strategy are exempt if seeing less than 100 Medicare patients and therefore may limit the number of Medicare patients seen in a geographical area. Awareness of patient responses to questions posed to the Medicare population may benefit the wise nurse in terms of becoming a stronger patient advocate. 

Nurses can also share MACRA and newly identified network resources with other nurses, physicians and other providers toward stronger patient advocacy and quality outcomes.
Education and awareness will become key attributes in managed care, no matter which way the regulations flow with MACRA or with others to come. Be prepared for future commercial and self-insured plans to follow suit. Reimbursements for quality care will come at a price to the patient and ultimately, to us all in the form of better quality care—when you can get it. I think our veterans know this system very well. Health care can only bear quality outcomes when and if the care is provided.

Note: The opinions in this blog entry are the personal opinions of the writer(s) and not necessarily reflective of AAMCN or URAC.

Image provided by the American College of Rheumatology

Thursday, August 25, 2016

Managed Care Nurse Leader of the Year (MCNLOY) Award

Every year, the American Association of Managed Care Nurses (AAMCN) awards an outstanding member of their association who demonstrates great leadership skills and has made an impact on managed care nursing. The award is presented at the annual Fall Managed Care Forum. This year, the forum takes place in Las Vegas, NV and is being held at the Delano-Mandalay Bay Resort on November 10-11, 2016.  

Last year's MCNLOY award, Stefany H. Almaden, PhD, RN, MSN, CCM, CPUM, CMCN.

AAMCN members who are nominated must demonstrate trust, individual consideration, intellectual stimulation, courage, dependability, flexibility, integrity, judgment, and respect for others.

Nominations are currently being accepted until October 1, 2016. Members of AAMCN may nominate themselves or another member. Winners will receive an award trophy and one year of free membership with AAMCN. Contact April at for a copy of the nomination criteria and an application link.

Thursday, August 11, 2016

Patrick Soon-Shiong to present keynote at Fall Managed Care Forum 2016

Patrick Soon-Shiong, a South African surgeon, medical researcher, businessman, philanthropist, and professor at University of California at Los Angeles, is currently chairman of the Chan Soon-Shiong Family Foundation and chairman and CEO of the Chan Soon-Shiong Institute for Advanced Health, National LambdaRail, the Healthcare Transformation Institute and NantWorks, LLC. Soon-Shiong has been selected as a keynote speaker for the annual Fall Managed Care Forum which is being held at the Delano/Mandalay Bay Resort in Las Vegas, Nevada on November 10-11, 2016. His presentation is entitled GPS Cancer and Cancer Moonshot 2020: The Era of Clinical Proteomics Has Launched to Provide Better Outcomes at Lower Cost. The conference will highlight the latest trends and practices in managed care. Nurses, medical directors, physicians, and other healthcare executives will be in attendance. The forum is sponsored by the American Association of Managed Care Nurses (AAMCN), NAMCP Medical Directors Institute, and the American Association of Integrated Healthcare Delivery Systems (AAIHDS).

Soon-Shiong founded NantHealth in 2007 to provide fiber-optic, cloud-based data infrastructure to share healthcare information. Soon-Shiong went on to found NantWorks in September 2011, which mission was "to converge ultra-low power semiconductor technology, supercomputing, high performance, secure advanced networks and augmented intelligence to transform how we work, play, and live." In October, 2012, Soon-Shiong announced that NantHealth’s supercomputer-based system and network were able to analyze the genetic data from a tumor sample in 47 seconds and transfer the data in 18 seconds. The goal of developing this infrastructure and digital technologies was to share genomic information among sequencing centers, medical research hubs and hospitals, and to advance cancer research and big science endeavors such as The Cancer Genome Atlas

In January 2013, he founded another biotech company, NantOmics, to develop cancer drugs based on protein kinase inhibitors. NantOmics and its sister company, NantHealth, were subsidiaries of NantWorks. Soon-Shiong stated that NantWorks’ vision for the future of cancer treatment was a convergence of multiple technologies that included diagnostics, supercomputing, network modeling of sharing data on tumor genes and personalized concoction of cancer drugs in combination for multi-targeted attacks. The goal was to manage cancer and achieve a sustained disease-free state.

In 2010, with Arizona State University and the University of Arizona, Soon-Shiong founded the Healthcare Transformation Institute (HTI), which he dubs a "do-tank". HTI's mission is to promote a paradigm shift in health care in the United States by better integrating the three now separate domains of medical science, health delivery, and healthcare finance.

Soon-Shiong heads the CSS Institute for Advanced Health, founded in 2011 with a mission to provide high-speed computing capabilities for human genotyping to target specific cancer treatments, as well as technologies for the better management of chronic disease. Through the CSS Institute, Soon-Shiong is working to create a national health information network for the secure sharing of biomedical information. He is supporting the development of various wireless technologies for the better management of chronic disease.

Soon-Shiong is on several boards. These include the Board of Directors of the Mendez National Institute of Transplantation, and the board of directors for the Technology Council for the Center for Cancer Nanotechnology Excellence at Northwestern University. He leads other organizations concurrently. He is Chairman of the National Coalition for Health Integration, and is the Executive Director of the UCLA Wireless Health Institute.

Soon-Shiong and his wife, Michele B. Chan, fund several health-related projects through the Chan Soon-Shiong Family Foundation. In 2007 they pledged US $1billion to support healthcare transformation and a national health information highway. The Foundation has given a total of $135 million to the Saint John's Health Center in Santa Monica, California. It gave a guarantee of $100 million that enabled the replacement of closed Martin Luther King Jr./Drew Medical Center with the new Martin Luther King, Jr. Community Hospital in Willowbrook. Its Summer 2015 opening restored healthcare access to the largely underserved residents of South Los Angeles. In 2010, Soon-Shiong and Chan were asked to and did join Bill Gates and Warren Buffett in taking The Giving Pledge, by which some of the wealthiest Americans have pledged to give the majority of their wealth to charitable causes. They will donate half their wealth. In 2011 Soon-Shiong and Chan endowed a new Chair at the USC Viterbi School of Engineering, to support research at intersection of engineering and medicine, specifically computer science, mobile vision, and robotics.

The American Association of Managed Care Nurses (AAMCN) was established in 1994 in response to an identified need to educate nurses about managed healthcare. The AAMCN is a non-profit membership association of Registered Nurses, Nurse Practitioners and Licensed Practical Nurses including top level administrators, managers, directors and consultants associated with a variety of managed healthcare organizations. The American Association of Managed Care Nurses is accredited by the American Nurses Credentialing Center’s Commission on Accreditation to provide continuing nursing education credits.

About NAMCP Medical Directors Institute
NAMCP was founded in 1991 to serve the educational interests and needs of medical directors and physicians working in all forms of managed healthcare. NAMCP’s mission is to improve patient outcomes by providing educational material, evidence-based tools and resources to medical directors from purchasers, plans and provider systems. NAMCP aggressively works with medical directors to identify and strategically position our industry to respond to the various opportunities and challenges on the horizon. We support initiatives empowering medical directors with information they need to make healthcare decisions and promote healthcare quality. NAMCP is accredited by the Accreditation Council for Continuing Education to provide AMA PRA Catergory 1 creditsTM to physicians.

Established in 1993, the American Association of Integrated Healthcare Delivery Systems (AAIHDS) is a non-profit organization dedicated to the educational advancement of provider-based managed care professionals responsible for accountable and integrated healthcare delivery. Members include payer and provider-based managed care executives i.e., VPs of Managed Care, CEOs and Board members of ACOs, IPAs, and PHOs, and other executives involved in integrated healthcare delivery systems and networks.

Wikipedia, the Free Encyclopedia. Patrick Soon-Shiong. Accessed August 11, 2016.

Thursday, August 4, 2016

Medical Limbo

The do-nothing dilemma

When Judy Refuerzo heard the word ‘carcinoma’, she began considering her treatment options. But two years on, she’s chosen surveillance over surgery. Was she right to? Charlotte Huff meets her and other so-called watchful waiters.

Imagine for a moment that you have a tiny but worrisome lung nodule or, say, a growing bulge in a crucial blood vessel. You have no choice but to continue with normal life: going to work, running errands, paying taxes, negotiating with your kids over screen time. But you’re always living, at least to some degree, under the looming shadow of a medical question mark.

Judy Refuerzo ventured further along that uncertain journey this summer, walking the full length of the Camino de Santiago – some 500 miles and 38 days across the Pyrenees into Spain – to commemorate her 60th birthday. It had been a long-planned trek, one that she tackled with a backpack and a close girlfriend for company. She’s not in denial, she insists, about the malignant cells that doctors found in her breast nearly two years ago.

She’s been getting regular imaging tests to make sure that the cells – collectively called ductal carcinoma in situ (DCIS), or sometimes stage 0 breast cancer – have not migrated beyond the milk ducts. But the California yoga teacher has decided against any kind of treatment, including surgery – at least for now. “I just don’t want to be cut open for no reason,” she says.

Through the ages, doctors have sometimes recommended hitting pause on treatment

In the process, Judy has joined a growing group of so-called watchful waiters, snared within a modern-day web of aggressive testing and medical uncertainty.

The concept of watchful waiting (synonymous, for some doctors at least, with ‘active surveillance’) is nothing new. Through the ages, doctors have sometimes recommended hitting pause on treatment. Increasingly, though, more and more people are caught up in a peculiar medical purgatory, particularly in countries like the USA where an emphasis on screening and high-tech imaging to rule out medical problems can cascade into more testing and other uncertainties.

“I think our technologies are moving faster than our ability to know what to do with the conditions we find,” says Shelley Hwang, a breast surgeon at Duke University Medical Center and a prominent DCIS researcher. “And once you know it, you can’t un-know it.”

Sometimes, as in Judy’s situation, people will choose that wait-and-see path. While still quite controversial, some doctors are willing to delay surgery and other treatment for DCIS unless there are signs that the malignant cells are moving into the surrounding breast tissue. In other medical scenarios, patients are told flat out that monitoring is the only immediate option, as it’s too risky to operate until circumstances become more life-threatening.

Medicine has reached a crossroads. Shadows, nodules and other changes can be flagged much earlier, in the maybe-or-maybe-not-worrisome stage. Meanwhile, researchers and clinicians are learning that, for some conditions, less medical care might be better, both in the short term and also possibly over the longer haul. Even some cancer cells, it seems, can flare and fade away.

But that shift in medical thinking raises other big questions: Are some people more psychologically able to cope with medical limbo? Can clinicians identify which patients might better weather uncertainty? And how do doctors counteract that innate human desire to ‘do something’, not only in their patients, but in themselves? 

“People don’t like this idea of watching,” says Rita Redberg, a cardiologist at the University of California, San Francisco. “The whole fact that we’ve told you to watch… makes you feel like something bad is going to happen.” Even though, she says, a lot of things that are watched will never progress, there is a drop in a person’s quality of life when they get into a surveillance situation.

If she chose to, Redberg could tout medical credentials that run for pages. She’s a long-standing cardiology researcher, a vocal opponent of inappropriate imaging, and the chief editor of JAMA Internal Medicine.

In the late 1970s, she and her fellow medical students were learning how to perform a physical exam, which meant practising on each other. One student found a lump in Redberg’s neck, which – after more than two decades of monitoring with blood tests – was eventually biopsied in 2000. It was papillary thyroid cancer, the most common form of thyroid cancer. Soon after, she had surgery.

If she had had her biopsy today, Redberg might have had another, albeit controversial, option: to simply monitor her cancer. Surveillance has long been considered an option for low-risk prostate cancer, and now researchers are exploring its use in other cancers, including papillary thyroid, which is, very often, so slow-growing that someone can fare well for years without it spreading.

The whole fact that we’ve told you to watch… makes you feel like something bad is going to happen

Another is DCIS, Judy’s diagnosis. As mammography and other imaging has become more common and more sensitive, diagnoses of DCIS now make up as many as a quarter of breast cancer diagnoses. Previously, it was virtually unheard of.

The question is: how risky is it to leave those cells alone?

Since few women choose surveillance, research answers are limited. But a recent look back at patients treated in Boston proved encouraging. After ten years, over 98 per cent of women hadn’t died from their low-grade DCIS, whether they had had surgery or not.

While the cancer outcomes are crucial, the impact on someone’s quality of life shouldn’t be ignored. Some women who choose surgery, radiation and other measures for DCIS might struggle with related pain and recovery for some time, Hwang says. But without surgery, she counters, “there’s another flavour of misery where you’re just worried every day of your life that you’re going to get cancer”.

Hwang is leading the first large-scale randomised DCIS study in the USA, known as the COMET trial, which will analyse cancer rates as well as the psychological ripple effects. Psychological and quality-of-life aspects also are part of a similarly designed study called LORIS, which was launched in 2014 in the UK.

Prior research shows that women with DCIS harbour similar fears about recurrence and dying as those who have invasive breast cancer, despite DCIS being less serious. “We’ve got a lot of worry going on and we don’t even know if the treatment that they’re receiving actually is of any value to them at all,” says Lesley Fallowfield, the principal investigator on the LORIS study’s quality-of-life assessment.

During discussions after her 2014 diagnosis, Judy’s doctors recommended a myriad of treatment approaches – mastectomy, lumpectomy, radiation and tamoxifen – in various combinations to prevent the malignant cells from spreading. Finally, a surgeon suggested that Judy talk to doctors at the University of California, San Francisco, early proponents of monitoring as an alternative strategy. “He said, ‘They have a different view of DCIS than the rest of the world,’” Judy recalls.

As she mulled over her options, Judy worried about the risk of surgery and radiation, including short-term discomfort and possible longer-term side-effects. Plus, no one could guarantee her that the malignant breast cells would be eradicated for good. Do I want to live my life healthy and feeling good, she asked herself, or miserable and not feeling good, with the same outcome?

Judy, who already avoided meat, has made other changes to her diet since her diagnosis, dropping wheat and dairy. She’s also taking vitamin D to supplement her low natural levels. She believes that many of us periodically harbour malignancies somewhere in our bodies, cells that can be beaten back with exercise, nutrition and other healthy habits. But she also admits to flickers of doubt: “Occasionally I’ll think, ‘Why do I think I’m special?’”

Theresa Monck, a 63-year-old from Brooklyn, New York, is soaking up her first years of retirement, especially the opportunities to travel. But her next lung scan lurks in the back of her mind. The former smoker started getting annual CT scans in 2013 to look for any early signs of lung cancer. Two small nodules were identified. Over the last several years they have not grown, a reassuring sign.

Still, Theresa has pushed for a biopsy. Doctors, she says, have told her that the nodules are too small to risk the procedure, which involves inserting a needle into her lung. “I don’t like having them…” she says. “But what am I going to do?”

Theresa and patients like her are providing some insights into just how much angst men and women living in medical limbo really suffer.

In 2013, the US Preventive Services Task Force recommended CT-scan screening for long-term current and former smokers. (European countries have been slower to conduct such screening outside of research studies, which are ongoing.) The goal is to find cancers at an earlier and likely more treatable stage.

But there’s a significant catch. Anywhere from 20 to 50 per cent of people, depending on the study cited, will have to deal with a false positive, where a nodule is found that, after further testing and scrutiny, doesn’t prove to be cancerous. Sometimes patients won’t know one way or the other for years, but will continue to undergo imaging to see if the nodule is growing.

For some people monitoring can morph into an endless loop, says Renda Soylemez Wiener, a pulmonologist at Boston University School of Medicine. While the typical guidance is to stop after several years if the nodule hasn’t changed, this regular scanning can highlight another nodule, and the clock starts over. “Patients wind up in this prolonged period of uncertainty,” she says.

Do I want to live my life healthy and feeling good, or miserable and not feeling good, with the same outcome?

How much distress those scans generate, though, is still not clear. One study tracked just over 2,800 participants in the US-based National Lung Screening Trial. Researchers found that those who had a suspicious nodule detected (and later ruled out) didn’t suffer any more anxiety than those whose imaging tests didn’t turn up anything.

Joanne Marshall, a former smoker, is among those who might have reason to fuss. Her mother was diagnosed with lung cancer in 2012. Soon after, Joanne got her first scan, which identified three small nodules. But they haven’t grown and neither has her concern. “Some people can be nervous nellies – that’s just not me,” says the 54-year-old, who lives near Los Angeles. “I need to watch it because I would like to have a fighting chance, and I can’t take back the smoking history.”

But Wiener says her research shows that not everyone is similarly sanguine if a nodule is found. Sometimes patients act as though they’ve already been diagnosed with lung cancer, she says. A woman in one of her studies quit her job to find another that would allow more time with her family.

In another study, Wiener assessed the perceptions of 122 veterans whose nodules had been picked up in the course of checking out another potential medical problem. Nearly 40 per cent reported at least mild distress after the nodule was identified; 16 per cent described their distress as moderate to severe.

And even when a doctor says that CT scans are no longer necessary, 29 per cent of patients report being ‘somewhat nervous’ to stop surveillance, and 10 per cent would be ‘extremely nervous’.

Theresa, the Brooklyn retiree, had a similar reaction when she learned that clinicians typically don’t follow nodules that haven’t changed for longer than several years. She’d continue the CT scans, she maintains, even if she had to go to another hospital, and even if her insurance wouldn’t cover them and she had to pay herself. How else would she know if one of those nodules ever began to grow? 

Theresa and Joanne both carry several small, relatively low-risk nodules in their lungs. Yet their reactions have been notably different. Fallowfield, the principal investigator on the LORIS study’s quality-of-life assessment, says research indicates that we all have personality filters through which we sift medical information, sometimes in surprising ways.

Years back, Fallowfield was involved with a study which looked at the processing styles of 154 women wrestling with the weighty decision of whether or not to have prophylactic surgery to remove both breasts. Just over half of the women – all of whom faced a high risk of breast cancer based on family history or other risk factors – chose surgery. Most of the rest declined, with a small number delaying their decision for various reasons.

Understandably, both groups reported high anxiety at the start. But among those who chose the double mastectomy, those feelings “by and large” eased over the course of 18 months, Fallowfield says. But they didn’t among those women who opted for surveillance.

How could that be? Researchers found some indications in a ‘ways of coping’ questionnaire that they had asked both groups to fill out in order to gauge how they handled life’s difficulties. The women who chose surgery tended to have a more proactive, problem-solving approach, and likely that helped ease their anxiety moving forward, says Fallowfield.

We all have personality filters through which we sift medical information, sometimes in surprising ways

The women who declined were prone to using “detachment or distraction as a way of coping with life’s traumas,” she says. “These were ostrich-head-in-the-sand-type people.” But that coping mechanism had a crucial flaw. Imaging tests and check-ups kept reminding them of their cancer vulnerability.

Suzanne Miller, a clinical health psychologist who studies medical decision making, believes that the UK women who turned down the operation fall into a subset known as ‘monitors’, one of two coping styles that she first described in the late 1970s. The others – ‘blunters’ – prefer to engage with medical details and discussions on an as-needed basis. “They hear what they’re told,” she says, but are not inclined to dig further.

Monitors are more likely to do research before an appointment and pepper the doctor with questions. They’re also more likely to amplify any medical risks, which can become stressful if they decide on surveillance for a condition such as DCIS, Miller says. They may choose it “on the basis of the rational concrete pros and cons,” she says. “But many of them understand going into it that this is going to have an emotional toll.”

In recent years, Miller has come to believe that monitors can be divided even further by coping style. ‘Non-strategic monitors’ likely haven’t taken steps to mitigate the emotional toll between scans and check-ups. They might continue to fret and stew, which can snowball into regret that they haven’t taken a more ‘active’ step, Miller says. Hence the pervasive anxiety suffered by the women who turned down prophylactic mastectomy in Fallowfield’s study. Another example is men with early-stage prostate cancer who initially commit to surveillance, but eventually go under the knife because they can’t stand the uncertainty.

Judy Refuerzo is what Miller describes as a ‘strategic monitor’, someone who relies on support, self-care and other strategies to dampen their own monitoring tendencies. Along with boosting her nutrition and striving to live life to the max – Judy says she’s probably a bit more spontaneous these days – she tries not to think too much about her cancer risk. Yet she still has scans every six months.

“I’m under surveillance,” Judy says. “I’m not an idiot – I’m proactive.” In February 2016, Judy’s most recent MRI scan showed some DCIS growth, but no signs of invasive cancer. 

Miller’s tool, the Monitor–Blunter Style Scale, is one way that clinicians can get a snapshot of a patient’s coping style. It would also be helpful if a doctor could capture a sense of an individual patient’s risk tolerance, says Shelley Hwang, the Duke breast cancer surgeon – something similar, she says, to how financial planners assess whether their client is capable of or interested in taking on additional financial risk.

Patients and doctors caught in this cycle of surveillance are fighting one of the most innate human tendencies: the desire to act, says Paul Han, a physician and researcher who studies medical uncertainty and risk communication. That impulse can infect far more mundane situations than expanding aortic aneurysms or early-stage cancers, Han says, noting that every day doctors must decide whether to prescribe antibiotics to patients with respiratory symptoms.

“Everybody wants something done, when in fact often nothing is really needed except observation and letting things run their course,” he says. “But there is this sort of general impatience in our medical culture, and in our culture at large.”

Han speculates that this discomfort with watchful waiting might figure more prominently in the USA than in countries in Europe and elsewhere where conversations about healthcare costs and trade-offs are more publicly hashed out. Fallowfield agrees, wondering if the US-based DCIS study (COMET) might struggle more than the UK one she works on (LORIS) to recruit patients willing to have their treatment randomly assigned, as Americans tend to be “less risk-tolerant”.

Everybody wants something done, when often nothing is really needed except observation

Fallowfield also echoes other clinicians who worry that misleading medical language can unduly alarm patients, ramping up their perception of their own risk status and thus influencing their treatment choices. When talking to LORIS study participants, clinicians use the term ‘active monitoring’ rather than ‘watchful waiting’. “‘Watchful waiting’ sounds quite passive – you are sitting there waiting for something to happen,” she says.

Using the term ‘ductal carcinoma in situ’ is similarly like waving a red flag in front of patients, Fallowfield says, because it includes the word ‘carcinoma’. If keeping DCIS as an acronym is important, she suggests other terminology, such as ‘ductal changes in situ’ or ‘ductal calcifications in situ’.

In the prostate field, there’s an analogous diagnosis to DCIS, a pre-cancerous condition called high-grade prostatic intraepithelial neoplasia. It’s the word ‘neoplasia’ that “can set off patient alarm bells,” says Ian Thompson, a prostate cancer researcher in San Antonio, Texas.

“Didn’t Ralph Nader call the Corvair unsafe at any speed? The terminology does affect behaviour.” Thompson and other clinicians have proposed a less malignant-sounding, albeit clunky, alternative: IDLE, short for indolent lesions of epithelial origin.

To reduce patient fears, clinicians should do a better job at communicating medical risk, says Renda Soylemez Wiener, the Boston pulmonologist. She points out that just one-quarter of 244 patients diagnosed with lung nodules were able to predict with any degree of accuracy the likelihood that their nodules would prove to be cancerous. Overall they pegged their risk at 20 per cent, but their actual risk based on nodule size was 7 per cent. Nearly three-quarters of them didn’t realise that some lung nodules grow so slowly that they will never prove to be life-threatening.

A surveillance contract could also help avert patient–doctor misunderstandings, says Brendan Stack, Jr, an Arkansas thyroid cancer specialist. A written agreement for patients considering thyroid monitoring could ensure an upfront discussion of the risks involved, he says. It could also lay out the circumstances under which the patient’s decision would be revisited.

Once a patient has ‘self-declared’ that surveillance is the best course, it can be difficult to convince them to deviate, even if the malignancy shows signs of becoming more aggressive, says Thompson. “Changing horses from doing nothing to something is sometimes difficult for people, if you will – to push a reboot to the computer and reassess.”

From Rita Redberg’s perspective, there is one easy way to reduce the expanding pool of watchful waiters: stop searching for medical ills so fiercely in the first place.

She now wishes that she hadn’t dug so far, literally, into her own thyroid.

There’s one easy way to reduce the pool of watchful waiters: stop searching for medical ills so fiercely

After the lump was detected during medical school, a radioactive iodine scan determined that it was a ‘hot’ nodule – one that produces excess thyroid hormone – but likely benign. Redberg did little more to check it out for some two decades, other than periodic blood tests, until her primary care doctor worried that it might be growing. She agreed to a needle biopsy, which she now regrets. Her surgery in 2000 left Redberg with a scar on her neck. Each day, she takes a thyroid replacement pill.

Strangely enough, Brendan Stack has a similar story. He was teaching medical residents about ultrasound technology and they were practising on his neck when they found a thyroid nodule. It was biopsied twice, but cancer still couldn’t be completely ruled out.

Watchful waiting was one possibility. “I couldn’t tolerate that,” Stack recalls. “I said, ‘We’re taking it out.’” In 2006, he had surgery to remove the half of his thyroid where the nodule was located. The pathology showed no signs of cancer. Even so, he has no regrets: “I’d do the same thing today.”

And Redberg? She’s not quite so unequivocal, given how slowly thyroid cancer typically grows. “Probably, on balance,” she says, “I would have been happier not to have known about it.”



This article first appeared on Mosaic and is republished here under a Creative Commons licence.

Thursday, June 30, 2016

How MAGGOTS Made it Back Into Mainstream Medicine

Circular ulcer on the leg packed with maggots and surrounding discolored area with multiple ulcers.

Ulcer after removal of maggots and debridement.

A writhing mass of maggots in a wound might seem like a good reason to seek medical help. But, reports Carrie Arnold, sometimes it’s the doctors who have put them there, adopting an ancient treatment to help heal painful infected injuries.

By the time Michelle Marineau saw her patient, James*, there was little she could do to help him. His big toe had been removed, a complication from years of uncontrolled type 2 diabetes, but the amputation site had stubbornly refused to heal. An infection had eaten away flesh and left tendon and bone exposed, streaks of off-white against the angry, red, weeping wound. Several of his other toes had developed gangrene, turning black and slowly dropping off.

If unchecked, diabetes leads to damaged nerve endings, meaning small injuries can go unnoticed and turn into ulcers prone to life-threatening bacterial infections. The bacteria build a nearly impenetrable shield called a biofilm that protects them from antibiotics, so instead surgeons use scalpels to clear away dead tissue and infected flesh, a procedure known as sharp debridement. Unfortunately, this often misses spots, letting the infection come roaring back with an even larger area to colonise.

Marineau, a nurse practitioner and wound care specialist on Oahu, Hawaii, had seen many patients like James before and decided that he, like over 70,000 other people with diabetes in the US each year, needed to have his foot amputated in order to save his life.
Seeing his father’s distress at the looming procedure, James’s son proposed a different solution: maggots.

The larvae of the greenbottle blowfly (Lucilia sericata) feast on the bacteria and dead tissue in chronic wounds, cleaning out the wound and giving it more of a chance to heal. This is an ancient therapy, used since Biblical times, but fell out of favour with the invention of antibiotics. However, the rise of drug-resistant bacteria, combined with skyrocketing rates of chronic wounds from diabetes, has led to a resurgence of interest in using creepy-crawlies as treatment, usually referred to these days as maggot debridement therapy or larval therapy.

Although larval therapy had been studied in the lab, few clinical trials had tested it head-to-head against more modern surgical techniques. So although Marineau agreed to try the maggots, she had no idea whether they would actually work for James.

She also had no idea how to use maggots, and had to be talked through the procedure over the phone. But it worked perfectly: “We had amazing success with him,” she says. “We were just astounded.” Lots of medical products hype the wonders they can work for patients, but Marineau says maggots are one of the only things that “really blow your mind at what a big difference they can make”.

Marineau received the maggots via overnight mail from Monarch Labs in Long Beach, California. As she placed them one by one on James’s foot in early 2009, she became the latest in a long series of healers. Cultures around the world, including the Maya of Central America, Aboriginal tribes in Australia and the Myanmar Hill People, have used maggots to treat wounds.

Much of the historical writing on the role of maggots in helping wounds heal revolves around battlefield injuries. Although such wounds can and do kill outright, the majority of deaths from war injuries have been caused by infection. Festering wounds often attract blowflies looking for a spot to lay their eggs, which then hatch into larvae. Napoleon’s battlefield surgeon, Dominique Larrey, noted in an 1832 book that they were “greedy only after putrefying substances, and never touch the parts which are endowed with life”. And they were not just harmless but helpful, by “cutting short the process of nature” to heal wounds more quickly. Despite Larrey’s advice, though, his wounded soldiers were annoyed and terrified by the larvae: “nothing short of experience” would convince them to trust the insects.

While Larrey noticed their benefits, he hadn’t deliberately placed blowfly larvae on the wounds. The first documented intentional use of maggots in modern times came during the American Civil War. Confederate physician John Forney Zacharias reported: “During my service in the hospital at Danville, Virginia, I first used maggots to remove the decayed tissue in hospital gangrene and with eminent satisfaction. In a single day, they would clean a wound much better than any agents we had at our command. I used them afterwards at various places. I am sure I saved many lives by their use, escaped septicaemia, and had rapid recoveries.”
"He bred maggots on the windowsill of his Baltimore laboratory."
19th-century knowledge of the intricate series of events by which a wound heals was primitive by today’s standards, but these doctors did know two things: infected wounds were likely to kill the patient, and healing would stop if the healthy tissue of a wound died. What maggots did was remove infection and dead tissue while sparing healthy flesh. It was a remarkably effective and efficient way to help wounds heal, deployed even in 20th-century conflicts.

Faced with battlefield wounds on an unprecedented scale in the trenches of France during World War I, Johns Hopkins University physician William Baer began seeing injuries that had become infested with maggots. His first instinct was to clean out the larvae but then, like other doctors before him, he noticed something strange: the wounds with maggots didn’t become infected, they healed faster, and the soldiers were much less likely to die of their injuries.

Common Fly Life Cycle
Photographed by Alan R Walker

After the war, Baer returned to Johns Hopkins and brought his insights into maggot therapy with him. In particular, he wanted to try it on chronic bone infections known as osteomyelitis. He bred and raised Lucilia sericata maggots on the windowsill of his Baltimore laboratory, and used the larvae on 21 patients for whom all previous treatments had failed. Two months later, Baer noted, all of their wounds had healed. However, he discovered that several of the wounds had become infected with tetanus and gangrene. He realised that he needed to sterilise the larvae before using them on patients. After several years of experiments, he finally found that a solution of mercuric chloride, alcohol and hydrochloric acid did the trick without killing the eggs.

Throughout the 1930s and 40s, the popularity of maggot therapy blossomed – at least, until the discovery of penicillin. Within a few decades, maggot therapy was relegated to a “historical backwater, of interest more for its bizarre nature than its effect on the course of medical science,” said the microbiologist Milton Wainwright. It was “a therapy the demise of which no one is likely to mourn”.
A tsunami of hard-to-heal wounds, however, brought this backwater back to the forefront of medicine.

Wounds go through a series of stages to close and heal. After bleeding stops, white blood cells flock to the scene to break down dead tissue and clear out any bacteria. When this process is finished, the body begins to lay down collagen, a protein that provides structural support as well as helping skin cells divide and mature. Skin cells at the edges of the wound begin to divide and slowly migrate to the centre. Once the surface of the wound is covered with a new, thin layer of cells, blood vessels form to service the new tissue, and slowly, a layer of scar tissue forms over the top.

Healing, however, doesn’t always go according to plan. Many people with diabetes develop foot ulcers as an indirect result of chronic high blood sugar levels destroying nerve endings and small blood vessels. While the destroyed nerves mean small injuries can be missed, the reduced blood flow means that injury-fighting cells and chemicals can’t get to the injury, so it just gets worse.

There are other conditions that interfere with healing. If the veins in your legs don’t return blood to your heart as well as they should, fluid can pool in your feet and ankles. This swelling means that a simple scratch can turn into a venous leg ulcer. A similar thing can happen if your arteries don’t deliver enough blood to your hands or feet. For people with conditions that mean they spend most or all of their time in bed or a wheelchair, pressure ulcers are common. For others, the problem is poor nutrition, old age, or any of a number of variables that suppress the immune system.
"Far from being a historical backwater, maggot therapy sounded exactly like what his patients needed."
The result in all these cases is wounds that won’t heal. The process gets stuck permanently in the very first stage. White blood cells hang around the wound longer and in higher numbers, secreting chemicals that interfere with the growth of new cells. They also trigger production of a group of enzymes that break down the base layer of collagen upon which wound healing is built, which in turn impedes the formation of new blood vessels. As a result, some of the cells around the wound begin to die, making the wound even larger and harder to repair.

With the wound open and unhealed, bacteria move in. Even when this doesn’t result in an overt infection, a thin layer of bacteria can create a biofilm that covers the sore. Large groups of biofilm bacteria coat themselves in sugars and other barriers that keep antibiotics from killing them off. Biofilms, along with dead tissue, mean that even the most advanced wound treatments won’t work.

As conditions like type 2 diabetes began to grow more common in the 1980s, physicians like Ron Sherman in California saw increasing numbers of patients with wounds that refused to heal. He remembered learning about chronic wounds and the archaic-sounding maggot therapy when he was fresh out of medical school. Far from being a historical backwater, maggot therapy sounded exactly like what his chronic wound patients needed.

“The maggots were able to dissolve the dead and infected tissue, thereby cleaning the wound faster than any of the other non-surgical treatments available,” he says. “I was able to treat patients who were scheduled for amputation because they had failed all other therapies.”

But there was a problem: US labs were no longer producing medical-grade maggots commercially. If he wanted to do more maggot therapy, he was going to have to breed his own.

Finding maggots is easy but, as Sherman discovered, finding the right maggots is hard. He needed a species of fly that could be reared in lab colonies over many generations and that wouldn’t be harmful to humans or animals. He settled on Baer’s favourite, the greenbottle blowfly Lucilia sericata. Sherman baited small traps with rotting beef liver and placed them at various locations around his hometown of Long Beach. Eventually, in the spring of 1990, he managed to capture a female fly that had yet to lay her eggs – she was exactly what he needed to start a lab colony. At first, he raised his flies in his apartment, constructing cages out of window screens, duct tape and cardboard. As the numbers grew, he transferred the boxes to a spare closet near his lab at the University of California, Irvine.

 Greenbottle Blowfly

In 2004, the US Food and Drug Administration (FDA) approved medical-grade maggots as a “medical device” to debride chronic or non-healing wounds. It gave Sherman’s maggots a level of legitimacy he needed to treat patients on a wider scale. It also meant that he needed to raise his maggots in a dedicated lab to create a better-quality product and stay within FDA guidelines. So in 2007, he founded Monarch Labs, the first modern American company devoted solely to the production of sterile therapeutic maggots.

In Europe, a competing company, BioMonde, was also gaining momentum. They used the same blowfly species, but they hoped that their 2005 invention of the BioBag would set them apart. Instead of selling their maggots loose, like Monarch Labs and others, BioMonde sold theirs in a white silk mesh bag that, to an outsider, looks like a large teabag containing miniature grains of rice.

“You don’t have to see the maggots, you don’t have to touch the maggots. Everything is contained in the bag. And when you’re done, you just pitch it and place a new bag on,” says Katy Nicell, a product manager at BioMonde’s new office in Gainesville, Florida.
"Whether you take your maggots loose or in a bag, they work in the same way."
Sherman maintains that loose larvae do a better job than the bagged ones, since their movement across the wound surface helps to remove dead cells. “The maggots are a little lumpy-bumpy on the outside, and as they crawl across the wound, they’re acting like a file, similar to how a toothbrush cleans teeth. The physical action is important – you don’t just use mouthwash on your teeth,” he says.

But the BioBag was perfect for Linda Cowan, a nurse investigator at the Malcom Randall Veterans Affairs Hospital in Gainesville. She wanted to start a trial of maggot therapy and the bagged larvae were just more convenient for patients and their caregivers. With loose larvae, you have to count them as you place them on the wound, and count them again as they’re removed, as part of a technique Cowan wryly refers to as “no maggot left behind”.
“The problem with that is when you put in 100 maggots, that’s a big, time-consuming thing,” she says. “And then if you bring out 90 maggots, there’s a huge concern, you can see on the face of the patient, where did the other 10 go? Did they climb in my ears at night? Did they escape? Where did they go?”

A bag avoids any such concerns. It’s also a bonus for patients in hospitals, where many physicians are reluctant to allow loose maggots into their facilities.

Whether you take your maggots loose or in a bag, they work on unhealed wound tissue in the same way. Although maggots do have a mouth, they don’t munch directly on a wound. Instead, enzymes in their saliva start to break down the bacteria and dead cells, a process called extracorporeal digestion. Laboratory studies have shown that these enzymes help to kill bacteria and also increase the production of immune-system chemicals that help the body fight infection and heal wounds. Once the cells have dissolved into a nutritious smoothie, the maggots slurp it up.

“The bacteria are mixed up in everything, and the maggots just suck it all right up and break it down internally,” says Cowan’s colleague, entomologist Micah Flores.

The larvae are left on the wound for two to four days, or until they stop eating and start to become adult flies. By this point, they have grown to the size of plump jellybeans.

“The maggots go in there as God’s miniature little surgeons,” says Cowan. “They can see what we can’t see, and they can eat the bacteria and the dead tissue, and our theory is that we think that they might even do a better job than sharp debridement, but we don’t know.”
"It’s not alternative medicine, it’s scientific medicine."
To find out if maggots were indeed better than a human with a scalpel, Cowan and Flores set up a clinical trial. People with chronic wounds, many of whom were middle-aged men with foot, venous or arterial ulcers, would receive either two applications of maggots in the BioBag or two treatments of sharp debridement. After eight days, the researchers would compare the amounts of biofilm left in the wounds to measure how effective each technique was. Cowan and Flores would also follow the patients for up to two years to see if there was a difference in how quickly their wounds healed.

They had planned their trial well. What they didn’t know was whether they could get enough people to sign up.

The nature of objections to the trial surprised Cowan. Instead of finding maggot therapy off-putting, as she had expected, nearly all of the people who signed up really wanted to have it. Several dropped out after being assigned to the sharp debridement group. The maggots were so overwhelmingly popular that BioMonde agreed to provide the sharp debridement group with two free rounds of maggot therapy after the trial was over. To be fair, Cowan offered two free sessions of sharp debridement therapy for those in the maggot group as well.

Far harder than convincing patients was convincing physicians: “Some care providers see it as ancient. ‘That’s old fashioned and ancient and we’re doing evidence-based practice’, which in their minds means new. But they’re not looking at the evidence behind larval debridement therapy, which there’s a lot of,” Cowan says.
"A chronic wound is uncomfortable and painful, caring for it is time-consuming and expensive."
While many patients don’t care what a treatment looks like as long as it might help them, doctors will often have to overcome their inherent aversion to creepy-crawlies as well. “Many physicians just don’t like the idea. They just don’t like maggots. When they see the therapy, they buck,” says Gwendolyn Cazander, a vascular surgeon in the Netherlands. “It’s not alternative medicine, it’s scientific medicine. They just don’t know the details.”

Dermatologist Ed Maeyens has spent more than two decades helping patients with all types of skin injuries, and it was only out of a sense of desperation that he initially turned to maggots to treat patients for whom nothing else had worked. “Doctors tend to believe they know more than maggots and can do a better job. But when I tried them, the maggots cleaned the wound beautifully,” he says. “It was love at first bite.”

Results from other clinical trials show that medical reluctance to embrace the maggot could be depriving patients of effective therapies, at least in the short term. In a study of 267 people in the UK with venous leg ulcers, the VenUS II trial compared loose and bagged maggots with hydrogel, an ointment that helps to promote the body’s own enzymes to remove dead tissue. In results published in 2009, scientists found that it took the same amount of time for the wound to heal in all three patient groups, although the maggots were better at actually debriding the wound. And in a 2011 French trial, researchers found that maggots did a significantly better job than conventional treatment at removing dead tissue in chronic wounds during the first week of treatment, although both treatments were equally effective by week two.

Given that it was debridement that maggots were approved for, these findings make sense to Cowan. We should see larval therapy as getting the wound ready for the next stage of healing, rather than the last step of the process, she says. “If we can clean up that wound bed and prepare it for an advanced therapy, I think that might be one of the key gaps to clinical treatment that larvae could fix.”

Sherman agrees. A chronic wound is uncomfortable and painful, caring for it is time-consuming and expensive, and it can have a huge impact on everyday life. Some people have been dealing with their wounds for five years.

“Compared to a large, weeping, infected wound, a bunch of baby flies aren’t that bad,” he says.

Maggots should only be used to treat wounds under medical supervision, using sterile therapeutic maggots.

* The patient’s name has been changed.