Dialysis from the sharp end of the needle

H1N1 Pandemic Flu 2009 in Review:The Deadly Facts

By Peter Laird, MD

Many have incorrectly listed the 2009 H1N1 pandemic flu as a mild outbreak. It is true that the usual march of death through the elderly population never materialized, as well we did not see large outbreak among the dialysis population, however, what we did see was the loss of life in the young and often healthy. There are many theories on why the elderly were spared this time, such as, prior exposure to similar viruses decades ago, but the fact remains that this pandemic was a pandemic of the young.  That is why comparing this flu outbreak to the usual seasonal flu is not correct.  The average deaths among children with the seasonal flu is in the range of 40-50 children a year. However, to date the 2009 H1N1 pandemic flu has killed up to an estimated 1800 children in America.

Swine flu has killed up to 17,000 in U.S.:

"CDC estimates that between 41 million and 84 million cases of 2009 H1N1 occurred between April 2009 and January 16, 2010," the agency said in a statement. Usually the CDC goes with a middle number, which it puts at about 57 million people infected.

Between 8,330 and 17,160 people died during that time from H1N1, with a middle range of about 12,000, the CDC said. But between 880 and 1,800 children died, up to 13,000 adults under the age of 65 and only 1,000 to 2,000 elderly.

In a normal flu season, the CDC estimates that 36,000 Americans die of flu, but 90 percent are over the age of 65. The CDC estimates that 200,000 go into the hospital, again mostly frail elderly people with other health conditions.

The swine flu pandemic has affected much younger people.

The H1N1 2009 pandemic flu is one of the deadliest flu epidemics seen in the younger generation and had many key features resembling the 1918 epidemic that killed millions worldwide. Why the elderly were spared is a subject of great interest, yet the facts remain that some nations had much higher death rates than others.  Japan for instance closed schools and used a Tamiflu blanket as their national strategy to reduce the toll of death to their population while America blindly let the disease rampage through the population that in retrospect were most at risk.

In fact, the death rate of American children soared up to 3600% while among the elderly it fell to only 6% of usual seasonal rates.  Among the young, the 2009 H1N1 rampaged through the population leaving death and destruction in its path. The only mystery is why the elderly were spared when compared to usual seasonal flu outbreaks. Epidemiological characteristics and low case fatality rate of pandemic (H1N1) 2009 in Japan:

In Japan, suspension of classes is commonly implemented even for seasonal influenza^[14]. For example, during the 2006–7 influenza season, 14,103 institutions (including day care centers, kindergartens and primary, junior high, and high schools) suspended classes^[15]. An even more aggressive suspension of class policy has been implemented for pandemic H1N1 in 2009. Between October 25 and December 5, 2009, 94,781 institutions had implemented suspension of classes^[16]. On the other hand, the CDC of the United States is not recommending such aggressive measures in the school setting^[17].

The policies of the CDC should be soundly compared to those of countries such as Japan lest we once again sacrifice the young and healthy children, who are the future of this country, to failed policies from those responsible for protecting their health. 

The deadly facts stand firm that the CDC failed our children.  It was God alone that spared the elderly.  We could and should have done better for our children.  Unfortunately, the short memory of Americans preoccupied with the latest and greatest fashions and fads may actually look back at the 2009 H1N1 pandemic believing that the dangers of this virus was simply media hysteria and fail to prepare any better for the next pandemic that shall surely come.  Implementing the same tactics with the next pandemic that does affect the sick and elderly could lead to death and misery of biblical proportions.

The deadly facts are in and we failed our children.  It is time for the CDC to renew this historic failure to those that they are charged with protecting and not make the same mistakes the next time we face a deadly flu virus.  It is time to learn from Japan and other nations who protected the young and innocent children.

H1N1 Flu (Swine Flu) Continues to Spread Rapidly

 
By Bill Peckham

Two weeks ago the CDC changed how they presented the data for percent of patient visits reported through the U.S. Outpatient Influenza-like Illness Surveillance Network. I created the image below based on the previous reporting style of layering each year's data:

Now for the last two weeks the CDC has been presenting the data as a continuous line with one year following on the one before:

The same data is being displayed in each graph but the upper graph gives a clearer picture of the current situation. Right now when influenza like illness should be at a yearly low ebb, influenza like illness is more prevalent than at any time during the peak of recent flu seasons.

This chart is updated to October 24; going by news reports the H1N1 virus is increasing in prevalence. I may have to extend my Y axis beyond 10%.

Is triage coming?

By Bill Peckham

RenalWEB links to four articles - three from JAMA (with introduction) and one overview from Reuters - reporting cases of severe complications from H1N1 illness. These severe cases are already straining ICU infrastructure causing the JAMA editors to worry as they look ahead:

Hospitals must develop explicit policies to equitably determine who will and will not receive life support should absolute scarcity occur. The controversy that erupted around triage decisions during Hurricane Katrina highlights the importance of advance planning and clear guidelines.10 Several groups have provided recommendations for allocating scarce therapies during the influenza pandemic.11-13 Any deaths from 2009 influenza A(H1N1) will be regrettable, but those that result from insufficient planning and inadequate preparation will be especially tragic.

This is another way of saying hospitals will need to impose triage guidelines.

I first wrote about dialyzors being on the wrong side of the pandemic triage framework in March of '08 (I was thinking of a different virus at the time: H5N1), Peter wrote about the potential triage threat with regard to H1N1 in August. Now as the pandemic is slowly unfolding instances of triage being used will increase. The most recent CDC FluView (for week 39) shows the trend - hospitalizations and deaths are increasing in advance of the normal flu season.

Dialysis units have not reported any problems related to the flu - the Kidney Community Emergency Response Coalition monthly calls have continued to emphasize preparedness (September minutes PDF link). Thus far the virus has been spreading in schools, there have been no reported breakouts in hospitals, clinics, businesses or hotels. There has not been a lot of adult to adult spread, which is great but with flu we can't say why. It could be that adults have some protection gained from previous bouts with flu or it could be something about the way the flu spreads. At this point we can say it is spreading more easily among young people but we don't know why and we don't know if that will continue.

Experts Warn: America Has Limited H1N1 Flu Resources (Except For Their Own Children)

By Peter Laird, MD

Since the H1N1 flu broke out in late spring, while many prepared and warned about the dangers of this fast moving pandemic, others chose instead to mock those preparations, calling them an over reaction.  The alleged but yet unproven knowledge that the majority of patients have a limited and mild H1N1 course does not mitigate the fact that this flu affects a different population than the seasonal flu.  Pregnant women, children and young adults are at the top of the list of those who have died.  Paradoxically, the elderly have fared better from a presumed latent antibody protection from prior flu outbreaks before 1957.

A recent article goes so far as to call these “exaggerated fears” the greatest threat above and beyond the actual expected impact that the H1N1 virus will have.

Could Swine Flu Panic Be Worse Than Outbreak Itself?

With infections typically causing only mild illness, experts point to exaggerated fears as the real threat

"We have limited resources in the U.S. -- if this [swine flu] captures our negative imagination, it's going to hurt our health-care system," said Dr. Marc Siegel, associate professor of medicine at New York University School of Medicine in New York City. "Our emergency rooms will be flooded with worried people, doctors' phones will be hanging off the hook, everyone will be afraid of every sniffle and wanting to get tested for the flu."

Overwhelming hospital capacity is a very real issue as I have discussed earlier, but not because concerned parents will seek medical care for their sick children, but instead because America has diminished its ability to deal with unexpected health demands and surges through a systematic destruction of our hospital infrastructure over the last three decades.

Hospital Capacity: The Silent H1N1 Waterloo

America’s health infrastructure is smaller and in many ways less effective than it was in the 1970’s at its peak capacity.  In my town of Antelope Valley California, in the early 1990’s there were four active, full service hospitals and 200,000 residents. Now in 2009, we have only two active hospitals and over 400,000 residents.  

Resource rationing is the survival mode of all American ER’s today with many facing severe physician staffing shortages.  Patients who would have been admitted routinely even ten years ago are returned to their primary care physician for continuation of out patient care. However, with a severe primary care shortage, many patients languish in limbo between urgent care centers and overflowing emergency rooms.

Yet, when the experts themselves encounter H1N1 face to face, there are no limits to resource expenditures. Monotreme's blog ventured into this discussion by pointing out the alleged hypocrisy that Dr. Siegel noted above poses when he not only prescribed Tamiflu for his son but then went so far as to recommend prophylactic treatment for all of the campers.  In doing so, Camp Modine spent $45,000 fighting this virus to protect his son and his fellow campers:

Summer Camp ’09: A Swim, a Cough, a Quarantine

Camp Modin brought the outbreak to a dead halt by offering prophylactic Tamiflu to all of the campers and counselors, a move it took on the advice of one of the parents, Dr. Marc Siegel.

“Tamiflu is used prophylactically in nursing homes quite successfully,” said Dr. Siegel, an associate professor of medicine at N.Y.U. Langone Medical Center. “And I think when there’s a big outbreak in summer camp, where kids live very close together in their bunks, it makes sense to follow the same protocol.”

“We’ve taken 6,000 temperatures this summer,” said Howard Salzberg, the camp director. “We’ve bought all the Clorox wipes in every Wal-Mart we could drive to. We’ve spent about $45,000 on this, $30,000 on Tamiflu alone, and probably another $15,000 on the masks, the gloves, the games for the kids in isolation.”

The CDC continues to advocate against the prophylactic use of Tamiflu except for certain high risk patients where even there they advise watchful waiting.  However, the take home message from Dr. Siegals correct intervention at his son's summer camp is that this approach worked:

Almost 300 campers and 100 staff members went on prophylactic Tamiflu for 10 days, Mr. Salzberg said, and the H1N1 virus stopped spreading.

When the H1N1 virus has finally run its full course during the next two years, the differences in case fatality rates between the developed nations will likely fall into the categories of those that used a Tamiflu blanket, and those that depended on herd immunity and let happen, what happens. Understanding the effectiveness of Tamiflu especially in close group environments such as our children's schools, with no vaccine readily available for weeks, refusing to use prophylactic Tamiflu will result in the unexpected deaths of many healthy children and young adults, nothing to speak of those with CKD and other chronic medical illnesses.  

Instead of speaking out about "negative imagination" that could result in panic, in my opinion, Dr. Siegel would do better to instead speak out against the CDC mindset of withholding widespread use of Tamiflu and instead advocate for delivering large quantities of Tamiflu at the first sign of a local and regional outbreak. After all, if his recommendations expended a large amount of Camp Modine's limited resources, don't your children deserve the same expenditure as they head back to school and face outbreaks of H1N1?  My question to Dr. Siegel is how shall history remember him?

2009 H1N1 pandemic influenza for dialyzors: Update – Outlook – Preparedness

By Bill Peckham

I have a H1N1 Pandemic flu article (or download a PDF version) up on Home Dialysis Central (HDC) in advance of the HDC H1N1 webinar presentation I'm giving on Wednesday September 23 (8PM Eastern/5PM Pacific). Take a look and let me know your questions so that I can be sure to address them on Wednesday.

H1N1 webinar Wednesday September 23

By Bill Peckham

I'll be presenting a Home Dialysis Central Webinar next Wednesday:

2009 H1N1 Pandemic Influenza
Background – Update – Outlook – Preparedness

While obviously from the sharp end of the needle it should be relevant to everyone. Here is Dori's announcement from the related thread at HDC:

Please join us for the next FREE Home Dialysis Central Webinar! Our own Bill Peckham will share the knowledge he's learned about pandemics in general and H1N1 in particular--with a special focus on practical tips for YOU to protect yourself. Get the latest info!

WEDNESDAY, September 23, 2009

• 5:00 PM (Pacific Time)
• 6:00 PM (Mountain Time)
• 7:00 PM (Central Time)
• 8:00 PM (Eastern Time)
• 8:00 AM - 9:30 AM THURSDAY - Western Australia
• 10:00 AM - 11:30 AM THURSDAY - Melbourne/Queensland/Sydney Australia

Please Click Here to Register and Receive Your Log-in Instructions:
http://www.instantpresenter.com/PIID=E955DA8988

Win Door Prizes! Several companies who have listings in our Helpful Products Catalog (http://www.homedialysis.org/hpc/) have donated door prizes. Five lucky winners will be able to choose from:

• ESBA LABORATORIES - Topicaine
• GENESIS WORLDWIDE - Headsets
• HEMA ASSISTANCE PRODUCTS - Hema Strap
• MED ACTION PLAN - Pack-M-Ups for pills
• SMITH BIO MEDICAL - Anacept skin and wound cleanser
• THERAWORX - Theraworx foaming skin cleanser
• VITAL REMEDY
• Kidney Assist dietary supplements
• Dialysis dietary supplements
• Vital4 Cholest dietary supplements
• Protein Bars

I'm writing an article and putting together a PowerPoint right now but I'll be updating right up to the presentation so I hope to have timely information. If you have questions ask away on the Home Dialysis Central Discussion Board thread. The HDC discussion board allows you to post anonymously but you'll have to sign in to view the webinar live.

Kidney Times provides H1N1 summary for those with CKD

By Bill Peckham

RenalWeb linked to an article up on Kidney Times by DSEN's own Dr. Laird, H1N1 pandemic Flu 2009: Preparation, Prevention and Treatment. If you've been following DSEN's coverage of the 2009 flu pandemic you've seen Peter's writings on the subject. (However, there is a bonus for reading the Kidney Times article - you get to see Peter's picture).

Reading Peter's post today before or after reading the Kidney Times article points up just how fast this story is evolving. We are all operating with incomplete information, no one has all the answers. Each day there is more news on the virus, its quirks and its projected impact. The influenza virus is very unpredictable.

Each strain of flu is as unique as an individual hurricane. But unlike the many hurricanes studied each year, we've only seen three pandemic flu strains in the last 100 years. With so little experience with pandemic influenza it's not possible to reasonably predict what will happen this time.

One thing is certain though: those on dialysis must take the H1N1 virus very seriously. Prepare. In the face of such uncertainty all we can do is prepare - pay particular attention to the Preparing section of Peter's article. The H1N1 virus is unlike anything you have experienced in your lifetime (assuming few 90 somethings read  DSEN), take it seriously.

H1N1 Spreads After the Fever Breaks: Time to Reevaluate the CDC Guidelines

By Peter Laird, MD

The H1N1 virus may be even more contagious than CDC guidelines suggest long after the fever abates in H1N1 patients.  In three related studies scientists have discovered that patients with H1N1 continue to shed the virus after the fever resolves but are still symptomatic, especially coughing.  This draws into question the wisdom of the recent CDC updated guidelines on how long H1N1 patients should be isolated at home:

CDC recommends that people with influenza-like illness remain at home until at least 24 hours after they are free of fever (100° F [37.8°C]), or signs of a fever without the use of fever-reducing medications.

This is a change from the previous recommendation that ill persons stay home for 7 days after illness onset or until 24 hours after the resolution of symptoms, whichever was longer. The new recommendation applies to camps, schools, businesses, mass gatherings, and other community settings where the majority of people are not at increased risk for influenza complications

Researchers in Seattle analyzed epidemiological data from the H1N1 outbreak in New York City last spring showing the likelihood of catching the virus at home and at school is higher than the seasonal flu:

The researchers analyzed reported data about the past spring's swine flu pandemic and concluded that — barring mutations in the virus — a person has about a one-in-four chance of catching it from an infected family member.

And based on the earlier H1N1 outbreak at New York's St. Francis Preparatory School, researchers estimate the likelihood is that a typical infected student will pass it on to a maximum of 2.4 classmates.

Many have rightly criticized the CDC for their lack of urgency regarding the spread of H1N1 by returning school children.  The recommendations that children may return to school 24 hours after the fever breaks and the recommendations to keep schools open despite outbreaks must be reevaluated in light of these recent studies on the length of time that H1N1 is shed.  The lessons from prior pandemic flu is that social distancing and isolation of symptomatic patients is still one of the most effective practices to slow the spread of illness.  Certainly, with the delayed deployment of H1N1 vaccine, parents and school officials should consider waiting until the student is at least no longer coughing.

CDC: Swine Flu 'Never Went Away'

By Peter Laird, MD

Three weeks ago, I placed the post, When Did the H1N1 Flu Bug Go Away?  The main purpose was to show the approach of the CDC in mitigating the potential impact that the H1N1 may have instead of the approach DSEN took to educate, warn and urge people to prepare for that which may come even if it never does.  Now, three weeks later, my post is even more important in the language that the CDC is now using.  Then it was, the H1N1 virus will return.  Now it is, the swine flu never went away:

Bill has dedicated a significant amount of time and effort educating all those that grace the pages of DSEN on the potential dangers of a pandemic flu especially to the dialysis/CKD population.  His posts and mine following in his example have bared the truth of the true potential for great loss of life due to poor preparation in the advent of a widespread influenza virus.  Words matter.  Words can bring to action effective strategies to prepare in time and avoid adverse outcomes if given in a timely enough manner.

The difficulty that I have with the language of the CDC and the government's in general regarding the H1N1 2009 pandemic is that it appears to me that the choice was made to placate the population to prevent panic but it may come at the price of poor preparation for those placated, but not fairly warned.  I believe the CDC H1N1 briefing today forebodes what shall follow.  From the epidemiology of over 500 deaths, we should already have a clear understanding of the at risk populations.   Not warning those populations and instead pandering to complacency and avoiding panic will not prepare these at risk populations.  Bill and I believe that this is the wrong approach.

The CDC in both the Bush and Obama administrations spoke of the great and effective preparations that they have taken with pandemic planning.  I have reviewed many articles on this preparation and it is my opinion that most of their preparation has been in the ethical and legal ramifications of overwhelming our meager hospital surge capacity.  Medical personal are protesting the lack of PPE’s for nurses and health care workers.  The CDC talks about treating people with a vaccine that is likely to be available to the majority of at risk patients after the virus has already peaked when it “returns” in the fall.  

Where are the boots on the ground so to speak that we usually associate with the words pandemic flu planning and preparation?  Words in a legal or ethical document directing health care workers on who to exclude from treatment when resource allocation demands difficult decisions is not the type of preparation most would consider when we hear of pandemic flu planning.

Words matter.  They call people to action if used properly as a warning to prepare.  They are useless once the pandemic has already caused widespread death and morbidity. Other nations may have a better approach in the truthfulness of the challenge that we may soon face.  My post of three weeks ago reflected the discord between the official statements of the CDC and the blatant fact that the H1N1 virus never went away over the summer.  This of course in retrospect was an understatement.

The CDC has also been less than forthcoming in publishing up to date details of which populations are most affected by the H1N1 virus.  Today at the news briefing, we learned some details about the risk to the older pediatric and adolescent population.  In all of the CDC sites, I have yet to hear any detailed risk assessment of the chronic renal disease population from the over 500 deaths to date.  Bill has decried this lack of information that should be readily available in several of his posts.  The truth is the best warning.  We still do not have these important details and important warnings for the renal population.  What good will these statistics be after the at risk populations are already decimated should poor preparation lead to adverse outcomes.

I am grateful that my post three weeks ago was accurate, but my fear is that many of the things that DSEN has warned about with pandemic flu preparation will likewise be the headlines weeks from now as well.  Preparing the nation for ethical and legal absolutions for denying specific populations care in an overwhelming flu surge is not preparing to keep those populations alive.  It is simply double speak that gives people false hope and leaves them poorly prepared.  Words matter.  My fear is that when the CDC finally speaks bluntly, it will be about the different risk factors that placed people in the morgue instead of keeping them at home alive and well.

Presidential Council needs H1N1 math help

By Bill Peckham

Bloomberg posted an article based on the President’s Council of Advisors[sic] on Science and Technology (PCAST) which just released a report assessing H1N1 pandemic preparations in the United States (PDF link). Bloomberg reports that:

Swine flu may infect half the U.S. population this year, hospitalize 1.8 million patients and lead to as many as 90,000 deaths, more than twice the number killed in a typical seasonal flu, White House advisers said.

That makes no sense.

If half the US population were to catch H1N1 between now and New Year's Day 2010 that would mean about 150 million cases of influenza. Given that number of people sick 90,000 deaths represents .06% case fatality rate (CFR) i.e. 6 deaths for every 10,000 people. Seasonal flu is thought to have a .1% CFR ((PDF link) one death in every 1,000 cases); the H1N1 2009 pandemic virus has been classified as a Category 2 pandemic by the CDC (PDF link). A Category 2 pandemic has a CFR between .1% and .5% (PDF link) which with 150 million sick would mean 150,000 to 750,000 deaths between now and the end of the year. I thought the article must have read the report wrong.

The full PCAST report is available online (PDF link); I was shocked to see that Bloomberg reported the contents correctly. From the report's  Executive Summary:

The Current Situation and a Plausible Scenario
Indeed, the 2009-H1N1 influenza is already responsible for significant morbidity and mortality world-wide — from its appearance in the spring, its continued circulation in the U.S. this summer, and its spread through many countries in the Southern Hemisphere during their winter season. While the precise impact of the fall resurgence of 2009-H1N1 influenza is impossible to predict, a plausible scenario is that the epidemic could:

• produce infection of 30–50% of the U.S. population this fall and winter, with symptoms in approximately 20–40% of the population (60–120 million people), more than half of whom would seek medical attention.
• lead to as many as 1.8 million U.S. hospital admissions during the epidemic, with up to 300,000 patients requiring care in intensive care units (ICUs). Importantly, these very ill patients could occupy 50–100 percent of all ICU beds in affected regions of the country at the peak of the epidemic and could place enormous stress on ICU units, which normally operate close to capacity.
• cause between 30,000 and 90,000 deaths in the United States, concentrated among children and young adults. In contrast, the 30,000–40,000 annual deaths typically associated with seasonal flu in the United States occur mainly among people over 65. As a result, 2009-H1N1 would lead to many more years of life lost.
• pose especially high risks for individuals with certain pre-existing conditions, including pregnant women and patients with neurological disorders or respiratory impairment, diabetes, or severe obesity and possibly for certain populations, such as Native Americans.

There is a complete disconnect between the first and the third point.

The Eurosurveillance Rapid Communication A preliminary analysis of the epidemiology of influenza A(H1N1)v virus infection in Thailand from early outbreak data, June-July 2009 presents a far grimmer picture. The authors discuss the short comings of their data but the differences in CFR among age groups seen in these sentinel cases from Thailand was confirmed on page 29 of the leaked July 17 CDC Director's Report (PDF link). The CDC report also presents data that the majority of the early H1N1 cases occurred in people of school age (page 25).

Taken together this data explains why the H1N1 virus will look much deadlier when it comes back this Fall even if it does not change in any way. As people over the age of 24 catch the virus this September and October the number of deaths will increase dramatically, without anything about the virus changing. I can not fathom how or why the President's advisErs came up with their pollyannaish scenario.

H1N1 ICU Triage Rules: Who Lives?

By Peter Laird, MD

In early April of this year, the first reports of a new flu hit the news. Slowly over a period of weeks, the reality came home that the world was dealing with its first influenza pandemic since 1968. The fear of a repeat of the deadly 1918 Spanish Flu were mitigated by the reports that the vast majority of infected patients had a mild clinical course with complete recovery. However, the reports aren't entirely accurate and the 2009 H1N1 pandemic flu has characteristics similar in many aspects to the 1918 flu. These worrying facts, including continued spread during the summer months and severe pneumonia affecting a number of young and healthy patients, is why the H1N1 virus should be taken very seriously.

The World Health Organization, CDC and other US Federal organizations have spent several years preparing a coordinated response to a pandemic disease. These preparations began in earnest under the Bush administration after the rapid spread and high case fatality rate of the SARS corona virus and the emergence of the high CFR H5N1 bird flu virus. It has always been the case that a deadly virus could arise and devastate the world's population as it did at the beginning of the 20th century so we always should have been planning. However, it was the recent emergence of pandemic potential viruses that truly spurred planning.

Then came H1N1. Television and online media outlets give us regular updates on how the current H1N1 pandemic flu is affecting people in America and most especially in the southern hemisphere as their flu season continues unabated. The planning and organization at the national level has been coordinated with every state in the union with many stockpiling large amounts of personal protective equipment and Tamiflu which remains effective against this virus. However, it is unclear how effective this national and state wide planning has been implemented on the local level and especially in vulnerable populations such as dialysis patients.

Northwest Kidney Centers is a model for participation in local and statewide pandemic planning as well as preparing to prevent the spread of H1N1 among both their staff and their patients. I suspect that few dialysis providers are as well prepared to weather this storm coming soon to our dialysis units. Bill has sought diligently to find any data showing how severe H1N1 affects renal patients, but to date the CDC has not been forthcoming with all of the current case fatality distribution of risk factors. Much is still unknown on how many we can expect to be infected as well as how many of those will have a severe reaction. However, planning best practices requires us to consider dire scenarios. For people on dialysis we should understand how the entities we rely on, e.g. doctors, dialysis providers, hospitals, will respond to a worst case.

For instance, few people are aware of some of the Federal guidelines for our hospitals should a major pandemic overcome the hospital surge capacity. In the event that our hospital capacity is overwhelmed tough decisions will have to be made. Triage guidelines have been developed and accepted widely as a strategy for resource allocation in times of severe shortages. These widely accepted guidelines include exclusion of care categories. In a mass casualty situation, hard decisions are made on resource allocation that would never be made in ordinary times. In a flu pandemic emergency this would mean less care for those patients with dim survival prospects even with maximal care.

An example can be found in this California Department of Health Services draft discussion, Guidelines Regarding the Transition from Patient-Based to Population-Based Outcomes (PDF link):

When a physician graduates from medical school, he / she swears to an oath that embodies the ethics and ideals of Hippocrates, the acknowledged father of modern medicine. Translated from the traditional Greek version, the Hippocratic Oath emphatically states that a physician should "Above all, do no harm" to the patients he / she serves. An excerpt from this oath reads, "I will remember that I remain a member of society, with special obligations to all my fellow human beings."  In the current state of medicine, each licensed provider of care has an overarching obligation to treat every individual patient to the best of his or her abilities. . .

Surge capacity planning for such resource poor environments must therefore consider a departure from the individual patient-based outcomes that physicians have been long conditioned to uphold in favor of an approach that saves the most lives. In other words, 'clinicians will need to balance the obligation to save the greatest possible number of lives against that of the obligation to care for each single patient.
...
A healthcare provider may determine that an individual will not receive care, or that care currently being provided to an individual will be discontinued or withdrawn, based on the criteria identified in Section V below. Examples of care that may be denied or discontinued or withdrawn in order to allocate limited resources in accordance with the criteria identified in Section V, include but are not limited to ventilator support, antibiotics, hydration and life-sustaining nutritional support, ICU and other facility beds and supplies, and blood.
...
Exclusion Criteria for Ventilator Access*

• Cardiac arrest: unwitnessed arrest, recurrent arrest, arrest unresponsive to standard measures; Trauma-related arrest  
• Metastatic malignancy with poor prognosis  
• Severe burn: body surface area >40%, severe inhalation injury  
• End-stage organ failure: 
• • Cardiac: NY Heart Association class III or IV  
  • Pulmonary: severe chronic lung disease with FEV1** < 25%  
  • Hepatic: MELD*** score > 20  
  • Renal: dialysis dependent 
  • Neurologic: severe, irreversible neurologic event/condition with high expected mortality

*Adapted from OHPIP guidelines  
** Forced Expiratory Volume in 1 second, a measure of lung function  
*** Model of end stage liver disease

These ICU pandemic triage rules could come into play if the current H1N1 2009 pandemic causes widespread and severe illness.

What the California DOH is contemplating is the reality of population outcome based pandemic planning and the exclusion criteria that could come to be. Knowing these policies could come into effect is what motivated Bill to be concerned about emergency planning. Given these policies, dialysis patients have to stay away from hospitals during a pandemic. That's the insight that has fueled Bill's advocacy. If every dialysis center was as prepared to maintain operations as the Northwest Kidney Centers I would be far less concerned. Unfortunately most patients and staff do not have access to Tamiflu or even personal protective equipment (PPE). Unfortunately current preparations rely on this being a mild event. If this should instead develop into a severe pandemic outbreak, closer to 1918 that to 1968, then the nation will have its first widespread experience with this new population based medical ethics.

My main hope is  that the current H1N1 flu will remain mild. I pray that the majority of cases will be mild and our medical infrastructure can handle the demand on their services. I pray that widespread shortages remain theoretical. DSEN's pandemic flu posts promoting pandemic planning is an ongoing effort in the hope that dialysis providers will take pandemic flu planning seriously. People on dialysis are at tremendous risk in this and any other unmitigated virus outbreak in the future. Providers have an obligation to take preparation seriously, which means taking dire scenarios seriously.

Dialysis patients need to be able to feed themselves if their dialysis schedule is interrupted. You need to have at least a weeks worth of the Emergency Diet. You need to have the ability to take your blood pressure, your temperature and your weight. Dialysis patients, if they can, should obtain personal protective equipment and further, discuss with their nephrologist and dialysis providers what steps have been taken to protect their patients.

It is certainly more prudent to be prepared than to be caught short in an emergency situation, it is a routine adult responsibility.

When Did the H1N1 Flu Bug Go Away?

By Peter Laird, MD

It's inexplicable to hear many of the H1N1 flu commentators talk about swine flu returning in the fall and their continuing to downplay the impact that this virus will have. That sort of commentary makes no sense. H1N1 has never gone away and it has continued to spread rapidly during what is normally flu's off season. Here in North America's summer months, where flu's spread should have abated by past experience we continue to have a drum beat of illness and death.

Despite this ongoing crises many experts continue to sound the all clear, announcing the end of the current H1N1 pandemic before we have seen the full brunt of its fall/winter rampage:

Harsh second H1N1 wave not inevitable: U.S. experts
We do think -- everybody thinks -- the virus will come back in the (northern hemisphere) fall," Morens said.

"Beyond that, it's hard to say what will happen -- whether it will be more severe, less severe or just the same. If you look at past pandemics, any one of those things happened at a particular time," he said.

This calming proclamation came as we saw a 24% increased mortality in one week alone here in the United States. During the summer!  The United States continues be a global hot spot for H1N1 flu deaths and hospitalizations even as the flu season in the southern hemisphere is picking up strength. 

The news that H1N1 flu is spreading rapidly during the usual flu free summer months here in America is a bad omen of the unabated and unrelenting assault we can expect to see in the coming months.  The initial attack rate in the spring disproportionately affected children who have the lowest rate of death giving a misleadingly low total death rate.  

Age Structure and Case Fatality Rate
The new H1N1 virus is very different. The vast majority of the deaths have been in people under the age of 65.  Perhaps the most detailed calculation of case fatality rates by age was provided in a leaked CDC Director’s brief (from July 16, 2009) that was apparently uploaded to Cryptome (PDF link). According to this document, here are the case fatality rates for different ages (n = 262):

• 0 -4 years: 0.17%
• 5-24 years: 0.22%
• 25-49 years: 1.5%
• 50-64 years: 3.33%
• 65 years and over: 5.24%

In the Spring and early Summer, most of the cases in the US were in children because the virus was spreading rapidly in schools and summer camps. Note, the case fatality rate for this age range is 0.22%. However, in the Fall, we can expect that although the virus will likely primarily affect school children in the beginning, it will eventually spread to the older age groups.

Based on the leaked information on case fatality rates from the CDC and the known population structure of the US, it is reasonable to project that the unmitigated case fatality rate for the US in the Fall/Winter will be much higher than in the Spring, even with no change in the killing power of the virus.

With rapidly increasing deaths across America long before the start of school that many predict will cause the H1N1 virus to return, speaking of the return of this virus belies the simple fact it has never left us.  

H1N1 Death Rate Surges

By Peter Laird, MD

While health officials talk about the expected H1N1 surge this fall when children return to school, the H1N1 virus has not taken any time off - H1N1 has been quite active through July. In a dramatic surge of death before the school year has even started, the CDC this week reports an 18% increase in hospitalizations for H1N1 related illness (5,515 to 6,506) and a staggering 24% increased death toll (353 to 436) in only one week.  

The World Health Organization (WHO) likewise revised the projected impact on the world’s population to over 2 billion people who will develop H1N1 infection in the next two years.  The continued media reports of mild H1N1 illness in the majority of people infected belies the true magnitude of death that this virus will reap, as it rampages around the world at a record pace. Although the majority of people infected will recover quickly, millions will succumb.

The CDC's report of the 24% increased death toll in America in the middle of summer is not good news. There seems to be mounting data that planning on an H1N1 case fatality rate of 0.4% is too optimistic; there is data is pointing to a higher rate:

H1N1 Mortality Rate Increases
As of July 31st, the World Health Organization reports 1154 deaths due to the H1N1 virus among a global total of 162,380 cases, for an overall mortality rate of 0.71%. Consequently the H1N1 death rate has increased more than 60% after holding steady at about 0.44% since mid-June. The current H1N1 death rate also surpasses the death rate from early June (0.66%). Among the tabulated deaths, 87% (1008) have occurred in North and South America.

The trends are not good.

The facts are emerging that H1N1 will soon explode in ever increasing numbers as the summer months give into the cooler and less humid fall.  The experiences in our summer camps captures the true nature that this pandemic is a real threat especially to renal patients and we should all take special precautions as Bill has advised for several years to first avoid and if needed, treat the coming flu.

Hospital Capacity: The Silent H1N1 Waterloo

By Peter Laird, MD

Few realize that Napoleon was in an excellent position to actually win the battle that bears the title of his ultimate defeat and retreat into the his banishment on Elba. I fear that the many naysayers critical of the capacity of H1N1 to inflict serious health consequences throughout our population have failed to take into account an analogous counter attack by an inferior force just as the arrival of the Prussians changed the final outcome of the battle in favor of the British and their allies.

I have battled in the halls of our emergency departments over many years struggling to find beds for patients kept on gurneys in hallways for up to five days even with serious conditions such as heart attacks and pneumonia.  Patients on ventilators next to coughing asthma patients is now the normal day at any given American emergency room while hospital beds have become the prime commodity in hospital resource allocations. Patients are routinely assigned to chairs instead of beds while waiting to be seen by any ER physician available.  This is the status of America’s emergency departments and hospitals across our great land.  This was also the status during ordinary influenza months, and not with any extraordinarily impacted demand.  There is a hospital season and an off season for those of us who have trudged through the trenches of twenty first century medicine in our hospitals.

The reports on H1N1 continue to gather momentum with England reaching early panic levels this week as cases doubled in only seven days.  Primary care physicians throughout the UK are completely overwhelmed coping with the onslaught of illness during the usually quiet summer months.  It is not the usual season for an internist to don the vestiges of battle in the middle of blazing heat waves.  This is the time for our R&R when we rest and prepare for battle against viruses large and small, a fight we expect when when snow caps the distant mountains.  But things are different this year and there are storm clouds brewing all over America.

Just as Napoleon spent himself defending against the British and their allies, when the Prussians arrived, Napoleon had no resources left to meet the new challenge.  What no one is discussing in the media is the effect that the usual seasonal flu will have on our battle against H1N1 when it joins H1N1 on the American battle ground in mid winter.  America’s health infrastructure is smaller and in many ways less effective than it was in the 1970’s at its peak capacity.  In my town of Antelope Valley California, in the early 1990’s there were four active, full service hospitals and 200,000 residents. Now in 2009, we have only two active hospitals and over 400,000 residents.  

Resource rationing is the survival mode of all American ER’s today with many facing severe physician staffing shortages.  Patients who would have been admitted routinely even ten years ago are returned to their primary care physician for continuation of out patient care. However, with a severe primary care shortage, many patients languish in limbo between urgent care centers and overflowing emergency rooms.  In the best of days, many nations did not have the capacity to deal with the Prussians by themselves let alone all of Wellington’s amassed forces.  Today, many are speaking of the battle against H1N1 and they are starting to look past this battle already as if is a fait accompli with a little touch of Tamiflu for all, but they have yet to see the seasonal flu coming in just when all of the resources of the H1N1 battle have depleted all of the supplies usually available to handle the annual influenza season.

Take note that H1N1 is gathering steam globally during the internist’s off season.  There will be no rest this year or perhaps even next until enough people have developed a herd immunity from direct and uncontrollable infections raging rapidly through our schools, our churches, our stores, our government centers and lastly, our own homes.  There will not be enough Tamiflu or swine flu vaccinations to fight this battle not for only the few weeks of the usual flu season, but for the several months it will run roughshod through our civilization.  Any unusual added demand to our overloaded hospital capacity running at full utilization during the summer months is the silent Prussian attack not spoken of at all in the general media but it is lurking in the shadows nevertheless.  Yet, for those who work in the trenches of our emergency departments, we all know the sad truth.  It will be a long winter when it begins in the summer.

May God have mercy on us all.

CDC reports "Chronic Renal Disease" present in 8% of hospitalized H1N1 cases

By Bill Peckham

The Centers for Disease Control posted the presentation Influenza Surveillance (PDF link). It presents details on 268 H1N1 pandemic influenza hospitalizations through June 2009. To the right is a screen capture of page 21 (click image to enlarge) which shows demographic information for the 268 hospitalizations. (The file is marked "Not For Further Distribution" but it is critically important that the CDC makes this information widely available in a timely manner. I was glad to see it posted) The Median age of the patients is 22 years old. Among the entire cohort the ages range from 21 days to 86 years.

Page 22 breaks down the underlying medical conditions among the 268 patients. One important point is that 29% of those hospitalized because of H1N1 had no underlying health conditions. Young healthy people are not normally sent to the hospital by seasonal flu. H1N1 is much worse than seasonal flu.  8% of the 268 cases are reported to have "Chronic Renal Disease" as an underlying condition. 8% is a tremendous problem if "Chronic Renal Disease" means "CKD5; on dialysis".  To evaluate the 8% number we need to know what illnesses are covered by the term "Chronic Renal Disease".

Unfortunately there is no easy way to know what the CDC means by "Chronic Renal Disease". This document from the CDC Swine Flu (H1N1) Case Report Form – Standardized Vocabulary (PDF Link) includes the CDC's form that collects the H1N1 epidemiology/surveillance data we see in the Influenza Surveillance presentation. On page 5 you can see where on the CDC's Swine Influenza Case Report Form you would circle 'yes' or 'no' to indicate "Kidney Disease".

Is "Kidney Disease" the same as "Chronic Renal Disease"? I don't know. To define "Kidney Disease" you look in the Swine Flu (H1N1) Standardized Vocabulary/Section C: Medical History (on page 12 of the document):

Kidney disease
Synonyms: Renal disease, Nephropathy, Nephrosis, Disease of Kidney

When you click the link you go to an extensive list of kidney problems. Between this list which includes many acute kidney diseases such as "Kidney Stones" and the language inconsistency itself, it is very hard to know how to interpret what "Chronic Renal Disease" is meant to communicate. Unless we know which diseases go in the "Chronic Renal Disease" bucket, we can't know if they're disproportionately represented. We need to know how many people, in a random sample of the population, we would expect to check the "Chronic Renal Disease" box.

If 8% of the general population has one or the other kidney disease covered by the term "Chronic Renal Disease" then we could likewise expect at least 8% of H1N1 hospitalizations to have "Chronic Renal Disease" as an underlying condition. We could then prepare knowing that "Chronic Renal Disease" does not appear to be an additional risk. However, if "Chronic Renal Disease" means "on dialysis" then we know we have a bigger problem. Dialyzors are just a bit over .1% of the population.

We need complete and timely epidemiology/surveillance data on H1N1 hospitalizations and fatalities. We need to know the age distribution of those with each underlying illness designation. If only the adults (19 and older) had "Chronic Renal Disease" as an underlying condition then the percent of people, among hospitalized adults with "Chronic Renal Disease" as an underlying condition is more like 15% (141 adults in sample, 21 with "Chronic Renal Disease"). If "Chronic Renal Disease" means that a person is "CKD5; on dialysis" then that would represent about a 2 magnitude increase in a risk of H1N1 hospitalization. The CDC has this data; the dialysis community deserves clarity.

The CDC has Epidemiology/Surveillance partners across the US. Some are HMOs that have extensive Personal Medical Histories available for H1N1 hospitalizations and H1N1 fatalities (it could be HMOs have their own Case Report Form that uses the term "Chronic Renal Disease" (but what does it mean?)). The CDC has a public health obligation to report the know risk factors for severe H1N1 illness clearly and transparently. Getting this data squared away at some conference a year from now isn't going to help.

Acute renal failure seen in severe H1N1 cases

By Bill Peckham

The CDC's Morbidity and Mortality Weekly Report for July 17th is online. Titled Intensive-Care Patients With Severe Novel Influenza A (H1N1) Virus Infection --- Michigan, June 2009 it reports clinical information on 10 hospitalized H1N1 patients admitted to the surgical intensive care unit (SICU) at the University of Michigan Health System.

These 10 patients all got sick in late May or early June. They range in age between 21 and 53.The report notes that nine of the patients had a BMI over 30; of those seven had a BMI over 40.

All 10 patients required initial advanced mechanical ventilation (high-frequency oscillatory or bilevel ventilation with high mean airway pressures [32--55 cm H20]). Two patients required veno-venous ECMO support. Six required continuous renal replacement therapy (CRRT) for acute renal failure. Upon transfer to the SICU, five had elevated white blood cell counts, and one had a decreased white blood cell count. The median white blood cell count (WBC) was 9,500 cells/mm3 (range: 3,700--19,700 cells/mm3; normal: 4,000--10,000 cells/mm3). All ten patients had elevated aspartate transaminase (AST) levels. The median AST level was 83.5 IU/L (range: 41--109 IU/L; normal: 8--30 IU/L). Six of the nine patients who were tested had elevated creatine phosphokinase (CPK) levels. The median CPK level was 999 IU/L (range: 51-- 6,572 IU/L; normal: 38--240 IU/L). Nine patients were admitted to the SICU with MODS, and nine manifested septic shock requiring vasopressor support. All 10 patients required tracheostomy.

The H1N1 pandemic influenza virus is not at all like the seasonal influenza virus. Seasonal influenza does not normally cause ARF in people in the prime of life. Of particular worry is that this happening outside of the normal seasonal flu season.

Acute dialysis providers should plan on increased demand for acute dialysis services. The CDC should release clinical details of severe H1N1 related illness so that trends relevant to the provision of dialysis (both acute and chronic) can be identified. The renal industry needs timely data from the CDC to inform preparations.

H1N1 Flu (Swine Flu) Continues to Spread Rapidly

By Peter Laird, MD

Seasonal flu viruses have an expected peak and waning period during their course. While practicing internal medicine at Kaiser, we would have weekly updates when the flu was first detected. These reports continued throughout the course of the seasonal flu season which was very useful to help us know when to use antiviral medications since the other common respiratory viruses often had different timing than the flu. However, the H1N1 pandemic influenza virus is not behaving like an ordinary seasonal flu viruses which essentially disappear during the summer months. H1N1 continues to increase both globally and in the US:

We've seen it in camps and military units," Dr. Schuchat said. "I'm expecting when school reopens and kids are all back together, in some communities at least we may see an increase."

The number of confirmed U.S. infections is now 40,617, with 263 deaths, the CDC said Friday. But the agency believes that more than one million people have been infected and weren't tested for the virus or didn't visit a doctor. The disease has become so widespread that the agency will probably suspend tallying individual case counts within the next few weeks and focus instead on tracking clusters, severe cases, deaths and other unusual events -- a more traditional approach to tracking diseases, Dr. Schuchat said.

Other sources using mathematical modeling based on the spread of the 1918 swine flu pandemic are predicting worsening outbreaks in the fall (note S-OIV (Swine Origin Influenza Virus) is used in some referenced articles in place of H1N1. DSEN will use the CDC's H1N1 nomenclature outside of direct quotes) :

Based on patterns of the 1918 influenza, models indicate that the H1N1 virus could become more severe in the fall. "Such models raise concern regarding the potential for the news [sic] S-OIV  strain to cause serious epidemics in the near term in the southern hemisphere: South American countries, Australia and New Zealand will enter their upcoming influenza season without a vaccine against this strain," write Dr. David Fisman and coauthors.

That message is not being heard here in the US where we too will enter the flu season without a vaccine.

The low case fatality rate (CFR) and initial mild symptoms in the majority of those infected early in the US has led to complacency among many in the health care field. Yet there are features of this current pandemic that are already showing a tragic similarity to the 1918 flu pandemic. First, pregnant women and infant children have had severe reactions to the H1N1 pandemic influenza virus during it's first two months of spread:

Human infections with a novel influenza A (H1N1) virus that is easily transmissible among humans were first identified in April 2009. Severe illnesses among pregnant woman and infants have been reported in this outbreak although the epidemiology and spectrum of illness among pregnant woman and infants are not fully understood at this time and are under investigation.

Secondly, otherwise young and healthy adults appear to be at a heightened risk compared to the usual mild symptoms this population traditionally experiences with the seasonal influenza virus. NEJM recently published an update on the first cases of H1N1 in Mexico:

This case series of the first 18 patients hospitalized in Mexico City with S-OIV infection documents the clinical findings of severe illness or death associated with S-OIV infection that were seen during the beginning of the S-OIV pandemic. The patients, most of them previously healthy, had an influenza-like illness that progressed during a period of 5 to 7 days, had pneumonia, and had findings during the first day of hospital admission that fulfilled the criteria of acute lung injury or the acute respiratory distress syndrome.¹² Seven patients died, all from multiorgan system failure.

It is still too early to know how the H1N1 pandemic influenza virus will affect renal patients here in America, but it is likely that we will have a very long and difficult winter especially if the low CFR of 0.4% increases significantly.

Australia and the other nations down under are heading into their own flu season with out the benefit of a vaccine that will not be available at best until mid October. For those in America with chronic medical conditions, it is time to take advantage of the last six weeks before the start of school to become better prepared. Dialysis units with the usual close proximity between staff and patients are at a particularly high risk for the spread of any infectious diseases, especially those that are spread by the respiratory system. Bill has spent the last several years working at the local and state level improving pandemic planning. Unfortunately, few communities have had this benefit. We are now in a tight race with time before we test America's nationwide pandemic preparedness.

Singapore dialysis units take H1N1 seriously

By Bill Peckham

In Singapore dialysis units are implementing social distancing measures to limit the spread of H1N1 flu. In the photo accompanying the Channel News Asia story it appears that people - both patients and staff - are wearing surgical masks which is another non pharmaceutical intervention that could be used to limit the spread of the pandemic flu virus.

US dialysis providers should be discussing these and other NPIs to prepare for what looks to be a very challenging flu season just three short months away.

What does an H1N1 pandemic mean for the provision of dialysis?

By Bill Peckham

This afternoon the World Health Organization raised the pandemic alert level to 6, the highest alert level. Dr Margaret Chan Director-General of the World Health Organization (WHO) made the announcement:

On the basis of available evidence, and these expert assessments of the evidence, the scientific criteria for an influenza pandemic have been met.

I have therefore decided to raise the level of influenza pandemic alert from phase 5 to phase 6.

The world is now at the start of the 2009 influenza pandemic.

The 2009 influenza pandemic. I thought we would see a level 6 pandemic announced a month ago, so this announcement shouldn't be a surprise. Chan's announcement does reveal a change in how the WHO perceives H1N1's severity:

Globally, we have good reason to believe that this pandemic, at least in its early days, will be of moderate severity. As we know from experience, severity can vary, depending on many factors, from one country to another.

On present evidence, the overwhelming majority of patients experience mild symptoms and make a rapid and full recovery, often in the absence of any form of medical treatment.

Previously the H1N1 virus was described as having a mild severity (there were many reports equating the severity of illness caused by H1N1 to the severity of illness caused by seasonal flu). This change to moderate was, I think, precipitated by H1N1's apparent severity in Canada's far north among the indigenous population - Canada's First Nations.

If the H1N1 virus causes moderate disease generally it appears to be causing severe disease in those with underlying health conditions, conditions that include CKD5. Over half of the deaths from H1N1 have been in people with underlying health conditions, while it is thought that about one third of the overall population would be said to have an underlying health condition.

We don't know the true severity of H1N1; we don't know what the practical difference is between mild and moderate influenza strain by the WHO's reckoning. The one piece of data that Chan provided in her announcement was:

In some of these countries, around 2% of cases have developed severe illness, often with very rapid progression to life-threatening pneumonia.

It is hard to have any confidence in Chan's 2% number. In order to calculate the virus's severity, e.g. What percent of those who get sick need hospitalization? And of those, what percent die?, we need to know the number of people infected. Right now we only have guesses since testing for the H1N1 virus has largely stopped. We also would have to calculate severity based on the number of people infected when those hospitalized or dead were first infected. If the disease takes several weeks to manifest its severity then calculating the attack rate or fatality rate by using current prevalence will understate the severity.

Mild, Moderate or Severe - What Should We Do right Now?

I think these four months before the start of our seasonal flu season is God given time that the US renal community should use to prepare for a significant influenza event. Preparation should focus on established emergency preparation best practices. For individuals this includes a two weeks stockpile of food and prescription medications, preparation for if someone in the household gets sick: over the counter medications, and basic medical supplies e.g thermometer, blood pressure device, and non-pharmaceutical interventions e.g. masks, hand sanitizer.

Dialysis units should follow emergency planning best practices:

• build infrastructure and strengthen relationships with local emergency planning officers
• planned flexibility; prepare for worst-case scenarios
• engage patients, staff and MDs in planning
• communicate plans to stakeholders and public

Every dialysis unit should have a working relationship with their local emergency planning department - in Seattle this is at the county level, in other jurisdictions it could well be someone else. Dialysis providers must consider bad scenarios. The course of the current H1N1 pandemic is very similar to the course of the 1918 H1N1 pandemic, frighteningly similar. Both started with the flu season extending into summer but with what was seen as a mild severity. There are a number of questions dialysis providers must answer now as part of their preparation.

Units need to consider what they will do if 50% of their staff does not report to work for a prolonged period; units need to establish policies if a staff person has flu symptoms; if a patient has flu symptoms; what to do if members of patient or staff households exhibit flu symptoms. These policies must be based on the assumption that local hospitals will be overwhelmed. Dialysis unit policies and procedures cannot rely on emergency medicine to treat patients that have the flu or exhibit flu symptoms.

Emergency planning best practices direct planners to include their stakeholders in the planning process - for dialysis providers this would include patients, doctors, staff and patient families - because building and maintaining trust is a vital component to successful emergency planning. By including all stakeholders in the emergency planning process and then communicating the plan before it is needed, dialysis providers can increase the trust that will be necessary to maintain the provision of dialysis.

Patients need to know that dialysis will not be withheld if they exhibit flu like symptoms. The provision of dialysis is going to face a severe challenge; we have four months to prepare. Let's use the time wisely.

H1N1 concern v. skepticism

By Bill Peckham

I just listened to RSN's new H1N1 KidneyTalk with Lana Kacherova, RN, Quality Improvement Director for the Southern California Renal Disease Council. Stephen takes the skeptics point of view expecting this will be another crises that doesn't amount to much - mentioning Y2K and the H5N1 "Bird Flu" virus. This is a pretty common view, and often this point will be made along with the point that seasonal flu kills tens of thousands of people every year, yet H1N1 has caused one confirmed death in the US. Therefor, how can H1N1 be a bigger problem than seasonal flu? (which is no big deal). I'd tell Stephen that I am worried, this is a bad situation particularly for those on incenter hemodialysis.

Flu is always a problem and we put a lot of effort into minimizing its impact each year through community vaccination programs that target at risk groups - such as people with chronic kidney disease. This flu has an almost wide open population to infect (there has been a report that people over 60 may have some natural immunity (probably from being infected during the 1957 H1N1 1918  echo pandemic) which would be great news for our dialysis population) and that is what defines a pandemic - a communicable disease, normally a flu virus (SARS, hepatitis are nonflu examples) which is spreading from human to human, across the globe. It's clear this is happening, that makes the H1N1 virus a pandemic virus.

I think we should expect that WHO will announce a stage 6 pandemic soon, the virus is sustaining human to human transmission - which means on average each person the virus infects goes on to infect more than one other person. That in itself does not create an health crises, the unanswered question is severity. Does the virus cause severe illness? Which is really a three or four part question: how many people will get sick? (Over what period of time?) What percent of those who get sick will need hospitalization? And of those, what percent will die? If, as we all hope, the virus does not cause serious illness then we can thank providence for this wake up call but at this point there is no way to know that that is how this will turn out.

We still don't know what this virus will look like in people who have not traveled to Mexico or been hanging around people who have traveled to Mexico. People with a Mexico connection - the first cases - have been treated with Tamiflu; over the next weeks we'll find out what course the disease takes in people who are blindsided by this and who do not get Tamiflu within 48 hours of symptoms. It is very good that this virus responds to Tamiflu but that will create its own problems around matching supplies with demand if the H1N1 virus turns out to be more severe than our hopes.

It is generally assumed that this flu will take the summer off, most flues go into a lull this time of year, but that does not have to happen. The influenza virus is extremely unpredictable. It is prone to mutation, it could get better or it could get worse. It could go away. It could stay and build into the summer. Or it could go and then come back. We just don't know. We have three modern examples of pandemic flu: 1918; 1957; 1968. How well could you predict a hurricane or an earthquake if you only had three examples? The three pandemics from the last century are three points on a continuum, there are more severe pandemics than 1918 possible, just as there are pandemics possible that are milder than 1968. We don't yet know where 2009 will end up on that continuum but it will be there, this is an historic event.

I would tell Stephen that it is too early to call this one and that the provision of dialysis is still threatened. As I have written few providers took preparation seriously. The Northwest Kidney Centers has posted their Pandemic Guidance for NKC patients and NKC staff; NKC intends to continue providing dialysis to their patients in the normal time and place - they have N95 masks, Tamiflu and pandemic policies and procedures in the units and ready to go. NKC is one of the few dialysis providers to have an established, close working relationship with their local emergency planning agency. NKC has thought about what they will do in a pandemic, which is more than most providers can say.

Right now is a hell of a time for dialysis providers to be making first contact with their local emergency planning entity. Dialysis providers have failed if their plan is to not dialyze their patients with flu like symptoms. They have failed as dialysis providers if their plan is to send patients with flu like symptoms to the local ER. If this turns out to be the least bit severe then I think the risk of failure is high and that is what is keeping me up at night.

Dialysis patients need to understand mask guidelines

By Bill Peckham

Last May the U.S. Department of Labor Occupational Safety & Health Administration (OSHA) released a proposed pandemic mask use and stockpiling guidance, CIDRAP had a good summary. This was used in dialysis pandemic planning circles to formulate plans that are now going into effect. The Kidney Community Emergency Response (KCER) Coalition Pandemic Preparedness Team's website links to the Summary of OSHA Respirator Requirements (PDF link). The OSHA endorsed KCER recommendation is for the patients to use surgical masks (OSHA calls these facemasks) and for staff to use disposable N-95 masks (OSHA calls these respirators).

Surgical masks do not offer the wearer reduce exposure to small inhalable particles, that's not their job. A surgical mask's job is to protect others, somewhat, from the wearer. The reason OSHA would like patients to wear surgical masks is to give staff an added layer of protection. It's not that the surgical masks will protect the patients from getting sick, it's that masked patients offer staff some level of protection from a communicable patient.

People on dialysis will be making their own calculation of risk as information comes in. Right now the news is only worrying if you think it represents the leading edge of a wave. If it does turn into an influenza wave then patients, in order to feel comfortable attending dialysis, will want some personal protective equipment - surgical masks don't do the job. The guidelines did not have the special circumstance of incenter dialysis in mind when they made their workforce-centric recommendations.

Patient use of N95 masks would increase patient safety and worker safety. Patients with the ability to purchase N95 masks should be told that it would be a good idea. Eventually people are going to learn that surgical masks don't offer protection, telling them now while Amazon.com has N95 masks in stock (as well as the more economically efficient and comfortable to wear reusable masks) is the right thing to do.

People on dialysis will be making their own calculation of risk as information comes in. Right now the news is only worrying if you think it represents the leading edge of a wave. If it does turn into an influenza wave then patients, in order to feel comfortable attending dialysis, will want some personal protective equipment - surgical masks don't do the job. The guidelines did not have the special circumstance of incenter dialysis in mind when they made their workforce-centric recommendations.

Patient use of N95 masks would increase patient safety and worker safety. Patients with the ability to purchase N95 masks should be told that it would be a good idea. Eventually people are going to learn that surgical masks don't offer protection, telling them now while Amazon.com has N95 masks in stock (as well as the more economically efficient and comfortable to wear reusable masks) is the right thing to do.

Flu of the Americas

By Bill Peckham

This makes sense "Swine flu" name is wrong -world animal health body. On the one hand what you call it won't change its course but the swine designation seems to confuse more than clarify. At some point the narrative will settle on a moniker, until then I'm going with Flu of the Americas.

CDC says to prepare for more bad news

By Bill Peckham

RenalWEB is tracking the latest news reports concerning the spread of a novel influenza virus. We've been told to expect bad news, more reports of cases and that we should expect deaths. From the CDC's Sunday news conference transcript:

[Elizabeth Cohen, CNN ] Is it just that our denominator isn't that big yet, we just don't have many cases and that's why we're not seeing deaths yet?

[Dr. Anne Shuchat, CDC] That's one possibility. Of course, we may be fortunate and not have them, but I think we really need to prepare for the idea that we will have additional cases, additional affected states and I do fear that we will have deaths here.

Much depends on the severity of this virus - how easily it passes among people and how sick it makes someone who catches it. If at the end of this week we have reason to believe that the virus passes easily among people and often causes illness that requires hospitalization, then dialysis units will need to be prepared with policies that maintain the provision of dialysis.

Dialysis units should have and should be able to communicate pandemic policies to their staff and patients. Dialysis units should be able to answer questions such as:

• If member of staff/patient household has flu what should be done?
• If staff/patient presents with symptoms what should be done?
• If staff/patient is confirmed as having the novel flu what should be done?

I'm not sure what the right answers are, but these policies should not be established in the moment, they need to be thought through and established before they are needed. I hope units have established policies because they may need them sooner rather than later.

It will be important to maintain good communication and trust throughout what could be a long period of challenge; patients need to know what to expect from their units.

Dialysis unit preparedness for novel influenza strains: Are we ready for Swine Flu?

Bill Peckham

The CDC is reporting 8 cases of influenza in San Diego and Texas and the New York Times is reporting swine flu concerns in Queens NY. This is worrisome news because this strain of influenza is novel. Novel means that no one has prior immunity to this strain of H1N1 influenza because it's new. Since it's new it has the potential to get more people sick then would normally get sick in the flu season which in the Northern Hemisphere is from about November to March, but you can get the flu throughout the year and a novel strain can spread rapidly often in waves.

I've written 32 posts categorized "Pandemic" as it relates to dialysis. I've tried to engage at various planning levels - that's me biting my lip behind the guy talking (page three at this PDF link) at a county planning exercise last year. I've been thinking about this for a while (my first pandemic post was almost exactly three years ago) mostly in regard to the H5N1 "bird flu" influenza virus. I don't think we are as prepared as we should be for an influenza pandemic no matter which flavor.

The experts always said that the next pandemic could be any type of influenza the only requirement is for there to be a new genetic form of influenza that passes easily among humans. The H1N1 cases in the US reported to date have not caused any death (deaths have been reported in Mexico but at this point things are not at all certain) so let's hope that what's know as the Case Fatality Rate is very low. The CDC considers a pandemic to be be severe if the CFR is 2%. This will be an important number to watch.

I'll need to go back and read some of my past posts but generally this is a big deal and we can hope that it is just a wake up call and not the event we've been fearing.

Seasonal flu activity increases, antiviral resistance holds lesson for planners

The Centers for Disease Control (CDC) reported that seasonal influenza case reports increased at the end of last month with five states (Colorado, Delaware, New York, Texas, Virginia) reporting widespread flu.  Almost all (97.4%) influenza A/H1N1 samples show resistance to the antiviral Oseltamivir (Tamiflu^®), but so far these same samples show no resistance to the antiviral Zanamivir (Relenza^®). The CDC now recommends using Zanamivir alone or in combination with the adamantanes (amantadine and rimantadine). This resistance to Oseltamivir is not necessarily due to past use, given the high natural mutation rates of RNA viruses resistance to a given antiviral can occur naturally.

This has implications for pandemic planning. Most antiviral stockpiling strategies focus on stockpiling Oseltamivir. The lesson of this year's seasonal flu is that antiviral stockpiles should be diversified. Current stockpiles should work to include Zanamivir and the the adamantanes (amantadine and rimantadine) along with Osteltamvir.

Pandemic planning, just in time supply chains and dialsyis ... not good

By Bill Peckham

On PandemicFlu.gov there is an archived 72 minute video of DHHS Secretary Leavitt’s October 29, 2008 speech and discussion of pandemic planning and pandemic preparedness. (I can't seem to get the video to embed properly, it does require flash to watch this).

The critical part of the video from the provision of dialysis point of view is the post speech discussion. The discussion is among Secretary Leavitt, Dr. Bill Raub (Science Adviser to Secretary Leavitt), Dr. Michael Osterholm (Director of the Center for Infectious Disease Research and Policy at University of Minnesota) and Maggie Fox from Reuters.

The whole hour is informative but listening to the post speech discussion through the provision of dialysis lens confirms that the industry is not where it needs to be. The last half of the video, from the 34 minute mark, should be wake up call to the provision of dialysis industry. In the video the discussion kept circling back to the global just in time economy, the just in time supply chain. Listen to the discussion keeping in mind that supply manufacturing and management best practices would get the artificial kidney from factory to dialysis unit in 2 months or less. Dialysis units have between 1 and 4 weeks of supplies on hand, which means at any one time there is 12 weeks worth of artificial kidneys in the world, in existence. A pandemic would last for months and months, if not years.

Watching the whole 72 minutes through the lens of dialysis highlights why the provision of dialysis is at great risk in the event of an event. Not from people on dialysis dying from the flu, the provision of dialysis is at risk because of various business risks.  Risks to the supply chain. Risks of scarcity. If the provision of dialysis is meant to continue under all events then the planning has barely begun.

Good habits for ongoing preparation

I started to seriously prepare for a prolonged  period of sheltering place about 18 months ago by buying food with at least a two year shelf life. Last week I happily gathered up supplies expiring in the next six months and donated them to the local food bank. It was about $30 to $40 worth of food which I am replacing as things come on sale. This amounts to a five dollar a month insurance policy.

The value of this habit, this insurance policy was driven home again with RenalWEB's link to aAP article via Yahoo, US health official says flu threat high:

U.S. Centers for Disease Control and Prevention director Dr. Julie Gerberding says bird flu fatigue among countries and the public is a growing concern.

The way to combat preparation fatigue is to make preparation a habit. Being in a position of donating food to the local food bank periodically feels good and is smart insurance.

I have six plastic bins - covering the range of expiration dates. As I buy food I store them by their donation date - every three months I will donate the food expiring in the next four months. The six bins are organized by food to donate in three months; six months; nine months; over a year; over two years; over three years. The best outcome would be if I never needed any of these supplies and this amounts to a habit of supporting the food bank: support the food bank while meeting my civic responsibility for personal preparation.

Pandemic? Why am I worried about a pandemic?

As I engaged more with the dialysis community I was happy to be a follower but at the same time I was thinking about what wasn't being done, where was leadership needed? I've written about my pandemic history (starting with reading an issue of Foreign Affairs that had at least two articles (here, here)), applying what I read to the provision of dialysis I identified the problem as a lack of leadership, a vacuum. An H5N1 pandemic was not being taken seriously, there was no one talking about the threat and what should be done.

Just once I would like to be surprised by the robustness of ESRD preparation, rather than dismayed by the absence of preparation. Here Lloyds of London provides 10 tips for businesses to cope  with a pandemic when we start to trial preparation plans in dialysis centers then we'll know the threat is being taken seriously.

OSHA mask guidance part II, for incenter dialyzors

What about dialyzors? What do the dialyzors, the folks on dialysis, need to know about masks? The Kidney Community Emergency Response (KCER) Coalition Pandemic Preparedness Team's website links to the Summary of U.S. Department of Labor Occupational Safety & Health Administration (OSHA) Respirator Requirements (PDF link) which was the principal driver of the mask recommendation which is to use surgical masks for the patients and disposable N-95 masks for staff. OSHA has now proposed some more detailed pandemic mask use and stockpiling guidance, what does it recommend for those getting the dialysis?

They don't get a pay check

OSHA is about worker safety and from the point of view of worker safety what OSHA calls "facemasks" (surgical masks) are good enough for patients. It's not that the facemasks will protect the patients from getting sick, it's that masked patients offer staff some level of protection from a communicable patient. Facemasks do not offer the wearer reduce exposure to small inhalable particles, that's not their job. A face mask's job is to protect others, somewhat, from the wearer. The reason OSHA would like patients to wear facemasks is to give staff an added layer of protection.

What about me?

People on dialysis will have to make their own calculation of risk during a pandemic - not for themselves so much as for those they live with, their families. In order to feel comfortable attending dialysis they'll want some personal protective equipment (PPE) - facemasks don't do the job. Considering the period of time you need to cover according to OSHA - 120 working days sounds a lot like 24 weeks, 48 to 72 dialysis treatments - we're back to the same choice of disposable vs. reusable, and again reusable is the least expensive choice. And again we have the same need for real world testing.

I don't think supplying patients with surgical masks gets patients to where they'll want to be. If patients plan on continuing to dialyze incenter, in the event of an event, then they should make preparations for their own PPE.

OSHA mask guidance part I, for dialysis unit staff

The U.S. Department of Labor Occupational Safety & Health Administration (OSHA) has released proposed pandemic mask use and stockpiling guidance. It's a thorough report, CIDRAP has a good summary. I know that the mask issue has been discussed in dialysis pandemic planning circles; the recommendation is to use surgical masks (OSHA calls these facemasks) for the dialyzors and disposable N-95 masks (OSHA calls these respirators) for staff.

Which masks; how many

The Kidney Community Emergency Response (KCER) Coalition Pandemic Preparedness Team's website links to the Summary of OSHA Respirator Requirements (PDF link) which was the principal driver of the mask recommendation. The problem comes when you start to contemplate the quantities needed. Some dialysis providers have begun to stockpile N-95 disposable masks - 10, 20, 100 N-95s per employee. This is a significant expenditure but is it enough?

This latest document from OSHA offers additional guidance to dialysis units, suggesting that a stockpile for 120 workdays would be prudent. OSHA suggest that a nurse in an outpatient clinic might need four disposable N-95s per shift, meaning 480 to cover the whole pandemic. I've not heard of any dialysis provider stockpiling that quantity of N-95 respirators. That's hundreds of dollars of expense per employee. Not to mention the additional expense of fit testing the eventual wearer and storing them until they're needed. If you're going to make the investment, you should invest in the most robust alternative.

Disposable v. Reusable

And there is an alternative - reusable repirators that can be cleaned and repaired. The OSHA report list them as Elastomeric Respirators (flexible, rubber-like facepiece). They run $20 to $50 for the silicone half face plate and a couple sets of filters, and like the disposable N-95 respirators they must be fit tested and can't be used with facial hair (men should make sure razors are part of their pandemic prep). But unlike the disposable respirators these respirators can be worn day after day. In a dusty environment the filters would have to be frequently changed but in a dialysis unit the $3 filters would need to be changed much less frequently. 

In dialysis provider circles there is resistance to going the reusable route (at least when I've brought it up at meetings) but I think that's short sighted. The OSHA proposed guidance lists "Harder to breathe through than a [N-95] facemask" as a mark against the reusable respirators but I am not sure that has to be the case. I've used disposable N-95 respirators when doing drywall and I've used the silicon half plate ones too - I can tell you that it is unpleasant to wear either one while working but the half plate reusable is less unpleasant. I think a high quality reusable half plate respirators makes much more sense financially and I think they're more comfortable.

What should be done

There is a way to resolve the question of which is the right respirator: side by side testing under actual conditions. The renal community needs to ask a dialysis unit(s) to operate using the various options. I seriously doubt the people making the stockpiling decisions have ever spent eight hours in either respirator but that would be instructive. One shortcoming that will be quickly identified during any testing is how any respirator or facemask acts as a barrier to communication. Testing during the operation of a dialysis unit would not only identify which respirator option makes the most sense, it would also identify practical problems that can then get addressed.

I'd bet a nickel that the reusables will test better.