Sunday, November 30, 2014

When Health Care is not a Public Good, why would hospitals agree to take Ebola patients?/ WaPo

The WaPo explores which hospitals will be approved by CDC to treat Ebola patients, and whether hospitals will lose or gain from such a designation. Treating an Ebola patient scares other patients away, puts staff at risk, and demands extraordinary levels of intensive care that exceed what can be reimbursed by insurers, and sometimes what can feasibly be provided. Excerpts follow:
U.S. officials trying to set up a network of hospitals in this country to care for Ebola patients are running into reluctance from facilities worried about steep costs, unwanted attention and the possibility of scaring away other patients.
“They’re saying, ‘Look, we might be willing to do this, but we don’t want to be called an Ebola hospital. We don’t want people to be cancelling appointments left and right,’ ” said Michael Bell, director of laboratory safety at the Centers for Disease Control and Prevention...
Just a few facilities in the United States have special bio-containment units, which are ideal for treating Ebola, and they can handle only two or three patients at a time. And the case of Thomas Eric Duncan, the Liberian man who was initially misdiagnosed at a Dallas hospital and died, shows how easily a community hospital can stumble.

Of the 5,000 hospitals in the United States, dozens have volunteered to treat Ebola patients. As of mid-November, CDC infection-control experts had visited 41 facilities in 12 states and the District of Columbia, according to agency Director Thomas Frieden.
But it is not clear how many medical centers will pass muster and whether the number will be enough for the administration to meet its goal of establishing an adequate network of Ebola-ready facilities.
The handful of U.S. hospitals that have treated Ebola patients have discovered that doing so can be costly, requiring around-the-clock care involving scores of nurses and other health workers. That would be a big challenge for many hospitals, where staffing is often stretched thin.

Adding to the burden is the widespread media attention that accompanies treating an Ebola patient and the potential loss of revenue if other patients steer clear of the facility. There is also the constant worry that a mistake could result in employees’ becoming infected...

Most of the 10 Ebola cases in the United States were treated at three hospitals with biocontainment units — Nebraska Medical Center, Emory University Hospital and the clinical center at the National Institutes of Health in Maryland.

Those hospitals would be “overwhelmed by even a modest surge of 10 to 20 patients,” Bryce Gartland, vice president of operations for Emory University Hospital, said in a Nov. 7 letter to Congress in support of more federal funds...
From today's Hartford Courant:
A spokesman for Day Kimball Hospital in Putnam said that, although the hospital is capable of safely identifying, isolating and providing initial care for an Ebola patient, dealing with an Ebola patient in the long term would shut down the hospital because of the costs involved.

Ebola Treatment: $1 Million/patient here with 80% survival; $20/patient in Africa with 35% survival: we need to find the sweet spot between them, where doable medical care significantly raises survival

I have been desperately seeking ideas to get us to that sweet spot: where medical providers will know how to manage Ebola in Africa, and their treatments will keep most Ebola victims alive, while not costing a million dollars per patient, or more.

I envision patients having access to lab tests, iv fluids, convalescent serum, automatic blood pressure cuffs, EKGs and cardiac monitors.  Dr. Paul Farmer of Partners in Health seems to have a similar vision.

Patients would see pictures of their caregivers pasted on their PPEs.  The medical equipment would be dedicated to Ebola patients, and so contamination would not be an issue. Doctors would be able to observe their patients through windows (and speak through HEPA-covered openings) in order to take adequate time making visual assessments and speaking to patients and caregivers in the "hot" zones.

I envision detailed record-keeping for each patient, which would be tremendously useful at figuring out which treatments are working better than others.

Already licensed and approved drugs could be tried in small clinical trials to see whether they seem to yield benefits in humans.  Who might need steroid replacement?  Antibiotics? Which ones?

Interested survivors could be convalesced nearby and enrolled in caregiver training programs. Unaffected local people could be tested for the possible presence of protective antibodies, since 8.6% of blood samples obtained in Kenema, SL between 2006 and 2008 tested positive for Ebola antibodies.

Liberia Ebola West Africa Chinese soldiers stand parade during the opening of a new Ebola virus clinic sponsored by China, in Monrovia, Liberia, Tuesday, Nov. 25, 2014, Liberia got another 100 treatment beds in the fight against Ebola on Tuesday, as yet another Sierra Leonean doctor became infected with the disease sweeping West Africa. Liberian President Ellen Johnson Sirleaf toured the Ebola treatment center built by China, calling it “first-class.”(AP Photo/ Abbas Dulleh)
See above:  China has completed a large Ebola Treatment Unit in Monrovia which is air-conditioned, and uses electronic medical recordkeeping. This will allow the use of PPE for much longer, and improve data collection.  China may have other innovations ready for use in Africa.

China's hospital raises the bar several notches regarding the level of care being provided to African Ebola victims.  Hopefully Western governments will take up the challenge and improve further on the Chinese model.

I'd like to invite readers to submit their ideas in the Comments section as we brainstorm to find better ways to beat Ebola.  I will keep this thread active and describe more about what is being created as the information becomes available. Thanks!

Monday, November 24, 2014

Has CDC stopped testing for H1N1 because the pediatric vaccine isn't working against H1N1?

The Tampa Bay Times (see below) reported today that two Florida children had died of flu. Which is odd, because if you scroll down to the current CDC charts below you will see a) that the mortality from flu and pneumonia is about as low as it gets, right now, and b) only one flu-associated child death has been reported this flu season for the entire country. So it is odd that two children just died in the same state.  It is also odd that authorities would not name the towns where these children lived.
There are more oddities. Although the story below says otherwise, this season's (and last season's) live, nasal pediatric flu vaccine is ineffective against swine flu, as noted here.  

CDC admits this lack of effectiveness:
"During 2013-2014 there was no measurable effectiveness for LAIV [live attenuated influenza vaccine] against influenza A (H1N1) among children enrolled in the study."
but couched it in a lot of confusing verbiage.

So, if these children got that vaccine, it would have offered them no protection against the swine (H1N1) flu.

Yet the Florida Department of Health used its report of two pediatric deaths to scare parents and push flu vaccines, while refusing to say whether the children who died were vaccinated, and lying about the effectiveness of the available vaccine.

It isn't only the Florida DoH acting oddly.  CDC is supposed to test flu strains to see which are circulating each season.  But suddenly, they are no longer testing for H1N1, despite the fact it was the predominant strain last year and they tested for it last year. For example, CDC noted extreme predominance of H1N1 last year:
"Effectiveness against the flu A "2009 H1N1" virus, which was the predominating flu virus during the 2013-14 flu season, was 62% (95% CI: 53% to 69%) for children and adults. During the study period (Dec 2, 2013 – January 23, 2014), the 2009 H1N1 virus accounted for 98% of flu viruses detected. (Note: There were not enough influenza B or influenza A (H3N2) viruses detected during the study period to make a mid-season estimate of vaccine effectiveness against either of those viruses.)"
And CDC tested for it yearly since 2009. I can't imagine another reason to stop testing for H1N1 besides avoiding embarrassment (to CDC and the vaccine makers) because the pediatric vaccine doesn't protect against it, even though H1N1 is one of its components.  If you don't know how much Swine Flu (H1N1) is causing people to get sick, then you can't blame the shot for contributing to cases. And that last sentence --"...not enough influenza B or A (H3N2) detected to ...estimate vaccine effectiveness" last year--is a dead giveaway CDC will be saying that about this year's H1N1.

But it is even worse than this.  If you look at the bottom chart, CDC acknowledges that 88% of flu specimens were Influenza A, and only 30% of these were H3... suggesting that 70% were H1, and probably nearly all of those were H1N1.  But instead of CDC saying it didn't know how many were H1N1, since CDC did not test for H1N1, CDC claims that there were 0.0% H1N1 Swine Flu specimens. That is a very precise number: 0.0%--and a total falsehood.
The Florida Department of Health announced Monday the deaths of two children, one in Pasco County and one in Orange County, from flu-related complications. Health officials refused to provide the ages and hometowns of the children. The Pasco child had an underlying health condition, said Deanna Krautner, a spokeswoman for the Pasco County Health Department. . . Experts say flu deaths in otherwise healthy people are unusual. Pre-existing health conditions often play a role in how individuals react to the flu. . .
"Our hearts go out to the family and friends of these children," said Dr. Celeste Philip, deputy secretary for health and deputy state health Officer for Children's Medical Services. "Getting the flu vaccine is the best way to protect yourself and others from the flu."
In Florida, the most common influenza subtype detected in recent weeks has been influenza A (H3). Officials refused to say if that's the type found in the two recent deaths. . .
Currently available vaccine formulations protect against all (sic) strains of influenza that have been identified as circulating in Florida this season, state health officials said. [But if you don't identify it, then you can make this claim without lying. Clever, huh?--Nass]
The U.S. Centers for Disease Control and Prevention recommends everyone age 6 months and older get vaccinated, with a few rare exceptions. State officials on Monday declined to say whether the two children who died had been vaccinated.
The following come from this CDC website:
Pneumonia And Influenza Mortality

Influenza-Associated Pediatric Mortality:

No influenza-associated pediatric deaths were reported to CDC during week 46. To date, one influenza-associated pediatric death has been reported for the 2014-2015 season.
Click on image to launch interactive tool

U.S. Virologic Surveillance:

WHO and NREVSS collaborating laboratories located in all 50 states, Puerto Rico, and the District of Columbia report to CDC the number of respiratory specimens tested for influenza and the number positive by influenza virus type and influenza A virus subtype. The results of tests performed during the current week are summarized in the table below. Region specific data are available at
Week 46
No. of specimens tested10,304
No. of positive specimens (%)955 (9.3%)
Positive specimens by type/subtype
  Influenza A836 (87.5%)
             2009 H1N10 (0.0%) 
             H3257 (30.7%) 
             Subytping not performed579 (69.3%) 
  Influenza B119 (12.5%)

Thursday, November 20, 2014

Americans' Ratings of CDC Down After Ebola Crisis: Gallup

From Gallup

Wednesday, November 19, 2014

Experts Tell Congress We Really Need High-Containment Facilities for Ebola (as I've been saying)/ NBC

From NBC News:
... Although the CDC initially said any U.S. hospital should be able to care for an Ebola patient, Gold (Chancellor of the University of Nebraska Medical School, where 3 victims were treated) argued that it really often does require a special biocontainment unit. There are only four in the country: at Nebraska, Emory University Hospital, the National Institutes of Health and Providence St. Patrick Hospital in Missoula, Montana. In addition, as Lakey said, states are setting up facilities and Bellevue Hospital in New York successfully treated Ebola patient Dr. Craig Spencer.
“A national readiness plan is absolutely necessary,” Gold said. “The number of actual beds is under 20. The number of usable beds is under 10.
Dr. Nicole Lurie, who is assistant secretary for preparedness and response at the Health and Human Services Department, said Ebola is very unlikely to spread in the U.S., but it’s essential to be prepared. “We might expect a handful of cases in the United States,” she told the hearing. “Ebola has told us that we really need high-containment facilities.
Senators Ed Markey and Rob Portman had similar comments
"...There are only four hospitals with biocontainment facilities in the United States, and together they have a total of eleven beds that can be used at any one time for Ebola patients. In the event that those facilities become full, it is imperative that we have the capability to isolate and treat newly diagnosed Ebola patients at appropriate alternative locations that are trained, staffed and prepared to provide specialized treatment for Ebola patients... 

Tuesday, November 18, 2014

The Abundance of Caution has returned

A woman arrived in NY 3 weeks ago from Guinea and was being monitored (presumably by phone) daily and allegedly had no Ebola symptoms.  But she just died.  No one seems to know why. And so, yes, they will test her remains for Ebola... but only out of an 'abundance of caution.'  What happens to those cases when CDC decides that testing is not needed?
A New York City official briefed on the woman's death told ABC News, "Earlier today, an individual who came to the U.S. from one of the three Ebola-impacted nations in West Africa within last three weeks died of an apparent non-Ebola condition. This individual at no time showed any symptoms of Ebola. However, due to travel history and an abundance of caution, an Ebola test will be performed on this individual's remains. Test results are expected later tonight or early tomorrow morning."
UPDATE Nov 19: "On Wednesday, the test came back negative, [NYC Department of Health] spokesman Levi Fishman told Reuters. Fishman declined to provide any information about the person, including gender, location and time of death." Why the secrecy, then? Elsewhere she is said to be 40 years old, and the Mail has a video clip of a bystander claiming she was bleeding from the nose and mouth. If you pass out and hit your nose or teeth on the ground, you usually bleed in this way.  Heart attacks alone don't cause bleeding. Forty year old women are at low risk of heart attacks.

A Sticky Issue: Quarantining Semen (or sweat) in India after Ebola Recovery/ TIME

Mayor Bill de Blasio hugs Dr. Craig Spencer. (Photo: NYC Mayor's Office)

US media have been silent about this elephant in the room: those who recover from Ebola are likely to have positive PCR tests of semen, vaginal fluid, breast milk, urine and skin (including sweat) for one to several months after recovery.  There are several anecdotes describing disease transmission to a partner following recovery. Because it is so difficult to culture Ebola virus, no one knows whether patients remain contagious (or how contagious, or how long) during this post-recovery period. The CDC and US media have preferred to show pictures of big hugs from Ebola patients as soon as they leave the hospital, in a calculated attempt to make light of this issue.  Both President Obama and NYC Mayor DeBlasio were recipients of such skin contact. I have to ask:
Do you feel like chumps now, guys?  Your public health officials, with their oft-quoted "abundance of caution" missing in action, put you in harm's way for some photo-ops -- photos designed to give the exactly wrong message to the American people, that those who recovered were absolutely not contagious. 
UPDATE: The Mayo Clinic provides a more accurate description of the recovery process: "For people who survive, recovery is slow. It may take months to regain weight and strength, and the viruses remain in the body for weeks. People may experience:
  • Hair loss
  • Sensory changes
  • Liver inflammation (hepatitis)
  • Weakness
  • Fatigue
  • Headaches
  • Eye inflammation
  • Testicular inflammation"
One solution to determining whether patients remain contagious is to develop better tests, so we know whether the PCR positivity reflects intact, infectious virus, or not. (If the person still harbors infectious virus, quarantine is probably appropriate, at least until we know more.) To improve our tests the US government needs to share its up-to-date Ebola specimen collection with test developers, and get them some BL-4 lab time.

India has dealt with the issue of potential long-term infectivity during convalescence with enforced quarantine. From TIME:
[A] 26-year-old man is being isolated in a facility at Delhi’s Indira Gandhi International airport, The Times of India reports.
According to the Times, the man had already been treated for Ebola in West Africa, currently does not have symptoms and tested negative for the virus before he flew. However, his semen tested positive for the virus.
He had a medical clearance certificate from the Liberian government saying the had been treated and was confirmed negative from blood tests—that would deem him Ebola-free, according to the World Health Organization and Centers for Disease Control and Prevention (CDC). His blood also tested negative in India. Semen can test positive after clinical clearance for up to three months, according to the CDC. The agency recommends abstinence from sex—including oral sex—for at least six months. If abstinence cannot be followed, the CDC recommends condoms to prevent disease spread.
According to Reuters, "Many experts say densely populated India is not adequately prepared to handle any spread of the highly infectious hemorrhagic fever among its 1.2 billion people." 

But according to many experts here, here and here, no country is prepared for Ebola, since none have the capacity to properly contain the virus outside a handful of bio-containment centers.  Ebola may be the game-changer for which no nation is prepared. Without fanfare, CDC has tacitly acknowledged this truth.  Today's Associated Press discusses the new units being built by a few hospitals across the country, in a piece titled Hospitals Improvise Ebola Defense, at a Cost.  Now only 20 US hospitals will be allowed to handle Ebola, quite a paring down from "all US hospitals" that CDC Director Frieden said could handle Ebola only 2 short months ago:
The U.S. Centers for Disease Control and Prevention is in the process of putting together a list of around 20 hospitals nationwide that it will certify as having the right safeguards in place to treat patients with Ebola.   
UPDATE Nov 19: Nicole Lurie, the DHHS Assistant Secretary for Preparedness and Response since Obama took office, is the person responsible for doling out many billions of dollars to get the US "prepared." It seems she finally sees the light. Testifying at a Congressional hearing yesterday, Lurie said, “Ebola has told us that we really need high-containment facilities.”  And it's a win-win for Lurie: think of the new funds that will flow through her hands now.

Sunday, November 16, 2014

Military and Nebraska Medical Experts Weigh In on Containment Needed for Ebola/ Annals of Internal Medicine online

Click here for the full, free text. 
Ideas and Opinions |

Mark G. Kortepeter, MD, MPH; Philip W. Smith, MD; Angela Hewlett, MD; and Theodore J. Cieslak, MD
The largest outbreak of Ebola virus continues unabated in West Africa. With the recent death of a patient with Ebola virus disease at a hospital in Dallas, Texas, and the sobering reality that nosocomial spread has occurred in a U.S. facility, U.S. medical centers are coming to grips with the need to prepare for care of patients with this devastating disease. The Centers for Disease Control and Prevention has developed a hospital preparedness checklist, and the latest guidelines continue to express confidence that patients with Ebola can be cared for safely in a conventional medical facility by using barrier methods (standard, contact, and droplet precautions) as the primary means of protecting medical staff (12). Recent experience with several Ebola-infected patients in the United States provides validation that such patients can be cared for safely in a facility that is adequately prepared.
Since the first reported outbreaks of Marburg (1967) and Ebola (1976), there has been an evolution in our thinking about the optimal personal protective measures for medical staff caring for patients infected with these viruses. From 1972 to 2010, a high-level containment care (HLCC) unit at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), often called “the slammer,” was considered the gold standard for such care. The unit's engineering controls were modeled after a biosafety level–4 (BSL-4) laboratory, with positive-pressure “space” suits, compressed in-line air, HEPA filtration, a decontamination shower, ultraviolet light pass boxes, an airlock, and antiseptic dunk tanks for movement of items in and out of the containment area. Toilet waste was discharged into the laboratory sewer system, and the facility possessed its own autoclave, operating room, and bedside laboratory. These built-in capabilities significantly reduced logistics challenges and provided reassurance that nosocomial spread could be reduced to near zero. Given the relatively high percentage of caregivers who have died of filoviral and other BSL-4 virus infections in the field, and the prior uncertainty in whether such high infection rates might be caused by droplet or airborne spread, utilization of such a containment facility seemed reasonable. Although used on occasion to quarantine field workers potentially exposed to highly hazardous viruses, the unit was used primarily for isolating individuals exposed to a BSL-4 virus in the laboratory. During the unit's 38 years of operation, 21 patients were quarantined after potential exposures—and none became ill (3).
Over time, we learned that the spread of filoviruses occurs primarily by direct contact with blood and body fluids (1). Thus, it was determined that a patient care facility with the full panoply of BSL-4 laboratory–like features was no longer needed. The facility was decommissioned and refurbished as a training facility for scientists working in the institute's containment laboratories.
If the USAMRIID HLCC is no longer needed because patients with filoviruses may be managed safely using barrier methods, one might ask whether any HLCC or biocontainment patient facilities are needed at all (4). Currently, 4 such facilities exist in the United States, operating at a higher level of containment (and possessing more sophisticated engineering controls) than a conventional hospital isolation room and yet lack some BSL-4 features present in the USAMRIID HLCC: Emory University Hospital, Atlanta, Georgia; University of Nebraska Medical Center, Omaha, Nebraska; Saint Patrick's Hospital, Missoula, Montana; and the National Institutes of Health Clinical Center, Bethesda, Maryland. All except the University of Nebraska serve as referral centers for laboratories that work with BSL-4 viruses. Although patients infected with such diseases as Lassa and Marburg have been safely managed in conventional settings, the serious nature of filoviral and arenaviral infections, their rarity and unfamiliarity to clinicians in developed settings, the lack of effective treatments and vaccines, their propensity to infect health care staff, and the infection control challenges they present argue for, in our opinion, specialized containment and treatment facilities...

Better approach to conducting Ebola treatment trials in Africa

Admittedly, I am biased about how I think clinical trials should be conducted.  I believe they necessitate the very finest care of patients, meticulous ethical conduct, and collection of the most complete data possible.  Most importantly, data obtained from human subjects, who have taken on some risk to advance medical knowledge, should imho never be considered solely the property of the trial sponsor: it must not be hidden or secretly massaged for proprietary considerations. I am proud to be a long-term board member of the Alliance for Human Research Protection in NYC.

A WHO expert committee on Ebola testing just noted (Nov 13) that conditions are such in Africa that consistently good standard of care is hard to achieve and only minimal data can be collected during drug trials.
... Noting that the standard of care in Ebola affected countries varies between different treatment centres and even in the same centres over time while standard of care is being established, it was agreed that clinical trials should only be conducted in facilities able to provide consistently good standard of care. The number of such sites in West Africa, capable of providing such care and with suitable infrastructure to conduct clinical trials, is limited... Collecting clinical data under the biosafety conditions required when treating Ebola necessitates careful consideration of the minimum data that should be collected...
Here's the thing.  Any company whose drug is approved will make an enormous profit on an Ebola therapeutic. Normally those companies would spend hundreds of millions of dollars on clinical trials to get their drug to market. If they want their drug tested, they should pony up now and help create the improved clinical centers in Africa that are capable of conducting reliable clinical trials. Deciding that only minimal data can be collected is like making a decision, early on, to impair the usefulness of such trials. Perhaps this is how Ebola clinical trials must start, but we should be developing better methods simultaneously. Let's re-envision the model for care. For example:

What we need is speedy drug testing, and for clinical testing to move quickly, the maximal amount of information needs to be obtained.  I submit that patients receiving experimental Ebola drugs must all be given the best care available in Africa.  This would include iv fluids, electrolytes, antibiotics and antimalarials when appropriate, iv alimentation when needed, and daily lab tests to guide therapy (particularly iv fluid/electrolyte administration, given the massive amounts required and potential for iatrogenic mistakes). Oxygen concentrators could supply additional oxygen. This would be a minimum standard in the US, available in every hospital.

Most of the direct caregivers would be recovered Ebola patients.

Patients would be placed on the other side of large glass windows, allowing physicians and nurses to monitor their visual appearance, and possibly even speak to patients, outside the limited periods they can assess patients while wearing PPE. Physicians and nurses could communicate with caregivers through or above the window to obtain additional information. Automatic blood pressure cuffs could take blood pressures frequently without need to touch patients. Cardiac monitors to check cardiac rhythms should be available. Central venous lines in the sickest patients could be used to monitor CVP for fluid administration and allow blood to be drawn without repeated needlesticks.

This type of setting would lend itself to the trialing of experimental drugs, yield bountiful clinical data, and greatly enhance clinical care. It would vastly improve patient monitoring, allowing doctors and nurses to be much more effective.  It doesn't cost a fortune, although everything, including generators, would need to be brought in. This effort is worth it to finally stop Ebola.

UPDATE Nov 19: Nature has characterized what low-tech, cheap, and local isolations units utilizing "lightly-trained" local labor might look like in Sierra Leone. These will work if and only if they improve survival. That is the real bottom line on which community acceptance depends. And if all we can provide are tents and oral rehydration fluids, where are the $billions being collected to fight Ebola actually going?

UPDATE Nov 19:  More to my liking, Maggie Fox of NBC reported on a Congressional hearing yesterday, in which CDC Director Frieden testified that we need to improve the quality of care in Africa:
“We must do more, and do it quickly, to strengthen global health security around the world, because we are all connected,” Frieden said. “Diseases can be unpredictable — such as H1N1 coming from Mexico, MERS emerging from the Middle East, or Ebola in West Africa, where it had never been recognized before — which is why we have to be prepared globally for anything nature can create that could threaten our global health security.”mergency shows the U.S. must build stronger hospitals here and abroad, exp

IOM workshop admits they don't know what we said they don't know

Ten months into the out-of-control Ebola epidemic, and 38 years since the first Ebola epidemic, the DHHS Assistant Secretary of Health for Preparedness, Nicole Lurie, had a workshop convened by IOM with NIH, CDC, NIOSH, academics, etc. to discuss what needs to be learned about Ebola, and how research can address these questions. Here is the link to download a copy, which the IOM published on November 14. There are no surprises, and there are no answers in this document.

As noted here and elsewhere, the IOM workshop report acknowledges, with my comments in parentheses:
  • how long the incubation period may last is unknown (40 days have been documented)
  • how long Ebola virus stays infectious on surfaces is unknown (depends on the surface and ambient conditions but days would not be unusual)
  • how to effectively kill it is unclear (the time during which the antiseptic must be in contact with virus is crucial and often prolonged)
  • the best PPE has not been established
  • whether Ebola can be transmitted before symptoms start is unknown (several cites suggest it can)
  • its potential to be aerosolized is uncertain (in other words, how far an aerosol may spread and how likely it is to cause infection are uncertain)
  • whether livestock or pets can be intermediate hosts is unknown, nor whether they may act as fomites to facilitate transmission via aerosol droplets
Now that the US government-medical system has admitted what it does not know, hopefully we can move to the next level and find answers.  (Maybe now CDC can be honest about its state of knowledge.) Some of the questions are not that hard to address, requiring only a few scientists at a government BL-4 lab, who have familiarity with Ebola, to do the tests.

The current PPE works.  Now it needs to be made usable for more than 40 minutes, through some form of safe ventilation.  I suspect this could be accomplished with the positive pressure suits worn in BL-4 labs.  Yes, it requires a lot of technology for Africa.  But with billions now being pledged for the fight, I think the money is sufficient to build western-style hospital units for Ebola patients. We need to move beyond the plastic tents as a precondition to improving the dismal case fatality rates. Only then will isolation and contact tracing be effective; only then will all victims be willing to identify themselves and seek treatment.

Saturday, November 15, 2014

Ebola Clinical Illness in Well-Described Patients: The US healthcare system can only successfully handle a little Ebola

Let me start this piece with the bottom line: I want to be clear that patients with Ebola virus disease are sicker, in general, than patients with any other medical condition, in the US or anywhere else. They are subject to many more serious complications than other patients. They require more care, more lab tests, more procedures, more medical staff than patients with any other disease. (That is, if you are serious about trying to keep them alive.) The US healthcare system will not collapse like Africa's, but it will be sorely tested by an Ebola outbreak: cracks in an already-overstretched system will become readily apparent, and future patients will not receive the million-dollar care that a carefully controlled handful of patients have gotten, so far.

UPDATE Nov 18: From NBC:
“At UNMC, it has cost around $1.16 million to treat the two patients directed to us by the federal government. Treatment costs vary based on the severity of the patient when they arrive, but the cost is well beyond the normal costs incurred for an intensive care patient,” the school’s chancellor, Dr. Jeffrey Gold, said in prepared testimony…
This was part of what I tried to indicate in my September 30 post, in which I pointed out that US community hospitals could not care for Ebola patients. They will never be able to. They lack the containment to do it safely. Only large hospitals can assign enough staff away from other duties. They have no ability to get most labs and X-rays for Ebola patients.  Finally, who will pay for such high-end care in our profit-driven system? Will your insurance cover Ebola, when insurers have great latitude to reject claims?

UPDATE Nov 18:  The Nebraska Medical School Chancellor also noted“I urge Congress to approve funding and policies supporting full reimbursement of the cost of care for these unique cases that are not recoverable from insurance policies."

I have now read detailed accounts of the clinical course of the first two US Ebola patients (Dr. Brantly and Nancy Writebol) and two African patients treated in Frankfurt and Hamburg (one a physician and one an epidemiologist).  At first, the patient in Frankfurt had eight doctors working on his case.

The two African patients, from Uganda and Senegal, respectively, were much, much sicker than Brantly and Writebol. A third African patient, treated in Leipzig, died. It is rather amazing that the other two lived. The bill for the patient treated in Hamburg came to 2 million euros. (And the cost of medical care in Germany is half that in the US.)

UPDATE Nov 16: Senator Schumer has asked the federal government for $20 million to be reimbursed for the care of Dr. Spencer. (Is that why they call it the Big Apple?)
Today Dr. Salia has arrived in Nebraska for treatment, and he is said to be extremely ill, possibly sicker than any previous patients treated in the US.  He has been sick for 9 days, but that is approximately the amount of time it took before Writebol and Brantly arrived in the US. A statement released early Sunday by Nebraska Medical Center said that doctors treating Dr. Martin Salia were "using the maximum amount of supportive care possible in an effort to save his life," while the head of the hospital's biocontainment unit described the treatments as "an hour-by-hour situation." 

Brantly and Writebol received ZMapp, and Brantly received 3 units of blood (one from a recovered patient) while still in Africa.  Salia received one dose of ZMapp in Nebraska, but died within 2 days of arriving there.

It is possible that Caucasians have a less severe illness.  It is possible that early treatments with convalescent serum or ZMapp lessened the severity of illness.  With only a handful of cases to extrapolate from, neither may be true; but these hypotheses should be explored.

Six doctors (besides Dr. Salia) from Sierra Leone contracted Ebola, and (updated) now ten have died. The Ebola case fatality rate for healthcare workers in Africa is said to be 56%-80%, and the overall case fatality rate seems to be 60%--71%--74%, depending on the group studied.

I, for one, believe that the more people treated in our bio-containment units, the better for everybody. Doctors here have much to learn about treating Ebola, and we need to speed up the learning curve. MSF and other medical providers in Africa need to learn more about the illness from the first world's ability to monitor patients closely, and this will help refine and improve the treatments available in Africa and elsewhere.

Speaking of learning curve, I was surprised that even at Emory, next door to CDC, in the bio-containment unit there was no ability to get X-rays or more than a few standard laboratory tests for Ebola patients.  (Recall that I have discussed this major problem in earlier posts.) Somehow, in Hamburg, there seems to have been more advanced care available.  So the learning curve in the US could benefit from knowledge of what Europe is able to do.

UPDATE Nov 18: Emory now seems to have figured out the X-ray problem.

Wednesday, November 12, 2014

Disinfecting Ebola: New Questions

I previously recommended alcohol hand rub (usually 70% ethyl or isopropyl alcohol) to kill Ebola on hands and gloves, which CDC recommends, along with soap and water.

From more reading, I no longer feel this is adequate, as it appears alcohol has not been tested on Ebola, and because other environmental tests have found Ebola to be hardier than one would have guessed (see Canadian discussion below). 

According to the manufacturer of a popular brand of alcohol hand sanitizer, Purell:

Ebola viruses are high risk pathogens that must be contained and are not readily available for laboratory testing. As of today, we are not aware of any hand sanitizers that have been tested against Ebola viruses, including PURELL® Hand Sanitizer. However, it is important to note that the Ebola virus is an enveloped virus. Enveloped viruses in general are easily killed or inactivated by alcohol. World Health Organization (WHO) and the Center for Disease Control and Prevention (CDC) are recommending handwashing and the use of alcohol-based hand sanitizer as a preventive measure during this outbreak.
As we have already noted, CDC speaks with forked tongue on Ebola, presumably because of the imperative to appear fully prepared, when it isn't. The following CDC document, which discusses how to decontaminate surfaces (not skin), admits that although Ebola is an enveloped virus, it may require stronger measures for decontamination than the enveloped viruses we are used to dealing with in hospitals.  Instead, CDC recommends we treat Ebola like we would treat Norovirus, which is not killed with alcohol rub.  
  • Use a U.S. Environmental Protection Agency (EPA)-registered hospital disinfectant with a label claim for a non-enveloped virus (e.g., norovirus, rotavirus, adenovirus, poliovirus) to disinfect environmental surfaces in rooms of patients with suspected or confirmed Ebola virus infection. Although there are no products with specific label claims against the Ebola virus, enveloped viruses such as Ebola are susceptible to a broad range of hospital disinfectants used to disinfect hard, non-porous surfaces. In contrast, non-enveloped viruses are more resistant to disinfectants. As a precaution, selection of a disinfectant product with a higher potency than what is normally required for an enveloped virus is being recommended at this time. EPA-registered hospital disinfectants with label claims against non-enveloped viruses (e.g., norovirus, rotavirus, adenovirus, poliovirus) are broadly antiviral and capable of inactivating both enveloped and non-enveloped viruses...
  •  For large spills, a chemical disinfectant with sufficient potency is needed to overcome the tendency of proteins in blood and other body substances to neutralize the disinfectant's active ingredient. An EPA-registered hospital disinfectant with label claims for non-enveloped viruses (e.g., norovirus, rotavirus, adenovirus, poliovirus) and instructions for cleaning and decontaminating surfaces or objects soiled with blood or body fluids should be used according to those instructions.
CDC also recommends sodium hypochlorite "wipes" for cleaning collections of infectious fluids. This may not be adequate either.

"Wipes" are convenient because they usually do not drip, or splash, which could spread viral contamination.  However, virus is killed as a function of the amount and concentration of the active ingredient, the concentration of virus, and the amount of time the two are in contact, as well as interfering substances that may be present.  Simply wiping a surface will not necessarily inactivate all virus on the surface. Nor will a quick spraying when the active ingredient evaporates rapidly.

The Canadian public health agency emphasizes that time is needed to kill the virus, not simply contact with a disinfectant that rapidly evaporates, like alcohol. Their guidance says the following:

"SUSCEPTIBILITY TO DISINFECTANTS: Ebolavirus is susceptible to 3% acetic acid, 1% glutaraldehyde, alcohol-based products, and dilutions (1:10-1:100 for ≥10 minutes) of 5.25% household bleach (sodium hypochlorite), and calcium hypochlorite (bleach powder) 
Footnote49 Footnote50 Footnote62 Footnote63. The WHO recommendations for cleaning up spills of blood or body fluids suggest flooding the area with a 1:10 dilutions of 5.25% household bleach for 10 minutes for surfaces that can tolerate stronger bleach solutions (e.g., cement, metal) Footnote62. For surfaces that may corrode or discolour, they recommend careful cleaning to remove visible stains followed by contact with a 1:100 dilution of 5.25% household bleach for more than 10 minutes.
PHYSICAL INACTIVATION: Ebola are moderately thermolabile and can be inactivated by heating for 30 minutes to 60 minutes at 60°C, boiling for 5 minutes, or gamma irradiation (1.2 x106 rads to 1.27 x106 rads) combined with 1% glutaraldehyde Footnote10 Footnote48 Footnote50. Ebolavirus has also been determined to be moderately sensitive to UVC radiation Footnote51.
SURVIVAL OUTSIDE HOST: Filoviruses have been reported capable to survive for weeks in blood and can also survive on contaminated surfaces, particularly at low temperatures (4°C)Footnote52 Footnote61. One study could not recover any Ebolavirus from experimentally contaminated surfaces (plastic, metal or glass) at room temperature Footnote61.  In another study, Ebolavirus dried onto glass, polymeric silicone rubber, or painted aluminum alloy is able to survive in the dark for several hours under ambient conditions (between 20°C and 25°C and 30–40% relative humidity) (amount of virus reduced to 37% after 15.4 hours), but is less stable than some other viral hemorrhagic fevers (Lassa) Footnote53. When dried in tissue culture media onto glass and stored at 4 °C, Zaire ebolavirus survived for over 50 days Footnote61. This information is based on experimental findings only and not based on observations in nature. This information is intended to be used to support local risk assessments in a laboratory setting.
A study on transmission of ebolavirus from fomites in an isolation ward concludes that the risk of transmission is low when recommended infection control guidelines for viral hemorrhagic fevers are followed Footnote64. Infection control protocols included decontamination of floors with 0.5% bleach daily and decontamination of visibly contaminated surfaces with 0.05% bleach as necessary...
SPILLS: Allow aerosols to settle and, wearing protective clothing, gently cover spill with paper towels and apply suitable disinfectant, starting at the perimeter and working towards the centre. Allow sufficient contact time before clean-up.
DISPOSAL: Decontaminate all materials for disposal from the containment laboratory by steam sterilisation, chemical disinfection, incineration or by gaseous methods. Contaminated materials include both liquid and solid wastes.
STORAGE: In sealed, leak-proof containers that are appropriately labelled and locked in a Containment Level 4 laboratory."
Of course, the obvious question is why hasn't CDC or EPA or OSHA or DOD tested Ebola against all usual/available disinfectants so we do not have to guess.  Can Sanjay or another TV doc find out for us?

UPDATE Nov 21:  Today CDC posted a document on disinfecting Ebola.  Ignore it; it is confusing and wrong. In 2 places it says Ebola is an enveloped virus, and these are usually very susceptible to disinfection. However, the document says to use agents labelled by EPA for non-enveloped viruses, which are harder to kill.  CDC lists a number of disinfecting agents, but fails to note that to kill Ebola virus they need to be in contact with it for specified times.