Texas federal judge halts US approval of abortion pill mifepristone


STORY HIGHLIGHTS

The 67-page ruling by US District Judge Matthew Kacsmaryk in Amarillo allows the Biden administration one week to appeal the decision, according to court documents.

A federal judge in the United States on Friday (April 7) halted the approval of the abortion pill mifepristone. The 67-page ruling by US District Judge Matthew Kacsmaryk in Texas allows the Joe Biden administration one week to appeal the decision, according to court documents.

Kacsmaryk’s ruling is a preliminary injunction that would essentially ban the sale of mifepristone while the case before him continues, according to a report by the news agency Reuters. The judge, appointed to the bench by former president Donald Trump, did not rule on the merits of the challenge. The injunction will remain in place until the judge makes a final judgment or it is reversed on appeal.

Some abortion providers said that if mifepristone is unavailable, they would switch to a regimen using only misoprostol for a medication abortion, Reuters reported. 

Four anti-abortion groups, headed by the Alliance for Hippocratic Medicine and four anti-abortion doctors, sued the US Food and Drug Administration (FDA) in November last year, contending the agency used improper process when it approved mifepristone back in 2000 and did not adequately consider the drug’s safety when used by girls under the age of 18 to terminate pregnancy.

Mifepristone is part of the regimen in the US for medication abortions, which accounts for over half of all abortions in the country.

Responding to the lawsuit, the Biden administration said the drug’s approval was well supported by science, and that the challenge comes much too late. Vice President Kamala Harris said the ruling  undermines the FDA’s “ability to approve safe and effective medications… based on science, not politics.”

Justice department vows to appeal the ruling

The US Justice department said on Friday that it would appeal the ruling by Judge Matthew Kacsmaryk, adding it strongly disagrees with the decision, the news agency AFP reported. 

“The Justice Department strongly disagrees with the decision…and will be appealing the court’s decision and seeking a stay pending appeal,” said Attorney General Merrick Garland.

Meanwhile, Planned Parenthood, which is one of the largest pro-abortion groups in the US, also slammed Friday’s court ruling. 

“The judge’s decision in Texas today blocking the (Food and Drug Administration’s) approval of mifepristone is an outrage and exposes the weaponisation of our judicial system to further restrict abortion nationwide,” the federation’s President Alexis McGill Johnson said in a statement. 

Johnson said that people should be enraged that one judge can unilaterally reject medical evidence and overrule the FDA’s approval of a medication that has been safely and effectively used for over 20 years. 

“This decision could threaten the FDA’s role in this country’s public health system, and — if allowed to stand — will have broad and unprecedented consequences that reach far beyond abortion,” Johnson added. 

Organic air pollutants tied to hepatocellular carcinoma incidence in Texas.


Texas counties with the highest rates of hepatocellular carcinoma (HCC) diagnoses tended to be those with the highest levels of certain airborne organic chemicals, such as benzene and toluene, known to be human carcinogens, researchers said here.

Although potential confounders were not adjusted for in the analysis, conducted by Ali Shirafkan, MD, and colleagues at the University of Texas Medical Branch in Galveston, Shirafkan told MedPage Todaythat the findings suggest that the association deserves more study to determine whether it may be causative.

A total of 20 such pollutants were significantly elevated in counties with high HCC incidence rates, he reported at the Digestive Disease Week annual meeting. In addition to benzene and toluene, they included other known carcinogens such as hexane, methyl-t-butylether, methyl chloroform, 1-3 butadiene, and 2-2-4 trimethylpentane.

Most of the pollutants identified are effluents from oil and gas extraction and processing.

Shirafkan said the study was motivated by recognition that Texas, in addition to being the nation’s largest oil and gas producer, also has one of the highest rates for HCC, at 9.9 per 100,000 population. The state is also a leading agriculture producer, another industry that exposes many people to chemical pollutants.

As a first look at potential relationships, his group pulled county-level cancer incidence data from the Texas Cancer Registry and several federal data sources, along with county-level pollution data on 188 compounds collected by the U.S. Environmental Protection Agency.

The researchers grouped counties with available data (118 of 254 in the state) into four clusters: one group of 10 that had HCC incidence of zero, one that was primarily agricultural, one comprising the urban centers of Houston, San Antonio, and Dallas-Fort Worth, and a fourth with other urban centers and concentrations of oil/gas extraction and refining. HCC rates in the latter three clusters ranged from 7.48 to 9.45 per 100,000 population.

For the clusters with zero HCC incidence and with agriculture as the dominant industry, there was no association with airborne pollutants, the researchers found. The associations were limited to the two clusters containing urban centers and concentrations of oil/gas facilities.

Shirafkan emphasized that these data did not take into account any potential confounders such as socioeconomic factors, obesity or other comorbidities, or exposures to other types of carcinogens. He readily agreed that air pollution exposure could be a marker for poverty or general poor health, for example. He said he plans to examine such relationships in the next phase of research, and also agreed that extending such analyses to other states would be worthwhile.

Birds detect approaching storm from 900km away.


Infrasound may have alerted warblers to the massive storm, prompting them to fly more than a thousand kilometres to avoid it.

A golden-winged warbler (Vermivora chrysoptera).
A golden-winged warbler (Vermivora chrysoptera).
The golden-winged warblers may have picked up infrasound from tornadoes, which travels through the ground.
A group of songbirds may have avoided a devastating storm by fleeing their US breeding grounds after detecting telltale infrasound waves.

Researchers noticed the behaviour after analysing trackers attached to the birds to study their migration patterns. They believe it is the first documented case of birds making detours to avoid destructive weather systems on the basis of infrasound.

The golden-winged warblers had just returned from South America to their breeding grounds in the mountains of Tennessee in 2013 when a massive storm was edging closer. Although the birds had just completed a migration of more than 2,500km, they still had the energy to evade the danger.

The storm, which spawned more than 80 tornadoes across the US and killed 35 people, was 900km away when the birds, apparently acting independently of one another, fled south, with one bird embarking on a 1,500km flight to Cuba before making the return trip once the storm had passed.

A tornado approaching homes in Texas
A tornado in Brisco County, Texas. The birds didn’t appear to have used changes in pressure, wind speed or precipitation to warn them of the approaching storm. Photograph: Reed Timmer/Jim Reed Photography/Corbis
“We looked at barometric pressure, wind speeds on the ground and at low elevations, and the precipitation, but none of these things that typically trigger birds to move had changed,” said David Andersen at the University of Minnesota.

“What we’re left with is something that allows them to detect a storm from a long distance, and the one thing that seems to be the most obvious is infrasound from tornadoes, which travels through the ground.”

The scientists had fitted trackers to 20 golden-winged warblers in 2013. Only nine returned to their breeding ground after migrating to South America. Of those nine, the researchers trapped and analysed the flight histories of five. All took evasive action to avoid the storm.

The birds started to leave their breeding grounds on 27 April 2013, when the storm was whipping up tornadoes in Oklahoma, Kansas and Texas. The next day, with the storm about 100km from their breeding site, the birds had moved a few hundred kilometres south east. When the storm moved over the study area, battering it with winds of up to 160 kilometres per hour, the warblers were on Florida’s Gulf Coast. One flew on to Cuba.

“In five to six days, they all made this big move around the storm,” Andersen said. “They all went south east in front of the storm, and then let it go by, or moved behind it. It was individual behaviour, they were several hundred kilometres away from each other most of the time.” Details are reported in the journal Current Biology.

The scientists cannot be sure that the birds picked up infrasound waves from the storm, but previous work in pigeons has suggested that birds might use infrasound to help them navigate. Infrasound waves range from about 0.5Hz to 18Hz, below the audible range of humans.

The discovery of the evasive action could be good news, said Andersen. “With climate change increasing the frequency and severity of storms, this suggests that birds may have some ability to cope that we hadn’t previously realised. These birds seemed to be capable of making really dramatic movements at short notice, even just after returning on their northwards migration,” he said.

Had the storm arrived a couple of weeks later, the birds may not have taken flight. By that time, they would have been nesting, and females especially may have been less likely to flee. “It’s hard to say what would happen. It may be more advantageous to survive than stay with a nest that is going to be destroyed anyway,” Andersen said.

“Biologists had not been looking at the use of infrasound in this way, but it certainly makes sense to me,” said Jon Hagstrum at the US Geological Survey in California, who has studied infrasound use by pigeons. “We may find that acoustics are a pretty significant way that birds in general view their environment, much like dogs use olfaction and humans use sight.”

A Smartphone App That Detects Radiation In A Disaster.


GammaPix just got a test run at the catastrophe simulation site Disaster City.

Disaster City is your one-stop for about every catastrophe you can think of. Train derailments, hurricanes, and other unfortunate happenings all get simulated at the Texas A&M site. As part of a test Wednesday, first responders test piloted something new: a smartphone app that detects radiation.

GammaPix, which sounds like one of those weird apps you accidentally find in the App Store and assume doesn’t work, is apparently a real thing for iPhone and Android that “can be used for the detection of radioactivity in everyday life such as exposure on airplanes, from medical patients or from contaminated products.” It works through a smartphone’s camera, so doesn’t require any external attachments. Chips inside of a smartphone’s built-in camera are sensitive to gamma rays; GammaPix uses its software to measure the impact of those rays, and give a picture of radioactivity in the area. The company says it works from up to 100 meters away.

Wednesday, at the Disaster City exercise, first responders measured radiation levels with the app, then practiced sending the data to officials through a wireless network. The idea’s that those officials will be able to make better-informed decisions more quickly with the data. Maybe one day civilians could download the app and be prepared to monitor radioactivity in an emergency, although they probably (hopefully) wouldn’t get much of a chance to use it.

Massive Toxic Japanese Tsunami Island of Trash Headed Toward US.


As our numerous commentaries on Fukushima and its perilous implications to life on planet earth have indicated, the nuclear industry is high-risk.  Anti-nuclear advocate Harvey Wasserman warned again of the nuclear power threat in a BuzzFlash at Truthout commentary posted today, “Pro-Nuke Scientists Should Go to Fukushima.”  

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Now The Independent UK reports that an island of trash, some of it presumed toxic from the Fukushima radiation leaks, is floating across the Pacific, headed toward North America:

An enormous floating island of debris from Japan’s 2011 tsunami is drifting towards the coast of America, bringing with it over one million tons of junk that would cover an area the size of Texas.

The most concentrated stretch – dubbed the “toxic monster” … – is currently around 1,700 miles off the coast, sitting between Hawaii and California, but several million tons of additional debris remains scattered across the Pacific.

If the rubbish were to continue to fuse, the combined area of the floating junkyard would be greater than that of the United States, and could theoretically weigh up to five million tons.

Even accounting for a bit of sensationalism in the projected size of the giant bobbing debris field, it is widely assumed that a significant percentage of the trash has essentially been soaked in radioactive water.  In short, more radiation fallout from Fukushima is likely headed our way, and if so in gigantic fashion.

According to The Independent, it may still be years before the colossal flotsam island reaches North America, but the newspaper notes:

Some of the debris may have already crossed the [Pacific], however, with reports of Japanese fishing vessels washing up on the shores of Canada as long ago as winter 2011. If that proves to be the case, the levels of toxic junk already littering US beaches is likely to be high.

This is the type of radiation whose long term impact is still unknown.  But one can safely say, it is not something that improves the health of Mother Earth or the people who will come into contact with it.  In this case, individuals on the West Coast of North America are potentially endangered by the breakdown of a nuclear power plant in Japan.

When the corporate world talks about globalization, this is not the kind of interconnectedness that they want people to think about: a noxious undulating junkyard floating toward us.

Death row inmates now executed with drug cocktail used to euthanize animals.


San Quentin Prison execution chamber, US (AFP Photo)

Compounding pharmacies, which create specialized pharmaceutical product meant to fit the needs of a patient, have begun producing the drugs for state authorities.

But because of the lack of transparency around the production process – one compounding pharmacy was responsible for a fatal meningitis outbreak in 2012 because of poor hygiene – prisoners argue that risky drug cocktails put them at risk of being subjected to “cruel and unusual punishment,” which is prohibited under the US Constitution.

Earlier this month three Texas-based death row prisoners filed a lawsuit arguing this type of pharmacy is “not subject to stringent FDA regulations” and is “one of the leading sources for counterfeit drugs entering the US,” the lawsuit reads, as quoted by AFP.

“There is a significant chance that [the pentobarbital] could be contaminated, creating a grave likelihood that the lethal injection process could be extremely painful, or harm or handicap plaintiffs without actually killing them,” it adds.

“Nobody really knows the quality of the drugs, because of the lack of oversight,” Denno told AFP.

Michael Yowell, who was convicted of murdering his parents 15 years ago, was executed in Texas Wednesday. He became the first inmate to be executed in Texas with pentobarbital since European nations halted production for this purpose. His lawyers unsuccessfully tried to stop him from being killed, saying the compounded factors in pentobarbital make the drug unpredictable and there have not been enough trials to guarantee the death is painless.

The states in question may find an applicable replacement for the short-term but, Denno argued, this development could be an indication that capital punishment is on the wane.

“How many times in this country can they change the way they execute?” she said. “There were more changes in lethal injections in the last 5 years than in the 25 preceding years.”

Rabies Vaccine Dropped from the Sky


Story at-a-glance

  • There are only 2-4 human rabies cases in the US each year, but annual prevention costs are more than $300 million
  • The Texas Department of Health is using helicopters to spread 100,000 rabies vaccines for skunks in the wilderness; other states have also conducted similar vaccination efforts
  • No one knows if such programs are effective or if the indiscriminate spreading of a pharmaceutical product into the environment is going to have any unforeseen consequences to wildlife or the surrounding ecosystem.
  • rabies

In 2009, there were just four human cases of rabies in the US. In 2010, there were two1… yet each year, the US spends more than $300 million for rabies prevention,2 which includes the vaccination of companion animals, animal control programs, maintenance of rabies laboratories and medical costs.

Even at the turn of the century, rabies-related human deaths only numbered around 100 annually, and by the 1990s, this had dropped to one or two.  While rabies is a serious, potentially deadly, illness, it is most often transmitted through the bite of a rabid wild animal – a risk factor that is negligible for many in the US.

Texas Department of Health Is Dropping Experimental Rabies Vaccines from the Sky

About 92 percent of the reported rabies cases in 2010 were in wild animals, including raccoons, skunks, bats, foxes, rodents and others. This poses a theoretical risk not only to humans but also to family pets, which could then transmit rabies to their owners.

Nonetheless, human rabies cases remain extremely rare… but efforts are still underway to knock out the rabies virus in wild skunk populations in Texas.

The Texas Department of Health is actually using helicopters to spread 100,000 rabies vaccines in two counties. The vaccines, which are contained in plastic cases coated with fishmeal to entice wildlife to eat them, are part of a pilot program to help reduce the number of rabid skunks in the area.

No one knows yet if the program is going to work – skunks will need to be caught and tested for rabies 30-60 days after the vaccines are dropped – or if the indiscriminate spreading of a pharmaceutical product into the environment is going to have any unforeseen consequences to wildlife or the surrounding ecosystem.

Should Wildlife Be Vaccinated Against a Disease That Infects 2-4 People a Year?

It’s also unclear why Texas is taking such aggressive measures against rabies. There has so far been only one reported case of human rabies in Texas in 2013, and the man was exposed in Guatemala, Mexico — not in Texas. The last case of human rabies in Texas prior to that was in 2009 and prior to that in 2004 – for a total of just 6 human cases in the last decade.3

For comparison, there were 2,390 cases of campylobacteriosis in Texas in 2012 alone… an illness largely spread by contaminated poultry raised on concentrated animal feeding operations (CAFOs). This illness, too, can be deadly if it infects a person with a compromised immune system, yet we’re not hearing about widespread efforts to curb its transmission…

Even if you factor in data from the US Centers for Disease Control and Prevention (CDC), which states there were 6,153 reported cases of rabies in animals in 2010, that’s for animals in the entire US, and not only skunks but also raccoons, foxes, bats and others. Texas isn’t the only state to opt for preventative rabies vaccination of wildlife, either. According to the Human Society of the United States (HSUS):4

“Federal and state wildlife officials have been vaccinating wildlife in many regions over the past 15 years. They distribute vaccine-laden baits that the target animals eat and thereby vaccinate themselves. Right now, oral rabies vaccination of wildlife focuses on halting the spread of specific types of rabies in targeted carrier species. Next, it’s hoped that this tool can shrink the diseases’ range.”

The end question remains the same, not only for Texas but for the entire US: is it really necessary to spend $300 million a year on rabies prevention… and what are the potential consequences of vaccinating wildlife?

What Exactly Is Rabies?

Rabies is a viral disease that most often enters your body through a bite or wound contaminated by the saliva from an infected animal. If it manages to infect the central nervous system, it can lead to early symptoms that include fever, headache, weakness and discomfort. As the disease progresses, it can lead to insomnia, anxiety, confusion, paralysis, hallucinations, difficulty swallowing, fear of water and death.

If you have been bitten by a wild animal (or a dog with unknown rabies status), wash the wound thoroughly with soap and water, as this will help to decrease your risk of infection.

Next, talk to a doctor about your next steps. He or she will probably contact the local or state health department and, if it’s deemed that the animal was rabid or at high risk of being rabid, you may need to start postexposure prophylaxis (PEP), which consists of a series of vaccines that can protect you from developing rabies. But remember, though rabies is serious, and frightening, it’s extremely rare. HSUS puts it into perspective:

Given all the media attention that rabies regularly receives, it may be somewhat surprising to learn that very few people die from rabies nationwide each year. Over the past 10 years, rabies has killed only a total of 28 people in the U.S. This amounts to fewer than 3 fatalities a year nationwide.

People who contracted rabies in the United States were mostly infected by a bat. Most didn’t even know they were bitten. Some may have been sleeping when bitten. Others handled a bat bare-handed without realizing they’d been potentially exposed to rabies. But don’t panic over every bat sighting. Less than one-half of one percent of all bats in North America carries rabies. Although raccoons suffer from rabies more than any other mammal in the United States (about 35 percent of all animal rabies cases), only one human death from the raccoon strain of rabies has been recorded in the United States.”

Bismuth-carrying nanotubes track stem cells in CT.


Texas researchers have succeeded in trapping bismuth in a nanotube cage, and the resultant structure could be used as a CT contrast agent to track stem cells, according to a new study in the Journal of Materials Chemistry B.

Specifically, the investigators from Rice University, in cooperation with the University of Houston and St. Luke’s Episcopal Hospital, are inserting bismuth compounds into single-walled carbon nanotubes to make a more effective CT contrast agent. In tests using pig bone marrow-derived mesenchymal stem cells, the researchers found that the bismuth-filled nanotubes, which they have dubbed Bi@US-tubes, produce CT images of higher attenuation than those with iodine-based contrast agents .

Bismuth has been used before as a contrast agent, but putting it in nanotube capsules allowed the researchers to get the substance inside cells in high concentrations, permitting the acquisition of CT images of the cell. The relatively high contrast is achieved with low bismuth loading (2.66% by weight) within the tubes, without compromising cell viability.

Bismuth is a heavy element and therefore is more effective at diffracting x-rays than almost any substance, according to study co-author Lon Wilson, PhD. Going forward, the nanotube surfaces can be modified to improve biocompatibility and their ability to target certain types of cells. They can also be modified for use with MRI, PET, and electron paramagnetic resonance imaging systems, he said.

The researchers are now working to double the amount of bismuth in each nanotube. They would also like to combine bismuth and gadolinium into a single nanotube to produce a bimodal contrast agent suitable for tracking in both CT and MRI, Wilson said.

Source: auntminnie.com

Transmission of Rabies Virus from an Organ Donor to Four Transplant Recipients.


Rabies is an acute encephalitis caused by viruses in the genus Lyssavirus, family Rhabdoviridae, that is nearly uniformly fatal in unvaccinated hosts. Although the virus is present in animal reservoirs, infection in humans is rare in the United States, with only two cases reported in 20031,2 and no more than six cases reported in any year in the past decade.3 The primary mode of transmission is through the bite of an infected animal, most commonly a bat in the United States.4 Although transmission of rabies virus from corneal transplants has previously been described,5 to our knowledge, no cases ascribed to organ or vascular-tissue transplants have been reported.

In May 2004, physicians at a hospital in Texas diagnosed encephalitis in three recipients of a liver and two kidneys from a common organ donor. It was later discovered that encephalitis also developed in a fourth patient, who had received a vascular graft from the same donor during liver transplantation. All four patients became progressively obtunded, lapsed into coma, and died within 50 days after transplantation. The initial diagnostic evaluation revealed no cause of the encephalitis, and assistance was sought from the Centers for Disease Control and Prevention (CDC) and the Texas Department of State Health Services. We report the results of this investigation.

CASE REPORTS

Transplant Recipients

In May 2004, encephalitis was diagnosed in three recipients of a liver and two kidneys (Patients 2, 3, and 4 in Figure 1FIGURE 1The Clinical Course of Four Recipients of Rabies-Infected Tissue or Organs.) from a common organ donor. In all three patients, signs and symptoms of altered mental status and progressively worsening encephalitis developed within 30 days after transplantation. Major clinical events and immunosuppressive medications are summarized in Figure 1. All patients had rapid neurologic deterioration characterized by agitated delirium and seizures. Respiratory failure requiring intubation developed within 48 hours after the onset of neurologic symptoms. Examination of cerebrospinal fluid from the three patients showed pleocytosis, with an average of 18 cells per cubic millimeter (range, 7 to 35), and elevated protein levels (mean, 135 mg per deciliter; range, 17 to 331). Neurologic imaging in the week after the onset of symptoms showed no evidence of an acute cerebral process. Magnetic resonance imaging (MRI) performed later in the course of illness demonstrated diffuse signal abnormalities, most often in the temporal lobes, basal ganglia, brain stem, and hippocampi on T2-weighted and fluid-attenuated inversion recovery images (Figure 2FIGURE 2Axial Fluid-Attenuated Inversion Recovery MRI Scan Showing Profound Signal Abnormalities within the Bilateral Frontal and Temporal Lobes, Hippocampi, Basal Ganglia, and Medulla in Patient 2.). There was minimal enhancement after the administration of gadolinium. The patients died an average of 13 days after the onset of neurologic symptoms (range, 7 to 23).

Organ Donor

Four days before death, the organ donor was seen twice at an emergency department for nausea, vomiting, and difficulty swallowing. He was subsequently admitted to another hospital with altered mental status requiring intubation. Physical examination revealed a temperature of 38.1°C (100.5°F) and fluctuating blood pressures, including systolic measurements of more than 200 mm Hg. On admission, a urine toxicology screen was positive for cocaine and marijuana, and computed tomography of the brain demonstrated a subarachnoid hemorrhage. The hemorrhage progressed, and the neurologic symptoms, including seizures and coma, worsened. The patient was declared brain-dead within four days after presentation. Donor-eligibility screening and testing performed by an organ-procurement organization, including a review of premortem blood, urine, and sputum bacterial cultures, did not detect any signs or symptoms of infection precluding solid-organ donation. The patient’s kidneys, lungs, and liver were removed for transplantation; in addition, iliac arteries were harvested for potential use in vascular reconstruction during the liver transplantation. In part because of the positive toxicology result, nonorgan tissues (e.g., tendons) were not removed. During contact investigations conducted after the rabies diagnoses were made, friends of the donor indicated he had reported being bitten by a bat.

METHODS

Clinical and Epidemiologic Review

Medical records of the donor and infected transplant recipients were reviewed to characterize clinical courses and diagnostic evaluations. After the laboratory diagnosis of rabies infection in the three organ recipients, case finding was performed to search for other possible cases. Hospital autopsy records on patients with encephalitis were reviewed for pathological findings consistent with the presence of rabies. Also, charts of patients who had been on the same floor as a patient with rabies and who had also had a lumbar puncture or neurology consultation for altered mental status were examined for documented clinical findings consistent with the presence of rabies. Procedures for organ recovery and handling were also reviewed.

Laboratory Methods

Formalin-fixed, paraffin-embedded tissue specimens, obtained at autopsy, were stained with hematoxylin and eosin and various immunohistochemical stains according to a method described previously.6 For immunohistochemical assays, 3-μm tissue sections were deparaffinized, rehydrated, and digested in proteinase K. Tissue sections were incubated for 60 minutes at room temperature with a hyperimmune rabbit antiserum or mouse ascitic fluid with reactivity to rabies virus. After sequential application of the appropriate biotinylated linked antibody, avidin–alkaline phosphatase complex, and naphthol fast-red substrate, sections were counterstained in Meyer’s hematoxylin and mounted with the use of aqueous mounting medium. Serologic analyses, detection of viral antigen in tissue by means of fluorescence microscopy, and identification of rabies virus variants were performed as described previously.7,8 Controls included serum specimens from noninfected animals, tissues from humans with nonrabies encephalitides, and rabies-infected human tissues. Immunohistochemical assays for various other viral, rickettsial, and protozoan agents of encephalitis were also performed on tissues from recipients.

Vero E6 cells were inoculated with CSF and 10 percent tissue suspensions from three of the four rabies-infected recipients (Patients 2, 3, and 4). Suckling mice were inoculated intracranially and intraperitoneally with cerebrospinal fluid and 10 percent clarified homogenates of brain tissue, spinal cord, and kidney suspensions. Tissue cultures and suckling mice were observed daily for cytopathic effects and signs of illness, respectively. Tissues obtained from suckling mice that developed neurologic signs or died were fixed in 10 percent neutral buffered formalin or 2.5 percent buffered gluteraldehyde or were frozen for further evaluation. At 14 days, the Vero E6 cells were suspended in saline, fixed on glass slides, and tested for the presence of rabies virus antigen by means of a direct fluorescence antibody assay according to a previously described method.9 Immunohistochemical studies were performed as described above, and formalin-fixed tissues were embedded for examination by electron microscopy.

RESULTS

Review of Transplantation Records

All organs obtained from the donor were transplanted; the lung recipient died of intraoperative complications. Iliac arteries from the donor were not used during the liver transplantation in Patient 2 and were placed in a sterile container and stored for potential use in subsequent transplantation procedures. One day after the organs were transplanted, the iliac-artery segment was retrieved and used to construct a vascular graft for another liver-transplant procedure (in Patient 1).

Rabies Case Finding

In addition to the three initial cases noted by physicians, autopsy review identified a fourth patient (Patient 1 in Figure 1) in whom progressive, fatal encephalitis had developed after liver transplantation. This patient had received the vascular segment from the rabies-infected donor. A review of the medical records of patients who had been on the same floor as a patient with rabies and who had had a lumbar puncture or neurology consultation for altered mental status revealed no further cases of encephalitis consistent with the presence of rabies.

Pathological Findings

Histopathological evaluation of tissues from all four rabies-infected transplant recipients demonstrated diffuse, predominantly lymphohistiocytic, infiltrates and microglial nodules involving the cerebrum, brain stem, cerebellum, and spinal cord. Cytoplasmic inclusions consistent with Negri bodies were identified throughout the central nervous system (CNS), particularly in the Purkinje cells of the cerebellum and in neurons of the frontal cortex, thalamus, hippocampus, midbrain, and pons (Figure 3AFIGURE 3Histopathological Findings in Patient 4.). Lymphohistiocytic infiltrates involving the peripheral nerves, heart, and kidneys were also noted in some patients. Electron microscopy of the midbrain of Patient 4 demonstrated abundant rhabdovirus particles (Figure 3B). Intracytoplasmic rabies virus antigens were detected on immunohistochemical staining in neurons from multiple areas of the CNS (Figure 3C); in peripheral nerves of the transplanted kidneys, liver, and arterial graft (Figure 4FIGURE 4Immunohistochemical Staining (Red) of Rabies Virus Antigens in Peripheral Nerves of the Liver (Panels A and B), Kidney (Panel C), and Arterial-Graft Transplants (Panel D).); and in renal tubular epithelium, smooth muscle, histiocytes, and vascular endothelium. No tissues were positive for enteroviruses, human herpesviruses 1 and 2, West Nile and other flaviviruses, eastern equine encephalomyelitis virus, lymphocytic choriomeningitis virus, Cache Valley virus, henipaviruses, measles virus, spotted fever and typhus group rickettsiae, Toxoplasma gondii, or Trypanosoma cruzion immunohistochemical analysis. Direct fluorescence antibody staining also demonstrated rabies virus antigens in CNS tissues from all recipients.

Serologic Analyses and Viral Identification

Antibodies (IgM and IgG) reactive to rabies virus were present in the donor’s serum at the time of death. Antibodies were also present in three of the four recipients in samples obtained on postoperative days 35 and 36; both IgM and IgG antibodies were present in one kidney recipient (Patient 3) and the recipient of the donor’s liver (Patient 2), whereas only IgG antibodies were present in the patient who received the arterial segment (Patient 1). Antigenic typing revealed a previously characterized rabies virus variant associated with bats.

Cell Culture and Mouse Inoculations

All suckling mice had neurologic abnormalities or had died seven to eight days after inoculation. Thin-section electron microscopy of CNS tissue demonstrated rhabdovirus particles, and IHC testing detected rabies virus antigens in mouse CNS tissues. Cultures of Vero E6 cells inoculated with brain, spinal cord, and kidney from a kidney recipient demonstrated rabies virus antigen on staining with DFA.

DISCUSSION

This report describes the transmission of rabies virus through the transplantation of solid organs and vascular material. Four patients who received transplants — three organs and one vascular segment — from a donor with unrecognized rabies infection subsequently died of rabies. The transmission of rabies from corneal transplants has been described previously.5

Rabies is seldom included in the differential diagnosis of encephalitis in the absence of a documented exposure or suggestive history.8,10 The symptoms in the cases reported here, including fever, changes in mental status, and autonomic instability, were, in retrospect, consistent with a diagnosis of rabies. However, the diagnosis was complicated by the absence of a history of exposure at presentation and by the number of other potential causes of illness in these immunosuppressed patients. A history of a bat bite in the donor was discovered during contact interviews only after rabies had been diagnosed, and the investigation initiated. The diagnosis in the donor was further complicated by the presence of a subarachnoid hemorrhage in the setting of hypertension and a positive toxicology screen for cocaine. It is not known whether rabies infection was the cause of the subarachnoid hemorrhage, since this finding has not been noted in previous reports.11-13

Signs of rabies developed in all four transplant recipients within 30 days after infection. According to previous reports, symptoms developed within 30 days after an animal bite in only 25 percent of patients.10 It is unknown whether the shorter incubation period in these patients was due to the immunosuppression, the route of transmission, or both. The effect of immunosuppression on rabies infection is currently not well understood. In reports of rabies transmission from corneal transplants in patients who were not immunosuppressed and did not receive postexposure prophylaxis, symptoms developed an average of 26 days after transplantation,14-17 suggesting that implantation of material from infected donors may lead to a shorter incubation period. Three of our patients presented with commonly described symptoms of tremors and changes in mental status, whereas the fourth presented with abdominal and flank pain, which may have been neuropathic, and changes in mental status occurred about 48 hours later. The rapidly progressive encephalitis, with death occurring an average of 13 days after the onset of symptoms, is consistent with the course in other reports.4

There is only one reported case of recovery from clinical rabies by a patient who had not received preexposure or postexposure prophylaxis against rabies.18 However, administration of postexposure prophylaxis with rabies immune globulin and vaccine is highly effective in preventing infection after exposure. In a previous report, administration of postexposure prophylaxis probably prevented infection in a patient who had received a cornea from a donor with rabies.19

This report and another, describing the transmission of West Nile virus through solid-organ transplantation,20 underscore the potential for transmission of unexpected infectious diseases through organ transplantation. Recognition and prevention of transplant-transmitted infections may be improved in various ways, including enhanced donor screening and testing, the development of standardized procedures related to storage and use of donor vascular segments, as well as methods to track their use or nonuse, and enhanced means of detection and diagnosis of illnesses in recipients.

To minimize the risk of transmitting infections during organ transplantation, the Organ Procurement and Transplantation Network (OPTN) has established standards that require organ-procurement organizations to assess the risks of infectious diseases through screening questions and blood testing for selected bloodborne viral pathogens and syphilis.21 Questions about potential exposure to rabies are generally not included, and laboratory testing for rabies infection is not performed. Organs can be procured from donors who are febrile, provided that the medical director of the organ-procurement organization and the transplantation physicians agree that the cause of the fever does not pose an unacceptable risk to the recipient. Given the growing importance of emerging and reemerging infectious diseases, the ability of general improvements in the donor-screening process, rather than disease-specific measures, to increase organ safety should be evaluated. A proposed revision of OPTN policies would expand the list of potentially transmittable diseases and conditions that clinicians should consider in determining a donor’s eligibility.22 The revision emphasizes that when any of these conditions is known or suspected in a donor, this information should be conveyed immediately to the organ-procurement organization as well as to all transplantation centers that received organs from the donor.

The successful use of donor arterial conduits has been reported in liver transplantation23-26 and in the management of vascular complications in recipients of both hepatic transplants27,28 and renal transplants.29 As with organs, these vessel segments have the potential to transmit infection. A careful accounting of and an ability to track donated material, such as vessel conduits, are essential in efforts to link unexplained illnesses or deaths to a common organ donor and will increase the probability of quickly identifying all recipients who may be at risk from donor infections. Proposed revisions of the policies of both OPTN22 and the Joint Commission on Accreditation of Healthcare Organizations30 may help address the storage of vessel conduits and documentation of their use or nonuse.

Our investigation underscores the challenge in detecting and diagnosing infections that occur in recipients of organs or tissues from a common donor. The potential for disease transmission from a donor as a cause of illness or death may not be considered in the evaluation of an individual recipient. In this investigation, and in the previous report of the transmission of West Nile virus through transplantation, the ability to connect illnesses to a common organ donor was facilitated by the fact that multiple recipients were hospitalized at the same facility. Improved national detection of unexpected or serious outcomes among transplant recipients may facilitate the discovery of transplant-related transmission of emerging and unusual pathogens by allowing connections to common donors to be made. The ability to make retrospective diagnoses of infections in organ donors when unexplained deaths or illnesses occur in recipients is hampered by the limited availability of donor samples, particularly tissue; currently, only serum samples from organ donors are retained for any length of time. Investigations into possible transplantation-associated infections would be facilitated by the availability of selected, archived tissue samples from the donor and by autopsy reports and materials. An improved diagnostic ability may have important implications for other patients who received material from the donors and for contacts of the patients and donors.

As organ and tissue transplantation becomes more common, the potential risks of disease transmission may increase. Cases of transplantation-associated infections provide important opportunities to review practices in an attempt to enhance the safety of transplantation without affecting the organ supply. The Department of Health and Human Services, including the CDC, is working with other partners in the organ- and tissue-transplantation community to review donor-screening practices, the use of retained vascular segments, and surveillance of recipients for illness. Clinicians who care for organ-transplant recipients should continue to be aware of the potential for disease transmission through transplantation and the challenges in recognizing atypical presentations of infections in this immunosuppressed population. Clinicians should report unexpected outcomes or unexplained illnesses in transplant recipients to their local organ- and tissue-procurement organization.

We are indebted to the state health departments in Oklahoma and Alabama, to the Southwest Transplant Alliance, and to the staff of the Baylor University Medical Center for their assistance with this investigation.

Source: NEJM

 

NASA Hints at Possible Life on Mars .


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This week NASA announced that its analysis of rock dust suggests there could have been life on Mars. We’re talking microbes. They can’t come right out and spill the beans about alien life because there’s that incident in Roswell, New Mexico, back in 1947 that’s had the federal government tongue-tied ever since.

Two months ago I went to Roswell. The place means one thing to me — UFO cover-up. Start with a debris field on a New Mexico ranch, add another location with part of a craft and dead aliens, toss in the U.S. military in a nuclear arms race with Russia immediately after WW II, and generals see a technology that renders our complete arsenal obsolete. The Pentagon starts defecating bricks to the cadence of “this can’t be happening!” Suddenly, it isn’t happening, not officially. That’s the Roswell Incident in a nutshell.

I left Austin, Texas, on a sunny and cold morning, stopped for breakfast at the German Bakery in Fredericksburg, then drove all day to Roswell, crossing the railroad tracks into town as night fell. The funeral home on South Main looked like it had been there since the aliens were hauled into town. The International UFO Museum a few blocks farther on was hard to miss. A crashed flying saucer was embedded in its southeast corner. Somebody here wanted to believe.

Next morning, I ducked around the embedded UFO and entered the museum under a theater marquis proclaiming “UFO Museum.” After watching the first 10 minutes of the movie Roswell, I moved on to read newspaper reports from 1947 and affidavits from the 1990s of people who, nearing life’s end, wanted to tell what they witnessed years ago but were then too afraid to say.

The newspapers reported how troops from Roswell Army Air Field secured a debris field on a remote ranch northwest of Roswell and collected all the foreign material. At a second location they recovered an intact portion of a craft, along with three or four bodies, and hauled everything back to base. Col. William Blanchard, base commander, told his public information officer to notify the press they’d recovered a crashed “flying disc” and were sending it to higher headquarters. They loaded it all onto a military aircraft and flew it to Ft. Worth, Texas.

When General Ramey of Ft. Worth got involved, the “flying disc” morphed into a “weather balloon.” End of story. It was simply a mylar balloon for carrying instruments to detect Soviet A-bomb tests. Col. Blanchard and his men just goofed in claiming they recovered something as otherworldly as a “flying disc.”

The odd thing about all this, other than the flying saucer and dead aliens, was Col. Blanchard. We’re not talking about a Kentucky colonel whose expertise tended toward fried chicken. Col. Blanchard commanded a bomb group, the 509th, the only atomic bomb group in the U.S.

Recovery of a flying saucer wasn’t an everyday announcement in 1947. Who would run way out on that limb to seize a “Doh!” moment? I looked up Col. Blanchard on my iPad.

He arranged and supervised the atomic bomb mission on Hiroshima and was the backup pilot for that bomb drop. In 1946, he commanded the bomb group involved in the Bikini atoll atomic bomb tests. Afterwards, he went to Roswell to command and train the 509th atomic bomb group.

Then came that flying disc snafu. But Col. Blanchard’s career didn’t crash and burn. He trained the crews of USAF’s first intercontinental atomic bomb group. Eventually he rose in rank to become Vice Chief of Staff of the Air Force as a four-star general. I want to believe Col. Blanchard knew better than to publicly tell General Ramey where he could put his “weather balloon” story.

I spent most of my time with the newspaper reports and photos. There was some UFO artwork but my kids would not have found it text worthy. There was a diorama like ones in the Smithsonian showing daily life of tribal people, only this one has a flying saucer and life size aliens standing on desert terrain looking around with expressions of consternation and where-the-hell-are-we? An exhibit booth with a glass window had a life size alien on a gurney like it was wheeled out of theAlien Autopsy video for viewing and a possible ID. If the blob, Mr. Spock or the green, female exotic dancer from the pilot episode of Star Trek were there, I missed them.

In the gift shop I picked up a t-shirt and some postcards and stepped out onto Main Street. It felt like I’d walked onto a movie set from the past. We are the new Amish and don’t even know it. The America before me reflected little if nothing of the quantum leaps in science and technology our government and defense contractors must have developed from studying crashed UFOs. We have fossil fuel, earth-bound technology and get around by shifting gears when we should be shifting dimensions. At Area 51, they probably are.

I felt like I was living on the poor side of the tracks in a parallel universe where we enjoy yesteryear’s technology today. With our hybrid cars, flatscreen TVs, smartphones and GPS devices, we think we’ve hit the jackpot of hi-tech. If ET’s great-grandmother found our stuff under her Christmas tree, she’d throw it in her dumpster, stamping her feet all the way there and back.

People in the UFO community say UFO/ET disclosure is right around the corner. From Roswell, I figured that corner must be on Mars.

I was ready for Mr. Scott to beam me up and spill the beans on alien life but it just wasn’t happening. Is Martian rock dust the best NASA can do? No photos of ET retirement communities on the Red Planet? No rest areas on the Moon?

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