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The Dilemma in Funding Zika and Other Pandemic Therapies
http://aethlonmedical.investorroom.com/2016-09-09-The-Dilemma-in-Funding-Zika-and-Other-Pandemic-Therapies
SAN DIEGO, Sept. 9, 2016 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
After a seven-week vacation, the U.S. Congress and Senate returned to work on Tuesday and immediately restarted the fight to advance a Zika virus funding program. Beyond normal political posturing, government officials face the dilemma of whether to allocate resources to support the advancement of traditional drugs and vaccines or emerging broad-spectrum therapies. As it relates to viral pandemics, there is often an assumptive complacency that drug and vaccine cures are just a matter of spending sufficient capital resources. In reality, the effort to align a disease-specific drug or vaccine with an emerging pandemic threat is immensely challenging and not often successful. Especially in the case of a virulent pathogen that may prohibit human studies from being conducted to demonstrate treatment efficacy.
Emerging pandemics represent significant threats to mankind and Zika is just one of many active pathogen threats not addressed with a traditional drug and vaccine. Beyond pathogens known to be infectious to man, a proliferation of international travel, urban crowding and global warming are expected to accelerate the emergence of new pandemic threats in the future. Then, there is the issue of pathogens created and released by man as agents of bioterrorism.
Our government has an opportunity to inspire the biotechnology industry to fuel innovation through the development of broad-spectrum treatment countermeasures that can cross the boundaries of treating different strains, species and families of life-threatening viral pathogens. The facts underlying the challenge of aligning a disease-specific drug or vaccine with each pathogen threat reinforces the need for broad-spectrum therapeutic innovation.
Statistical Improbability
It is statistically improbable for traditional pathogen-specific drugs and vaccines to be developed, proven to be effective, manufactured and then delivered in a timeframe necessary to combat a life-threatening bioterror or pandemic threat. As pathogen outbreaks cannot be predicted, the current universe of therapeutic developers is extremely limited as there is no commercial incentive to develop such countermeasures from a business model perspective.
Conversely, the U.S. Food and Drug Administration (FDA) reports that hundreds and sometimes thousands of chemical drug compounds must be made and tested to find one that can achieve a desirable result without serious side effects. To further support this statement, the FDA website reports that the Pharmaceutical Research and Manufacturers of America estimates that only 5 in 5,000 compounds that enter preclinical testing make it to human testing, and only 1 of those 5 may be safe and effective enough to be approved. Beyond those statistics, expectations for traditional countermeasures should further be tempered as each pathogen threat may require multiple drug mechanisms to address the corresponding pathogen threat. In regards to Zika, there are likely no more than a handful of candidate drug compounds that have been proposed to treat the virus.
Too Many Threats
Of the more than 300 viruses known to be infectious to man, only a small fraction are addressed with a proven antiviral drug or vaccine countermeasure. It has been estimated that our government has spent more than $80 billion to defend against biological threats since 2001. Yet, just one of 13 viruses classified as "Category A" have been addressed with a treatment countermeasure. The National Institute for Allergy and Infectious Diseases (NIAID) considers "Category A" pathogens to be biological agents that pose the highest risk to national security and public health as they are easily disseminated, result in high mortality rates, and cause public panic and social disruption. Furthermore, the development of disease-specific drug and vaccine countermeasure against unknown viral threats is not possible until the pathogen has either emerged naturally or been released by man as an agent of bioterrorism.
Inability to Demonstrate Effectiveness
Perhaps the greatest challenge in advancing a disease-specific drug or vaccine is the inability to ethically or feasibly conduct controlled human studies that demonstrate treatment efficacy against a virulent threat. As a result, treatment efficacy is required to be demonstrated in animal models, which in many cases either don't exist or don't equate to treatment efficacy in humans. As a result, at-risk populations (those most likely to need protection) such as pregnant women (a primary treatment target for Zika), children, elderly adults and those with other underlying medical conditions are not recommended to receive therapeutic candidates that are not proven to be effective in humans studies.
A Shift Towards Broad-Spectrum Treatment Countermeasures
The challenge of aligning a drug and vaccine with each pathogen threat has already established an impetus for U.S. government health agencies to support innovative therapeutic mechanisms that can be deployed against a wide-range of pathogen threats. Such evidence is best reflected in the 2015 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan (SIP), which describes the priorities that the U.S. Department of Health and Human Services (HHS) will implement over the next five years to protect against bioterror and emergency pandemic threats. A primary objective of the PHEMCE SIP includes the advancement of platform technology medical countermeasures with broad-spectrum capabilities. We are working to establish the Aethlon Hemopurifier®, which is being advanced clinically in an FDA approved study, as a leading broad-spectrum treatment countermeasure.
The Hemopurifier® is an immunotherapeutic technology designed for the single-use elimination of infectious viruses from the circulatory system. The technology provides a post-exposure treatment strategy to mitigate illness, suffering, and death resulting from exposure to virulent viral pathogens that are often beyond the reach of drug and vaccine therapies. In addition to Zika virus, in vitro studies have validated the broad-spectrum capture of numerous viral threats. These include: Chikungunya, Dengue and West Nile virus, which is currently spreading in the U.S. and is responsible for numerous deaths. Vaccinia and Monkey pox, which serve as models for human Smallpox infection, have also been validated. Specific to pandemic influenza threats, we have validated the capture of H5N1 avian flu, H1N1 swine flu, and the reconstructed 1918 influenza virus, which killed as many as 50 million individuals. In regards to human studies, Hemopurifier therapy has been successfully administered to individuals infected with Ebola virus, Hepatitis C virus (HCV) and the Human Immunodeficiency virus (HIV).
Additional studies are currently being conducted to validate the capture of Middle East Respiratory Syndrome Coronavirus (MERS-CoV), which has a fatality rate of approximately 40%, and Marburg Virus, which is classified as a "Category A" bioterror and pandemic threat with a fatality rate exceeding 50%.
Zika and other emerging pandemic viruses represent a significant threat to mankind. We believe that broad-spectrum treatment countermeasures that cross the boundaries of different strains, species and families of viruses, should be the basis for life-saving innovation that will be necessary to combat emerging pandemic threats around the globe. With Congress and the Senate now back at work, the political debate of how to protect against Zika and other pandemics can now continue.
About Aethlon Medical
Aethlon Medical (Nasdaq: AEMD) is a leading developer of immunotherapeutic technologies to combat infectious disease and cancer. To augment the body's natural immune defenses, the Aethlon Hemopurifier® eliminates life-threatening disease targets that are often shielded from the immune system and not well addressed by traditional drug therapies. The technology captures circulating viruses, bacterial toxins and cancer promoting exosomes through affinity attachment to a unique structure that cloaks these targets from immune detection. At present, the Hemopurifier® is being advanced under an FDA approved clinical study. Aethlon is also the majority owner of Exosome Sciences, Inc., a company focused on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases. Aethlon is part of the Russell Microcap® Index. Additional information can be found online at www.AethlonMedical.com or you can connect with us on Twitter, LinkedIn, Facebook and Google+.
The Hemopurifier® in Cancer
Upwards of ninety percent of all cancer-related deaths are attributed to metastasis; the spread of cancer from a primary site of origin to other organs or areas of the body. The mechanism of how tumors metastasize to distant sites in the body has long been one of cancer's greatest mysteries. That mystery was recently solved when circulating particles known as tumor-derived exosomes were discovered to be the seeds that promote the spread and growth of cancer metastasis.
Aethlon initiated its tumor-derived exosome research at a time when the medical community believed exosomes were merely cellular debris with no biological function. Today, a therapeutic to address tumor-derived exosomes represents a significant unmet need in cancer care. Aethlon has demonstrated that the affinity mechanism of the Hemopurifier® can capture tumor-derived exosomes underlying several forms of cancer, including breast, ovarian and metastatic melanoma.
Beyond their role in metastasis, researchers have also published mounting evidence that tumor-derived exosomes contribute to tumorigenesis (the formation of cancer), cancer progression, angiogenesis (creation of blood vessels to fuel tumor growth), immune evasion, and resistance to radiation and chemotherapeutic drugs. Recent discoveries also reveal that exosomes may contribute to bacterial and viral pathogenesis, the progression of Alzheimer and Parkinson's diseases, the spread of prion proteins, and numerous inflammatory conditions.
The Hemopurifier® in Infectious Disease
Emerging pathogens pose a significant threat to mankind. Of the hundreds of viral pathogens known to be infectious to man, only a few are addressed with proven antiviral drug or vaccine therapies. Beyond the looming threat of bioterrorism, a proliferation of international travel, urban crowding and global warming is expected to accelerate the emergence of future pandemics. In response, the U.S. Department of Health and Human Services (HHS) has established an initiative to support platform technology medical countermeasures with broad-spectrum capabilities. Based on preclinical studies and human treatment experiences, the Aethlon Hemopurifier® defines this initiative.
To date, Hemopurifier therapy has been administered to individuals infected with Ebola virus, Hepatitis C virus (HCV) and the Human Immunodeficiency virus (HIV). In the case of Ebola, a remarkable response to a single administration of Hemopurifier therapy (comatose physician with multiple organ failure at the time), led to Time Magazine naming the Hemopurifier to be one of the "Top 25 Inventions" as well as one of the "Eleven Most Remarkable Advances in Healthcare."
Beyond human treatment experiences, pre-clinical Hemopurifier studies have validated the broad-spectrum capture of numerous viral threats. These include: Chikungunya, Dengue and West Nile virus, as well as Vaccinia and Monkey pox, which serve as models for human Smallpox infection. Specific to pandemic influenza threats, Aethlon has validated the capture of H5N1 avian flu, H1N1 swine flu, and the reconstructed 1918 influenza virus, which represents a model for the strain of influenza that killed an estimated 50 million victims in 1918 and 1919. In vitro studies of other viral threats are ongoing.
Aethlon has also demonstrated that the Hemopurifier captures the bacteria toxins lipopolysaccharide (LPS) and lipoteichoic acid (LTA). These studies were conducted under a contract with the Defense Advanced Research Projects Agency (DARPA) related to the treatment of sepsis.
About Exosome Sciences
Exosome Sciences, Inc., in collaboration with majority shareholder Aethlon Medical (Nasdaq: AEMD), is focused on the discovery of exosomal biomarker candidates to diagnose and monitor life-threatening diseases. The proprietary Enzyme-Linked Lectin-Specific Assay (ELLSA™) serves as a platform to isolate exosomal biomarkers from a wide-range of bodily fluids. In preliminary studies, ELLSA™ demonstrated the ability to isolate exosomes from urine, which resulted in high-sensitivity detection of HIV-infection. Specific to neurological disorders, Exosome Sciences discovered TauSome™, an exosomal biomarker that may be the first non-invasive candidate to detect Chronic Traumatic Encephalopathy (CTE) in living individuals. In a study of former National Football League (NFL) players, TauSome levels were found to be significantly higher as compared to athlete control subjects who participated in non-contact sports. TauSome levels also correlated with cognitive decline based standardized tests of memory and psychomotor speed. Visit www.exosomesciences.com for additional details.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. Factors that may contribute to such differences include, without limitation, the Company's ability to maintain its listing on the Nasdaq Capital Market, or any other national securities exchange, that the Company or its subsidiary will not be able to commercialize its products, that the FDA will not approve the initiation or continuation of the Company's clinical programs or provide market clearance of the Company's products, including any products relating to the Zika virus, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies, the impact of government regulations, patent protection on the Company's proprietary technology, the ability of the Company to meet the milestones contemplated in its contract with DARPA, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2016, and in the Company's other filings with the Securities and Exchange Commission. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.
Contacts:
Mike Smargiassi/Brad Edwards
Brainerd Communicators, Inc
212-986-6667
smarg@braincomm.com
SOURCE Aethlon Medical, Inc
http://www.wsj.com/articles/mosquitoes-are-deadly-so-why-not-kill-them-all-1472827158
"By BETSY MCKAY
Updated Sept. 2, 2016 1:37 p.m. ET
456 COMMENTS
The death toll from diseases carried by mosquitoes is so huge that scientists are working on a radical idea. Why not eradicate them?
Mosquitoes kill more humans than any other animal and were linked to roughly 500,000 deaths in 2015, mostly from malaria. For more than a century, humans have used bed nets, screens and insecticides as weapons, but mosquitoes keep coming back. They are now carrying viruses like Zika and dengue to new parts of the world.
Powerful new gene-editing technologies could allow scientists to program mosquito populations to gradually shrink and die off. Some efforts have gained enough momentum that the possibility of mosquito-species eradication seems tantalizingly real.
“I think it is our moral duty to eliminate this mosquito,” entomologist Zach Adelman says about Aedes aegypti, a species carried afar over centuries by ships from sub-Saharan Africa. It derived from a forest dweller and adapted to thrive among humans, to whom the mosquito spreads at least four viruses that cause major diseases.
Prof. Adelman, a virologist and associate professor of entomology at Texas A&M University, is working to program Aedes aegypti mosquitoes to develop as males.
Eventually, the mosquitoes would run out of mates, crashing the species’ population in places it invaded and “cleaning up a global mess,” he says. Female mosquitoes are the only ones that bite people and transmit viruses.
A technician separates genetically modified mosquito larvae used to fight the spread of disease. Other efforts include breeding bacteria-infected mosquitoes at a laboratory in Guangzhou, China. Mosquitoes are fed from a bag of blood.PHOTOS: PAULO FRIDMAN/BLOOMBERG NEWS; BOBBY YIP/REUTERS; ANDRE PENNER/ASSOCIATED PRESS
Purposely engineering a species into extinction—or just diminishing it—is fraught with quandaries. Scientists must weigh the potential impact of removing a species on the environment and food chain. It will take years of more research, testing and regulatory scrutiny before most genetically altered mosquitoes can be released into the wild. And the strategy might not work.
Wiping a species off the face of the earth is “an unfortunate thing to have to do,” says Gregory Kaebnick, a research scholar at the Hastings Center, a bioethics research institute in Garrison, N.Y.
He says humans shouldn’t force a species into extinction to meet their own preferences. “We ought to try not to do it,” says Mr. Kaebnick. One justification, he says, would be to avert a serious public-health threat.
Related Video
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Mosquitoes have an ugly track record of spreading everything from the Zika virus to dengue fever to malaria. Could they be killed off? Here’s a short look at a controversial question.
Out of more than 3,600 mosquito species, only a few dozen transmit viruses and parasites that can sicken or kill humans. Even the killer mosquitoes pollinate plants and are food sources for other animals, though usually not the only staple, entomologists say.
For decades, agricultural officials have used a “sterile insect technique” to eliminate pests that are dangerous to crops or humans. Insects are sterilized with radiation and then released into the wild.
Insects that mate with the sterilized ones produce no offspring, and the populations die off within a few generations. The technique was used to rid the U.S. and a few other countries of the New World screwworm fly, and it is now being used to battle fruit flies.
Imperial College London researchers are refining a system under development for the past several years to drive a self-destructive genetic trait into the Anopheles gambiae mosquito, the major carrier of malaria in sub-Saharan Africa. The trait could eventually shrink the malaria carrier’s population. Malaria kills an estimated 438,000 people a year.
Aedes aegypti is high on the hit list of more scientists now that Zika has spread from Brazil to Miami, spawning an epidemic that has left hundreds of babies with devastating birth defects.
The same type of mosquito caused dengue to proliferate through tropical regions world-wide during the last quarter of the 20th century. The dengue virus infects an estimated 390 million people a year, killing thousands of them.
Aedes aegypti also is a carrier of chikungunya, a crippling disease that causes lasting joint pain, and yellow fever. In Africa, officials are struggling to contain a large outbreak of yellow fever, which can lead to fatal liver disease.
“Aedes aegypti is literally probably the most dangerous animal in the world,” says Omar Akbari, a molecular biologist and assistant professor of entomology at the University of California, Riverside. His conclusion is based on the number of infections to which the mosquito is linked.
Many entomologists say eradicating Aedes aegypti would have a minimal impact on the environment. Such mosquitoes thrive around humans, breeding in water that collects in tires, pipes and plastic containers. Humans are their only source of food.
Zika-carrying mosquitoes aren’t very appealing to other animals as a food source, entomologists say. “They’re so tiny a bat would have to eat thousands of them to equal a couple of moths,” says Michael Doyle, an entomologist and former executive director of the Florida Keys Mosquito Control District, which battled a dengue outbreak several years ago.
Weapons used against the spreading Zika virus include sprays to kill adult mosquitoes in Duarte, Calif., street-cleaning machines in Miami Beach, Fla., and fumigating a Singapore residence.PHOTOS: PATRICK T. FALLON FOR THE WALL STREET JOURNAL; CRISTOBAL HERRERA/EUROPEAN PRESSPHOTO AGENCY; WONG MAYE-E/ASSOCIATED PRESS
Genetic-engineering technologies used by mosquito-fighting scientists include a new tool known as Crispr/Cas9.
With Crispr/Cas9, scientists can use an enzyme to snip DNA and insert changes, then build something called a “gene drive” that makes those changes more likely to be inherited by future generations, altering them. Normally, genes have only a 50% chance of being inherited.
Prof. Adelman and Virginia Tech biochemistry professor Zhijian Tu see a way to do this with genes involved in mosquito reproduction. In a paper published in Science last year, the researchers identified a gene that makes Aedes aegypti mosquitoes male.
“This was the master switch that controls sex,” says Prof. Tu. He and Prof. Adelman were co-authors of the research.
The researchers now are working on a system to program mosquitoes to develop as males. Since only females bite, that change could reduce the ability to spread disease. The researchers aim to then use Crispr/Cas9 to build a gene drive that would spread the change through successive generations.
“If you’re successful, then you end up with all males, and the local population crashes,” says Prof. Tu. Prof. Adelman cautions that a system to target Aedes aegypti would have to be designed to leave the African forest-dwelling mosquito Aedes aegypti formosus intact. That type of mosquito doesn’t threaten human, he says.
Prof. Akbari at UC Riverside is using Crispr/Cas9 to design a gene-drive system that would inactivate a fertility gene in female Aedes aegypti mosquitoes and then pass on the inactivated gene. That would sterilize future generations of females.
He hopes to test the system within the next several months. “We’re working as fast as we can,” Prof. Akbari says.
Using different technology, Oxitec Ltd. has developed what it calls a “self-limiting” Aedes aegypti mosquito, a male genetically modified to produce offspring that don’t survive or reproduce.
In August, the Food and Drug Administration allowed Oxitec to go ahead with a field trial in Key Haven, Fla. Oxitec is a unit of biotechnology firm Intrexon Corp., based in Germantown, Md.
Oxitec’s technology isn’t as powerful as those using gene drive, because the trait isn’t pushed through multiple generations of mosquitoes. As a result, Oxitec’s genetically modified mosquitoes need to be released regularly.
The company says its tests in Brazil, Panama and the Cayman Islands, where the engineered insects are released in a small area, have cut the Aedes aegypti population in those areas by more than 90%.
ENLARGE
In one field trial in a district of Piricicaba, Brazil, cases of dengue fever fell 91% from the same period a year earlier, Oxitec says.
“We focused on Aedes because we saw it as a great unmet need,” says Haydn Perry, Oxitec’s chief executive. “If you look at the statistics, the rise in dengue has been absolutely shocking since the 1970s.”
In June, a committee of the National Academies of Sciences, Engineering and Medicine said in a report that organisms modified by gene drive aren’t ready to be released into the wild.
More research is needed on how the modified organisms work and might affect the environment, the report said, concluding that their proposed uses “are based on limited proof-of-concept studies.”
“We need to think through what responsible conduct looks like when you have these tools in your hand,” says James Collins, a professor of natural history and the environment at Arizona State University who is one of the committee’s leaders.
Field trials and releases of genetically modified mosquitoes require regulatory approval and can take years.
In the Florida Keys, Oxitec’s “self-limiting” mosquitoes face opposition from residents who worry that the insects could harm local ecosystems.
The field trial that got a go-ahead from the FDA will face a nonbinding referendum from voters in Key Haven on Nov. 8. After that, the field trial must be approved by the Florida Keys Mosquito Control District, spokeswoman Beth Ranson says.
Winning consent from the many countries infested with Aedes aegypti for eradication through the use of gene drive will be difficult. That could limit the impact of the mosquito-fighting technique.
“How on earth are we going to manage informed consent and diplomatic agreement?” says Kevin Esvelt, an evolutionary engineer at the Massachusetts Institute of Technology. In 2014, he outlined how using Crispr/Cas9 gene drives could spread genetic traits through wild populations.
Some scientists and foundations say total eradication isn’t necessary. One alternative strategy is to suppress the population of virus-carrying mosquitoes low enough that there are too few left to transmit pathogens from one person to another. That approach could be combined with traditional mosquito-control strategies such as spraying and bed nets.
“We’re not targeting to eliminate mosquitoes. We’re really targeting to eliminate the human diseases,” says Scott Miller, deputy director of the malaria team at the Bill & Melinda Gates Foundation.
The foundation started by Bill Gates and his wife, Melinda, is investing in a genetic project aimed at cutting the population of malaria-carrying mosquitoes. During World War II, U.S. forces at Guadalcanal worked on mosquito control.PHOTOS: DAVE THOMPSON/AFP/GETTY IMAGES; ASSOCIATED PRESS
In December, researchers at Imperial College reported in the journal Nature Biotechnology that they engineered genetic changes that could make Anopheles gambiae populations plummet. That is the most common carrier of the deadliest form of malaria in sub-Saharan Africa, where the vast majority of cases and deaths occur.
The researchers used Crispr/Cas9 to disrupt genes involved in producing eggs in females, then built a gene drive that passed that trait along to as many as 99.6% of their offspring. As the trait spreads, more females become sterilized, gradually reducing the population, the researchers said.
Imperial College evolutionary geneticist Austin Burt says he and his colleagues are now refining their work.
The Gates Foundation is investing $75 million in the Target Malaria project, partly to help prepare laboratories in Mali, Burkina Faso and Uganda, lay the groundwork to seek regulatory approvals and train staff to conduct field trials. Dr. Miller says release of the engineered mosquitoes into the wild is about a decade away.
Researchers in Australia have developed a way to inject mosquito eggs with a common, naturally occurring bacteria. The eggs need to be injected just once and then pass down the bacteria.
The method is likely to be ready for use far sooner than gene-drive strategies, says Scott O’Neill, director of vector-borne diseases at Australia’s Monash University and head of the mosquito-injection program, called Eliminate Dengue. Large-scale trials are planned in Brazil and Colombia. Financial backers include the Gates Foundation.
Despite the early progress in using gene-editing to conquer the world’s deadliest mosquitoes, many scientists are chastened by history.
A truck sprays the pesticide DDT on Jones Beach, N.Y., in 1945. The push to go after Aedes aegypti mosquitoes with DDT was largely abandoned by the 1970s.
A truck sprays the pesticide DDT on Jones Beach, N.Y., in 1945. The push to go after Aedes aegypti mosquitoes with DDT was largely abandoned by the 1970s. PHOTO: GAMMA-KEYSTONE/GETTY IMAGES
In the 1940s, public-health leaders declared war on Aedes aegypti, going after the insects with aggressive spraying campaigns that included DDT, or dichloro-diphenyl-trichloroethane. By the 1970s, the push was largely abandoned. It succumbed to high costs, feared health risks from DDT, a lack of strong U.S. support and the insect’s resurgence in some areas.
Right now, says Texas A&M’s Prof. Adelman, gene drive seems like “an all-powerful tool that will win the war for us, but that is exactly the sentiment that people felt when things like DDT first came along.…It’s good to be optimistic. But we need to be realistic as well.”
Write to Betsy McKay at betsy.mckay@wsj.com
CHICAGO/TAMPA, Fla., Aug 26 (Reuters) - The U.S. Food and Drug Administration recommended on Friday that all blood donated in the United States and its territories be tested for Zika virus, as it moves to prevent transmission of the virus through the blood supply.
The agency said its decision to expand blood screening in the United States was based on concerns about more cases of local transmission in Florida, the growing number of travel-related infections and concerns that Zika-tainted blood could unwittingly be given to a pregnant woman, putting her unborn baby at risk of severe birth defects.
"The transfusion of a pregnant woman with blood infected with the Zika virus could have terrible consequences," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said during a conference call with reporters.
With Congress Deadlocked, White House Diverts Funds to Fight Zika
http://www.nytimes.com/2016/08/12/us/politics/with-congress-deadlocked-white-house-diverts-funds-to-fight-zika.html?_r=0
Four people in Miami likely contracted Zika locally through mosquito bites, Florida's governor said on Friday, the first evidence that the virus tied to a rare but serious birth defect is circulating in the continental United States.
Governor Rick Scott said the state believed active transmission of the virus was occurring within an area of Miami about the size of a square mile (2.6 square kms). Testing showed that one woman and three men had been infected, Scott said.
While health officials have yet to identify mosquitoes carrying the virus, the state has ruled out other means of transmission, including travel to another country with a Zika outbreak, and sexual contact.
source: Reuters
Strange New Case Might Change What We Know About Zika
link to the story:
http://news.nationalgeographic.com/2016/07/mysterious-new-zika-transmission-utah/
Florida health officials are investigating a possible second case of the Zika virus that may have been locally transmitted. The announcement of the case, in Broward County, comes two days after the state said it was investigating a possible homegrown case in Miami-Dade County.
Florida health officials said Tuesday they were investigating a possible case of Zika that wasn't carried back by a traveler.
If it's confirmed, it would be the first evidence that Zika has spread to mosquitoes in the continental U.S. All cases up to now have been in people who traveled to Zika-affected regions or their sexual partners.
A dysfunctional Senate split along party lines has blocked a $1.1B proposal to fight the Zika virus, leaving just two weeks to reach a deal before lawmakers leave for a summer recess in the midst of mosquito season.
Democrats accused Republicans of sabotaging the legislation with provisions designed to deny new funding for Planned Parenthood clinics in Puerto Rico and ease rules on pesticide spraying.
Senate approves $1.1 billion compromise bill to combat Zika
http://www.cnn.com/2016/05/17/politics/zika-virus-congress-bill/index.html
Everything you should know about Zika Virus and wish you didn't need to.
http://www.huffingtonpost.com/news/zika/
Best to all and be careful out there... Enjoy dp
GOVX Research Collaboration Agreement w/Centers for Disease Control and Prevention
The Research Collaboration Agreement between GeoVax and the CDC should further broaden and accelerate the company's Zika vaccine development through access to Zika virus antibodies available at the CDC and testing of vaccine candidates by the CDC in appropriate animal models.
http://www.marketwired.com/press-release/geovax-extends-research-collaborations-on-zika-vaccine-otcqb-govx-2110183.htm
Zika May Cause Brain Anomalies
Highlighted section for Aethlon Medical mention. The Aethlon hemopurifier has already been used successfully on ebola patient Dr. Mowanda who besides having ebola also had multiple organ failure and was treated at Frankfurt University Hospital. The good Doctor has fully recovered and is reported to be back in Africa continuing on his work with ebola patients. The hemopurifier has been approved by the FDA for emergency and compassionate use during the current testing phase at select ebola centers in the US.
Check out the The Aethlon Hemopurifier® at link below. Zita link follows:
http://www.aethlonmedical.com/products/hemopurifier.htm
Enjoy dp
http://www.businessfinancenews.com/28147-buckle-up-sanofi-inovio-merck-zika-may-cause-brain-anomalies/
Buckle Up Sanofi, Inovio, Merck; Zika May Cause Brain Anomalies
Published by Raheel Farooq on March 9, 2016 at 1:32 pm EST
The virus is becoming epidemic slowly and evolving more leading to complicated neurological diseases
Zika virus has now been declared as an Epidemic. It has become a leading cause to multiple chronic diseases for which a cure has not yet been developed. Sanofi SA (ADR) (NYSE:SNY), Merck & Co, Inc. (NYSE:MRK), Inovio Pharmaceuticals Inc. (NASDAQ:INO), and others are under a threat now as the world is in desperate need of a cure. The aforementioned companies are very diligently working on the research and development of its vaccine that can stop the invasion of the Zika virus.
The virus’ infection list is expanding geographically from Latin America to the US, Asia, Africa, and Europe. Studies proved that the virus could be a main causative agent of Guillain–Barré syndrome (GBS) as well as brain anomalies in the newborns. The virus is also causing severe neurological ailments in adults such as paralyzing disorder.
ACUTE MY ELITIS
In the latest updates, the researchers working on the virus agreed on the conclusion that the virus can cause an inflammation of the spinal cord termed as “acute myelitis.” A French study was published in the Lancet Medical Journal, discussing a case of a 15-year-old girl who was diagnosed with myelitis in January 2016.
The case was reported at Pointe-a-Pitre Hospital in Guadeloupe. The girl was affected by partial paralysis. The diagnostic tests confirmed Zika virus in the spinal fluid as well as in blood and urine.
Another case was published in relation to the French study in February 2016 providing evidence that the virus can causeGBS, a rare condition, which directly affects the human body’s immune system and specifically the portion of the nervous system controlling the muscle movement and strength. GBS is a combination of symptoms that can affect musculoskeletal system.
Myelitis is a condition affecting the limb movement resulting in muscle weakness leading to paralysis. In the chronic stages, it can be fatal as the whole body suffers from severe muscle stretching as well as spams resulting in dyspnea and might lead to the need of intubation.
HISTORY
The virus was basically a mosquito-borne flavivirus causing symptoms similar to the flu, first reported in Brazil. The World Health Organization (WHO) has already declared it a “global public health emergency.”
The estimates given by the WHO were alarming as per the regulatory agency it can affect more than four million people. First it was thought to be limited only in Latin America, but now it is spreading slowly. Cases are reported on a daily basis in the US as well as Asia and Africa. Along with a mosquito bite, the virus can also spread by sexual contact with the infected person.
In late February, France confirmed its first European case of Zika being transmitted through sexual contact. Two similar cases were confirmed by the US Centers for Disease Control and Prevention (CDC).
ZIKA MANAGEMENT APPROACHES
STEM CELL REVOLUTION
Stem cell transplantation has already opened new doors for the treatment of chronic and life-threatening diseases. A very productive study was published on March 4, 2016, in the Journal of Stem Cell, which proved that Zika virus is causing microcephaly.
The researchers used the lab-grown human stem cells to assess the infected site. The results showed that the neural progenitor cells were directly affected by the virus, killing them within three days’ time. The role of these cells is very vital in the development of the cortex.
According to the research team, the study’s findings are consistent with the hypothesis that Zika is responsible for causing microcephaly.
PHARMACEUTICALS
Approximately 15 drug makers were in touch with the WHO regarding the development of vaccines. Another 20 were involved in the manufacturing of the diagnostic tools for testing.
Till date, the vaccines used globally are either killed-virus or live-attenuated virus vaccines. The development of a single vaccine takes more than a decade to be used in humans without compromising any safety and efficacy profiles.
On the other hand, DNA-based vaccines take less time to develop and have fewer side effects. Food and Drug Administration (FDA) does not approve any DNA-based vaccine till today.
Sanofi has already started the vaccine’s research and development program. The drug maker has a vast experience in relation to the mosquito-borne disease and has developed vaccines for the treatment of yellow fever and dengue. The company has launched its dengue virus vaccine by the name of Dengvaxia. According to the drug maker, Zika virus vaccine will need approximately three years to be marketed.
DIAGNOSTICS
Besides the vaccine development, the diagnostic kit is of utmost importance as the virus remains asymptomatic. Multiple companies are working on the development of the diagnostic kit such as Germany’s Genekam Biotechnology, who claims that they have already developed a kit and is applying to the European and US authorities for approval.
The Scripps Research Institute is using a robotic technique for the clinical tests by injecting fluorescent luciferase into modified Zika cells. This substance will help to show either the drug or vaccine is capable of destroying the virus.
DIALYSIS APPROACH
There is a concept of washing away the virus from the body, similar to dialysis process. Premier Biomedical Inc. is working on using sequential dialysis for the purpose, but the technique has been tested only in mice so far.
Aethlon Medical Inc. is also working on the same format of filtering out the pathogens from the body. The drug maker is planning to test the technique and solution in the patients suffering from dengue in Delhi, India.
GENETIC
Inovio is way ahead in the development of the Zika virus vaccine. The company is working on the DNA sequence for its eradication from the human body. At present, the vaccine is ready to be tested in primates. Depending upon the results, the decision will be taken to go ahead for the trial on humans, which is expected at the end of this year.
WHO is funding trials of genetically-modified mosquitoes. These mosquitoes will play a vital role inhibiting its reproduction. The modification is done in a way that the mosquitoes will die before they reach the age of reproduction. Intrexon has conducted trials of this modification.
GLOBAL PARTICIPATION
Google has taken a step ahead by donating $1 million along with a team of helping associates to UNICEF. The grant will be used in eradicating the mosquito population as well as in the development of the vaccines.
The tech giant is playing its role in creating awareness about the virus and its risks to the public via different media sources.
World Bank (WB) has also announced $150 million for the worst hit countries in the Caribbean and Latin America. This financial aid will help in the monitoring and controlling infection vectors, identifying risk groups, monitoring follow-up care, and promoting activities to overcome the virus.
Does anybody know what company this is? Greg
The Next Pandemic Is Here... Here's What You Should Know
The Stansberry Digest <customerservice@exct.stansberryresearch.com>
To greg17jvs@yahoo.com
Today at 5:03 PM
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March 2, 2016
The next 'pandemic' is here… 'Three to four million could be infected'… What you should know about Zika… A vaccine could already be here… The latest from P.J. O'Rourke…
As if we didn't have enough to worry about…
The U.S. stock market appears to be starting a bear market… Credit markets are as stressed as they've been since the last financial crisis… Central banks are as clueless as ever… And it looks like American voters will have the pleasure of "choosing" between Donald Trump and Hillary Clinton this fall (be sure to see the latest essay from contributing editor P.J. O'Rourke below).
Now, you can add another big concern to the list…
The Centers for Disease Control and Prevention ("CDC") reports Zika – a frightening virus spread by mosquitoes – has officially reached "pandemic" levels in South America. As a result, it has already moved its emergency operations center to its highest activation status – Level 1 – for only the fourth time in history.
The World Health Organization is also concerned… It says Zika is "spreading explosively," and could infect as many as 4 million people in the Americas this year alone.
This is because it's spread by a particular species of tropical mosquito – Aedes aegypti. Unlike most mosquitoes, which bite mostly at night, mosquitoes of this species are known as "aggressive" daytime biters. This means they're most active when most people are, too.
While mosquitoes are the primary route of transmission to date, the CDC recently confirmed that the virus can also be sexually transmitted.
According to the CDC, about one in five people who become infected with the virus becomes ill. The illness typically lasts from several days to a week, and the most common symptoms of Zika are fever, rash, joint pain, conjunctivitis (eye inflammation), muscle pain, and headache.
But there is growing evidence linking Zika to a serious birth defect in babies of mothers who have been infected while pregnant. Microcephaly, as it's known, is a condition in which the baby's head (and often brain) is far smaller than normal, often leading to developmental problems.
But that's not all…
A new study, published Monday in prestigious British medical journal The Lancet, suggests Zika could also be linked to Guillain-Barré syndrome ("GBS") in adults. GBS is a rare condition that causes the body's immune system to attack peripheral nerves by mistake, leading to muscle weakness, breathing problems, and, in severe cases, paralysis or death.
The study analyzed patient blood samples from the last outbreak of Zika – in French Polynesia during 2013 and 2014 – and found evidence the virus could cause GBS. As lead author, Arnaud Fontanet of the Institut Pasteur in France, explained…
This is the first study to look at a large number of patients who developed Guillain-Barré syndrome following Zika virus infection and provide evidence that Zika virus can cause GBS. Most of the patients with GBS reported they had experienced symptoms of Zika virus infection on average six days before any neurological symptoms, and all carried Zika virus antibodies.
If the current outbreak behaves like the last, the study's authors predict as many as one in 4,000 people infected with Zika could ultimately develop GBS.
While the outbreak is most severe in South American countries like Brazil, where more than 1.5 million cases have been reported, the virus has already spread throughout most of Central America and Mexico.
It's also spreading quickly in U.S. territories like the U.S. Virgin Islands, American Samoa, and Puerto Rico. In fact, a report in yesterday's Washington Post said there are now 117 confirmed cases in Puerto Rico. That's four times more than in January, and officials predict at least one in five Puerto Ricans will become infected. The territory has already declared a state of emergency due to the outbreak.
To date, the CDC reports there are 107 confirmed cases of Zika in the U.S. But importantly, none of these were "locally acquired, vector-borne" cases.
That means none of these individuals was infected by a mosquito in the U.S. Instead, most were infected while traveling to another country. And several others were infected through sexual contact with someone else who had been infected while traveling.
In other words, if you haven't traveled to these countries, and haven't had contact with anyone who has, your risk of infection today is extremely small.
But that could soon change…
Officials say it's unlikely we'll see true pandemic levels of Zika here in the U.S. for a number of reasons. For example, more folks live and work in sealed, air-conditioned homes and offices in the U.S. than in poorer South and Central American countries. Access to health education and services is also higher.
But that doesn't mean Zika won't be a problem here, too…
According to official data, Aedes aegypti is already present in many southern states, including Florida, Georgia, South Carolina, Alabama, Arkansas, Louisiana, Texas, Arizona, and parts of Tennessee, New Mexico, and California. It's likely only a matter of time before Zika arrives in one or more of these states.
In addition, some researchers believe this mosquito species' range may be even greater than believed. These mosquitoes are able to breed in very small pools of water – even as small as an overturned bottle cap – making them hard to track. And a recent study in the American Journal of Tropical Medicine and Hygiene showed these warm-climate mosquitoes are surviving and breeding in small pockets as far north as Washington, D.C. As the study's authors told news network CNN today…
If [we] had just told people that these mosquitoes had overwintered in Washington, D.C., they wouldn't believe [us]. Those mosquitoes shouldn't have been there.
It's really weird that [they're] here, so who knows where else [they are]?
Today, there is no treatment for Zika… The only way to prevent infection is to avoid getting bitten by an infected mosquito, and avoid those who have been. That's obviously much easier said than done.
Fortunately, we may be close to a solution. And our colleague Dave Lashmet – editor of the excellent Stansberry Venture advisory – has been all over this development from the beginning.
Last summer – before Zika was making headline news – Dave identified one tiny drugmaker that was developing an incredible new vaccine technology.
In simple terms, it was working on something like an "antibiotic" for the virus world… a technology that could potentially be used against a number of different viruses, rather than just one. As Dave explained in the August issue of Stansberry Venture…
This is a world-changing possibility for medicine that has never before existed… a potential antidote to viral infections.
Most viral infections are untreatable: When a virus attacks your body, your immune system is on its own to fight off the bug. If it succeeds, you recover. Otherwise, it can fight the virus to a stalemate – leaving you with a chronic condition – or it fails, and the virus eventually kills you. Regardless, no pill will help make the virus go away.
We've made great progress lately with hepatitis C. And acquired immune deficiency syndrome (AIDS) is now controllable if you can tolerate seven different classes of drugs. But broadly speaking, we have never had an equivalent to antibiotics or antifungals when it comes to viruses. Until now…
This tiny company has been quietly working for months on a preventative vaccine for Zika. And it now has one.
This vaccine has already been shown to work in mice, and is in larger animal testing now.
Because there is currently no treatment for Zika, animal testing and a small human safety trial should be enough to gain U.S. Food and Drug Administration approval. Dave says "provisional" approval could be granted in less than a year.
But Stansberry Venture subscribers likely won't have to wait even that long to profit…
If the vaccine works as expected, Dave believes a big vaccine maker like Merck (MRK), GlaxoSmithKline (GSK), or Pfizer (PFE) is virtually guaranteed to buy this tiny company at a huge premium. Today's investors could quickly double their money or more.
That may sound unbelievable, but if you know anything about Dave's track record, it won't surprise you.
Last year alone, Dave recommended four separate companies just days or weeks before they soared 100% or more.
And that was out of just 11 total recommendations in 2015. That's right… 36% of Dave's Stansberry Venture recommendations doubled last year.
And Dave believes this tiny vaccine maker could be the next.
Incredibly, despite the recent positive news on the company's Zika vaccine, shares are still trading below Dave's maximum buy price. But that may not be the case much longer.
$FHCO The Female Health Company Featured in Documentary Television Series "Big Questions"
The Female Health Company (NASDAQ:FHCO) (FHC or the Company) today announced that it will be featured in an upcoming episode of "Big Questions," an Emmy® Award winning documentary television series that explores new ideas and projects that are changing the way the world works. The episode “Empowering Kenya” focuses on the critical roles the Company and its FC2 Female Condoms play in preventing the spread of HIV/AIDS, the leading cause of death globally for women ages 15 to 44, and other sexually transmitted infections. “Empowering Kenya” will be featured on WTTW/PBS in Chicago at 10:30 PM CT on February 19, 2016, check your local listings for dates and times in your area. The episode will also be available to view online after the broadcast.
For more than 20 years, FHC has been dedicated to improving the health and well-being of women around the world. FC2 helps protect against unintended pregnancies, an ongoing major health and economic issue worldwide, with adolescents accounting for a disproportionate percentage of the overall burden of disease (disability - adjusted life years) associated with pregnancy and childbirth. And, more recently, we are working closely and actively engaging with leading health organizations throughout the world, especially North America and South America, regarding the Zika virus. Our goal is to provide information and options to effectively protect women from sexually transmitted infections.
http://ih.advfn.com/p.php?pid=nmona&article=70445708
$FHCO on fire since listed here!
GOVX GeoVax is way ahead of any Zika vaccine maker and we are also working on cancer and HIV vacccines. Bloomberg News 2/15/2016~
"Bharat of Hyderabad, India started working on the virus a year ago, Chief Executive Officer Krishna Ella said in an interview. Many others embarking on Zika product-development are starting from scratch, according to Farshad Guirakhoo, senior vice president of research and development at GeoVax of Smyrna, Georgia, which is working on a vaccine in collaboration with the University of Georgia."
http://www.bloomberg.com/news/articles/2016-02-15/zika-fears-spur-pharmaceutical-gold-rush-amid-vaccine-vacuum
Upsurge in paralysis condition accompanies Zika virus
From yesterday. See link below for video.
http://news.yahoo.com/doctors-upsurge-paralysis-condition-accompanies-050831706.html
Doctors: Upsurge in paralysis condition accompanies Zika
Associated Press By FRANK BAJAK and LIBARDO CARDONA
CUCUTA, Colombia (AP) — The doctor taps Zulay Balza’s knees with a hammer and she doesn’t feel a thing. She can’t squeeze his outstretched fingers or shut her eyelids. Her face is partially paralyzed.
“The weakness started in my legs and climbed upward. The face was last. After three days, I couldn’t walk,” said Balza, 49. “My legs felt like rags.”
Balza is a patient at the public University Hospital in Cucuta, at the epicenter of the Colombian outbreak of the mosquito-borne Zika virus. Only Brazil has more cases.
Two weeks ago, she came under assault by Guillain-Barre (gee-YOHN-bah-RAY), a rare and sometimes fatal affliction that is the Western world’s most common cause of general paralysis.
Alarm over the Zika epidemic spreading across the Americas has been chiefly over birth defects, but frontline physicians believe a surge in Guillain-Barre cases may also be related.
The World Health Organization says Guillain-Barre cases are on the rise in Brazil, Colombia, El Salvador, Suriname and Venezuela, all hit hard by Zika, though a link remains unproven.
The auto-immune disorder historically strikes only one or two people in 100,000. About one in 20 of those cases ends in death in the developed world, and it is frightful.
“I thought my body was going to explode,” said Balza, sitting on her hospital bed and apparently over the worst.
Guillain-Barre attacks skeletal muscular nerves as if they were a foreign enemy. Fine motor skills rapidly erode, arms and legs tingle and weaken to numbness. Patients lose their balance, their speech. In rare cases, they require ventilators to stay alive.
The syndrome typically strikes after a bacterial or viral infection, such as influenza, HIV or dengue, though its cause can’t always be determined.
Dr. Jairo Lizarazo, the neurologist treating Balza, has seen cases increase more than tenfold since December — 30 cases in all — in this muggy city bordering Venezuela. Like Balza, many patients never showed the characteristic symptoms of Zika — fever, rashes, joint pain and conjunctivitis. Four in five don’t.
He’s convinced the virus boosts susceptibility to Guillain-Barre.
“It’s an epidemiological association,” said Lizarazo. “We don’t know exactly how it works. But it’s there, for sure.”
Associated cases confirmed or suspected based on clinical evidence number in the hundreds. Guillain-Barre cases believed to be linked to the virus have killed three people in recent weeks in Colombia and health officials have attributed another three Guillian-Barre deaths in Venezuela to suspected Zika infections.
WHO said Zika has been confirmed present in apparently just one Guillain-Barre death, in the northwestern Venezuela state of Zulia in January.
Dr. Maria Lucia Brito Ferreira, chief neurologist at Hospital da Restauracao in Recife, Brazil, said she hopes to get laboratory confirmation this month that nine Guillain-Barre deaths recorded there in the past year were Zika-related.
Cases of Guillain-Barre in Colombia — about 450 annually before Zika struck — were up nearly threefold in the past month and a half.
El Salvador has reported 118 cases since November, nearly as many as previously seen in a year. “The only explanation is the Zika virus,” said Deputy Health Minister Eduardo Espinoza.
Dr. Osvaldo Nascimento, a leading Rio neurologist, estimates Brazilian cases of Guillain-Barre are up fivefold. Reporting is not compulsory, so the government’s partial figure of 1,868 cases requiring hospitalization last year is a sketchy parameter.
An upsurge in Guillain-Barre was documented in 2013 during a major Zika outbreak in French Polynesia, with a study finding cases up twentyfold. WHO said all 42 cases recorded in the Pacific archipelago tested positive for Zika as well as dengue fever, which is also currently present in Colombia, Venezuela, Brazil and other Zika-affected countries.
Antibodies for the dengue and chikungunya viruses, which are far more debilitating than Zika, are often being found in infected patients. That is making establishing a direct Zika-Guillain-Barre link more complicated.
Like Zika, both viruses are transmitted by the Aedes aegypti mosquito and could also trigger Guillian-Barre, experts say.
Under normal circumstances, eight in 10 patients nearly fully recover from Guillian-Barre, though it sometimes takes months.
Data on Guillain-Barre is scant in most of the developing world. Of 18 countries participating in a clinical study launched by Dutch physicians in 2012, only two are in Latin America: Mexico and Argentina. Brazil just joined.
Across the region, investigators were simply unable to get government funding to participate, said Dr. Ken Gorson, a Tufts University neurologist and president-elect of an international foundation that combats Guillain-Barre.
Poorer countries were ill-prepared to manage the crisis.
Colombia’s National Health Institute is overwhelmed with a weeks-long backlog in completing tests for Zika.
The three Guillain-Barre deaths that the country’s Health Ministry attributed to Zika on Feb. 5 have not yet been confirmed by laboratory tests, said spokesman Ricardo Amortegui. Nor have the three deaths in the Venezuelan state of Lara announced last week.
One Guillian-Barre fatality in Colombia suspected of being linked to Zika was a 51-year-old man from the Caribbean island of San Andres who died in November, said Rita Almanza, epidemiology chief in Medellin. The others were a 45-year-old man and a 41-year-old woman flown from Turbo on the Caribbean coast who died in Medellin in February.
Guillain-Barre grabbed hold of Nancy Pino in neighboring Venezuela with devastating effect.
The 68-year retired school administrator developed fever, rashes and muscle pain while celebrating Christmas with her family in the hot lowland state of Anzoategui.
She recovered quickly. Days later, her hands and feet started to go numb. Her tongue felt like it was asleep. She stopped eating.
The family rushed her to a Caracas hospital. She could barely walk.
Bed-ridden, she lost the ability to talk and soon, to breathe. Doctors attached her to a respirator.
“It was so quick,” daughter Nihara Ramos said between sobs. “It was like a flame consuming her from the bottom up.”
Doctors diagnosed Guillain-Barre with a spinal tap — they assumed she had Zika earlier — and suggested that the relatives obtain immunoglobulin, an expensive treatment that pools healthy antibodies from hundreds of donors. Gorson said it costs $15,000-$45,000 in the United States.
The family, straightjacketed by Venezuela’s economic crisis, couldn’t find or afford enough.
In less than three weeks, a woman who once bounded up seven flights of stairs to her apartment was dead.
___
Associated Press writer Frank Bajak reported this story from Lima, Peru, and AP writer Libardo Cardona reported in Cucuta, Colombia. AP writers Hannah Dreier in Caracas, Venezuela; Marcos Aleman in San Salvador, El Salvador; and Luis Henao in Santiago, Chile, contributed to this report.