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Science Policy Around the Web – March 22, 2019

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By: Caroline Duncombe.

Image by 1388843 from Pixabay

FDA Approves First Drug for Postpartum Depression

In the USA, about 400,000 women develop post-partum depression (PPD) each year. Up until Tuesday, there was no FDA approved pharmaceutical treatment designed specifically for PPD. In attempts to alleviate PPD episodes, doctors previously prescribed drugs designed for general depression, such as selective serotonin-reuptake inhibitors (SSRIs). Such drugs were not specifically designed for PPD which involves distinct mechanisms of action that are directly related to pregnancy and childbirth. SSRIs often take months to achieve remission or adequate response, if ever. Such deficiencies are supposedly addressed by the new drug, brexanolone, marketed at Zulresso, which was designed specifically to address post-partum depression and acheives rapid onset of response alleviation.

Although brexanolone is the first FDA approved treatment for PPD, the long infusion period, the high cost of the treatment, and lacking evidence on the effectiveness of this treatment demonstrate the long road ahead before PPD treatment is ubiquitous and operational. The Brexanolone treatment is not simple: it involves a continuous intravenous (IV) infusion over the course of 60 hours. Due to the risk of the treatment, patients will be required to stay within an in-patient unit of a hospital for those 2.5 days. Considering that the treatment alone cost $34,000 for a full course, the additional cost of in-patient care would make this treatment inaccessible for many who demonstrate severe PPD. Some insurance providers may decide to cover the treatment cost, but for those who do not have insurance or are denied coverage this treatment will be inaccessible.

Additionally, the FDA approval application was largely informed by a flawed phase III clinical trial funded by Sage Pharmaceuticals, the producer of Zulresso. The trial only included 246 participants, which is a relatively small sample size for a phase III trial. A large sample size is important to providing a conclusive clinical trial result on drug side-effects. This is crucial because if a severe side effect is found within 1 in every 1000 participants (or 1 in 10,000, etc) that level of risk would most likely not be detected within a trial only enrolling 246 participants. Additionally, this specific trial compared participants to a placebo, and not existing treatment standards of anti-depressants like SSRIs. The trail also only assessed the women volunteers over a 30-day follow-up period post infusion, which means that the lasting effects beyond the first month of Brexanolone are still unknown.

Further research on Brexanolone will be necessary to definitively assess its impact of reducing PPD. At this moment Sage Therapeutics is also implementing a phase III trialon a PPD treatment drug that is structurally similar to Bexanolone but is capable of being administered via a pill. If successful, such a drug could make treatment for post-partum depression more accessible to all. 

(Pam Belluck, New York Times)



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March 22, 2019 at 5:24 pm

Science Policy Around the Web – February 5, 2019

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By: Neetu Gulati, Ph.D.

Source: Pixabay

Macedonia name change paves way for science cooperation with Greece

Greece and the Republic of Macedonia have been at odds for decades over the name of the latter country. After the dissolution of Yugoslavia in the early 1990s, the nation known colloquially as Macedonia was founded. However, because a region in northern Greece shares a name with the republic, Greece has disputed the country’s name, and tried to bar its entry to international organizations such as NATO and the UN. The Prespa Agreement, ratified by the Republic of Macedonia on January 11, 2019 and Greece on January 25, 2019, is set to relieve tensions by changing the disputed country name to ‘The Republic of North Macedonia,’ and the short name of ‘North Macedonia.’

The Prespa Agreement not only ends the political stand-off between the two nations, but also opens the door for strategic partnerships in many ventures, including science. While some people opposed the Agreement, scientists in both nations welcomed the change, commenting that political tensions and bureaucratic procedures will hopefully no longer hinder collaboration. “Science is done by people, and many people were affected by the mutually negative spirit among the two countries that prevailed in the past years,” commented Ioanna Chouvarda, a Greek scientist.

Many are hopeful that the name change will positively impact scientific and diplomatic ties between the two nations. A spokesperson for the Republic of Macedonia’s science ministry commented that they hope the agreement will lead to more formal scientific and technological cooperation between the two nations. Greek Alternate Minister for Research & Innovation Costas Fotakis commented, “scientific diplomacy is an effective tool that can strengthen the relations between Greece and North Macedonia, as well as the Western Balkans in general. This agreement is very timely, especially considering that several research themes are of mutual interest in both countries.” 

(Julianna Photopoulos, Nature)

The modern tragedy of fake cancer cures

The news media can sometimes sensationalize and overclaim the results of scientific advances. This is especially dangerous when results have yet to be vetted by the peer-review process, as was the case when the Dan Aridor, chairman of a small biotechnology company in Israel claimed, “we believe we will offer in a year’s time a complete cure for cancer.” The story, published by the Jerusalem Post, made bold and likely unattainable claims that the new technology would have no side-effects, be less expensive than current therapies, and be “effective from day one.” However, the new treatment has so far only been tested in a single study in mice. Furthermore, it has not yet been published and therefore has not been scrutinized or validated by other scientists in the field of cancer research. 

The claims made by Aridor may just his optimism and faith in his product, but if taken at face value they are completely unbelievable. For one thing, the original article points out that the company has not yet started clinical trials, which would take years to complete, negating the hope of a cure within a year’s time. But even those clinical trials are not likely to succeed. The odds that a cancer therapy will successfully pass clinical trials is 3-5%, according to data from MIT and the Biotechnology Industry Organization. However, even the hurdle of getting from animal studies to clinical trials is not to be overlooked, which can easily take over five years.

Cancer therapies are still worth the investment of time and money. Successful drugs like Keytruda have made a large impact on those suffering from the cancer. However, therapies do not perform the same in every patient, and ‘cancer’ is not just one disease. Often, proper dosing of cancer therapies involves a balance between the effectiveness of the treatment and the harm of the side effects. Thus, it is unlikely that a single treatment will cure all cancers without a hitch, as boldly claimed by Aridor. It is much more realistic that some treatments will work for particular types of cancers more effectively than others, with limited side effects. Speaking more conservatively about the new treatment, the CEO of the company, Ilan Morad, commented that while the company believes their therapy will cure cancer, “we still have a long way to go.”

(Matthew Herper, STAT)

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February 5, 2019 at 12:22 pm

Science Policy Around the Web – February 1, 2019

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By: Caroline Duncombe, B.S.

Source: Pixabay

How old emails hold new clues to Coca-Cola and CDC’s controversial relationship

The mission of the Centers for Diseases Control and Prevention (CDC) is to protect America from health, safety, and security threat. Yet, private emails obtained through the Freedom of Information Act reveal that a Coca-Cola Company’s influence over the federal agency refutes such a mission. Email correspondences between top CDC officials and Coca-Cola employees exposed how the soda giant tried to push the World Health Organization (WHO) to emphasize exercise over diet as the solution to the obesity epidemic via CDC’s influencing power.

            Within the 295 pages of communications from 86 emails was a request by former Coca-Cola senior vice president Alex Malaspina that WHO “should not only consider sugary foods as the only cause of obesity but consider also the lifestyle changes that have been occurring throughout the universe.” Other uncovered emails revealed that the former CDC director of Division for Heart and Disease, Barbara Bowman, gave advice to a Coca-Cola executive on potential contacts that have influence over WHO’s regional office and then director-general Dr. Margaret Chan.

            Though Coca-Cola enacted a policy in 2015 to disclose on its website its funding portfolio for scientific research and partnerships. There is little to no federal oversight over sugar and beverage industries. This is a startling fact when considering the extent of the obesity epidemic in America and the significant role that sugary drinks play in augmenting such an epidemic. After the revelation of the relationship between Coca-Cola and the CDC, discussions have increased on restricting direct contact between federal agencies and soda giants. 

(Jacqueline Howard, CNN)

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February 1, 2019 at 4:24 pm

Science Policy Around the Web – January 28, 2019

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By: Allison Cross, Ph.D.

Source: Pixabay

A Drug That Eases Miscarriages Is Difficult For Women To Get

The CDC estimates that each year in the U.S. alone, over 1 million women suffer miscarriages during the first trimester of pregnancy.  When a woman finds out that her pregnancy is not viable, she is usually given three options: wait for the miscarriage to occur on its own, take medicine to induce the miscarriage, or undergo a surgical procedure (known as a D&C) to remove the contents of the uterus.  For women who want to avoid a surgical procedure but do not want to wait for the miscarriage to occur on its own, the medically induced miscarriage is a favored option. 

Misoprostol is the medication currently prescribed in the U.S. to induce miscarriage.  Although this medication works for many, a single dose of the medicine is ineffective for about 30% of women.  When the medicine is ineffective, women end up either returning to their doctor for another dose or moving forward with surgery.  However, a recent studyin the New England Journal of Medicine found that combining the currently used medication, misoprostol, with mifepristone is more effective than misoprostol alone in inducing miscarriage.  The study followed 300 women experiencing first trimester pregnancy lose and found the combination of misoprostol and mifepristone increased the chance of successfully inducing miscarriage to 90%, a 14% increase over misoprostol alone. 

Although this new study may provide hope for women suffering an early pregnancy loss and wishing to avoid surgical intervention, most doctors in the U.S. are unable to prescribe mifepristone due to current FDA regulations.  Mifepristone was approved by the FDA in 2000 but is currently regulated under what is known as a Risk Evaluation and Mitigation Strategy (REMS).  The REMS designation means that the FDA can restrict how and where the medication is distributed.  For mifepristone, the REMS restriction prohibits its availability in commercial pharmacies; the drug can only be distributed from clinics or hospitals designated as mifepristone suppliers.  

As mifepristone is commonly used for abortions, some argue that the REMS designation for the drug is driven by political motives rather than due to concerns about drug safety.  Currently, medical societies including The American College of Obstetricians and Gynecologists, the American Academy of Family Physicians and the American Medical Association are trying to overturn the FDA REMS classification of mifepristone.  

(Mara Gordon and Sarah McCammon, NPR)

Ebola Vaccine Supplies Are Expected to Last

The Democratic Republic of Congo (DRC) is currently facing a devasting Ebola outbreak and recently reported 689 confirmed and probable infections and 422 deaths. However, the World Health Organization (WHO) recently announced that they expect to have adequate supplies of an experimental Ebola vaccine to stop the outbreak. 

The experimental vaccine, known as V920, is made by Merck and was first shown to be highly effective in a clinical trial during the West African Ebola crisis of 2014-2016. In the current outbreak, Dr. Peter Salama, WHO’s deputy director-general of emergency preparedness and response, has reported that the vaccine is “highly, highly efficacious”, showing a efficacy rate well above 90%.  

After the West African Ebola crisis of 2014-2016, Merck made an agreement with the WHO and with Gavi, the Vaccine Alliance to maintain a stockpile of 300,000 doses of the vaccine at all times while they worked to get the vaccine licensed. As most Ebola epidemics have been controlled after less than 100 cases, the 300,000-dose stockpile seemed more than sufficient. However, tens of thousands of doses of the vaccine have already been used with the recent outbreak in the DRC, raising concerns that the supply would be depleted.  

Merck’s team lead for the Ebola vaccine project, Beth-Ann Coller, confirmed that in addition to the 100,000 doses of the vaccine that the company has already sent to the WHO, they still have about 300,00 doses on hand. However, due to the uncertainly of around the outbreak, Coller said the company is also exploring options to expand the stockpile further. 

(Helen Branswell, STAT)

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January 29, 2019 at 3:18 pm

Science Policy Around the Web – January 25, 2019

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By: Allison Dennis B.S.

Source: Pixabay

A safe prenatal genetic test is gaining popularity with young moms-to-be and their doctors

The DNA sequencing revolution is giving pregnant women and their doctors an earlier-than-ever-before glimpse into the health of the fetus as it develops. Marketed as the “noninvasive prenatal test” (NIPT), the diagnostic examines small fragments of fetal DNA derived from a blood sample provided by the mother for genetic abnormalities. Small amounts of fetal DNA are released as cells making up the placenta are turned over. This cell-free DNA enters the mother’s blood stream, where it can be accurately detected by NIPT in as early as 10 weeks. By measuring the amounts of DNA derived from each chromosome, the tests can screenfor Down syndrome and other chromosomal abnormalities including Edwards Syndrome and Patau syndrome. The test poses no risk to the fetus, and is highly regarded by OB/GYNs as a highly effective diagnostic tool. It is much less risky and invasive while being more accurate compared to amniocentesis and chorionic villus sampling, which was the previous standard of care for high-risk pregnancies. 

Most U.S. insurance plans only cover the test for mothers older than 35, whose pregnancies are at elevated risk for genetic abnormalities. Yet many younger mothers and their doctors are embracing the diagnostic. Because NIPT also offers the earliest chance for parents to determine the sex of their baby, some OB/GYNs are worried that parents may pursue the test without wanting or understanding the full implications of the results provided. Following a NIPT result indicating an abnormality a more invasive method will be recommended to confirm the diagnosis. Medical professionals and genetic counselors are working together to learn how to best help patients understand complex genetic information so they can make informed decisions regarding their care and not be blindsided by unexpected results.

(Sarah Elizabeth Richards, The Washington Post)

Science with borders: A debate over genetic sequences and national rights threatens to inhibit research

The Nagoya Protocol was adopted in 2010 as part of the United Nations Convention on Biodiversity to undercut the threat of biopiracy by giving countries an express right to any assets derived from the use of biological and genetic materials naturally occurring within their borders. The U.S. did not attend the Convention, but it is subject to following the established standards when interacting with countries who have ratified the protocol. Currently under the protocol, a donor country must certify their permission for an international researcher to take possession of a genetic resource. Prior to the outside party gaining access, both parties agree to the extent of benefit-sharing arising from genetic resource. 

Debate has arisen over the interpretation of the the agreement, specifically whether the sharing the genetic sequences derived from pathogens, the strings of letters that represent their genomes, require the same burden of documentation as the pathogens themselves. Researchers have expressed concern that including sequences under the regulations of this international treaty may hinder disease surveillance and international collaborations. Yet many understand that proteins can be synthesized following the instructions held in the genetic sequences, narrowing the gap between knowing a pathogen’s sequence and producing the physical components characteristic of that pathogen. As it stands, whether genetic sequences must be certified before they are shared is up to the donor country. 

Concern arising from the ambiguity surrounding digital genetic sequences sparked the WHO to draft of a Code of Conduct to guarantee the “open and timely sharing of pathogen genetic sequence data during outbreaks of infectious disease.” As pathogens emerge, it is often necessary to rapidly disseminate genetic data to characterize and track the spread of a particular disease strain. Experts must often work across borders to develop vaccines that match the relevant threat. In the spirit of benefit-sharing, the code requires scientists who obtain sequence data during outbreak situations to collaborate with the scientists who generated the sequence data when possible and acknowledge their contributions upon publication.

At the United Nations Biodiversity Conference held in November 2018, it was agreed that an Ad HocTechnical Expert Group would continue to consider the implications of the protocol on digital sequence information. Hopefully, clarity will be offered on the subject and any changes be adopted at the 2020 United Nations Biodiversity Conference. 

(Helen Branswell, STATNews)

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January 25, 2019 at 5:00 pm

Science Policy Around the Web – July 3, 2018

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By: Jennifer Patterson- West, PhD

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source: wikimedia commons

Women’s Health

Pregnant Women: Avoid Soft Cheeses, But Do Get These Shots

During pregnancy, expecting mothers are advised to avoid a slew of activities, foods and medications to protect their unborn child including alcohol, unpasteurized cheese, lunch meat, ibuprofen and even hot baths.  What may come as a surprise is that the American College of Obstetricians and Gynecologist (ACOG) recently released an immunization guide that advise expecting mothers on which vaccine to receive during pregnancy and which to avoid.  It also highlights vaccines that should only be given to high risk patients or immediately following birth.

The influenza vaccine is given to protect the mother who is more likely to get seriously sick if she contracts the flu. The Tdap vaccine is recommend at 27-36 weeks of gestation during each pregnancy to boost the maternal immune system in order to protect the newborn.  In addition to this recommendation, the CDC also recommends anyone who plans to come in contact with the baby receive the Tdap vaccine at least 2 weeks prior if they are not up-to-date with their vaccines.

In 2015, 20,762 cases of pertussis, the infectious agent responsible for whooping cough, were reported to the CDC by the State Health Department. Although this is a 37% decrease compared to 2014, these numbers can be further improved by improved coverage of those in contact with unvaccinated infants.

The goal of these guidelines is to further reduce the number of cases of whooping cough in babies younger then 3 months old, a time when the disease is most fatal.  For babies that contract whooping cough, half of them will end up in the hospital and some will die. Although these recommendations are not new, many expecting parents may be unaware of what vaccinations should be received during pregnancy. The CDC estimates that only half of pregnant women in the United States receive the Tdap vaccine.

(Selena Simmons-Duffin, NPR)

Drug Approvals

FDA approves Country’s first medicine made from marijuana

On June 25, the FDA announced the approval of the first drug with an active ingredient derived from marijuana.  Epidiolex is an oral solution approved for the treatment of seizures associated with  Lennox-Gastaut syndrome and Dravet syndrome.

Both are rare and severe forms of epilepsy.  Lennox-Gastaut syndrome typically presents between the ages of 3 and 5 as frequent seizures. The majority of children with the syndrome exhibit learning and intellectual disabilities and delayed motor skills.

Dravet syndrome is a rare genetic disorder that presents as frequent fever-related seizures during the first year of life.  Children with this disorder commonly have underdeveloped language and motor skills. With age, other seizure types and symptoms typically arise that are potentially life-threatening. No drug had previously been approved specifically for the treatment of Dravet syndrome, which is why FDA granted Priority Review to the application and orphan drug designation.

The approval of Epidiolex has the potential to increase the quality of life for many patients with these rare syndromes The active ingredient derived from marijuana is cannabidiol (CBD), which was shown to be effective at reducing the frequency of seizures compared to a placebo in clinical trials.  Epidiolex does not contain THC, the psychoactive component of marijuana, that causes a euphoric high.

CBD is currently classified as a Schedule I substance in accordance with the Controlled Substance Act (CSA).  Schedule I substances include drugs or chemicals with no accepted medical use and a high potential for abuse.  Although more than thirty states have passed legislation that permits the use of medical marijuana or CBD, cannabis is still categorized as a Schedule I substance under the CSA.

The approval of Epidiolex provides a path forward for the approval of other marijuana-derived medications, or treatment of additional indications, that do not conflict with federal law.  The FDA Commissioner, Dr. Scott Gottlieb, stated that “We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products.”

(Andrew Joseph, STAT News)

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July 3, 2018 at 2:19 pm

Zika Update: Current Knowledge and New Directions

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By: Keith Jacobs, Ph.D.

Zika is the newest international viral outbreak alarming physicians, researchers and the general public. The virus, which is related to dengue, yellow fever, and West Nile viruses, was first isolated in 1947 from a rhesus monkey in the Zika forest of Uganda. Very limited research was performed on the virus over the next several decades. Of the limited work that was done – including one researcher even injecting himself (under the generic description of a “human volunteer”) and several others documenting their symptoms from accidental exposure – none of it was able to shed any light on the true nature of the virus. Due to its relative obscurity and mild symptoms, there was not any interest in even studying Zika.

Times have certainly changed, however, as Zika has now been declared a “public health emergency of international concern” by the World Health Organization (WHO) in the wake of a 2015 outbreak in Brazil. Zika is transmitted through the Aedes aegypti mosquito which is endemic to South America, however strong evidence suggests that Zika may be sexually transmitted as well. While mosquitos carrying Zika have not been found in the US, over 300 Americans have contracted Zika through either travel or sexual contact with a partner who has traveled to regions where Zika is endemic. The majority of adult patients infected with Zika fail to show any symptoms, with the minority who do only exhibiting mild, general maladies such as aches, fever and rash (with no deaths reported).

While Zika infection is not a concern for adults, Brazilian physicians have noticed a stark increase in cases on microencephaly (small heads/brains) in newborns concurrent with the recent epidemic. Zika virus has also been found in the brains of affected fetuses. These correlations did not provide enough evidence however to definitively state that Zika infection was causing these deformities. A careful assessment of the reported cases cited in Brazil indicates that the recent increased incidence of microencephaly may be at least partially due to awareness bias and a lack of standardized criteria for defining deformations. In other words, physicians may be simply observing what they are already looking for based off the initial reported correlation.

As the Zika story began to spread, an alternative explanation for the explosion of microencephaly surfaced. A group of Argentinian doctors argued that it is not the Zika virus but instead the larvicide pyriproxyfen that is responsible for the increased risk of microencephaly. Ironically, pyriproxyfen is added to water in order to control the spread of the very mosquito that carries Zika and other viruses. This report cited a recommendation by the nonprofit Brazilian public health organization the Brazilian Association for Collective Health (BACH) that criticized the use of pyroxifen and warned against its potential environmental and neurotoxic effects. To add to the controversy, pyriproxyfen is manufactured by a Japanese company that is very loosely connected to the agricultural corporation Monsanto, a popular enemy of environmentalists due to its corporate practices concerning the sale of genetically modified crops. Following these assertions, BACH curiously backed off their initial claims and decried the misinterpretation of their statement. In addition to the increasingly strong data connecting Zika infection with fetal brain abnormalities, there is no evidence to support a link between microencephaly and larvicides, and these claims have been disparaged by numerous authorities including the Brazil Ministry of Health:

“Unlike the relationship between the Zika virus and microcephaly, which has had its confirmation attested in tests that indicated the presence of the virus in samples of blood, tissue and amniotic fluid, the association between the use of pyriproxyfen and microcephaly has no scientific basis.”

A case study reported in late March provided the strongest connection to date between maternal Zika infection and fetal brain abnormalities. A woman was infected with Zika 11 weeks into her pregnancy, after which uterine imaging demonstrated a progressive reduction in fetal head size and eventually abnormal gross morphology of the brain. The pregnancy was eventually terminated, and autopsy confirmed large viral loads in the fetal brain and placenta with lower amounts present in other fetal tissues as well. Zika also remained present in the mother for up to 10 weeks following infection. Finally, on April 13th the Centers for Disease Control (CDC) officially declared that the preponderance of evidence supports a causal link relationship between Zika and birth defects.

Prior to this case, physicians believed that Zika only remained active in the body for a week following infection. Likely due to this study, the Centers for Disease Control now recommends that women wait at least 8 weeks after exhibiting symptoms before trying to conceive, or up to 6 months when a male sexual partner has contracted the disease. The absence of any strong symptoms in adults along with the long duration required for viral clearance may thus contribute to Zika’s danger, as pregnant and soon-to-be-pregnant women may be infected without having any knowledge of their exposure. The true risk of Zika, its potential effect on fetal neural development, can therefore be a hidden danger.

While severe birth defects are the most common and perhaps the most threatening aspect of Zika infection, the dangers of Zika are not restricted to pregnant women. Recently, more severe consequences of Zika exposure have been identified in adults. A study published in late February identified a causal link between Zika infection and diagnosis with Guillain-Barré Syndrome. Guillain-Barré syndrome is an auto-immune neurological disease that affects the peripheral (external from brain/spinal cord) nervous system, resulting in potentially severe muscle weakness. Guillain-Barré is often preceded by infection, especially from viral pathogens such as the related dengue fever virus. Systemic infection with these viruses induces an overactive immune system leading to persistent inflammation, and Zika likely acts through this same mechanism.

By leaving its host alive and utilizing abundant mosquitos as a carrier, Zika is likely more contagious than Ebola (which only spreads through direct contact between bodily fluids). The virus therefore has the potential to spread rapidly over a wide range, and without overt visible symptoms it may be difficult to track its true reach. In contrast with Ebola however, where local African culture and poor infrastructure promoted the spread of the disease, the Americas have much better public health resources and preparation. Additionally, a great deal of research is already underway working towards both improved understanding and treatment of Zika. Published studies have described the cell biology of Zika infection, the Food and Drug Administration in the US is reviewing diagnostic tests, and international efforts have already made progress on a vaccine. While the Zika outbreak is somewhat under control, the virus is not likely to go away any time soon. Hopefully the sum of these efforts will neutralize Zika before it becomes an even more significant international public health issue.

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April 14, 2016 at 1:00 pm