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Science Policy Around the Web – February 19, 2019

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By: Mohor Sengupta Ph.D.

Source: Maxpixel

New AI fake text generator may be too dangerous to release, say creators

Artificial intelligence. In a Beijing competition last year, it identified patterns in brain MRI scans from hundreds of individuals and diagnosed their conditions far more accurately than human doctors. In modern journalism, AI is being trained by humans to scan financial reports and dish out an immediate news story with pertinent facts and figures. Bloomberg uses the bot “Cyborg”, which helps it compete against its rival, Reuters, in financial journalism. The Washington Post uses “Heliograf”, which covered the 2016 Olympics and the 2016 US elections. But, AI can create a completely fake human image by teaching itself from several real images. It can produce a completely fake video by literally putting words in a person’s mouth. And, owners of the nonprofit research company, “OpenAI”, realized, to their concern, that a new AI text generator called GPT2, created by its researchers, is so smart that it can make up connected and logical sentences following a random one-liner input. 

Take this example. When fed with the opening line of George Orwell’s Nineteen Eighty-Four – “It was a bright cold day in April, and the clocks were striking thirteen” – GPT2 comes up with this: “I was in my car on my way to a new job in Seattle. I put the gas in, put the key in, and then I let it run. I just imagined what the day would be like. A hundred years from now. In 2045, I was a teacher in some school in a poor part of rural China. I started with Chinese history and history of science.” It recognizes the futuristic reference in the input. It had an interesting and obviously fake statement to say about UK Prime Minister Theresa May when fed with an unfinished line from a Guardian article about Brexit. In short, GPT2 is quick and creative. 

It is not difficult to imagine the mischief this kind of groundbreaking technology can create. Generating fake news is one that comes to the mind easily. 

Take for example, this false and incomplete phrase presented to GPT2 by a group of humans at MIT: “Russia has declared war on the United States after Donald Trump accidentally”.

OpenAI chillingly demonstrated how it can be a lethal hoodwinker by completing that phrase into this: “Russia has declared war on the United States after Donald Trump accidentally fired a missile in the air. Russia said it had “identified the missile’s trajectory and will take necessary measures to ensure the security of the Russian population and the country’s strategic nuclear forces.” The White House said it was “extremely concerned by the Russian violation” of a treaty banning intermediate-range ballistic missiles. The US and Russia have had an uneasy relationship since 2014, when Moscow annexed Ukraine’s Crimea region and backed separatists in eastern Ukraine.”

Don’t panic, none of that is true!

Machine learning was used to train GPT2 on a dataset containing about 10 million articles, selected by scouring the social news site Reddit for links with more than three votes. “We need to perform experimentation to find out what they can and can’t do,” said Jack Clark, policy director of OpenAI. “If you can’t anticipate all the abilities of a model, you have to prod it to see what it can do. There are many more people than us who are better at thinking what it can do maliciously.” For now, the company has decided to keep GPT2 behind closed doors until such a time when they know the bot’s full potential. Only a simpler version will be made publicly available. 

While there are skeptics of AI, there are also critics of the skeptics. They argue that humans can produce fake news as well as an AI. But take a moment to think of the number, variations, creativity and logical or factual supports that can be weaved in seconds by a bot like GPT2. How is it possible that any human can outsmart a program that has learnt 10 million articles about current and past politics, about wars, about famous fictional characters, about sports, about celebrities, about nature and about anything under the sun, and beyond? 

Downsides of a technology cannot confine it behind closed doors. We have learnt that from the past. AI is becoming increasingly necessary in many areas, for example, identifying medical conditions from MRI as mentioned above. Nature Medicine recently published an article where an AI accurately diagnosed common childhood diseases by analyzing digital and electronic health records. But like any revolutionizing technology, AI can be misused for malicious purposes. And it will be used for that, sooner or later. The idea here is to prepare the world for what is about to become mainstream in a few years. Clark calls this an “escalator from hell”. 

(Alex Hern, The Guardian)

Searching Tardigrades for Lifesaving Secrets

In the series “Cosmos: A Spacetime Odyssey”, Neil deGrasse Tyson talked about five cataclysmic events, separated by eons, that wiped out almost all life on Earth. Every time this happened, a miniscule proportion of existing life escaped and adapted to the new environment. Among this population there is an organism that survived ALL five purges. This animal is the size of a sand particle and it dwells in moisture. It is called a Water bear, or a Moss piglet, or Tardigrade.  

It is not entirely clear how these organisms survive extreme environmental conditions, but research on their physiology suggest involvement of certain proteins that protect its cells from dehydration. In an event of environmental emergency, the tardigrade can desiccate itself within minutes into a firm, curled-up ball called a “tun”, only to resume normal functions within minutes of sensing moisture. This remarkable feat is called anhydrobiosis in scientific jargon. A group of scientists from Japan have found certain heat-soluble proteins that help tide over the anhydrobiosis period. Separately, another group of scientists from USA and Italy have found intrinsically disordered proteins (IDPs) specific to tardigrades (TDPs) to confer to them the protection against desiccation.  

A team of three scientists at Harvard Medical School and are now using computational biology and machine learning to design TDPs tailored to slow down metabolism in human cells. “It really started out as a wacky, high-risk idea,” said Pamela Silver who spearheads the project. In 2008 Dr. Silver came across a grant challenge posted by the US military seeking novel solutions to stabilize hemorrhage of personnel in war zones. Together with her bioinformatician colleague and machine-learning expert Roger Chang and computational biologist Debora Marks, she set out to engineer novel TDPs that would lower the metabolism in eukaryotic cells during a state of shock. This is akin to “slowing biological time”, only to return back to normal pace when the critical period has passed. Although it is still unclear how these proteins might work, Dr. Chang has suggested that they might form a biological glass that physically immobilizes everything inside the cell during the stress period. 

The group was recently awarded a five-year cooperative agreement by the Defense Advanced Research Projects Agency (DARPA) to pursue the idea. If it works, the engineered TDPs could be a benchmark in modern medicine, revolutionizing current understanding of not only trauma management, but also address several pressing issues, like, long-term transportation of protein-based drugs or to-be-transplanted organs and keeping the egg cell viable without freezing it. 

(Steph Yin, New York Times)

Embryo ‘Adoption’ Is Growing, but It’s Getting Tangled in the Abortion Debate

In Vitro Fertilization (IVF) has changed the way people understand reproduction. It has made conceiving a reality for many women who are not able to conceive naturally for medical or social reasons. During the IVF process, sperm from a male donor are used to fertilize an egg cell from a female donor (generally the would-be biological parents). Usually, more than one embryo results from such a process, but only one is transplanted in the recipient’s uterus. Commonly, when a biological child is desired, donor and recipient are the same woman. In a relatively new trend, couples other than the donor are “adopting” these extra embryos. While this may seem as a very uncomplicated way of giving new life and a great option for many women, it is fraught with problems arising from religious and social issues. 

Monica Broecker is a woman in her mid-forties who found out that she couldn’t conceive, after repeated miscarriages. She decided to adopt an embryo and approached National Embryo Donation Center, based in Knoxville, Tennessee, which is also the largest embryo donation clinic in USA. Despite being financially stable, Ms. Broecker was turned down by the agency because she is a single woman. 

Some of the better-known embryo adoption agencies are funded by a grant by the Department of Health and Human Services (HHS), called the “Embryo Awareness Adoption Program” which has had $1 million in annual funding since 2003. To date, all the grant recipients, barring two, are affiliated with anti-abortion or Christian organizations. 

Ms. Tyson, who works for Snowflake Embryo Adoption, one of the recipient agencies of the HHS grant, says that her clients are mostly Christian. In almost all embryo donations, the donor family selects the recipient. Ms. Tyson has had a difficult time finding donors for single women, LGBTQ people or people from diverse religious practices and atheists. She usually refers such recipients to Embryo Donation International, an agency that is not affiliated to any religious organization. Unsurprisingly, Embryo Donation International doesn’t receive the HHS grant. 

On an average, embryo donation costs much less than a single round of IVF. Increasingly, many women wanting to become mothers are seeing this approach as a perfect synergy of their requirements and giving life to an embryo rather than it being frozen indefinitely. Matching with a donor is the biggest problem that many of them are experiencing. Although all grant recipients deny that they consider religion, sexual orientation or marital status while considering clients, statistics show a different picture. The government should look more carefully into its grant applicants and take measures to diminish bias in granting the awards. 

(Caroline Lester, New York Times)

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February 19, 2019 at 4:19 pm

Science Policy Around the Web – February 15, 2019

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By: Saurav Seshadri Ph.D.

Source: Pixabay

Hundreds protest against Washington state vaccine bill that would require measles shots

With over 58 people infected so far, the measles outbreak affecting the Pacific Northwest since January is a genuine public health emergency.  Still, local lawmakers are finding that they may have an even bigger challenge to overcome in preventing the next one.  The epicenter of the outbreak, Clark County, has one of the lowest vaccination rates in the country, with fewer than 80% of children receiving the recommended two doses of the measles-mumps-rubella (MMR) vaccine (far below the herd immunity threshold of 93-95%).  A bill sponsored by state Rep. Paul Harris, which aims to rectify this by limiting vaccine exemptions for non-medical reasons, was recently met with stiff opposition from anti-vaccination activists, who are particularly prominent in the region and turned out in the hundreds to protest.  Activists argue that the legislation would force parents to expose their children to risky medical procedures.  Such opposition, from groups such as Informed Choice Washington, prevented a similar bill introduced in 2015 from even making it to a vote.

However, while activists have been the most vocal and visible opponents of the bill, they may not be representative of the parents who are actually opting not to vaccinate in Clark County.  Portland is home to a large number of families from the former Soviet Union, many of whom are wary of vaccines for cultural or religious reasons.  Some Russian-language schools have vaccine exemption rates of over 50%.  The strain of measles in Clark County is the same one that recently sickened over 40,000 people in Ukraine, suggesting that the current outbreak may have originated within this community.  Any legislative solution may therefore have to tread carefully to avoid singling out a specific ethnic group.  

Furthermore, it’s unclear whether the proposed bill would be effective in promoting vaccination.  After a measles outbreak in 2015 that sickened 147 people, California eliminated ‘personal belief’ exemptions in both public and private schools; since then, medical exemptions (often issued with little justification and/or in exchange for a fee) have more than tripled.  While old studies linking vaccines to autism have been thoroughly debunked, their core message, that vaccines are inherently unsafe, has been tougher to eradicate.  This is partly because it bears a grain of truth: the CDC acknowledges that side effects of the MMR vaccine can include seizures and brain damage, and lists several scenarios in which its administration is contraindicated.  Despite these risks, in the wake of a potentially deadly outbreak, many will likely agree that public health must be prioritized and voluntary vaccination will resume.  If not, parents who truly fear the consequences of vaccination may be left with no other option but to educate their children at home.

(Ashley May, USA Today

Antidepressant based on party drug gets backing from FDA advisory groupT

Since 2006, scientists have known that the anesthetic ketamine is shockingly effective in treating depression.  Moreover, it can improve mood within hours, and is mechanistically distinct from existing antidepressants, meaning it can potentially help patients who are currently suicidal or whose depression is treatment-resistant.  While ketamine itself has been used as an anesthetic since the 1960s and cannot be patented, these findings were promising enough to motivate several drug companies to try to develop marketable variants.  One such compound, esketamine (produced by Johnson and Johnson), has just gotten a step closer to FDA approval: an independent advisory panel has voted to recommend its use for treating depression, based on the results of five phase III trials and several other supporting studies. The drug had previously received a Breakthrough Therapy Designation by the FDA, and an official decision from the agency is expected by early March.     

Ketamine is also a hallucinogen, a club drug known as Special K, a potential drug of abuse, and described by the DEA as ‘sometimes used to facilitate sexual assault crimes’.  Its transition to respectable pharmaceutical is therefore somewhat surprising, and could be indicative of a change in how such compounds are perceived by the government and society in general.  Medical marijuana is often prescribed to treat seizures, and last year, the FDA approved the first drug containing an active (though not psychoactive) ingredient derived from marijuana.  A more relevant example may be psilocybin, the active component of magic mushrooms.  The DEA describes psilocybin as a hallucinogenic drug of abuse, whose side effects include panic attacks, psychosis, and death; yet the FDA recently granted Breakthrough Designation to psilocybin therapy for treatment-resistant depression (a large-scale clinical trial, conducted by COMPASS Pathways, will take place this year).    

While the overall clinical efficacy reported by J&J for esketamine was modest, at least some panelists were convinced to approve the drug based on patient reports that its effects were worth any side effects.  As we enter the seventh decade since the discovery of the last novel antidepressant (or antipsychotic), such feedback may play a larger role in convincing regulatory bodies to try new treatments, even if they have been previously stigmatized or their mechanisms of action are unclear.  By allowing supervised administration, patient registration, monitoring, and research, bringing such drugs out of the shadows could provide welcome relief for people suffering from mental illness.  

(Sara Reardon, Nature)

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February 15, 2019 at 3:23 pm

Intellectual property theft and its effects on US-China trade relations

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By: Neetu Gulati, Ph.D.


China and the US are currently in the midst of a trade war that, if not resolved my March 1, 2019, will lead to another increase in tariffs by the US. This trade war, which started over the US accusing China of stealing intellectual property from American companies, has already affected the economy of the two countries and could have global effects. The US has evidence that information including biomedical research breakthroughs, technological advances, and food product formulations have been stolen. In response to these illicit trade practices, the US imposed tariffs on Chinese imports, leading to the beginning of the trade war.

So how did we get here? 2019 marks forty years of diplomatic relations between the United States and China, which officially began on January 1, 1979. Since relations began, the two countries have benefited from ongoing trade, and China has become the largest goods trading partner with the US. Bilateral economic relations have increased from $33 billion in 1992 to over $772 billion in goods and services in 2017.  Despite strong economic ties, relations between the two countries have come under strain in recent years. The US State Department has identified concerns over military conflict in the South China Sea, counter-intelligence and security issues, and the trade deficit, among other issues. These issues came to a head in April 2018 when President Donald J. Trump issued a statement that China had stolen America’s intellectual property and engaged in illegal trade practices. In response, the US imposed additional tariffs on approximately $50 billion worth of Chinese imports. China then countered with tariffs on US imports, and thus a trade war between the two countries began.

To understand how intellectual property, or IP, fits into the trade war, it is important to first understand what it is. According to the World Intellectual Property Organization, IP “refers to creations of the mind, such as inventions; literary and artistic works; designs; and symbols, names and images used in commerce.” More simply, IP is something created or invented through human intellect, but not necessarily a tangible product. These products often have important scientific implications, as the umbrella of IP can cover genetically engineered crops, newly developed technologies and software, and new therapeutics, just to name a few. IP is legally protected through means such as patents, trademarks, and copyright, which allow people to gain recognition and financial benefits from their creations. These protections are country-specific, and the US Patent and Trademark Office gives guidance about protecting IP overseas, including in China. The process of transferring IP from the creator to another entity, often for distribution purposes, is known as technology transfer. This process is at the heart of the accusation of theft of American IP.

According to a seven-month long investigation done by the United States Trade Representative (USTR), China’s unreasonable technology transfer policies meant they did not live up to the commitments made when joining the World Trade Organization. The report found that Chinese laws require foreign companies to create joint ventures with domestic Chinese companies in order to sell goods within the country. The investigation by USTR found that “China’s regulatory authorities do not allow U.S. companies to make their own decisions about technology transfer and the assignment or licensing of intellectual property rights.  Instead, they continue to require or pressure foreign companies to transfer technology as a condition for securing investment or other approvals.” By pushing for technology transfer, these laws opened up American companies to theft of their IP. Stolen IP has included things like software code for a wind turbine, genetically modified corn seeds, the idea behind a robot named Tappy, and even the formulation for the chemical that makes Oreo filling white.

Beyond stealing information for goods entering China, it is also possible that Chinese workers in the United States may be stealing IP and sending it back to their home country. For example, a Chinese scientist known as ‘China’s Elon Musk’ was accused by his former research advisor of stealing research done at Duke University and replicating it in China for his own gain. A former assistant director of counterintelligence at the FBI suspects that the Chinese scientist was sent by the Chinese government intentionally to steal IP. This was not an isolated incident, either. According to a report from an advisory committee to the National Institutes of Health (NIH), research institutions in the US may have fallen victim to a small number of foreign researchers associated with China’s “Talents Recruitment Program,” which the National Intelligence Council identified as an effort to “to facilitate the legal and illicit transfer of US technology, intellectual property and know-how.” This comes mere months after the NIH announced that it had identified undisclosed financial conflicts between US researchers and foreign governments. Without giving details of specific countries, NIH Director Francis Collins reported to a Senate Committee hearing that “the robustness of the biomedical research enterprise is under constant threat.” Nevertheless, these threats should not hinder the research enterprise. During a hearing in April 2018, House Science Committee Chair Lamar Smith remarked, “on the one hand, we must maintain the open and collaborative nature of academic research and development. On the other, we must protect our research and development from actors who seek to do us harm.”

The balance between research collaboration and theft is delicate. Information sharing is increasingly necessary as scientific pursuits become more interdisciplinary in nature, and can lead to more productivity in research. However, voluntary collaboration is different from unwilling or coerced transfer of ideas. The ability of US scientists and entrepreneurs to innovate and create new IP is an important driver of the American economy, and further allows for the ability to research new scientific pursuits. Not only does IP theft undermine the incentive and ability for Americans to innovate, it has had drastic negative effects on the American economy, with annual losses estimated to be between $225 billion and $600 billion according to a report put out by the IP Commission. These losses directly affect those who own and/or license IP, as well as those who are associated with these companies or individuals. This can then lead to downsizing or cutting jobs, further harming American science and technology industries. It is for this reason that the US responded so strongly against the evidence of IP theft.

In response to the accusations from the US, Chinese President Xi Jinping promised to resolve the “reasonable concerns” of the US regarding IP practices. The Chinese government announced punishments that could restrict Chinese companies from state funding support due to IP theft and at the G20 Summit in December 2018, the Presidents of the two nations agreed to a 90-day financial truce, which will end March 1, 2019. 

The two countries are currently working on a trade deal to end the escalating tariffs, which would lessen tensions between the world’s two largest economies. The US wants China to commit to buying more American goods and services, and to agree to end the practice of requiring American companies to give technology transfers in order to do business in China. Without hashing out details, China has agreed to increase imports of U.S. agriculture, energy, industrial products and services. Delegations from the two countries will meet again in mid-February in China to continue negotiating. Trump was optimistic that the two nations would be able to make a deal before the deadline, saying, “I believe that a lot of the biggest points are going to be agreed to by me and him.”  

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February 7, 2019 at 9:39 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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Written by sciencepolicyforall

January 25, 2019 at 5:00 pm