Science Policy For All

Because science policy affects everyone.

Posts Tagged ‘regulation

The need for regulation of artificial intelligence

leave a comment »

By: Jayasai Rajagopal, Ph.D.


Source: Wikimedia

The development and improvement of artificial intelligence (AI) portends change and revolution in many fields. A quick glance at the Wikipedia article on applications of artificial intelligence highlights the breadth of fields that have already been affected by these developments: healthcare, marketing, finance, music and may others. As these algorithms increase their complexity and grow in their ability to solve more diverse problems, the need to define rules by which AI is developed becomes more and more important.

            Before explaining the potential pitfalls of AI, a brief explanation of the technology is required. Attempting to define artificial intelligence begs the question of what is meant by intelligence in the first place. Poole, Mackworth and Goebel clarify that for an agent to be considered intelligent, they must adapt to their surrounding circumstances, learn from changes in those circumstances, and apply that experience in pursuit of a particular goal. A machine that is able to adapt to changing parameters, adjust its programming, and continue to pursue a specified directive is an example of artificial intelligence. While such simulacra are found throughout science fiction, dating back to Mary Shelly’s Frankenstein, they are a more recent phenomenon in the real world. 

            Development of AI technology has taken off within the last few decades, as computer processing power has increased. Computers began successfully competing against humans in chess as early as 1997 with DeepBlue’s victory over Garry Kasparov. In recent years, computers have started to earn victories in even more complex games such as Go and even video games such as Dota 2. Artificial intelligence programs have become common place for many companies which use them to monitor their products and improve the performance of their services. A report in 2017 found that one in five companies employed some form of AI in their workings. Such applications are only going to become more commonplace in the future.

In the healthcare field, the prominence of AI is readily visible. A report by BGV predicted a total of $6.6 billion invested into AI within healthcare by the year of 2021. Accenture found that this could lead to saving of up to $150 billion by 2026. With the recent push towards personalized and precision medicine, AI can greatly improve the treatment and quality of care. 

However, there are pitfalls associated with AI. At the forefront, AI poses a potential risk for abuse by bad actors. Companies and websites are frequently reported in the news for being hacked and losing customer’s personal information. The 2017 WannaCry attack crippled the UK’s healthcare system, as regular operations at many institutions were halted due to their compromised data infrastructures. While cyberdefenses will evolve with the use of AI, there is a legitimate fear that bad actors could just as easily utilize AI in their attacks. Regulation of use and development of AI can limit the number of such actors that could access those technologies.

Another concern with AI is the privacy question associated with the amount of data required. Neural networks, which seek to imitate the neurological processing of the human brain, require large amounts of data to reliably generate their conclusions. Such large amounts of data need to be curated carefully to make sure that identifying information that could compromise the privacy of citizens is not easily divulged. Additionally, data mining and other AI algorithms could information that individuals may not want revealed. In 2012, a coupon suggestion algorithm used by Target was able to discern the probability that some of their shoppers were pregnant. This proved problematic for one teenager, whose father wanted to know why Target was sending his daughter coupons for maternity clothes and baby cribs. As with the cyberwarfare concern, regulation is a critical component in protecting the privacy of citizens.

Finally, in some fields including healthcare, there is an ever present concern that artificial intelligence may replace some operations entirely. For example, in radiology, there is a fear that improvements in image analysis and computer-aided diagnosis by the use of neural networks could replace clinicians. For the healthcare field in particular, this raises several important ethical questions. What if the diagnosis of an algorithm disagrees with a clinician? As the knowledge an algorithm has is limited by the information it is exposed to, how will it react when a unique case is presented? From this perspective, regulation of AI is important not only to address practical concerns, but also pre-emptively answer ethical questions.

While regulation as strict as the Asmiov’s Three Laws may not be required, a more uniform set of rules governing AI is required. At the international level, there is much debate among the members of the United Nations as to how to address the issue of cyber security. Other organizations, such as the European Union, have made more progress. A document recently released by the EU highlights some ethical guidelines which may serve as the foundation for future regulations. At the domestic level, there has been a push from scientists and leaders in the field towards harnessing the development of artificial intelligence for the good of all. In particular, significant headway has been made in the regulation of self-driving cars. Laws passed in California restrict how the cars can be tested and by 2014, four states already had legislation applying to these kinds of cars. 

Moreover, the FDA recently released a statement expressing their approach to the regulation of artificial intelligence in the context of medical devices. At the time of this writing, there is a discussion paper that is open for commentary describing the proposed approach that the FDA may take. They note that the conventional methods of acquiring pre-market clearance for devices may not apply to artificial intelligence. The newly proposed framework adapts existing practices to the context of software improvements.  

Regulation must also be handled with care. Over-limitation of the use and research in artificial intelligence could lead to stifling of development. Laws must be made with knowledge of the potential benefits of new technological advancements could cause. As noted by Gurkaynak, Yilmaz, and Haksever, lawmakers must strike a balance between preserving the interests of humanity and the benefits of technological improvement. Indeed, artificial intelligence poses many challenges for legal scholars.

In the end, artificial intelligence is an exciting technological development that can change the way we go about our daily business. With proper regulation, legislation, and research focus, this technology can be harnessed in a way that benefits the human experience while preserving development and the security of persons.

Have an interesting science policy link? Share it in the comments!

Advertisements

Written by sciencepolicyforall

April 18, 2019 at 2:25 pm

Science Policy Around the Web – November 30, 2018

leave a comment »

By: Allison Cross, PhD

Global-Warming-Change-Climate-Change-Climate-Desert-2063240.jpg

Source: Maxpixel

 

Fire, drought, flood: Climate challenges laid bare in US government report

On Black Friday, and amid the news of deadly wildfires in California, the federal government released the Fourth National Climate Assessment (NCA4).  This report, detailing global warming and climate change, is mandated every four years as part of The Global Change Research Act of 1990.  The report was released by the U.S. Global Change Research Program which includes scientist and policy experts from 13 federal agencies.  It affirms that the effects of climate change are already being felt across the country, and that current global efforts to combat it, as well as regional efforts to adapt to it, do not reach the levels needed to avert substantial damage to the US economy, environment, and public health.

The NCA4 describes the latest in climate-change science and examines how global warming is likely to differentially effect regions across the country and the economy.  The report explains how higher temperatures and drier conditions will result in more large fires across the west coast.  The southwest and midwest can expect persistent droughts to continue, while the east coast will suffer from increased flood risks. These conditions will disrupt agricultural productivity.  The US National Oceanic and Atmospheric Administration estimated that the 2017 economic loss in the US from major storms, floods and droughts was $290 billion, and the NCA4 declares that storms are expected to become even more powerful as global warming continues.

The report states that if the current trends in global greenhouse-house emissions continue, some US economic sectors can expect to experience annual losses of hundreds of billions of dollars by the end of the century.

Though the report was intended to inform policy-makers, it makes no specific policy recommendations to address the issues outlined in the report.  With President Trump having removed the US from the Paris climate change agreement after he took office, and repeatedly blaming the deadly California wildfires on poor forest management, many scientists are concerned that the government will not take action to address the grave findings outlined in the report.

This report released by the  U.S. Global Change Research Program  comes after, and is in agreement with, a report released in October by the Intergovernmental Panel on Climate Change (IPCC) stating that major and costly changes would be needed to avert the disastrous effects to come from climate change.

 

(Jeff Tollefson,  Nature Briefing)

 

FDA plans overhaul of decades-old medical device system

Just 24 hours after a global investigation into medical device safety was published, the Food and Drug Administration announced they will be overhauling the medical device approval process.  The FDA says the changes were planned before the new stories broke, referring to the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health issued by the FDA back in April. The investigation into medical device safety that made the headlines was led by the International Consortium of Investigative Journalists and found that, over a 10-year period, the FDA received reports of more than 1.7 million injuries and close to 83,000 deaths suspected of being linked to medical devices.

Under current regulations, most medical devices can undergo an expedited approval process if the manufacturers can prove the devices are similar to those already on the market.  This approval process was implemented by the FDA in 1976 and is known as the 510(k)clearance process.  This process means that extensive clinical safety and efficacy testing is only required for a handful of new devices. It has been reported that under this clearance process almost 20% of products are approved based on similarity to devices that are more than 10 years old.  Critics of the expedited clearance process point out that this system has allowed defective devices to be cleared included hip replacements that failed prematurely, and surgical mesh linked to pain and bleeding.

The FDA has said that under the modernized 510(k) clearance process, medical devices that come to the market “should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria.”  The proposed changes to the approval process include pushing companies to compare their devices to more up-to-date technology.  The FDA also plans to pursue actions to allow them to retire outdated base-products when safer, more effective technology emerges.

The FDA has set a deadline of early 2019 to finalize its guidance on establishing an alternative accelerated pathway for medical device approval but the reforms being proposed may take years to implement.

 

(Matthew Perrone, Associated Press, Stat News)

 

 

Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

November 30, 2018 at 3:46 pm

Science Policy Around the Web – November 16, 2018

leave a comment »

By: Ben Wolfson, Ph.D.

e-cigarette-1301664_1920.jpg

Source: Pixabay

 

F.D.A. Seeks Restriction on Teens’ Access to Flavored E-Cigarettes and a Ban on Menthol Cigarettes

Stricter regulation on E-cigarettes by the Food and Drug Administration (FDA) has been rumored since last week, when market leading E-cigarette company Juul Lab stopped accepting orders for some if it’s most popular flavored products. In an announcement on Thursday of this week the FDA said that while it would allow stores to continue to sell flavored E-cigarettes, they would have to be restricted to areas that are inaccessible to minors.

In the same announcement, the FDA stated that it will move to ban additional flavored tobacco products, menthol cigarettes and flavored cigars. Flavored tobacco products are disproportionately used by young people, with a recent study finding that over 80% of youth and young adult tobacco users reporting using flavored tobacco. The same study also reported that 75% of youth tobacco users said that they would stop using tobacco if it was not flavored. These trends are exactly why the FDA has moved for new regulation. While youth use of combustible tobacco products has dropped, people who try E-cigarettes are more likely to use combustible in the future.

The exact way new regulations will be applied remain to be determined, and public health advocates have indicated disappointment that the FDA did not announce and outright ban. Age restrictions are already in place or tobacco products, and many underage individuals get tobacco from older people as opposed to stores illegally selling them.

For these same reasons, the ban on menthol cigarettes and flavored cigars is being lauded by advocates, especially in the African-American community where use of these products is especially high, and restrictions have been fought by the tobacco industry for years.

(Sheila Kaplan and Jan Hoffman, New York Times)

Offering free DNA sequencing, Nebula Genomics opens for Business. But there’s an itsy-bity catch

As personal genome sequencing becomes accessible and popular, so do the privacy concerns related to it. While individuals may choose to get their genome sequenced for recreational purposes, the data generated is highly valuable and of great interested to researchers, companies and law enforcement individuals, an evolving paradigm which was recently delved into in more detail on this blog. Individuals who sequence their genomes have the opportunity to share their (anonymized) data with researchers, however these systems remain one-sided and simplistic.

While AncestryDNA and 23andMe are currently the most popular companies for personal sequencing, a new genetics company run by famed geneticist and genome engineering/synthetic biology pioneer George Church, recently announced plans to enter the market. Church’s company, Nebula Genomics, plans to offer genome sequencing for a range of costs. Those who wish to opt out of sharing any information will pay $99 for genome sequencing, however the information provided will be low resolution. If the customer opts-in to sharing data the test will be free, and the accuracy of the data will be increased.

Regardless of whether they choose to answer questions about themselves, both free and paying costumers will still be able to refuse to share data with researchers. While other companies have an “all-or-nothing” approach to data sharing, Nebula will allow customers to audit data requests on a case-by-case basis. Any data shared will remain anonymized. Church stated that individuals with especially unique genetic traits that a company wants to study would even receive payment for their data. This approach would give people back control of their data, and is a push-back against the current system where companies control all data and the profits gathered from it.

(Sharon Begley, Stat News)

Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

November 16, 2018 at 4:33 pm

Science Policy Around the Web – November 13, 2018

leave a comment »

By: Mohor Sengupta, Ph.D.

Insect-Barley-Midge-Fly-Hessian-640860.jpg

Source: Max Pixel

 

Is The Pentagon Modifying Viruses To Save Crops — Or To Wage Biological Warfare?

Defense Advanced Research Projects (DARPA), a US government agency, has recently been accused of trying to develop bio-weapons on the pretext of using plant viruses and insect vectors to edit crop genes. Dr. Blake Bextine, who is the program manager of the 2016 “Insect Allies” program of DARPA has stated that using virus infected insects to deliver genes to crops, also known as horizontal transfer in scientific jargon, is a potentially powerful and quick measure to protect crops against sudden, unforeseen environmental offenses like drought. Alternative vectors currently in use, such as insecticide sprays, and plant genetic modification strategies, including vertical gene transfer, are either not robust or take several crop generations to become fully functional, he argues. On the other hand, the Insect Allies program’s three-step technical workflow, viral manipulation, insect vector optimization, and selective gene therapy in mature plants, will ensure a quick result, effectively within a generation.

The new plan by DARPA has resulted in international concerns about the ulterior motive for developing viral carriers to infect plants. An editorial published in Science last month by Richard Guy Reeves from the Max Planck Institute for Evolutionary Biology, in Germany, explicitly states that the DARPA program could be used for potential development of biological weaponry targeting crops of enemy nations. The editorial discusses the profound environmental, biological, economic and social implications of dispersing such horizontal environmental genetic alteration agents (HEGAAs) into ecosystems. Silja Voeneky from University of Freiburg in Germany, who is an expert in international law and a co-author of the commentary, states that according to the Biological Weapons Convention (BWC), which USA ratified in 1975, use of living organisms are banned as war weapons. She doesn’t believe that the proposed Insect Allies program by DARPA will be exclusively restricted towards benefitting crops.

The most important concern raised in the commentary is the proposed use of insects to infect the crops with genetically modified viruses. The authors have questioned the use of insects, a potential bio-weapon, against simpler methods of dissemination, like sprays. The plan by DARPA to use infected insects is probably its response to similar, covert initiatives already in development by other nations towards bio-weaponry, the commentators believe. On the other hand, the authors also see the unveiling of Insect Allies program as the initiation of efforts from various nations to develop similar strategies. Effectively, it has opened the Pandora ’s Box.

Meanwhile, the program is in full swing with DARPA-funded scientists from several institutes participating in the research that will develop the HEGAA technology. One of them, Jane Polston from University of Florida, points out that the new technology can be used in many ways, including ones she can’t predict.

DARPA denied the assertions made by Reeves and his colleagues, stating that they acknowledge that the new technology can have potential dual use but they also have numerous, layered safeguards in place, to maintain biosecurity.

(Dan Charles, NPR)

 

Drug for rare disease disappoints in key trial

Niemann-Pick type C disease (NP-C) is a rare genetic disorder where lipid molecules accumulate in various tissues, like brain, liver or spleen, instead of being recycled or cleared. This inherited condition affects infants, children and adults and an estimated one in 120,000 live births has this condition. The symptoms may vary depending on the organ that has the lipid deposits. Some of the common symptoms are prolonged jaundice, enlarged liver or spleen, learning difficulties and psychiatric problems. Young patients with NP-C commonly present symptoms such as difficulty in maintaining posture and balance and difficulties in swallowing. NP-C is, however, progressive and ultimately fatal.

Mallinckrodt Pharmaceuticals, a USA based company headquartered in St. Louis, Missouri, had been carrying out a 52 week clinical trial of the efficacy of a cyclodextran  (sugar molecule) VTS-270 to limit the progression of NP-C. VTS-270 was brought into clinical trials jointly by National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH) in Bethesda, Maryland and Vtesse, an orphan drug developer based in Gaithersburg, Maryland, that funded the first clinical trial of the drug at the NIH Clinical Center. Vtesse was acquired by Sucampo Pharmaceuticals in March 2017, which, in turn, was acquired by Mallinckrodt, along with the pipeline of the pivotal VTS-270 phase 2/3 trial, earlier this year.

The trial recently came to a disappointing conclusion when no difference in clinical outcomes was found in treatment and placebo groups. The news was first circulated by investors of Mallinckrodt, through whom the families of trial participants came to know of the study results. It was a huge disappointment for these families to learn that this drug was found to be ineffective, after months of invasive treatment and some positive effects observed in several participants.

Steven Romano, the executive vice president of Mallinckrodt and its chief scientific officer told investors on a conference call on last Tuesday that although the expectation was that the treatment group would show slower disease progression than the control group, the study results surprisingly showed that the disease in both groups progressed at a similar rate during the study period, with was lower than the expected rate of progression without any treatment.  

Like most clinical trials, the VTS-270 study used traditional double-blinded and randomized control trial (RCT) statistics to arrive at their conclusions. Also, the participants were assessed only during the 52 week window of the trial, where they received spinal injections of the drug or placebo every two weeks. There are some anomalies in this research protocol, say researchers in the field. A double-blinded, RCT might not be the best method to study extremely rare diseases, where symptoms could overlap vastly with other disorders, leading to a general under-reporting. They say that the “difficulty of enrolling patients may prevent traditional trials from having enough statistical power to achieve predefined statistical significance, even when the experimental agent is actually effective”.

Dr. Mark Patterson, a child neurologist at Mayo Clinic in Rochester, Minnesota, says that the same drug was shown to be effective in studies involving mouse and cat model of the disease. He thinks that the treatment might be effective in some children, but not all of them. Moreover, observing the trial participants only during the one year trial window is not an effective assessment of the disease progression, particularly for a slow-progressing disease like NP-C, he believes. Progression should have been assessed before the commencement of the trial and followed up after the end of the trial to detect an effect of the trial medication versus placebo.

Dr. Patterson has suggested that the FDA should consider setting a different “bar” while assessing therapies for extremely rare and individually variable diseases, like NP-C.

(Meredith Wadman, Science)

 

Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

November 13, 2018 at 9:07 pm

Science Policy Around the Web – November 9, 2018

leave a comment »

By: Neetu M. Gulati, Ph.D.

vaccination-2722937_1280

Source: Pixabay

 

 The FDA just approved the first new flu treatment in nearly 20 years

In the midst of flu season, there is a new treatment option available for the first time since 1999. On October 24, 2018, the FDA approved the use of a new antiviral drug Xofluza (baloxavir marboxil), for the treatment of influenza (flu) in patients 12 years of age and older who have been symptomatic for fewer than 48 hours. The drug is taken as a single oral dose, and is expected to shorten flu symptoms by more than a day. Now that it has been approved, Xofluza should be available within the next few weeks for purchase according to Genetech, which distributes the medication in the US.

The flu is one of the most common infectious diseases, resulting in 3 to 5 million severe cases annually worldwide. Last year the flu season was particularly deadly, resulting in nearly 80,000 deaths in the US alone according to the CDC. This could be due to a mismatch between the available flu vaccine and circulating strains of the influenza virus. However it could also be attributed to the fact that only about 4 out of every 10 Americans received the flu vaccine during the 2017 season. “With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option,” said FDA Commissioner Dr. Scott Gottlieb in a news release about the drug.

Xofluza, the first in a new class of antivirals for treating flu, acts differently than previously approved antiviral medications like Tamiflu. While both classes of antivirals  shorten the duration of infection and can reduce flu symptoms, they have different ways of killing the virus. Xofluza acts by inhibiting the cap-dependent endonuclease protein of the influenza virus, which is essential for viral replication, thus stopping the spread of infection.

This new medication offers a promising new treatment option for individuals with the flu. Nevertheless, Gottlieb warned that antiviral medications like Xofluza are not an alternative to getting vaccinated, saying, “seasonal flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can result in hospitalizations. Yearly vaccination is the primary means of preventing and controlling flu outbreaks.”

(Angelica LaVito, CNBC)

 

New generation of ‘flow batteries’ could eventually sustain a grid powered by the sun and wind

 

Renewable energy sources have become increasingly popular in recent years. Advancements in renewable technologies lay the groundwork towards a cleaner and more sustainable future. These renewable sources, such as wind and solar power, depend on nature to comply with the energy needs of the masses. But what happens when the sun isn’t shining? In that case, energy companies could turn to a new technology called flow batteries, large devices capable of storing enough electricity to power thousands of homes for many hours.

Flow batteries use tanks of liquid electrolyte that store electric charge. The electrolyte is pumped through electrodes to extract electrons used in electricity, and then spent electrolyte then returns to the tank. When solar panels or wind turbines provide electrons, the pumps push spent electrolyte back to the electrode, where it is recharged and returned to the holding tank. These batteries typically rely on an expensive and rare metal called vanadium for the electrolyte component. Alternatives to vanadium such as zinc-bromine and organic molecules are often short-lived or toxic, limiting their use. However, the price of vanadium has risen in recent years, and so the cost of these batteries may rise as well. The current market for flow batteries is about $230 million and is predicted to grow to nearly $1 billion by 2023.

There is a need for cheap, long-lived, safe alternatives to vanadium in flow batteries. Recently researchers reported developing an organic electrolyte that is much longer-lived than previous attempts at organic liquid electrolytes; this material loses only 3% of its charge-carrying capacity per year. This is a significant improvement over previous organic flow batteries, but still may not be good enough for commercial use. Another alternative electrolyte is iron. Iron is cheap and can grab and give up electrons. However, iron-containing flow batteries currently on the market must be operated at very acidic pH, which raises concerns about environmental damage in the case of a battery leak. Now, researchers have developed iron-containing flow batteries that can be kept at neutral pH. Furthermore, this flow battery shows no signs of degradation after the equivalent of 3 years of use. However, they are less energy-dense than vanadium flow batteries, somewhat limiting their usefulness.

These improvements in battery technology are provide hope for supporting the renewable energy moving forward. However, it remains unclear which electrolyte chemistry, if any, will win out. There is great potential for innovation and growth, but scientists are undoubtedly making progress.

 

(Robert F Service, Science)

 

Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

November 9, 2018 at 4:16 pm

Science Policy Around the Web – November 6, 2018

leave a comment »

By: Patrick Wright, Ph.D.

syringe-1884779_1280

Source: Pixabay

FDA

FDA says it will consider approval of first dengue vaccine, despite controversy

Dengvaxia is the world’s first licensed vaccine against dengue, and has recently entered the FDA review process. Upon starting the review process the company behind the drug, Sanofi Pastuer, received notice of priority review from the U.S. Food and Drug Administration (FDA), meaning a decision will be made regarding its status within six months. Despite the expedited review and the vaccine’s promise in the fight against dengue, there remain concerns around its safety.

There are 400 million infections of dengue a year worldwide. It is transmitted via mosquito bite and can cause high fever, severe headache, hemorrhage, and death. Although it is uncommon on the U.S. mainland, there are notable and not-insignificant levels of infection in U.S. territories, including Puerto Rico, Guam, and the U.S. Virgin Islands. In Puerto Rico, for example, 3,000-9,000 suspected cases are reported during non-outbreak years. Since 1990, there have been four large epidemics, with one as recent as 2010, in which almost 27,000 cases of suspected dengue were reported.

Dengvaxia targets all four serotypes of dengue. Infection with one is not protective against subsequent infection, and in fact the risk of having severe dengue is highest during a person’s second infection due to a phenomenon called antibody-dependent enhancement (ADE). ADE occurs when preexisting antibodies from an initial dengue infection find a viral particle from a new infection. These antibodies do not neutralize the new virus, instead allowing the new virus to infect target cells (e.g. monocytes) more efficiently. While Dengvaxia is currently licensed in 20 countries, it is only available in 10.

In November 2017, Sanofi reported that the vaccine raised the risk of severe disease in children without prior dengue infection. These data showed that children who were vaccinated after at least one dengue infection were protected by the vaccine; it lowered the risk of hospitalization for severe infection. However, in children with no history of dengue, the vaccine not only acted like a first infection, but also made any future infection of dengue more severe.

Sanofi’s findings drove the Strategic Advisory Group of Experts on Immunization of the World Health Organization (WHO) to recommend that the vaccine be given only to people who have had a previous infection. In a September 2018 position paper, the WHO stated “…countries should consider introduction of the dengue vaccine CYD-TDV [Dengvaxia] only if the vaccination of seronegative individuals can be avoided”.

Because many people infected with dengue experience mild to no symptoms, they often do not see seek formal medical care. This is especially problematic in light of the necessity for a confirmed previous infection in order to receive the vaccination. This will require people to be tested for the presence of antibodies (indicating a prior infection) before receiving vaccination, or to have a documented laboratory confirmed history of dengue infection. These concerns must be balanced against the potential widespread positive impact that dengue vaccination could have all over the world.

(Helen Branswell, StatNews)

FDA

Despite Warnings, FDA Approves Potent New Opioid Painkiller

On October 12th,  the Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 to approve Dsuvia (sufentanil), a powerful opioid painkiller produced by AcelRx. The Committee assesses a drug’s safety and efficacy to guide Food and Drug Administration (FDA) decisions, and following the vote the FDA approved Dsuvia.

Notably, the committee convened in the absence of the Committee’s Chair, Dr. Raeford Brown, who had previously expressed concerns regarding opioid approval, and without the full attendance of the FDA’s Drug Safety and Risk Management Advisory Committee. Dr. Brown, an anesthesiologist at the University of Kentucky, disagrees with the approval of the drug, saying that he does not “think this [Dsuvia] is going to help us in any way”. He was unable to attend the meeting due to a scheduling conflict that he had informed the FDA about months in advance, but the meeting was held anyway. Dr. Brown stated, “I have strong feelings about the opioid crisis, as someone who lives in the Commonwealth of Kentucky. My forthright nature may have played a role in their decision about how the agency was going to manage this advisory committee.”

Before the FDA’s final decision, four U.S. senators, Claire McCaskill (D-Missouri), Ed Markey (D-Massachusetts), Joe Manchin (D-West Virginia), and Richard Blumenthal (D-Connecticut) sent a letter to the FDA’s commissioner, Scott Gottlieb, asking the FDA to deny approval to Dsuvia until the full drug safety committee and Brown were allowed to participate. The letter states: “Given the tragic arc of the opioid epidemic, it is imperative that the FDA thoroughly and completely vet any new opioids or formulations of existing opioids through a robust, transparent, and fair process. We do not believe the FDA’s process for Dsuvia has remotely met this standard.”

Dr. Pamela Palmer, an anesthesiologist and co-founder of AcelRx, argues that the risk of Dsuvia ending up with people who are not prescribed the drug (known as diversion) is low given that it will not be dispensed to patients via pharmacies; it will be only provided by health care providers directly in medical centers, such as hospitals, surgical centers, and emergency departments. AcelRx describes Dsuvia as filling a unique niche given that it is delivered sublingually (e.g. instead of injection) and is fast-acting. Dr. Palmer stated that the Department of Defense helped fund the company’s research because of Dsuvia’s potential use on the battlefield as an alternative to morphine. Sufentanil is as much as 10 times more potent than its parent drug, fentanyl, and hundreds of times more potent than morphine.

FDA Commissioner Gottlieb issued a statement on November 2nd discussing the ongoing issue of balancing the opioid crises with patients’ needs for pain management. He stated that the true underling source of discontent among critics of Dsuvia’s approval is “…the question of whether or not America needs another powerful opioid while in the throes of a massive crises of addiction. It is an important question that has surfaced in past approval decisions and will come up again in the future. We owe it to Americans who want the FDA to do our part to help end one of the biggest addiction crises of modern times, while we carefully balance these grave risks against patient needs.”

(Jake Harper, NPR)

 

Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

November 6, 2018 at 3:44 pm

Science Policy Around the Web – November 2, 2018

leave a comment »

By: Allison Cross, Ph.D.

Picture1

Source: Flickr

Opioid Epidemic

Signing Opioid Law, Trump Pledges To End ‘Scourge’ Of Drug Addiction

The nation is facing a devastating opioid epidemic.  In 2017 alone, the CDC reported over 70,000 drug overdose deaths in the US, with about two-thirds of those deaths linked to opioids.  More strictly, it is estimated that more than 115 people die every day in America from opioid-related overdose. President Trump declared the opioid epidemic a national public health emergency in October of 2017. And now, on October 24th 2018, President Trump signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.  The bill received bipartisan support, passing 393–8 in the House and 98–1 in the Senate.

 What does the new legislation do?

The new law is intended to combat the opioid crisis though Medicaid, Medicare and public health reforms. These will address over prescription of opioids, advance treatment options, encourage development of non-addictive painkillers and stop the flow of illicit drugs from outside the country.

What does the new law mean specifically for the FDA?

With the passing of the bill,  FDA Commissioner, Scott Gottlieb, released a statement that the new legislation grants the FDA additional authorities they believe will be meaningful in advancing their efforts to combat the opioid crisis. The FDA has taken new steps over the past 18 months to work towards combating the crisis, and has focused its efforts in 4 main areas; decreasing exposure to opioids, advancing innovation in low-risk pain medications, developing and implementing improved treatment for opioid use disorder and increasing efforts to prevent the illegal shipment of drugs including fentanyl into the US.

The new law gives the FDA authority to destroy illegally imported or hazardous drugs and halt the distribution of any drug that is deemed a public hazard. It also gives the FDA authority to prohibit all future drug importation from those convicted of a felony involving illegal import of drugs and from manufacturers, distributors, or importers who have shown a pattern of importing misbranded drugs. This will allow the FDA to expand and improve their oversight of international mail facilities and prevent drugs from entering the US illegally.

The SUPPORT Act also gives the FDA authority to order a recall for a controlled substance that is found to cause serious adverse health consequences or death.  Up to this point, a recall was a voluntary action taken by a company to remove their product from the market.

With the new legislation, the FDA has the ability to require specific packaging and disposal of drugs that pose a risk of abuse. This could help lower the number of opioids in the hands of patients by requiring packaging such as unit dose blister packs and requiring that opioids be dispensed with a mail-back pouch or other safe disposal option.

The SUPPORT Act clarifies the FDA’s authority to require post-approval studies of drugs that contain controlled substances.  These studies will help advance the understanding of opioid pain medicines including the long-term efficacy of opioids for the treatment of chronic pain.  Furthermore, the act requires that the FDA provide guidance for collecting data on opioid sharing and including this information on product labels.

Is it enough?

Despite bipartisan support, and most experts and advocates viewing the changes in the law as positive, some people are already voicing concerns that the bill is just not enough. The biggest criticisms come down to money.  The legislation makes a lot of legal and regulatory tweaks, but it does not provide a significant increase in spending for the opioid crisis.

(Ayesha Rascoe and Scott Horsley, NPR)

(FDA Commissioner Scott Gottlieb, FDA Press Announcements)

Vaccination

Officials: Number Of Measles Cases Doubles In Just Days, 33 And Climbing

As of October 19, 2018 there were 17 cases of measles reported in New York state linked to recent travel to Israel.  These cases, 11 of which were reported in Rockland County, sparked the Rockland health commissioner to require unvaccinated students attending schools in which confirmed cases were reported to remain home until November 3rd.  On October 28th, health officials announced that the number of confirmed cases had more than doubled, with a total of 33 confirmed cases.

This news comes at the same time as misleading headlines suggesting a multi-state measles outbreak in the United States.  Though the CDC has reported 142 individual cases of measles confirmed in 25 states and the District of Columbia as of October 6th 2018, the CDC recently tweeted that the “number of US-reported cases in 2018 is similar to recent years & in expected range.”  Despite the lack of a multi-state outbreak, the CDC does warn that the measles is still common in many parts of the world and people should get vaccinated.  The prevalence of measles across the globe allows it to be brought to the US by unvaccinated travelers, as it was in the recent local outbreak in New York.

A vaccine to measles first became available in United States in 1963, with an improved version developed in 1968. The vaccine, normally combined with the mumps and rubella vaccines, is commonly known as the MMR vaccine. With availability of a vaccine, disease rates were dramatically reduced and the disease was declared eliminated (absence of continuous disease transmission for greater than 12 months) in the United States in 2000.

Despite the availability of the MMR vaccine and disease elimination, local outbreak of measles (like other vaccine-preventable diseases) occur every year in the United States.  There are no US federal vaccination laws, but children attending public schools in all 50 states are required by state law to be vaccinated against measles.  All states, however, do allow medical exemptions, 47 states allow exemptions for religious reasons, and 18 states allow personal belief exemptions.

A recent study published in PLOS Medicine examining the relationship between non-medical expectation (NME) rates and actual vaccine coverage showed that states with higher NME rates exhibited lower rates of MMR vaccination among kindergarteners.  The 2015 measles outbreak linked to the Disneyland Resort in Anaheim, California was believed to be the result of substandard vaccination compliance, with a 50%–86% vaccination rate reported among the exposed population.  Following this outbreak, the California State Legislation passed a statewide bill banning NMEs beginning in January 2016, resulting in an increase in the state’s kindergarten vaccination rate.

In 2017, the CDC reported that 91.1% of children between 19-35 months received the MMR vaccine nationwide.  With measles being a highly contagious disease, a study from 2015estimated that vaccination rates need to be as high as 96 to 99% are to preserve herd immunity and prevent outbreaks.  This raises the question of whether stricter legislative action should be taken to put an end to NMEs in order to protect children from the measles and other vaccine-preventable diseases.

(CBSNewYork)

Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

November 2, 2018 at 2:22 pm