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Science Policy Around the Web – November 6, 2018

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By: Patrick Wright, Ph.D.

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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)

 

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November 6, 2018 at 3:44 pm

Science Policy Around the Web – November 2, 2018

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By: Allison Cross, Ph.D.

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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)

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November 2, 2018 at 2:22 pm

Science Policy Around the Web – October 30, 2018

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By: Ben Wolfson, Ph.D.

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Retractions

What a massive database of retracted papers reveals about science publishing’s “death penalty”

One of the biggest issues facing research is the high number of retractions of published papers. Almost a ten years ago, members of the scientific community began to realize that there the number of retractions was increasing. The blog Retraction Watch was formed in 2010 to report on the phenomenon, and in October 2011, Nature published an article finding that retractions had increased 10-fold in the past decade. These and other sources sparked introspection within the scientific community and calls for structural reforms, however these have yet to result in systematic change. In part this is due to the inherent difficulty of examining the retraction phenomenon. While the increase in retraction was alarming, the lack of consistency in how journals reported them confounded statistics, making direct analysis and subsequent action difficult. One strategy for dealing with this has been for third parties to create their own databases. Over the past decade of reporting, Retraction Watch compiled a list of retractions, which was made public as a searchable database this past week. 

Through analysis of the database, Science magazine made several conclusions, including that the rate of increase of retractions has slowed, and that the a high percentage of the growing number of retractions is likely due to improved oversight rather than increased research misconduct. Moreover, of the retractions due to misconduct, a disproportionate number of them are from a small population of authors, demonstrating a potential pattern of “bad-actors” within the scientific community. 

In addition to the confounding statistics, the stigma associated with retractions makes it more difficult for reforms to be carried out. Authors whose papers are retracted often do not want to cooperate, and journals are sometimes hesitant to retract a paper, knowing that such action bears serious implications for the author.

Retraction Watch’s database is currently the most detailed source on retractions and an official database is necessary infrastructure for the future of scientific research. While the conclusions drawn by Science are a good first step, they also indicate the breadth of the work yet to be done.

(Jeffrey Brainard, Jia You, Science)

Stem cell clinics

Federal Trade Commission takes action against stem cell clinics

On October 12th the Federal Trade Commission took its first action against stem cell clinics when they filed a complaint concerning unsupported health claims made by two Californian stem cell clinics. The clinics had advertised that their amniotic stem cell therapy was capable of treating a variety of diseases, including heart attacks, autism, macular degeneration, Parkinson’s disease, cerebral palsy, and multiple sclerosis, none of which currently have FDA approved stem cell therapies. After negotiation, the companies have settled the complaint, agreeing to pay a fine and not engage in false advertising in the future.

Hundreds of stem cell clinics have come into existence in recent year, selling treatments for a multitude of conditions. While stem cell research is a current hot topic and researchers hope that stem cells may one day be used to repair damaged tissues and organs, the treatments sold by these clinics are not proven or FDA approved. As of 2016, there were 570 stem cell clinics throughout the United States. These clinics advertise autologous stem cell procedures, wherein a patient’s own stem cells are harvested from their adipose tissue (fat) or bone marrow and reinjected into the patient. Stem cell clinics claim that these treatments should not be FDA regulated as they are made up of patient’s own cells, and that they are merely facilitating patients utilization of their own natural healing ability. 

This action by the FTC follows the Food and Drug Association seeking a permanent injunction against two clinics in California and Florida in May of 2018 as a result of reports of misconduct by both clinics. The California clinic, Stem Cell Treatment Center, created an experimental cancer treatment from a non-commercially available smallpox vaccine, and procedures conducted by the Florida-based US Stem Cell clinic resulted in 3 women becoming legally blind in 2015. 

These are not the only cases of patients being harmed by stem cell treatments, and experts hope that this FTC and FDA activity indicate a new beginning for regulation of U.S. stem cell clinics. 

(Ashley P. Taylor, The Scientist)

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October 30, 2018 at 4:36 pm

Science Policy Around the Web – October 26, 2018

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By: Mohor Sengupta, Ph.D.

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Source: Pixabay

Environmental Problems

A 14-year-long oil spill in the Gulf of Mexico verges on becoming one of the worst in U.S. history

In the year 2004, hurricane Ivan leveled an oil production platform in the Gulf of Mexico, owned by Taylor Energy. Its striking magnitude destroyed the colossal platform which had drilled into several oil wells. The result was a huge mound of muck, filling the broken steel structure and leaking oil. To date, efforts to seal off the leakage have not been successful.

Taylor Energy at first denied that there was any leakage and then underreported the extent of the leakage. According to current estimates, about 700 barrels of oil are leaking per day, with each barrel holding 42 gallons of oil. The company has kept this information a secret for many years, and few people are aware of the actual level of spillage. The Taylor Energy spillage in fact pre-dates the Deepwater Horizon oil spill (also called the BP leak), so far the largest marine oil spill in history at 168 million gallons. While BP has coughed up $66 billion for fines, legal settlements and cleanup, Taylor Energy is a comparatively smaller operation and financially too cash-strapped to afford cleanup on such a large scale.

In these actions Taylor Energy flouted both the EPA’s Oil Pollution Act of 1990, which mandates that spillage must be reported to the U.S. Coast Guard National Response Center (NRC), and the Clean Water Act of 1972, which created a structure for regulating water pollutants. Taylor Energy was taken to court by environmentalists, and Taylor Energy and the NRC have been jointly found accountable in presenting false numbers and data. In an assessment submitted to Taylor Energy in 2009 by Waldemar S. Nelson and Company, a private firm, risks involved in ingesting fish from the affected area were discussed. A recent and independent analysis by the Justice Department showed that the original estimate of 1 to 55 barrels of leakage per day provided by NRC was inaccurate. After several spillage tests Oscar Garcia-Pineda, the author of the article, concluded that his results didn’t tally with those reported by NRC and the actual rate of spillage was 48 to ~1700 barrels per day.

These disturbing findings have arrived at a delicate time for environmental protection policy. Earlier this year, the Trump administration proposed a wide expansion of leases to the oil and gas industry. This would render all off-shore areas on the continental shelf, including those along the Atlantic coast, amenable to drilling. Oil and gas representatives are lobbying for this cause and have provided financial justifications including billions of dollars’ worth of annual economic growth, increased jobs and lower heating costs. However, multiple governors representing states across the four planning areas, from Maine to the Florida Keys, are opposed to this proposal.

Reports show that on average there are 20 uncontrolled releases of oil per 1000 wells under state or federal governments. In Louisiana alone, approximately 330,000 gallons of oil are spilt from off-shore and on-shore rigging platforms. With changing climate patterns, hurricanes on the Atlantic are predicted to be more intense in future, and given the government’s plans to extend rigging along the Atlantic coast, a bleak prospect looms ahead.

(Darryl Fears, Washington Post)

Health Supplements

The Problem with Probiotics

The healthy balance or maintenance of the natural flora of the gut, also called the gut microbiome,is essential for a healthy digestive system. Antibiotics have been shown to disrupt the gut-microbiome, resulting in diseases such as diarrhea and infections with Clostridium difficile. As an antidote, it has been common practice to pop in “good bacteria”, or probiotics, while on antibiotic treatment. These probiotics are essentially a mixture of supposedly healthy gut microbiota and are meant to replace those disrupted by the antibiotic.

Although people commonly take probiotics, this class of product is not regulated by the FDA and there are rising concerns about the standard of manufacture and quality of these commonly sold over-the-counter health supplements. Most recently, Dr. Pieter A. Cohen cautioned against overlooking the harmful effects of widely marketed probiotics in his recent article published in “JAMA Internal Medicine”.

There have been several studies discussing the benefits of probiotics, so much so that the journal “Nutrition” recently published a systematic review of systematic reviews. In a nutshell, all the studies ever done on efficacy of probiotics have produced very limited positive results and only pure microbial strains were used as the probiotic supplement in these studies. On the other hand, there has been no evidence to show that probiotics have been beneficial in treating conditions such as Crohn’s Disease, chronic diarrhea, ulcerative colitis or liver disease, all related in some way to the gut microbiome.

Safety assessment studies have found probiotics to be contaminated with unwanted microbial strains, and without FDA regulation of the manufacturing process production doesn’t often follow a well-defined pipeline. It is not known what kinds of health hazards might be caused by these contaminants, warns Dr. Cohen, and they can be lethal. In a notorious case, the death of an infant was attributed to a contaminated dietary supplement.

Unfortunately, none of these events have deterred Americans from using probiotics. Almost four million people, or 1.6 percent of adults in the United States used probiotics in 2012 and the global market for probiotics is steadily on the rise. In this situation, it is of great importance for dietary supplements be given the rigorous assessment and quality control checks that a prescription drug undergoes. There should be increased efforts to make consumers aware of adulterations in probiotics.

(Aaron E. Carrol, New York Times)

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October 26, 2018 at 12:36 pm

Science Policy Around the Web – October 19, 2018

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By: Ben Wolfson, Ph.D.

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Source: Pixabay

Climate Change

 

Climate Change prompts a rethink of Everglades management

The Florida Everglades is a large area of tropical wetlands that has received significant attention due to the degradation of its unique ecosystem by urban development. The Everglades were designated a World Heritage Sitein 1979 and Wetland Area of Global Importancein 1987, and in 2000 Congress approved the Comprehensive Everglades Restorative Plan (CERP) to combat further decline and provide a framework for Everglades restoration.

For the past 18 years, these efforts have been directed towards curtailing damage from urbanization and pollution. However, as outlined in a congressionally mandated report released on October 16th by the National Academies of Science, Engineering, and Medicine, new strategies may be necessary. In the biennial progress report, an expert panel called for CERP managers to reassess their plans in light of new climate change models. The report focuses on the 7 centimeters of sea level rise seen since 2000, and points out that Southern Florida is especially at risk from climate change and is expected to experience a 0.8-meter rise in sea level by the year 2100.

It is clear that as more is learned about the realities of climate change, the goals and methods of conservation projects are shifting, and past strategies must be adapted to fit the realities of a warming world.

(Richard Blaustein, Science)

Animal Research

NIH announces plan for chimp retirement

 

In 2015, the NIH announced that it would no longer support biomedical research on chimpanzees, two years after pledging to significantly reduce the numbers of chimpanzees used in research. These decisions were made based on a combination of reduced demand for chimpanzees in research and the designation of captured chimpanzees as an endangered species in 2015.

On Thursday October 18th, the NIH announced the next step in the process of retiring research chimps. While research was stopped in 2015, many of the chimpanzees had nowhere to go and remained housed at laboratories. One federal chimpanzee sanctuary, Chimp Haven, exists in Keithville, Louisiana, however lack of space and the difficulty of relocating some animals has slowed their transition to better habitats.

In the Thursday announcement NIH director Francis Collins outlined the guidelines for future chimpanzee relocation. These include streamlining medical records and determining whether chimpanzees are physical healthy enough to be relocated. Many of the chimpanzees are at an advanced age, meaning they have developed chronic illnesses similar to those experienced by humans. However, Collin’s emphasized that there must be a more acute medical problem for relocation not to take place. In addition both the research facility and Chimp Haven must agree that the former research chimpanzees are capable of being relocated, and disagreements will be mediated by a panel of outside veterinarians.

Collins additionally stressed that while transfer to Chimp Haven is the ideal outcome for all retired chimps, those housed at NIH-supported facilities do not live isolated in cages or in laboratories and are housed in social groups with appropriate species-specific accommodations.

The development of these clear guidelines will expediate chimpanzee relocation while emphasizing chimpanzee health and comfort.

(Ike Swetlitz, Statnews)

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October 19, 2018 at 3:25 pm

Science Policy Around the Web – October 16, 2018

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By: Sarah L. Hawes, Ph.D.

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Transparency

AAAS CEO Defends Scientific Evidence, Urges EPA to Scrap “Transparency” Rule

On October 3, a Senate subcommittee heard support and opposition to the “Transparency Rule” initiative proposed to guide which scientific evidence could be considered when forming EPA policy. The House version of the rule passed in March 2017, and the context within which the rule would be implemented is discussed in the May 8, 2018 Science Policy for All linkpost EPA Cites “Replication Crisis” in Justifying Open Science Proposal by Saurav Seshadri, PhD.

During recent Senate hearings, the American Association for the Advancement of Science CEO Rush Holt testified that in his view a requirement that research make all data publicly available would eliminate specific types of research, and that this could be used to justify reliance on a subset of science supporting particular policy, and producing politically motivated results “in order to loosen regulations” rather than for the purpose of increasing independent evaluation and reproducibility. He testified that in many cases within EPA purview, such as analyses of the effects of natural disasters or accidental human and environmental toxin exposures, reproducing results is not realistic or relevant. Furthermore, making all collected data public would violate privacy rules where medical records are involved, and studies conducted under conditions of confidentiality would be unusable although data such as individual names are irrelevant to statistical outcomes.

Professor of toxicology, Edward Calabrese from the University of Massachusetts, and Robert Hahn of the Georgetown University Center for Business and Public Policy both testified in favor of the Transparency Rule. Professor Calabrese additionally urged all data initially considered in crafting policy be included in public documentation along with explanations of why any was discarded – potentially requiring a substantial burden during the policy formation process making development of new policies prohibitively difficult. Dr. Hahn urged the Transparency rule be applied across all federal agencies.

(Anne Q. Hoy, AAAS News)

Antibiotic Resistance

New study links common herbicides and antibiotic resistance

Executive Order 13676 established the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) which developed a five year (2015 – 2020) National Action Plan emphasizing surveillance, identification of resistant bacterial characteristics, resistance prevention, and development of new antibiotics. No reference to agriculture occurs outside of surveillance of antibiotic resistance within livestock, transmission of resistant pathogens to humans, and developing appropriate livestock practices. Despite thoroughly delineating the lines of inquiry expected of various agencies, nowhere does the plan mention agricultural crops or agricultural chemicals. However, a 2015 study found antibiotic resistance developed significantly faster in pathogens exposed to common herbicides in conjunction with antibiotics. According to the paper herbicides are routinely tested for toxicity “but not sublethal effects on microbes,” although it is known sublethal effects contribute substantially to antibiotic resistance.

A new study finds bacterial resistance to antibiotics increasing at rates up to 100,000 times faster in the presence of dicamba (Kamba) and glyphosate (Roundup) – herbicides commonly used worldwide. The earlier paper found the presence of herbicides increased the resistance of bacteria to the antibiotics or increased the effectiveness of the antibiotics against bacteria, depending on the combination of herbicide, bacteria type and antibiotic. The present study finds that even when the herbicide increased the lethality of the antibiotic, the rate at which the bacteria became resistant is also accelerated in the presence of herbicide. Informal peer comments note one of the antibiotics in the study (ciprofloxacin) has also been used recently as an herbicide, underscoring the importance of research into effects between these categories of chemicals.

It is becoming clear, as scientists pursue the goals of the National Action Plan to reduce antibiotic resistance, that the most carefully delineated 2015 plan cannot entirely encompass the scope of influences on antibiotic resistance. Continuing research shows that there is much we do not yet know.

(Margaret Agnew, University of Canterbury News)

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October 17, 2018 at 3:15 pm

Science Policy Around the Web – October 12, 2018

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By: Allison Dennis B.S.

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The power of genetics

We will find you: DNA search used to nab Golden State Killer can home in on about 60% of white Americans

In April, the worlds of law enforcement and personal DNA sequencing collided to forever change the game of forensics when detectives were able to identify a California man now charged with thirteen murders using a public database intended for connecting relatives through genetic ancestry. For almost 40 years, an unprocessed rape-kit from the case remained in storage, preserving the perpetrator’s DNA until forensic technology emerged that allowed investigators to profile thousands of DNA markers contained in the genetic material extracted from the kit. The markers used were part of the expansive panel usually included in direct to consumer DNA tests rather than those routinely included in law enforcement DNA databases. After submitting the complete DNA profile to the ancestry website GEDmatch, law enforcement agents found hits for several people genetically third-cousins to the killer, massively narrowing the list of suspects.

Since April, this so called “genetic genealogy” technique has been used by Parabon Nanolabs to identify about twenty other perpetrators from DNA queried from a hundred other cold cases using the 1 million profiles available through the GEDmatch database. While the science and methods behind this company’s success remain private, scientists have gotten curious about how realistic it is to use these types of searches.

Yaniv Elright, a computational geneticist at Columbia University, used a similar database of 1.28 million DNA profiles, MyHeritage, to find out. Searches revealed that for someone of European ancestry living in the United States the odds are as high as 60% that a genetic relative can be identified. This drops to 40% for someone of sub-Saharan ancestry, most likely due to 75% of the database being primarily of North European genetic background and therefore offering fewer potential matches.

As a further exercise, the researchers sought to use this approach to explore the feasibility of re-identify an anonymous DNA donor included in a public collection. While the process took a full day and was “time consuming and not trivial” according to the authors of the study, they were able to re-identify the individual. This finding calls into question the assumption baked into US federal research rules that removing identifying information is enough to anonymize DNA profiles. Just this week, half a million de-identified genomic profiles were made publicly available through the UK Biobank resource, which could be queried by “genetic genealogy.”

It is clear that DNA profiles when combined with genetically defined family trees represent a tremendous opportunity for identification. Already, ethicists and law experts are calling for legislative bodies to draw the line defining in what types of criminal cases these techniques can reasonably be used.

(Jocelyn Kaiser, Science)

 

Dietary Supplements

Dietary Supplements Can Contain Viagra, Steroids, or Worse

More than half of the adults living in the US report taking dietary supplements, an industry that is only regulated once products hit the shelves. It has been estimated that supplement use is responsible for more than 23,000 emergency room visits each year in the US, stemming from symptoms including heart palpitations, chest pain, and choking. The FDA maintains a list of Tainted Products Marketed as Dietary Supplements, whose disclaimer warns that it “only includes a small fraction of the potentially hazardous products with hidden ingredients marketed to consumers.” Testing is usually only pursued by the FDA once a consumer or physician has issued an alert.

Between 2007 and 2016, the FDA discovered that 776 tested dietary supplements contained unapproved pharmaceutical ingredients. Of these, 360 were voluntarily recalled by the manufacturer. For others on the list, the FDA issued warnings about 342, news releases for 58, consumer updates for eight, direct warning letters for seven, and a suggestion to the US Justice Department to investigate one for criminal wrongdoing. Although the FDA was granted the power to do so as early as 2011, the only mandatory recall that has been issued by the agency came in April of 2018 when a batch of Kratom capsules was discovered to contain salmonella, a known bacterial cause of diarrhea, fever and abdominal cramps.

Sexual enhancement, weight loss, and muscle building seem to be the common ailments targeted by the adulterated supplements, which were laced with sildenafil, sibutramine, and synthetic steroids. Sildenafil is the active pharmaceutical ingredient in Viagra, which is closely regulated by the FDA and requires a prescription. Sibutramine, which has been used for the medical treatment of obesity, was withdrawn from use in 2010 due to an increase risk of cardiovascular events. Short-term synthetic steroid use can lead to mental problems including paranoid jealousy, irritability, delusions, and impaired judgment. Long-term, they can lead to kidney problems, liver damage, and high blood pressure.

To what extent consumers perceive these over-the-counter supplements to be safer than regulated pharmaceuticals is unknown. Advocates for visible regulation, suggest that firms register all supplements before they are sold, which would give the FDA the opportunity to step in before customers risk injury.

(Emily Dreyfuss, Wired Magazine)

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Written by sciencepolicyforall

October 12, 2018 at 4:19 pm