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Science Policy Around the Web – February 13, 2018

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By: Saurav Seshadri, PhD

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Experimental drugs

Trump Endorses “Right to Try” for Terminally Ill Patients

Proponents of the ‘right to try’ received some encouragement from President Trump’s recent State of the Union address, in which he announced his support for such legislation at the federal level.  Right to Try laws are designed to allow terminally ill patients to obtain unapproved but possibly lifesaving drugs directly from pharmaceutical companies, without involving the FDA.  While such laws already exist in 38 states, they are currently superseded by the Food, Drug, and Cosmetic Act; a bill that would eliminate this legal conflict was passed by the Senate last August, but has yet to be approved by the House of Representatives.

In general, Right to Try laws permit terminal patients, with their informed consent, to access investigational treatments if recommended by a physician.  However, they do not mandate that the manufacturer provide the drug or that insurance cover it, and in some cases, they absolve drugmakers and physicians from liability for adverse outcomes.  In addition, the FDA already offers a path to treatment for terminal patients under its ‘expanded access’ program, in which patients are treated as clinical trial participants and their doctor’s office becomes a satellite site, with appropriate regulatory oversight.  Opponents of Right to Try legislation, including FDA Commissioner Scott Gottlieb, argue that bypassing such oversight would critically undermine the clinical trial process (for example, a patient death from a drug obtained under a Right to Try law would not factor into the FDA’s consideration of that drug for approval).  They also suggest that these laws provide false hope for desperate patients – experimental drugs need only clear the safety phase of FDA trials, meaning no data exists on their efficacy – and open patients up to risks of physical harm and medical fraud.

Despite these concerns, Right to Try laws have gained momentum on the strength of anecdotal success stories, and politicians’ unwillingness to appear heartless towards patients suffering from terminal diseases.  Yet in reality, without securing financial support for patients, these laws are likely to result in some patients going bankrupt. Without requiring that treatments be demonstrated to be beneficial and at least safe, these laws are likely to result in patients pursuing ineffective treatments, while reducing their quality of life by enduring side effects, risking complications, and forgoing hospice care.  The future of Right to Try legislation may be influenced by new Health and Homeland Security Secretary (and former Eli Lilly executive) Alex Azar, who seems likely to support Trump’s agenda, though he didn’t mention the right to try in his response to the State of the Union address.  Ideally, the final bill will prioritize the existing drug review process, ensuring safety for the majority of patients while still providing hope for the sickest.

(Ike Swetlitz, STAT news)

Chemical safety

The truth about glyphosate may be getting lost in the weeds

The World Health Organization (WHO) kicked off a massive controversy in 2015 with its report labeling glyphosate, a component of an herbicide marketed by Monsanto, as ‘probably carcinogenic to humans’.  The report has faced stiff opposition from Republican Representatives on the US House Science, Space, and Technology Committee, largely fueled by a pair of Reuters reports suggesting that key data was suppressed by the WHO to support its conclusion.  Now Dr. Christopher Wild, Director of the group that conducted the research (the IARC, International Agency for Research on Cancer) has sent a detailed response to the Committee to rebut these criticisms and defend its original finding.

The response, which was presented at a recent Committee hearing by Democratic Representative Suzanne Bonamici, specifically addresses two issues raised by Reuters.  First, that a senior scientist failed to disclose data that would have exonerated glyphosate: the data was unpublished and therefore didn’t meet IARC’s criteria for consideration.  Second, that the published version of the report had several changes from an earlier draft, all of which involved deleting or revising statements that cast doubt on glyphosate’s link to cancer.  Dr. Wild claims that most of these changes were related to a single review article, whose conclusions were reconsidered when it was found to have been ghostwritten by a Monsanto scientist, and that its drafts are works in progress and therefore confidential.  Still, the response doesn’t explain the IARC’s discrepancy with other regulatory agencies: the European Food Safety Authority (EFSA) and US Environmental Protection Agency (EPA) have both found glyphosate to be safe, and claim their review processes are more transparent than the IARC’s.

The IARC’s stance on glyphosate puts it in a delicate position with the US government, from which it receives ‘valuable support’, especially as the topic becomes more partisan.  Republican lawmakers have already threatened to pull funding to the IARC, ostensibly over its refusal to provide a witness for the hearing (Dr. Wild invited them to visit his facility in France instead).  On the other side, the EPA’s assessment has been called into question by the discovery that an EPA official may have colluded with Monsanto to ‘kill’ investigation into glyphosate, leading Democratic Representative Ted Lieu to request a probe into the issue.  In the midst of a heated debate on climate change, the glyphosate story may initially seem to be another case of Republicans denying science to fight regulations and side with big business; however, the reality may be more complicated.  A recent protest in Paris by farmers, opposed to a proposed ban on glyphosate, highlights how those most affected by such policies must balance their economic stability against potential health risks.  Ultimately, though lawmakers may earn political points by siding with these individuals, if the price is discrediting accurate science and eroding public trust in regulatory agencies, no one wins.

(Corbin Hiar, E&E News)

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February 13, 2018 at 6:01 pm

Science Policy Around the Web – December 8, 2017

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By: Roger Mullins, Ph.D.

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Chemical Safety

Chlorpyrifos Makes California List of Most Dangerous Chemicals

Last Wednesday, the California Office of Environmental Health Hazard Assessment (OEHHA) passed a vote to add the organophosphorus pesticide Chlorpyrifos to Proposition 65, an extensive list of over 900 chemicals known to cause cancer, birth defects, or reproductive harm. While Chlorpyrifos was previously considered for inclusion on this list in 2008, updated scientific information gave the OEHHA cause for reassessment.

This new data included further information on the neurodevelopmental toxicity of Chlorpyrifos in humans and wildlife. Of particular concern to this board was its harmful effect on fetal brain development. Central to this decision was the extensive review of scientific evidence provided in the 2014 and 2016 EPA Human Health Risk Assessments, as well as new and additional findings not previously reviewed in these assessments.

On a national level, the findings of earlier EPA risk assessments resulted in a national ban on homeowner use as far back as 2000. The recent 2014 and 2016 reports further cemented the evidence for pervasive neurodevelopmental toxicity and also highlighted the danger of dietary exposure from residues in drinking water and crops. An all-out ban on Chlorpyrifos was proposed in 2015, revoking all pesticide tolerances and cancelling its registrations, but this was ruled out by the current Environmental Protection Agency (EPA) in 2017. This pesticide is still under registration review by the EPA, which re-evaluates their decision on a 15-year cycle.

Inclusion on California’s Proposition 65 list does not amount to a ban within the state, though products containing Chlorpyrifos will have to be labeled as such starting in late 2018. This action on the state level stands in contrast to federal decisions, and is a revealing lesson in regard to the complexity of national response to scientific evidence.

(Sammy Caiola, Capital Public Radio)

Gene Drives

US Military Agency Invests $100m in Genetic Extinction Technologies

Gene-drives, an emerging powerful gene-editing technology, have been drawing considerable attention and controversy for their proposed use in disease vector control. This method involves the release of an animal that has been genetically modified into a wild population, with the aim of breeding in genes that have been designed to reduce the species’ ability to spread disease. These introduced genes are preferentially inherited, resulting in their eventual dominance in the population. For example, a gene could be designed and introduced to provide resistance to a particular parasite or reduce fertility. This technique is proposed for use in controlling mosquito-borne diseases such as malaria and the Zika virus, as well as to halt the spread of invasive species.

Controversy over this technique however also hinges on its strengths. The primary concerns are the likelihood of animals with favorable modifications crossing over international borders, downstream effects on dependent species, and the possibility of irreversible harm to the ecosystem if the technique is misapplied. Appropriately, much of this concern comes from fellow scientists. In light of this, scientists and policy-makers alike have been proactive about addressing the safety and ethical issues presented, coming up with a set of specific guidelines to advance quality science for the common good. These entail an effort to promote stewardship, safety, and good governance, demonstrate transparency and accountability, engage thoughtfully with affected communities, stakeholders, and publics, and foster opportunities to strengthen capacity and education. Consensus on these issues is intended to help move this promising field forward in the face of growing public scrutiny.

Recently, a trove of emails from US scientists working on gene drive technology was acquired under the Freedom of Information Act and disseminated to the media. Some of these emails revealed the Bill and Melinda Gates Foundation’s engagement with a public relations company to influence the UN moratorium on the use of this technology. The Foundation has long been a financial supporter of the Target Malaria research consortium that seeks to develop gene drives for the eradication of Malaria. The concern surrounding the release of these emails realizes the common fear of scientists involved in research with the potential to fall under the public eye, as ironically, even attempts to recruit expertise in portraying your research favorably may be seen as damning.

This will inevitably be true of any powerful emerging technique to come in the future as well. With the advance of science’s ability to address problems effectively, there will be obstacles towards implementing new technologies and addressing concerns from the communities they may affect. Some of these will be valid and cause for moratorium and introspection, and some will be more attributable to sensationalism. Understanding and navigating these differences will be an increasing and ever-present concern for policy-minded scientists.

(Arthur Neslen, The Guardian)

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Written by sciencepolicyforall

December 8, 2017 at 1:35 pm

Science Policy Around the Web – June 10, 2017

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By: Allison Dennis, BS

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Animal Testing

Lack of Clarity Puts Chemical Safety and Animal Welfare at Odds

In the lineup of American stereotypes, the health-nut who cares about the chemicals in his shampoo is often the same person who cares if that shampoo was tested on animals or not. However, a bill signed June 22, 2016, known as the Frank R. Lautenberg Chemical Safety for the 21st Century Act, may be placing those two views at odds. The bill requires the U.S. Environmental Protection Agency (EPA) to implement a risk-based process to evaluate the safety of chemical substances currently being used in the marketplace and approve the use of new chemicals before their introduction. The bill was passed with bipartisan support and offered EPA the new-found power to fully regulate the use of well-known carcinogens like asbestos.

Yet the pathway forward for the EPA is daunting. More than 62,000 substances find their way into and onto our bodies through the products we use and our environment. While many of these substances have become associated with disease over time, how can the EPA certify the risks associated with different exposures to varying amounts of each substance on such an extensive list? The Act itself suggested that once the EPA has evaluated the existing information on the 62,000 substances currently in use, it spend the next twelve months triaging chemicals according to their potential risk. Next, the highest priority chemicals will be evaluated on a three-year deadline to develop knowledge of their toxicity and guidelines for their regulation. Ultimately, by clearly cataloging the risk of common chemicals the Frank R. Lautenberg Chemical Safety for the 21st Century Act promises to greatly reduce the amount of animal testing needed in the long-term.

In the meantime, however, the companies that use to-be-regulated substances in their products may be inclined to undertake independent toxicity testing, collecting enough data to guarantee that their favorite substances meet the low-risk criteria and avoid a drawn-out evaluation. Defining toxicity requires careful experimentation, which can sometimes be carried out in human cells outside of the body, but often require evaluation in animals. Animal rights groups like the Human Society find concern with the lack of transparency in the pre-prioritization process. They fear the eagerness of companies to provide data without any clear guidelines about how that data will be evaluated or what substances will require extensive evaluation could result in extensive and unnecessary animal testing. Further they suggested that the EPA require any new pre-approval data obtained by companies to be collected using non-animal methods. (Maggie Koerth-Baker, FiveThirtyEight)

CRISPR

Small Study may Reveal Big Concerns over CRISPR-Based Therapy

A one-page letter published in Nature Methods last week reports unexpectedly high levels of unintended changes to the genomes of mice that underwent a CRISPR-based therapy. Since it’s renaissance as a therapeutic tool in 2012, CRISPR has occupied the imaginations of scientists, doctors, patients, investors, and ethicists. CRISPR technology provides a relatively straight-forward and reproducible means to gene editing on the cellular level, but its applications to create heritable mutations in the human germ line is on hold until more is understood about the long-term effects such treatments would have.

The original study sought to explore potential long-term effects of germline manipulation by CRISPR in a mouse model. Guide RNA along with the Cas9 enzyme were injected into mouse zygotes, which introduced a correction in a mutation in the rd1 gene of otherwise blind mice. Initiating this change before the first cell division enabled this corrected mutation to be inherited by all cells arising in the developing mouse, consequently restoring the ability for the eyes to develop normally. In a follow-up experiment described in their one page letter, the researchers looked for mutations in the genomic DNA of two CRISPR-treated adult mice compared with a control mouse, revealing over 2,000 unintended mutations following CRISPR treatments. None of these mutations appeared to affect the mice, suggesting that deep genomic sequencing may be required to reveal unanticipated changes in an outwardly healthy mouse. Further, the nature of these unintended mutations offered few clues explaining how they might have occurred.

This result stands in contrast with other reports quantifying the extent of these unintended changes, which found CRISPR to be highly specific. While the CRISPR-Cas9 system has been observed to sometimes alter off-target regions of the genome, this activity can usually be curbed through the careful design and evaluation of the guide RNA. The limitations of this small study have been discussed extensively since its publication. However, the findings have sparked the need for further investigation into the long-term-whole-animal effects of germline-editing by CRISPR. As human germline-editing creeps closer to reality, the FDA will be tasked with developing an entirely new means of evaluating the safety of such technologies (Megan Molteni, Wired)

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Written by sciencepolicyforall

June 10, 2017 at 11:33 am

Science Policy Around the Web – May 31, 2016

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By: Emily Petrus, Ph.D.

Biomedical Research Salaries

Higher Salary for Postdocs Coming Soon

What do a Metrobus driver and a recent biomedical PhD graduate in have in common? Their salary! Although both positions are important to keeping society moving forward, figuratively or literally speaking, one can imagine the disparity between the educational time commitment between these two positions.

New rules set forth by the US Department of Labor dictate that employees with annual salaries falling below $47,476 must be paid overtime for hours they work beyond 40 hours per week.  Research scientists who have recently (typically within 5 years) received a PhD in biomedical sciences will undergo additional training before the next step in their career, similar to residency among medical school graduates.  These highly skilled postdoctoral researchers are called postdocs, and they fall below this threshold, with an average starting salary of $45,000.

This gives research organizations such as academic universities and the National Institutes of Health two options: track the hours their postdocs log at the bench and pay them overtime, or raise the base salary above the threshold.  Because scientific research rarely falls neatly into a 9-5 time table, NIH director Francis Collins is leading the NIH to increase postdoc pay to avoid logging hours for overtime pay.  Most academic research labs follow NIH guidelines for postdoc salary, so the NIH’s commitment to increase their pay should spill over into most other areas of biomedical research.  In a recent article penned by Collins and Thomas Perez, the U.S. Secretary of Labor, they called on the nation to “embrace the fact that increasing the salary threshold for postdocs represents an opportunity to encourage more of our brightest young minds to consider choosing careers in science.”

Although these salary increases will increase the pressure on labs already struggling with tight funding, it may serve as an incentive for future generations to choose biomedical research careers over driving a Metrobus. (Beryl Lieff Benderly, Science Articles)

Chemical Safety

United States poised to approve major chemical safety overhaul

Did you know that companies can use new chemicals in their products without demonstrating their safety for consumers or the environment? How about that the Environmental Protection Agency (EPA) cannot ask them to remove it until they demonstrate toxicity, which requires a costly amount of research and legislative action? If this sounds backwards to you, take heart: the House of Representatives has approved a long overdue overhaul of the Toxic Substances Control Act (TSCA).  This measure is expected to be approved by the Senate and President Obama with the next few months.

The TSCA was originally passed in 1976, and contains wording difficult for environmentalists, consumers, and even industry to follow. The original act required the EPA to consider regulatory costs during safety review, effectively reducing the importance of science-based research into chemical safety for consumers and the environment while favoring regulatory cost saving measures. It also made toxicity testing difficult by the EPA by requiring the minimal (“least burdensome”) amount of testing instead of full-fledged studies. The new TSCA will enable the EPA to order companies to prove chemicals are safe for consumers and/or the environment before introducing them to the marketplace, to hopefully avoid another issue such as the widespread use of asbestos in construction until the 1970’s.

Other components of the revised TSCA include an emphasis on reducing numbers of animals used in toxicity studies by replacing them with other testing methods when possible. The act also aims to identify and increase studies on “cancer clusters,” areas of the country which have higher incidences of cancer which may be due to environmental effects.

The revision of the TSCA is arguably the biggest environmental legislative success since the Clean Air Act amendment of the 1990’s. By containing clearer language, it makes the act “a careful compromise that’s good for consumers, good for jobs, and good for the environment” – said John Shimkus (R-IL). (Puneet Kollipara, ScienceInsider)

Mental Health

Children in Poverty at Risk for Increased Incidence of Mental Health Issues

Is it the chicken or the egg?  When it comes to mental health and poverty, it can be difficult to determine causation versus correlation: are mentally unstable people unable to provide for themselves, or is the stress of poverty causing mental health issues?  A recent study in children has determined a third genetic component to the puzzle, related to how the structure of DNA differs between poor and healthy children.

Although it has long been known that children from families below the poverty line have increased incidences of mental and physical ailments such as depression and diabetes, many have pointed to environmental factors such as relatives smoking or poor nutrition as the main culprits. New evidence suggests exposure to stress in utero and during childhood changes the very DNA of these children. Serotonin is a neurotransmitter important for maintaining “happy” brain chemistry and is often targeted for treating depression. New researchers found that the DNA for a serotonin transporter protein is altered in poor children, which may decrease the amount of serotonin allowed to get into brain cells. This was also correlated with higher levels of stress, indicating that growing up in poverty can change fundamental biological components and create lifetime mental health issues for these children.

Growing up in poverty is stressful for children; however there are ways to attenuate their suffering.  High quality, affordable, preschool and childcare is one way the government can step up to the plate.  “Headstart” is a program which enables children of families below the federal poverty line to enjoy a stimulating, warm environment and may reduce the burden of their families to choose between working and providing for their families or staying home to avoid daycare expenses. There are a multitude of issues creating stressful environments for poor families, but providing high quality child care and healthy meals for kids for part of the day is a small investment towards a big, epigenetic payoff in generations to come. (Sara Reardon, Nature News)

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May 31, 2016 at 12:00 pm

Science Policy Around the Web – June 30, 2015

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By: Eric Cheng, Ph.D.

Photo credit link: Affordable Care Act via photopin (license)

Health policy

Affordable Care Act survives Supreme Court challenge

On June 25, 2015, the Supreme Court upheld a key provision of the Affordable Care Act that allows the federal government to provide subsidies to people in all 50 states, and not just the 16 states that administer their own online insurance exchanges. This ruling means that people in states without their own exchanges can still get federal subsidies for the purchase of health insurance allowing an estimated 6.4 million people to keep their health care coverage, according to the Kaiser Family Foundation. Without access to subsidies, millions of Americans would have been at risk of failing to meet the mandate that requires every American to buy health coverage. This ruling affirmed that the legislation that created the Affordable Care Act intended to improve the health care system and to provide support to all who needed help to buy health insurance.

Two of the court’s conservatives, Chief Justice John G. Roberts Jr. and Justice Anthony Kennedy, joined the court’s four liberal Justices in rejecting the lawsuit in a 6-3 vote to side with the Obama administration. “Congress passed the Affordable Care Act to improve health insurance markets, not to destroy them,” Roberts wrote for the majority. While Justice Antonin Scalia, who wrote in dissent, called the majority’s reasoning “quite absurd” and “interpretive jiggery-pokery.”

President Obama made a statement on the recent ruling, saying the Affordable Care Act “is here to stay.” (Robert Barnes, Washington Post)

Federal research funding

Senate panel approves $2 billion raise for NIH in 2016

A Senate appropriations subcommittee voted to approve $32 billion in funding for the National Institutes of Health (NIH) for the 2016 fiscal year, representing an increase of $2 billion from 2015. This increase in funding could be the largest increase since 2003. Senator Roy Bunt (R-Mo.), chairman of the Senate Labor, Health and Human Services, and Education and Related Agencies Appropriations Subcommittee commented that “this year’s Labor-HHS appropriations bill prioritizes programs that will provide a significant benefit to all Americans and, most importantly, provides the National Institutes of Health with a $2 billion increase to make critical life-saving medical treatments and high-quality cures available to all Americans.”

The Senate panel approval will match the $200 million request by President Obama for the development of the Precision Medicine Initiative along with a $100 million increase for new funding to combat antibiotic resistance from the previous fiscal year. Other highlights include a $350 million increase for the National Institute on Aging, the lead Institute researching Alzheimer’s disease, and an additional $70 million for the BRAIN Initiative to map the human brain. These increases to every Institute and Center are intended help NIH to continue their development of new therapies, diagnostics, and preventative measures to enhance health, lengthen life, and reduce illness and disability. (Jocelyn Kaiser, ScienceInsider)

Environment and public health

House Advances Chemical Safety Reform Bill, Teeing Up Senate Vote

The U.S. House of Representatives passed legislation to overhaul the nearly 40 year old Toxic Substances Control Act (TSCA). This bipartisan bill aims to improve chemical safety. Some updates include the determination of risk by the Environmental Protection Agency (EPA) based on scientific evidence of its health impact instead of the cost of regulation. For new chemicals, the bill would shift the burden to industry to show that the substances they manufacture are not unreasonably risky. Other provisions in the bill would increase transparency by preventing industry efforts to keep safety data secret by declaring them confidential business information. This would allow EPA to more easily share chemical information with states, doctors, and first responders. These new reforms will help address an outdated law to protect human health and the environment from significant risks while also protecting commercial and competitive interests of the United States chemical industry and the national economy. (Kate Sheppard, Huffington Post; Puneet Kollipara, ScienceInsider)

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June 30, 2015 at 9:00 am