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Science Policy Around the Web – April 20, 2018

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By: Jennifer Patterson-West, Ph.D.


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source: USEPA via flickr

Food waste

Grocery Stores Get Mostly Mediocre Scores On Their Food Waste Efforts

Food waste is often thought of as unavoidable. Everyone creates food waste. However, steps can be taken to minimize or eliminate waste.

The Environmental Protection Agency (EPA) has issued simple guidelines to reduce food waste. These ‘guidelines’ have been outlined into a hierarchical ranking based on their effectiveness at preventing food waste. The most effective tier is ‘Source Reduction’, which entails reducing the total volume of food generated. Source reduction reduces pollution and cost associated with the growth, preparation, transport, and disposal of excess food.   Producers can save money by reducing the cost of labor and other resources (such as water and pesticides) associated with unused food.

The second tier is focused at ‘Feeding the Hungry’ by donating extra food. In 2016, it was estimated that ~15.6 million American households faced low or very low food-security at some point. Low food security is defined as households that obtained enough food by participating in food assistance programs, such as community food pantries, whereas very low food security applies to those that experienced a disruption in normal eating patterns due to insufficient money or other resource for food. Taken into account, that over 38 million tons of food was wasted in 2016 alone, the donation of excess food could significantly reduce food-insecurity in America. Food donation programs have already been implemented by the 10 largest U.S. supermarkets. To promote donations by corporations, potential tax deduction for food donation are available to companies and they are protect from liability by the Bill Emerson Good Samaritan Food Donation Act.

The third tier promotes diverting food scraps to ‘Animal Feed’. Converting food scraps to animal feed is often cheaper then transporting it to a landfill. Although this practice has been implemented by farmers for centuries, corporations can also participate by donating extra food to producers of animal feed or zoos. The fourth and fifth tiers are ‘Industrial Uses’ and ‘Composting’, respectively. For industrial purposes, food can be converted into biofuel or other bio-products. Composting, which creates nutrient-rich soil amendments, is a great option for inedible parts of food waste that remains after all other actions are taken.

These guidelines were recently used by the Center of Biological Diversity and The Ugly Fruit and Veg Campaign to score the 10 largest U.S. supermarkets for their handing of food waste. A report of their findings was recently released. They found that the surveyed companies focused on donating and recycling food waste instead of preventing it with none of them achieving an A scoring. A limitation to this survey is incomplete tracking and reporting of the amount of food waste throughout an entire company. Some practices that were specifically noted as reducing food waste include Whole Food’s use of produce that is pulled from shelves to make prepared meals, Walmart’s replacement of eggs within partially damaged packages to reduce waste, and Walmart’s standardization of expiration labels.

(Menaka Wilhelm, NPR)

The opioid crisis

Nursing homes routinely refuse people on addiction treatment – which some experts say is illegal

Opioids account for more than 50% of all drug overdoses, however, total deaths are likely underestimated due to under coding in mortality data The opioid epidemic which was largely isolated to Appalachian communities and minority populations in the 1990s has rapidly spread across the United Stated into more affluent suburban communities. The surge in opioid use correlates with an acceleration in the prescription of legal opioid pain relievers, such as OxyCotin. For this reason, many individuals with opioid use disorder (OUD) became addicted due to long-term use of prescription pain medication. This link between prescription drugs and addiction are likely why evidence-based medication-assisted treatments (MAT) are treated skeptically by the public.

MAT has been shown to reduce symptoms of withdrawal, thereby significantly reducing the risk of relapse and overdose. These drugs, such as methadone or buprenorphine, reduce cravings associate with withdrawal by activating the same receptors in the brain without providing the euphoria associated with other opioid use. Contrary to evidence, many patients are directed away from medications and toward treatment programs that have no scientific or medical evidence supporting their efficacy. In fact, only 1 out of 5 OUD patients receive MAT of any kind.

Two major barriers to MAT, including prescribing restrictions and issues finding extended care facilities. Currently, authorized physicians can use buprenorphine to treat a maximum of 275 patients for opioid dependency. In order to get authorization to prescribe buprenorphine, physicians must apply for a waiver from the Substance Abuse and Mental Health Services Administration. However, the physician must have already been authorized under the Drug Addiction Treatment Act of 2000 to prescribe buprenorphine to up to 30 patient for one year prior to applying. These restrictions are thought to be essential to limit over use of these drugs; however, they increase the administrational burden on physicians and decrease assess to MAT. In an effort to expand access to treatment, the declaration of public health emergency under the Trump administration in 2017 gave doctors the ability to prescribe medications for addiction remotely through telemedicine services.

In addition to limited access to MAT treatment, patients also face the possibility that if they receive MAT they may be refused for admittance into nursing home facilities. For instance, a trade group in Ohio released a written statement that none of its more than 900 member facilities will accept patient receiving either methadone or buprenorphine for addiction. Experts exert that refusal of OUD patients receiving MAT is illegal under the Americans with Disabilities Act (ADA) for nursing facilities. Despite an unknown prevalence of such restrictions, Massachusetts Department of Public Heal release a circular letter in 2016 providing guidance for nursing facilities caring for patient on medications for addiction. Similar efforts can be expanded by other states to educate nursing facilities of their legal obligations and to provide guidance for proper care.

(Allison Bond, STAT news)

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April 20, 2018 at 9:29 pm

Old Wounds and Shifting Tides: Potential Consequences of and Remedies for Health Disparities and Inequity in the United States

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By: Calais S. Prince, Ph.D.

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By Jsonin [CC-BY-4.0], via Wikimedia Commons

By the year 2060, the percentage of racial and ethnic minorities is expected to increase by 49% in the United States. As the country becomes more diverse, it will become imperative to understand the genetic/epigenetic, molecular, cellular, and environmental differences associated with increased risk for disease onset. Currently, it is still clear that certain minority groups have a greater propensity for several diseases including diabetes, stroke, heart disease, and cancer. Health disparities are preventable differences in disease manifestation that can be attributed to social, political, and environmental factors. These factors can include, but are not limited to: discrimination, poverty, access to education, and exposure to hazardous chemicals.

Segregation in health care and the potential influence on participation in biomedical research

Although commonly perceived as a relic of the past, health care segregation in the United States persists and can be attributed to the Jim Crow laws that were designed and implemented following the Civil War through the 1960s. For example, “[m]any hospitals, clinics, and doctor’s offices were totally segregated by race, and many more maintained separate wings or staff that could never intermingle under threat of law” contributing to “subpar health care standards.” A glaring, present day example is that of Boston City Hospitals and Mass. General, which is both a reflection of the “the referral system that dates back five decades” and the type of care that will be covered by insurance. Another powerful, and personally relevant, example that demonstrates the importance of understanding how environment influences the risk for disease was discussed in a recent article. In African American/Black women, the consequences of racism had a significant impact on intrauterine stress as there are higher incidences of complicated pregnancies, miscarriages, premature births, and infant deaths which correlate with self-reported experiences with racism and discrimination. Conversely, African women were reported to have similar birth rates as Caucasian/White women. However, maternal health, pregnancy, and neonatal health of the grandchildren of African immigrant women born in the United States trend towards the patterns described in African American/Black women. These disparities are believed to contribute to the low percentages of minorities that participate in clinical and biomedical research as some of the barriers to participation are “distrust, provider perceptions, and access to care.” The cyclical nature of disparities: disparate living environments, disproportionate access to education and health care, postnatal complications, wealth inequalities, accelerated aging and morbidity, warrants a multifaceted solution to a pervasive, generational problem.

Mechanism that can potentially facilitate health care integration and improve participation in research

In 2010, the redesigned National Institute on Minority Health and Health Disparities (NIMHD) was established with a vision in which “all populations will have an equal opportunity to live long, healthy, and productive lives.” To accomplish this, NIMHD raises national awareness about the prevalence and impact of health disparities and disseminates effective “individual-, community-, and population-level interventions to reduce and encourage elimination of health disparities.” This vision recognizes the need to study health disparities within a variety of different modalities ranging from biomedical to social sciences as the majority of clinical and translational studies have been conducted in Caucasians/Whites. Specifically, there are four major NIMHD sponsored programs that provide funding to address the components of health disparities, inequity, and inequality at the levels of academe (Research Endowment Program), community (Community Based Participatory Research Program, Small Business Innovation Research/Small Business Technology Transfer Program), and internationally (Minority Health and Health Disparities International Research Training Program). It is also essential to facilitate mentoring of up-and-coming scientists and clinicians from underrepresented groups. The National Research Mentoring Network is a consortium composed of biomedical and clinical professionals that provide “evidence based mentorship professional development” for undergraduates through professionals; this serves as an important way to make inroads to increasing diversity in biomedical sciences. Earlier exposure to the sciences for underprivileged youth, as well as parental and community support, could serve as valuable avenues to combat health inequity.

Concluding thoughts: Demographic changes in the United States and the impact on biomedical research

The conversations surrounding disparities can be difficult, however, they are necessary. A concerted effort to improve the lives of those that are at risk/underserved have the potential to improve the lives of the individual as well as strengthen the scientific community. The projected increase of minorities in the United States warrants improved access to life saving treatment and encouragement of participation in biomedical research, as there is mounting evidence that environmental factors can influences the cellular and physiological response to stress. We also need to examine methodologies that will build trust in the scientific community which starts by: continuing to dismantle the remnants systematic discrimination, introducing science to underrepresented minorities earlier in their didactic training, providing community support, and train future researchers and clinicians to be more sensitive and responsive to the needs of the community in which they serve.

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April 16, 2018 at 9:57 pm

Science Policy Around the Web – April 13, 2018

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By: Maryam Zaringhalam, Ph.D.

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source: pixabay

Public Health

Flint school children to be screened for effects of lead after agreement

April 25th will mark four years since Flint, Michigan had clean drinking water. In that time, the water has been contaminated with lead at levels above hazardous waste and with pathogens like Legionnaires’, which resulted in an outbreak that left 12 dead. The mishandling of Flint’s water crisis has resulted in a number of lawsuits and several felony convictions, with charges ranging from conspiracy to involuntary manslaughter.

Most recently, a judge approved a $4 million legal agreement on Thursday to screen children for exposure to lead poisoning and evaluate their cognitive development, memory, and learning. The lawsuit was first filed in 2016 by a coalition of local and national groups sued the Michigan Department of Education and school districts in Flint. Exposure to lead — a neurotoxin — during childhood can have long-term adverse health effects on cognitive and physical development. As a result, children exposed to lead may require special education services. The results of these evaluations, which will begin in September, will be used to better provide services to the children affected by lead exposure. Dr. Mona Hanna-Attisha, director of the Michigan State University-Hurley Children’s Hospital Pediatric Health Initiative and an early advocate for the Flint community, will oversee the program. The lawsuit will continue in Michigan federal court to increase special education services and reforms with representation by the ACLU of Michigan.

The Flint water crisis began in 2014 when the city switched its water supply from Lake Huron to the Flint River, which had long been polluted by industrial byproducts. Flint residents immediately reported poor-tasting water, however, their complaints were ignored by government officials despite robust community advocacy efforts. Finally, in September 2015 scientists at Virginia Tech published an extensive report (made possible by collaboration with members of the Flint community) documenting dangerous levels of lead in Flint residences, followed by a report from the Environmental Protection Agency (EPA). Pollution in the river had created a fertile breeding ground for bacteria, so the river was treated with chlorine, making the water acidic, in turn leaching lead from Flint residents’ plumbing. The crisis could have been prevented if appropriate corrosion control measures were taken.

On April 6, Michigan Governor Rick Snyder announced Flint’s water is once again safe for drinking, terminating the free bottled water program designed to give Flint residents safe water as part of a $450 million state and federal aid package. Nevertheless, mistrust remains.

(Alex Dobuzinskis, Reuters)

Healthcare

Trump administration rewrites ACA insurance rules to give more power to states

After several unsuccessful Congressional attempts to repeal the Affordable Care Act (ACA) last year, the Trump administration has taken steps to roll back ACA regulations with 523 pages worth of new and revised rules. The new regulations will take effect for ACA health plans sold this fall for 2019 coverage.

Perhaps the most significant change comes from a new rule aimed at shrinking the authority of the individual mandate — the ACA provision that every individual must have healthcare or face a penalty. Individuals can seek exemption from that requirement through one of two broad channels. On Monday, April 9, the Centers for Medicare & Medicaid Services issued a final notice that individuals living in counties with only one or no ACA insurers qualify for a “hardship exemption” because the marketplace is not competitive in their region. Notably, in 2018, around half of US counties had only one or ACA insurers. Individuals opposing abortion can also qualify for exemption if their only ACA provider options cover abortion. In November, the Congressional Budget Office projected that a straight repeal of the individual mandate would increase premiums by ten percent; so even a partial effective repeal could lead to increased premiums for customers opting to stay on ACA plans.

The new rules also grant states much more authority and flexibility when determining whether healthcare plans meet ACA standards. The old ACA rules required insurers provide a standard set of ten essential health benefits to ensure customers had access to the same core set of benefits and allow them to comparison shop. Before, states were required to base these ten categories on the same benchmark plan within state borders. The rule has now been changed so that states can select different benchmark standards across state lines a la carte (i.e. a maternity care standard from New Jersey paired with a laboratory services standard from Arkansas).

CMS Administrator Seema Verma told reporters: “Ultimately the law needs congressional action to repeal.” But in the meantime, the above examples are only two of several changes that will reign in the ACA’s powers.

(Amy Goldstein, The Washington Post)

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April 13, 2018 at 4:02 pm

Science Policy Around the Web – April 10, 2018

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By: Allison Dennis B.S.

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source: pixabay

Mental Health

Many People Taking Antidepressants Discover They Cannot Quit

15 million American adults have taken antidepressants for a period longer than five years, in spite of the fact that these drugs were originally approved for short-term treatment, lasting less than nine months. Many doctors agree that a lifetime prescription may be necessary for the treatment of some patients. However, many are concerned that some patients may simply be accepting long-term use of antidepressants when faced with the challenge of stopping.

Surveys have shown that choosing to stop long-term medications is not a straightforward process with many patients reporting withdrawal effects. Some antidepressants take weeks to break down and leave the body, and their absence can induce feelings of anxiety, insomnia, nausea, “brain zaps,” and even depression itself. Antidepressants are one of the most frequently prescribed therapeutics by physicians, yet the drugs’ labels do not outline how to end a prescription safely. Patients may have to turn to online resources, including  The Withdrawal Project, which provides a community based approach to provide support, but whose writers are self-described as “laypeople who have direct personal experience or who have supported someone else in the process of reducing or tapering off psychiatric medication,” but are not medical professionals.

The benefits of antidepressants in the treatment of depression is undeniable, leaving government regulators cautious about limiting their availability. Antidepressant manufacturers appear unwilling to dive into research characterizing the discontinuation syndrome experienced when patients try to stop, feeling their efforts to demonstrate the drugs are safe and effective is sufficient. Academic and clinical researchers have occasionally tackled the issue, but few studies have looked at the barriers facing open-ended antidepressant prescription holders.

(Benedict Carey and Robert Gebeloff, The New York Times)

Alzheimer’s Disease

Scientists Push Plan To Change How Researchers Define Alzheimer’s

Currently, the 5.7 million Americans living with Alzheimer’s are identified through a panel of symptoms including memory problems or fuzzy thinking. However these symptoms are the product of biological changes scientists feel may be an earlier and more accurate marker of disease. On the biological level, Alzheimer’s can be characterized by the accumulation of several characteristic structures in brain tissue including, plaques, abnormal clusters of protein that accumulate between nerve cells, tangles, twisted fibers that form inside dying cells, and the build up of glial cells, which ordinarily work to clear debris from the brain. It is unclear if these changes are driving the widespread disconnection and destruction of neurons exhibited in the parts of the brain involved in memory and later in those responsible for language and reasoning in the brains of Alzheimer’s patients or just a byproduct of a yet-to-be-discovered process.

A work group formed by collaborators at the National Institute on Aging and the Alzheimer’s Association are putting forward a research framework which defines Alzheimer’s by the progression of a panel of risk factors, including neuropathology, tangles, plaques, and neurodegeneration. By allowing these biomarkers to fall along a continuum, the group is accommodating the observation that the exhibition of these traits can vary widely between individuals and may not always co-occur with symptoms. Yet the framework is intended to “create a common language with which the research community can test hypotheses about the interactions between Alzheimer’s Disease pathologic processes.”

Although much of the research is preliminary, specialized brain scans and tests of spinal fluid are already being designed to identify these biomarkers directly. The biomarkers included on the continuum can be observed 20-30 years prior to symptoms, fostering the hope that early interventions could be implemented to slow disease progression or even prevent it in the first place.

(Jon Hamilton, NPR)

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April 11, 2018 at 6:11 pm

Science Policy Around the Web – April 6, 2018

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By: Sarah L. Hawes, PhD

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source: pixabay

Biomedical Research

Mitochondrial Replacement moratorium – are we over-regulating cures?

You may recall learning in grade-school science about the ‘mighty’ mitochondria which function as cellular power-plants, translating energy from your food into ATP to fuel subcellular processes. Failure in this fundamental process results in devastating mitochondrial diseases. Power-hungry tissues of the body – brain, heart, lungs, muscles – are hard hit by mitochondrial dysfunction, leading to degradation of heart, liver, kidney, gastrointestinal, respiratory and brain function. Perhaps you also recall learning that your mitochondrial DNA is a very small fraction of your total DNA, and is inherited solely from your mother? This feature has made it possible for researchers to develop mitochondrial replacement (MR) therapy which can be targeted to the egg prior to fertilization. In this procedure, donated mitochondria replace mutation-bearing mitochondria within unfertilized eggs, allowing women who carry aberrant mitochondrial DNA to give birth to genetically related, healthy children.

Unfortunately, a 2016 moratorium on U.S.-based research in which a human embryo is intentionally created or modified currently prohibits clinical MR therapy despite modification taking place prior to fertilization. Nonetheless, replacing mutation-bearing mitochondria with donated genetic material falls under a broad category of genetic modification prohibited by the moratorium – which has no named authors, and was passed without major congressional or public discussion.

A recent commentary in Obstetrics & Gynecology calling for this moratorium lift was authored by Professors Eli Adashi at Brown University’s Warren Alpert Medical School, and Glenn Cohen at Harvard Law School. Adashi points out the high number of children born in the U.S. annually with mitochondrial disease, and states “…this issue is not about the sanctity of life. There is an inherent hypocrisy in holding this procedure hostage at the expense of 1,000 children each year who are doomed to die a painful death.”

Adashi and Cohen detail a comprehensive process to move forward with reevaluating the moratorium, and laying the groundwork for policy enabling MR therapy in the U.S. These processes would engage the public, medical professionals, patient advocacy groups, the U.S. Food and Drug Administration and Congress. Authors describe a careful 15-year process of policy development in the U.K. ending in 2015 with Parliament approving MR under stringent regulatory oversight and within a single licensed clinic. They also note that, without FDA oversight and approval at home, American families seeking to safeguard their children against mitochondrial disease will seek care abroad given that successful MR therapy has now taken place in both the U.K. and Mexico.

(Gillian Kiley, News from Brown)

The Opioid Crisis

Provisions for legal medical cannabis are associated with reduced opioid use

Last year, the U.S. Department of Health and Human Services declared a public health emergency due to the more than 42,000 deaths from opioid overdose in 2016, with more than 40% of these deaths resulting from prescription medications. Two studies published this week in the Journal of the American Medical Association, Internal Medicine examined the number of opioid prescriptions filled in a recent five-year period, and related this number to coincident medical marijuana laws.

Co-author Bradford from one study explains that “Some of the states we analyzed had medical cannabis laws throughout the five-year study period, some never had medical cannabis, and some enacted medical cannabis laws during those five years,” enabling researchers to ascertain “what happens to physician behavior in terms of their opiate prescribing if and when medical cannabis becomes available.”

Bradfords’s team found that availability of legal medical marijuana via dispensaries was associated with a significant decrease in opiate use, amounting to about 14% fewer annual opiate prescriptions relative to states without legal access. Clearly these findings are correlative, however researchers included a useful control:  the examination of prescription rates for non-opioid drugs such as flu medicine and blood thinners – none of which might be replaced by medical marijuana. The study found no relationship between these prescriptions and marijuana laws. These results suggest that availability of marijuana as an alternative pain treatment alleviates public use of prescription painkillers.

A separate but similar study reports a more modest 6% reduction in the rate of opioid prescription writing coincident with medical marijuana laws. This figure includes states with a broader range of legal access to marijuana, regardless of whether dispensaries exist. Researchers in this group investigated fiscal impact as well:  medical and adult-use laws were associated with a 9.78% reduction in Medicaid spending on opiates, and 8.36% reduction in Medicaid spending on non-opiate pain medications.

There are clear caveats to medical marijuana usage. Effects of cannabis are inadequately understood and require further study. Proper dosage has yet to be clearly defined for this drug.

“Regardless, our findings suggest quite clearly that medical cannabis could be one useful tool in the policy arsenal that can be used to diminish the harm of prescription opioids, and that’s worthy of serious consideration,” said Bradford. Such policy may find broad public backing. In fact, a recent poll by University of Michigan Medical school indicates roughly 80% of persons aged 50-80 (a prime demographic for pain medication) support allowing medical marijuana if recommended by a physician. Given the opioid crisis and public reliance on physician actions (recommendations, prescription-writing), it would be prudent to focus on developing basic and clinical research and policy geared at defining and permitting safe use of opioid alternatives – including marijuana.

(Kate Sheridan, Stat News)

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April 9, 2018 at 11:31 am

Science Policy Around the Web – April 3, 2018

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By: Allison Dennis, B.S.

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source: pixabay

Gene Editing

CRISPR’d Food, Coming Soon to a Supermarket Near You

The United States Department of Agriculture has given a green light to plant breeders to use gene-editing technology to produce plant varieties that could have been made the old fashioned way. Traditionally, simple changes in genes have been cultivated in crops through selective breeding over generations, which relies on the naturally occurring mutations in the genome to produce new traits. In more recent history, would-be crop innovators rapidly introduced DNA changes to crop genes through mutagens such as radiation, vastly increasing the chances of producing a desirable genetic change in the next generation.

The first product of the gene-editing tool CRISPR-Cas9 to officially go unregulated was a variety of white button mushrooms whose genome was edited to resist browning. The mushroom was engineered by making a small deletion in its polyphenol oxidase gene, preventing the organism from making the enzyme that interacts with oxygen in the air to form melanins, think of that green bowl of guacamole on your counter slowly turning brown. Since this process did not introduce any new genetic material, the USDA ruled that it would not be regulated.

The USDA and FDA are currently drafting policy to oversee whether foods derived by this impossibly-sped-up-but-otherwise-natural method of crop development will need to be specifically labeled to inform the consumer. However US Secretary of Agriculture Sonny Perdue has made clear that under his direction the “USDA seeks to allow innovation when there is no risk present.”

(Megan Molteni, Wired)

 

Personalized Medicine

Anyone Can Now Take This Breast Cancer Gene Test, But It Probably Won’t Tell You Much

The personalized DNA testing company, 23andMe has had mixed success seeking FDA approval, but may have taken a step closer medical validity this month. The FDA has approved their direct-to-consumer genetic test which can identify three variants of the BRCA1 and BRCA2 genes which are associated with an increase in the risk of developing breast and ovarian cancer. From the comfort of their home, curious patients can spit in a tube that comes at a $199 price tag to learn their result on a panel of FDA approved Genetic Health Risk reports. However, the real value of such diagnostic tests, remains a point of debate.

Because the test will only capture a subset of the known genetic markers for cancer risk, 23andMe stresses that a negative result “cannot rule out your chances of getting cancer.” In fact, most women who are diagnosed with breast or ovarian cancer have no known genetic factors. Those who receive a positive test are still advised to validate their results and seek counseling from a medical professional. The company has conceded the value for such direct-to-consumer genetic tests may be the simple act of raising awareness and inspiring them to take a more proactive role in their healthcare.

(Christie Aschwanden, FiveThirtyEight)

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April 3, 2018 at 11:47 pm