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Science Policy Around the Web – August 29, 2017

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By: Allison Dennis, BS

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Science funding

1 Million fewer dollars available for studying the health impacts of coal mining

The National Academies of Sciences, Engineering and Medicine, was instructed to stop its ongoing research into the potential health effects of surface mining by the U.S. Department of the Interior on August 18, 2017. The US$1 million study was established on August 3, 2016, “at the request of the State of West Virginia,” by the Office of Surface Mining Reclamation and Enforcement (OSMRE). OSMRE, an office within the U.S. Department of the Interior, selected the National Academy of Science to systematically review current coal extraction methods, the framework regulating these methods, and potential health concerns. Critics of the study point to the findings of a similar review undertaken by the National Institute of Environmental Health Sciences that were made public on July 21, 2017, which determined that the current body of literature was insufficient to reach any conclusions regarding the safety of mountaintop removal on nearby communities.

Mountaintop removal, a form of surface mining, employs the use of explosives to efficiently expose coal deposits that would otherwise require a large number of workers to extract over time. The excess soil and rock that has been blasted from the mountain is placed in adjacent valleys, leading to alterations of stream ecosystems, including increases in selenium concentrations and declines in macroinvertebrate populations.

The people of rural Appalachia experience significantly higher rates of cancer than people in the rest of the U.S., of which environmental exposures are only one potential risk factor. Widespread tobacco use, obesity, and lack of accessible medical care are all believed to underlie the cancer epidemic in Appalachia, culminating in a tangled web of risk.

It is unclear how the money from this study will be repurposed. The Obama administration cancelled a study of surface mining to redirect funds towards examining the little known effects of hydraulic fracturing.

(Lisa Friedman and Brad Plumer, The New York Times)

Cancer treatments

For breast cancer patients the cost of peace of mind may be both breasts

Between 2002 and 2012 the rates of women with a breast cancer diagnosis opting for a double mastectomy increased from 3% to 12%. In a majority of these cases, a lumpectomy may be medically sufficient. However for many women, this choice may stem from a personal pursuit of peace of mind rather than the advice of their doctors. The mastectomy procedure can extend time of recovery from a few days, in the case of a lumpectomy, to 4 to 6 weeks. Yet for many women, undergoing a lumpectomy followed by 5 to 7 weeks of radiation therapy would offer the same long-term survivorship. Additionally, 1 in 8 women with invasive cancer in a single breast is electing to remove both breasts.

The reasons for this increase is unknown. While the procedure has not been demonstrated to increase survivorship, the procedure itself is relatively risk free. Breasts are not vital organs, and improvements in reconstruction methods have provided women with a natural-looking, cosmetic replacement. For many women the cost of feeling their struggle with breast cancer is behind them is the removal of both breasts. Double mastectomies, along with the reconstruction surgeries they normally require, are usually covered by insurance.

Breast cancer is the most commonly diagnosed cancer type in the U.S. Mortality from the disease decreased by 1.9% per year from 2003 to 2012. Yet, for many women facing breast cancer, the choice of a double mastectomy may feel like the only empowering choice, one their doctors are willing to let them make.

(Catherine Caruso, STAT News)

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August 30, 2017 at 8:57 pm

Science Policy Around the Web – August 15, 2017

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By: Liu-Ya Tang, PhD

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Public Health

Obesity and Depression, Entwined or Not?

It might seem that obesity and depression are not related since they are diseases from different parts of the body; however, health care practitioners have observed that these two diseases have a close relationship. The development of obesity and depression can be a vicious cycle, one favoring the other. Extra weight brings anxieties to obese people, which can cause poor self-image and social isolation. These are known contributors to depression. On the other hand, people experiencing depression tend to overeat and avoid exercising. According to the federal Centers for Disease Control and Prevention, about 43 percent of people with depression are obese, compared with 36.5 percent of the general population. People with obesity have a higher risk to develop depression, and vice versa, according to one 2010 study.

Both obesity and depression are chronic diseases that are hard to treat, placing a big burden on the health care system. Obesity rates in the United States are among the highest in the world. Obesity alone costs almost $150 billion per year in direct expenses, and this number is estimated to increase about $1.24 billion each year till the year 2030. The cost of treating depression is even higher, which is more than $200 billion every year. So it is urgent to find ways to treat both diseases more effectively if they are bidirecitonally comorbid.

When depression and obesity coincide, the combination of physical and mental health interventions becomes important, which has been supported by several studies. Researchers from the University of Texas-Southwestern found that patients’ depression were alleviated when they did weekly exercise sessions, which were prescribed by physicians. Another study from Duke University found that the rate of depression in obese women was decreased by 50 percent simply by helping them control their weight. The combinatorial treatment has been adopted. Dr. Sue McElroy, a psychiatrist in Mason, Ohio, screens patients for weight and BMI, and treats obesity and depression together. She tailors her prescription, as some antidepressants can cause weight gain. Her “self-taught” method was welcomed by her patients. However, this is not a general practice in treating patients with both symptoms. To benefit patients’ health and reduce cost for curing obesity and depression, the whole health care system needs a change.

(Shefali Luthra, Kaiser Health News)

 

The ACA

What do people and health-policy experts think about repealing the ACA?

Since March, the Trump administration has strived to repeal and replace the Affordable Care Act (ACA), but the Senate rejected this repeal, as 3 republican senators voted “no” last month. How do people feel about repealing the ACA? What do most people say the Trump administration should do after the Senate failed to repeal? There were two reports about it.

The first one was about a survey conducted Aug. 1-6 by the Kaiser Family Foundation, which capture the opinions of 1,211 adults. Their analysis found that a majority of people (78 percent) think that the government should make the ACA work better. Grouping this majority by Political Party ID, reveales 95 percent are Democrats, 80 percent re independents and 52 percent are Republicans. Even 51 percent of President Trump’s supporters think both parties should work together to improve the health law.

The second report said that a coalition of liberal and conservative health-policy leaders is making suggestions for how to strengthen the existing ACA law, aligned with a favorable view in the public. The nine group members are from think tanks, universities and advocacy groups, who can be influential in health-policy formation of the government. The coalition was founded when it appeared that the Republican-controlled Congress would pass a repeal of the ACA without a replacement plan. It took the group eight months to come up with a five-point set of principles. It says that the government should continue providing subsidies to insurers that extend plans to 7 million lower-income customers and strong incentives for Americans to carry health insurance. The latter will help the cost of expensive care be shared by a stable insurance pool with healthy customers. They also urge the government to bring health plans to about two dozen counties, which would be left providerless in the ACA marketplace for 2018. The group said they intend to present their idea to Republican and Democratic lawmakers. “We are trying to model bipartisanship so incremental steps can be taken,” said by Ron Pollack, chairman emeritus of the liberal consumer-health lobby Families USA.

To prevent the potential collapse of health insurance market, the Senate is planning a bipartisan hearing on health care in September. In the House, a group of around 40 Republicans and Democrats known as the Problem Solvers Caucus aims to making urgent fixes to the ACA law. On September 27th, insurers will sign contracts with the federal government over what insurance plans to sell on the marketplace for 2018, which pushes Congress to come up with a solution before then.

(Phil Galewitz, Kaiser Health News, and Amy Goldstein, The Washington Post)

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August 15, 2017 at 6:27 pm

Science Policy Around the Web – July 25, 2017

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By: Allison Dennis B.S.

TopSecretMosquito

Gene Drives

With Great Power There Must Also Come–Great Responsibility!

 

On the horizon of life-changing biotechnology up for ethical debate, nestled between CRISPR and whole genome sequencing, are gene drives, which have the potential to alter genes for better or for worse across generations. During sexual reproduction each of the two versions of a gene carried by a parent has a 50% chance of being inherited by each offspring. The frequency of each version of a gene across a population is influenced by rates of mutation, migration, genetic drift, and natural selection. Gene drives present the technology to circumvent these natural forces. By introducing molecular machines capable of damaging a particular version of a gene along with the version they prefer to the cells that give rise to eggs or sperm in an organism, scientists can shift the likelihood that their version will be inherited by that organism’s offspring from 50% to 100%. Upon fertilization the undesired gene will be damaged by the molecular machine and the desired gene will used as a template to repair the damaged copy, allowing two copies of the desired gene to be permanently introduced in the offspring and inherited by the next generation. Clever applications have been proposed to design mosquitoes resistant to malaria, mice unable to transmit lyme’s disease, or salmon able to grow to full size in half the time. More bold applications would use the technology to render female mosquitoes sterile, the ultimate insecticide. However, for each one of these beneficial applications exists the devastating opposite, which could be employed to accelerate the spread of disease. Altering population genetics of one species could accidentally devastate ecosystems.

U.S. defense organizations have taken notice of this powerful technology. DARPA, the Defense Advanced Research Project Agency, has launched the Safe Genes program in an effort to anticipate and address potential risks of introducing uncontrolled or undesired gene drives. The program awarded a collective $65 million to seven labs hoping to develop counter technologies including self-fizzling drives, chemical control methods, and gene drive vaccines. This summer, to delve deep into the intellectual discussion JASON, tackled the issue. This independent group of scientists, holding stellar academic records and top-secret clearances, meets once a year to address questions posed by the U.S. Department of Energy, Department of Defense, CIA, and FBI. However, their report is likely to be classified. (Ewen Callaway, Nature News)

Violence Against Women

Beginning to Understand the Nature of Intimate Partner Violence Through Data Curation

Careful evaluation of the nature of homicides of women has revealed that 55% result from intimate partner violence (IPV). The study conducted by the US Center for Disease Control (CDC) looked into the circumstances surrounding the deaths of 10,018 women over the age of 18 between 2003 and 2014 across 18 states. In addition to cases where the victims were intimate partners of the suspect, IPV-related homicides included cases where the female victims were friends, family, or those who intervened during an incident of IPV.

Nationwide political attention was drawn to the issue of IPV starting in the 1990s. The Violence Against Women Act was passed by Congress in 1994 and sought to legally define domestic violence as a crime external to the purview of private family matters. Research has revealed several risk factors associated with intimate partner violence, including threats with weapons, stalking, obsessive jealousy, sexual assault, and controlling behavior. However, the effectiveness of political and public health interventions remain unclear due to the overall decline in violence over the last decade and believed underreporting of individual incidence.

In an effort to more broadly understand the “who, when, where and how” surrounding violent deaths that occur in the United States, including those connected with IPV, the CDC created the National Violent Death Reporting System in 2002. By pooling information gathered by local law enforcement officers, coroners, medical examiners, and state agencies the CDC is hoping learn more about “why” so many violent deaths occur, towards the goal of developing and evaluating public health interventions. At its inception, funding only supported the participation of six states. However, involvement has been increasing from 17 states in 2006 and 42 in 2016 with the goal of eventually including all 50 states, U.S. territories, and the District of Columbia.

This study confirmed that homicide as a result of IPV occurs across all age groups and racial ethnic groups. However, young black and Hispanic women are disproportionately affected compared with white and Asian women of the same age group. Overall, black and indigenous women experienced significantly higher higher homicide rates, including non IPV related cases, than women of other races. Women died as a result of the use of firearms in 53.9% of all cases. While the “why” still remains unclear, this 15 year glance back sheds some light on the groups most affected by violence inflicted by their own partners, providing opportunity for targeted prevention. (Camila Domonoske, NPR)

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July 25, 2017 at 6:42 pm

Science Policy Around the Web – July 7, 2017

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By: Leopold Kong, PhD

Food Policy

Food and Microbiota in the FDA Regulatory Framework

More and more probiotic food products, or microbiota-directed foods, claiming to “improve” the body’s microbiota have been hitting the shelves, with sales valuing over US$700 million in the US alone and US$36.6 billion globally this past year. However, there is little framework regulating their ingredients or guaranteeing the scientific accuracy of their health claims that has resulted in costly legal action. For example, in September 2009, Dannon settled a US$35 million consumer class action suit challenging the claimed health benefits in their ads. A similar class action suit against Procter & Gamble’s Align probiotic has been certified and set for Oct. 16, 2017. A paper recently published in the journal Science calls for greater clarity in policy regulating probiotic products. Importantly, the authors urge that probiotics should be clearly classified as a dietary supplement, a medical food, or a drug. If classified as a dietary supplement, probiotics can make claims on nutrient content and effect on health, but not on treatment, prevention or diagnosis of disease. If classified as a medical food, probiotics must contain ingredients that aid in the management of a disease or condition, with “distinctive nutritional requirements”, that is scientifically recognized. Finally, if classified as a drug, probiotics will require clinical trials to prove its medical claims. An alternative, and perhaps cheaper, way forward is to regulate probiotics as a kind of over-the counter medical food, requiring testing only for their active ingredients that can be used in a variety of products. (Green et al., Science)

Antibiotic Resistance

Untreatable Gonorrhoea on the Rise Worldwide

Over 78 million people are infected with gonorrhea each year, a sexually transmitted disease that has traditionally been treated effectively with anti-microbials. However, recently published data from 77 countries show that antibiotic-resistant gonorrhea is getting more pervasive and harder to cure. “The bacteria that cause gonorrhea are particularly smart. Every time we use a new class of antibiotics to treat the infection, the bacteria evolve to resist them,” said Dr. Teodora Wi, Medical Officer, Human Reproduction, at the WHO. The data found widespread resistance to ciprofaxacin, azithromycin, and even to the last-resort treatments, oral cefixime and injectable ceftriaxone. New drugs are under development, including a phase III trial of a new antibiotic, zoliflodacin, launched by the non-governmental organization Drugs for Neglected Diseases Initiative and Entasis Therapeutics, a biotech company in Waltham, Massachusetts. Better prevention through education on safer sexual behavior and more affordable diagnostics will also be needed moving forward. (Amy Maxmen, Nature News)

Maternal Health

U.S. has the Worst Rate of Maternal Deaths in the Developed World

A recent six-month long investigation by NPR and ProPublica has found that more women in the US are dying of pregnancy related complications than any other developed country. Surprisingly, this rate is increasing only in the US, which stood at ~ 26.4 deaths per 100,000 births in 2015, translating to nearly 65,000 deaths annually.  This is three times worse than for women in Canada, and six times worse than for women in Scandinavian countries. Reasons include older new mothers with more complex medical histories, unplanned pregnancies, which are the case half the time in the US, greater prevalence of C-sections, and the fragmented health system. This is in contrast with progress in preventing infant mortality, which has reached historic levels in the US. Better medical training for maternal emergency and more federal funding for research in this area may improve the situation for American mothers. (Nina Martin and Renee Montagne, NPR)

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Science Policy Around the Web – May 16, 2017

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By: Sarah L Hawes, PhD

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Preventative Medicine

Fresh Foods a Day Keep Disease and Deficit Away

If you have recently shopped for health insurance, you likely encountered incentives for self-maintenance, such as discounted gym membership, or reimbursement for a jogging stroller. These incentives are motivated by the enormous ticket price of failing health. The CDC estimates that over $500 billion is spent annually on direct medical expenses to treat chronic diseases, which can be prevented or postponed through lifestyle practices – including heart disease, obesity, and diabetes.

The Geisinger health care system reports encouraging results from the first year of a lifestyle-modification program called Fresh Foods Pharmacy, piloted in central Pennsylvania. This program provides patients with Type 2 diabetes nutrition counselling, hands-on classes in healthy cooking techniques, and a weekly prescription for five days’ worth of fresh food – fillable for free at a hospital based “food pharmacy.” This means patients are not just advised to eat better; they are comprehensively enabled to eat better.

David Feinberg, president and CEO of Geisinger, reports that all 180 participants in the pilot group have made substantial improvements in their health, including reductions in blood pressure and body weight, and that many have seen a several-point reduction in a blood marker used to diagnose and monitor their disease, called A1C. A1C reduction means that blood sugar levels are being better controlled, which also means fewer costly diabetic complications for patients down the line. Feinberg calls the program “life changing,” adding that participants “won’t go blind; [they] won’t have kidney disease, amputations.”

Many Fresh Foods Pharmacy participants are low-income, so there is powerful financial incentive to ‘follow doctors’ orders’ and eat the free, healthy food. But what does supplying a person with nutritional counsel and weekly fresh foods cost?

Geisinger spends approximately $1,000 per year on each Fresh Foods Pharmacy patient. Meanwhile, a mere one-point drop in A1C levels saves Geisinger roughly $8,000 per year. Feinberg says that many participants trimmed about 3 points off their A1C level in the first year, saving roughly $24,000 on a $1,000 investment. “It’s a really good value” says Feinberg, who is already working to expand the program to additional sites.

Improved patient health and medical cost-cutting in the first year of this program are independently exciting. In addition, the value of engendering better patient health through comprehensive dietary support is very likely to extend beyond patient and provider. Patients who are enabled to engage in healthful food preparation will share a healthier diet and food-culture with their families, enhancing program benefits in as-yet unmeasured dimensions. (Allison Aubrey, NPR)

Research Funding

Climate Science Policy Lessons from Down Under

Pretend for a moment that everyone firmly believes that climate change is real, and is a real threat. Is this enough to safeguard basic climate science research? Recent events in Australia give us our answer – no.

Australia is the most active contributor to climate science in the Southern Hemisphere. As such, Australian researchers provide a truly international service. Public appreciation of this fact, together with public activism, recently saved funding for Australian climate science.

In 2015, Dr. Larry R. Marshall was appointed to lead Australia’s national scientific agency (CSIRO). Dr. Marshall planned to champion initiatives motivated by his faith in climate science. He wanted to develop technologies to respond to inescapable climate change, and to mitigate damage through reduced emissions. Paradoxically he proposed to fund these by laying off droves of basic climate researchers.

Dr. John A. Church was a climate scientist at CSIRO, having published highly regarded studies indicating accelerated sea level rise paralleling greenhouse gas emission. On catching wind of Marshall’s plan, Church reached out to his contacts in the media and wrote an open letter to Marshall in defense of basic science. Public marches, hearings, and protests from thousands of international scientists ensued.

Ultimately, the rally of public voices instigated by Dr. Church and others like him was effective. Far fewer layoffs occurred than were initially slated to occur. Dr. Church was among those let go by CSIRO, but was rapidly recruited by the University of New South Wales to continue his climate research.

Bear in mind that Dr. Marshall was no climate change denier. He showed great willingness to use scientific findings to guide policy, which is admirable. He addressed an Australian Senate committee saying that the climate “absolutely is changing,” and “we have to do something about it.” In a recent interview, he summarized his reasons for wanting to lay off scientists saying this: “Unfortunately, with a finite funding envelope, you’ve got to make choices where you fund.”

Australia’s example shows us that even in a political environment with great faith in science, reverence for basic research is a separate issue, and merits independent attention and protection. Staying abreast of science policy matters. And for those of us who believe there is no shortage of natural complexity, and no end to the fruitful pursuit of knowledge, it pays to speak out in defense of basic research. (Justin Gillis, The New York Times)

 

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Science Policy Around the Web – May 5, 2017

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By: Thaddeus Davenport, PhD

Healthcare Policy

House Passes Bill to Repeal and Replace the Affordable Care Act

Thomas Kaplan and Robert Pear reported for the New York Times yesterday that Republicans in the US House of Representatives voted to pass a bill that would undo a number of central elements of the Affordable Care Act. Only six weeks ago, House Republicans failed to gather enough support to even vote on the first version of this bill, which was predicted to eliminate insurance coverage for twenty-four million Americans over the next decade. Since that time, Republican lawmakers have modified the so-called American Health Care Act (AHCA) bill to appeal to the more conservative members of the House – including provisions that would limit federal support of the Medicaid program, allow states to opt out of requiring that insurance cover services like maternity and emergency care, and also enable states to apply for waivers that would let insurance companies charge higher premiums for some individuals with pre-existing conditions. Like the first version, the bill that passed the House on Thursday does away with the ‘individual mandate’, which imposes a tax on people who can afford to buy insurance but do not – an aspect of the Affordable Care Act that was relatively unpopular but critical to ensure sustainability of the insurance markets. It also replaces government-subsidized insurance plans with tax credits between $2,000 and $4,000, depending on age. Other provisions in the bill would stop federal funding to Planned Parenthood for one year as well as eliminate taxes on high-income individuals, insurance companies, and pharmaceutical companies that helped to fund the Affordable Care Act. Yesterday, 217 Republicans voted in favor of the revised AHCA bill that will certainly  not provide healthcare insurance for everyone, without waiting for a non-partisan Congressional Budget Office analysis of the bill’s impact on the federal deficit or on the American people. These representatives’ haste reveals that they care little about how the AHCA will actually affect their constituents’ lives, and Democrats are counting on voters remembering this in upcoming elections. (Thomas Kaplan and Robert Pear, The New York Times)

Science Funding

NIH Funding Changes to Support More Early Career Investigators

The NIH budget has gradually declined over the last fourteen years, from $40 billion in 2003 to about $32 billion in 2017. Given that a proposed budget from the Trump administration for fiscal year 2018 would further cut funding for NIH by $5.8 billion, it is unlikely that funding for the NIH will increase dramatically in the coming years. To address these budget limitations, and in an attempt to do more with less, Jocelyn Kaiser reported for ScienceInsider this week that the National Institutes of Health will impose a cap on the number of grants awarded to investigators. In an open letter announcing the decision, NIH director, Francis Collins, writes that 40% of NIH funding is concentrated in the hands of 10% of NIH-funded investigators. He notes that this is not inherently problematic, except that many studies indicate that there are diminishing scientific returns on each additional dollar that is granted to any individual investigator. Under the new guidelines, investigators will be limited to a maximum of three R01-equivalent grants in order to support approximately 1,600 more grants to early career and mid-level researchers, who have been particularly affected by the declining NIH budget. While it is difficult to quantify scientific impact, the NIH decision is admirable for its intent to support diversity and efficiency in funding research. (Jocelyn Kaiser, ScienceInsider)

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Science Policy Around the Web – May 2, 2017

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By: Allison Dennis, BS

Public Health

You Can’t See What You Don’t Test For

The CDC relies on blood testing by pediatric health care providers to monitor lead exposure in children nationwide. However, many doctors may not be prompted to seek a test. According to a recent study, only half of estimated cases of elevated blood lead levels were reported to the CDC. From 1999 to 2010 an estimated 1.2 million cases of elevated lead blood level counts were predicted by state-by-state surveys conducted by the CDC. In contrast, only 607,000 cases were reported to the CDC by the 39 states that report elevated blood lead levels.

There is no safe threshold for lead exposure, however the CDC moved to revise the acceptable limit to 5ug/dL from 10ug/dL in 2012. Currently all doctors who treat children receiving Medicaid benefits are required to submit lead level tests for children at age 12 and 24 months or for those who have not received a test by the age of 7 years to meet formal eligibility. However, the number of tests performed annually falls short of those expected if doctors were following the rules. Each state maintains its own guidelines for when doctors should request testing and report to the CDC. And 12 states do not submit data to the CDC.

The greatest discrepancies between numbers predicted from survey data compared with state reported values were observed in Western states. When diagnosing lead exposure doctors may overlook environmental risk factors when treating patients in communities where lead has not been an issue historically. While public housing in Northeast cities like Baltimore have been recognized as a systemic source of lead exposure, the risk may not be so obvious in communities in California where buildings are assumed to be newer than 1978 when lead paint was banned nationally. (Susan Scutti, CNN)

Drug Policy

Access To Lethal Injection Drugs Challenges States To Get Creative

The FDA ruled on Thursday, April 20th that the Texas Department of Criminal Justice and the Arizona Department of Corrections have 90 days to destroy or return a batch of execution drugs imported from India. The Texas bound shipment seized by the FDA in July 2015 consisted of a thousand or more vials of sodium thiopental, which is used as the anesthetic in three-drug lethal injection protocols. While the FDA had abstained from enforcing a law preventing the import of sodium thiopental, which has no approved use in the United States, a US District Court permanently ordered the FDA to impose the ban.

Implementation of the import ban on sodium thiopental follows a long line of restricted access to lethal injection drugs. Political pressure on drug manufacturers has dramatically reduced the availability of products appropriate for use in lethal injection protocols. The last US manufacturer of sodium thiopental, Hospira, discontinued its production in 2011. In 2012, the European Commission blocked the export of drug for lethal injection to the United States. In May 2016, Pfizer announced it would end the use of its products in lethal injections, making it the final FDA approved manufacturer of potential drugs to do so. States have been responding by adapting protocols to meet drug availability or seeking third-party suppliers.

The modern use of lethal injections for corporate punishment were proposed in 1977 by the Oklahoma state medical examiner as being more humane and was first executed in Texas in 1982. While the practice is associated with drugs and medical professionals, it has never been subject to clinical trials or peer review. (Susan Scutti, CNN)

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May 2, 2017 at 10:08 am