Science Policy For All

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Posts Tagged ‘public health

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

Source: pixabay

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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Written by sciencepolicyforall

May 2, 2017 at 10:08 am

Science Policy Around the Web – April 21, 2017

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By: Rachel F Smallwood, PhD

Source: pixabay

Scientific Awareness

Earth Day and the March for Science

This Saturday, April 22, is Earth Day and the day scientists have chosen to hold demonstrations in the name of science. The March for Science primary demonstration will be held in Washington, D.C., with over 500 satellite events in other locations around the world. According to their website, the goal of the marches, rallies, and teach-ins is to “defend the vital role science plays in our health, safety, economies, and governments.” In a time where there has been increasing disregard and disdain for sound scientific research, scientists and science enthusiasts are passionate about raising awareness of the importance of scientific research and the funding and support of that research. Many scientists are also hoping to clear up commonly held stereotypes and allow people to see the diversity in scientific careers and that careers can be collaborative, interesting, and enjoyable.

There are those, however, who disagree that these demonstrations and events are the way to bolster funding and awareness. The March for Science professes to be non-partisan, but there are some who see it as a chance to protest against President Trump and his controversial views and statements on various scientific matters. Those who oppose the march feel that there could be unintended consequences for speaking out against a political figure or party, and many believe science should remain objective and not politicized in general. There are many supporters of the march who agree that science should remain politically unbiased but are further motivated to march given the recent budget proposals that would significantly cut funding to the National Institutes of Health and the Environmental Protection Agency.

Not surprisingly, there will also be scientists working at the March for Science. Sociologists from the University of Maryland will be conducting surveys of march attendees. Their goal is to learn more about the people who protest in support of science: their motivations, work backgrounds, and political activism levels. They hope to better understand our current political culture and attitudes about science, as well as see what kind of impact these demonstrations have in the future. (Adam Frank, NPR)

Vaccination

California Vaccination Rate Hits New High after Tougher Immunization Law

Following an outbreak of measles in Disneyland in late 2014, California passed a law that abolished the right for parents to refuse to have their children vaccinated based on personal beliefs. The students enrolling in kindergarten for the 2016-2017 academic year were the first that this law applied to. Comparing this year to the previous, vaccination rates increased from 92.8 percent to 95.6 percent, making this California’s highest year for vaccination rates since the new set of requirements was instated fifteen years ago. This rate is considered high enough to prevent measles transmission which, after being eliminated in 2000, has reemerged as a risk due to an increase in parents exempting their children from receiving vaccinations because of personal beliefs.

California still has a number of at-risk students and residents, however. These requirements have only been in place for the current school year, meaning older class years still have many students whose parents opted to not vaccinate them based on personal beliefs. There are even more unvaccinated adults who were already through school before the current set of requirements. California is still being vigilant to protect the unvaccinated. An unvaccinated high school student in Laguna Beach contracted measles earlier this month, and the school quickly moved to identify other unvaccinated students in the school and bar them from returning until it could be assured that transmission would not occur. The Centers for Disease Control and Prevention (CDC) provide a recommended schedule for vaccination of children (and adolescents and adults) who have no health contraindications. To provide the maximum resistance to measles, a highly contagious disease, the CDC recommends vaccinating between 12-15 months and again between 4-6 years of age. It will likely take some time before the long-term effect of the new law can be observed. (Lena H. Sun, The Washington Post)

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How Science Policy Affects Pandemic Pathogen Research

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By: Samuel Porter, PhD

         In 2012, a pair of studies were published in Nature and Science weeks apart igniting one the biggest national debates about science in recent memory. These studies demonstrated that a few mutations in the highly pathogenic H5N1 strain of influenza virus (colloquially known as “bird flu”) could enable it to be transmitted through the air to mammals. At the heart of controversy was the question of whether scientists should be creating more virulent and/or pathogenic strains of deadly viruses in the lab. This controversial research is known as “gain of function” studies.

Critics claimed that the research was too dangerous that the risk of an accidental or deliberate release of these lab strains was far greater than the scientific and public health benefits. In an attempt to respond to the growing concern over their work, the community of researchers working with these pathogens voluntarily agreed to suspend this gain of function research for 60 days to discuss new policies on conducting the research safely.

But that was not enough to satisfy critics of the research, who continued to lobby the Obama administration to take official action. On October 17, 2014 the White House Office of Science and Technology Policy (OSTP), abruptly announced a pause on all U.S. Government funding of gain of function research on influenza, Middle East respiratory syndrome (MERS), and severe acute respiratory syndrome (SARS) coronavirus until the National Science Advisory Board for Biosecurity (NSABB) could make recommendations for policy regulating the research going forward. The NSABB was formed in 2005 (in the wake of the anthrax attacks in 2001), and is composed of scientists from universities around the nation, and administrators from 14 separate agencies in the federal government. The board reports to the Secretary for Health and Human Services (HHS) and is tasked primarily with recommending policies to the relevant government entities on preventing published research in the biological sciences from negatively impacting national security and public health.

The move drew harsh criticism from researchers in the field, many of whom thought that it was too broad. They claimed it would jeopardize their ability to predict, detect, and respond to potentially emerging pandemics. In the private sector, several companies said that the order would prevent them from working on new antiviral drugs and vaccines. Furthermore, many young scientists worried that an inability to do their experiments could jeopardize their careers. In an effort to bring attention to the issue, many scientists (including the two flu researchers whose research triggered the pause) formed the group Scientists for Science, which advocates against blanket bans on research. In addition, researchers were especially upset by the recommendation of the NSABB to censor the publications resulting from the experiments due to fears that this research could have a “dual use” that would threaten national security. However, not all researchers in the field support gain of function research (the opposition group is called Cambridge Working Group) and maintain that the risks of the research outweigh benefits.

The moratorium lasted until January 9th, 2017, when the OSTP released the guidelines for funding this research in the future. The new rules are essentially the same recommendations put forth by the NSABB seven months earlier. The NSABB had concluded that these studies involving “potentially pandemic pathogens” (PPP) do indeed have important benefits to public health, but warranted additional screening prior to funding approval. It directed federal agencies to create a pre-funding review mechanism using eight criteria (including whether the pathogen is likely to cause a naturally occurring pandemic, and if there are alternative methods of answering the scientific question). The results of these reviews must be reported to the White House OSTP. Importantly, the policy was implemented in the final days of the Obama administration rather than leave it to the incoming Trump administration, who, as of this date, has yet to fill nearly any top science positions, and may not have issued guidance for months, if at all.  Researchers welcomed the decision to finally lift the ban, but questioned when the projects would be allowed to resume.

What can we learn from this situation from a science policy perspective? First, we must learn not to overreact to hysteria regarding the risks of this type of research. Indeed, there are risks in performing research on potentially pandemic strains of influenza and other pathogens, as there are with other types of research. But issuing overly broad, sweeping moratoriums halting ground breaking research for years is not the answer, nor is government censorship of academic publication. While in the end, the studies were given the green light to resume, and were published without modification, there is no making up for the lost time. These studies are not machines than can simply be turned on and off on a whim without repercussions. When we delay research into learning how viruses become pandemic, we hurt our ability to detect and respond to naturally occurring outbreaks. Additionally, when American scientists are prevented from doing research that other countries are still pursuing, American leadership in the biomedical sciences is at a competitive disadvantage. (The European Academies Science Advisory Council also recently updated its recommendations for PPP research in 2015, but did not institute a moratorium.) What we learn from these studies could potentially save countless lives. Secondly, the freedom to publish without any government censorship must be valiantly defended in any and all fields, especially with a new administration with an aggressively anti-science and anti-climate stance. Lastly, the scientific community must do a better job educating the public both on the importance of these studies from a public health perspective, and on the precautions put into place to ensure that these studies are conducted safely.

In the future, there will inevitably be debates over the safety or ethics of the latest experiments in a particular field. In attempting to wade through the murky waters of a complex controversy, science policy makers should make decisions that balance public health, safety, and ethics, rather than reactionary policies like censorships and moratoriums.

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Written by sciencepolicyforall

April 21, 2017 at 8:47 am

Science Policy Around the Web – April 14, 2017

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By: Leopold Kong, PhD

Fatty foods: By Lucasmartin2 (Own work) [CC BY-SA 4.0], via Wikimedia Commons

Health Policy

Banning Trans Fats in New York Prevented Thousands of Heart Attacks

In an effort to lower the incidence of heart disease, the leading cause of death in the United States, the FDA will prohibit food manufacturers from using trans fats next summer. FDA’s decision was based on decades of research linking trans fat consumption with increased risk of heart disease. A study published this Wednesday in JAMA Cardiology provided further support for the ban. Using data from the New York State Department of Public Health, collected from 11 counties where trans fats restriction was recently implemented, the researchers showed a statistically significant decline in heart attack (7.8%) and stroke (3.6%) events since then. “The most important message from these data is that they confirm what we predicted — benefit in the reduction of heart attacks and strokes,” said the lead author, Dr. Eric J. Brandt, a fellow in cardiovascular medicine at Yale. “This is a well-planned and well-executed public policy.” With the rising cost of health care in the United States, the FDA’s long awaited trans fat ban is urgently needed to lighten the public health burden. (Leah Samuel, STATNews)

Vaccine Research

The Human Vaccines Project, Vanderbilt and Illumina Join Forces to Decode the Human Immunome

Rapidly evolving viruses such as HIV and Hepatitis C have been difficult targets for traditional vaccine development, in which inactivated viruses or viral proteins are used as vaccine components. Despite the success of small molecule therapeutics against HIV and Hepatitis C, an effective vaccine remains the most cost effective solution to curb the global pandemics caused by these viruses. Scientists now seek to optimize vaccine candidates based on a deeper understanding of host-pathogen interactions using multidisciplinary approaches, ranging from protein engineering and evolutionary biology to immunology and genetics. To facilitate these sophisticated efforts, the Human Vaccines Project, an international public-private collaboration, was established. A major initiative of the project, the Human Immunome Program, is led by Vanderbilt University Medical Center. Now, Illumina has joined the collaboration to help decipher the genetic features of the immune system, or the “immunome,” using cutting edge sequencing technology. DNA sequences from immune cells during infection may capture how the immune system adapts to viruses, providing guidelines for vaccine design. “Successfully defining the human immunome will provide the foundational knowledge to usher in a new era of vaccine, diagnostic, and therapeutic development,” says Gary Schroth, vice president for product development at Illumina. Greater understanding of the immunome may also lead to more effective cancer vaccines. (Human Vaccines Project)

 

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