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Archive for December 2016

Science Policy Around the Web – December 23, 2016

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By: Joel Adu-Brimpong, BS

Source: Flickr, by Ben Gordon, under Creative Commons

Public Health

Looking Beyond Flint

All eyes turned to the city of Flint, Michigan as it burst onto the national scene after reports revealed that children were being exposed to dangerously high levels of lead in their drinking waters. Although shocking, a recent study shows that the Flint narrative is no abnormality. “In fact, it doesn’t even rank among the most dangerous lead hotspots in America,” states Reuters, an international news agency and investigative body that conducted the study.

In this Reuters report, it was discovered that almost 3000 areas in the country had at least twice the lead poisoning rates of the infamous Michigan city, with much less press coverage. In some areas, such as Baltimore, Cleveland and Philadelphia, areas with multigenerational lead poisoning, about 40 to 50 percent of children had elevated levels of lead. Nationwide estimates by the Centers for Disease Control and Prevention (CDC) purport that approximately 2.5 percent of small children, children between ages one and five, present highest levels.

For this study, Reuters obtained lead poisoning data from state health departments and the CDC. But rather than peruse and detail state or county-level data, Reuters pursued more granular results; testing for lead poisoning at the neighborhood-level. Altogether, Reuters observed 2,606 census tracts, or small county subdivisions, and 278 zip codes across the country with at least twice the prevalence rate of lead poisoning as Flint. It was noted that while poverty remains an integral predictor of lead poisoning, victims span the American tapestry of rich and poor, urban and rural and black and white.

Federal aid to assist states in lead poisoning management is quite limited. After the Flint debacle, Congress delivered $170 million in aid to Flint. However, the budget allocated to the CDC to assist states in lead poisoning control is only a fraction of the Flint package. With the 21st Century Cures Act set to withdraw approximately 3.5 billion from the Prevention and Public Health Fund, a fund established under Obamacare, and a pervasive political rhetoric regarding the repeal of Obamacare, lead poisoning may return to its obscure position in the public sphere. (M.B. Pell and Joshua Schneyer, Reuters)

Drug Policy

When Drug Prices Rise, Americans Turn Outward?

A recent study revealed that 70 percent of Americans take at least one prescription drug a day. And if you are among this group, or care for someone on medication, you are most likely aware that drug prices have been rising. In fact, a 2015 poll by the Kaiser Family Foundation (KFF) found that roughly 80 percent of Americans deemed costs of prescription drugs ‘unreasonable.’ A report by the IMS Institute for Healthcare Informatics earlier this year indicated that, after accounting for estimated reimbursements, net medication spending for the 2015 year was roughly $310 billion. So what happens when drug prices exceed affordability in the U.S.?

A poll by KFF last month found eight percent of survey respondents, or roughly 19 million adults in the U.S., had or knew someone in their household who had imported a drug at some point. Drug prices when obtained outside the country (i.e., Canada, Mexico, etc.) may be half the sticker price in the U.S., or even cheaper. This finding comes on the heels of recent spikes in prescription drug prices such as that of Daraprim, a life-saving drug often prescribed for AIDS patients, Cycloserine, a drug used to treat tuberculosis, Epipen, an injection device for patients with severe allergies, and others which have caused national outrage.

Although illegal for Americans, in most instances, to import drugs into the U.S. for personal use due to safety and effectiveness concerns, experts contend that eight percent is a conservative number. Some respondents may be reluctant to report violations of the law or are uncomfortable with talking about daily struggles with drug affordability. Demographics of individuals who imported prescription drugs ranged from young adults in college to elderly retirees, with prescription drugs imported spanning treatments for chronic and acute conditions.

Earlier this week, Senate Democrats sent a letter to Donald Trump urging the President-elect to effect bipartisan support to curb rising drug prices. But with no assurances in sight to curtail the epidemic of rising drug costs, will even more Americans turn outward in order to meet their prescription needs? If so, how might this affect the quality of circulating drugs and medication adherence practices? (Rachel Bluth, Kaiser Health News)

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December 23, 2016 at 9:00 am

Mental Health Policy and its Impact on the American Population

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By: Fatima Chowdhry, MD

           In the last 50 years, the U.S. has seen a migration in which individuals diagnosed with a mental illness, defined by the Diagnostic and Statistical Manual of Mental Disorders as “a syndrome characterized by clinically significant disturbance in an individual’s cognition, emotion regulation, or behavior”, are treated not in a mental health institution but rather in prisons, nursing homes, and outpatient facilities. To understand the implications of this trend, it’s important to frame this issue as a cascade of events. For example, we can start with a member of law enforcement, not adequately trained to recognize someone in the throes of a manic phase or a schizophrenic not on their medication, arresting an individual with a mental illness. We then find that this individual, upon release, did not receive treatment and now has trouble reintegrating into their community and is unable to find gainful employment. The combination of a lack of treatment, stable community, and employment leads them to continuous run-ins with the law, restarting a vicious cycle that had led us to a prison population in which the majority has a mental illness.

The move to deinstitutionalize people with mental illness from mental institutions began in the 1960’s and accelerated with the passage of the Community Mental Health Act of 1963. This bill was an important step forward to improve the delivery of mental health care because it provided grants to states to set up community health centers. In 1981, President Ronald Reagan signed the Omnibus Budget Reconciliation Act, which sent block grants to states in order for them to provide mental health services. Aside from these two bills, and the Mental Health Parity Act of 1996, which ensured insurance coverage parity of mental health care with other types of health care, there has been little in the way of significant mental health legislation. Mental health was put on the backburner and the result is a mental health infrastructure in tatters.

During the Great Recession, states cut billions in funding dedicated to mental health. A vivid example of how decreased state funding affects mental health services can be seen in the state of Iowa. The current Governor has been put in the difficult position of balancing fiscal responsibility with maintaining access to mental health care. At one point, there were four state mental health hospitals that provided care to each corner of the state. The Governor closed down two of the facilities to save the state money. While they were old facilities built in the 19th century and cost millions to maintain, many people in Iowa felt that he moved too quickly before alternative services were in place. In addition to closing these mental health facilities, the governor obtained a waiver from the federal government to modernize the state’s Medicaid program and move from fee-for-service to managed care. Under fee-for-service, health care providers are paid for each service provided to a Medicaid enrollee. Under managed care, Medicaid enrollees get their services through a vendor under contract with the state. Since the 1990s, the share of Medicaid enrollees covered by managed care has increased, with about 72% of Medicaid enrollees covered by managed care as of July 1, 2013. The move can be difficult because hospital networks and providers have to contract with a vendor and Medicaid beneficiaries may have to switch providers. Needless to say, it can be an administrative nightmare. The transition in Iowa, to say the least, has been rocky with the vendors threatening to pull out because of tens of millions of dollars in losses. The vendors and the providers might not get paid as much as they want but the people getting the short end of the stick are people on Medicaid, which includes individuals with mental health illnesses.

Given the patchwork of mental health care across the country and the lack of funding, what can be done? According to NAMI, 43.8 million Americans experience a mental illness in a year. Many don’t receive the treatment they need. It’s a multi-faceted problem facing families, employers, health care providers and community leaders. At the federal level, lawmakers have introduced several bills to address mental health. In the United States Senate, a bipartisan group of four Senators introduced S. 2680, the Mental Health Reform Act of 2016. This bill encouraged evidence-based programs for the treatment of mental illness, provided federal dollars to states to deliver mental health services for adults and children, and created programs to develop a mental health workforce.

It was encouraging to see that many components of S.2680 were included in H.R 34, the 21st Century Cures Act, which was signed into law on December 13th, 2016.  H.R 34 faces some headwinds because some of the funding portions are subject to Congressional appropriations, and if Congress is feeling austere, they can tighten the purse strings. Moving forward, a major issue of concern for mental health is the future of the Affordable Care Act. Under the Affordable Care Act, states were initially mandated to expand their Medicaid rolls. A Supreme Court decision, however, made the decision to expand optional. So far 32 states, including Washington D.C., have expanded. Some red states, like Iowa, Arkansas and Indiana have utilized the waiver process of the ACA to expand their program. If the ACA is repealed, policymakers will have to contend with the effects on the private insurance market as well as Medicaid.

Right now, the crystal ball is murky. Only time will tell.

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December 22, 2016 at 10:45 am

Science Policy Around the Web – December 20, 2016

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By: Liz Spehalski, PhD

Source: Flickr, under Creative Commons

In-Vitro Fertilization

UK Approves Mitochondrial Replacement Therapy Trials For Assisted Reproduction

The UK Human Fertilization and Embryology Authority (HFEA) has given the green light to allow mitochondrial replacement therapy, a type of assisted reproduction that can help families to avoid passing on genetic diseases. The method is controversial because the embryos contain genetic material from three people: two eggs and one sperm. The decision has been widely anticipated and comes after years of debate and a change in the country’s laws in 2015.

Mitochondria are responsible for generating more than 90% of the energy required by the body to sustain life and support organ function. When mitochondria fail, cells generate less and less energy, resulting in cell injury and cell death. The parts of the body that require the most energy; the heart, brain, muscles, and lungs, are the most affected by mitochondrial disease. Mitochondrial disease is difficult to diagnose due to its wide range of symptoms, which can include seizures, strokes, developmental delays, blindness, and heart problems.

Mitochondrial replacement therapy involves exchanging damaged mitochondria for heathy ones by transferring only the nuclear DNA from one egg or fertilized embryo from the mother into a donor egg, whose mitochondrial DNA is intact but nuclear DNA is removed. The technique has already been performed in Mexico and the Ukraine, and John Zhang, a physician at New Hope Fertility Center in New York City, has said that a baby boy conceived by the technique in Mexico seems healthy to this point. Recent work with eggs from affected women, however, found that some of the defective mitochondria from the mother’s egg was transferred to the embryo along with the DNA, raising questions about the effectiveness of the treatment. Currently, congressional action has blocked the FDA from allowing mitochondrial replacement procedures to be attempted in the United States.

On December 15, the HFEA announced that it would allow clinics to apply for licenses to conduct limited trials of the technique, with the goal of preventing mothers from passing down mutations in mitochondria. “Today’s historic decision means that parents at very high risk of having a child with a life-threatening mitochondrial disease may soon have the chance of a healthy, genetically related child. This is life-changing for those families,” said HFEA chair Sally Cheshire. An HFEA spokesperson projected that the UK’s first child with three people’s DNA could be conceived as early as March 2017. (Ewen Callaway, Nature News)

Biotechnology

Commerce Secretary Announces New Biopharmaceutical Manufacturing Institute

Penny Pritzker, US Secretary of Commerce, announced on Friday a new institute to be added to the Manufacturing USA Institute; the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). The institute is the eleventh of Manufacturing USA Institute, the first funded by the Department of Commerce (DOC), and the first awarded under the Manufacturing USA “open topic” competition, in which industry was encouraged to propose institutes allocated to any manufacturing area that is not already being tackled.

While pharmaceutical manufacturing relies on chemistry, biopharmaceuticals are a drug product manufactured in or isolated from biological sources. They include vaccines, blood and blood components, stem cell and gene therapies, recombinant proteins, among other biologics. Many of these products are widely used for the treatment of an array of diseases such as cancer, autoimmune disorders and infectious diseases, generating billions of dollars worldwide.

The goals of this institute will be to keep biopharmaceutical manufacturing in the USA and to scale up the production of complex biological drugs. “In communities from coast to coast, the Manufacturing USA network is breaking down silos between the U.S. private sector and academia to take industry-relevant technologies from lab to market,” said Secretary Pritzker. “The institute announced today is a resource that will spread the risks and share the benefits across the biopharmaceutical industry of developing and gaining approval for innovative processes. The innovations created here will make it easier for industry to scale up production and provide the most ground-breaking new therapies to more patients sooner.”

NIIMBL received $70 million from the US Department of Commerce, and will be getting another $129 million from a public-private consortium of 150 companies, academic institutions, and nonprofits, as well as 25 states. The University of Delaware will be coordinating the institute’s partnership with the DOC. The hope is that NIIMBL will help to advance U.S. leadership in the biopharmaceutical industry, foster economic development, improve medical treatments, and ensure a qualified workforce by collaborating with educational institutions to develop new training programs matched to specific biopharma skill needs. (Press Release, Department of Commerce)

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December 20, 2016 at 9:07 am

Science Policy Around the Web – December 13, 2016

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By: Allison Dennis, BS

Source: pixabay

Whistleblowers in Science

Keep your reviewers close and your online, anonymous, post-publication reviewers closer

A recent ruling by the Michigan Court of Appeals has ruled that anonymous online scientific reviews are a protected form of speech. Fazlul Sarkar, a former researcher at Wayne State University, had sued the site PubPeer in 2014 in an attempt to reveal the identity of several anonymous online reviewers to mixed success. Sarkar claimed that the defamatory and public nature of several online reviews posted anonymously to PubPeer had cost him a forthcoming tenure position at the University of Mississippi, one that came with a $350,000 a year salary. These reviews brought into question the validity of several images found in his published works.

While the initial ruling in March of 2015 largely sided with PubPeer to protect the anonymity of their online posters, a follow-up just two weeks later compelled PubPeer to reveal the IP address of a user who had gone as far as to repost quotes from an email response from the Senior Executive Assistant to the President of Wayne State University confirming their knowledge of the online allegations.

PubPeer filed an appeal of the decision by the end March, which garnished the collective support of science and internet moguls, Bruce Alberts, and Harold Varmus, Google, and Twittter in addition to the ACLU who filed amicus briefs in support of online anonymity. The summer brought more trouble for Sarkar as thirteen of his papers were retracted.

On December 9, 2016, the Michigan Court of Appeals found upon further review that Sarkar was “not entitled to unmask the identities of any speakers on pubpeer.com” citing “anonymity protections afforded by the First Ammendment.” Although this ruling does not dismiss Fazlul Sarkar’s case against John and Jane Doe, the protection of anonymity makes the suit moot. (Adam Marcus and Ivan Oranksy, STAT)

Federal Funding

Bipartisan cure found for stalled 21st Century Cures Initiative

In an end of the year push, the House and Senate passed the 21st Century Cures Initiative, a bill aimed at bringing legislation and regulation up to speed with biomedical research. At the end of November, a draft of the bill emerged from negotiations that were largely palatable to both Republican and Democrats across the House and Senate. A previous draft of the bill had successfully passed the House in July. However agreement over the source of funding could not be reached, arresting any further progress of the bill. The passing months brought Fred Upton, the Republican Representative who had originally spearheaded the bill close to the term limit afforded, as the chair of the Energy and Commerce Committee. The results of the recent elections seemed to be enough to incentivize compromise for Democrats in the final months of the Obama administration. Both parties returned to negotiations settling on a combination of funds derived from the selling of petroleum reserves and the Affordable Care Act.

In the end, the bill won 392-26 in the House and 94-5 in the Senate. Highlights of the bill under the title of Development include the accepted substitution of “data summaries” for full clinical trials when a new indication is to be added for a previously approved drug and expansion of off label-uses. The FDA has been tasked with evaluating evidence from the real world in an effort to speed-up and improve patient access. Highlights under the title of Discovery include a $4.8 billion boost to the NIH budget and $1.8 billion power pack for Joe Biden’s Cancer Moonshoot. A complete play-by-play of the winners and losers of the final version of the bill can be found in Sheila Kaplan’s article on STATnews. (Sheila Kaplan, STAT)

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December 13, 2016 at 10:38 am

Science Policy Around the Web – December 9, 2016

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By: Amy Kullas, PhD

Infectious Diseases

Current Mumps Outbreak is the Worst in Recent History

2016 has been the worst in recent history for mumps outbreaks. According to a report released by the Center for Disease Control (CDC), almost 4,000 cases of mumps have been reported. This number is almost triple the number of cases reported in 2015. Mumps symptoms include: puffy cheeks and a swollen jaw (due to swollen salivary glands), fever, headache, tiredness, and loss of appetite.

In prevention of mumps, the measles, mumps, and rubella (MMR) vaccine is ~88% effective when a person gets both of the recommended doses and ~78% effective when a person received a single dose. The mumps vaccination program began in 1967. Prior to this, mumps was considered a ‘classical’ childhood disease in the United States. Some clinicians say, “the efficacy of the vaccine wanes after 10 to 15 years.”

Though mumps outbreaks can still occur in vaccinated communities (particularly in close-contact settings like colleges), high vaccination rates aids to limit the size, length, and spread of the outbreak. This ongoing outbreak is hard-hitting college campuses. In fact, some universities have scaled back dining hall hours in addition to asking students to “cancel nonmandatory social gatherings” in an attempt to thwart the infectious disease. Other universities have begun to recommend and offer a third dose of the mumps vaccine to students. (Melissa Korn, The Wall Street Journal)

Vaccination

Antivaxers Meet with Trump

Andrew Wakefield, the orchestrator of the “anti-vaccine movement”, met with Donald Trump this past summer. This misguided movement began with a paper published in 1998 by the now discredited Wakefield in The Lancet. The authors claimed that 2/3 of children developed autism soon after receiving the measles, mumps, and rubella (MMR) vaccine. Though this study has been disproven numerous times and has been retracted, the impact still flows not only through the scientific community, but also into the general public. This is why the scientific community cringed when Trump appeared to be sympathetic towards their cause.

When parents refuse to vaccinate their children, they cite the belief that vaccines cause autism or state that vaccines are “unnecessary”. Vaccination is an extremely effective strategy for preventing infectious diseases. However, this strategy is only successful when the vast majority of individuals are immunized against a particular pathogen in order to offer some protection to individuals who are not medically able to receive the vaccine.

Wakefield stated, “For the first time in a long time, I feel very positive about this, because Donald Trump is not beholden to the pharmaceutical industry. He didn’t rely upon [drug makers] to get him elected. And he’s a man who seems to speak his mind and act accordingly.” While Trump has appeared to be interested and open-minded on vaccines, there are limits to what he can do to undercut vaccination policies. But the antivaxers remain hopeful that Trump will be a powerful ally who would trigger more of a cultural impact as opposed to passing laws. (Rebecca Robbins, STAT news)

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December 9, 2016 at 9:40 am

Perspective on Climate Change: Supporters versus Skeptics

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By: Nivedita Sengupta, PhD

        A recent United Nations report shows that earth’s surface temperature is rapidly hurtling towards a two degrees Celsius increase. Scientists say that the world must stay below two degrees to avoid the worst effects of climate change. However solving this issue can be challenging and overwhelming. The science used to generate the evidence for climate change is complicated and the predictions carry many caveats and asterisks. Nonetheless the major question that stands out is, “What is climate change and why people are skeptic about it?”

The definition of climate change itself triggers a difference in opinion. According to the Intergovernmental Panel on Climate Change (IPCC), climate change refers to “A change in the climate that persists for decades or longer, arising from either natural causes or human activity”. This definition differs from that in the United Nations Framework Convention on Climate Change (UNFCCC), where climate change preferentially refers to “A change of climate that is attributed directly or indirectly to human activity that alters the composition of the global atmosphere.” Instead, UNFCCC defines a change in climate over comparable time periods because of natural causes as climate variability.

Keeping these definitions aside, many policymakers and major corporations worldwide have agreed and expressed willingness to address climate change. They believe the scientific evidence generated so far demands action. But some scientists, economists, industry groups, and policy experts continue to insist that there is no need for policy changes. Ironically many people concede with them and insist that the entire problem is exaggerated. The debate between the supporters and the skeptics is ingrained, and both groups deride each other with countless claims and counterclaims on both the science and proposed policy solutions.

Surprisingly, some climate-change skeptics do admit that the earth is warming. But they debate the cause, its potential impact, and whether human intervention is affecting it. As Myron Ebell, the president elects’ select candidate for leading the transition of the Environmental Protection Agency, stated his views on climate change “I agree that carbon dioxide is a greenhouse gas, and its concentrations in the atmosphere are increasing as a result of human activities—primarily burning coal, oil, and natural gas, where I disagree is whether this amounts to a crisis that requires drastic action.”

So what are the premises on which the skeptics insist that the current policies addressing the issue of climate change are unwarranted and dispensable? Broadly, this question can be answered by discussing the views of skeptics versus supporters on three major points of concern.

First, what is global warming and is it really happening?

Skeptics

The skeptics argue that the earth is not warming. They contend that the satellite-based temperature measurements, taken across the earth’s surface, indicate no measurable change in the last 30 years, and that the measuring standards are different in every place resulting in inconsistent readings. Besides, the IPCC’s graph of “global” temperatures is incorrect as they do not state the earlier cool period of about 1400 or a very warm period from about 900 to 1050 when the temperatures in Europe were several degrees warmer than today. They also make the point that warming is natural and if the earth was warmer during those periods and consecutively cooled down via some natural mechanisms, then that will happen in the future too.

Supporters

According to IPCC and National Aeronautics and Space Administration (NASA), records of temperature that date back to the distant past, generated by analysis of ice cores and sediments, are quite accurate and suggest that the warming in recent decades is way higher than any period over the past millennium. Gavin Schmidt, director of NASA’s Goddard Institute for Space Studies, said, “It’s unprecedented in 1,000 years.” 15 out of the 16 hottest years in NASA’s 134-year record have occurred since 2000.

Second, is there any real impact because of climate change?

Skeptics

Skeptics believe that climate change has no impact whatsoever and is not responsible for the extreme weather catastrophes in recent times. It has happened in the past and has no connection with either global warming or increased levels of carbon dioxide.

Supporters

The supporters says that the impacts are everywhere starting from the melting of polar ice sheets to endangered biodiversity, which will eventually risk human health and society. In the US alone, numerous weather and climate-born billion-dollar disasters have occurred from 1980-2016, the most recent being the historic flood devastating a large area of southern Louisiana.

Third, and the most disputed subject is…

Are human beings really responsible for climate change?

Skeptics

According to skeptics the carbon dioxide levels are not high enough to elicit concern as the current carbon dioxide levels were exceeded in the last 150 years. Besides, they argue that water vapor, and not carbon dioxide, is the significant greenhouse gas because it absorbs more radiant heat than carbon dioxide and makes up about 3% of the atmosphere compared to 0.03% by carbon dioxide. The current level of carbon dioxide contributes to about 3% of the total warming and hence the anthropogenic carbon dioxide contribution to total warming is, at the most, about 0.1%. Therefore carbon dioxide generated because of “human interference” has no discernible role in global warming. They consider carbon dioxide as beneficial for the environment and attribute other factors like aircraft exhaust, cosmic rays, solar winds, magnetic fields and solar intensity as causes of climate change. They state that no definitive factor for climate change has been established yet and any assertive statements about current and future climates should be regarded with skepticism.

Supporters

IPCC in its 2014 climate change report states, “Human influence on the climate system is clear, and recent anthropogenic emissions of greenhouse gases are the highest in history.” Global warming is primarily a problem of too much carbon dioxide in the atmosphere. This carbon overload is caused mainly when we burn fossil fuels like coal, oil and gas or cut down and burn forests. Burning of fossil fuels to make electricity is the largest source of heat-trapping pollution. Though water vapor is the most abundant heat-trapping gas, it has a short cycle in the atmosphere and cannot build up in the same way carbon dioxide does. Preventing dangerous climate change requires very deep cuts in carbon dioxide emissions, as well as the use of alternatives to fossil fuels worldwide.

In 2015, the Paris Agreement was made within the UNFCCC to deal with climate change by reducing greenhouse gases emissions starting in 2020. So far, 114 out of 197 countries have ratified with the agreement and vouched to cut down emission. On September 2016, the United States of America joined the Paris agreement along with China, another big emission producing country. President Obama called it a top concern and said “For all the challenges that we face, the growing threat of climate change could define the contours of this century more dramatically than any other challenge”. In contrast, president-elect Donald Trump has shown a skeptic view on this matter and has described climate change as “bullshit” and a “hoax. He vowed to dismantle the EPA and withdraw United States from the Paris Agreement to reduce the damage on economy created by climate change alarmists. However, there are a handful of elected members who offer some hope to fight the cause of climate change in coming years. Five candidates with strong climate credentials won offices in Congress, and they have impressive personal and political backgrounds. In the present situation it’s critical that the world stays on course with rational, prompt and comprehensive action to mitigate climate change.

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December 8, 2016 at 9:00 am

Streamlining Human Research by Centralizing Review: Could It Slow Things Down?

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By: Leopold Kong, PhD

Source: NIH Image Gallery on Flickr, under Creative Commons

       Human research in the United States in the form of clinical trials and other scientific studies has been regulated by Institutional Review Boards (IRBs) since 1974 after the passage of the National Research Act. The initial policies were inspired by the Nuremberg Code, a set of international research ethics principles developed in the aftermath of the second world war when Nazi medical officers conducted large-scale human experimentation atrocities. Policies that regulate IRBs in the United States are codified in the Common Rule, which mandates requirements such as membership qualifications and guidelines for protections of certain vulnerable research subjects. Although the Common Rule has not been modified since 1991, the changing face of medical research has led to recent proposals to improve the efficiency, accountability and qualification of IRBs. What has motivated change? The following situations may be illustrative.

In November 2015, the consumer advocacy group Public Citizen, and the American Medical Student Association contacted the Office for Human Research Protections (OHRP) to criticize two studies on how longer-than-21-hour shifts of first-year medical students may affect 30-day patient mortality rates. Public Citizen noted that even though the studies forced new residents to work “dangerously long shifts”, placing all involved in danger, they were readily approved by IRBs. Similarly, IRBs approved a study on the hazards of pediatric exposure to lead paint, in which researchers did not clearly reveal to households that they detected high levels of lead in their homes, resulting in neurological problems for at least one child. Also, a publication last year in the European journal Acta Informatica Medica found that only 26.5% of individuals in IRBs correctly answered 11 simple True or False questions designed to test understanding of study design and ethics. Part of the problem may be research fatigue since, according to OHRP, there are only about 3,500 registered IRBs that review more than 675,000 research protocols annually. Inefficiencies in the review process may further exacerbate the situation.

Late last year, Kathy Hudson and Francis Collins, the Deputy Director for Science, Outreach and Policy at the National Institutes of Health (NIH), and the Director of the NIH, respectively, published a Perspective in the New England Journal of Medicine on the proposed revisions to the Common Rule. In order to bring the Common Rule into the 21st century, the revisions will focus on implementing broad biospecimen consent, enhanced privacy safeguards, streamlined IRB review, and requirements for more agencies to follow the Common Rule. One of the more interesting and key revisions to improve review efficiency, the requirement for a single IRB (sIRB) for multisite studies, will be implemented on May 25, 2017. The rest of this essay focuses on this proposed change.

The time it takes for a clinical trial protocol to be reviewed by an IRB depends on the type of review, and varies from location to location. For example, a protocol can be deemed exempt, which might take only 1-2 weeks of review, expedited, which might take a few weeks longer, or be required for full review, which would take even longer. Re-evaluations are required if the protocol is sent through expedited or full reviews every year, after any changes to the method, or after any adverse event in the study. The review generally evaluates proof of human subjects’ training, consent, recruitment materials, and data collection instruments, as well as individual conflicts of interests, all of which may depend on the specific population studied and local restrictions. However, clinical trials are increasingly spread across multiple sites in order to recruit enough people for their studies. Under the current rule, each site must conduct local reviews of the same protocol independently of each other, potentially causing delays due to unneeded redundancies. “The problem that this [proposed sIRB] policy was trying to solve was that we were seeing delays and complications in moving research forward in a way that wasn’t providing commensurate protections for human research participants,” said Carrie D. Wolinetz, NIH associate director for science policy, to Bloomberg BNA.

From December 3, 2014 to January 29, 2015, the NIH received 167 comments from individual researchers, academic institutions, IRBs, advocacy groups, scientific societies, healthcare organizations, Tribal National representatives and members of the general public on the sIRB proposal. Many of the comments were highly positive and supportive of the revision. For example, the Federation of American Societies for Experimental Biology (FASEB), which represents over 120,000 researchers across 27 scientific societies, stated that “[t]his change would facilitate collaborative review arrangements and reduce the obstacles that investigators encounter when embarking on multi-center projects.” David M Pollock, the president of the American Physiological Society, added further support, commenting that the current rule results in “lack of uniformity” while the proposed changes may reduce administrative burden, and improve efficiency and quality of review.

However, many of the comments displayed reservations and harsh criticism. For example Harry W. Orf representing Massachusetts General Hospital was skeptical that the costs to move into the sIRB system would outweigh the benefits, commenting “there is currently little research or data to demonstrate that these potential benefits will materialize.” In much stronger terms, Curtis Meinert from the Johns Hopkins Bloomberg School of Public Health stated,” [t]he expectation is that the change will save money. Good luck on that. The reality is that the change will increase costs given what IRBs of record have to do to acquire the necessary assurances and certifications. The expectation also is that the single IRB will shorten the time to start, good luck on that one also.” Meinert and others, including the Human Subjects Protection Branch at Walter Reed Army Institute of Research, pointed out that the time it takes to start a study is mainly determined by other factors such as the time it takes for investigators to agree on a protocol, not IRB review. Meinert also warns that, “A likely unintended effect of the one IRB requirement is to further diminish the means and incentives for individual investigators to propose and initiate multicenter studies..” Finally, some communities also viewed the revision as a threat to local autonomy and representation. For example, Bill John Baker, the Principal Chief of the Cherokee Nation, commented, “Tribal IRB members have firsthand knowledge of local tribal customs, cultural values, and tribal sensitivities. If Tribal IRB members are not able to participate […] our citizens are affected by persons who are not sensitive to their distinctive needs.”

Analysis of all comments made regarding sIRB by the Council on Government Relations indicated that 51% opposed the proposal while 42% supported it and 6% offered qualified support. Interestingly, most commercial IRBs, which might be more favorably biased towards the needs of industry sponsors, supported this change. A breakdown of the numbers indicates that while the majority of advocacy groups, professional societies, disease registries and individual researchers supported the change, 89% of universities and medical centers, the organizations that are directly involved with clinical trials and representing thousands of researchers and medical support staff, opposed it. “The spirit of the changes are well intended, but it fails to address the fact that roles and responsibilities of the IRB have expanded beyond those initially dictated when the use of IRBs were first formed“ says Annika Shuali, certified clinical research coordinator at the University of Virginia.

Clearly, reforms are needed to update the aging IRB system. In theory, centralization through the sIRB may improve efficiency. However, in practice, the complexities and details of conducting clinical trials at specific sites such as resolving individual conflicts of interest, being compliant with local regulations, and accounting for the specific rights of certain populations make centralization extremely difficult. To address these site-specific issues, local IRB’s may still need to be in place, but now required to communicate to the sIRB, potentially increasing administrative burden, which undermines the original motivation to streamline review. Hopefully, the sIRB revision to be implemented next year will be further revised to address the critiques from the majority of the community.

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Written by sciencepolicyforall

December 3, 2016 at 11:46 am