Science Policy For All

Because science policy affects everyone.

Posts Tagged ‘NIH

Science Policy Around the Web – April 4, 2017

leave a comment »

By: James Taylor, PhD

Photo source: pixabay.com

Research Funding

NIH Research Grants Yield Economic Windfall

Assessing the social and economic benefits of basic research – research conducted with no clear medical or financial goal in mind – has is often tricky with the former being philosophical in nature whilst the later sometimes coming years later from unexpected angles. A classic example of this process is the polymerase chain reaction (PCR), which was built on basic research on DNA replication in bacteria from hot springs published years before its invention.  Critics of publicly funded research often take studies out of context in order to ridicule them, such as Sarah Palin’s infamous “fruit flies” comment.

A recent analysis of the economic effects of the National Institutes of Health (NIH) funding has shone light on the economic benefits of basic research. Danielle Li and colleagues found that although 8.4% of NIH grants between 1980 and 2007 led directly to patents, 30.8% produced a scientific article which was later cited in a commercial patent for a drug, device or other medical technology. This demonstrates an enormous but indirect benefit of publically funded research. Furthermore, when the studies were broken down into basic or applied (research with a stated medical or commercial goal) they found no difference between the two in terms of how likely they were to be cited in a patent. This should give funding bodies pause for thought, as it calls into question their growing emphasis on applied research.

Taking into account the indirect effects of NIH funded research, the authors estimate that every $1 in NIH funding returns $1.40 in drug sales. This report is timely with proposed budget cuts for science funding looming large in the horizon, and exposes such cuts as sheer economic folly. (Elie Dolgin, Nature News)

HIV/AIDS

HIV Infections are Spiking Among Young Gay Chinese

Recent surveys of HIV infections in China have shown a worrying spike in HIV infections among young gay and bisexual men, and have sparked the implementation of a broad 5-year plan to raise awareness and boost research into new treatments by the country’s ruling State Council. In the early 2000s, HIV infections were most prevalent amongst drug users in China, but there has been a steady decrease in prevalence amongst this group. The increase in HIV infections amongst men who have sex with men (MSM) has bucked this trend, and instead has been rising at an alarming rate. The cause of this increase remains unknown, with researchers at the National Health and Family Planning Commission in Beijing and China Medical University in Shenyang rather hopelessly suggesting that it was “possibly due to several unidentified and yet unaddressed risky sexual behaviors”.

China has previously mounted an effective response to the initial HIV epidemic by providing free antiretroviral to all HIV patients. This does little good, however, if you are afraid to admit you have HIV because it may out you as gay or bisexual. Despite recent improvements in LGBT rights and growing acceptance of LGBT people among the younger generation, being LGBT in China still carries with it significant stigma. This stigma, along with that of having HIV, may be causing young men to avoid seeking help out of fear. To reach out to gay men who may be at risk, the government and concerned nongovernmental organizations are working on novel outreach programs, such as working with dating apps popular with young gay and bisexual men to spread HIV awareness. The director of the Chinese Centre for Disease Control (China CDC), Wu Zunyou, has proposed increasing the availability of HIV self-test kits and pre-exposure prophylaxis medications, both of which would help those at risk whilst lessening the pressure from social stigma. (Kathleen McLaughlin, Science)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

April 4, 2017 at 10:00 am

Sickle Cell Disease in Sub-Saharan Africa: Using Science Diplomacy to Promote Global Health

leave a comment »

By: Steven Brooks, PhD

         Science diplomacy is an important conduit through which nations can cooperate with each other to help address issues of common concern. Establishing international collaborations based on scientific research and resource sharing can be a valuable tool to promote advances in global health and to help foster research communities in developing nations. In 2001, Nelson Mandela proposed a model for building and advancing a network of institutions investing in Science, Engineering, and Technology (SET) across sub-Saharan Africa (SSA) to enhance economic diversification, promote job growth, and improve living conditions for peoples across the region. Since then, significant strides have been made by many international organizations, including the World Health Organization, World Bank, and United Nations, to invest in SET institutions and researchers across SSA. Much work is still needed, however, to address the significant global health disparities affecting SSA. According to the United Nations Development Programme, life expectancy in SSA is on average only 46 years. Among the largest contributory factors to this gap is HIV/AIDS, but non-communicable diseases and genetic conditions such as Sickle Cell Disease (SCD) contribute as well. SCD in particular offers a stark geographic contrast in disease outcome: in the United States, childhood mortality (up to age 18) from SCD is below 10%, while in SSA the early childhood mortality rate is 50-90% by age 5. This drastic difference in childhood mortality from SCD raises an important question- why is the difference in mortality rates so large, and what can be done to eliminate it?

SCD represents a significant public health success in the United States. From the early 1970s, average life expectancy of people with SCD has substantially increased from 14 years of age to over 40 years, and childhood mortality rates have continued to decline. These vast improvements in SCD mortality in the US are attributable to improvements in screening and early diagnosis, as well as surveillance for early childhood infections and prophylactic treatments.  Availability of therapies like hydroxyurea and access to blood transfusions have also contributed to reducing childhood mortality, while several currently ongoing clinical trials in the US are testing the use of bone marrow transplantation as a curative procedure for patients with severe complications of SCD. While the best practices for diagnosing and treating SCD are well-established in developed nations, lack of global implementation has meant that these advances in treatment have had very limited effect on reducing mortality and improving quality of life in developing nations. More than 85% of all new SCD cases occur in SSA, with over 240,000 infants with SCD born in SSA annually (compared to less than 2,000 in the US). Many nations in SSA do not have the resources or personnel to implement protocols for screening and diagnosis, and many children are born outside of hospitals. As a result, most children born with SCD in SSA will go undiagnosed, and therefore untreated, leading to devastatingly high rates of early childhood mortality for children with SCD.

The disparity in health outcomes between children born with SCD in developed nations and developing nations in SSA should be addressed through science diplomacy. An opportunity exists for diplomatic cooperation between scientists and health officials from the US and their counterparts in SSA to build infrastructure and train researchers and healthcare professionals to diagnose, treat, and innovate new solutions for SCD. The crucial first steps towards improving outcomes in SCD – parental and newborn screening, early childhood nutrition standards, parental and community education, and anti-bacterial and anti-viral vaccinations and prophylaxis – are achievable through diplomatic efforts and collaboration with governmental health agencies across SSA. Proof of this concept has been demonstrated in Bamako, Mali, with the success of the CRLD (The Center for Sickle Cell Disease Research and Control), a SCD-specific treatment and research center that reflects an effort of the government of Mali, with funding and medical resources provided by the Foundation Pierre Fabre. The CRLD utilizes modern diagnostic techniques to screen for SCD. It also provides immunizations, hospitalizations, and access to preventive medicine, and provides education and outreach to patients and to the larger community. Historically, the infant mortality rate from SCD in Mali was estimated to be 50% by age 5. Since the opening of the CRLD in 2005, only 81 of the over 6,000 patients enrolled at CRLD have died, a mortality rate for this cohort that is comparable to rates in the US and UK. The CRLD also has modern laboratories that conduct research, with over 20 academic papers published from the CRLD so far. The ongoing success of the CRLD is proof that investment in, and collaboration with, governments and medical professionals in Africa can lead to equitable health outcomes in SCD. Similar investments by the US government and the National Institutes of Health (NIH), possibly through intramural research programs, and in cooperation with health-focused private foundations, could lead to similar success stories in communities across SSA.

The NIH supports and facilitates collaborations in global health research through the NIH Fogarty International Center (FIC), which currently sponsors projects in 20 countries across SSA. NIH has also invested intramural resources into collaborations in SSA to combat Malaria. The National Institute of Allergy and Infectious Diseases (NIAID) trains and sponsors investigators to independently conduct research in Mali (NIAID’s Mali ICER (International Centers of Excellence in Research)). Despite its significant history of investment in SSA, the NIH offers almost no international support for research related to SCD. The NIH FIC only currently funds one project related to SCD, preventing pediatric stroke in Nigerian Children. The Division of Intramural Research at the NIH is currently home to robust basic science and clinical-translational research on SCD. Intramural researchers can and should collaborate with clinicians and scientists from SSA who will lead the effort to combat SCD in their home nations. More broadly, the NIH could spearhead an initiative to bring together stakeholders from the US government, health ministries from nations in SSA, and private foundations that support efforts to reduce or eradicate global disease, to begin establishing a network of laboratory and clinical facilities for testing and treatment, as well as to train clinicians and researchers from SSA in diagnostic and research techniques specific to SCD, and to design and disseminate educational resources for increasing communal knowledge regarding SCD across SSA.

In addition to significantly improving SCD mortality and health outcomes in SSA, these efforts of science diplomacy will have substantial benefits in the US as well. The US is home to a sizeable, and growing population of people living with SCD. As life expectancy continues to increase, new challenges will arise for effectively treating serious complications associated with SCD, such as renal disease, stroke, cardiovascular disease, heart failure, cardiomyopathy, and pulmonary hypertension. By collaborating with researchers and healthcare leaders studying large populations of people with SCD in SSA, the NIH will foster innovation and generate new insights about SCD that are uniquely informed by the data and perspectives of African scientists and populations. The NIH and the US government can establish a mutually beneficial program of treatment, education, and research that will enable developing nations to treat their patients with the same methods available in the US. Investing in 21st century methods of diagnosis and treatment, as well as contributing funding, training, and infrastructure to clinicians and researchers in SSA, can strengthen diplomatic relationships between governmental leaders and scientists alike and lead to lasting collaborations that strengthens research and innovation into new treatments for SCD.

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

March 3, 2017 at 9:21 am

Science Policy Around the Web – January 24, 2017

leave a comment »

By: Leopold Kong, PhD

Landfill by Dhscommtech at GFDL, via Wikimedia Commons

Environment

New Discovery Could Lead to a Safer Solution to Plastic Pollution

Polyethylene terephthalate (PET) is a commonly used resin of the polyester family used in the fibers for clothing and liquid containers. In 2015 alone, 56 million tons of PET was produced. Although recyclable, with 1.5 billion pounds recovered annually in the United States, PET is not biodegradable and is a major presence in landfills. Screening 250 samples of contaminated soil, waste water and sludge from a bottle recycling factory for microorganisms that can grow on PET, a team of Japanese scientists has discovered a bacterium, Idoenella sakaiensis, that can break down this tough plastic. Recently spotlighted as a major breakthrough of 2016 by the American Chemical Society, research on the bacterium continues as scientists seek to unlock the mechanism behind the biodegradation pathway that was previously thought to be impossible. Professor Kenji Miyamoto, one of the study authors, said, “This is the first PET-degrading bacterium found [with potential] to develop a new and nature-friendly system”. (Research Highlights, Keio University).

Biomedical Research

Trump Asks NIH Director Francis Collins to Stay On

Last Thursday, on the eve of the inauguration, the National Institutes of Health (NIH) announced that Dr. Francis Collins has been asked to continue his role as NIH director by the Trump administration for an unspecified time. This eleventh hour development came as Collins received back the letter of resignation he had sent late last year, something all presidential appointees do. If asked to stay on through this presidential term, Collins, part of Obama’s science ‘dream team’, would be the first NIH director since the 1970s to be chosen by two presidents.

Ezekiel Emanuel, a bioethicist at the University of Pennsylvania said, “In general, I think more than eight years has not been a good idea. There’s a cycle, and eight years is hard to have new ideas and new energy.”  Nonetheless, Collins, a National Academy of Sciences member who led the human genome project and a highly vocal Christian apologist, would serve as an effective bridge between the research community and the new Republican administration to secure much needed funding for basic research. Tony Mazzashi, senior director for policy and research at the Association schools and Programs of Public Health in Washington DC said, “ I think everyone in the research community will be thrilled.” (Jocelyn Kaiser, Science)

Public Health

Novavax Starts New Clinical Trial in Bid to Prove Failed RSV Vaccine

Respiratory Syncytial Virus (RSV) is a significant public health burden, infecting almost all children by age 2, with 5 to 20 out of 1,000 requiring hospitalization and with a mortality rate of 8 to 34 out of 10,000. Unfortunately, the development of an effective vaccine has been challenging. In the late 1960s, an RSV vaccine for infants devastatingly failed clinical trials with 80% of children receiving the shot being hospitalized. Recent advances in immunology and the RSV vaccine target has led to a new generation of potentially safer and more effective vaccine candidates from industry giants Novavax, GlaxoSmithKline, Global Vaccines, AstraZeneca and MedImmune. Also being explored is vaccination of expectant mothers to protect infants.

However, the field took a hit last year when Novavax’s candidate vaccine failed its phase 3 clinical trials, resulting in a 30% layoff of its workforce. Nonetheless, last Thursday, the company announced that it has started a new phase 2 trial on older adults in the southern hemisphere.  “We expect the results from this trial to inform the next steps in our older adults program and would ensure we maintain our leadership position in this very attractive market opportunity,” said Stanley Erck, president and CEO of Novavax. (Tina Reed, Washington Business Journal)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

January 24, 2017 at 10:04 am

Science Policy Around the Web – December 13, 2016

leave a comment »

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)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

December 13, 2016 at 10:38 am

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

leave a comment »

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.

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

December 3, 2016 at 11:46 am

How Much Neuroscience Funding is the Right Amount?

leave a comment »

By: Brian Russ, PhD

Source: pixabay

       Scientific funding can be a very tricky proposition. Unfortunately, there is a finite amount of money that is put towards science each funding cycle. This means that at any given time funding agencies need to decide where they believe their funds will be best spent. Every funding cycle, one can find different groups lamenting that their favorite topic is “being underfunded” while some other group is getting “too big a piece of the pie”. There is often no right answer to the question of how much is the right amount of funding to provide different topics, and the likelihood is that at the end of the day every group will feel that they are not getting the right amount of respect and funding.

This debate has come to the forefront recently in the fields of psychiatry and neuroscience with a change in the leadership at the National Institute of Mental Health (NIMH). In September, Dr. Joshua Gordon became the new director of the NIMH. Dr. Gordon’s directorship of the NIMH comes after a 13-year period of leadership by Dr. Tom Insel. During the previous administration, there had been an increasing focus on funding neuroscience related work, often at the expense of purely behavioral work, such as cognitive behavioral therapies for psychiatry patients. It is important to point out that the NIMH’s definition of neuroscience research includes basic, translational, and clinical neuroscience research. This direction led to a new research framework for studying mental health disorders termed the Research Domain Criteria (RDoC), which has a very strong neuroscience component. The goal of RDoC is to provide a new framework in which researchers and clinicians can study and treat mental health disorders. The RDoC framework involves neuroscience components of brain circuits and physiology, and cognitive components of behavior and self-reports. The end goal is to provide a more comprehensive description of mental health disorders with the intention of developing cures and treatments. This push toward RDoC, and more neuroscience in general, has led to both praise and criticism of where the NIMH is directing its funding opportunities.

Recently, an opinion piece was published in the New York Times stating that the NIMH needs to reverse their push towards more neuroscience. Specifically, Dr. Markowitz, a research psychiatrist from Columbia University, believes that the NIMH has been funding neuroscience at the expense of clinical psychological research, in the absence of a brain oriented component. His argument is that in the current funding environment only 10% of the NIMH’s research budget is going towards clinical research. From the content of his article the research he is speaking of involves behavioral studies and interventions that contain no neuroscience component. Dr. Markowitz brings up many important points, and his main thesis that we cannot forget about behavioral interventions while pursuing the biological bases of clinical disorders is critical. For example, he makes the strong point that neuroscience research is unlikely to help solve the problem of suicide. And his final argument is for a “more balanced approach to funding clinical and neuroscience research.”

However, one can argue what that balance should actually look like. Is ten percent of the budget actually a small amount? And does that number include the multitude of basic neuroscience studies that are investigating the neural underpinning of a given disease? For example, based on the NIH reporter, schizophrenia research has been funded for approximately 250 million dollars for each of the last three years. A quick look at the total budget (32.3 billion in 2016, with ~25 billion going to research grants) suggests that that would be on the order of about 1% of the total NIH research budget. This is only one disease, and is being calculated from the whole NIH budget, not just from the NIMH budget. Only a portion of that funding is going towards clinical research, as Dr. Markowitz would define it, however the rest of that funding is going to research that will in all likelihood provide clinical benefits to patients down the road, in the form of new physiological targets or potentially new drugs.

So how can one make a determination about the correct of amount of funding that should go towards different mental health fields? Should 25% or 50% of the budget go towards clinical research? It seems that comparing the percent of money going to clinical research versus neuroscience is simply a bad comparison. Neuroscience is not one homogenous topic; it includes tens of, if not over a hundred, different fields. The various mental health fields fighting each other over funding doesn’t help anyone. Both neuroscience and clinical research need to be funded. It seems that the best way to divide the funding from NIMH would not be to specify what field gets priority but instead to fund the best grants regardless of whether there is a specific component involved. This would open the door to more clinical research while not requiring a shift in the priorities of the NIMH, whose mission is to understand and treat mental illnesses though both basic and clinical research. For instance, RDoC already contains both behavioral and self-report components. These components should be given as much priority as the other neuroscience components. If 10% of the budget is given to behavioral work, in this way, that would seem reasonable, possibly even greater than other areas might be getting.

On a final note, while we should always be looking internally at how we are funding different types of science, and if we, the public, are getting our money’s worth out of projects, it is also important for us to ensure that science funding as a whole is increasing. The current funding environment has been relatively static for years. We need, through advocacy and outreach, to get the public and government to provide more funding opportunities to the NIH. As the saying goes “a rising tide raises all boats”.

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

November 17, 2016 at 6:53 pm

Science Policy Around the Web – October 28, 2016

leave a comment »

By: Emily Petrus, PhD

Source: Flickr, under Creative Commons

Technology and Health

Can You Please Pass the iPad?

As digital media screens have become more prevalent, doctors have warned parents of its negative impact on developing minds. In 1999, screen time was first addressed, with doctors mandating that no screen time was recommended for children under age 2.   The argument goes that children need parents present in real-time to interact with to develop the ability to read social cues and engage on a personal level.

Now the American Academy of Pediatrics (AAP) has dictated that one hour per day of high-quality educational screen time may be allowed for children between 2 and 5 years of age. For children 18 months to 2 years, some screen time is ok as long as a parent is actively engaged and watching with the child. This is especially relieving for parents of children who have relatives far away who use Skype or FaceTime to communicate. Although this is technically screen time, it does benefit children with those important social interactions and reading facial and vocal cues.

Overall the goal of the AAP is to ensure that media is used in a mindful way, not to replace social interactions but to enhance family discussions and provide supplementary education material for older age groups. They also recommend media-free family time to ensure children develop a healthy relationship with technology. Jenny Radesky, MD, FAAP and lead author for the statement said, “What’s most important is that parents be their child’s media mentor. That means teaching them how to use it as a tool to create, connect and learn.” In relation to screen time rules, it seems the amount of parent involvement and moderation are the keys to success. (AAP)

Mental Health Research

New Director of National Institutes of Mental Health (NIMH)

NIMH has a tall order to fill: bridge the gap from the breakneck speed of basic neuroscience research advances to bring solid and reliable treatments to the clinic. Last month NIMH welcomed a new director, Dr. Joshua Gordon, to take the helm and direct the institute toward a balance between these two priorities. After 19 years as a faculty member at Columbia University, Gordon hopes to bring his experience as both a clinician and a researcher to achieve this delicate result.

NIMH’s strategic plan for research was laid out in September, with four priorities highlighted to combat mental illness. These include describing mechanisms of complex behaviors, at the molecular, cellular, circuit and genetic levels. Second, characterizing mental illness trajectories to determine best intervention procedures and time points, which would include detecting biomarkers and understanding how behavior reflects neuropathology. Third, NIMH strives to marry tried and true existing treatments with new therapies which can be implemented in community settings, thus bringing help to patients. Finally, NIMH funded research must improve public health, with better clinician education about new treatments, and new service delivery models that can be implemented to reach more patients suffering from mental illness.

These are all monumental tasks but Gordon seems up for the challenge. In a recent Q&A session by Meredith Wadman of Science Magazine, he was asked about the op-ed pieces in the Washington Post and the New York Times by NIMH clinical psychiatrists where they accused previous director Thomas Insel of putting too much priority on basic research and letting clinical neuroscience fall by the wayside. Gordon replied by saying, “I think my first priority is good science. Where there are opportunities in psychiatry for short-term effects, we are going to try to take advantage of them. Absolutely. We’d be mad not to. We know so little about the brain, we have so few truly novel treatments in the pipeline that I’m all ears.” (NIH News Release)

Autism

Autism early intervention – help the parents, help their children

The plight of the working parent has become an important and almost bipartisan issue this election season. Politicians are proposing policies that will help families with paid family leave and some help with childcare costs, however there is a growing segment of people who desperately need even more help. Raising a child with autism is increasingly common, currently 1% of children and young people in the US are on the spectrum.

The cost of having an autistic child can be tremendous, with extra health care expenses, special equipment, classes and educational requirements. Often one parent must leave the workforce to care for their child as they require extensive and specialized care. Early interventions such as classes and therapy are thought to be effective for lessening the symptoms of autism, but until now the trials have been small and have had short end points. This week The Lancet published an article demonstrating that interventions aimed at educating parents of autistic children had long-term (up to 6 years) benefits. 152 children aged 2-4 years old were recruited to the study, with half given interventions that included therapy, monthly support and a parent-mediated 20-30 minute daily session of planned activities. The children who received this extra support reported lower levels of severe autism and had better teacher and parent assessed behaviors. However, the study did not find significant reductions in anxiety or depression or a language benefit.

This study demonstrates that providing education and resources for parents of autistic children are a worthwhile endeavor. Government resources are often aimed at providing services for the child, which are equally important. Parents armed with the proper educational tools can become personalized therapists for their children, which could reduce societal costs and improve outcomes. (Heidi Ledford, Nature)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

October 28, 2016 at 10:50 am