Science Policy For All

Because science policy affects everyone.

Posts Tagged ‘NIH

Science Policy Around the Web – June 16, 2017

leave a comment »

By: Emily Petrus, PhD

Source: pixabay

Science and Politics

Politics in Science – It’s Not Just the U.S.!

Romania is a country in eastern Europe that joined the European Union (EU) in 2007. Scientists there are few and far between; research spending only accounts for 0.49% of GDP, the lowest in Europe (the US spent 2.7% in 2016). After joining the EU, Romanian researchers were encouraged to apply for European merit-based grants and sit on international review boards such as the National Research Council and the National Council of Ethics. It seemed that research was making slow but steady progress, but the new administration elected this year has shaken things up in all facets of government, including scientific research.

The new research minister, Serban Valeca, removed the international members appointed to government councils that oversee research funding, ethics, innovation and science policy, and replaced them with city council members, government-loyal union members, researchers from second tier Romanian institutes and even a surgeon being investigated for embezzlement. Grant review panels have been shuffled to remove international scientists and replace them with domestic researchers, but only if they have a certificate saying their university approves of their participation. These changes mark a departure from welcoming international input into Romanian proceedings and a movement towards scientific isolation.

To combat these changes, Romanian scientists have formed an organization, Ad Astra, which calls on researchers to boycott grant evaluations. Combined with the shuffling, the councils have been suspended for 3 months, which delays funding and puts already under-funded researchers in peril. The European University Association calls the policies deeply concerning, and although the current president may disagree with the research minister’s handling of the situation, his political ties ensure he won’t hold much sway over how this plays out. A computer scientist at the University Politehnica in Bucharest, Costin Raiciu, is concerned that the policies will affect talented researchers who have returned to Romania and says, “Without [merit-based] funding, people would either give up research altogether or move out of the country”. This is an all too familiar scenario in which it is apparent that policy and science must cooperate to produce ideal outcomes. (Alexandra Nistoroiu, ScienceInsider)

Mental Health

Clinical Trials Down, Basic Research Up at NIMH

Mental health is a notoriously tricky field. The development of the Diagnostic and Statistical Manual of Mental Disorders (DSM) in the 1950s has historically been a way to diagnose patients with mental health issues, and then give appropriate treatment. This has proved to be an imprecise treatment strategy, because within a category of diagnosis there is a broad spectrum of behaviors, and underlying this behavior there may be multiple causes. The NIH’s Precision Medicine Initiative (PMI) seeks to characterize 1,000,000 people by behavior, genetics, environment, and physiology. Researchers from the NIMH will send questionnaires evaluating behavior to detect mood and reward responses for this group of people. When this mental health evaluation is combined with information about their genetics, lifestyle and environment, scientists can characterize mental health disorders more specifically.

Many clinician researchers are upset by the steep decline in clinical trial research funded by NIMH, which has become higher profile with director Joshua Gordon’s arrival in 2016. NIMH seeks to route funding to study mental disorders using a basic research approach before spending time and money on costly clinical trials which too often lead to inconclusive or disappointing results. In 2011 NIMH launched the Research Domain Criteria (RDoC), which encourages research proposals to include a hunt for the mechanism underlying mental health studies. Since the initial call to include a RDoC perspective in grant applications, the incidence of RDoC appearing in funded applications has increased while mention of the DSM has decreased. Other buzzwords that are present in funded grants include biomarker, circuit, target and mechanism.

These data represent a shift in how funding decisions will proceed in mental health but may have broader reaching implications for other areas of research. In a blog post Dr. Gordon writes, “the idea that RDoC will facilitate rapid, robust and reproducible neurobiological explanations for psychopathology (as observed within and across DSM disorders) represents a hypothesis”. It remains to be seen if RDoC is an effective metric to evaluate successful grants. (Sara Reardon, Nature News)

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

Science Policy Around the Web – June 13, 2017

leave a comment »

By: Nivedita Sengupta, PhD

By Mikael Häggström, used with permission. [Public domain], via Wikimedia Commons

Stem Cell Therapy

Texas on Track to Become First State to Explicitly Back Stem Cell Therapies

On 30th May, Texas passed a bill  authorizing unapproved stem cell therapies, making Texas the first state to openly recognize experimental treatments. The bill will make the use of unapproved stem cell therapies legal for patients and is currently awaiting the approval of Governor Greg Abbott, who already supports the measure. Experimental stem cell therapies for terminal and chronic conditions have struggled for years to gain support without much success. Until now, no state has provided legal validation for these kind of therapies and the current stem cell procedures are mostly done under strict regulations.

Amendments were added to the bill, which require that the treatments be delivered by doctors with the approval of an institutional review board, which deals with human research. It will also add another amendment that will allow patients to have authority to sue in case the treatments go wrong. Many scientists and advocates opposed the measure stating that unapproved stem cell therapies can be harmful rather than beneficial. They state that though the amendments add protection to the patients, there are a few aspects of the bill that make them uncomfortable. Two other bills focused on patient access to experimental therapies, also known as “right-to-try” policies, failed to pass in the Texas Senate. (Andrew Joseph, STATNews)

Research Funding

NIH Scraps Plans for Cap on Research Grants

US National Institutes of Health (NIH) decided to drop the controversial proposal of capping the number of grants that an investigator can have at a time. The initial capping attempt was suggested to gather funds for younger researchers by NIH in May. The proposal was based on studies that suggested that a lab’s productivity decreases once it holds too many grants. Younger scientists often face more difficulties in obtaining NIH RO1 grants compared to their older more experienced colleagues. As a result, many researchers applauded the NIH’s effort to provide more funding for younger scientists. Yet the capping proposal received major adverse response from the scientific community stating that the NIH’s interpretation of the productivity study data does not apply to all labs, especially to the collaborative lab groups with four or five R01s that are more productive than labs with only one. Researchers also complained that the proposed point-based scoring system will also make collaborations difficult thus hampering productivity in the long run.

NIH director Dr. Francis Collins stated that the original idea was still a work in progress and NIH is going to put a hold on it. Instead of the cap, on 8th June, NIH announced the creation of the special fund, the Next Generation Researchers Initiative (NGRI), starting with US$210 for funding young researchers. The initiative will focus on investigators with less than 10 years of experience as NIH- funded principal investigators, and on high score grant proposals that were rejected because of lack of money. The initiative will grow up to $1.1 billion over the next five years. According to NIH principal deputy director Larry Tabak, NIH will immediately start creating an inventory of investigators who meet these criteria and expects that this approach will allow more than 2,000 additional R01 grants to be funded to younger scientists compared to the cap-based plan, which would have supported only 1600 awards. Nonetheless, the current proposal is still going to generate controversy as it will affect the older researchers because of NIH’s diversion of funding. (Sara Reardon, Nature News)

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

Written by sciencepolicyforall

June 13, 2017 at 7:08 pm

Science Policy Around the Web – May 5, 2017

leave a comment »

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)

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

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