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Posts Tagged ‘clinical trials

Science Policy Around the Web – September 12, 2017

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By: Saurav Seshadri, PhD

Vaccination Medicine Vaccine Ampoules

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Infectious Diseases

Is a Zika vaccine worth the effort?

A collaboration between pharmaceutical giant Sanofi and the US Army to develop a vaccine for the Zika virus has come to an end.  About a year ago, Sanofi received $43.2 million in funding from the Biomedical Advanced Research and Development Authority (BARDA, a division of DHHS) to move a Zika vaccine candidate, generated by the Walter Reed Army Institute of Research, into Phase II development.  BARDA has now decided to ‘de-scope’ the project, leading Sanofi to abandon its efforts to develop or license the candidate.

The number of cases of Zika has declined sharply since its peak in early 2016.  While this ‘evolving epidemiology’ has hampered Zika-related clinical research and drug development, it may actually be a welcome relief for Sanofi. The French company has endured months of political pressure to agree to pricing assurances for any vaccine produced from the collaboration, with lawmakers, including Senator Bernie Sanders, arguing that it would be a ‘bad deal‘ for a private company to profit from research funded in part by American taxpayers.  In particular, the exclusivity of Sanofi’s license,  uncommon for such agreements, has been singled out as ‘monopolistic’.  Sanofi has been defending itself vigorously against this characterization, pointing out that it took on significant risk itself for a vaccine that was far from approval, and that it has already discussed reimbursing the US government for its investment through milestone and royalty payments.  Ultimately, ending the collaboration puts this PR-damaging debate to rest, while also providing Sanofi a face-saving opportunity to avoid committing to a drug with limited prospective demand and profitability (as recently transpired with the dengue fever vaccine Dengvaxia, which only reached 55 of its projected 200 million euros in sales in 2016).

In its statement, Sanofi says that it continues ‘to believe that public-private partnerships are the right model to address…public health challenges’ posed by infectious diseases.  Indeed, several pharmaceutical companies responded to the WHO’s declaration of Zika as a public health emergency in 2016; of these, Takeda and Moderna appear to still have ongoing large-scale collaborations with BARDA to develop Zika vaccines.  While the drop in Zika prevalence is clearly a good thing, it’s unclear how it will affect the economic and scientific feasibility of such collaborations in the future.  One solution is to promote vaccine development before an outbreak occurs: groups such as the Coalition for Epidemic Preparedness Innovations (CEPI) hope to facilitate this approach, but the need to allocate limited resources makes its practicality questionable.  However, the alternative is usefully illustrated by the Ebola epidemic of 2014.  Despite concerted global efforts that led to successful vaccine development by Merck, current outbreaks are small enough that the deployment of vaccines may not even be warranted.  Barring an overhaul of regulatory processes and/or financial priorities, it seems likely that when the next epidemic emerges, we’ll be playing catch-up again.

(Eric Sagonowsky, FiercePharma)

Neuroscience

Is every human brain study a clinical trial?

Basic research into the mechanisms underlying cognition and their impairment in a range of brain disorders is the primary focus of hundreds of neuroscience laboratories.  While such studies feed into drug discovery for diseases such as autism, schizophrenia, and bipolar disorder, since they do not directly involve testing any treatments, they are not commonly considered to be clinical trials.  This perception became technically incorrect in 2014, following an NIH announcement broadly redefining ‘clinical trial’ to include any study in which ‘one or more human subjects’ receive an intervention and ‘health-related biomedical or behavioral outcomes’ are observed.  Last year, the NIH revised its data reporting policies for such trials.  These more stringent policies are now being implemented, and will affect grant applications submitted in 2018.

Several members of the scientific community have begun to voice their concern about the changes.  The Association for Psychological Science (APS) and Federation of Associations in Behavioral & Brain Sciences (FABBS) have both sent critical letters to the NIH. A petition by neuroscience researchers pushing back against the policy has garnered over 3,400 signatures.  Opponents argue that the requirements imposed by the ‘clinical trial’ label are overly burdensome and would impede basic research.  These requirements include timely study registration and public disclosure of results through ClinicalTrials.gov. Further, they demand that all staff receive Good Clinical Practices training. Investigators dread the bureaucracy that will be involved in complying with these mandates.  Perhaps most concerning for scientists is the constraint that new proposals must respond to a Funding Opportunity Announcement, which have specific stipulations about study objectives, design, oversight, and evaluation.  While these rules are intended to promote scientific rigor and transparency, the more immediate effects may be to stifle exploration and creativity and to deter basic researchers who may not know how to tailor their applications to reflect clinical values.

For its part, the NIH is steadfast that the broad redefinition is ‘intentional’ and that current standards of data reporting are ‘unacceptable’.  Policymakers argue that they are simply asking scientists to inform the public about the existence and outcome of their research.  While this sounds unimpeachable in theory, scientists are already reporting practical challenges: for example, asking potential study participants to sign a clinical trial consent form can scare them away.  While the NIH is making efforts to provide guidance to the community, it is running out of time to stamp out confusion before next January, let alone achieve enthusiastic compliance.  Neuroscientists are likely to face setbacks in funding and progress as a result.

(Sara Reardon, Nature News)

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September 12, 2017 at 5:52 pm

Science Policy Around the Web – July 21, 2017

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By: Rachel F Smallwood, PhD

Source: pixabay

Cancer

Engineered Cell Therapy for Cancer Gets Thumbs Up from FDA Advisers

A panel of advisers has recommended that the FDA approve chimeric antigen receptor T-cell (CAR-T) therapy for treatment of acute B-cell lymphoblastomic leukemia. The committee unanimously agreed that the risk to benefit ratio was favorable enough to proceed with approval of the drug (tisagenlecleucel), manufactured by Novartis. CAR-T therapy utilizes a patient’s own immune cells to find and attack cancer cells. In a recent trial in humans, 82.5% of patients went into remission following treatment with the drug; there have also been promising results from its use in glioblastoma treatment. The treatment would specifically be for pediatric and young adult patients who did not respond well to initial treatments or who relapsed from being in remission.

Despite have strong positive effects, there are potential risks posed by CAR-T therapy. In the study mentioned above, almost half of the patients experienced an inflammatory reaction called cytokine release syndrome. Although all of those cases were treatable, the condition can be life-threatening. Novartis also reported neurological problems. Other CAR-T trials have had several deaths due to brain swelling, but those were in adult populations and were some differences in the therapies.

The FDA often does take the recommendations of its advisers, but there is much to consider in this decision. It would essentially be approving a living drug that is individualized to each patient; the patients’ own blood cells are sent to a manufacturing center, where they are genetically engineered to target leukemia cells. The cell population is then allowed to proliferate, and the entire process takes around twenty-two days. This process presents a quality assurance and control problem to the FDA. However, the target population typically has a poor prognosis and very few options, so the panel considers the potential for increased survival and quality of life to be worth the risks. (Heidi Ledford, Nature News)

Stem-Cell Therapy

Unapproved Stem-Cell Treatments Touted on Federal Database Clinicaltrials.Gov

ClinicalTrials.gov is an online database, curated by the National Library of Medicine and the National Institutes of Health, that logs clinical studies occurring around the country and allows them to be searched by patients, family members, healthcare providers, and researchers. The information on the site is provided by the researchers or sponsors of the individual studies themselves. It allows patients and healthy people to become aware of opportunities to participate in medical research. These studies involve a wide range of treatments, including drugs, devices, behavioral therapies, and procedures.

A recent study found that the database is being abused by clinics advertising for stem cell trials. These trials target individuals looking for treatment for a variety of conditions, and all of them charge for participation. There are very few FDA-approved stem cell therapies, and most clinics that utilize stem cell therapies assert that they do not need FDA approval since they are practicing medicine and do not substantially alter the stem cells (although that is disputed).  Since the researchers themselves indicate in the database whether they need FDA approval, there is little oversight to ensure these studies are correctly representing the risks and benefits of their treatment.

Although a disclaimer was added this spring that informs visitors that the presence of a trial in the database does not indicate government endorsement of it, many people do not realize that they could potentially be participating in a for-profit procedure that does not have the proper oversight to ensure patient safety. In one such case, three women were blinded who paid to receive stem cell therapy for macular degeneration. Most legitimate research studies will not require payment for participation, although travel and lodging costs associated with participation may be incurred.

While many patients may receive treatment at one of these clinics without an adverse event or even with a positive result, critics of these types of clinics are calling for regulation of entries into the ClinicalTrials.gov system. They assert that a federal resource for medical research should not be used to advertise for for-profit clinics that are utilizing therapies that have not been studied or reviewed for safety and efficacy. (Laurie McGinley, Washington Post)

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July 21, 2017 at 10:08 am

Science Policy Around the Web – June 16, 2017

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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)

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Growing Need for More Clinical Trials in Pediatrics

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By: Erin Turbitt, PhD

Source: Flickr by Claudia Seidensticker via Creative Commons

      There have been substantial advances in biomedical research in recent decades in the US, yet children have not benefited through improvements in health and well-being to the same degree as adults. An illustrative example is that many drugs used to treat children have not been approved for use by the Food and Drug Administration (FDA). Comparatively, many more drugs have been approved for use in adult populations. As a result, some drugs are prescribed to pediatric patients outside the specifications for which they have been approved for use, referred to as ‘off-label’ prescribing. For example, some drugs approved for Alzheimer’s Disease are used to treat Autism in children. The drug donepezil used to treat dementia in Alzheimer’s patients is used to improve sleep quality in children with Autism. Another example is the use of the pain medication paracetamol in premature infants in the absence of the knowledge on the effects among this population. While decisions about off-label prescribing are usually informed by scientific evidence and professional judgement, there may be associated harms. There is growing recognition that children are not ‘little adults’ and their developing brains and bodies may react differently to those of fully developed adults. While doses for children are often calculated by scaling from adult dosing after adjusting for body weight, the stage of development of the child also affects responses to drugs. Babies have difficulties breaking down drugs due to the immaturity of the kidneys and liver, whereas toddlers are able to more effectively breakdown drugs.

The FDA requires data about drug safety and efficacy in children before issuing approvals for the use of drugs in pediatric populations. The best way to produce this evidence is through clinical drug trials. Historically, the use of children in research has been ethically fraught, with some of the early examples from vaccine trials, such as the development of the smallpox vaccine in the 1790s. Edward Jenner, who developed the smallpox vaccine, has famously been reported to have tested the vaccine on several young children including his own without consent from the children’s families. Over the next few centuries, many researchers would test new treatments including drugs and surgical procedures on institutionalized children. It was not until the early 20th century that these practices were criticized and debate began over the ethical use of children in research. Today, in general, the ethical guidance for inclusion of children in research specifies that individuals unable to exercise informed consent (including minors) are permitted to participate in research providing informed consent is gained from their parent or legal guardian. In addition to a guardian’s informed consent, assent (‘affirmative agreement’) of the child is also required where appropriate. Furthermore, research protocols involving children must be subject to rigorous evaluation by Institutional Review Boards to allow researchers to conduct their research.

Contributing to the lack of evidence of the effects of drugs in children is that fewer clinical trials are conducted in children than adults. One study reports that from 2005-2010, there were 10x fewer trials registered in the US for children compared to trials registered for adults. Recognizing the need to increase the number of pediatric clinical trials, the FDA introduced incentives to encourage the study of interventions in pediatric populations: the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). The BPCA delays approval of competing generic drugs by six months and encourages NIH to prioritize pediatric clinical trials for drugs that require further evidence in children. The PREA requires more companies to have pediatric-focused drugs assessed in children. Combined, these initiatives have resulted in benefits such as improving the labeling of over 600 drugs to include pediatric safety information, such as approved use and dosing information. Noteworthy examples include two asthma medications, four influenza vaccines, six medications for seizure disorders and two products for treating migraines. However, downsides to these incentives have also been reported. Pediatricians have voiced concern over the increasing cost of some these drugs developed specifically for children, which have involved minimal innovation. For example, approval of liquid formulations of a drug used to treat heart problems in children has resulted in this formulation costing 700 times more than the tablet equivalent.

A further aspect that must be considered when conducting pediatric clinical trials is the large dropout rates of participants, and difficulty recruiting adequate numbers of children (especially for trials including rare disease populations) sometimes leading to discontinuation of trials. A recent report indicates that 19% of trials were discontinued early from 2008-2010 with an estimated 8,369 children enrolled in these trials that were never completed. While some trials are discontinued for safety reasons or efficacy findings that suggest changes in standard of care, many (37%) are discontinued due to poor patient accrual. There is insufficient research on the factors influencing parental decision-making for entering their child to a clinical trial and research into this area may lead to improvements in patient recruitment for these trials. This research must include or be informed by members of the community, such as parents of children deciding whether to enroll their child in a clinical trial, and disease advocacy groups. The FDA has an initiative to support the inclusion of community members in the drug development process. Through the Patient-Focused Drug Development initiative, patient perspectives are sought of the benefit-risk assessment process. For example, patients are asked to comment on what worries them the most about their condition, what they would consider to be meaningful improvement, and how they would weigh potential benefits of treatments with common side-effects. This initiative involves public meetings held from 2013-2017 focused on over 20 disease areas. While the majority of the diseases selected more commonly affect adults than children, some child-specific disease areas are included. For example, on May 4, 2017 public meeting was held on Patient-Focused Drug Development for Autism. The meeting included discussions from a panel of caregivers about the significant health effects and daily impacts of autism and current approaches to treatment.

While it is encouraging that the number of pediatric trials are increasing, ultimately leading to improved treatments and outcomes for children, there remain many challenges ahead for pediatric drug research. Future research in this area must explore parental decision-making and experiences, which can inform of the motivations and risk tolerances of parents considering entering their child to a clinical trial and potentially improve trial recruitment rates. This research can also contribute to ensuring that clinical trials are ethically conducted; adequately balancing the need for more research with the potential for harms to pediatric research participants.

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May 24, 2017 at 5:04 pm

Science Policy Around the Web – April 25, 2017

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By: Eric Cheng, PhD

Photo source: pixabay.com

FDA

FDA Nominee Gottlieb Tackles Vaccines, Trial Design at Hearing

The President’s nominee to head the FDA, Scott Gottlieb, MD, sat before lawmakers for his confirmation hearing before the Senate’s health committee. Gottlieb, a hospitalist and former FDA official, was questioned on many controversial topics on health.  On the topic of vaccines and autism, Gottlieb said, “I think we need to come to the point where we can accept ‘No’ for an answer, and come to the conclusion that there is no causal link between vaccinations and autism.”

On the topic of double-blind randomized trials as the “gold standard” for medical treatment research, Gottlieb was more cautious. He believed that there are more “opportunities to modernize how we do clinical trials in ways that aren’t going to sacrifice on the gold standard of safety and effectiveness. Perhaps there are ways to think of clinical trial constructs that don’t require the tight randomization that current clinical trials do.” What this suggests is a push towards more adaptive trials that would allow researchers to review results before a study’s endpoint and would allow changes to treatment groups in a study, which is in contrast to traditional randomized controlled trials.

Another less controversial but popular topic in the hearing was on opioid abuse. Gottlieb believed that opioid abuse is “a public health emergency on the order of Ebola and Zika” and that bolder steps will be needed to address this issue.

The committee will vote on whether to move Gottlieb’s nomination to the Senate floor after the Senate returns in late April from a 2-week recess. (Joyce Frieden, MedPage Today)

Healthcare Policy

Trump Administration Still Plans to Undo Parts of the ACA, Tom Price Testifies

Health and Human Services Secretary Tom Price made one thing clear during his testimony to the House appropriations committee: “The administration is still intent on dismantling parts of the Affordable Care Act even if Republicans lack the votes to rewrite it.”

Price discussed how, as the Health and Human Services Secretary, his department could scale back several federal mandates that include “essential benefits” in coverage to make insurance plans cheaper. He did not say if the administration will continue to provide cost-sharing subsidies for insurers, which has been a topic of discussion on items to change in the Affordable Care Act. However, removing subsidies will bring “significant premium increases,” said Michael Adelberg, a health-care principal at FaegreBD Consulting. He predicts that the removal of these subsidies will cause some insurers to drop out while the remaining insurers will seek rate increases to compensate.

Regardless of these discussions, the individual mandate remains in place with Price telling the panel, “So long as the law’s on the books, we at the department are obliged to uphold the law.” (Juliet Eilperin and Mike DeBonis, Washington Post)

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April 25, 2017 at 9:53 am

Science Policy Around the Web – April 18, 2017

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By: Nivedita Sengupta, PhD

Source: pixabay

DNA Testing

23andMe Given Green Light to Sell DNA Tests for 10 Diseases

On April 6th, the US Food and Drug Administration (FDA) approved the first at-home genetic test kits, which can be sold over the counter in pharmacies, to determine the risk of developing certain genetic diseases. Since 2006, 23andMe, a company based in California, has been analyzing DNA from saliva samples of its customers to provide genetic insights into their risk of developing 240 different diseases and disorders. However, in 2013, FDA was concerned about customers using test results to make medical decisions on their own, and ordered 23andMe to halt the service. In 2015, FDA eased some of the restrictions and allowed the company to reveal to their customers only the information regarding genetic anomalies that can be transferred to their children, and not any information about the person’s own disease risk.

23andMe now has permission to inform its customers about genetic mutations that are strongly associated with a small group of medical conditions such as Parkinson’s disease, late-onset Alzheimer’s disease, celiac disease and a hereditary blood-clot disorder called thrombophilia. However, it should be noted that the results from these tests are not equivalent to a medical diagnosis, as the development of a disease is also influenced by a person’s family history, lifestyle and environment.

The decision made by the FDA paves the way for a wave of do-it-yourself diagnostic tests, which will be flooding the market in the coming years. “It’s a watershed moment for us and the FDA,” says Kathy Hibbs, chief legal and regulatory officer at 23andMe. However, there are concerns regarding the limits of medical knowledge among common people to understand and interpret the results and the limitations of these tests, which could lead to misinterpretation of the results and complications. (Amy Maxmen, Nature News)

Neonatal Care

Giving Newborns Medicine is a Dangerous Guessing Game. Can We Make it Safer?

Medical emergencies in neonates are on the rise. It might be surprising for many parents to know that 90% of the medications administered in a neonatal intensive care unit are not medically approved by the FDA for use in newborns. Neonates are routinely treated with drugs that are not adequately tested for safety, dosing, or effectiveness. This is a global problem, and many factors contribute to it. Firstly, parents and doctors are afraid of enlisting newborns in clinical trials. Secondly, pharmaceutical companies are afraid to test drugs on neonates as the risk of liability is very high. It is also a small market, so pharmaceutical companies may not make money by getting drugs approved for neonates.

In 2015, an FDA funded nonprofit organization launched two global efforts to encourage clinical trials in newborns. One of which is the International Neonatal Consortium (INC), which published a guide to clinical trials in neonates last year. Dr. Jonathan Davis, Director of INC said, “We’ve got to do something.” Without information on drug data for newborns, “we can’t be certain which drugs, in which doses, to use when.” Under the current system, doctors are making decisions based on either anecdotes or intuition, which essentially means that every sick newborn is an uncontrolled, unapproved study without the guarantee of seeing improvement. No data collection is done, thus not providing any information for treating other infants around the world.

Physicians often take decisions by scaling down from how medications are used in adults. But this can be fatal and lead to disasters as we have seen in the past, with the use of the antibiotic chloramphenicol in the 1950s, and the preservatives benzyl alcohol and propylene glycol in the 1980s. Infants are not tiny adults, and they adsorb, metabolize, and excrete drugs in different ways than adults. The majority of studies done in neonates in recent years have not been able to establish efficacy. More studies need to be done, and this requires proper designing of clinical trials with reduced risk, and eliminating unnecessary interventions. (Megan Scudellari, STATNews)

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April 18, 2017 at 10:45 am

Science Policy Around the Web – January 24, 2017

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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)

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January 24, 2017 at 10:04 am