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Posts Tagged ‘biomedical research

Science Policy Around the Web – January 27, 2017

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By: Nivedita Sengupta, PhD

Source: NIH Image Gallery on Flickr, under Creative Commons

Human Research Regulation

US Agency Releases Finalized ‘Common Rule’, Which Govern Human-Subjects Research

On September 8, 2015 the US Department of Health and Human Services (HHS) proposed significant revisions to the Federal Policy for the Protection of Human Subjects which is also known as the “Common Rule”. “Common Rule” is the set of federal regulations governing the conduct of clinical research involving human subjects. Among the proposed changes, an important one was regarding getting peoples’ consent before using the biological samples for subsequent studies. On 18th January 2017, the final version of the rule was released in which the proposed change was abandoned. This is a blow to the patient-privacy advocates, however the US National Academies of Sciences, Engineering and Medicine argued against that requirement and others citing that the changes would impose an undue burden on researchers and recommended that it be withdrawn.

The current version of Common Rule has generated mixed feelings among people. Researchers are happy that the government listened to scientists’ fears about increased research burdens whereas people like Twila Brase, president and co-founder of Citizens’ Council for Health Freedom in St Paul, Minnesota, are disappointed as they believe that these specific changes are ought to be made. Moreover the new version of the Common Rule requires that scientists include a description of the study, along with the risks and benefits, on the consent forms used by patients, and federally-funded trials should post patient consent forms online. However, these requirements do not extend to trials that are conducted with non-federal funds. (Sara Reardon, Nature News)

Biomedical Research

An Open-Science Effort to Replicate Dozens of Cancer-Biology Studies is Off to a Confusing Start

The Reproducibility Project on Cancer Biology was launched in 2013 to scrutinize the findings of 50 cancer papers from high-impact journals. The aim is to determine the fraction of influential cancer biology studies that are sound. In 2012, researchers at the biotechnology firm Amgen performed a similar study and announced that they had failed to replicate 47 of 53 landmark cancer papers but they did not identify the studies involved. In contrast, the reproducibility project makes all its findings open. Full results should appear by the end of the year and eLife is already publishing five fully analyzed reports in January. Out of the five, one failed to replicate and the remaining four showed replication results that are less clear.

These five results paint a muddy picture for people waiting for the outcome to determine the extent of impact of these studies. Though some researchers praised the project, others feared unfair discredit of their work and career. According to Sean Morrison, a senior editor at eLife, the reason for the “uninterpretable” results is “Things went wrong with tests to measure the growth of tumors in the replication attempts and the replication researchers were not allowed to deviate from the protocols, which was agreed at the start of the projects in consultation with the original authors”. “Doing anything else — such as changing the experimental conditions or restarting the work — would have introduced bias”, says Errington, the manager of the reproducibility project.

According to Errington, the clearest finding from this project is that the papers include very few details about their methods. The replication researchers had to spend hours to work out the detailed protocols and reagents along with the original authors. Even after following the exact protocols, the final reports include many reasons why the replication studies might have turned out differently, including variations in laboratory temperatures to tiny variations in how a drug was delivered. He thinks that the project helps to bring out such confusing details to the surface, and it will be a great service for future follow up work to develop a cure for cancer. However, scientists think that such conflicts mean that the replication efforts are not very informative and couldn’t be compared to the original and will only cause delays in advancing future clinical trials. (Monya Baker and Elie Dolgin, Nature News)

 

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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

Science Policy Around the Web – January 13, 2017

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By: James Taylor, PhD

Source: pixabay

Brexit and Science

Scientists Need To Wake Up to the Opportunities of Brexit

The decision of the United Kingdom to leave the European Union last July has raised numerous concerns about the future of science within the UK, most notably regarding access to EU funding, such as Horizon 2020, and the effect of new immigration controls on non-UK researchers and students. A recent House of Lords report has called for the UK government and scientists to come together and address these concerns.

Firstly, the government should engage scientists throughout the negotiation process and not just in regards to funding. Leaving the EU will require reworking and harmonizing numerous consumer protection, environmental and manufactory laws, for which technical advice is indispensible. The report welcomes the recent increase in science funding from the government, but states that any loss in EU funding should be compensated for. They recommend that both the Department for International Trade (DIT) and the Department for Exiting the European Union (DExEU) appoint scientific advisors immediately.

Secondly, the report calls for the scientific community’s voice to be heard alongside that of business during the negotiations. The UK’s relationship with the EU has been consistently harmonious in regards to research, providing a solid point of agreement amongst more difficult negations.

Thirdly, the UK should explore research collaborations beyond the EU. The report suggests this could be realized if the UK were to offer to host a large, international research facility comparable to the Crick Institute or the Diamond Light Source. They also highlight the potential for industrial collaboration and reform of R&D taxation which would not be possible within the EU.

Immigration remains a key concern in regards to Brexit, with many EU scientists in the UK uncertain of their futures with many now considering leaving. The report emphasizes the need to attract and retain the best international talent going as far as to suggest 10 year research grants and support for immediate family for foreign scientific leaders. They also call for the government to clearly state how immigration laws will affect researchers coming to work in the UK, and that the number of international students coming to study in the UK should not count against any immigration targets. (Graeme Reid, The Guardian)

Biomedical Research

The New Face of US Science

A recent analysis has found that the face of biomedical research has changed considerably over the last few decades. The study, which pooled data on holders of PhDs working as biological or biomedical scientists from the Survey of Doctorate Recipients and the American Community Survey, found that the doubling of NIH funding between 1998 and 2004 had a profound effect on the demographics of the scientific workforce. The authors classify scientists who entered the workforce around this time (i.e. under 40s) as a new cohort, giving them the not so snappy title of “doubling boomers”.

The 1998 to 2004 funding increase meant the number of PhD graduates increased significantly during this time, but the lack of growth in academic positions and funding cuts mean that only 1 in 5 still work in academia (as compared to 1 in two in 1990). For the aspiring academic this may seem like terrible news, but the report also found that the majority of biomedical PhDs now work in the private sector where they earn around $30,000 more a year than their academic peers and report lower pressure to publish publications.

The work force is more diverse than ever, with almost half of young biomedical scientists coming from US minority races. The largest growth has come from Asian ethnic groups, followed by a modest increase in researchers from Latino backgrounds. However the proportion of black scientists showed only a minor increase. These demographics should be borne in mind when devising recruitment and retention strategies to make the workforce more egalitarian.

Finally they found that scientists under 40 are likely to have children around the time they will be applying for their first grant. This is particularly problematic for female scientists, who the study found were less likely to have a stay-at-home spouse who can shoulder household responsibilities. The current academic career trajectory does not take in to account these important differences.

Despite many of these problems being discussed anecdotally for quite some time, the systems for tracking the fates of holder of PhDs after they graduate remain lacking, especially for those who leave academia. The authors insist that better and more transparent data is critical for designing new policies to assist young researchers. (Misty Heggeness, Kearney Gunsalus, José Pacas and Gary McDowell, Nature News)

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January 13, 2017 at 10:37 am

Science Policy Around the Web – November 22, 2016

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By: Rachel Smallwood, PhD

Photo source: pixabay

Federal Research Funding

US R&D Spending at All-Time High, Federal Share Reaches Record Low

Recently released data from the National Science Foundation (NSF) showed trending increases in scientific research funding in the US across the past several years. Estimates of the total funding for 2015 put the value at an all-time high for research and development (R&D) funding for any country in a single year. In 2009, President Obama stated a goal to devote 3% of the USA’s gross domestic product (GDP) to research, and we have been making slow progress to that point; in 2015, 2.78% of the GDP went to research. Businesses accounted for the largest portion of overall scientific funding, contributing 69% of the funds. The second largest contributor was the federal government; however, it had the lowest percentage share of the total since the NSF started tracking funding in 1953, and the actual dollar amount contributed has been declining since 2011. Therefore, although the overall percentage of GDP going to research is increasing, that increase is driven by businesses, whereas the GDP percentage contributed by the federal government has dropped to almost 0.6%.

When taking a closer look at types of research, the federal government is the largest funding source for basic science research, covering 45% of the total. However, businesses make up the majority of the funding for applied research (52% in 2014) and experimental development (82% in 2014). This disproportionality in funding types combined with the decreases in federal research spending are concerning for the basic science field. There is more competition for less money, and this concern is compounded by uncertainty and questions about President-Elect Trump’s position on and plans for scientific funding. Aside from a couple of issues, primarily concerning climate change and the environment, he has said very little about science and research. Many scientists, institutions, and concerned citizens will be watching closely to see how science policy develops under Trump’s administration and its effects on federal spending and beyond. (Mike Henry, American Institute of Physics)

Biomedical Research

‘Minibrains’ Could Help Drug Discovery for Zika and for Alzheimer’s

A group of researchers at Johns Hopkins University (JHU) is working on a promising tool for evaluating disease and drug effects in humans without actually using humans for the tests. ‘Minibrains’ are clusters of human cells that originated as skin cells, reprogrammed to an earlier stage of development, and then forced to differentiate into human neural cells. They mimic the human brain as far as cell types and connections, but will never be anywhere near as large as a human brain and can never learn or become conscious.

A presentation earlier this year at the American Association for the Advancement of Science conference showcased the potential utility for minibrains. A large majority of drugs that are tested in animals fail when introduced in humans. Minibrains provide a way to test these drugs in human tissue at a much earlier stage – saving time, money, and animal testing – without risking harm to humans. Minibrains to test for biocompatibility can be made from skin cells of healthy humans, but skin cells from people with diseases or genetic traits can also be used to study disease effects.

A presentation at the Society for Neuroscience conference this month demonstrated one such disease – Zika. The minibrains’ growth is similar to fetal brain growth during early pregnancy. Using the minibrains, Dr. Hongjun Song’s team at JHU was able to see how the Zika virus affected the cells; the affected minibrains were much smaller than normal, a result that appears analogous to the microcephaly observed in infants whose mothers were infected with Zika during the first trimester.

Other presentations at the meeting showcased work from several research groups that are already using minibrains to study diseases and disorders including brain cancer, Down syndrome, and Rett syndrome, and plans are underway to utilize it in autism, schizophrenia, and Alzheimer’s disease. Though there might be a bit of an acceptance curve with the general public, minibrains potentially offer an avenue of testing that is a better representation of actual human cell behavior and response, is safer and more affordable, and reduces the need for animal testing. (Jon Hamilton, NPR)

Health Policy

A Twist on ‘Involuntary Commitment’: Some Heroin Users Request It

The opioid addiction epidemic has become a significant healthcare crisis in the United States. Just last week the US Surgeon General announced plans to target addiction and substance abuse. He also stated the desire for a change in perception of addiction – it is a medical condition rather than a moral or character flaw. Earlier this year, the Centers for Disease Control published guidelines that address opioid prescribing practices for chronic pain, strongly urging physicians to exhaust non-pharmacologic options before utilizing opioids. In response to the rising concern over prescription opioid abuse, steps have been taken to reduce prescriptions and access. This has resulted in many turning to heroin – which is usually a cheaper alternative anyway – to get their opioid fix.

One of the first steps in treatment and recovery for addiction and dependence is detoxing. However, opioids are highly addictive and many people struggle with the temptation to relapse. Additionally, many of the programs designed to help with the initial detox have long wait lists, are expensive, and may not be covered by insurance, further deterring those with addiction and dependence from getting the help they need. These factors have caused many to start turning to their states, asking to be voluntarily committed to a program on the basis that they are a danger to themselves or others because of their substance abuse. This is currently an option in 38 states. These programs can be held in either privately-run institutions or in state prisons. However, this practice is controversial because if the person’s insurance does not cover their stay, it falls to tax payers to foot the bill. While this is unpopular with some, advocates say the civil commitment laws are important options while there may be no other immediate ways for an individual to get help. (Karen Brown, NPR)

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November 22, 2016 at 9:00 am

Science Policy Around the Web – November 18, 2016

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By: Thaddeus Davenport, PhD

Source: pixabay

2016 Presidential Elections

How the Trump Administration Might Impact Science

Donald Trump is now the President-elect of the United States of America. Mr. Trump’s loose speaking (and tweeting) style, affinity for controversy, relative disregard for facts, and his lack of experience in domestic and foreign policy, led him to make a number of vague, and sometimes contradictory statements about his specific policy positions over the course of his campaign. In light of this, there are few people on earth – and perhaps no people on earth, including Mr. Trump – who know exactly what to expect from his presidency. In Nature News last week, Sara Reardon, Jeff Tollefson, Alexandra Witze and Lauren Morello considered how Mr. Trump’s presidency might affect science, focusing on what is known about his positions on biomedical research, climate change, the space program, and immigration. The authors’ analyses are summarized below:

Biomedical Research – Mr. Trump will be in a position to undo the executive order signed by President Obama in 2009, which eased some restrictions on work with human embryonic stem cells, a decision criticized at the time by the current vice-president elect, Mike Pence. In his characteristically brash speaking style, Mr. Trump also called the NIH ‘terrible’ in a radio interview last year, but beyond this, he has said little about his plans for biomedical research.

Climate Change – Early signs suggest that Mr. Trump will dramatically shift the direction of the Environmental Protection Agency (EPA) and undo some of its work to curb greenhouse gas emissions under the Clean Power Plan implemented by President Obama. Mr. Trump has already appointed Myron Ebell, a denier of climate change, to lead the transition at the EPA and other federal agencies involved in climate change and environmental policy. Mr. Trump has also vowed to pull out of the Paris Climate Agreement which, under the terms of the agreement, may not happen immediately, but it may influence how and whether other countries participate in the agreement in the future.

Space Program – Based on writings from Trump’s campaign advisers there may be continued support for deep space exploration, especially through public-private partnerships with companies such as Orbital and SpaceX, but not earth observation and climate monitoring programs, which account for one third of NASA’s budget.

Immigration – A central pillar of Mr. Trump’s campaign was his strong and divisive stance on immigration. He has vowed to build a wall on the US border with Mexico, deport millions of illegal immigrants, defund ‘sanctuary cities’ throughout the United States, impose “extreme vetting” of immigrants, and stop immigration from countries where “adequate screening cannot occur”, which he believes includes Syria and Libya, and set new “caps” on legal immigration into the United States. These proposals have drawn objections from human rights advocates, and scientists worry that they may discourage international students and researchers from working in, and contributing their expertise to, the United States.

It remains to be seen how Mr. Trump will shape the future of science in the United States and the world, but it is clear that he is taking office at a pivotal moment. He would do well to seriously consider how his policies and his words will impact research, discovery, and innovation within the United States, and more importantly, the long-term health of vulnerable populations, economies, and ecosystems around the globe. (Sara Reardon, Jeff Tollefson, Alexandra Witze and Lauren Morello, Nature News)

Public Health

Soda Taxes on the Ballot

Given the focus that has been placed on the outcome of the Presidential election, you may NOT have heard about the results of smaller ballot items including a decision to begin taxing sodas in four US cities – San Francisco, Oakland, and Albany, California, and Boulder, Colorado – as reported by Margot Sanger-Katz for the New York Times. These cities join Berkeley, California and Philadelphia, Pennsylvania, which passed soda taxes of their own in 2014 and June of 2016, respectively. The victory for proponents of soda taxes came after a costly campaign, with total spending in the Bay Area region campaign on the order of $50 million. Former New York City mayor, Michael Bloomberg, and Laura and John Arnold spent heavily in support of taxing sodas, but did not equal the spending by the soda industry, which opposed the taxes. During his time as mayor, Mr. Bloomberg attempted to ban the sale of sodas larger than 16 ounces in New York City in 2012, but this was struck down in the New York State Court of Appeals in 2014.

Soda tax advocates see the outcome of this year’s ballot initiatives as a sign of a sea change in public acceptance of programs intended to discourage soda consumption (and increase revenue for municipalities), but it is indisputable, especially in light of the results of the presidential election, that the set of relatively liberal cities that have adopted soda tax measures do not accurately represent the thinking of people throughout the United States. Though it is still too early to know if soda tax programs lead to improvements in public health, evidence from Berkeley and Mexico – which passed a soda tax in 2013 – indicates that these programs have the potential to decrease soda consumption. Regardless of how similar initiatives may perform in other cities on future ballots, the increasing number of cities participating in soda tax programs will provide valuable data to inform policy decisions aimed at reducing obesity and diabetes. (Margot Sanger-Katz, New York Times)

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November 18, 2016 at 9:00 am

Science Policy Around the Web – October 4, 2016

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By: Cheryl Smith, PhD

Source: Flickr, under Creative Commons

Health Policy

FDA approves first drug for Duchenne muscular dystrophy

The Food and Drug Administration (FDA) approved a drug, Exondys 51, to treat Duchenne muscular dystrophy, a rare, debilitative disease that destroys muscle and confines boys to wheelchairs and eventually death. The decision was made by the FDA in opposition to its own medical staffers who questioned the effectiveness of the drug. One of the key issues medical staffers were concerned about was whether the drug can produce a sufficient amount of a protein called dystrophin to reverse muscle damage and, as a consequence, overall mobility and strength.

However, patients and their families lobbied hard for drug approval. Laura McLinn, an Indiana mother whose 7-year-old son has Duchenne muscular dystrophy, was in tears Monday when she heard the news of the drug’s approval. “I’m really overwhelmed,” McLinn said. “We’ve been waiting a long time to hear this.”

In reaching its decision, the agency essentially overruled its own medical staffers, who earlier this year questioned the effectiveness of the drug over concerns about a small clinical trial. The wrangling raised still larger questions about standards for approving a drug, but some FDA officials also acknowledged that unmet medical needs for patients with some rare diseases warranted endorsement under a program known as accelerated approval. (Ed Silverman, Scientific American)

Biotechnology and Forensics

DNA breakthrough finally gives ‘a face to this crime.’ But can it solve a woman’s 1992 murder?

Lisa Ziegert was murdered in 1992 and her killer was not found, however, a sliver of her attacker’s DNA was recovered. But that DNA lead went cold – like all the other evidence in the case. Now, prosecutors say that the DNA left by Ms. Ziegert’s attacker has given them a new lead in the case as well as a face. The Reston-based company Parabon Nanolabs has developed a new technology that uses DNA to make predictions about the suspect’s ancestry, eye color, hair color, skin color, freckling, and face shape. The DNA technology uses these characteristics to reconstruct faces based on DNA characteristics.

In the past, DNA has typically been used as a biometric identifier capable of identifying individuals with great certainty. Now, this technology can literally put a face to a crime.

Ms. Ziegert’s killer, according to Parabon, was likely a man of European descent with hazel eyes and brown or black hair. For the first time in twenty-four years, we have a face to this crime,” Hampden District Attorney Anthony Gulluni said in a statement released Wednesday. “The technology we have put to use is at the leading edge of the industry. No expense, effort, or means will be spared to bring the person(s) to justice who killed Lisa. We will never forget her.” (Cleve R. Wootson Jr., The Washington Post)

Biomedical Research

Yoshinori Ohsumi of Japan wins Nobel prize for study of ‘self-eating’ cells

Dr. Yoshinori Ohsumi, a Japanese cell biologist, was awarded the Nobel Prize in Physiology or Medicine on October 3, 2016 for his discovery of autophagy – a Greek term for “self-eating”. It is a crucial process for cellular survival. During starvation, cells are able to break down proteins and reuse them for energy internally running their recycling plant for survival. Autophagy is also critical during infections and can serve to protect the cell by destroying invading viruses or bacteria and then sending them for recycling. Cells can also use autophagy to get rid of damaged protein structures. In diseases such as cancer, neurodegenerative disorders, or immunological diseases, autophagy is thought to be defective. The importance of this cellular recycling mechanism was not known until Dr. Ohsumi studied the process in baker’s yeast in the 1990s.

Dr. Ohsumi received his Ph.D. from the University of Tokyo in 1974 in molecular biology. His ‘unimpressive’ Ph.D. thesis made it difficult for him to find a job. His advisor suggested a postdoctoral position at Rockefeller University in New York where he was to study in vitro fertilization in mice. Because Dr. Ohsumi grew ‘very frustrated’ he switched to studying the duplication of DNA in yeast. This work led him to a junior professorship at the University of Tokyo where he began his autophagy work. Dr. Ohsumi later moved to the National Institute for Basic Biology, in Okazaki, and since 2009, has been a professor at the Tokyo Institute of Technology.

“All I can say is, it’s such an honor,” Dr. Ohsumi told reporters at the Tokyo Institute of Technology after learning he had been awarded the Nobel, according to the Japanese broadcaster NHK. “I’d like to tell young people that not all can be successful in science, but it’s important to rise to the challenge.” (Gina Kolata and Sewell Chan, New York Times)

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October 4, 2016 at 9:02 am

Science Policy Around the Web – September 27, 2016

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By: Nivedita Sengupta, PhD

Source: pixabay

Alzheimer’s Disease

Larger studies are under way to test whether the promising early data holds up

Recent clinical trials reported that the drug “Aducanumab” might remove toxic amyloid-β proteins thought to trigger Alzheimer’s disease from the brain. In the study involving 165 people, 103 patients received the drug once a month for 54 weeks and the other group received a placebo. Patients receiving infusions of aducanumab experienced a reduction in the amount of amyloid-β in their brains, which was in accordance with the findings of a pretrial mouse study in which the drug cleared amyloid-β plaques from the animals’ brains. “This drug had a more profound effect in reversing amyloid-plaque burden than we have seen to date,” says psychiatrist Eric Reiman, executive director of the Banner Alzheimer’s Institute in Phoenix, Arizona.

Whether aducanumab works to ameliorate the memory and cognitive losses associated with Alzheimer’s is currently under phase III clinical trials. Scientists have debated for years whether accumulation of amyloid-β causes memory loss and other symptoms of Alzheimer’s. This trial is in favor of the “amyloid hypothesis”, and suggests that elimination of the protein might alleviate the symptoms. In the past, other Alzheimer’s drugs have looked promising in early-stage trials, but ended in failure and even caused deaths of patients because of brain inflammation. Aducanumab also showed abnormalities on brain-imaging scans but it was in less than one-third of the patients. Hence, to avoid death of participants, researchers closely monitored such anomalies in these Alzheimer’s trials. All of the reported imaging abnormalities eventually disappeared in about 4 to 12 weeks, and no patients were hospitalized.

Patients who received higher doses of the drug, or who had genetic risk factors for Alzheimer’s, were more likely to develop the brain anomalies. Accordingly, Biogen — the company that makes aducanumab —adjusted the drug’s dosage and the monitoring schedule for people with genetic risks for Alzheimer’s in its phase III trials.

Aducanumab is a bright spot in the field of Alzheimer’s therapeutics after years of failed antibody and other types of drug trials. “This is the best news we’ve had in my 25 years of doing Alzheimer’s research, and it brings hope to patients and families affected by the disease,” says neurologist Stephen Salloway of Butler Hospital in Providence, Rhode Island, who was on the team that ran the initial trial. (Erika Check Hayden, Nature)

Clinical Trials

Investigators are now required to disclose all clinical trials, whether successful or not

On 16th September 2016, the US Department of Health and Human Services (HHS) and the US National Institutes of Health (NIH) announced the new rules for clinical-trial disclosures. According to the new law, it is required that all researchers must report the design and results of all clinical trials whether successful or not. The revised law also empowers the government to enforce penalties for those who fail to comply. The new rule will be effective from 18th January onwards and researchers have 90 days to comply. The disappointing results of clinical trials will no longer remain unpublished, and the new rule intends to crack down on the large number of clinical trials that are conducted but never reported. Robert Califf, head of the US Food and Drug Administration (FDA) says, “A lot of major universities just miss the point that if you do an experiment on a person and get consent, you really have the obligation to make the results known.”

The old rule mandated that researchers conducting trials with human subjects had to register their study with the HHS website, ClinicalTrials.gov, before starting their work, and should follow up with information about their methods and results. But there were many exceptions and loopholes which created a lot of ambiguity. This allowed researchers to avoid reporting all the trials, particularly the failed ones. Christopher Gill, a health researcher at Boston University in Massachusetts says, “This can bias the literature and obscure important information on whether an experimental therapy is harmful. From the perspective of consumers and science, failures are as important as successes”.

Under the new rule, all trials must be registered on ClinicalTrials.gov within 21 days of enrolling their first patient and researchers can no longer wait for the results of their trials to report their data. Additionally the NIH’s companion rule edicts that NIH-funded researchers have to register phase I trials and also trials that do not involve an FDA-regulated product, such as behavioral interventions. Further changes dictate reporting the details of plans to conduct trials, outlining the statistics to be used to analyze the results, and revealing any changes in the protocol over the course of the study. The final HHS rules will give regulators a greater ability to enforce existing regulations, because many studies of drugs that are eventually licensed are still not reported. (Sara Reardon, Nature)

Income Inequality

Wages for top scientists are shooting skywards while others are being left behind

Income inequality in science is in the rise and is evident in all universities across several countries. The salary gap between elite scientists and those toiling in the benches is expanding over the past few decades. Limited data on the salaries of scientists is available making it difficult to determine the full extent and causes of income inequality. “But the gap in wages has reached a point at which it could be driving talented young people away from careers in academic science”, says Richard Freeman, an economist at Harvard University in Cambridge, Massachusetts. The results of Nature‘s 2016 salary survey also support this concern.

One of the metrics used to measure disparities in salaries is the Gini coefficient in which 0 means everyone earns the same and 1 indicates maximum inequality. In 2012, economist Paula Stephan found that the Gini coefficient has more than doubled between 1973 and 2006 in most fields and faculty ranks in science, with the biggest increases in the life sciences. In contrast, it grew only 35% for full-time male earners in the United States and 18% for US households.

A major issue responsible for the rise of the Gini coefficient is the doubling of the National Institutes of Health’s budget during the late 1990s and early 2000s. This created competition among institutions for a small pool of top-ranked, grant-winning scientists. Everybody wanted to employ the most productive scientists who could bring in grants thus driving up the salaries. “One way for universities to minimize risk is to pick someone who is a demonstrated winner,” says Donna Ginther, a labour economist at the University of Kansas. Like the US, in the UK too, the salaries of top-earning professors have been pulling away from the pack since the late 1990s. An analysis of full-professor salaries in UK in July suggested that low ranking universities, to improve their REF (Research Excellence Framework – an assessment, done by UK funding agencies roughly every five years) performance, are offering high salaries to recruit researchers with high-quality papers to boost their scores. A similar trend is seen in other countries like China and Germany.

On the other end of the salary spectrum, there is little pressure to boost pay. With grants getting harder to win, labs are employing low-cost workforce to maximize research output. This labor environment benefits from the willingness of postdocs to sacrifice income for a chance at an academic research career. Even those lucky enough to land offers for tenure-track junior faculty positions find that starting salaries are not very negotiable.

High salaries at the top can attract productive workers, but low pay at the bottom signals that there may not be a good future in this career. If big rewards become concentrated among a smaller group of people in a highly competitive area, then others who could still have been productive scientists end up losing a disproportionate amount in terms of earnings and career prospects and it could keep promising people from further pursuing a research career. (Corie Lok, Nature)

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Written by sciencepolicyforall

September 27, 2016 at 11:47 am