News Article | May 25, 2017
Overhead costs, such as fees for administrative support and building maintenance, are on a slow rise and becoming a larger share of federal research spending, a congressional investigator said May 24. A study by the Government Accountability Office, the research arm of Congress, shows that some $1.3 billion out of NSF’s $6 billion annual research budget is consumed by payment of these indirect costs to universities and research institutions. Similarly, in 2015, the National Institutes of Health spent some $6.3 billion on indirect costs, accounting for 27% of its $24 billion extramural research budget, notes John Neumann, director of natural resources & environment at GAO. He discussed GAO’s findings at a U.S. House or Representatives hearing. “We must look at whether or not those overhead funds are being spent efficiently,” said Rep. Barbara Comstock (R-Va.), “particularly in a time of tough budgets, when only one out of five research grant proposals are funded.” Comstock, who chairs the panel’s Subcommittee on Research & Technology, pointed out that since the 1960s, every institution negotiates its own indirect cost rate with the federal government. Indirect cost rates for universities and institutions vary widely from less than 1% to more than 60%. This overhead, says Science Committee Chair Lamar Smith (R-Texas), “would pay for 2,000 more scientific research projects. It raises a question of whether or not we have inadvertently created a system of ‘haves and have nots,’ where wealthy institutions benefit the most.” Overhead spending varies by region and research type, Duke University’s James Luther told lawmakers. Medical research’s high overhead costs, he said, stem from complex facilities and equipment. Public policy research, in contrast, calls for more computers and office space. But, Luther stressed, direct costs, which cover the cost of researchers’ salaries and equipment, inseparable from indirect ones. “If direct costs are the gas for the research engine, facilities and administrative reimbursements are the oil. A research engine requires both.” Lawmakers and hearing witnesses talked about possible reforms, including a ranking system that weighs overhead costs or a fixed overhead cap. Overall, however, they expressed concern along the lines of committee member Rep. Don Beyer (D-Va.), who warned of “unintended consequences” in cutting science budgets or reducing overhead costs. “Let’s be certain any changes we make keep the best scientists doing the most important work,” Beyer said. “Let’s make sure we are not initiating a race to the bottom, with prizes to the lowest bidder doing the least valuable research.”
News Article | April 8, 2017
The same week President Trump signed an Executive Order aimed at undermining crucial climate and health protections, the House Science Committee held a hearing that had no purpose other than to flaunt the latest in industry funded pseudo-science on climate change. This committee has a track record of lacking scientific rigor, and with the Chairman literally questioning whether Science Magazine or the industry-funded Heartland Institute was more reliable as a source, this hearing was no different. These events are part of a long term, unrelenting effort on the part of well-funded, entrenched fossil fuel interests to fight climate safeguards at every turn, prioritizing polluter profits above the health of the American people. Make no mistake; there are serious human health consequences to ignoring the facts on climate change, including more asthma attacks, the expansion in disease migration, heatstroke, and increased mortality. How in the world—after decades of research and overwhelming scientific evidence—could these peddlers of pollution have such a prominent voice in this Congress and Administration? Simple: they’re selling a surprisingly effective product: doubt. Selling doubt has been used for decades to keep deadly products on the market. We’ve seen this game before. By the 1950s, the strong link between smoking and lung cancer had become increasingly well identify in the scientific literature. Additional research and growing pressure from prominent health associations led to the 1964 declaration by the Surgeon General that smoking causes lung cancer and presents significant health risks, including emphysema and heart disease. The tobacco industry knew better than anyone the state of the science. And for nearly fifty years, the industry skillfully seeded and manufactured scientific doubt and effectively spread propaganda to delay and slow a global public health response to a deadly and addictive—not to mention highly lucrative— killer. In 1994, the chairman of a major tobacco company, came before the U.S. House of Representatives and still declared that he did not believe that nicotine was addictive. It wasn’t until the late 1990s and early 2000s that smoking bans in public and private spaces in the U.S. finally took hold, however tobacco use continues to be a global health epidemic. How have tobacco companies succeeded in expanding the market for this deadly product when the science has been so clear for so long? The strategy was succinctly captured in a 1969 memo by a tobacco executive: “doubt is our product since it is the best means of competing with the ‘body of fact’ that exists in the minds of the general public. It is also the means of establishing a controversy.” (See Merchants of Doubt for more on the connections between the tobacco and climate doubters.) The lead industry fought against the link between lead and childhood poisoning for a good sixty years When the story of lead in Flint’s water supply finally gained national attention, Americans were dismayed, and knew there was a problem. This is because the public trusts the best science including that being done by the Centers for Disease Control which called lead poisoning “the most common and societally devastating environmental disease of young children in the United States,” and declares that there is no safe level of lead in children’s blood. This, however, was not always the case. Lead was once commonly added to gasoline and paint and used in the pipes that deliver water to homes. Lead poisoning in children was a national issue by the 1940s and 1950s, and yet lead-based paint continued to be used to cover the walls of most American homes and was aggressively marketed to families through the late 1970s. Lead-based paint continues to be the primary source of children’s exposure to this chemical. Major policies to limit the use of lead in paint, gasoline, and food cans were enacted in the late 1970s, and we’ve seen levels in children’s blood decline ever since (see EDF’s interactive graph of the impacts of lead policies on lead exposure in children.) Despite decades and decades of clear and ample scientific evidence of lead’s toxicity, this industry expanded its market in the U.S. and globally. Using similar tactics of manufacturing scientific doubt, lobbying, and propaganda, the industry stayed focused on protecting its profits and in the process robbed millions of children of healthy and prosperous lives. You wouldn’t know it from looking at Washington these days, but not only is the House Science Committee vastly out touch with science – which now clearly indicates that human are causing climate change– they are also at odds with the American people who overwhelmingly say climate change is happening. They are also working against the tide of the American economy; there are now over 3 million Americans working in clean energy, well past the number employed in coal, with many of these jobs in Republican districts. Over 1,000 top businesses have also committed to staying on a low-carbon path, stating that addressing climate change is good business. Some polluters and their well-paid lawyers (including firms that literally worked on the tobacco fight) continue to manufacturer doubt and pedal in climate denial propaganda, and the House Committee gave them a prominent platform to do so last week. Such boldfaced efforts to put profits over our children’s health—as was done with tobacco and lead—must be confronted by the truth. To call out these lies, to demand integrity and truth in the face of deceit, is what we all must do.
News Article | May 8, 2017
Both the Environmental Protection Agency and the Interior Department are overhauling a slew of outside advisory boards that inform how their agencies assess the science underpinning policies, the first step in a broader effort by Republicans to change the way the federal government evaluates the scientific basis for its regulations. EPA Administrator Scott Pruitt decided to replace half of the members on one of its key scientific review boards, while Interior Secretary Ryan Zinke is “reviewing the charter and charge” of more than 200 advisory boards, committees and other entities both within and outside his department. EPA and Interior officials began informing current members of the move Friday, and notifications continued over the weekend. Pruitt’s move could significantly change the makeup of the 18-member Board of Scientific Counselors (BOSC), which advises EPA’s prime scientific arm on whether the research it does has sufficient rigor and integrity. All of the people being dismissed were at the end of serving at least one three-year term, although these terms are often renewed instead of terminated. EPA spokesman J.P. Freire said in an email that “no one has been fired or terminated” and that Pruitt had simply decided to bring in fresh advisers. The agency informed the outside academics on Friday that their terms would not be renewed. “We’re not going to rubber-stamp the last administration’s appointees. Instead, they should participate in the same open competitive process as the rest of the applicant pool,” Freire said. “This approach is what was always intended for the board, and we’re making a clean break with the last administration’s approach.” [EPA website removes climate science site from public view after two decades] Separately, Zinke has postponed all outside committees as he reviews their composition and work. The review will effectively freeze the work of the Bureau of Land Management’s 30 resource advisory committees, along with other panels focused on a range of issues, from one assessing the threat of invasive species to the science technical advisory panel for Alaska’s North Slope. “The Secretary is committed to restoring trust in the Department’s decision-making and that begins with institutionalizing state and local input and ongoing collaboration, particularly in communities surrounding public lands,” Interior spokeswoman Heather Swift said by email Monday. “As the Department concludes its review in the weeks ahead, agencies will notice future meetings to ensure that the Department continues to get the benefit of the views of local communities in all decision-making on public land management.” These moves came as a surprise to the agencies’ outside advisers, with several of them taking to Twitter to announce their suspensions. John Peter Thompson, who chairs Interior’s Invasive Species Advisory Panel, tweeted Monday that he had been notified that “all activities are suspended subject to review by Depart of Interior.” Members of EPA’s Board of Scientific Counselors had been informed twice — in January, before President Barack Obama left office, and then more recently by EPA career staff members — that they would be kept on for another term, adding to their confusion. “I was kind of shocked to receive this news,” Robert Richardson, an ecological economist and an associate professor in Michigan State University’s Department of Community Sustainability, said in an interview Sunday. Richardson, who on Saturday tweeted, “Today, I was Trumped,” said that he was at the end of an initial three-year term but that members traditionally have served two such stints. “I’ve never heard of any circumstance where someone didn’t serve two consecutive terms,” he said, adding that the dismissals gave him “great concern that objective science is being marginalized in this administration.” Courtney Flint, a professor of natural resource sociology at Utah State University who had served one term on the board, said in an email that she was also surprised to learn that her term would not be renewed, “particularly since I was told that such a renewal was expected.” But she added, “In the broader view, I suppose it is the prerogative of this administration to set the goals of federal agencies and to appoint members to advisory boards.” [EPA just buried its climate site for kids] Ryan Jackson, Pruitt’s chief of staff, noted in an email that all the board members whose terms are not being renewed could reapply for their positions. “I’m not quite sure why some EPA career staff simply get angry by us opening up the process,” he said. “It seems unprofessional to me.” Terry F. Yosie, who directed EPA’s Science Advisory Board from 1981 to 1988, noted in an email that the Board of Scientific Counselors does not report directly to the administrator or his office. “It’s quite extraordinary that such a body would receive this level of attention by the Administrator’s office,” he said. Pruitt is planning a much broader overhaul of how the agency conducts its scientific analysis, said a senior administration official who spoke on the condition of anonymity to discuss internal deliberations. Pruitt has been meeting with academics to talk about the matter and putting thought into which areas of investigation warrant attention from the agency’s scientific advisers. The agency may consider industry scientific experts for some of the board positions as long as these appointments do not pose a conflict of interest, Freire said. Conservatives have complained for years about EPA’s approach to science, including the input it receives from outside scientific bodies. Both the Board of Scientific Counselors and the 47-member Scientific Advisory Board have come under criticism for bolstering the cause for greater federal regulation. A majority of the members of the Board of Scientific Counselors have terms expiring this fiscal year, along with the terms of 12 members of the Scientific Advisory Board. GOP lawmakers have frequently criticized the Clean Air Scientific Advisory Committee (CASAC)—a committee within the Scientific Advisory Board—for its recommendation that the EPA impose much stricter curbs on smog-forming ozone. The seven-person panel, which is charged under the Clean Air Act to review the scientific basis of all ambient air quality standards, is legally required to have a medical doctor and a member of the National Academy of Sciences as members. Sen. James M. Inhofe (R-Okla.), who questions the link between human activity and climate change and has several former aides now working for Pruitt, said in an interview earlier this year that under the new administration, “they’re going to have to start dealing with science, and not rigged science.” House Science Committee Chairman Lamar Smith (R-Tex.) held a hearing on the issue in February, arguing that the Scientific Advisory Board should be expanded to include more non-academics. The panel, which was established in 1978, is primarily made up of academic scientists and other experts who review EPA’s research to ensure that the regulations the agency undertakes have a sound scientific basis. “The EPA routinely stacks this board with friendly scientists who receive millions of dollars in grants from the federal government,” Smith said at the time. “The conflict of interest here is clear.” In a budget proposal obtained by The Washington Post last month, the panel’s operating budget is slated for an 84 percent cut — or $542,000 — for fiscal 2018. That money typically covers travel and other expenses for outside experts who attend the board’s public meetings. The document said the budget cut reflects “an anticipated lower number of peer reviews.” Joe Arvai, a member of the Scientific Advisory Board who directs the University of Michigan’s Erb Institute for Global Sustainable Enterprise, said in an email that Pruitt and his colleagues should keep in mind that the board’s membership, just like its standing and ad hoc panels, “already includes credible scientists from industry” and that its “work on agency rulemaking is open to public viewing and comment. So, if diversity of thought and transparency are the administrator’s concerns, his worries are misplaced because the SAB already has these bases covered. “So, if you ask me, his moves over the weekend — as well as the House bill to reform the SAB — are attempts to use the SAB as a political toy,” Arvai said. “By making these moves, the administrator and members of the House can pander to the president’s base by looking like they’re getting tough on all those pesky ‘liberal scientists.’ But, all else being equal, nothing fundamentally changes about how the SAB operates.” New EPA documents reveal even deeper proposed cuts to staff and programs For more, you can sign up for our weekly newsletter here and follow us on Twitter here.
News Article | April 19, 2017
Following on from the ‘interesting’ House Science Committee hearing two weeks ago, there was an excellent rebuttal curated by ClimateFeedback of the unsupported and often-times misleading claims from the majority witnesses. In response, Judy Curry has (yet again) declared herself unconvinced by the evidence for a dominant role for human forcing of recent climate changes. And as before she fails to give any quantitative argument to support her contention that human drivers are not the dominant cause of recent trends. Her reasoning consists of a small number of plausible sounding, but ultimately unconvincing issues that are nonetheless worth diving into. She summarizes her claims in the following comment: … They use models that are tuned to the period of interest, which should disqualify them from be used in attribution study for the same period (circular reasoning, and all that). The attribution studies fail to account for the large multi-decadal (and longer) oscillations in the ocean, which have been estimated to account for 20% to 40% to 50% to 100% of the recent warming. The models fail to account for solar indirect effects that have been hypothesized to be important. And finally, the CMIP5 climate models used values of aerosol forcing that are now thought to be far too large. These claims are either wrong or simply don’t have the implications she claims. Let’s go through them one more time. 1) Models are NOT tuned [for the late 20th C/21st C warming] and using them for attribution is NOT circular reasoning. Curry’s claim is wrong on at least two levels. The “models used” (otherwise known as the CMIP5 ensemble) were *not* tuned for consistency for the period of interest (the 1950-2010 trend is what was highlighted in the IPCC reports, about 0.8ºC warming) and the evidence is obvious from the fact that the trends in the individual model simulations over this period go from 0.35 to 1.29ºC! (or 0.84±0.45ºC (95% envelope)). Second, this is not how the attribution is done in any case. What actually happens is that the fingerprint of different forcings are calculated independently of the historical runs (using subsets of the drivers) and then matched to the observations using scalings for the patterns generated. Scaling factors near 1 imply that the models’ expected fingerprints fit reasonably well to the observations. If the models are too sensitive or not enough, that will come out in the factors, since the patterns themselves are reasonably robust. So models that have half the observed trend, or twice as much, can still help determine the pattern of change associated with the drivers. The attribution to the driver is based on the best fits of that pattern and others, not on the mean or trend in the historical runs. Patterns of variability that don’t match the predicted fingerprints from the examined drivers (the ‘residuals’) can be large – especially on short-time scales, and look in most cases like the modes of internal variability that we’ve been used to; ENSO/PDO, the North Atlantic multidecadal oscillation etc. But the crucial thing is that these residuals have small trends compared to the trends from the external drivers. We can also put these modes directly into the analysis with little overall difference to the results. 3) No credible study has suggested that ocean oscillations can account for the long-term trends The key observation here is the increase in ocean heat content over the last half century (the figure below shows three estimates of the changes since 1955). This absolutely means that more energy has been coming into the system than leaving. Now this presents a real problem for claims that ocean variability is the main driver. To see why, note that ocean dynamics changes only move energy around – to warm somewhere, they have to cool somewhere else. So posit an initial dynamic change of ocean circulation that warms the surface (and cools below or in other regions). To bring more energy into the system, that surface warming would have to cause the top-of-the-atmosphere radiation balance to change positively, but that would add to warming, amplifying the initial perturbation and leading to a runaway instability. There are really good reasons to think this is unphysical. Remember too that ocean heat content increases were a predicted consequence of GHG-driven warming well before the ocean data was clear enough to demonstrate it. Solar activity impacts on climate are a fascinating topic, and encompass direct radiative processes, indirect effects via atmospheric chemistry and (potentially) aerosol formation effects. Much work is being done on improving the realism of such effects – particularly through ozone chemistry (which enhances the signal), and aerosol pathways (which don’t appear to have much of a global effect i.e. Dunne et al. (2016)). However, attribution of post 1950 warming to solar activity is tricky (i.e. impossible), because solar activity has declined (slightly) over that time: 5) Aerosol forcings are indeed uncertain, but this does not impact the attribution of recent trends very much. One of the trickier issues for fingerprint studies is distinguishing between the patterns from anthropogenic aerosols and greenhouse gases. While the hemispheric asymmetries are slightly larger for aerosols, the overall surface pattern is quite similar to that for greenhouse gases (albeit with a different sign). This is one of the reasons why the most confident statements in IPCC are made with respect to the “Anthropogenic” changes all together since that doesn’t require parsing out the (opposing) factors of GHGs and aerosols. Therefore in a fingerprint study that doesn’t distinguish between aerosols and GHGs, what the exact value of the aerosol forcing right is basically irrelevant. If any specific model is getting it badly wrong, that will simply manifest through a scaling factor very different from 1 without changing the total attribution. What would it actually take to make a real argument? As I’ve been asking for almost three years, it is way past time for Curry to shore up her claims in a quantitative way. I doubt that this is actually possible, but if one was to make the attempt these are the kind of things needed: Absent any evidence to support these statements, the claim that somehow, somewhere the straightforward and predictive mainstream conclusions are fundamentally wrong just isn’t credible.
News Article | May 4, 2017
May 2016 - Manuel Barange assumed responsibilities as Director of the FAO Fisheries and Aquaculture Policy and Resources Division (FIA). His professional record includes several high profile roles in the fisheries academic world: Deputy Chief Executive and Director of Science at the Plymouth Marine Laboratory, U.K., Chair of the ICES Science Committee, leader of the international IGBP GLOBEC programme, Head of the Surveys and Fish Behaviour Division of the Sea Fisheries Research Institute in Cape Town, South Africa. In recent years Prof Barange has been very active in leading research on the development of quantitative tools to estimate the impacts of climate change on marine ecosystems, their resources, and their dependent communities, globally, regionally and nationally. He has published over 120 peer-reviewed papers and has edited several books. He has become an expert in understanding the two-way relationship between environmental and societal change. Prof Barange holds an Honorary Professorship with the University of Exeter, U.K. and in 2010 was awarded the UNESCO-IOC Roger Revelle Medal for his accomplishments and contributions to ocean science. Mr Barange can be reached via e-mail at Manuel.Barange@fao.org and FIA-Director@fao.org
News Article | May 8, 2017
CHICAGO & CLEVELAND--(BUSINESS WIRE)--A group of nationally renowned plaintiffs’ attorneys has teamed up to create a new breed of plaintiffs’ law firm, representing victims of injustice ranging from those who have suffered catastrophic personal injuries, to small businesses, to institutional investors. DiCello Levitt & Casey’s founding partners have served in leadership roles in some of the largest class action and mass tort cases in U.S. history, including litigation arising from the Volkswagen emissions scandal, which recently resulted in a $16 billion civil settlement. Led by Mark DiCello, Adam Levitt, and James Casey, the new firm is unique among plaintiffs’ firms in offering deep experience across a wide spectrum of matters, including class action, mass tort, catastrophic injury, civil rights, and commercial litigation. Representing individuals; corporate clients, including private equity firms and hedge funds; institutional investors; whistleblowers; and states and municipalities, the firm’s litigators are esteemed for their rigorous focus grouping, jury analysis, and cognitive neuroscience prowess. With additional capabilities in antitrust, securities, and intellectual property law, DiCello Levitt & Casey launches with 11 attorneys—including partners John Tangren, Robert DiCello, and Amy Keller—and a full support staff, with offices in Chicago and Cleveland. “Mark and Jim are exceptional advocates who I like, respect, and have successfully collaborated with for many years,” Levitt said. “We share a vision for a sophisticated plaintiffs’ firm with the ability to not only participate in the nation’s most significant litigation, but to be in at the ground floor, shaping strategies that ensure our clients achieve the justice they deserve.” Prior to forming the new firm, Levitt was a director at Grant & Eisenhofer P.A., where he led the firm’s Consumer Protection and Products Liability Litigation group. In addition to his work on the Volkswagen emissions case and other major automotive and financial services litigation, Levitt served as co-lead counsel in several of the largest biotechnology class actions in recent years, achieving recoveries exceeding $1.7 billion in lawsuits involving genetically modified crops and a turf-damaging herbicide (In re Genetically Modified Rice Litigation, In re StarLink Corn Products Liability Litigation, and In re Imprelis Herbicide Marketing, Sales Practices and Products Liability Litigation). He also maintains a robust public-client practice, counseling local and state governments, including state attorneys general. “We are proud to create an elite plaintiffs’ firm capable of handling the nation’s most consequential matters, regardless of size, industry, or geography,” DiCello said. One of the nation’s leading plaintiffs’ attorneys, DiCello previously headed the Cleveland-based DiCello Law Firm. He regularly spearheads major personal injury and mass tort actions. He served as co-lead counsel in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, overseeing litigation on behalf of women around the country injured by transvaginal mesh products. Additionally, DiCello serves as head of the Plaintiffs’ Science Committee in the New Jersey based metal-on-metal hip litigation In re: Stryker Rejuvenate and ABG II Modular Hip Implant Litigation, in which settlements have exceeded $1.5 billion and continue to grow. He also serves in leadership in other ongoing complex litigation while he continues to represent clients who have suffered catastrophic and life-changing injury. Firm co-founder James Casey launched his career by earning a million-dollar medical malpractice verdict with a performance so striking the defense subsequently hired him to represent physicians and hospitals against malpractice claims. Casey later returned to the plaintiffs’ side, where he has participated in 25 verdicts in excess of $1 million and 4 in excess of $10 million. Mr. Casey has helped recover more than $500 million on behalf of catastrophically injured clients and their families. “We can try any matter. With collective experience covering medical, pharmaceutical, automotive, biotech, financial services, and securities-related matters, we have created something new at DiCello Levitt & Casey,” Casey said. “The market is ready for a plaintiffs’ firm with our range, and we are excited to represent clients of all types that deserve vindication through aggressive, attentive, and creative legal action.”
News Article | March 2, 2017
"A group of 15 state attorneys general call on House Science Committee chair to withdraw his attack on legal state investigations." "A coalition of 15 Democratic state attorneys general has urged Congressman Lamar Smith to withdraw subpoenas sent to the AGs of Massachusetts and New York seeking records related to their investigations of ExxonMobil. In a letter to Smith sent Tuesday, the attorneys general argue the demand for documents interferes with the investigative authority of the states. The attorneys general of Massachusetts and New York have ongoing investigations of Exxon under each state's securities and consumer protection laws related to whether Exxon properly disclosed risks posed by climate change to the company's business. "Under the Constitution and the principle of comity that has been honored by Congress and federal courts since the Nation's founding, the states' attorneys general must be free to fulfill the responsibilites they owe to the people they serve, unimpeded by interference from a committee of Congress," the AGs said in the letter."
News Article | February 15, 2017
ThinkGenetic, Inc. is pleased to announce the election of two new members to the ThinkGenetic Board of Directors. New board members include Theodore (Ted) T. Pasquarello of Sudbury, Massachusetts and Gary Butter of Short Hills, NJ. Ted is the Founder and Former President and Chief Executive Officer of Chiswick Trading, Inc., and a former Advisor to Guaranty First Bank. He is the Managing Member of Paris Trust LLC and currently serves on the Boards of UV Tech Systems, and Peddock Capital Advisors (a private wealth management firm). Also, Ted is a Governing Trustee at the Dana Farber Cancer Institute, as well as a member of their Science Committee. In addition, Ted is a current member of Boynton Angels, Inc. Gary is a graduate of the United States Naval Academy where he was a classmate of ThinkGenetic co-founder Len Barker. After graduating with a degree in Electrical Engineering, Gary entered the Navy nuclear power program where he served on a fast attack submarine. He remained in the Navy reserves after his five years of active duty and retired from the reserves as a Navy Captain after 24 years of service. After his active duty time Gary attended law school at NYU and then worked for the law firm Baker Botts LLP in Manhattan as a patent attorney for more than 20 years before joining Google as a corporate patent attorney in 2012. “I am pleased to welcome Ted and Gary as new Board members,” said Dave Jacob, CEO of ThinkGenetic, Inc. “These individuals bring a wealth of experience and expertise and will be tremendous assets to our organization as we further our mission of providing reliable information online to those living with genetic conditions.” The ThinkGenetic Board of Directors is comprised of individuals from the medical, business, academic communities. It is the Board’s responsibility to provide counsel and guidance in the direction and operation of the organization as well as raise awareness of ThinkGenetic.
News Article | February 27, 2017
HORSHOLM, Denmark, Feb. 28, 2017 /PRNewswire/ -- ALK (ALKB: DC / OMX: ALK B / AKABY / AKBLF) today announced that for the first time, allergy immunotherapy is now recommended as a treatment option in the Global Initiative for Asthma (GINA) report: Global Strategy for Asthma Management and Prevention. This global strategy is a widely recognised practical resource developed to guide healthcare professionals and policy makers, and represents the latest clinical evidence and medical practice for the treatment and management of asthma. The strategy is updated annually based on review of recent scientific literature by an international panel of experts on the GINA Science Committee. The 2017 update, which includes new information regarding the use of allergy immunotherapy, has just been released and features the following addition to steps 3 and 4 of GINA's recommended stepwise treatment of asthma in adult house dust mite (HDM) sensitive patients: Consider adding SLIT (sublingual allergy immunotherapy) in adult HDM sensitive patients with allergic rhinitis who have exacerbations despite ICS (inhaled corticosteroids), provided FEV is > 70% of predicted lung function. This change draws upon recently published results from ALK's Phase III clinical trial evaluating the treatment of HDM allergic asthma with the HDM SLIT-tablet, ACARIZAX® in The Journal of the American Medical Association (JAMA)  Henrik Jacobi, Executive Vice President of Research & Development at ALK, said: "We are extremely pleased to see the recognition of ACARIZAX® clinical evidence in the management of asthma. This confirms our long-held conviction that allergy immunotherapy has an important role to play in the treatment of allergic asthma, a belief confirmed by the unprecedented clinical development programme for ACARIZAX®, currently the only HDM SLIT-tablet indicated for use in patients with house dust mite allergic asthma that is not well controlled." House dust mite allergy and asthma often coexist. More than half of asthmatic patients have been reported to have house dust mite sensitisation. He continued: "ALK is committed to gathering further evidence to support the wider recognition of allergy immunotherapy as a treatment option for asthma, and to investigating the potential role for allergy immunotherapy in preventing the onset of asthma." Professor J. Christian Virchow, of the University of Rostock and lead author of the recently published paper in JAMA says: "This is very encouraging. I am pleased to see findings from this important trial translated into clinical guidelines. This underlines the importance of performing robust evidence based trials in allergy immunotherapy." ACARIZAX® is currently approved for the treatment in HDM allergic asthma in 12 European countries and Australia. ALK is a research-driven global pharmaceutical company focusing on allergy prevention, diagnosis and treatment. ALK is a world leader in allergy immunotherapy - a treatment of the underlying cause of allergy. The company has approximately 2,300 employees, with subsidiaries, production facilities and distributors worldwide. ALK has entered into partnership agreements with Torii, Abbott, and Seqirus to commercialise sublingual allergy immunotherapy tablets in Japan, Russia, and South-East Asia, and Australia and New Zealand, respectively. The company is headquartered in Hørsholm, Denmark, and listed on Nasdaq Copenhagen. Find more information at http://www.alk.net. House dust mites (HDM) are the most common cause of allergy in the world. HDM allergy is estimated to affect around 90 million people in Europe, North America and Japan, and more than 100 million in China. It is estimated that one in 10 adults with allergic rhinitis are poorly controlled with current standard therapies. The condition appears early in life, is present all year round and patients face an elevated risk of developing asthma and other allergies. For some of these patients, the HDM SLIT-tablet is a relevant treatment option which can improve their quality of life and potentially modify the underlying cause of their disease. ALK's HDM SLIT-tablet is a treatment for house dust mite-induced allergic rhinitis (AR) with or without conjunctivitis and allergic asthma (AA) that is not well controlled by symptomatic medication. In Europe, where it is marketed as ACARIZAX®, the product has been approved in 14 countries for the treatment of AR, 12 of which also include the HDM AA indication. It is also approved in Japan for AR, where it is licensed by ALK to Torii and marketed under the trade name MITICURE[TM] and in Australia for HDM AR and AA, where it is licensed by ALK to Seqirus. The product is also being developed for a number of other markets around the world, including China, North America and countries in Southeast Asia. Altogether, clinical development activities for the HDM SLIT-tablet have involved more than 6,000 patients worldwide. In the 12 European countries where ACARIZAX® has been approved for HDM AR and AA, ACARIZAX® is indicated in adult patients (18-65 years) diagnosed by a clinical history and by a positive test for HDM sensitisation with at least one of the following conditions: Treating physicians should refer to full summary of product characteristics before considering ACARIZAX® for treatment in patients with house dust mite allergic asthma. GINA was launched in 1993 in collaboration with the National Heart, Lung, and Blood Institute, National Institutes of Health, USA, and the World Health Organization. GINA's programme is determined and its strategies for asthma care are shaped by committees made up of leading asthma experts from around the world. The GINA Scientific Committee prepares updates to their reports and guidelines each year, which are made available on the GINA Website as they are completed. The Scientific Committee has developed a sophisticated set of procedures to review the world's literature with regards to asthma management and to update the GINA documents to reflect this state-of-the-art information.
News Article | February 15, 2017
Members of a House of Representatives committee hammered the Environmental Protection Agency on Tuesday at a hearing titled “Making EPA Great Again,” accusing it of basing its regulations on biased, politicized science, and calling for reforms in the EPA’s rule-making process. But a number of scientific organizations call this an attempt to covertly strip the agency’s power—and ultimately to interfere with the scientific process itself. In his opening statement at the House Committee on Science, Space and Technology hearing, Chair Lamar Smith—a Republican from Texas—excoriated the EPA over what he has called its “secret science.” In setting past environmental regulations the EPA has “routinely relied on questionable science, based on nonpublic information, that could not be reproduced…and deliberately used its regulatory power to undercut American industries and advance a misguided political agenda that has minimal environmental benefit,” Smith said. With Pres. Donald Trump’s administration newly in charge, Smith added that he now sees a chance to rein in an agency he thinks has run amok. “There is now an opportunity to right the ship at the EPA, and steer the agency in the right direction,” he said. Many believe that means Smith plans to revive legislation called the Secret Science Reform Act, which he co-sponsored in 2014 and introduced again in 2015—but which Pres. Barack Obama vowed to veto. The bill would prohibit the EPA from creating regulations based on science that is “not transparent or reproducible.” Scientific organizations say this would make it more difficult for the EPA to create rules at all, and craft them based on the best available science. For example, if the bill requires the EPA only use studies that can be identically reproduced, that would impose an unreasonable demand on scientists, according to Rush Holt, who testified at the hearing as CEO of the American Association for the Advancement of Science. “Many studies cannot be repeated in exactly the same way—the populations have changed, those people [in the studies] have grown up or moved away or the forest you’re studying has been overtaken by an invasive [species],” Holt explained. “The Secret Science Act has been based on a misunderstanding of how science works—the gold standard is to find other approaches to come up with the same conclusions. Rarely can you repeat an experiment in exactly the same way.” Critics also worry the legislation could keep the EPA from using important multiyear studies—say, for example, a 10-year study examining air pollution’s effect on human health—in the agency’s rule-making process. Those critical long-term studies are extremely difficult to replicate because they require so much time and money. Because of this, they may not fall under the definition of “reproducible.” Although the bill’s supporters might argue long-term studies would not be excluded, the law’s language would likely leave the term “reproducibility” open to interpretation. For instance, someone could potentially sue the EPA for using one of those long-term studies in its rule-making, leaving it to the courts to determine the definition of “reproducibility.” All of this means the bill could limit the number of studies the EPA might consider, if either the courts decide a study is not “reproducible” or if the EPA refrains from using a multiyear study because it believes the research will not meet the bill’s “reproducibility” demand. In other words, the agency may not be able use the best available science to make its rules. “I think [the Secret Science bill] is fundamentally substituting a politically originated revision of the process for the scientific process,” Holt said in the hearing. The Secret Science Reform Act would also require the EPA use only studies for which data is publicly available online—or the agency makes publicly available—in the name of transparency. But critics of this approach note that scientific studies often include private data, including individual health information, or industry records that cannot be made public for competitive, ethical or legal reasons. During the hearing the representative from the American Chemistry Council (ACC), an industry group, asked that confidential commercial data be protected in the bill. “That was another great illustration that the bill is not about transparency—it’s about what is politically expedient to move industry’s agenda forward,” says Yogin Kothari, a representative with the Center for Science and Democracy at the Union of Concerned Scientists. As for medical data, supporters of the bill say names and other private information could be scrubbed—but that would likely be expensive and time-intensive, and thus another factor limiting the number of studies the EPA could use to make its environmental protection rules. “You don’t need access to the raw data to figure out what information the EPA is relying on,” Kothari wrote in an e-mail. “The idea of secret science is based on a false premise.” The Congressional Budget Office estimates that implementing the latest version of the Secret Science bill (the 2015 version) would cost the EPA $250 million annually over the next few years. The bill, however, allots the EPA only $1 million per fiscal year to carry out its new requirements. “The goal [of the bill] is really to throw a wrench in the rule-making process at the agency,” Kothari says. Smith’s office referred queries to the House Science Committee, whose spokesperson was not immediately available for comment. Industry groups including the ACC have supported the latest version of the bill. “A more transparent EPA helps to foster the kind of regulatory environment that gives our members the confidence and certainty they need to continue to invest in the U.S. economy and develop transformational, innovative products,” an ACC spokesperson wrote to Scientific American in an e-mail after the hearing. Other industry groups that supported the latest version of the bill declined to commment. The House panel also focused on reforming the EPA’s Science Advisory Board, which some committee members and industry groups say does not represent a balanced view of science. In 2015 Smith co-sponsored a bill called the “EPA Science Advisory Board Reform Act,” which never became law—it is widely believed Smith will revive that legislation this year, along with the Secret Science bill. Opponents say the Advisory Board act would make it possible to stack the board with members who favor industry. “[The board] will not function better by having fewer scientists on it,” Holt said at the hearing. Committee members also devoted a significant portion of the hearing to a recent controversial article about climate change research, recently published in the Daily Mail, a London tabloid newspaper. A whistleblower at the National Oceanic and Atmospheric Administration (NOAA) reportedly told the newspaper the agency violated scientific integrity and rushed to publish a landmark scientific paper, which showed no pause in global warming, for political reasons. Smith referenced the story in his opening statement at Tuesday’s hearing, saying, “Recent news stories report that NOAA tried to deceive the American people by falsifying data to justify a partisan agenda.” The whistleblower, John Bates, told another publication on Tuesday, however, that the agency had broken protocol when it rushed to publication—but that the data had not been manipulated. The points Bates complained about made no difference in the scientific paper’s overall conclusions, according to Zeke Hausfather, a climate scientist and an energy systems analyst at the University of California, Berkeley. Hausfather noted other studies, including one of his own, have independently verified the NOAA paper’s results. “I would strongly recommend,” he adds, “that if Congress wants to assess matters of science, they should rely on peer-reviewed publications rather than tabloid articles.”