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Science Policy Around the Web – April 10, 2018

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By: Allison Dennis B.S.

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source: pixabay

Mental Health

Many People Taking Antidepressants Discover They Cannot Quit

15 million American adults have taken antidepressants for a period longer than five years, in spite of the fact that these drugs were originally approved for short-term treatment, lasting less than nine months. Many doctors agree that a lifetime prescription may be necessary for the treatment of some patients. However, many are concerned that some patients may simply be accepting long-term use of antidepressants when faced with the challenge of stopping.

Surveys have shown that choosing to stop long-term medications is not a straightforward process with many patients reporting withdrawal effects. Some antidepressants take weeks to break down and leave the body, and their absence can induce feelings of anxiety, insomnia, nausea, “brain zaps,” and even depression itself. Antidepressants are one of the most frequently prescribed therapeutics by physicians, yet the drugs’ labels do not outline how to end a prescription safely. Patients may have to turn to online resources, including  The Withdrawal Project, which provides a community based approach to provide support, but whose writers are self-described as “laypeople who have direct personal experience or who have supported someone else in the process of reducing or tapering off psychiatric medication,” but are not medical professionals.

The benefits of antidepressants in the treatment of depression is undeniable, leaving government regulators cautious about limiting their availability. Antidepressant manufacturers appear unwilling to dive into research characterizing the discontinuation syndrome experienced when patients try to stop, feeling their efforts to demonstrate the drugs are safe and effective is sufficient. Academic and clinical researchers have occasionally tackled the issue, but few studies have looked at the barriers facing open-ended antidepressant prescription holders.

(Benedict Carey and Robert Gebeloff, The New York Times)

Alzheimer’s Disease

Scientists Push Plan To Change How Researchers Define Alzheimer’s

Currently, the 5.7 million Americans living with Alzheimer’s are identified through a panel of symptoms including memory problems or fuzzy thinking. However these symptoms are the product of biological changes scientists feel may be an earlier and more accurate marker of disease. On the biological level, Alzheimer’s can be characterized by the accumulation of several characteristic structures in brain tissue including, plaques, abnormal clusters of protein that accumulate between nerve cells, tangles, twisted fibers that form inside dying cells, and the build up of glial cells, which ordinarily work to clear debris from the brain. It is unclear if these changes are driving the widespread disconnection and destruction of neurons exhibited in the parts of the brain involved in memory and later in those responsible for language and reasoning in the brains of Alzheimer’s patients or just a byproduct of a yet-to-be-discovered process.

A work group formed by collaborators at the National Institute on Aging and the Alzheimer’s Association are putting forward a research framework which defines Alzheimer’s by the progression of a panel of risk factors, including neuropathology, tangles, plaques, and neurodegeneration. By allowing these biomarkers to fall along a continuum, the group is accommodating the observation that the exhibition of these traits can vary widely between individuals and may not always co-occur with symptoms. Yet the framework is intended to “create a common language with which the research community can test hypotheses about the interactions between Alzheimer’s Disease pathologic processes.”

Although much of the research is preliminary, specialized brain scans and tests of spinal fluid are already being designed to identify these biomarkers directly. The biomarkers included on the continuum can be observed 20-30 years prior to symptoms, fostering the hope that early interventions could be implemented to slow disease progression or even prevent it in the first place.

(Jon Hamilton, NPR)

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April 11, 2018 at 6:11 pm

Science Policy Around the Web – March 27, 2018

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By: Patrick Wright, Ph.D

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source: pxhere

Right to Try Drug Access

Why Can’t Dying Patients Get the Drugs They Want?

The United States House of Representatives passed “Right to Try” legislation last week (HR 5247, the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018”), which allows terminally ill patients access to experimental drugs that are only required to have completed Phase 1 of a clinical trial, bypassing approval of the Food and Drug Administration (FDA). These patients are those with life-threatening illnesses who have exhausted approved treatment options and are not eligible to participate in a clinical trial (e.g. due to not meeting inclusion criteria) designed to evaluate the desired drug. However, this access still requires cooperation and permission from the drug companies themselves. Hesitation on the side of these companies can be rooted in the potential risk of jeopardizing ongoing clinical trials and the long process of bringing a drug to market. Furthermore, drug companies often do not have a sufficient extra supply of a product to provide to patients. The logistics of granting access could slow efforts to get the drug approved. Opponents of this legislation cite patient safety concerns and the failure to address the fundamental issue of pharmaceutical company denial of access as the most significant problems that still must be addressed.

Some companies acknowledge the importance of FDA oversight and would continue to seek FDA permission even if a Right-to-Try bill becomes law. Dr. Joanne Waldstreicher, the Chief Medical Officer of Johnson & Johnson, said “In our view, the FDA plays a really important role.” It has “information that we don’t have necessarily; they see safety and efficacy information on products that may be similar.” The legislation includes language that could potentially encourage companies to participate, including preventing the FDA from considering the experiences of patients using the drug when approving drugs. The FDA itself already approves 99 percent of applications to its expanded access program for access to investigational drugs for patients facing serious illnesses.

The Right to Try campaign was initiated by the Goldwater Institute, a libertarian, free-market public policy research and litigation organization, and championed by Vice President Mike Pence. Currently, Right to Try legislation has been enacted by 38 states. Victor Riches, president and Chief Executive Officer of the Goldwater Institute said the passing of this bill “is a win for patients. Millions of Americans who have been told they are out of options and it’s time to get their affairs in order, are closer to having the opportunity for one last treatment, without having to get permission from the federal government first.”

In August 2017, the United States Senate unanimously also passed a Right to Try bill (S 204); notably, it was passed under pressure by Ron Johnson (R-WI) who threatened to hold up a five-year reauthorization of FDA user fee programs if he did not get a vote on the bill. However, the narrower House bill has key differences compared to the Senate version, with House Energy and Commerce Committee Chairman Greg Walden (R-OR), along with FDA Commissioner Scott Gottlieb and other interest groups, having specified additional provisions including limiting the types of patients who can access the pathway and giving the FDA more information regarding the use of the pathway. Because the House bill differs from the earlier Senate bill, the Senate must vote on this revised version. Last week, Senator Minority Leader Chuck Schumer (D-NY) blocked Ron Johnson’s attempt to secure unanimous consent in the Senate to pass the House version of the bill. Senator Schumer stated that the Senate had already passed its version and that he wanted to work on a compromise bill.

(Katie Thomas, The New York Times)

Animal Welfare

Congress Orders USDA to Restore Transparency, Completeness, to Animal Welfare Reports

The U.S. Department of Agriculture (USDA) blacked out a public database containing animal welfare inspection reports and records of enforcement actions that the USDA carried out against violations of the Animal Welfare Act in early 2017. The records were often later reposted after varying levels of redaction, eliciting resistance and objection from proponents of animal research and animal welfare activist groups. Last week, Congress released a report that accompanied the USDA’s 2018 spending bill. It stated that these redactions and the obfuscation in accessing USDA information on inspections and their subsequent enforcement violates previous congressional direction and that “the online searchable database should allow analysis and comparison of data and include all inspection reports, annual reports, and other documents related to enforcement of animal welfare laws.”

On the same day that the report was released, the Humane Society of the United States (HSUS) filed a lawsuit against the Animal and Plant Health Inspection Service (APHIS), the USDA entity responsible for conducting animal welfare inspections. HSUS had requested documentation (e.g. inspection reports) for three puppy breeding facilities (“puppy mills”) via the Freedom of Information Act (FOIA) and were, in response, provided reports by APHIS with significant contents redacted. The USDA’s FOIA office wrote that because the requested reports were about businesses that operated out of an individual’s private home, they could not be disclosed without that person’s consent. This is not the first lawsuit in response to the blackout that has been filed by animal welfare groups against the USDA. The Animal Legal Defense Fund as part of a coalition with other animal activist organizations (Stop Animal Exploitation Now, Companion Animal Protection Society, and Animal Folks) previously filed a lawsuit in February 2017 against the USDA’s handling of inspection report transparency and availability (Animal Legal Defense Fund v United States Department of Agriculture) that was dismissed by federal Judge William H. Orrick on the grounds that FOIA provides an “adequate, alternate remedy”. The coalition has since appealed the decision.

To explicitly describe the approach and process underlying the blackout and redactions, APHIS states on its website: “APHIS, during the past year, has conducted a comprehensive review of the information it posts on its website for the general public to view. To conduct the review, the entire agency search tool database, along with additional documents, was taken off line. As a result of this review, APHIS has removed certain personal information from APHIS’ website involving the Horse Protection Act and the Animal Welfare Act. APHIS recently reposted certain inspection reports and research facility annual reports that were determined to be appropriate for reposting.” It also states “The agency will continue to review records and determine which information is appropriate for reposting. Those seeking information from APHIS regarding inspection reports not currently posted to the website, regulatory correspondence, and enforcement related matters may submit FOIA requests for that information.”

It appears that the language in the new Congressional report, part of the new omnibus spending bill that was just approved by Congress and President Donald Trump, has support among the animal welfare community. Cathy Liss, president of the Animal Welfare Institute, based out of Washington, D.C., stated “The Animal Welfare Institute applauds Congress for forcing USDA to lift its veil of secrecy.” Similarly, Kathleen Conlee, vice president for animal research at HSUS said she is “very pleased” with the report and that the “HSUS has been working closely with Members of Congress over the past year to address USDA’s outrageous purge and redaction of these vital documents.”

(Meredith Wadman, Science)

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March 27, 2018 at 12:27 pm

Pharmaceutical Detailing: in the US the Details are Tied the Prescriber’s Name

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By: Allison Dennis B.S.

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Source: pixabay

While U.S. privacy laws protect patients from direct pharmaceutical marketing and shield their personal information from data mining, physicians are routinely identified based on their prescribing habits and targeted by pharmaceutical companies through personalized marketing campaigns. By their very nature, these campaigns aim to influence the behavior of prescribers. In other countries, including those protected by the European Union’s Data Protection Act, the personal identification of prescribers through medical data is strictly forbidden. However, in the U.S. these personalized campaigns are made possible by a robust pipeline of data sharing.

The pipeline begins with pharmacies, who routinely sell data derived from the vast volume of prescriptions they handle. While the prescribers’ names are usually redacted, IMS Health, a key health information organization in the pipeline, can easily use the American Medical Association (AMA)-licensed Physician Masterfile to reassociate physician ID numbers with the redacted names. The physician ID numbers are issued by the U.S. Drug Enforcement Administration (DEA) and are sold to AMA through a subscription service. IMS Health uses the prescription data to develop analytic tools for sale to pharmaceutical companies desperate to gain a marketing edge with individual prescribers. The tools consolidate the activity of nurse practitioners, dentists, chiropractors, and any professionals who can legally file a prescription. Marketers can use these tools to determine how much each named physician is prescribing, how that compares to other named physicians, what their specialty is, etc.

The data contained in the AMA’s Physician Masterfile is applicable for informing research and conducting surveys of practicing physicians, yet the need to identify physicians by name is usually not needed for public health research and enables prescriber manipulation.  The prescriber reports compiled by IMS Health enable pharmaceutical companies to take a data-driven approach to direct-to-physician advertising, a practice known as detailing. During a 17-month period between 2013 and 2015, pharmaceutical companies reported spending $3.5 billion in payments to physicians covering promotional speaking, consulting, meals, travel, and royalties. While many of the expenditures may be tied to legitimate collaborations between pharmaceutical companies and medical professionals, the U.S. Department of Health and Human Services warns that free samples, sham consulting agreements, subsidized trips, and industry-sponsored continuing education opportunities are all tools used by vendors to buy medically irrelevant loyalty. Indeed, physicians themselves seem conflicted over the significance of these relationships. When residents were asked if contact with pharmaceutical representatives influenced their prescribing practices, 61% believed they were unaffected. However, the same residents felt that only 16% of their peers were similarly immune to contact with pharmaceutical representatives.

Studies examining the role of detailing  have found it associated with higher prescribing frequency, higher costs, and lower prescribing quality, all with no contrasting favorable associations. Recent concerns over conflicts  of  interest arising from increased exposure of physicians to detailers led several academic medical centers to restrict sales visits and gift giving and implement enforcement mechanisms. Compared to hospitals with no detailing limitations, hospitals with limitations underwent an 8.7% relative decrease in the market share of detailed drugs and a 5.6% relative increase in the market share of non-detailed drugs. Overuse of brand-name drugs, which are most commonly associated with detailing, cost the US approximately $73 billion between 2010 and 2012, one-third of which was shouldered by patients. Advocates of the practice lament the lack of formal academic opportunities for physicians to learn about new drugs, believing the educational materials provided by pharmaceutical representatives fulfills a need.

The most tragic example of the potential harms of detailing targeting individual prescribers comes from the early days of the prescription opioid crisis. Purdue Pharma, the maker of OxyContin, used prescriber databases to identify the most frequent and least discriminate prescribers of opioids. Sales representatives, enticed by a bonus system that tracked their success according to upswings captured in the prescriber database, showered their target prescribers with gifts while systematically underrepresenting the risk of addiction and abuse from OxyContin. Recruitment into Purdue’s national speaker bureau and subsequent paid opportunities were further used to entice lukewarm and influential prescribers.

The last decade has seen several attempts to address the influence of detailing at the institutional, professional, and executive levels. Individual hospitals have begun limiting the access of physicians to vendors. The American Medical Student Association began issuing a conflict-of-interest scorecard, allowing all U.S. medical schools to track and assess their own detail-related policies, including those related to the limiting of gifts from the industry, industry-sponsored promotional speaking relationships, permitted accesses of pharmaceutical sales representatives, and overall enforcement and sanction of these policies. In 2016, 174 institutions participated. The AMA, which licenses the list of physician names used by health information organizations companies, has offered physicians the chance to block pharmaceutical representatives and their immediate supervisors from accessing their prescribing data. However, the Physician Data Restriction Program does not limit the ability of other employees at a pharmaceutical company to access prescribing data of doctors who have opted out. Physicians must renew their request to opt out every three years and are automatically added to the Masterfile upon entering medical school. Five years after the program’s introduction in 2006, just 4% of practicing physicians listed on the file had opted out.

In 2007, the state of Vermont outlawed the practice of selling prescription data for pharmaceutical marketing without prescriber consent. The law was quickly challenged by IMS Health, the Pharmaceutical Research and Manufacturers of America, and other data aggregators and eventually struck down by the U.S. Supreme Court. Vermont legislators held that detailing compromises clinical decision making and professionalism and increases health care costs and argued that the law was needed to protect vulnerable and unaware physicians. However, the Court held that speech in the aid of pharmaceutical marketing is protected under the First Amendment and could not be discriminately limited by Vermont law.

Congress made the first federal attempt to address the issue by enacting the Physician Payment Sunshine Act in 2010, which required companies participating in Medicare, Medicaid, and the State Children’s Health Insurance Program markets to track and collect their financial relationships with physicians and teaching hospitals. The transparency gained from the disclosures have allowed many researchers to systematically evaluate connections between conflicts of interests and prescribing behavior.

As policy makers and private watchdogs scramble to address the issues of detailing, the availability of physician names and prescription habits continues to facilitate the implementation of novel tactics. Limits on face time have pushed detailers to tap into the time physicians are spending online. When the names of prescribers are known, following and connecting with prescribers through social media accounts is straightforward. Companies like Peerin have emerged, which analyze prescriber Twitter conversations to learn whose conversations are most likely to be influential and which prescribers are connected. LinkedIn, Facebook, and Twitter all offer the ability to target a list of people by name or e-mail address for advertising. While all online drug ads are limited by the U.S. Food and Drug Administration, pharmaceutical companies are experimenting with the use of unbranded awareness campaigns to circumvent direct-to-consumer regulations.

While personalized prescriber marketing campaigns may be turning a new corner in the internet age, a simple opportunity exists at the federal level to de-personalize the practice of physician detailing. It is unclear the extent that the DEA stands to gain from selling physician ID subscriptions. However, in context of the downstream costs of the overuse of name-brand drugs this may be an appropriate loss. The U.S. Government’s central role in the reassociation of prescribers’ prescriptions could be directly addressed through systematic implementation of revised policy in order to preempt downstream prescriber manipulation.

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November 9, 2017 at 10:41 pm

Science Policy Around the Web – October 20, 2017

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By: Patrick Wright, Ph.D

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Image: By Tom Varco [CC BY-SA 3.0], via Wikimedia Commons

Drug Pricing

California governor signs drug pricing transparency law

A recently signed bill in California aims to improve transparency of future changes to drug prices. The new law requires drug manufacturers to provide a 60-day notice of any upcoming price increases of more than 16 percent over a two-year period. It comes as an attempt to assuage public and political concern over increased pricing and price gouging practices in the pharmaceutical industry. For example, a new study in the Journal of Clinical Oncology reports that for a group of 24 FDA-approved, patented, injectable anticancer drugs, the mean cost increase was 18% over a mean follow-up period of 8 years following release, substantially outpacing inflation and unaffected by the addition of competition in the market.

This legislative venture is not without reproach, however. The Biotechnology Innovation Organization, the largest biotechnology industry trade group, issued a statement condemning the California bill, arguing: “This law will neither provide meaningful information to patients nor lower prescription drug costs”. Pharmaceutical companies and drug makers have also contended that whole price increases are not representative of the actual prices paid for medicines with discounts and rebates are considered.

On the other hand, an early positive consequence of the proposed legislation is that it has encouraged some companies including AbbVie Inc to voluntarily pledge a single annual price increase of under 10 percent on branded prescription medications in contrast to the industry-standard practice of biannual, double-digit cost increases.

This law is part of a larger pursuit across states to address rising healthcare and prescription drug costs. Another recent, analogous law in Maryland (House Bill 631) is aimed at price gouging of generic medicines, those drugs created after branded medicines are no longer patented, by companies not facing competition from other distributors; a plea by a pharmaceutical industry group was turned down by U.S. District Judge Marvin J. Garbis in September. Maryland and California are not alone. According to the National Conference of State Legislatures, at least 176 bills on pharmaceutical pricing and payment across 36 states have been introduced in 2017.

(Bill Berkrot, Reuters)

 

Genetic Testing

Gene-expression study raises thorny ethical issues

A National Institutes of Health-backed consortium, known as the Genotype-Tissue Expression (GTEx) consortium, aims to accumulate data about gene sequences and activity across 44 types of human tissue, collected from approximately 1000 anonymous deceased donors. It was established in 2010 to pursue questions related to the propensity of the same DNA sequence that is present throughout a human body to give rise to varied tissues; it aims to identify the genetic factors encoded by nucleotide variants that underpin different levels of gene expression in each of these tissues. To encourage widespread participation toward this cause, the data are made freely available to qualified scientists and companies.

As part of the collection process, loved ones representing the deceased donors are asked to consent on behalf of the donor to provide a medical history and collect genetic information and tissue from the deceased. However, the study was not designed to provide the results of genome sequencing and other tests to the loved ones of the deceased donors. This raises some important ethical considerations regarding informed consent and the potential moral obligations of scientists to donor families and loved ones. Susan Wolf, a lawyer and bioethicist at the University of Minnesota in Minneapolis, stated studies such as GTEx should allow for families to be identified if downstream research discovers a mutation, for example, that would dramatically predispose relatives to cancer if inherited.

Laura Siminoff, a bioethicist at Temple University, led a study to assess the feelings of donor families in GTEx on the entire process, finding that the stress of losing a family member may have clouded the extent of analysis and research pursuits for which they had provided consent; most recalled that they had agreed to donate their relatives’ tissue for research, but little else. Siminoff suggests that the informed-consent process could be expanded to included genetic counseling in tissue-donation projects of this nature.

Currently, three federal agencies play a role in the regulation of genetic testing: the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Federal Trade Commission (FTC). Generally, CMS is responsible for regulating the clinical laboratories performing genetic testing to ensure testing quality. The FDA regulates the safety and effectiveness of genetic tests and pharmacogenomics (the use of genomic information to predict patient response to a particular drug), as well as genomics tools in clinical research. Finally, the FTC regulates how tests are advertised. Interestingly, the collection of biospecimens from deceased individuals is not legally classified as human subjects research under the Department of Health and Human Services policy regarding the Protection of Human Subjects, but because potentially impactful genetic information could be uncovered in the study that is of direct significance to donor families, possible ethical implications still should be considered on their behalf.

(Ewen Callaway, Nature)

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October 20, 2017 at 9:02 am

Science Policy Around the Web – February 10, 2017

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By: Saurav Seshadri, PhD

Source: pixabay

Sleep

The Purpose of Sleep? To Forget, Scientists Say

Humans spend approximately one third of their lifetime sleeping, yet the purpose of sleep is still largely unknown. A pair of recent studies in the journal Science suggest that a key function of sleep is to give the brain a chance to rewire itself, specifically by cutting down connections between neurons, which naturally scale up during wakefulness, and especially during learning.

In one paper, researchers used 3D electron microscopy to measure the sizes of these connections, called synapses, in mouse brain slices. They found that sleep produced a significant decrease in the size of synapses. Interestingly, this effect was more pronounced in smaller synapses, which were likely strengthened by general information processing while awake, than large ones (~20% of synapses), which may encode more well-established memories. In the other, researchers used two-photon imaging in live mice to observe sleep-induced changes in synapses. They found a similar decrease in synaptic strength, and went on to identify the signaling pathway that caused this effect; blocking this pathway prevented a normal reduction in the scope and magnitude of a learned behavioral response.

These findings underscore the importance of sleep, especially for memory consolidation involved with learning. Studies like these can have far-reaching effects on the public’s perception of sleep, influencing individual habits as well as policy related to education. For example, they suggest that prioritizing sleep when setting school start times (an issue currently under debate in Montgomery County schools) could improve students’ lesson retention and ultimately their test performance. They also point to important cellular and molecular processes that take place during sleep, which could help explain how existing sleep aids adversely affect brain functioning and memory (a public health concern), and ultimately lead to the development of better drugs. (Carl Zimmer, The New York Times)

Drug Policy

Massive Price Hike for Lifesaving Opioid Overdose Antidote

Increased public exposure to the epidemic of opioid abuse, which continues to intensify in the US, has made it increasingly influential in politics, possibly including the recent presidential election.  A crucial tool for communities at the forefront of this public health crisis is naloxone, which can reverse potentially fatal symptoms associated with overdose. The Evzio naloxone auto-injector, produced by Kaleo, is one of two such products approved by the FDA. Kaleo has recently come under fire for increasing the price of Evzio from $690 to $4,500.

Kaleo cites several justifications for the price hike. Firstly, they offer coupons to patients whose insurance doesn’t cover Evzio. Second, they argue that large insurance companies and government agencies (such as the Veterans Health Administration, which sees a high rate of opioid use) can negotiate prices, while other organizations are currently well funded (thanks to public concern) to absorb the increase. Thirdly, they are expanding their donation supply to allow smaller groups to apply for free devices. However, experts say that the increase is not justified by production costs, and some organizations have been forced to switch to alternative drugs.

News of the decision arrives at a time when the public is particularly sensitive to drug pricing, and have made their concern clear to lawmakers. Negotiation with drug companies over prices has been a prominent campaign issue in recent elections. Public outcry following similar moves by investor Martin Shkreli and Mylan led to hearings by a special congressional committee. Soon after the last election, a bill that would have allowed patients to import cheaper drugs from Canada became a high-profile occasion for posturing in the Senate, where it failed despite overwhelming public support. These stories highlight the often antagonistic relationships between the American public, its government, and the pharmaceutical industry, and illustrate how disruptive drug pricing can directly affect policy. (Shefali Luthra, Scientific American)

Scientists in Politics

Geneticist Launches Bid for US Senate; while Empiricists Around the Country Will March for Science

Donald Trump’s agenda of self-serving lies and denial of evidence has led to unprecedented levels of engagement and activism across the country. The scientific community has been especially impacted by Trump’s brand of broad, allegedly populist anti-intellectualism. Thus, although the empirical facts uncovered by scientific research are inherently apolitical and should be treated as such, scientists are beginning to mobilize to oppose the Trump administration in several ways.

One essential path to policy change is increased representation. With that in mind, evolutionary biologist Dr. Michael Eisen, an HHMI-funded investigator at UC Berkeley and co-founder of the People’s Library of Science (PLOS), recently announced his candidacy for the US Senate in 2018. Dr. Eisen’s platform seems to center on bringing a scientific perspective to Senate proceedings, and working towards comprehensive yet practical solutions to issues such as climate change. More of Dr. Eisen’s views can be found on his twitter feed and blog.

Protests are another way for individuals to make their voices heard by policy makers. The March for Science, which currently has over 350,000 followers on Facebook, will be an opportunity for ‘scientists and science enthusiasts’ to both call for and demonstrate support for the scientific community, and promote solidarity between science and the public. The main march will be held on April 22nd, 2017 in Washington D.C.; satellite marches are scheduled in over 100 additional cities. Organizers hope to maintain the momentum gained by January’s Women’s Marches, which saw historic attendance. (Sara Reardon, Nature News; Lindizi Wessel, ScienceInsider)

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Science Policy Around the Web – April 11, 2014

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By: Kaitlyn Morabito

photo credit: EssjayNZ via photopin cc

photo credit: EssjayNZ via photopin cc

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

Guarded Optimism after breast cancer drug shows promising results  –  In a recent Phase II clinical trial, Pfizer’s breast cancer drug, palbociclib, was shown to decrease the risk of cancer progression by half. This results in about a 10-month difference in the time until progression in the treatment group compared to the control group. Although there was a trend towards increased survival by 4 months, the results were not significant.   Palbociclib inhibits cyclin-dependent kinase 4 and 6 curbing growth of cancer cells.   If the FDA waves the requirement for a Phase III clinical trial, this drug may be on the market as early as next year. If a Phase III clinical trial is required, approval will be delayed for several years. (Andrew Polluck)

Cheaper fuel from self-destructing treesIn an effort to decrease the cost of turning plants into biofuel, scientists at the University of Wisconsin, Madison, have genetically modified trees to express ferulic acid. In order to access the energy source of plants, long chains of sugars called cellulose, lignin that holds cellulose and hemicellulose fibers together must be degraded. This process includes the use of heat and chemical compounds to breakdown lignin and accounts for more than 25% of the cost of cellulosic ethanol based biofuels. Ferulic acid bonds with two other compounds to make up a modified lignin, which is easier to breakdown. The group has made genetically engineered popular trees and is working on making modified corn.  (Robert F. Service)

NIH stem cell programme closes – Amid uncertainty, the NIH’s Center for Regenerative Medicine (CRM), which specializes in stem cell research, has been closed.   Although the center’s Director Mahendra Rao resigned on March 28th, and the institute’s website has been shutdown, there has been no official announcement from the NIH.   Many of the researchers associated with the institute have not received any information on the future of the center. According to officials, a panel of stem cell researchers will gather in May to discuss the fate of the program, including whether to move CRM projects to the National Center for Advancing Translation Sciences and what to do with the remaining budget. The closure of the center follows the funding of clinical trials for only one of the center’s projects, while preparations for clinical trials of 4 additional projects had already begun. (Sara Reardon)

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April 11, 2014 at 12:00 pm

Science Policy Around the Web – April 21, 2013

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By: Jennifer Plank

photo credit: limowreck666 via photopin cc

photo credit: limowreck666 via photopin cc

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

FDA’s rejection of generic OxyContin may have side effects – With the patent on the original OxyContin ending, the FDA has declared that they will not approve generic versions of the drug. In order for drug developers to compete in the prescription pain relief market, they will have to develop abuse resistant forms of the drug. In 2010, Purdue Pharma LP, the developer of the original OxyContin, produced a form of the drug that includes a polymer that makes it impossible to snort and inject the drug. The patent on the drug resistant form expires in 2025.  (Nancy Shute and Audrey Carlsen)

Stereotype threat for girls and STEM – According to Facebook executive and author Sheryl Sandberg, women are being held back by what social scientists call a “stereotype threat”- an idea that suggests that the more we are aware of the stereotype, the more likely we are to act in accordance with it. Sandberg suggests that the stereotype threat is what is responsible for preventing women to pursue leadership roles and careers in highly technical field, such as computer science. A recent study looking at author gender and gender typing of projects suggests that publications from male authors were more highly regarded scientifically. The author also presents many links aiming to encourage interest in STEM. (Chris Gunter)

Gene patents are sabotaging the future of medicine – A case currently being debated by the Supreme Court, Association of Molecular Pathology v. Myriad Genetics, has the potential to influence how clinicians can report the results of genome wide sequencing to their patients. Currently, Myriad holds the patents on the BRCA1 and BRCA2 genes, which are associated with the onset of breast and ovarian cancers. Therefore, Myriad has a monopoly on all diagnostics and therapeutics related to the BRCA genes. The Association for Molecular Pathology states that a person has a right to know their own genetic code and should not have to have permission from patent holders to know the sequence of their own genes. The Supreme Court will rule on the case in late June. (Daniela Hernandez)

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April 21, 2013 at 8:17 pm