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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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Written by sciencepolicyforall

March 27, 2018 at 12:27 pm

Science Policy Around the Web – February 24, 2017

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By: Alida Palmisano, PhD

Source: usda [Public domain], via Wikimedia Commons

Public Access to Data

Lawsuit Aims to Force USDA to Repost Scrubbed Animal Welfare Records

“Put the records back on the internet.”

An article published in Science discusses a lawsuit filed on February 13 against the U.S. Department of Agriculture (USDA) by an animal law expert at Harvard University. According to the plaintiffs, USDA violated the federal Freedom of Information Act (FOIA) when it removed thousands of animal welfare inspection reports and other records from a publicly accessible website. USDA generated records that document animal facility inspections, enforcement actions, animal censuses, and other information collected by the agency in the course of enforcing the federal Animal Welfare Act.  The law covers animals in more than 7800 facilities, including zoos, roadside circuses, and research laboratories at government agencies and academic medical centers.

The decision to remove the public access to these records may have been a response to a lawsuit involving another law, the Horse Protection Act. The plaintiffs in a 2016 Texas lawsuit accused USDA of violating their rights under the Privacy Act by posting inspection documents required by the Horse Protection Act. A resulting USDA review of all its public postings led the agency to scrub from its website documents generated under both the Horse Protection Act and the Animal Welfare Act.  In the future, the agency announced, people who want access to those records will need to file a FOIA request. The agency’s most recent FOIA report states that it takes an average of 94 days for the agency to respond to a simple FOIA request and 234 days on average for more complicated requests.

In February 13’s lawsuit, the plaintiffs invoke a section of FOIA that requires agencies to make publicly available electronically all records that it has released under FOIA which “because of the nature of the subject matter, the agency determines have become or are likely to become the subject of subsequent requests for substantially the same records.” (Meredith Wadman, ScienceInsider)

Science and Immigration

Grad Students, Postdocs with U.S. Visas Face Uncertainty

While U.S. courts are busy handling President Donald Trump’s travel ban on immigration from seven majority-Muslim countries, the temporary shut down of the executive order, the appeal to reinstate the travel ban, the rejection of the immediate restoration of the ban, and more appeals and rulings, graduates and postdoctoral students already in the United States are weighing their options and trying to plan rationally in an unpredictable and fluid situation.

Many scientists in the U.S. are on student or other working visas. All these visas may not be renewable, depending on future executive orders and regulations. The dilemma “simply ruins their future. It’s a catastrophe,” says a Yemeni biologist who is on a university faculty on an H-1B, a 3-year visa for professionals. For years, lawmakers in Washington have tried to reform abuses of visa regulations by companies using visas to bring workers to the U.S. to learn the ropes, and then send the trained workers to other countries where the job can be done cheaply. The H-1B system is contentious: on one side labor advocates want the exploitation of the H-1B system to stop supporting an outsourcing business model. On the other hand, tech companies like Google and Facebook say they can’t get enough visas for top foreign talent, as the cap on the number of H-1Bs issued every year means that sometimes foreign graduates from top U.S. universities, places like the Massachusetts Institute of Technology and the University of California, Berkeley, can’t get one. The travel ban already has harmed the top universities in the U.S., stranding students, faculty and scholars abroad, and making foreign schools more attractive to some of the world’s brightest students.

In papers filed in Brooklyn federal court, the schools (that include Columbia, Duke, Harvard, Johns Hopkins, Princeton, Stanford, Yale, Massachusetts Institute of Technology and several more) said that the order blocking travel from seven predominantly Muslim countries threatens their abilities to educate future leaders from every continent. They said the executive order has “serious and chilling implications” and that the ban “casts doubt on the prospect and value of studying and working here for everyone,” the papers said. (Meredith Wadman, Richard Stone, Science)

Genetic Engineering

US Science Advisers Outline Path to Genetically Modified Babies

“Scientists should be permitted to modify human embryos destined for implantation in the womb to eliminate devastating genetic diseases such as sickle-cell anaemia or cystic fibrosis — once gene-editing techniques advance sufficiently for use in people and proper restrictions are in place. That’s the conclusion of a 14 February report from the US National Academies of Science, Engineering, and Medicine.”

The report follows a 2015 National Academies summit between scientists, ethicists, legal experts and patient groups from around the world. At the time of the meeting, given the outstanding scientific, ethical and legal questions surrounding the issue, the organizers concluded that scientists shouldn’t yet perform germline editing on embryos intended for establishing a pregnancy. However, the organizers also stated that altering human embryos for basic research was acceptable.

The latest iteration of this ongoing CRISPR debate moves the bar a little further. The report recommends restricting the technique to severe medical conditions for which no other treatment exists. Eric Lander, president of the Broad Institute of MIT and Harvard, said, “It’s a very careful, conservative position that’s just a little bit beyond an absolute bar.” In the report, the committee also called for international cooperation, strict regulatory and oversight framework, public input into decisions and long-term follow-ups of children who have edited genomes. The report adds that for now, genome editing should not be used for human enhancement, such as improving a person’s intelligence or giving them super-strength.

The report drew immediate criticism from a California-based non-profit organization called the Center for Genetics and Society. “This report is a dramatic departure from the widespread global agreement that human germline modification should remain off limits,” said Marcy Darnovsky, executive director of the center. “It acknowledges many of the widely recognized risks, including stigmatizing people with disabilities, exacerbating existing inequalities, and introducing new eugenic abuses. Strangely, there’s no apparent connection between those dire risks and the recommendation to move ahead.” (Sara Reardon, Nature)

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February 24, 2017 at 11:23 am

Science Policy Around the Web – August 7, 2015

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By: Cheryl Jacobs Smith, Ph.D.

Drug Policy

First 3D-printed drug approved by FDA

In an unprecedented move, the Food and Drug Administration (FDA) approved a prescription pill formulated using 3-D printing. The drug, Spritam levetiracetam, will be used to treat seizures that arise in people suffering from epilepsy. The drug’s manufacturer, Aprecia Pharmaceuticals, says it creates the pill using a 3-D printing process which adds layers upon layer to the pill until the right dosage is reached. Using 3-D printing technology, the manufacturer claims that the pill is more readily dissolved after oral administration thereby delivering a higher dosage of medicine to the patient efficiently and quickly. “As a result, Spritam enhances the patient experience – administration of even the largest strengths of levetiracetam with just a sip of liquid,” Aprecia said in a statement on Monday. “In addition, with Spritam there is no measuring required as each dose is individually packaged, making it easy to carry this treatment on the go.” Be prepared to see more medical manufacturers using this approach to not only produce new drugs but to also use this technique for tissue regeneration, bone replacements, and even prosthetics. (Hope King, CNN Money)

Climate Policy

What you need to know about Obama’s biggest global warming move yet — the Clean Power Plan

On Monday, President Obama unveiled a major climate change plan called the Clean Power Plan. What is the Clean Power Plan? This is a ‘plan’ of regulation advanced by the Environmental Protection Agency (EPA) under the Clean Air Act that strives to cut carbon dioxide emissions from U.S. power plants 32 percent below their 2005 levels by the year 2030. Although federally mandated, this regulation allows states to make their own cuts due to the diversity in energy needs across the U.S. This legislation is stricter than the existing Clean Air Act and the finalized plan can be found on the White House fact sheet. Here, it outlines that although the Clean Power Plan is stricter than the Clean Air Act, the new legislation adds two extra years to get started on cutting emissions. A clear difference is that the Clean Power Plan does not rely upon natural gas as a source for electricity generation. Rather, the Clean Power Plan incentivizes “early deployment of renewable energy and energy efficiency.” Many see this as a push back from the Administration to slow down the switch to natural gas and promote other renewable resources for energy. The U.S., along with other nations, has promised, as part of the United Nations climate negotiations, to reduce total emissions by 2025 to 26-28 percent below 2005 levels. The newly released Clean Power Plan will be a key component of getting there. (Chris Mooney, The Washington Post)

Government Science and Public Access

Reporters See Barriers to Science Information at Federal Agencies

The Union of Concerned Scientists (UCS) released a new report on August 4, “Mediated Access,” that found that journalists find it hard to keep the public informed about government science due to barriers put in place by federal agencies. The journalists identified difficulty in conducting interviews with scientists because agency public information officers would frequently sit in on the interviews making open conversation more difficult. Additionally, pre-approval rules put in place by government agencies often required science writers/journalists to submit questions beforehand. In some cases the interviews were denied or interview questions evaded. “Federal agency scientists set policies that affect the air we breathe, the water we drink, the food we eat and the products we buy,” said Dr. Andrew Rosenberg, director of the Center for Science and Democracy. “When agencies limit access to those scientists, the public loses. We need better media policies and better practices to make sure scientists can share the work they’re doing in a clear, straightforward way.” Perhaps not only government agencies should increase their transparency regarding scientific and medical issues. This rhetoric is even more applicable amidst the Planned Parenthood controversy over aborted fetal tissue. Many argue that increased Planned Parenthood visibility would allow the public to have input regarding fetal tissue distribution and research. Agencies should strive to increase transparency to the public maintaining the integrity and safety of the working place. (Union of Concerned Scientists)

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August 7, 2015 at 11:00 am

Science Policy Around the Web – February 20, 2015

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By: Nicholas Jury, Ph.D.

Photo credit: Jared Rodriguez / Truthout / Flickr

Academic Records – Privacy Regulation

Open records laws becoming vehicle for harassing academic researchers, report warns

In this digital age of communication where almost every public document is stored on a server, it is much easier for information to be disseminated to the public concerning academic research. However, a recent report entitled, “Freedom to Bully: How Laws Intended to Free Information are Used to Harass Researchers”, by the Union of Concerned Scientists (UCS) states that these same public records that are protected by open records laws to promote transparency are being used as a weapon by activists and lobbying firms to harass academic researchers with whom they disagree. The report specifically identifies discrepancies in how states may need to revise some of the laws that are used to promote transparency, while balancing the rights of privacy and academic freedom in responding to requests for information.

Journalists and activists have typically used these laws, most notably, the Freedom of Information Act (FOIA), to request documents that could expose mismanagement and financial conflicts of interest. However, some groups have requested these documents in an effort to discredit the research often including water and air pollution, climate change, genetically modified organisms, and gun violence.

A few recent attempts include a request by former Virginia Attorney General Ken Cuccinelli, a climate change denier, to obtain documents from the University of Virginia for research conducted by Michael Mann. However, Michael Halpern, a program manager with the USC says, “If lawmakers, universities, and researchers develop a shared understanding of what they should disclose and a system for proactively doing so, they can avoid costly and time-consuming lawsuits and other battles.   And that, in turn, will allow researchers to get back to what they are supposed to be doing: learning more about our world.”   Source: Puneet Kollipara (Science Insider)

 

Source: Val Altounian, Science

Source: Val Altounian, Science

Public Health – Ebola

Rapid test for Ebola now available

According to the World Health Organization (WHO), it has just approved a new rapid diagnostic test for the detection of the Ebola virus. The test is particularly useful in areas that are remote without electricity and far away from a well-equipped laboratory. Prior to this rapid test, the only available technology for detecting the virus was a PCR-based test that required a significant amount of blood from a needle draw. This was a slower way to test for the virus, as results could take more than a day. This new test only takes 15 minutes, and requires only a few drops of blood from a finger prick.

The new test is produced by Corgenix, a Colorado-based company that uses specific antibodies to identify specific Ebola virus protein. The total cost of each test will be roughly $15 says, Robert Garry, a disease expert at the University of Tulane in New Orleans. The WHO has determined that the kit has a success rate of 92% of identifying people that are infected with Ebola. This rapid test could assist health care workers and public health officials in determining new hotspots of Ebola outbreak.  Source: Gretchen Vogel (ScienceInsider)

Source:  Ashley Fisher / Flickr

Source: Ashley Fisher / Flickr

Federal Research Policy

A new shot at reducing research red tape

Running a research laboratory can be tough these days with very limited and highly competitive funding bids. On top of trying to maintain funding levels to keep a laboratory productive are the requirements of reporting progress to government entities. Scientists have long complained about how federal oversight can be a hindrance to their research. Perhaps it is time for some changes to make federal oversight of research better?

There is a new panel at the National Academies that is charged with determining exactly how the government is monitoring it’s nearly $40 billion per year investment. The panel considered a report that came out in 2005 that reports that some researchers spend up to 42% of their time working on reporting guidelines for federally funded research projects.

One concern is that the federal government doesn’t provide enough funding for universities to comply with new rules. Such new rules may cost universities about $4000 extra per student each year, said Arthur Bienenstock, physics professor and special assistant to the president of Stanford University. Larry Faulkner, president emeritus of the Univeristy of Texas at Austin spoke at the National Academies panel and said, “It would be a mistake to think that the only purpose of this study is to lighten the regulatory burden on universities. Regulation is required, it’s justified, and it’s needed. What we’re trying to do is guide both government and higher education to find more efficient ways to address those needs.”   Source: Jeffrey Mervis (ScienceInsider)

 

 

 

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Written by sciencepolicyforall

February 20, 2015 at 8:01 pm