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Science Policy Around the Web – February 13, 2018

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By: Saurav Seshadri, PhD

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Experimental drugs

Trump Endorses “Right to Try” for Terminally Ill Patients

Proponents of the ‘right to try’ received some encouragement from President Trump’s recent State of the Union address, in which he announced his support for such legislation at the federal level.  Right to Try laws are designed to allow terminally ill patients to obtain unapproved but possibly lifesaving drugs directly from pharmaceutical companies, without involving the FDA.  While such laws already exist in 38 states, they are currently superseded by the Food, Drug, and Cosmetic Act; a bill that would eliminate this legal conflict was passed by the Senate last August, but has yet to be approved by the House of Representatives.

In general, Right to Try laws permit terminal patients, with their informed consent, to access investigational treatments if recommended by a physician.  However, they do not mandate that the manufacturer provide the drug or that insurance cover it, and in some cases, they absolve drugmakers and physicians from liability for adverse outcomes.  In addition, the FDA already offers a path to treatment for terminal patients under its ‘expanded access’ program, in which patients are treated as clinical trial participants and their doctor’s office becomes a satellite site, with appropriate regulatory oversight.  Opponents of Right to Try legislation, including FDA Commissioner Scott Gottlieb, argue that bypassing such oversight would critically undermine the clinical trial process (for example, a patient death from a drug obtained under a Right to Try law would not factor into the FDA’s consideration of that drug for approval).  They also suggest that these laws provide false hope for desperate patients – experimental drugs need only clear the safety phase of FDA trials, meaning no data exists on their efficacy – and open patients up to risks of physical harm and medical fraud.

Despite these concerns, Right to Try laws have gained momentum on the strength of anecdotal success stories, and politicians’ unwillingness to appear heartless towards patients suffering from terminal diseases.  Yet in reality, without securing financial support for patients, these laws are likely to result in some patients going bankrupt. Without requiring that treatments be demonstrated to be beneficial and at least safe, these laws are likely to result in patients pursuing ineffective treatments, while reducing their quality of life by enduring side effects, risking complications, and forgoing hospice care.  The future of Right to Try legislation may be influenced by new Health and Homeland Security Secretary (and former Eli Lilly executive) Alex Azar, who seems likely to support Trump’s agenda, though he didn’t mention the right to try in his response to the State of the Union address.  Ideally, the final bill will prioritize the existing drug review process, ensuring safety for the majority of patients while still providing hope for the sickest.

(Ike Swetlitz, STAT news)

Chemical safety

The truth about glyphosate may be getting lost in the weeds

The World Health Organization (WHO) kicked off a massive controversy in 2015 with its report labeling glyphosate, a component of an herbicide marketed by Monsanto, as ‘probably carcinogenic to humans’.  The report has faced stiff opposition from Republican Representatives on the US House Science, Space, and Technology Committee, largely fueled by a pair of Reuters reports suggesting that key data was suppressed by the WHO to support its conclusion.  Now Dr. Christopher Wild, Director of the group that conducted the research (the IARC, International Agency for Research on Cancer) has sent a detailed response to the Committee to rebut these criticisms and defend its original finding.

The response, which was presented at a recent Committee hearing by Democratic Representative Suzanne Bonamici, specifically addresses two issues raised by Reuters.  First, that a senior scientist failed to disclose data that would have exonerated glyphosate: the data was unpublished and therefore didn’t meet IARC’s criteria for consideration.  Second, that the published version of the report had several changes from an earlier draft, all of which involved deleting or revising statements that cast doubt on glyphosate’s link to cancer.  Dr. Wild claims that most of these changes were related to a single review article, whose conclusions were reconsidered when it was found to have been ghostwritten by a Monsanto scientist, and that its drafts are works in progress and therefore confidential.  Still, the response doesn’t explain the IARC’s discrepancy with other regulatory agencies: the European Food Safety Authority (EFSA) and US Environmental Protection Agency (EPA) have both found glyphosate to be safe, and claim their review processes are more transparent than the IARC’s.

The IARC’s stance on glyphosate puts it in a delicate position with the US government, from which it receives ‘valuable support’, especially as the topic becomes more partisan.  Republican lawmakers have already threatened to pull funding to the IARC, ostensibly over its refusal to provide a witness for the hearing (Dr. Wild invited them to visit his facility in France instead).  On the other side, the EPA’s assessment has been called into question by the discovery that an EPA official may have colluded with Monsanto to ‘kill’ investigation into glyphosate, leading Democratic Representative Ted Lieu to request a probe into the issue.  In the midst of a heated debate on climate change, the glyphosate story may initially seem to be another case of Republicans denying science to fight regulations and side with big business; however, the reality may be more complicated.  A recent protest in Paris by farmers, opposed to a proposed ban on glyphosate, highlights how those most affected by such policies must balance their economic stability against potential health risks.  Ultimately, though lawmakers may earn political points by siding with these individuals, if the price is discrediting accurate science and eroding public trust in regulatory agencies, no one wins.

(Corbin Hiar, E&E News)

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February 13, 2018 at 6:01 pm

Science Policy Around the Web – February 9, 2018

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By: Rachel Smallwood Shoukry, PhD

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Ethics

Big tobacco’s offer: $1 billion for research. Should scientists take it?

A controversial debate has arisen in recent years about whether scientists should accept funding from sources that have interests at odds with improving the human condition and promoting health. Specifically, should researchers accept research money from tobacco companies? This practice used to be generally accepted up until a couple of decades ago, but as the harmful effects of smoking have become more clear, as well as evidence of the tobacco industry’s attempts to cover-up and misdirect the public from becoming aware of those effects, the scientific community has become reluctant to partner with “big tobacco” and is more aware of conflicts of interest.

The tobacco company Philip Morris International (PMI), makers of Marlboro and other cigarette brands, is looking to invest in research of illegal cigarette trade and smuggling. It recently established a partnership with the University of Utrecht (UU) in the Netherlands to investigate this phenomena, but UU has now pulled out of the deal after a large amount of backlash. However, PMI is still looking to fund research on the tobacco industry, setting up the potential for more controversy.

There is additional concern about this possibility due to PMI’s funding of the Foundation for a Smoke-Free World. The foundation has stated that its goals are related to smoking cessation and preventing smoking deaths through several approaches. However, many fear that the foundation is simply a front for PMI to be able to distribute funds under a better-sounding name while continuing to fund research that can be presented in a misleading way to distract from legitimate health concerns. Several top institutions have denounced the Foundation for a Smoke-Free World for using PMI’s funds, and many have vowed that they will not seek grants from or collaborations with the foundation.

Proponents of allowing the funding via the tobacco industry are interested in research of cigarette alternatives aimed at harm reduction, arguing that little is known about their long-term health implications. They say there is little funding outside of the tobacco companies for these types of studies and don’t know where else to turn. They are also worried about the climate surrounding the topic, after the response UU received when accepting research dollars from PMI. But opponents do not believe that PMI and other companies are seeking harm reduction or to hide the truth about tobacco’s health effects through their research activities and marketing tactics. This ethical debate is sure to continue as PMI disclosed that it has had over 50 applications for funding.

(Martin Enserink, Science)

NSF

US science agency will require universities to report sexual harassment

The NSF has announced it will implement a new requirement that institutions receiving grants must report grant-funded investigators who have sexual or other types of harassment claims against them and whether they were put on leave pending investigation. Many are welcoming this step as movement toward a code of conduct that has been called-for in recent years. It is also coming on the heels of several research initiatives into sexual harassment in STEM fields and other organizations implementing policies to expose and prevent harassment. Although the #MeToo movement only brought sexual harassment claims to the forefront of our culture a few months ago, the STEM field had its own bombshell revelation followed by the unveiling of many stories of sexual harassment a couple of years ago when a renowned astronomer resigned after an investigation revealed years of sexual misconduct and harassment. This new policy is also likely related to the US Congress commissioning the Government Accountability Office to look into sexual harassment by individuals funded by federal scientific agencies.

The notice the NSF sent out also directs the recipient institutions to have clear policies on what constitutes harassment and what is appropriate behavior, as well as giving clear instructions to students and employees on how to report harassment. The institutions themselves will be responsible for conducting investigations and deciding repercussions. Until now the NSF has had an option to voluntarily report sexual misconduct of award recipients, but it was rarely used. The notice states that the NSF can remove the responsible personnel from the grant or even suspend or terminate the grant following the mishandling of a report.

Despite the general positive view of this attempt by the NSF to deter harassment and establish serious consequences, some have expressed concerns at the potential implications and logistics of implementation. It was suggested that this step may discourage universities from undertaking investigations of sexual harassment, since universities benefit from grant money and reputation just as the investigators do. Another aspect to consider is that universities have different policies on sexual harassment and misconduct, and what may be allowable at one institution may be a severe breach at another. It was not immediately clear from the notice how decisions will be made with regard to the grant following investigations. While perhaps not perfect, this policy by the NSF is a first step in the right direction to ensuring everyone can pursue their scientific endeavors in a harassment-free environment.

(Alexandra Witze, Nature)

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February 9, 2018 at 4:01 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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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 6, 2013

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By: Jennifer Plank

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

NFL Crusaded Against Science – An investigative book claims that the NFL denied a growing number of scientific studies linking playing football and brain damage. As part of their effort to discredit publications demonstrating a link between the two, the league created the Mild Traumatic Brain Injury Committee in 1994. The studies published by the committee were controversial and included findings such as: concussions were minor injuries, concussions do not increase the risk of further injury, and football does not cause brain damage. Earlier this year, former NFL players sued the NFL over the fraudulent findings by the committee and received a $865 million settlement. (Don Van Natta Jr.)

NIH Trial Turns Away New Patients as Shutdown Obstructs Work of Scientists, Researchers – With 3/4 of NIH employees furloughed, new patients are unable to be enrolled in clinical trials. On average, 200 new patients enroll in trials each week, including 30 children being enrolled in cancer trials. As the government shutdown continues, those individuals’ health and well being are in danger. Additionally, other science agencies including the NSF, NASA, and DOE have either furloughed or have plans to furlough the majority of their employees. If the shutdown continues for an extended period of time, outside agencies and universities that receive federal government funding can be affected as well. (Joel Achenbach)

Vaccine Refusal Linked to California Pertussis Outbreak –  In 2010, over 9000 individuals were infected with pertussis in California. Several causes of infections have been previously described, including decreased immunity years after receiving the vaccine. However, a new study published in “Pediatrics” indicated that populations that were largely intentionally unvaccinated also contributed to the outbreak. The study identified nearly 40 geographical clusters with an unusually high number of non-medical exemptions for the pertussis vaccine were more likely to have a pertussis outbreak than surrounding areas. (Michelle Healy)

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October 6, 2013 at 8:39 pm

Science Policy Around the Web – August 24, 2012

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By: Rebecca Cerio

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

The Widespread Problem of Doctor Burnout – Emotionally exhausted, detached…and prone to errors.  A new study in the Archives of Internal Medicine suggests that nearly half of doctors have some sign of burnout and that emergency care and other front-line doctors are at highest risk.  As Pauline Chen suggests in the NY Times, this is particularly troubling given that we already have a doctor shortage and are about to add 30 million more people into the US health care system.

Forensic investigation needs more science – The Innocence Project has appealed to chemists to support standards and more rigorous scientific independence in forensic science.   The Project is hoping that scientists will lobby Congress in support of a proposed bill that would provide funding for forensic science research and require national standards for forensic testing.  (via Daniel Cressey in Nature)

Bias is Unavoidable – Lisa Cosgrove  in The Scientist points out that simply stating conflicts of interest is not sufficient to actually prevent bias in the scientific decision-making process.  She makes a good point that science has proven that what we expect (or what our paycheck depends upon) can affect the interpretation of scientific data and thus policy based upon that data.

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August 24, 2012 at 6:17 pm

Science Policy Around the Web – May 25, 2012

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By: Rebecca Cerio

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

Dangers of Disclosure The PLoS Medicine Editors suggest that disclosing conflicts of interest does nothing to address the problem of biased advice…and may make it worse.  The original article can be read in its entirety in PLoS Medicine.  (by Ruth Williams via The Scientist)

Large-Scale Analysis Finds Majority of Clinical Trials Don’t Provide Meaningful Evidence – The main problem with gaining “meaningfulness”?  The lack of standardization between trials.  This is a huge, costly problem that will require a lot of restructuring of the research climate and culture to fix.  (Duke University Medical Center via Medical Daily)

New Database Gives Hard Numbers on Health Care Cost – Sarah Kliff’s blog post on the Washington Post website highlights the usefulness of a new database available through the Health Care Cost Institute.  “…health insurance data is crucial to understand how health care dollars get spent….  Health insurers, however, have tended to keep that data private, as it could tip competitors off to how they handle business.  That all, however, changes today. This morning a new nonprofit called the Health Care Cost Institute will roll out a database of 5 billion health insurance claims (all stripped of the individual health plan’s identity, to address privacy concerns).”  This database could provide hard evidence to hard questions about why health care costs are increasing so rapidly.  Are costs the culprit, or is it simply usage going up?  The HCCI’s own economists have already crunched some numbers from 2010 and found increased prices have driven health care costs.

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May 25, 2012 at 12:02 pm

Science Policy Around the Web – March 29, 2012

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By: Rebecca Cerio

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

Thoughts on academic scientists giving media interviews –  David Kroll on the Take As Directed blog gives 7 great tips for how scientists can prepare for media interviews.

The APA’s response to DSM-V panel conflict of interest paper – The American Psychiatric Association has released a response to the Cosgrove and Krimsky paper examining conflicts of interest among the panel writing the next version of the “bible” of psychiatric illness diagnosis and treatment.  Their letter states that nearly three-fourths of the DSM-V panel members report no ties with industry and that their screening process for significant conflicts of interest is solid.  Others have pointed out that the conflicts of interest are more prevalent in areas where medication is a front-line treatment.  What do you think?

One-click science marketing – Martin Fenner’s commentary in Nature Materials gives a short primer on how scientists can use free web services to promote, communicate, and collaborate with both colleagues and the general public.

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March 29, 2012 at 4:51 pm