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Science Policy Around the Web – February 16, 2018

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By: Mohor Sengupta, PhD

Health Bacteria Cell Infection Microbiology Black

source: Max Pixel

Antibiotic discovery

A potentially powerful new antibiotic is discovered in dirt

Antibiotics have been in an ongoing, constant battle with the pathogens they are aimed to eliminate. Bacteria constantly mutate their genetic material to acquire resistance to anti-microbial drugs, making multi-drug resistance a global concern. Misuse or overuse of antibiotics contributes to this phenomenon. To address the issue of multi-drug resistance, a team of microbiologists at the Rockefeller University, NY, have conducted a large screen of natural products produced by soil-dwelling bacteria. According to Dr. Sean Brady, who heads the group, only a small fraction of the bacterial biodiversity is cultured in the lab and only a tiny fraction of chemicals produced by these bacteria are detectable. Identification of naturally produced chemicals by bacteria that have never been cultured in the lab provides a promising new direction towards anti-microbial therapies.

Dr. Brady’s group adopted a “culture-independent”, metagenomics approach to analyze chemicals secreted by unknown bacteria from soil samples. Their aim has not been to identify the bacteria in the samples but to look for DNA signatures associated with calcium dependent antibiotic properties. This means that the chemical they are looking for will act against bacteria only in the presence of calcium. After the identification of a gene potentially encoding a calcium dependent antibiotic, the researchers cloned it and made a laboratory grown bacteria (S. albus J1074) express it. The gene product is a new class of antibiotics that have been named “malacindin”. Dr. Brady’s research has shown that malacidins act by interfering with bacterial cell wall formation and have shown this antibiotic to be effective against a range of superbugs, including methicillin-resistant Staphylococcus aureus (MRSA). Calcium dependent antibiotics are believed to make it more difficult for the target bacteria to evolve resistance. Dr. Brady’s research was published in Nature Microbiology on February 12.

Conventional methods to isolate new antibiotics from laboratory cultured bacteria often lead to the same antibiotics being found over and over again, resulting in abandonment of such approaches in recent times. The novelty of Dr. Brady’s work lies in the use of natural sources, like soil, sewage, water etc. to isolate the genetic blueprint encoding anti-microbial chemicals, made easier with the use of metagenomics and large-scale sequencing. Researchers elsewhere are also using this approach to identify new antibiotics from natural sources. In the modern scenario of increasing deaths due to multi-drug resistance, this type of research is critical to rapid discoveries of novel antimicrobial therapies. Of course, getting the newly discovered drug into the market will not be fast, as Dr. Brady warns, yet this is an ingenious solution to discovering clinically useful antibiotics.

(Sarah Kaplan, The Washington Post)

Risk assessment

He Took a Drug to Prevent AIDS. Then He Couldn’t Get Disability Insurance

Pre-exposure prophylaxis (PrEP) is a practice of taking a drug to prevent HIV infection in persons with high risk of contracting it. In the year 2012, the F.D.A. approved Truvada, a drug originally approved for HIV treatment a decade earlier, for prevention of HIV infection (PrEP). Since then PrEP has become increasingly popular and as of 2017, an estimated 136,000 people in the United States were on PrEP. Several studies have shown that Truvada is highly effective in preventing HIV infection. However in the initial days of Truvada use,  some thought that individuals taking prophylaxis might overestimate its level of protection, leading them to engage in risky behavior they otherwise would have avoided. This belief is prevalent even today, as several insurance companies across the United States regularly deny disability and life insurance to men on PrEP on the basis that this treatment is indicative of an increased level of personal risk.

The repercussions of this policy, was exemplified when Dr. Philip J. Cheng of Brigham and Women’s Hospital at Harvard accidentally cut himself while preparing an HIV positive patient for surgery. The responsible behavior in this situation is to immediately take steps to prevent infection. Dr. Cheng did just that, by enrolling into PrEP. However, when he applied for a disability insurance, he was denied coverage because he was taking Truvada. He could not get the insurance company to cover him even after agreeing to sign a waiver of benefits in case he got infected.

Disability insurance is usually applied for by people whose livelihood depends on their income. For people like Dr. Cheng this insurance will guarantee him his lifetime of income in the case of a disability. Use of Truvada has not shown any adverse side-effects till date. In fact, it is said to be safer than aspirin, whose long term usage causes gastro-intestinal bleeding. It is a consensus among AIDS doctors across the USA that PrEP is necessary for individuals at high risk of contracting HIV. Denial of insurance to PrEP users by insurance companies has been likened to denying insurance for using car seat-belts by Dr. Robert M Grant, whose group led the clinical trial that established the importance of PrEP. Even more perplexing is the fact that life insurance companies are regularly providing insurance to people with other conditions that are managed by regular medications, like diabetes and heart diseases. Even former alcoholics who are now un-addicted are not denied.

Mr. Bennet Klein, a lawyer with Boston based GLAD, an organization of legal advocates and defenders of GLBTQ community has asked several insurance companies the reason for denying insurance to men on PrEP. In most interviews with various insurance companies he and others have heard a range of answers, some ambiguous. The general understanding is that insurance companies are increasingly following this trend because they suspect potential high-risk behavior in PrEP users. The crux here is that regardless of risky sexual behavior, PrEP is highly protective. A prominent work of research published in The New England Journal of Medicine in 2010 showed that tenofovir, one of the chief components of Truvada reduced the risk of HIV infection by 95 percent. The famous HPTN 052 clinical trial of 2011 also showed the efficacy of PrEP.

Because of the prevalence of insurance denials, several people, like Dr. Cheng have stopped using PrEP. It is critical that this trend is reversed, in the light of clear benefits of taking PrEP. While there are insurance companies that do provide disability and life insurance to PrEP users, cases like Dr. Cheng’s result in disappointment and eventual withdrawal from using PrEP.

(Donald G. McNeal Jr, The New York Times)Have an interesting science policy link?  Share it in the comments!

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February 16, 2018 at 4:58 pm

Science Policy Around the Web – February 13, 2018

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By: Saurav Seshadri, PhD

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source: pixabay

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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source: pixabay

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

Science Policy Around the Web – February 6, 2018

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By: Liuya Tang, PhD

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source: pixabay

Cancer treatment

Breast cancer treatments can raise risk of heart disease, American Heart Association warns

Common cancer treatments include surgery, chemotherapy and radiation therapy. Chemotherapy and radiation therapy are always applied before or after surgical removal of a tumor, or applied to cancer patients when surgery cannot be performed. Not only will they attack tumor cells, chemotherapy or radiation therapy will also damage normal cells at the same time, which increases risks for other diseases. A recent report in the journal Circulation said that breast cancer treatments can raise risk of heart disease. It has been noticed that “breast cancer survivors who are 65 and older and were treated for their cancer are more likely to die of cardiovascular problems than breast cancer.” The possible cardiovascular consequences of breast cancer treatments may not be new to oncologists, but new cancer treatments have complex side effects which may not fully understood as they work differently from conventional cancer treatments. For example, the newly-developed cancer treatment, immunotherapy, stimulates the patient’s immune system to attack tumors, but sometimes the surging immune response can overshoot its target and attack healthy tissues and organs.

It is not a good idea to stop cancer treatment due to side effects, as saving ones life from a dangerous cancer is critical. But for this double-edged sword, how to make one edge blunt while keeping the other edge sharp? This requires surgeons and oncologists to work together to make a personalized treatment plan. As suggested by Dr. Deanna Attai, a breast surgeon at the University of California at Los Angeles, the patients with less-aggressive tumor may skip chemotherapy based on the test results on the cancer’s risk of recurrence. In addition, adopting different ways to deliver chemo drugs and developing more-targeted radiation can reduce the risks of cardiac damage for breast cancer patients.

It is not solely a doctor’s responsibility to monitor the side effects of cancer treatments, patients also need to be aware of what types of treatments and what the possible side effects are. Wrong treatments of side effects can aggravate symptoms, which may lead to severe problems. The new emerging immunotherapy presents a big challenge to the health care system as the side effects are not thoroughly understood. Doctors’ organizations and nonprofit groups are joining information campaigns to narrow the knowledge gap on immunotherapy, which will help patients better understand procedures of cancer treatment and manage any side effect if it occurs.

(Laurie McGinley, The Washington Post)

 

Drug development

Racing to replace opioids, biopharma is betting on pain drugs with a checkered past

The opioid epidemic has become a significant problem in the US, as 116 people died every day from opioid-related drug overdoses in 2016. To resolve this issue, biopharma continues to develop pain drugs. The class of drugs are called NGF inhibitors, which were halted by FDA in 2010 due to their severe side effects. NGF is short for nerve growth factor, which is a neuropeptide. When an injury occurs, the production of NGF is increased, which helps the brain perceive the pain. Theoretically antibodies that specifically bind NGF before it reaches cell receptors could be a good choice to inhibit NGF function, therefore treating people with chronic pain. But it was found that NGF antibodies are not suitable for a subset of patients with osteoarthritis, for whom treatment lead to dramatic joint deterioration. To obtain FDA’s approval of entering further clinical trials, drug companies showed that NGF drugs will probably be safe for patients not at risk of joint deterioration and shouldn’t be taken with nonsteroidal anti-inflammatory drugs such as Advil. So the clinical study was resumed in 2015. Will it become a replacement drug of opioids? Will the benefits outweigh its risks? The results will be put on table this year after drug companies finish their Phase 3 studies.

 

The severity of the opioid epidemic and the high need of non-addictive painkillers have kept drug companies optimistic about developing NGF drugs despite the side effects. However, there are opposite voices. The watchdog group Public Citizen criticized that the side effects are obvious and “further pursuit of testing in humans was an unreasonable course of action”. Criticisms also come from the business side. Leerink analyst Geoffrey Porges has warned Regeneron’s NGF drug would carry “all of the liabilities” of the past and scolded their continuing to pour money into the project. The failure has already been seen in the development of fulranumab, which is one type of NGF antibody. Even if NGF antibodies were approved by FDA, doctors would have concerns for prescribing a medication with potentially dangerous outcomes for patients with certain conditions.

(Damian Garde, STAT News)

 

 

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February 6, 2018 at 10:53 pm

Science Policy Around the Web – February 2, 2018

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By: Michael Tennekoon, PhD

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source: pixabay

Bias in research

Gender bias goes away when grant reviewers focus on the science

Increased scrutiny has been given to the knowledge that there is a lack of senior female faculty in science. Many reasons have been postulated for this, including a lack of appropriate mentoring, a lack of adequate support when balancing family needs, and a general bias in the field. Highlighting the possible impact of bias, a new study from Canada shows that women are rated less favorably than men when reviewers assess the researcher as compared to when reviewers assess the research proposed on a grant application.

To address the issue of gender bias, the Canadian Institutes of Health Research (CIHR) phased out traditional grant programs that focused on both the science and the investigator. Instead, they ran two parallel programs, in which one focused primarily on the applicant’s credentials and the other focused on the science proposed. In addition, reviewers were trained to recognize unconscious biases that may impact the impartiality of their review decisions.

When grant reviewers focused on the quality of the applicant, the success rate for male applications was 4% higher than for female applicants. When grant reviewers instead focused on the quality of the science that was proposed, this gap reduced significantly to 0.9%, a level similar to traditional grant funding programs.

Furthermore, the impact of training reviewers on unconscious bias was of particular interest. Previous work suggested this type of training could exacerbate the situation, however, in this case, training appeared to help the situation by reducing the gap in successful applications between genders. The authors of the current study are planning to further explore the intricacies of how the training could be neutralizing some of the unconscious bias.

While a strength of this study was that it accounted for applicant’s research areas and age, this study was not randomized, which could have impacted the results. For example, there could have been a sample bias based on who chose to apply for the grants, which could have resulted in differences between male and female applicants in various aspects of their applications (such as publication records).

Is this gender bias prevalent in the United States as well?

Somewhat encouragingly, research has shown that males and females are funded at equivalent rates early in their careers by the NIH. Of graver concern, however, is that the research also showed that the number of women who apply for funding drops dramatically as their careers progress. As funding success rates do not appear to contribute to this, other factors, such as a lack of senior role models and mentors, or inadequate support for women that wish to have children and continue working in research, may contribute to the drop in female faculty in research. It is also important to note that biases are not limited to gender, but also exist with race. A 2011 study showed that white researchers are funded at nearly twice the rate of African American researchers despite similar publication and training records. While approaches such as those used by CIHR may help increase representation in senior faculty positions, solutions that tackle systemic biases may be needed to address the full scope of the problem.

(Giorgia Guglielmi, Nature News)

Influence of Social Media

Google’s new ad reckons with the dark side of Silicon Valley’s innovations

Studies have shown a rise in the number of teen suicides and self harm in recent years. There is growing concern that an increase in the amount of time spent on social media is playing a role in increasing the rates of teen suicide. Conscientious of this, Google recently debuted a new advertisement to highlight mental health implications of social media and other modern technology. The advertisement starts off by showing pictures of people sharing happy moments and pictures. However, the advert then pivots to suggest that not everything is as it seems in the perfect pictures, as all the people involved had sought support through the national suicide prevention number at one point in time.

Recent research has raised questions about the effects of social media, in particular with the ‘pressure of perfection’ and the impact it can have on social media users. Specifically, the research shows that users who passively scroll through news feeds could be most susceptible to feelings of unhappiness. In addition to this effect, technology companies are under fire for helping to spread offensive material. A recent pertinent example of this was when Logan Paul documented on YouTube how he discovered a dead body in a Japanese forest known for suicides. Furthermore, after Netflix aired ‘13 reasons why’, a documentary centered on a teen’s suicide, googles searches for suicide methods spiked. Alarmingly it has been documented that searches about suicide are linked to individuals committing suicide.

Large technology companies such as Facebook, Apple, Google and others are making efforts to try to rectify the situation. Facebook has begun using artificial intelligence to recognize suicidal thoughts and connect affected individuals with first responders. However, the capability of these companies to effectively prevent suicides is limited by the essence of what these companies are designed to be. For example, while a Google search asking how to commit suicide will display resources to suicide prevention resources and hotline numbers to the user, the search will also bring up pages detailing the “right way” to commit suicide along with would be instructional videos on YouTube. Clearly these companies still have much work to do when it comes to reducing teen suicide rates.

(Drew Harwell, The Washington Post)

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February 2, 2018 at 1:11 pm

Science Policy Around the Web – January 30, 2018

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By: Kelly Tomins, BSc

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By RedCoat (Own work) [CC-BY-SA-2.5], via Wikimedia Commons

Cloning

Yes, They’ve Cloned Monkeys in China. That Doesn’t Mean You’re Next.

Primates were cloned for the first time with the births of two monkeys, Zhong Zhong and Hua Hua, at the Chinese Academy of Sciences in Shanghai. Despite being born from two separate mothers weeks apart, the two monkeys share the exact same DNA. They were cloned from cells of a single fetus, using a method called Somatic Cell Nuclear Transfer (SCNT), the same method used to clone over 20 other animal species, beginning with the now infamous sheep, Dolly.

The recently published study has excited scientists around the world, demonstrating the potential expanded use of primates in biomedical research. The impact of cloned monkeys could be tremendous, providing scientists a model more like humans to understand genetic disorders. Gene editing of the monkey embryos was also possible, indicating scientists could alter genes suspected to cause certain genetic disorders. These monkeys could then be used a model to understand the disease pathology and test innovative treatments, eliminating the differences that can arise from even the smallest natural genetic variation that exists between the individuals of the same species.

Despite the excitement over the first cloning of a primate, there is much work to be done before this technique could broadly impact research. The efficiency of the procedure was limited, with only 2 live births resulting from 149 early embryos created by the lab. In addition, the lab could only produce clones from fetal cells. Now it is still not possible to clone a primate after birth. In addition, the future of primate research is uncertain in the United States. Research regarding the sociality, intelligence, and DNA similarity of primates to humans has raised ethical concerns regarding their use in research. The US has banned the use of chimpanzees in research, and the NIH is currently in the process of retiring all of its’ chimps to sanctuaries. In addition, there are concerns regarding the proper treatment of many primates in research studies. The FDA recently ended a nicotine study and had to create a new council to oversee animal research after four squirrel monkeys died under suspicious circumstances. With further optimization, it will be fascinating to see if this primate cloning method will expand the otherwise waning use of primate research in the United States.

The successful cloning of a primate has additionally increased ethical concerns over the possibility of cloning humans. In addition to the many safety concerns, several bioethicists agree that human cloning would demean a human’s identity and should not be attempted. Either way, Dr. Shoukrat Mitalipov, director of the Center for Embryonic Cell and Gene Therapy at the Oregon Health & Science University stated that the methods used in this paper would likely not work on humans anyways.

(Gina Kolata, New York Times)

Air Pollution

EPA ends clean air policy opposed by fossil fuel interests

The EPA is ending the “once-in always-in” policy, which regulated how emissions standards differ between various sources of hazardous pollutants. This policy regards section 112 of the Clean Air Act, which regards regulation of sources of air pollutants such as benzene, hexane, and DDE. “Major sources” of pollutants are defined as those that have the potential to emit 10 tons per year of one pollutant or 25 tons of a combination of air pollutants. “Area Sources” are stationary sources of air pollutants that are not major sources. Under the policy, once a source is classified as a major source, it is permanently subject to stricter pollutant control standards, even if emitted pollutants fall below the threshold. This policy was intended to ensure that reductions in emissions continue over time.

The change in policy means that major sources of pollution that dip below the emissions threshold will be reclassified as an area source, and thus be held to lower air safety standards. Fossil fuel companies have petitioned for this change for years, and the recent policy change is being lauded by Republicans and states with high gas and coal production. The EPA news release states that the outdated policy disincentives companies from voluntarily reducing emissions, since they will be held accountable to major source standards regardless of the amount of emissions. Bill Wehrum, a former lawyer representing fossil fuel companies and current Assistant Administrator of EPA’s Office of Air and Radiation, stated reversing this policy “will reduce regulatory burden for industries and the states”. In contrast, environmentalists believe this change will drastically increase the amount of pollution plants will expel due to the softening of standards once they reach a certain threshold. As long as sources remain just below the major source threshold, there will be no incentive or regulations for them to lower pollutant emissions.

(Michael Biesecker, Associated Press)

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January 30, 2018 at 3:30 pm

Science Policy Around the Web – January 26, 2018

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By: Jennifer Patterson-West, Ph.D.

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source: pixabay

Drug Pricing

At $850,000, price for new childhood blindness gene therapy four times too high, analysis says

Advances in medicine have greatly shifted the prognosis of many diseases. Heart disease is still the leading cause of death in the United States, nevertheless, deaths due to cardiovascular disease have declined by over 50% since the 1950s. This sharp decline correlates with the introduction of the first beta blocker in 1964, which could effectively lower high blood pressure. Diseases, such as childhood leukemia, AIDS, and hepatitis C, that were once considered a death sentence are now being treated.

However, these advances come at a cost.  In 2014, the Tufts Center for the Study of Drug Development (CSDD) released a report estimating the cost to develop a new drug to be $2.5 billion. With the high cost of drug development, it is not surprising that drug prices are soaring in all sectors. Pharmaceutical price hikes have sparked significant controversy due to the financial stress they put on patients. Last year, Mylan Pharmaceuticals increased the cost of an EpiPen by 500% fueling the debate on instituting government control on drug pricing in the U.S. The pricing of a new gene therapy for blindness at $850,000  has once again sparked this debate.

Advocates of price control point to Europe, where drug pricing is already bureaucratically controlled. In Europe and elsewhere, many drugs are available at a fraction of the cost. Prices in these countries have been significantly reduced by the implementation of external price referencing (EPR). In this system, Drugs are categorized into classes based on therapeutic effect and a reference point is set for each drug class.  This system follows the logic that manufacturers have considerable pressure to minimize cost when there are good alternatives.

Opponents of price control underscore a widening gap in the innovation of new drugs between the United states and Japan and Germany, where drug price controls have been enacted over the past few decades. It has been proposed that price control inadvertently limits the funds pharmaceutical companies direct to research and development. Pharmaceutical development comes with a high risk for investors, therefore, without the incentive of high profits, it is speculated that investors would move to other sectors of industry, such as high technology. Despite these odds, investment into research and development by the global pharmaceutical industry is only second to the tech industry.

(Andrew Joseph, STAT News)

Ethics

When A Tattoo Means Life Or Death. Literally

In the United States, an advanced directive or living will is the standard way that individuals inform medical professionals of the treatments they would like to receive if they are dying or permanently unconscious. These forms can provide instructions regarding the use of machines to maintain life, feeding tubes, and intravenous fluids, “do not resuscitate” (DNR) orders, as well as organ and tissue donation preferences. Do not resuscitate (D.N.R.) means that doctors will not intervene with CPR or advanced cardiac life support (ACLS) if a patient stops breathing or their heart stops. Nevertheless, under this advisement, patients will continue to receive palliative care to mitigate pain or other physical symptoms.

These legal documents give patients control over their health care when serious illness may impair their judgement or overwhelm their ability to make a decision.  Although, if a patient arrives at a hospital unconscious or alone these directives may not be communicated to the medical staff. For this reason, individuals have taken to wearing their medical preferences on their body predominately in the form of a bracelet or necklace.

A recent case study reported an instance where a 70-year-old man arrived at the University of Miami hospital unconscious without an advance directive on file. The patient had a tattoo stating “do not resuscitate” with his signature across his chest. The tattoo gave doctors pause regarding how to proceed when the patient stopped breathing. Their initial reaction was to disregard the tattoo and provide necessary care since the alternative was an irreversible path. The legal recognition of the tattoo’s directive was uncertain. After reviewing the patient’s case, Dr. Kenneth Goodman, an expert medical ethicist advised the medical staff to honor the tattoo. Fortuitously, this decision was subsequently supported by a D.N.R. on file with the Florida Department of Health.

In contrast, a separate case study reported a patient with a D.N.R. tattoo that specified that it did not reflect his current preference for end-of-life care. These two cases left doctors uncertain about how to respond in future cases and emphasized the need for a central database containing advanced directives that is accessible to medical professionals.

Some states have established electronic databases for advanced directives. These states include New York, Oregon, Utah, West Virginia, and California. Residents of other states are recommended to file their living will at a private registry, such as the U.S. living will registry. In all cases, the usefulness of these registries is limited by a hospital or doctor’s use of the service.  With decentralized registries, it is inefficient for medical staff to search for a patient’s living will, especially when rapid response is necessary.  For this reason, many hospitals rely on an internal system containing patient records. A careful discussion of standard practices for obtaining documentation or recognizing physical identification of D.N.R. needs to be established among the American Medical Association so that medical staff can rapidly respond to a patient’s medical needs and wishes.

(Rebecca Hersher, NPR)

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Written by sciencepolicyforall

January 26, 2018 at 5:23 pm