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Science Policy Around the Web – August 28, 2015

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By: Sylvina Raver, Ph.D.

Photo source: pixabay.com

Drug Policy

FDA approves drug for female libido amid controversy and lingering questions

On August 18, the FDA approved the drug flibanserin to treat female sexual dysfunction. Flibanserin, which will be sold under the brand name Addyi, has been billed as “female Viagra” and as a remedy for Female Sexual Interest/Arousal Disorder. With its recent approval, flibanserin becomes the first drug approved to specifically address female sexual problems, compared to the 26 pharmaceuticals approved for this purpose in men. Indeed, highlighting this stark gender inequality in treatment options was instrumental in the drug’s FDA approval. Sprout Pharmaceuticals, Addyi’s manufacturer, joined with non-profit and health care organizations in 2013 to form Even The Score, an advocacy organization that waged a hugely successful lobbing campaign to seek FDA approval of flibanserin by framing its approval as one “women’s sexual health equality.” Critics say that an accusation that the FDA is biased against women, championed by Even The Score, had greater influence on the drug’s approval than did data on the compound’s efficacy and safety. Addyi was found to have an effectiveness rate of between 8 and 13 percent, and led to side effects ranging from dizziness to sudden drops in blood pressure that were exacerbated by alcohol or hormonal contraception. Flibanserin will carry a warning that it can not be taken with alcohol, despite the odd fact that the alcohol safety study submitted to the FDA by Sprout Pharmaceuticals listed 23 of the 25 participants as men. This has led to lingering questions about how women – the intended users of the drug – would react to a flibanserin alcohol interaction, particularly because, unlike Viagra, Addyi is taken daily rather than just before a sexual encounter. The mild effectiveness of flibanserin, combined with concerns about its safety, resulted in two prior rejections of FDA approval prior to the third successful attempt. Addyi comes to market in October 2015. (Cari Romm, The Atlantic; Editorial, Nature)

Health Policy

A universal flu vaccine may soon be a reality

Every fall, millions of people are vaccinated against the flu with vaccines that are developed by scientists who predict which influenza strains are most likely to be problematic that particular year. New shots are required every year because there are thousands of influenza strains that constantly mutate, and one shot cannot protect against them all. Sometimes, the predictions are correct; sometimes, like in 2014, they miss the mark and tens of thousands of US citizens die from influenza. Furthermore, because flu vaccines are currently based on portions of the influenza virus that evolve throughout the flu season, protection is not guaranteed. Two independent groups of scientists have recently reported considerable progress towards a universal flu vaccine by using a novel approach. Both labs targeted hemagglutin, a protein found on the surface of the H1N1 influenza virus, that is composed of a head region that mutates and varies between different flu strains, and a stem region that is constant between different strains and does not mutate.

The two reports – published in Nature Medicine and Science on Wednesday, August 26 – employed different molecular engineering techniques to stabilize the stem portion of hemagglutin when it is isolated from the head region, thus producing a stable structure for the vaccine that is common between different strains. This new method resulted in almost 100% immunity in mice against the lethal H5N1 flu strain, which is distantly related to the H1N1 strain, and partial protection in ferrets and non-human primates. More research is needed to determine whether immunity extends to other strains of the influenza virus, as well as to determine the degree of protection in humans using a vaccine derived with these new approaches. (Hanae Armitage, Science; The Economist)

Public Health and Drug Control Policy

Illicit Version of Painkiller Fentanyl Makes Heroin Deadlier

An extremely potent opioid analgesic called fentanyl, often administered prior to surgical procedures or prescribed for severe cancer-related pain, is increasingly being added to heroin and causing deadly consequences for heroin users across the United States and Canada. Fentanyl is 30-50 times more potent than heroin, and nearly 80-100 times more potent than morphine, and results in a drug combination that is much stronger than what heroin users expect to be administering. The flood of fentanyl-laced heroin is exacerbating the ongoing epidemic of heroin-related overdose deaths, as authorities in some states report a more than 600% increase in fentanyl-related deaths from 2013 to 2014, and see no sign of a slowdown. Drug dealers are increasingly adding fentanyl to heroin in order to restore the potency of the drug that’s been previously diluted by those higher in the distribution chain. Law enforcement officials and policymakers are scrambling to keep pace with the problem. In the past two years, Mexican drug cartels have increased production of a synthetic form of the compound, acetyl fentanyl, that is not yet included in many screens for toxic drugs in the US, and is currently classified as a banned substance in only a few states. Last year the US DEA added acetyl fentanyl to its list of federally banned substances, and in March 2015 the agency issued a warning that fentanyl poses a “threat to health and public safety.” Drug enforcement and public health authorities are attempting to boost public awareness of the dangers of fentanyl-laced heroin, and are alerting local communities when a compound drug batch is detected. (Fred Bever, NPR; Nadia Whitehead, NPR)

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August 28, 2015 at 9:00 am

Science Policy Around the Web – February 10, 2015

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By: Agila Somasundaram, Ph.D.

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Precision Medicine

The Problem with Precision Medicine

President Obama unveiled the Precision Medicine Initiative last week. Precision medicine, i.e. personalized, genetics-based medical treatments, would deliver “the right treatments at the right time, every time, to the right person.” But is the science ready for it? DNA testing is increasingly used to detect and treat various diseases, including cancer and birth defects, and the cost of genetic analyses has dropped significantly. But many doctors are not qualified enough to correctly interpret the data, make the right connections between DNA and disease, and successfully communicate it to their patients. Incorrect diagnoses based on genetic data are common. Children have been mistakenly diagnosed with serious syndromes. Sometimes mistakes can cause greater harm than just increasing anxiety of patients or their loved ones. In 2012, The Cancer Journal described the case of a woman who underwent major surgery because her genetic-test results were not interpreted correctly. There is a paucity of genetic expertise among physicians, partly because most of the currently practicing physicians went to medical school before the human genome was sequenced, when only a handful of genes had been identified/associated with diseases. “It’s very complicated, especially for generalists, who have a million other things on their minds besides genetics,” says Mary Norton, a clinical geneticist at the University of California, San Francisco. Doctors could seek help from specialists, but there is a dearth of trained medical geneticists, so doctors end up receiving instructions from companies that are pushing their products without adequate proof of their efficacy. A survey published in the journal Genetics in Medicine reported that a majority of the participants do not fully understand genetic test results or devote sufficient time to discuss outcomes with patients. MedSeq, launched by Robert Green, a medical geneticist at Brigham and Women’s Hospital and Harvard Medical School, is an example of an initiative that educates physicians about genetic testing. Martin Solomon, a MedSeq participant and a physician at Brigham and Women’s, says genetics is simply a new tool with a learning curve, like the electrocardiogram. But Mary Norton does not think that it is that simple. Given the pace of genetics research, the variability of test methods and results, and the companies’ marketing strategies, she says that though “over time everyone will come to have a better understanding of genetics… It will probably be a bit worse before it gets better.” (Cynthia Graber, The New Yorker)

 

Vaccines

Psychological Biases Play A Part In Vaccination Decisions

Why do some people choose not to vaccinate their children? The recent outbreak of measles in the US has triggered discussions around this topic. Misinformation is one reason – people’s belief that there is a link between vaccines and autism. But what might be the psychological biases that contribute to parents not willing to ‘intervene’ on their kids? Omission bias might be playing a role here, where parents judge vaccination (an action) as more harmful to their kids than failing to vaccinate (an omission) even if the risks associated with vaccination are lower than that from not vaccinating their children. People also exhibit this omission bias to varying degrees. A study published in the journal Medical Decision Making in 1994 showed that parents who objected to vaccinating their kids were more likely to think that vaccinating was more dangerous than not vaccinating their kids. Participants were asked if they would vaccinate their child under 3, in a hypothetical situation, if 10 out of 10,000 kids not vaccinated will die from the flu, while vaccination could have a fatal side effect on 5 out of 10,000 children. If a straight assessment of risk is done, parents should have opted to vaccinate their kids. But the study showed that parents who did not believe in vaccination had a lower mean ‘tolerable risk’ than parents who did not object to the vaccine. In other words, they would vaccinate their children only if the hypothetical vaccine had a risk of 2.4 deaths per 10,000 (even though the risk from the flu itself is 10 in 10,000), while the parents who were not opposed to vaccinating their kids had a mean tolerable risk of 5.4 deaths per 10,000. To vaccinate their children, both sets of parents needed a higher risk from the disease than from the vaccine itself, but the gap was greater for the non-vaccinators. One reason could be that the non-vaccinators did not wish to ‘intervene with nature.’ Another reason could be causal responsibility for a death resulting from an action (vaccination) versus an omission (failure to vaccinate). And lastly, a related reason could be anticipated regret – parents who feel they would be causally responsible for negative consequences of vaccination also anticipate feeling greater regret about having vaccinated their children if something went wrong. But how do we define ‘act’ and ‘omission’? The author concludes that merely educating people about the benefits of vaccinations maybe insufficient to change peoples’ attitudes. However, in a society where vaccination is the norm, and not vaccinating the exemption, interpreting failure to vaccinate as the deliberate ‘act’ could have some positive effects. (Tania Lombrozo, Psychology professor at the University of California, Berkeley, NPR)

 

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February 10, 2015 at 11:12 am

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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 29, 2013

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By: Jennifer Plank

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photo credit: Teseum via photopin cc

Measles outbreak tied to Texas megachurch sickens 21 – A visitor to the Eagle Mountain International Church that previously traveled to Indonesia and became infected with measles, has spread the infection to the largely unvaccinated congregation. To date, 16 people in Tarrant County, including a 4 month old infant, and 5 people in Denton County have contracted the illness and the number is expected to increase. All of the individuals infected have been linked to the church. As many as 1,000 people may have been exposed to the disease. Due to the outbreak, the church will be holding vaccination clinics for uninfected individuals. (JoNel Aleccia)

Government must step in to halt Fukushima leaks – A leak at the Fukushima Daiichi plant has resulted in the spillage of hundreds of tons of radioactive water, and experts believe the power company overseeing the plant is unable to cope with the leak. Therefore, many are calling on the Japanese government to intervene. Initially, the leak was labeled a Level 1 incident, but as of this week, it has been upgraded to Level 3. Several countries have offered to help Japan deal with the leak. (Quirin Schiermeier and Jay Alabaster)

Free papers have reached a tipping point, study claims – A study funded by the European Commission demonstrates that 50% of all scientific papers published are freely available after 1-2 years from publication, and the number is set to increase. US agencies funding scientific research and the European Commission are proposing plans for papers to be open access within 12 and 6 months, respectively. (Jocelyn Kaiser)

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August 29, 2013 at 10:43 am

Science Policy Around the Web – Aug 2, 2013

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By: Jennifer Plank

photo credit: Army Medicine via photopin cc

photo credit: Army Medicine via photopin cc

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

The Pertussis Paradox – As the number of incidences of pertussis (whooping cough) neared 50,000, scientists were forced to evaluate the efficacy of the newer pertussis vaccine. A new, safer pertussis vaccine was introduced in 1990. The newer vaccine, called DTaP (Diphtheria, Tetanus, acellular Pertussis), had fewer adverse side effects than the older DTP (Diphtheria, Tetanus, Pertussis) vaccine that was introduced in the 1940s. Possible side effects of the DTP vaccine included high fevers and seizures. After following the efficacy of the DTaP vaccine for several years, it became clear that while DTaP caused fewer adverse effects, the immune-protection is not as long lasting. Initially, the DTaP vaccine creates an immune response that is similar to that of the DTP vaccine, however, over time the immune-protection declines with the DTaP vaccine. In fact, children who received 1 dose of DTP were twice as likely to be protected during a whooping cough outbreak than children who received 5 DTaP vaccines during infancy. Today, efforts to determine the cause of the declining immune-protection in DTaP and methods for making the DTP vaccine safer are underway. (Arthur Allen, subscription required)

Astrophysicist tapped to lead NSF – Earlier this week, President Obama nominated astrophysicist France Cordova to head the National Science Foundation. If her nomination is confirmed by the Senate, Dr. Cordova will be only the second woman to lead the agency. Cordova, who is a former Purdue University administrator and NASA chief scientist, currently serves as the chairwoman for for the governing board of the Smithsonian Institution. Interestingly, Cordova’s career didn’t start with science; she earned her bachelors in English from Stanford University. (Lauren Morello)

Experts warn of dangers of over diagnosis and treatment of cancer –  A panel advising the National Cancer Institute has recommended that the word “cancer” be selectively used in diagnoses to prevent patients from panicking and seeking unnecessary, extreme treatments. The committee recommended using the word “cancer” only when lesions have a “reasonable likelihood of lethal progression if untreated.” For example, some women have localized lesions that look like cancers but are not lethal, and these women are unnecessarily treated with radiation therapy or mastectomies despite the fact that the lesions will never harm them. While preventative care is not necessary in some cases, removal of non-cancerous lesions in the colon or on the cervix has reduced the incidence of cancer. (Lenny Bernstein)

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August 2, 2013 at 10:26 pm

Science Policy Around the Web – June 11, 2013

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pills and money

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By: Katherine Donigan

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

An Experimental Drug’s Bitter End– Clinical trials for a promising drug that could ease the behavioral symptoms Fragile X syndrome and autism were recently halted, after failing to meet goals for both syndromes.  Despite failing in trials, some patients saw improvements, including reduced social withdrawal and the ability to express emotions or verbalize for the first time.  Drug developer Seaside Therapeutics has indicated that they can no longer afford to produce the drug for the select group of responsive patients and will be halting production.  This incident raises a few important questions about clinical trials.  How should results be assessed for drug trials targeting disorders characterized by a diverse spectrum of neurological symptoms?  What is the responsibility of the drug developer to the responsive trial participants when a drug has failed trials? Parents have organized to petition Congress and increase awareness through social media in pursuit of a new funding source to continue the trial.  (NYTimes, Andrew Pollack)

Michael Douglas HPV Comment Highlights Rise in Cancers, as Few Boys Vaccinated– Actor Michael Douglas made headline news when he revealed that his case of oral cancer could have been linked to HPV infection.  Oral cancer incidence has been on the rise in the US, increasing over 200% from 1998 to 2004.  The majority of oral cancers are thought to be caused by HPV, with about 3000 new cases being diagnosed in the US every year.  Compared to women, men are four times as likely to develop this type of cancer.  Only 2% of boys in the US have received the HPV vaccine, which protects against several common cancer-causing strains of the virus. HPV vaccination rates of US girls now top 50%, accompanied by a decline in cervical cancer rates.   Ideally, increased public awareness about HPV-related cancers in men will lead to a similar result. (ABC News, Susan Donaldson James)

Few children get hepatitis A in frozen berry outbreak– Since late April, a nationwide outbreak of food-borne Hepatitis A has affected 79 people, but only one of them was a child.  Health officials are attributing this to routine HepA  childhood vaccines that were recommended by the CDC starting in 2006.  The single child who fell ill had not received the vaccine.  Since the vaccine became available in 1996, the US has seen a dramatic drop in infection rates – from over 31,000 in 1995 to just over 1600 in 2010.  Hepatitis A is highly contagious and can result in liver failure, making it all the more critical that young children who are able to do so receive their vaccinations.  (USAToday, Elizabeth Weise)

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June 11, 2013 at 5:59 pm

Legislating health care: balancing between vaccine mandates and personal freedoms

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syringe

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By: Jessica Lamb

To establish my perspective, let me begin by stating that I believe unequivocally everyone who can be vaccinated should be.  I think boys should be vaccinated against HPV [i], and everyone should get a yearly flu shot.  For a long time I was on the fence – I certainly wanted to get vaccines against diseases like measles for myself and my family, but I was undecided regarding whether I should bother to get the flu shot if I am currently healthy.  Should I worry if others don’t want to get their shots?  I approached this issue purely in terms of individual protection – how likely am I to benefit from my decision? Read the rest of this entry »

Written by sciencepolicyforall

June 6, 2013 at 3:28 pm

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