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Science Policy Around the Web – June 18th, 2019

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By Allison Dennis, B.S.

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Congress is debating-again-whether genes can be patented

The last time the U.S. government issued an official guidance on human gene patenting, it was from the Judicial Branch in 2013. By a unanimous decision, the Supreme Court ruled that two genes whose DNA sequence can be used to predict the probability of a patient developing breast or ovarian cancer, BRCA1 and BRCA2, could not be patented. Companies are still free to pursue patents manipulating or mitigating the effects of specific genes, but the ruling invalidated the patents held by Myriad Genetics for these two genes and opened the door for clinical labs to begin widely testing patient samples for mutations across a wide variety of disease predicting genes that might have otherwise been patented.

Insurance claims filed in 2004 indicate that only one in four women received a BRCA mutation test before being diagnosed with cancer. By 2014, more than 60% of these tests were administered diagnostically, allowing women confirmed to be at risk to pursue prevention and early detection of breast and ovarian cancer before developing either. The effect of the 2013 Supreme Court ruling to dramatically reduce testing costs in combination with technological developments and public health awareness have been attributed to this shift.

Now lawmakers in the legislative branch are weighing in. Senators Thom Tills and Chris Coons filed a bipartisan draft bill that would expand the types of inventions eligible for a U.S. patent to include previously restricted subject matter falling under “abstract ideas,” “laws or nature,” or “natural phenomenon,” which could be interpreted to include human genes. While Tillis has since made clear that it was “was never the intent” to again give companies ownership over single human genes, the changes could allow companies to limit examination of specific genetic variants like those most likely to cause disease. Supporters of the bill feel it is necessary to provide companies with sufficient intellectual property to incentivize their research into isolated natural products. Many point to less-restrictive patent codes abroad, which they feel put the U.S. at a disadvantage.  

Following two weeks of Congressional hearings, and a letter signed by 170 scientific organizations, nine nobel prize winners along with 74 leading physicians and scientists have weighed in by urging lawmakers to more carefully consider the proposed changes. The level of concern or eagerness expressed for the bill seems largely up to the interpretation of the reader, suggesting that much more work is needed for the bill to achieve its stated goal of reducing frustration and confusion generated by the Supreme Court rulings.

(Megan Molteni, Wired Magazine)

Federal Grants Restricted To Fighting Opioids Miss The Mark, States Say

Of the 70,237 drug overdose deaths captured by the CDC in 2017, nearly a third involved cocaine, psychostimulants, which include MDMA and methamphetamine, or both. The CDC cites “changes in the drug supply, mixing of substances with or without the user’s knowledge, and polysubstance use” as emerging threats. Yet the opioid-focused way grant money is allocated may be restricting the ability of states to adapt.

At the frontlines of the opioid epidemic are state officials dedicated to making the most of federal grants designed to offer struggling states a financial lifeline. For example in 2017, Arizona used funds from a State Targeted Response grant to train 9,197 individuals in Naloxone usage and purchase 8,798 Naloxone kits, allowing first responders to perform 5,649 overdose reversals. Many states are using the money to implement the hub-and-spoke model, first developed and demonstrated to be effective by Vermont, in which intensive addiction treatment is offered at a limited number of hubs connected by a local network of outpatient addiction programs and primary care physicians. Through this structure, the hub-and-spoke model can make at least one licensed mental health or addiction counselor accessible per 100 patients.

While the framework provided by the hub-and-spoke model may intuitively help address addiction beyond the specific use of opioids, they rely on Medication Assisted Treatment, an intervention that has only been approved for opioid addiction. Similarly the use of Novaxalone is only effective in reversing opioid overdoses, in the case of cocaine overdose it is ineffective. Additional research is underway to develop parallel treatments for other substances, but these efforts have been eclipsed by the national focus on opioids.  

In 2017, opioids accounted for less than half of the overdoses suffered in eleven states, including Pennsylvania, Texas, and California. This may point to the effectiveness in opioid specific treatment, but it also the persistent dangers of drug-use. Currently, the funding opportunities are insufficient to address the gaps in the mental health system needed to more completely help patients living with addiction. The pathways leading to drug-abuse, no matter the current drug of choice, may provide a common point of intervention resilient against the so called “emerging threats” of substance abuse.

However, similar to the shift seen as users transitioned from OxyContin to Heroin, public health fear that the next shift will turn to drugs not classified as opiods and therefore ineligible to be combated with the funds. In 2017, eleven states

(Carmen Heredia Rodriguez, Elizabeth Lucos, and Orion Donovan-Smith, Kaiser Health News)

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June 18, 2019 at 5:22 pm

Science Policy Around the Web – July 26, 2016

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By: Ian McWilliams, Ph.D.

photo credit: Newport Geographic via photopin cc

Infectious Diseases

Research charities help marry two major South African HIV/TB institutes

Two institutes, the Wellcome Trust and the Howard Hughes Medical Institute (HHMI), have announced that they are joining efforts in to fund the fight against HIV and Tuberculosis (TB) in South Africa. South Africa has the largest population infected with HIV. Because TB thrives in HIV-infected individuals, South Africa is experiencing a co-epidemic that has been challenging to battle. This collaboration will mark the first time that HHMI and The Wellcome Trust have worked together on a global health institution.

The new Africa Health Research Institute combines the Africa Centre for Population Health’s detailed population data gathered from over 100,000 participants with basic laboratory science and medical research of the KwaZulu-Natal Research Institute TB-HIV (K-RITH). Together the organization will work towards eliminating HIV and TB by training African scientists and will “link clinical and laboratory-based studies with social science, health systems research and population studies to make fundamental discoveries about these killer diseases, as well as demonstrating how best to reduce morbidity and mortality.” Projects funded by the institute include maintaining the longest running population-based HIV treatment as prevention (TasP) trial in Africa and using genomics to study drug resistant TB.

The organization is funded by a $50 million grant from The Wellcome Trust that is renewable over the next five years. Additionally, HHMI has already spent $40 million for the construction of new facilities, including a new biosafety level 3 laboratory that is designed to handle dangerous pathogens. These new efforts aim to apply scientific breakthroughs to directly help the local community. Deenan Pillay, the director of the new institute, has expressed his support of the organization’s mission by stating “There’s been increasing pressure and need for the Africa Centre not just to observe the epidemic but to do something about it. How long can you be producing bloody maps?” (Jon Cohen, ScienceInsider)

Scientific Reproducibility

Dutch agency launches first grants programme dedicate to replication

While a reproducibility crisis is on the minds of many scientists, the Netherlands have launched a new fund to encourage Dutch scientists to test the reproducibility of ‘cornerstone’ scientific findings. The €3 million fund was announced on July 19th by the Netherlands Organisation for Scientific Research (NWO) and will focus on replicating work that “have a large impact on science, government policy or the public debate.”

The Replication Studies pilot program aims to increase transparency, quality, and completeness of reporting of results. Brian Nosek, who led studies to evaluate the reproducibility of over 100 reports from three different psychology journals, hailed the new program and stated “this is an increase of infinity percent of federal funding dedicated to replication studies.” This project is the first program in the world to focus on the replication of previous scientific findings. Dutch scientist Daniel Lakens further stated that “[t]his clearly signals that NWO feels there is imbalance in how much scientists perform replication research, and how much scientists perform novel research.” The NWO has stated that it intends to include replication in all of its research programs.

This pilot program will focus both on the reproduction of findings using datasets from the original study and replication of findings with new datasets gathered using the same research protocol in the original study. The program expects to fund 8-10 projects each year, and importantly, scientists will not be allowed to replicate their own work. The call for proposals will open in September with an expected deadline in mid-December. (Monya Baker, Nature News)

Health Care Insurance

US Sues to block Anthem-Cigna and Aetna-Human mergers

United States Attorney General Loretta Lynch has announced lawsuits to block two mergers that involve four of the largest health insurers. Co-plaintiffs in the suits include eight states, including Delaware, Florida, Georgia, Illinoi, Iowa, Ohio, Pennsylvania, Virginia, California, Colorado, Connecticut, Main, Maryland, and New Hampshire, as well as the District of Columbia. The lawsuits are an attempt by the Justice Department to block Humana’s $37 billion merger with Aetna and Anthem’s $54 billion acquisition of Cigna, the largest merger in the history of health insurers. The Justice Department says that the deals violate antitrust laws and could mean fewer choices and higher premiums for Americans. Antitrust officials also expressed concern that doctors and hospitals could lose bargaining power in these mergers.

Both proposed mergers were announced last year, and if these transactions close, the number of national providers would be reduced from five to three large companies. Furthermore, the government says that Anthem and Cigna control at least 50 percent of the national employer-based insurance market. Lynch further added that “competition would be substantially reduced for hundreds of thousands of families and individuals who buy insurance on the public exchanges established under the Affordable Care Act.” The Affordable Care Act (ACA) aimed to encourage more competition between insurers to improve health insurance options and keep plans affordable. The Obama administration has closely watched the health care industry since the passing of that legislation and has previously blocked the mergers of large hospital systems and stopped the merger of pharmaceutical giants, such as the proposed merger of Pfizer and Allergan.

Health insurers argue that these mergers are necessary to make the health care system more efficient, and would allow doctors and hospitals to better coordinate medical care. In reaction to the announcement by the Justice Department, Aetna and Humana stated that they intend to “vigorously defend” the merger and that this move “is in the best interest of consumers, particularly seniors seeking affordable, high-quality Medicare Advantage plans.” Cigna has said it is evaluating its options. (Leslie Picker and Reed Abelson, New York Times)

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July 26, 2016 at 11:00 am

Science Policy Around the Web – November 3, 2015

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By: Danielle Friend, Ph.D.

Photo credit: photo credit: Grandfather Healing via photopin (license)

Healthcare Costs

Costs for Dementia Care Exceed Most Other Diseases

A recently study examining the cost of care for individuals suffering from dementia found that the cost of this care is exceeding the cost for caring for those that die from heart disease or cancer. In addition to costing more, the new study also reports that out-of-pocket spending for these patients and their families is 81 percent higher than for people without the disease and suggests that the economic burden is higher for individuals with dementia if the patient is black, has less than a high school education, or is widowed or unmarried. The study used data from Medicare recipients who died between 2005 and 2010 and found that the average cost for caring for these patients was $287,038 compared to $175,136 for those who died from heat disease or $173,383 for those who died from cancer. The increased costs for caring for an individual with dementia have been attributed to the fact that these individuals often require care for many years, that there are currently no treatments that effectively slow the disease, and that the care is not covered by insurance. For example, Medicare does not cover homecare service and non-rehabilitative nursing care, support often need for those with dementia. Additionally, individuals with dementia often need constant supervision as well as assistance with everyday activities such as eating, dressing, and bathing – again, care that is costly but not covered by Medicare. Certainly as the Baby Boomer population nears their elderly years concerns for how individuals pay for this much needed care will increase. (Gina Kolata, New York Times; Tara Bahrampour, Washington Post)

International Scientific Community

Canadian Scientists have High Hopes for Increased Government Support Following Election

Prior to Canada’s Election Day on October 19th, Canadian scientists made a rare push for federal science funding to be an issue in the elections. The Professional Institute of Public Service of Canada, a union made up of 15,000 scientists, aired radio ads accusing the governing Conservative Party of not supporting scientists.  However, with the ousting of the Conservative Party, which had held power for nearly 10 years and the election of Canada’s Liberal Party to a majority government led by Justin Trudeau, Canadian scientists are looking to the future with higher hopes for science. Since taking hold of leadership in 2006, the Conservative Party had eliminated the position of the national science adviser, a position that the Liberal Party states they will restore.  Additionally, the Conservative Party was also accused of ending climate and environment science programs and closing research libraries in government departments, as well as placing a greater emphasis on applied industrial research which left basic science lacking resources. In Canada, government support for science research is particularly important because private industry contributes proportionally less to research compared to other countries. If commitments are upheld by the new Liberal Party, Canadian scientists hope a new era of Canadian science will see a bright future. (Brian Owens, ScienceInsider)

Infectious Diseases

Ebola Virus Appears to be Long-Lived

As the number of new cases of Ebola appears to be dwindling, researchers are startled by new findings that the Ebola virus may leave traces in survivors that could contribute to new epidemics. Although researchers have known since 1999 that Ebola virus could be found in the semen of male survivors for months, new work published in The New England Journal of Medicine demonstrate that in 93 Ebola virus survivors, Ebola viral RNA could be found in semen samples from 46 men up to 9 months after contacting Ebola. Additionally, a second paper details the sexual transmission of the Ebola virus to a Liberian woman. The paper indicates that there were no cases of Ebola in the 30 days prior to the woman being diagnosed, however she reported having unprotected vaginal intercourse with an Ebola survivor prior to being diagnosed in March 2015. The male survivor had Ebola in September of 2014 but had tested negative in October 2014. However, a semen sample taken from the man in March tested positive for Ebola. Much more work will need to be done to definitely determine whether Ebola can be sexually transmitted and for how long after the survivor has recovered. The original articles detailing these findings can be found here and here.

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November 3, 2015 at 9:00 am

Science Policy Around the Web – September 28, 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.

Deadly Amoeba in Water Supply Possibly Linked to Hurricane Katrina –  Following the death of a 4 year old child, a deadly brain eating amoeba (Naegleria fowleri) was found in the water in St. Bernard Parish’s (a suburb of New Orleans) water supply. Following hurricane Katrina, there was a significant drop in the population in the region potentially affecting the water supply and allowing water to remain stagnant for longer periods of time. The parish is currently flushing the water systems with chlorine to eliminate the amoeba.(Gillian Mohney)

Humans Almost Certainly Cause Global Warming – A panel of scientists found that, with 95 percent certainty, humans have been greatly contributing to global warming since 1950. They also concluded that sea level will continue to rise and it will do so at a greater rate than we have been experiencing.  In fact, the current sea level could rise 3 feet by 2100. The group who conducted the study, the Intergovernmental Panel on Climate Change (IPCC) is comprised of 800 scientists from around the world. (Darryl Fears)

Antibiotic Resistant Infections Lead to 23,000 Deaths Per Year – For the first time, the CDC quantified the number of individuals affected by antibiotic resistant organisms- approximately 2 million are infected by antibiotic resistant bacteria with approximate 32,000 fatalities. The number of fatalities is a baseline estimate, so only causes where the infection is listed of the cause of death is included. The report includes infections from 17 bacterial and 1 fungal pathogen. Potential causes for the surge of antibiotic resistant infections are increased antibiotic use in animals and inappropriate use of antibiotics in humans. (Sabrina Tavernise)

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September 28, 2013 at 3:08 pm

Science Policy Around the Web – June 21, 2013

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By: Jennifer Plank

photo credit: ZaldyImg via photopin cc

photo credit: ZaldyImg via photopin cc

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

HPV Vaccine is Credited for Fall of Teenagers’ Infection Rate – Despite low vaccination rates in the US, the incidence of high risk HPV infection, the virus that causes the majority of cases of cervical cancer, in girls aged 14-19 was cut in half between 2006 (when the vaccine was introduced) and 2010. This comes a surprise to public health experts because only approximately 1/3 of teenaged girls in the US have been vaccinated, as compared to 80 percent vaccination rates in Denmark and Britain. One possible explanation for the drop in HPV infection despite low rates of vaccination is “herd immunity”  which means that vaccinated individuals in the population reduce the total number of infections and overall, HPV becomes less prevalent. At the current vaccination rate, approximately 45,000 future cases of cervical cancer in girls who are under the age of 13 will be prevented. (Sabrina Tavernise)

SARS-like Virus has High Mortality Rate in Saudi Arabia – To date, 32 out of 49 individuals infected with a new SARS-like respiratory virus, called MERS-CoV, have died, resulting in an unusually high 65 percent mortality rate. Findings published in the New England Journal of Medicine indicate that the virus is spread by person-to-person contact and can spread quickly in a hospital setting. The majority of MERS-CoV infections have occurred in Saudi Arabia, however, there have been instances reported elsewhere. All instances of infections have been linked to travel to the Middle East. MERS-CoV has an incubation time of 5 days (similar to SARS), during which, the virus is highly contagious. (Meeri Kim)

ASBMB Gives Mixed Review to the Supreme Court Decision on Gene Patenting – Last week, the Supreme Court unanimously ruled in favor of the Association for Molecular Pathology (Association for Molecular Pathology v. Myriad Genetics) and overturned the patents on the BRCA1 and BRCA2 genes. The American Society for Biochemistry and Molecular Biology (ASBMB) has mixed feelings on the ruling: while the ASBMB agrees with overturning the patents on BRCA1 and BRCA2, they do not agree with the ruling that because cDNA is not naturally occurring, it is patentable. (Chris Pickett)

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June 21, 2013 at 10:20 am

Science Policy Around the Web – May 17, 2013

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By: Jennifer Plank

photo credit: ynse via photopin cc

photo credit: ynse via photopin cc

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

Will insurance cover genetic testing, preventative surgery? – This week, Angelina Jolie was in the news following her op-ed piece discussing her preventative double mastectomy once she learned that she had a mutated BRCA1 gene. Women with a mutation in either of the BRCA genes are at an increased risk of developing breast and ovarian cancer. Due to their patent, Myriad Genetics is the only company allowed to perform genetic testing on either of the BRCA genes resulting in the test being very expensive- on average, BRCA genetic screening costs approximately $4000 when not covered by insurance. Doctors recommend that a patient with a positive result receive yearly mammograms and/or MRIs, adding thousands of dollars to the cost of preventative care. Once the Affordable Care Act is fully implemented, BRCA genetic testing will be classified as preventative care and require no out of pocket costs for the patient. (Melanie Hicken)

Scientists report first success in cloning human stem cells – 17 years after the cloning of Dolly the sheep, scientists generated stem cells from human skin cells. Until recently, human cells have been unable to be reprogrammed using “nuclear transfer”, a technique that has been effective in many other species. Dr. Shoukhrat Mitalipov, a scientist at Oregon Health and Science University, has used the technique to reprogram human skin cells into cells resembling embryonic stem cells. This new advance in technology provides another source for deriving embryonic stem cells to be used for stem cell based therapies. (Alice Park)

Supreme Court supports Monsanto in seed-patent case – In a unanimous ruling, the Supreme Court opined that farmers cannot use Monsanto’s genetically altered soybeans to make new seeds without paying the company. According to the opinion written by Justice Elena Kagan, the ruling was narrow in scope and will not automatically be extended to every self-replicating product. Normally, farmers who buy soybeans from Monsanto must sign a contract stating that they will not harvest seeds from one season’s crop to use in following seasons. This ensures that the farmers will buy new seeds yearly. However, in this case, the farmer obtained seeds through a second-hand source and determined which seeds were Monsanto’s genetically modified seeds. He then harvested seeds from those plants to use in subsequent seasons. The Supreme Court ruled that the farmer must pay Monsanto over $84,000. (Adam Litpak)

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May 17, 2013 at 5:48 pm

Science Policy Around the Web – May 2, 2013

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By: Jennifer Plank

photo credit: ZaldyImg via photopin cc

photo credit: ZaldyImg via photopin cc

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

NIH discontinues Immunizations in HIV vaccine study – Immunizations in an NIH sponsored HIV vaccine trial (HVTN 505) were halted last week. The study was in Phase IIb and aimed to determine if the vaccine could prevent infection or reduce viral load in patients who become infected with HIV. The trial consisted of a DNA-based vaccine to “prime” the immune system followed by a recombinant vaccine with the adenovirus type 5 vector housing genetic material encoding HIV antigens. Approximately 2500 people enrolled in the study. This phase of the study was limited to men who have sex with men and transgender individuals who have sex with me. Of the participants, 1250 received the vaccine and 1244  received the placebo.  Overall, 71 cases of HIV were reported (30 placebo recipients and 41 vaccine recipients). Additionally, there were 30 participants with a measurable viral load (15 placebo/15 vaccine). Based on these findings, the NIH decided to halt vaccination at each of the trial sites.  (NIH News)

Oregon’s math problem: How to measure health? – In an effort to improve health care and reduce unnecessary expenses, the Obama administration granted the state of Oregon almost $2 billion to coordinate better health care practices. The state has decided on 33 different measurements in evaluating health care providers. For example, health care providers are encouraged to ask patients if they use drugs or alcohol. If the patients answers affirmatively, the clinician is supposed to ask follow up questions and refer the patient to facilities to help them if necessary. The goal of the program is to have doctors refer patients for additional services only when necessary. The state has 5 years to fully implement the evaluations and prove that medical costs have not increased. (Kristian Voden-Vencil)

U.S. lawmakers propose new criteria for choosing NSF grants – A new bill drafted by Lamar Smith (R-TX) would replace NSF peer review with funding criteria chosen by Congress. Additionally, the bill includes language that suggests that every other scientific agency could be evaluated by the same process. All awarded NSF grants would have to meet the following criteria:

1) “… in the interests of the United States to advance the national health, prosperity, or welfare, and to secure the national defense by promoting the progress of science;

2) “… the finest quality, is groundbreaking, and answers questions or solves problems that are of utmost importance to society at large; and

3) “… not duplicative of other research projects being funded by the Foundation or other Federal science agencies.”

The top Democrat on the House of Representatives science committee, Eddie Bernice Johnson (TX), strongly opposes the legislation stating that no chair of the science committee has ever deemed themselves an expert in the science underlying the grant proposals. (Jeffrey Mervis)

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Written by sciencepolicyforall

May 2, 2013 at 1:01 pm