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Science Policy Around the Web November 29th, 2019

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By Maria Disotuar, PhD

Source: Pixneo

To Drive Down Insulin Prices, W.H.O. Will Certify Generic Versions

Without insulin, a person with type 1 diabetes cannot survive, and the cost and accessibility to insulin continues to be a problem for individuals suffering from this incurable autoimmune disease. Diabetes mellitus is a chronic metabolic disease characterized by high blood glucose levels. There are two types of diabetes, Type 1 diabetes results from the loss of pancreatic β-cell function, resulting in an inability to produce insulin, a peptide-based hormone. On the other hand, Type 2 diabetes patients are resistant to insulin. Those suffering from Type 1 diabetes require daily insulin therapy to stay alive, and patients with type 2 diabetes require insulin therapy to maintain a healthy lifestyle. Currently, more than 400 million people worldwide have diabetes and this number is expected to increase in the coming years. The main problem being that there are no generic forms of insulin and the price for current insulin analogs has gone from approximately $20 per vial to $250 per vial depending on the type of insulin. This price increase over the past 20 years has made insulin unaffordable for many individuals particularly for younger generations of Americans struggling to pay student loans. For these individuals, seeing the price of insulin jump from $4.34 to $12. 92 per milliliter has meant rationing the lifesaving drug to the bare minimum – a deadly decision for some.

As a response to the growing demand for insulin and skyrocketing prices, the World Health Organization (WHO) has proposed a two year prequalification pilot project, which will allow pharmaceutical companies to produce generic insulin to be evaluated by WHO for efficacy and affordability. These types of pilot projects have been previously deployed to improve the accessibility of life saving drugs for malaria, HIV, and tuberculosis. These efforts have led to an increase in production and market competition leading to reduced costs for individuals.

Currently, the major producers of insulin, Eli Lilly, Novo Nordisk, and Sanofi have welcomed the prequalification program, vowing to be a part of the solution not the problem. According to WHO, companies in several countries, including China and India, have already expressed interest in the pilot project. This shift in insulin production would allow companies producing insulin domestically to enter the global market. As WHO-certified suppliers, these new competitors could dramatically drive down the price of insulin and improve accessibility on a global scale. Despite this positive global outlook, there are still some hurdles to cross for Americans to obtain these generic insulin products. The main one being that the pharmaceutical market is regulated by the FDA and the review process can be expensive for smaller companies. Nonetheless, Americans are fighting back to reduce the cost of insulin and other life savingdrugs, prompting lawmakers, presidential candidates, and the President to prioritize reduced drug prices for Americans. These mounting pressures will hopefully lead to a faster solution for this life or death situation.

(Donald G. McNeil Jr., The New York Times)

Will Microneedle Patches Be the Future of Birth Control?

In 2018, the The Lancet reported that between 2010 and 2014 44% of all pregnancies in the world were unplanned. Despite medical advances in sexual and reproductive health, new contraceptive methods are needed to expand accessibility and improve reliability for women. In the United States, the establishment of the Affordable Care Act (ACA) and health policies such as the Federal Contraceptive Coverage Guarantee, which requires private health plans to include coverage for contraceptives and sexual health services, has improved family planning for women of reproductive age. Despite the social and economic benefits of improved family planning and enhanced accessibility, conservatives continue to challenge these beneficial health policies. Unfavorable changes to these policies could result in major barriers for women to access some of the most effective, yet pricier forms of contraceptives such as intrauterine devices (IUDs) and implants. Studies show these long-acting forms of birth control are up to 20 times more effective in preventing unintended pregnancies than shorter-acting methods such as the pill or ring. Thus, new long-term contraceptives with reduced cost barriers would be essential in reducing unintended pregnancies and enhancing economic benefits on a global scale.

To address this issue, researchers at the Georgia Institute of Technology and University of Michigan in partnership with Family Health International (FHI) – a non profit human development organization, have developed a long-acting contraceptive administered by a patch containing biodegradable microneedles. The patch is placed on the surface of the skin and the microneedles painlessly come into contact withinterstitial fluid resulting in the formation of carbon dioxide bubbles, which allow the microneedles to detach from the patch within 1 minute of application. The needles themselves do not introduce a new contraceptive hormone, rather they provide levonorgestrel (LNG), which is regularly used in IUDs and has been deemed as safe and efficacious. After dissociation from the patch the needles slowly release LNG into the bloodstream. 

Thus far, the pharmacokinetics of the patches has been tested on rats and a placebo version has been tested in humans to test the separation process between the patch and the needles. The in vivo animal studies indicate the patch is able to maintain LNG concentrations at acceptable levels for more than one month and the placebo patch was well tolerated among study participants with only 10% reporting transient pain or redness at the site of patch application. Lastly, the researchers analyzed conceptions and acceptability of this new contraceptive method among American, Indian, and Nigerian women compared to oral contraceptives and monthly contraceptive injections administered by a physician. The results indicate women overwhelmingly preferred the microneedle patch method over the daily pill (90%) or monthly injections (100%). The researchers expect the patch to be simple to mass produce and a low-cost contraceptive option, which will reduce cost barriers and improve accessibility for women. Although the results of the study are promising, additional studies will have to be completed to address some of its limitations. Future studies will have to increase the number of animals used in the study and the number of human participants. Additionally, the release profile for LNG will likely need to be extended beyond 1-month to truly address the need for new long-acting forms of contraceptives. Finally, clinical trials will have to be completed to test the efficacy and general reliability of this method at reducing unintended pregnancies. If the microneedle patch is approved, it would be the first self-administered long-term birth control to enter the market, which could ultimately lead to enhanced accessibility for women with limited access to health care.

(Claire Bugos, Smisothian) 

Science Policy Around the Web – June 7th, 2019

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By: Mary Weston, Ph.D.

Source: Pixabay

Pfizer had clues its blockbuster drug could prevent Alzheimer’s. Why didn’t it tell the world?

Last Tuesday, the Washington Post reported that the biopharmaceutical company Pfizer had hints that their rheumatoid arthritis drug Enbrel might reduce the risk of Alzheimer’s disease, but chose not to report these findings to the public.

In 2015, after analyzing hundreds of thousands of insurance claims, a team of Pfizer researchers observed that their anti-inflammatory drug Enbrel might also decrease the risk for Alzheimer’s by 64%. They recommended that the company conduct a costly clinical trial to prove the link but, after several years of internal debate, the company decided not to pursue the lead.  The question remains: why did Pfizer not release these findings to the scientific community?

Pfizer claims they did not pursue the research due to scientific considerations – they argue that since Enbrel cannot cross the blood-brain barrier and directly reach brain tissue, it is unlikely to prevent the debilitating neurodegenerative disease. Further, Pfizer claimed that they did not to report the research because the statistical findings did meet “rigorous scientific standards” and were concerned about misleading researchers down a false path. However, Pfizer is also losing its patent protection on Enbrel soon, meaning that generics will become available and the drug will be much less profitable, reducing any financial incentive for further research or clinical trials (likely to cost around $80 million).

Some in the scientific community are questioning Pfizer’s justification. Keenan Walker, an assistant professor of medicine at Johns Hopkins, argues that the scientific community benefits when the data is available, stating that ““[w]hether it was positive data or negative data, it gives us more information to make better informed decisions.’’

Several scientists argue that Pfizer’s results should be release because they could provide clues to combating the disease and slowing cognitive decline in its earliest stages. Specifically, recent research is hinting that inflammation may promote Alzheimer’s disease. Further, neurodegenerative research is notoriously challenging and there are no major drugs that treat Alzheimer’s. Even several recent phase 3 clinical trials have been halted because the drugs were not effective. Due to a lack of progress in the field, a couple large pharmaceutical companies, including Pfizer, have just closed their neurology-related research programs.

 (Christopher Rowland, Washington Post)

Trump administration halts fetal-tissue research by government scientists

The Trump administration has announced that government scientists will stop using human fetal tissue for research and is placing new limitations on researchers in academic settings who use federal funding from the NIH.

It is not entirely known how many research projects will be affected by the new regulations. Government scientists will be allowed to continue their current work, but are prohibited from acquiring new tissue samples. Current extramural research at universities and privately funded work can continue but any new grant proposals or renewals of existing projects must be approved by an ethics advisory board that will be formed.

In addition to halting government fetal tissue research, the administration has decided to cancel an ongoing HIV research contract with the University of California San Francisco, effectively ending a 30-year partnership. The project involves using fetal tissue to develop mouse models with human-like immune systems to develop new HIV therapies.

Use of fetal tissue is essential to for studying certain human biological processes, such as kidney development. Often biomedical research uses mice as substitutes of people, but in this case, murine kidney development is too different from their human counterparts to be of use. Some researchers fear that these new restrictions will set back certain research for years to come. Important areas of research that depend on using fetal tissue including HIV, neurodegeneration, human organ growth and regeneration, Zika (determining how/why the virus affects developing fetuses so severely), and certain types of vaccine development.

POLITICO reports that this decision was made after much debate between the White and the Department of Health and Human Services (HHS), which wanted a less restrictive policy. In a statement released Wednesday, HHS said that “promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration.” HHS is now reviewing whether sufficient alternatives to human fetal tissue exist and will be supporting the development and validation of these models. However, good alternatives for certain fetal tissue research are elusive and many scientists say that the tissue is essential for some fields.

 (Sara Reardon, Nature)

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June 7, 2019 at 6:11 pm

Living in America with a chronic disease: Drug prices here and why they are so high.

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By: Mohor Sengupta Ph.D.

Image by Liz Masoner from Pixabay 

The USA has the highest average prices on drugs compared to all other developed nations across the globe. The average expenditure on drugs per person is around $1200 per year in the U.S., while it is roughly $750 in Canada, according to a 2014 survey. Let us look at a specific example. Nexium is a drug that helps reduce stomach acidity. It is manufactured by AstraZeneca in Sweden and sold to customers in the U.S., Canada, U.K., Australia, New Zealand, India and Turkey. The 40 mg pill costs $3.37 in Canada, $2.21 in the U.K., Australia and New Zealand, less than 37 cents in India and Turkey and $7.78 in the U.S. Specialty medicines, like those used for cancer can cost $10,000 a month in the U.S

Fred Smith, whom I interviewed recently, is a 26-year-old freelance musician and trumpet instructor. Shortly after his 26thbirthday, his health insurance coverage under his mother’s provider plan ended. He went on to buy his medical insurance from the private provider Blue Cross Blue Shield only to realize that he had to pay nine times the cost for each of two medicines, Vyvanse and Viibryd, and 18 times the cost for a third medicine, Adderall, compared to the amount paid while on his mother’s insurance. 

So why do Americans pay more for their medicines? 

  • Drug manufacturers in the U.S. can set the price of their products. 

While this is not the norm elsewhere in the world, federal law in the U.S. does not allow FDA or public insurance providers to negotiate drug prices with manufacturers. Medicare Part D is a 2003 legislation that prevents the nation’s largest single-payer health system from negotiating drug prices. Medicaid, which is the public healthcare program for people with limited income and resources, must cover all FDA-approved drugs, irrespective of the cost. However, drug makers must provide rebates to the government for drugs billed to Medicaid. In general, the biggest cost of medicines is borne by Medicare and private insurers. Private insurance providers do not usually negotiate prices with drug manufacturers. This is because middlemen or third-party pharmacy benefits managers that administer prescription drugs, such as CVS Health, receive payments from drug companies to shift market share in favor of these insurers. These deals also leave consumers with a limited choice. 

Drug makers in the U.S. not only set their own prices but they are also authorized to raise prices. Martin Shkreli became the “most hated man in America” overnight when he raised the price of a generic anti-parasitic drug Daraprim from $13.5 a pill to $750 a pill, a 5000% increase. Mr. Shkreli explained to critics that the hike was warranted because Daraprim is a highly specialized medicine and likened it to an Aston Martin previously sold at the price of a bicycle. He added that the profits from the price increase would go into improving the 62-year-old recipe of the drug. 

Deflazacort, a steroid used to treat Duchenne muscular dystrophy, is a generic compound that has been available worldwide for decades and costs $1000-$2000 per year. Yet, Illinois-based Marathon Pharmaceuticals acquired FDA approval to sell deflazacort under the brand-name Emflaza at $89,000 per year. 

Speaking of generic drugs, here is the next big reason for unaffordable brand-name medicines. 

  • Government-protected monopolies for certain drugs prevent cheaper generics from entering the market. 

The U.S. has a patent system that allows brand-name drug makers to retain exclusive selling rights for 20 years or more. Makers of drugs for rare diseases can also enjoy indefinite monopoly of sale. Moreover, these rare drug makers can extend their solo market dominance by making minor and non-therapeutic modifications to the patented product, like changing the dye component in the coating. They also often pay generic manufacturers to delay their products from entering the market. 

Additionally, FDA approval of generics following expiration of brand-name drug patents can be a long process; it can take up to 3-4 years for generic drug manufacturers to get FDA approval. It is estimated that prices of generic medicines fall to 55% of the brand-name medicine price once two generics enter the market and 33% of the brand-name cost when five generics become available. 

However, why would a brand-name manufacturer applying for a patent cite an unaffordable price to begin with?

  • Unjustified cost of research and development are cited by drug makers. 

It is generally agreed among critics that drug makers put an unjust price on their product citing the research that went into producing it. Because most of the R&D is funded by the National Institutes of Health via federal grants or by venture capital, the cost of research cited by the drug makers is above exaggeration. In reality, companies spend no more that 10-20 percent of their revenue on the research. 

Sofosbuvir was made by Michael Sofia, a scientist with a Princeton-based pharmaceutical company called Pharmasset. He even received the 2016 Lasker-DeBakey Clinical Medical Research Award for inventing it. Sofosbuvir is recommended for management of hepatitis C. After Gilead Sciences acquired Pharmasset for $11 billion in 2011, it applied to FDA for a new drug combining Sofosbuvir and Ribavirin, first made in 1972 by scientists at International Chemical and Nuclear Corporation (currently Canada-based Bausch Health Companies). Gilead priced their product at $84,000 for a single course of treatment in the U.S. The pricing caused a huge controversy when patients on Medicaid were denied the drug until becoming seriously ill. Moreover, generic licensing agreements to produce Sofosbuvir in 91 developing countries, which bear the burden of more than half the world population with hepatitis C, came under fire when Gilead asked for prices unaffordable by consumers in these countries. 

This brings us to the final cause of high drug prices. 

Doctors are often unaware that their prescriptions could be cheaper for their patients if they purchased two generic medicines instead of the brand-name prescription drug that is just a combination of the two. Vimovo, manufactured by Horizon Pharma, is a drug used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It is a combination of two generic medicines, naproxen (brand-name Aleve) and esomeprazole (brand-name Nexium). Naproxen is the anti-inflammatory component (NSAID) and esomeprazole is the aforementioned stomach-acidity reducer. It is added to the combination to reduce side effects of the NSAID. Whereas a month’s supply of Aleve and Nexium cost one patient $40, his insurance company was billed $3252 for the same supply of Vimovo. Moreover, not everyone who uses NSAIDs experiences stomach problems and do not need the additional esomeprazole component. 

Several Americans do not fill their prescriptions because they cannot afford to. Data show that 36 million Americans between the ages of 18 to 65 did not fill their prescriptions in 2016. Many resort to buying medicines online from foreign sellers or get them imported. Both routes are illegal and therefore we do not know the exact percentage of the population participating in these practices. 

I interviewed Tammy Connor, who regularly gets her medications from abroad. Tammy takes Synthroid, a brand-name drug, which is used to manage symptoms of hypothyroidism. She has been procuring it from Canada at 1/3rd its U.S. price for many years. In the middle of 2018, the U.S. began blocking drug purchases from Canada, preventing her from continuing this cost-saving practice. Eventually, she got a referral to a U.K.-based drug company called Medix Pharmacy, where she pays 1/3rd the amount that she would have to pay if she purchased Synthroid from the U.S. “Ironically, Medix gets its Synthroid supply from Canada”, Tammy said.

Big Pharma” is a major lobbying group in the U.S. This is a group of a few gigantic pharmaceutical companies which have together kept their profit margins rising amidst public outcry of drug unaffordability. Big Pharma also includes corporations that push overpriced drugs to customers. With their deep pockets, they can spend astronomical amounts on advertising and lobbying. 

Unaffordable prices of life-saving medicines cause many people to skip taking necessary medications, thanks to the Big Pharma. Now, more than ever, is the time that something was done about this. 

Recommended links: 

  1. http://money.com/money/4462919/prescription-drug-prices-too-high/
  2. https://jamanetwork.com/journals/jama/article-abstract/2545691
  3. https://www.cnbc.com/2017/05/10/americas-10-most-expensive-prescription-drugs.html
  4. https://www.renalandurologynews.com/home/news/almost-1-in-10-americans-cant-afford-medications-says-cdc/

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Written by sciencepolicyforall

May 9, 2019 at 4:23 pm

Science Policy Around the Web – April 12, 2019

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By: Saurav Seshadri, PhD

Photo by Elijah Hiett on Unsplash

With Vertex, NHS back at the pricing table, CF advocates ratchet up the pressure

petition demanding coverage of the cystic fibrosis (CF) drug Orkambi in the UK has now garnered over 100,000 signatures, and must therefore be considered by Parliament for debate.  The milestone is the latest development in the struggle between Orkambi maker Vertex Pharmaceuticals and the British government, which began soon after Orkambi was approved in 2015.  The main point of contention is the price of the drug.  The UK’s National Institute for Health and Care Excellence (NICE) has refused to recommend Orkambi at Vertex’s asking price of £104,000 ($136,000) per patient per year, but Vertex has rejected the UK’s offer of £500 million for 5 years’ access, leaving both parties at an impasse.

The UK is not the first country to clash with Vertex over pricing. Several health agencies have refused to pay for Orkambi on the grounds that it is only marginally effective; some now face lawsuits, as programs like Medicaid are required to provide available drugs for qualifying patients.  While Orkambi is not as effective as Vertex’s first drug Kalydeco, it can be prescribed to more patients (up to 50% of those with CF).  Life expectancy for patients with CF is less than 40 years, and many patients are children, so even small improvements can be life-changing.  However, as with the multiple sclerosis drug Ocrevus, NICE seems unlikely to relent; on the contrary, UK Health Minister Matt Hancock recently accused Vertex of ‘hold[ing] the NHS to ransom’ and ‘profiteering’.  

For its part, Vertex is unlikely to compromise on the price of its best-selling drug, which brought in $1.26 billion in 2018.  CEO Jeffrey Leiden insists that this revenue is critical to the company’s continued investment in CF research.  Ironically, this stance may be pushing the UK closer to a measure that would jeopardize all future medical R&D efforts: invoking ‘Crown’ use, which allows the government to sell a patent without the consent of its owner. While the idea has gained support among some British lawmakers, and has been used in the past (to make Pfizer-owned antibiotic tetracycline available in the 1960s), it would face legal challenges that could render it ineffective.  But with public pressure mounting, especially after Vertex recently admitted to destroying almost 8,000 packs of Orkambi amid the standoff, inaction may not be an option for much longer.

(Eric Sagonowsky, FiercePharma)


Why some low-income neighborhoods are better than others

A recent study, published in PNAS, builds upon a body of evidence that while race can influence upward mobility (with white children having a 4-fold higher chance of moving from the lowest to highest income brackets than their black peers), environmental factors also play a major role.  Previous work demonstrated that the neighborhood in which a child grows up has a large effect on their future success, with better outcomes for children raised in low-poverty neighborhoods, regardless of race.  However, black children are significantly less likely to live in such neighborhoods.  To combat racial inequality, it is critical to understand which aspects of poverty impact long-term socioeconomic progress. 

The new study is based on the Opportunity Atlas, and pulls together data from tax returns, Census surveys, police reports, prison admission records, and blood tests conducted by the health department. The data tracks a cohort of children born in 1978-1983 (age 31-37 in 2014), living in 754 Census tracts in Chicago.  The authors report that even after controlling for other variables, a large proportion of the racial disparity observed in adults can be explained by three factors: violence, incarceration, and lead exposure during adolescence.  Since these factors were highly correlated with each other, the authors combined them into a single ‘neighborhood harshness/toxicity’ factor; this variable proved to be a much stronger predictor of income, incarceration, and teen pregnancy than more traditional factors, such as poverty or college education rates.   

That these elements impair social mobility is perhaps not surprising, as exposure to both violence in the community and high levels of lead have both been linked to cognitive impairment. But the magnitude of the effect is striking: for example, according to their model, toxicity exposure could account for 60% of the difference in incarceration rates between black and white men in their sample, and a 10% increase in teen births among black women.  While the authors acknowledge they cannot establish causality, they conclude that ‘Chicago’s residential segregation is disproportionately exposing its black children to neighborhoods that are hazardous to their development’.  Recently elected mayor Lori Lightfoot ran on a platform that includes stopping violence, expanding affordable housing, and ‘investing in our neighborhoods’.  Insight into the mechanisms that perpetuate inequality can only enhance these policies’ power to improve the trajectories of vulnerable kids.      

(Sujata Gupta, Science News


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April 12, 2019 at 5:21 pm

Science Policy Around the Web – February 26, 2019

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By: Mary Weston, Ph.D.

Source: Wikimedia

A Century-Old Debate Over Science Patents Is Repeating Itself Today

In 1923, after the economic devastation of World War I, the Italian senator Francesco Ruffini wanted to bolster scientific research by giving scientists ownership of their discoveries. His scheme would have awarded scientists a patent of sorts on the laws of nature they found. Although he had reasonable scientific support and the backing of the newly formed League of Nations, ultimately scientists around the world strongly rejected the plan for various reasons. Recent proposed changes to scientific discovery patent law possess a striking similarity to these events and proposals nearly 100 years ago.

Ruffini, desiring to increase scientific research, argued that scientists should be able to receive “scientific property” for a discovery, similar to patents awarded for inventions. He cited the example of “Hertzian waves” (i.e. radio waves) as something that resulted in many valuable products. The proposal was a large deviation from the existing law, where patents could only be assigned for inventions – artificial things made by humans, like machines – but not for discoveries of the natural world. Ruffini “was clear that scientific property would not prevent all uses of a natural law. But only practical commercial applications”.

In 2017, the American Intellectual Property Law Association (AIPLA) and the American Bar Association’s Intellectual Property Section (ABA’s IP) both submitted proposals to change current laws (Amendment 35, Section 101) and allow for patents on scientific discoveries. Motivation for change stems from recent Supreme Court decisions regarding patents for medical techniques (use of the BRCA1/2 gene for detecting breast cancer and a blood diagnostic test to fine-tune autoimmune disease treatments). Currently legislators, specifically Senators Thom Tillis and Chris Coons, are revisiting these guidelines and roundtables were held in both January and February of this year. 

The demise of the previous 1920s proposal was due to details in implementation, very similar to the problems current proposals face today. These include how to:

  • attribute scientific property when there are many contributors to one discovery (i.e. who “discovered” electricity? Benjamin Franklin? George Ohm?). 
  • deal with unexpected liability, potentially requiring some sort of scientific property insurance scheme. 
  • deal with the scope of some scientific discoveries, possibly being so large that it leads to tremendous and costly amounts of ligation. 
  • write the patents with the specificity required without being too vague and/or speculative. 

Edward S. Rogers, a Chicago lawyer who assisted Ruffini with his proposals in the 1920s, ultimately warned against it in 1931, saying that while the plan was appealing, “the whole scheme seems impractical.”

If changes to the patent law are to occur, the same issues that prevented change nearly 100 years ago will need to be solved – a daunting and challenging task.

(Charles DuanSlate

Japanese Spacecraft Successfully Snags Sample of Asteroid Ryugu

The Hayabusa2, a Japanese asteroid-sampling spacecraft, just successfully retrieved surface pieces from Ryugu, a 3000-foot wide asteroid. To obtain the sample, the probe fired a 0.2 ounce tantalum “bullet” into the boulder-covered surface at close range, and then collected disturbed particles using a “sampling horn” located on the underside of the machine. 

The Japanese Space Agency (JAXA) launched the Haybusa2, Japanese for Peregrine Falcon, in December 2014. They told CNN that even reaching the asteroid, 180 million miles from earth, is the “equivalent of hitting a 2.4-inch target from 12,400 miles away”. Upon arrival, the probe circled the small asteroid for 1.5 years collecting data. Then, last September, two probes were successfully released to image and document the asteroid surface. 

The goal of this exploration journey is to better understand the early history and evolution of the solar system. Ryugu is a C-type asteroid, the category that ~75% of known asteroids falls into, and is thought to contain water and other organic materials. One theory suggests that much of earth’s water and organic compounds may have been delivered by asteroids and comets. This will be the first time scientists have visited and collected samples from this type of asteroid and evaluation of its composition may “clarify interactions between the building blocks of Earth and the evolution of its oceans and life,” JAXA described

JAXA is planning two additional sampling expeditions in the next couple of weeks. This second mission will collect additional surface material. The third will use a copper projectile to create a surface crater in order to obtain samples from beneath the asteroid’s surface, which has been weathered by deep-space radiation. The Haybusa2 will depart the asteroid in December 2019 and should arrive back to earth in December 2020.

(Mike WallSpace.com)

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March 1, 2019 at 12:58 pm

Science Policy Around the Web – February 26, 2019

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By: Jennifer Patterson-West, Ph.D.

Source: Ellsworth Airforce Base

Scientists Release Controversial Genetically Modified Mosquitoes In High-Security Lab

Malaria is a parasitic disease that affects more than 200 million people each year.  Symptoms can range from mild to severe, and include high fever, chills, and flu-like symptoms.  These symptoms are more dangerous to children under the age of 5, which account for 77% of related deaths.

The life cycle of malaria requires two hosts: humans and female Anopheles mosquitoes.  It is important to note that not all species of Anopheles mosquitoes are good vectors, in fact, only 30-40 of the approximately 430 species transmit malaria in nature. The life cycle of malaria is also dependent on additional environmental factors including ambient temperature and humidity. Together these factors account for the geographic distribution of malaria. Although malaria is found more than 100 countries, transmission is most prevalent in Sub-Saharan Africa and in parts of Oceania including Papua New Guinea. 

In the past decade, major gains have been made to control the disease in developing nations thanks to increased funding. Current preventative measures include insecticide-treated netsindoor residual spraying, and intermittent preventative treatment for individuals at increased risk including pregnant women and infants.

In early February, a high-security laboratory in Terni, Italy launched a study to evaluate a new powerful weapon against the mosquito vector.  This new weapon is a genetically modified mosquitothat can spread a genetic mutation lethal to its own species. Researchers targeted the gene “doublesex” to producing female mosquitos that are sterile and have mouths resembling male mosquitos, which are unable to bite.  

The goal is to dramatically crash or reduce the local population of the main species of malaria spreading mosquitoes, Anopheles gambiae. To increase heritability of the mutation, researchers utilized CRISPR technology to engineer a “gene drive” into the genetically modified species. Gene drive inheritance ensures that nearly all progeny inherits the mutation.

Despite the need for new methods for reducing malaria, activists and other scientists warn that the technology can have unforeseen effects on the environment.  The environmental group, Friends of the Earth, is part of international coalition protesting the use of these new genetically modified organisms. Jim Thomas of the ETC group, has noted concern that gene drive technologies can also be used to develop biological weapons.  

To reduce the risk associated with releasing the gene-drive mosquitoes, the project plans years of additional study that will methodically and cautiously evaluate the mosquitoes and their potential environmental impacts with close consultation from other scientists, government officials, and local residents in Africa.

(Rob Stein, NPR)

With one manufacturer and little money to be made, supplies of a critical cancer drug are dwindling

Bacillus Calmette-Guerin (BCG) is a potent immunotherapy for the treatment of fast-growing bladder cancer.  BCG was initially used in 1921 as a tuberculosis vaccine.  In the 1970s, BCG was shown to stimulate the immune system to attack tumor cells when administered through a catheter into the bladder of cancer patients. Since then, BCG has become a potent treatment for intermediate and high-risk non-muscle invasive (NMI) urothelial cancer (UC) of the bladder.

Bladder cancer is the nation’s sixth most prevalent cancer with approximately 80,000 new cases each year.  About 20% of these patients are diagnosed with a type of bladder cancer that can be treated with BCG.  Although BCG doesn’t work for all eligible patients, the response rate is more than 70%.

Despite the established potency of BCG, there is a critical national shortage.  Supplies of BCG have been erratic since 2011, when the United States Food and Drug Administration (FDA) promptly shut down the Sanofi manufacturing lab after a failed inspection.  After continued regulatory issues, Sanofi stopped production of BCG in 2016. Merck is now the only manufacturer of BCG for the Unite States and European markets.

Merck has acknowledged short supplies and indicated that they are currently working at capacity.  Tyrone Brewer, the vice president of global oncology marketing at Merck, has indicated that the company intends to continue producing BCG for “the foreseeable future.”

During shortages, chemotherapies, such as mitomycin, can be used as alternative therapies.  However, they have lower efficacy and a higher price tag than BCG. During the 2014 BCG shortage, the cost of mitomycin increased by 99% further exacerbating the financial burden of these alternative therapies. 

In response to erratic supply of BCG, the Southwest Oncology Group has launched a clinical trial (S1602) to compare the TICE BCG strain currently used in the United States to the Tokyo Strain.  The FDA will consider the results of this trial as critical information for approving the Tokyo strain for use in the United States. 

In the meantime, urologists have begun to divide dosages into thirds to prolong supplies.  However, a recent literature review indicated that a large scale, well-designed, prospective study is need to establish a standard dose and maintenance instillation for reducing recurrence rate since the efficacy of lower dosage is unclear from existing data.

The University of Utah Drug information Service reported that in 2015 approximately 265 generic drugs were in short supply in the United States.  Of potentially greater concern than the current shortage of BCG are generic drugs that can have immediate life and death consequences. For instance, a retrospective study of the norepinephrine shortage in 2011 indicated a 10% higher mortality rate during hospitalization when the alternative vasopressor, phenylephrine was used.

A recent perspective from Davies et al. argues that current policy efforts have not sufficiently prevented supply disruptions of important generic drugs.  A major consideration for dealing with generic drug shortages are the unintended consequences of current policies. For instance, the 2003 Medicare Modernization Act, which sought to protect consumers by limiting the cost increase for generic drugs to 6% above the Medicare average sale price (ASP). This restriction may not provide manufactures with sufficient proficient to invest in production facilities.  

Further compounded these issues is the fact that manufacturers face few negative consequences during shortages, whereas an excess in supply cuts in to profit margins. To provide additional incentive for maintaining reliable supplies of generic-drugs, Davies et al. suggested that the FDA prioritize the review of future generic-drug applications from companies that “maintain generic drug production without quality-control problems”.  In November, the FDA issued a news release about efforts to address drug shortages, which included remedying the underlying problems when a shortage arise within their current authorities.  In today’s political climate, any policy reform or expanse to FDA’s authority to mitigate future shortages and provide incentives for the production of generic medications will require cross-party support. 

(Meghana Keshavan, STAT news)

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Written by sciencepolicyforall

February 26, 2019 at 1:44 pm

Science Policy Around the Web – April 10, 2018

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By: Allison Dennis B.S.

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source: pixabay

Mental Health

Many People Taking Antidepressants Discover They Cannot Quit

15 million American adults have taken antidepressants for a period longer than five years, in spite of the fact that these drugs were originally approved for short-term treatment, lasting less than nine months. Many doctors agree that a lifetime prescription may be necessary for the treatment of some patients. However, many are concerned that some patients may simply be accepting long-term use of antidepressants when faced with the challenge of stopping.

Surveys have shown that choosing to stop long-term medications is not a straightforward process with many patients reporting withdrawal effects. Some antidepressants take weeks to break down and leave the body, and their absence can induce feelings of anxiety, insomnia, nausea, “brain zaps,” and even depression itself. Antidepressants are one of the most frequently prescribed therapeutics by physicians, yet the drugs’ labels do not outline how to end a prescription safely. Patients may have to turn to online resources, including  The Withdrawal Project, which provides a community based approach to provide support, but whose writers are self-described as “laypeople who have direct personal experience or who have supported someone else in the process of reducing or tapering off psychiatric medication,” but are not medical professionals.

The benefits of antidepressants in the treatment of depression is undeniable, leaving government regulators cautious about limiting their availability. Antidepressant manufacturers appear unwilling to dive into research characterizing the discontinuation syndrome experienced when patients try to stop, feeling their efforts to demonstrate the drugs are safe and effective is sufficient. Academic and clinical researchers have occasionally tackled the issue, but few studies have looked at the barriers facing open-ended antidepressant prescription holders.

(Benedict Carey and Robert Gebeloff, The New York Times)

Alzheimer’s Disease

Scientists Push Plan To Change How Researchers Define Alzheimer’s

Currently, the 5.7 million Americans living with Alzheimer’s are identified through a panel of symptoms including memory problems or fuzzy thinking. However these symptoms are the product of biological changes scientists feel may be an earlier and more accurate marker of disease. On the biological level, Alzheimer’s can be characterized by the accumulation of several characteristic structures in brain tissue including, plaques, abnormal clusters of protein that accumulate between nerve cells, tangles, twisted fibers that form inside dying cells, and the build up of glial cells, which ordinarily work to clear debris from the brain. It is unclear if these changes are driving the widespread disconnection and destruction of neurons exhibited in the parts of the brain involved in memory and later in those responsible for language and reasoning in the brains of Alzheimer’s patients or just a byproduct of a yet-to-be-discovered process.

A work group formed by collaborators at the National Institute on Aging and the Alzheimer’s Association are putting forward a research framework which defines Alzheimer’s by the progression of a panel of risk factors, including neuropathology, tangles, plaques, and neurodegeneration. By allowing these biomarkers to fall along a continuum, the group is accommodating the observation that the exhibition of these traits can vary widely between individuals and may not always co-occur with symptoms. Yet the framework is intended to “create a common language with which the research community can test hypotheses about the interactions between Alzheimer’s Disease pathologic processes.”

Although much of the research is preliminary, specialized brain scans and tests of spinal fluid are already being designed to identify these biomarkers directly. The biomarkers included on the continuum can be observed 20-30 years prior to symptoms, fostering the hope that early interventions could be implemented to slow disease progression or even prevent it in the first place.

(Jon Hamilton, NPR)

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April 11, 2018 at 6:11 pm