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Posts Tagged ‘diabetes

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 – March 12, 2019

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By Andrew Wright, BSc

Source: Pixabay

The war on ‘prediabetes’ could be a boon for pharma—but is it good medicine?

Diabetes is highly prevalent in the United States, affectingnearly 10% of the US populationand accounting for approximately 80,000 deaths every year. While the pursuit to reduce or mollify the societal and economic impact of this disease is undoubtedly necessary in a country where fully 39.8% of adults are obese, there are some who wonder if such efforts have slipped into problematic territory. 

            Similar to how the introduction of pain as a fifth vital signhelped to unintentionally spur on the devastating opioid crisis, there is fear that the expanding diagnostic criterion of prediabetes could lead to the familiar territory of unnecessary treatment. For one, the risk of prediabetic patients developing diabetes from year to year is low: just under 2% according to the Centers for Disease Control (CDC).  At the same time the methods of treatment for prediabetes, designed to prevent progression to the full disease, are not particularly effective in achieving that goal. While a 2009 study demonstrated that exercise intervention or metformin, a common drug used to treat diabetes, did prevent some prediabetic patients from transitioning to full diabetes, methodological concerns have been raised with the authors’ results. One of the major issues is that the study used high risk patients at the upper end of the prediabetic spectrum, which is significant given that the American Diabetes Association (ADA) reduced the lower threshold of what counts as prediabetes around the same time. Of these “less” prediabetic patients, many never transition to the full disease. This suggests at the very least that treating these patients, especially pharmacologically, is not necessary or beneficial.

            Despite these issues being raised, there is a worrying trend of medical professionals doing just that. While no drug has been approved to treat prediabetes, doctors are continuing to treat prediabetic patients with diabetes drugs by prescribing them off-label at the recommendation of the ADA. Not only does this include metformin, which has its own difficult side-effects, but also several medications with “black box” labels that denote severe risks. Particularly when one considers that those who progress to full diabetes will be treated with these same drugs as their condition worsens, using them prophylactically is likely overzealous.

            Finally, there have been concerns raised about financial conflicts of interest, to which the medical and pharmaceutical industry are certainly not strangers. The companies behind the most prominent diabetes drugs have gifted millions of dollars to those in positions of influence at the ADA and other medical institutions. Perhaps as a result, while international groups such as the World Health Organization (WHO) have rejected prediabetes as a condition outright, the American medical community seems to be falling in line with the diagnosis. When top-down societal changes to reduce obesity may a be more effective means to reduce diabetes according to the WHO, the over-medicalization of prediabetes could ultimately do more harm than good.

(Charles Piller, Science)

Microplastic pollution revealed ‘absolutely everywhere’ by new research

With estimates that the ocean will have more plastic than fishby weight by 2050, it should come as no surprise that global plastic pollution is becoming rapidly untenable.  It is well understood that plastic does not biodegrade, but rather breaks down into increasingly smaller pieces know as microplastics. These pieces of plastic can become so small that they can be ingested by zooplankton, one of the fundamental building blocks of the marine food chain, which means they eventually make their way to the human digestive system.  

            While the problem was previously thought to be relegated to the worst polluted waterways and places like pacific vortexes (colloquially known as the “Great Pacific Garbage Patch”), recent studies have shown that microplastic pollution is so pervasive that pieces are found in every area tested. This includes freshwater bodies in the United Kingdom, groundwater supplies in the United States, the Yangtze river, off the coast of Spain, and in tap water around the world.

            The problem is not relegated to shallow water bodies either, with microplastics being found at the bottom of the Mariana Trench at levels of up to 2,200 pieces per liter of sediment. While these levels of contamination are undoubtedly perilous to wildlife, the affect they might have on humans is unclear. However, research from the National University of Singapore has demonstrated that microplastics harbor both bacteria that cause coral bleaching and those that cause gastroenteritis.  Further,  the possibility remains for chemicals contained in microplastics such as polychlorinated biphenyls (PCBs), which are carcinogenic, to cause deleterious health effects as chronic exposure leads to cumulative effects. What is clear is that without some method of reducing plastic pollution or monumental cleanup efforts, microplastics will become a troubling global burden in the years to come.

(Damian Carrington, The Guardian)

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Written by sciencepolicyforall

March 12, 2019 at 4:53 pm

Science Policy Around the Web – March 6, 2014

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By: Kaitlin Morabito

photo credit: subarcticmike via photopin cc

photo credit: subarcticmike via photopin cc

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

Giant virus resurrected from 30,000-year-old ice – Scientists from Aix-Marseille University in France discovered an ancient giant virus, dubbed Pithovirus sibericum, frozen in Siberian permafrost. Since the known giant viruses, Mimivirus and Pandoraviruses, infect ameobae, the group incubated permafrost samples with amoebae and watched for cell death.  Within these dying amoebae, the scientists, lead by Jean-Michel Claveria and Chantal Abergel, could visualize the virus within the walls of the amoebae via microscope.  Despite similarities with the other giant viruses in host, size, and shape, Pithovirus sibericum has very different properties including mechanism of replication and a much smaller genome.  As global temperatures rise and glaciers melt, the virome in the frozen environment may potentially have an impact on human health. (Ed Yong)

Rare gene protects against Type 2 Diabetes even in obese people – A mutation in one allele of a gene, known as ZnT8, has been shown to mitigate Type 2 diabetes even among the overweight and obese.  The gene was initially identified in a studying comparing 758 people on either end of the weight, age, and risk spectrum.  Of these 758 people, only 2 people in the high-risk group with diabetes had this mutation.  To confirm these results, the researchers added 18,000 people to their study and found an additional 31 obese individuals who were seemingly protected from diabetes.  The findings were further authenticated using bioinformatics.  Interestingly, the mutation of the gene has the opposite result in mice, causing Type 2 diabetes.  Researchers are now focuses on developing drugs which targets the ZnT8 gene. (Gina Kolata)

U.S. Army agriculture development teams – To help combat counterinsurgency in Afghanistan, the United States Army National Guard has deployed Agriculture Development Teams (ADT) made up of environmental scientists, engineers, and professors, who tackle projects aimed at improving agriculture and agricultural education in rural Afghanistan.  An example of militarized aid, this program is focused on small scale, local efforts to engender a good rapport with the United States Army and Afghan government in rural areas where counterinsurgency is problematic.  These projects not only involve endeavors such as delayed-action dams, but are also highly education focused, so the locals and universities can continue to reap benefits after the ADTs leave.  (Alexander Stewart)

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Written by sciencepolicyforall

March 6, 2014 at 2:37 pm