Science Policy For All

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Posts Tagged ‘cancer

Science Policy Around the Web – July 21, 2017

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By: Rachel F Smallwood, PhD

Source: pixabay

Cancer

Engineered Cell Therapy for Cancer Gets Thumbs Up from FDA Advisers

A panel of advisers has recommended that the FDA approve chimeric antigen receptor T-cell (CAR-T) therapy for treatment of acute B-cell lymphoblastomic leukemia. The committee unanimously agreed that the risk to benefit ratio was favorable enough to proceed with approval of the drug (tisagenlecleucel), manufactured by Novartis. CAR-T therapy utilizes a patient’s own immune cells to find and attack cancer cells. In a recent trial in humans, 82.5% of patients went into remission following treatment with the drug; there have also been promising results from its use in glioblastoma treatment. The treatment would specifically be for pediatric and young adult patients who did not respond well to initial treatments or who relapsed from being in remission.

Despite have strong positive effects, there are potential risks posed by CAR-T therapy. In the study mentioned above, almost half of the patients experienced an inflammatory reaction called cytokine release syndrome. Although all of those cases were treatable, the condition can be life-threatening. Novartis also reported neurological problems. Other CAR-T trials have had several deaths due to brain swelling, but those were in adult populations and were some differences in the therapies.

The FDA often does take the recommendations of its advisers, but there is much to consider in this decision. It would essentially be approving a living drug that is individualized to each patient; the patients’ own blood cells are sent to a manufacturing center, where they are genetically engineered to target leukemia cells. The cell population is then allowed to proliferate, and the entire process takes around twenty-two days. This process presents a quality assurance and control problem to the FDA. However, the target population typically has a poor prognosis and very few options, so the panel considers the potential for increased survival and quality of life to be worth the risks. (Heidi Ledford, Nature News)

Stem-Cell Therapy

Unapproved Stem-Cell Treatments Touted on Federal Database Clinicaltrials.Gov

ClinicalTrials.gov is an online database, curated by the National Library of Medicine and the National Institutes of Health, that logs clinical studies occurring around the country and allows them to be searched by patients, family members, healthcare providers, and researchers. The information on the site is provided by the researchers or sponsors of the individual studies themselves. It allows patients and healthy people to become aware of opportunities to participate in medical research. These studies involve a wide range of treatments, including drugs, devices, behavioral therapies, and procedures.

A recent study found that the database is being abused by clinics advertising for stem cell trials. These trials target individuals looking for treatment for a variety of conditions, and all of them charge for participation. There are very few FDA-approved stem cell therapies, and most clinics that utilize stem cell therapies assert that they do not need FDA approval since they are practicing medicine and do not substantially alter the stem cells (although that is disputed).  Since the researchers themselves indicate in the database whether they need FDA approval, there is little oversight to ensure these studies are correctly representing the risks and benefits of their treatment.

Although a disclaimer was added this spring that informs visitors that the presence of a trial in the database does not indicate government endorsement of it, many people do not realize that they could potentially be participating in a for-profit procedure that does not have the proper oversight to ensure patient safety. In one such case, three women were blinded who paid to receive stem cell therapy for macular degeneration. Most legitimate research studies will not require payment for participation, although travel and lodging costs associated with participation may be incurred.

While many patients may receive treatment at one of these clinics without an adverse event or even with a positive result, critics of these types of clinics are calling for regulation of entries into the ClinicalTrials.gov system. They assert that a federal resource for medical research should not be used to advertise for for-profit clinics that are utilizing therapies that have not been studied or reviewed for safety and efficacy. (Laurie McGinley, Washington Post)

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July 21, 2017 at 10:08 am

Science Policy Around the Web – June 23, 2017

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By: Saurav Seshadri, PhD

Drug Policy

Trump’s New Policy to Tackle Sky-High Drug Prices Makes Sense — Sort Of

Tackling high prescription drug prices was a repeated promise of the Trump campaign. The Trump administration has now taken its first step towards fulfilling this pledge, outlined in a blog post by Food and Drug Administration (FDA) commissioner Scott Gottlieb. The agency will pursue a Drug Competition Action Plan, whose goal will be to eliminate obstacles to the development of cheap generic drugs – particularly those caused by loopholes in existing FDA policies, which are exploited by pharmaceutical companies to extend their patent exclusivity period and maximize profits. An example of such ‘gaming’ the system, cited in the post, is the practice of limiting access to branded products for comparative testing by generic developers. Ultimately, the FDA will work closely with the Federal Trade Commission (FTC) to address such issues, since directly regulating business practices is outside its mandate.

On its face, the FDA’s effort is a step in the right direction. Availability of generics reduces the cost of medications by over half within the first year, and according to a recent Congressional report, manufacturers state that ‘competition…is the primary driver of generic drug prices’. However, it ignores evidence that the real driver of increased drug spending is new, branded medicines, not overpriced generics. In fact, early indications are that Trump’s policies will favor the pharmaceutical companies that produce such medicines, by reducing regulations and apparently abandoning his promise to enable the government to negotiate drug pricing through Medicare. Overall, these actions signal a commitment to promoting free market mechanisms in the pharmaceutical industry; time will tell whether this approach will actually lead to more affordable drugs. (Julia Belluz, Vox)

Cancer

In a Major Shift, Cancer Drugs go ‘Tissue-Agnostic’

With the landmark approval of Keytruda in May, the Food and Drug Administration (FDA) appears to have ushered in a new era of cancer drug development.  So far, cancer treatment and drug evaluation have largely used the tumor’s tissue of origin as a starting point. Keytruda (an immune system enabling drug developed by Merck and approved for melanoma in 2014) marked the first departure from this approach, receiving priority approval to treat any solid tumor containing a mutation in the mismatch repair pathway, regardless of context. Recently released data suggests that another tissue-agnostic cancer therapy is on the way: larotrectinib (a cell growth inhibitor developed by Loxo Oncology) showed high efficacy for any tumor with a certain biomarker (TRK fusion). Several other such drugs, whose indications will be based on tumor genetics rather than location, are in the clinical pipeline.

Although these advances have generated significant excitement in the cancer community, some caveats exist. First, identifying the patients that could benefit from tissue-agnostic treatments will require individual initiative and depend on the cost of screening, particularly when considering markers that are rare for a certain tumor type. A potential solution is suggested by the NCI-MATCH trial, part of the NIH’s Precision Medicine Initiative (PMI) – in it, patients can enroll in one of several parallel clinical trials if a corresponding drug-targeted mutation is found in their tumor’s genome. If these trials prove effective, patients could eventually be regularly matched with a personalized, tissue-agnostic, biologically valid treatment, based on a standardized screen.  Second, researchers caution that tissue-agnostic studies should have a strong scientific rationale and/or breakthrough-level efficacy. Otherwise, such efforts ‘could actually slow drug development if there are differential effects across tumor types by diverting resources from enrolling patients in a predominant population or in the tumor type most likely to respond’.

Despite these concerns, the tissue-agnostic paradigm offers great promise for cancer patients. NIH-funded resources such as The Cancer Genome Atlas could be invaluable to this field moving forward. (Ken Garber, Science)

Scientific Publishing

US Court Grants Elsevier Millions in Damages from Sci-Hub

A New York district court has awarded academic publishing giant Elsevier $15 million in damages from Alexandra Elbakyan, founder of the website Sci-Hub, for copyright infringement. Elbakyan, a 27-year-old neuroscientist turned programmer, started Sci-Hub in 2011 with the goal of ‘remov[ing] all barriers in the way of science’. The site allows users to download research papers that would normally be blocked by a paywall, by obtaining credentials from subscribing institutions and using them to access publisher-run databases like ScienceDirect. Over 60 million papers are posted on Sci-Hub, and users downloaded 28 million articles in 2016.

Elbakyan’s case is reminiscent of Aaron Swartz, another high-profile champion of open access to scientific research. Faced with federal charges related to his hacking of journal archive JSTOR, Swartz tragically committed suicide in 2013. Both Elbakyan and Swartz found publishers’ ability to profit from restricting access to scientific literature, effectively withholding knowledge from anyone outside of a privileged inner circle, as well as the legal protection provided to this system, to be deeply unethical. Their willingness to act upon these convictions has earned each a sizable following in the scientific community.

For their part, publishers claim that fees go towards overhead, and point to significant efforts to expand free and open access programs. While judges have so far been sympathetic, Elsevier’s legal battle has been largely one-sided. Elbakyan has been ignoring rulings requiring her to shut down Sci-Hub since 2015, opting to simply change domains instead, and since she is currently based in Russia and has no American assets, she is unlikely to pay any damages. (Quirin Schiermeier, Nature News)

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June 23, 2017 at 11:00 am

Science Policy Around the Web – April 7, 2017

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By: Kseniya Golovnina, PhD

Cancer Research

RNA-Seq Technology for Oncotargets Discovery

One of the most significant discoveries in cancer research, using the “Big Data” approach with experimental validations, was made recently by Chinese and American scientists together with Splicingcodes.com. They described the first cancer predisposition, familially-inherited, fusion gene, KANSARL, specific to populations with European ancestry, by using advanced RNA-sequencing (RNA-seq) of cancer transcriptomes.

A fusion gene is a hybrid formed from two previously separate genes as a result of chromosomal rearrangements. Often, fusion genes are oncogenes. The first fusion gene abnormality was described in a human malignancy and was called the Philadelphia chromosome. In the early 1980s, scientists showed that a translocation between chromosomes 9 and 22 led to the formation of a fusion gene (BCR/ABL1), which produced a chimeric protein with the capacity to induce chronic myeloid leukemia. KANSARL is the most prevalent cancer gene discovered so far. Scientists systematically analyzed the RNA-seq data of many cancer types from different parts of the world, together with RNA-seq datasets of the 1000 Genome Project. KANSARL fusion transcripts were rarely detected in tumor samples of patients from Asia or Africa, but occurred specifically in 28.9% of the population of European origin.

Scientists from Cancer Genome Anatomy project at the National Cancer Institute (NCI), using sophisticated sequencing techniques, have identified 10,676 gene fusions among cancer-related chromosomal aberrations. Splicingcodes.com has identified over 1.1 million novel fusion transcripts, many of which are likely biomarkers of diseases. Fusion genes play an important role in diagnosis and monitoring of cancer treatment progress by measuring the disappearance of the fusion and, thereby, the disappearance of the tumor tissue. Currently, several clinical trials are aimed at treating fusion-positive patients with a range of targeted therapies, which will hopefully lead to novel therapy development and save patients’ lives. (Splicingcodes)

Biotechnology

Turning Mammalian Cells into Biocomputers to Treat Human Disease

Engineering cells by manipulating DNA and controlling their performance is a growing field of synthetic biology. Scientists have been working with bacterial cells for years to perform different controlled actions, for example, lighting up when oxygen levels drops. Bacterial cells, including Escherichia coli, have a simple genome structure and are relatively easy to manipulate. Using bacterial cells, it was possible also to join several genetic circuits within a single cell to carry out more complex actions.

After successful engineering in bacteria, researchers have aimed to create genetic circuitry to detect and treat human disease in mammalian cells. Most of the attempts have failed due to the complexity of the mammalian genome, until a group of biomedical engineers from Boston and Basel, Switzerland decided to upgrade their DNA “switches”. They used an ability of special enzymes, DNA recombinases, to selectively cut and stitch DNA. The new system in mammalian cells is called ‘Boolean logic and arithmetic through DNA excision’ (BLADE). BLADE founders built a wide variety of circuits (113), each designed to carry out a different logical operation with 96.5% success. This Boolean system has great potential for applications in cell and tissue engineering. One exciting possibility is engineering T-cells with genetic circuits that initiate a suicide response to kill tumors when they detect the presence of two or three “biomarkers” produced by cancer cells. (Robert F. Service, ScienceNews)

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April 7, 2017 at 9:22 am

Science Policy Around the Web – October 21, 2016

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By: Leopold Kong, PhD

Source: Flickr, under Creative Commons

2016 Elections

The polling crisis: How to tell what people really think

The conflicting polling results for the US presidential elections have been a source of no small confusion for American voters. Skepticism over polling is further justified by recent failures, as in the 2013 provincial elections in British Columbia when the Liberal Party won against expectations, or the Brexit referendum. Two major challenges make polling less accurate, and changes are underway to address these issues.

The first major challenge is obtaining public opinion. In the past, pollsters can simply call people at home, but this is increasingly difficult with the rise of cell phone use. Currently, only 50% of US households have landlines compared to 80% in 2008. Federal regulations require mobile phones be called manually, and people often don’t answer cell phones from an unfamiliar number. People who do answer these numbers might represent a biased population. Despite these limitations, calling cell phones are more accurate than online polls, which are less regulated and could easily be manipulated. Using texting instead of direct calls could also increase response rates.

The second major challenge is predicting who will vote, which is particularly difficult in the US with low voter turnouts of about 45-50%. To predict this, each pollster organization uses a proprietary mix of factors such as voting history and political engagement. “Likely voter modeling is notoriously the secret-sauce aspect of polling,” says Courtney Kennedy, Director of survey research at the Pew Research Center in DC. Furthermore, these models may generate unconscious bias for pollsters to “herd” polling to better reflect predicted expectations. Improvements are underway, including using a probability model versus a discrete yes/no model, and greater transparency in methodology.

With the changing face of demographics and technologies, polling science is evolving to keep pace. (Ramin Skibba, Nature)

Health Policy

Two HPV shots instead of three

Human papilloma virus (HPV) is responsible for about 5% of all cancers in the world, including 70% of throat, neck and oral cancers, and 90% of all anal cancers. Originally, an effective vaccine was approved in 2006 for a three-dose regimen to confer protection. Since then, clinical data reviewed has shown protective efficacy with only two doses in Costa Rica. The Advisory Committee on Immunizations Practices at the Centers for Disease Control and Prevention (CDC) has now recommended two doses of the vaccines for pre-teen boys and girls.

“The pediatricians and other people I talked to said the new recommendation is a game changer with that schedule,” said Kevin Ault, MD, professor of OBGYN at the University of Kansas Hospital. “It’ll make it easier for the doctors, easier for the parents and easier for the kids.”

This recommendation is very timely, and may boost vaccination rates, which have risen very slowly so far. Teen girls getting the vaccine only increased from 60% in 2014 to 62.8% in 2015. Doctors have been timid about promoting the shots with parents, who may not want to have discussions about their children having sex. A lighter vaccination schedule may help. Furthermore, it reduces cost significantly for implementing the vaccine in low and middle-income countries, and thus may greatly aid in curbing the global cancer burden. (Associated Press, STAT)

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October 21, 2016 at 9:00 am

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Science Policy Around the Web – September 20, 2016

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By: Valerie Miller, PhD

Source: Flickr, under Creative Commons

Public Health

How More Kids Could Avoid the Dentist’s Drill

Earlier this summer, the question of whether or not to floss has gotten a lot of attention. As it turns out, there is not much evidence to support the idea that flossing can prevent cavities. Yet, for children, the use of dental sealants, which protect molars from plaque and decay, has been shown to reduce the risk of cavity formation by over 75 percent. According to guidelines from the American Dental Association (ADA) and the American Academy of Pediatric Dentistry, sealants can be used not only to prevent the start of tooth decay, but can also stop the progression of early decay that has already begun. An analysis of nine randomized control trials demonstrated that for each 1,000 sealants placed, 207 cavities would likely be prevented.

Despite overwhelming evidence that dental sealants can prevent tooth decay and cavities, sealants remain underused in children, with the CDC reporting that, in 2011-2012, only 41 percent of children between the ages of 6 and 12 had at least one dental sealant placed on a permanent tooth. This data also showed that 21 percent of kids between the ages of 6 and 12, and 58 percent of adolescents ages 12 to 19, experienced cavities in permanent teeth, demonstrating the underuse of dental sealants. Most concerning, of the kids in the 6- to 12-year age range, 44 percent of kids without dental insurance coverage were found to have untreated decay, indicating that kids in a population who don’t get regular dental care would likely benefit the most from the use of dental sealants. One way to reach more children is through the use of school-based programs, in which dental hygienists provide sealants in schools to at-risk students. Such programs have been shown to result in 50 percent fewer cavities in the following four years in students who received sealants, compared to students who did not get them.

Although the use of dental sealants is highly recommended by the ADA, concern has been raised because some sealant materials contain a small amount of bisphenol A (BPA), which has estrogenic properties. However, a 2010 study recommended the use of dental sealants while minimizing exposure by rinsing the mouth out after placement. In addition, despite ADA research and guidelines, a survey of dentists in 2011 found that 40 percent felt that sealing early tooth decay was not good practice, believing that decay may continue underneath the sealant. While it can be hard to change the mindset of getting rid of decay with a drill and filling, 24 percent of dentists reported that they didn’t currently seal early tooth decay lesions, but they would be willing to consider it. Thus, parents may have to ask for sealants for their children in order to receive them. (Katherine Hobson, FiveThirtyEight)

Cancer Treatment Guidelines

Prostate Cancer Treatment Doesn’t Save More Lives than Active Surveillance

In recent years, a number of concerns regarding prostate cancer screening have been raised by doctors, as screening may lead to so-called “over-treatment” of prostate cancer, increasing the risk of adverse effects while doing little to save lives. A new study published in the New England Journal of Medicine has shed light on this issue by demonstrating that 10-year outcomes following surgery, radiotherapy or “active surveillance,” which involves regular testing and monitoring of cancer progression while forgoing therapy, were nearly identical. In each case, the rate of death due to prostate cancer was around 1 percent. These results may help men who are reluctant to pursue treatment, which comes with adverse side effects including sexual and urinary dysfunction.

Although survival outcomes were nearly identical in all three groups studied, there were some differences noted between each group. For example, patients in the active surveillance group were found to have twice as much cancer progression, including metastasis to bone and lymph nodes, when compared with patients in either the surgery or radiotherapy group. While increased cancer progression did not necessarily lead to higher risk of death, nearly 55 percent of men in the active surveillance group chose to pursue surgery or radiotherapy after their cancers progressed. The results suggested that active surveillance is a safe choice, when taking into account various factors such as disease progression and aggressiveness, age, and overall health. For example, for men who are older and are suffering from other health issues, immediate action might not be necessary if diagnosed with prostate cancer, as these patients are more likely to die from other causes before dying from prostate cancer. Yet, for younger men who are diagnosed with prostate cancer when they are otherwise healthy, the choice to pursue treatment or active surveillance may be more difficult, due to the side effects from treatment, as well as the potential consequences and increased need for aggressive treatment if the cancer progresses. In any case, the results of this study will provide more information to help each patient make an informed decision regarding their treatment. (Alice Park, Time)

Sports Policy

Sorry Redskins Fans: Native American Mascots Increase Racial Bias

A debate that has perpetuated within the American sports world is the use of Native American mascots to represent sports teams. Proponents of Native American mascots argue that these symbols respectfully honor Native American history, while opponents believe that such mascots perpetuate negative stereotypes against Native American peoples. At the center of the debate is the Washington Redskins football team, which has faced numerous protests and lawsuits over the use of “Redskins” as a team name. Team officials have used the results of a recent Washington Post survey, which found that 9 out of 10 Native Americans don’t take offense to the use of “Redskins” to represent the team, as evidence that a change isn’t needed. However, polls and studies such as this ignore the possibility that the use of Native American imagery may affect how others perceive Native Americans, potentially reinforcing stereotypes.

Recently published research has provided evidence that Native American imagery could induce implicit bias. Study participants were unaware that their viewpoints regarding Native Americans were being affected by the images they were shown. These results led researchers to conduct a “real-world” study, which examined if there were differences in attitudes towards Native Americans when comparing participants from cities that host teams with Native American mascots, to participants from cities with neutral sports mascots. The study found that residents of cities with Native American mascots were more likely to associate Native Americans with warlike traits, thus demonstrating that incidental exposure to such representations can influence perceptions regarding actual members of a certain group, and cause the active promotion of stereotypes within the general population. (Justin Angle, The Washington Post)

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September 20, 2016 at 10:04 am

Science Policy Around the Web – July 1, 2016

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By: Daniël P. Melters, Ph.D.

Image source: Scientia Salon blog

Research Participant Protection

National Academy of Sciences advises White House to rewrite Common Rule

In order to protect participants of clinical studies from being harmed by the very same studies, a set of regulations was set-up for this purpose. These regulations are called the Common Rule and most researchers will encounter the Common Rule when they submit their proposal for ethical review with their local Institutional Review Board (IRB). The rules (45 CFR 46) that apply today were drafted back in 1991 and have not been updated since. Thus last year the U.S. Department of Human and Health Services (HHS) proposed a major revision. The proposal was greeted with criticism and on June 29th, 2016 the National Academy of Sciences, Medicine, and Engineering (NAS) joined the critics. According to the NAS, the HHS proposal is “marred by omissions, the absence of essential elements, and a lack of clarity.” Therefore, NAS made bold suggestions to the Obama administration withdraw the proposed revision to the Common Rule and create a independent national committee modeled on the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research to essentially rewrite the Common Rule from scratch. (Rob Stein, NPR News)

Science Funding

Interdisciplinary research proposal are less frequently funded

Although interdisciplinary research is frequently praised and encouraged, funding such projects has proven to be difficult. The latest report by an Australian group is similar to those conclusions drawn by the U.S. National Institutes of Health (NIH) before it launched the Roadmap for Medical Research in 2004 to stimulate interdisciplinary research. What makes the most recent Australian study stand out is the metric they developed to determine how interdisciplinary a proposal was. This metric is called “interdisciplinary distance”. The measure assigns a value between 0 and 1 on the basis of the information included in the proposal. A value of 0 represents a proposal that only covered one discipline, whereas all other proposals would receive a value up to 1 depending on how distant and abundant the disciplines were. The method is similar to a biodiversity metric that takes into account the distance between species on an evolutionary tree and their relative abundance in an ecosystem. The group then analyzed over 18,000 proposals submitted to the Australian Research Council Discovery Programme between 2010 and 2014. Betsy Wilder from the NIH Office of Strategic Coordination wants to use the new metric to see if the Roadmap has made progress in funding interdisciplinary research over the last 10 years. (Elena Bozhkova, Nature News)

Cancer MoonShot

Vice-President Biden threatens to cut funding to non-compliant medical research institutes

During the 2016 State of the Union, President Obama revealed his latest biomedical initiative: the moonshot to cure cancer. This initiative is led by Vice-President Joe Biden. The goal of this initiative is to stimulate collaborative research to accelerate the potential of combination immunotherapy as the next generation standard for cancer treatments. The goal is to initiate randomized Phase II clinical trials in patients at all stages of disease in 20 tumor types in 20,000 patients within the next 36 months. These findings will inform Phase III trials and the moonshot to develop an effective vaccine-based immunotherapy to combat cancer by 2020. On June 29th, 2016, Biden attended the National Cancer Summit at Howard University. Here he made comments following a STAT investigation revealing frequent lapses in reporting clinical trials. If this is found to be true, Biden promises to cut funding. This falls in line with new rules imposed by the National Institutes of Health that will help crack down on institutions that lapse, not just individual investigators. In addition, the Food and Drug Administration (FDA) will soon be able to impose a $10,000/day fine to non-compliant companies. All together, this is a push to make clinical trials funded with public money be part of the public record and thereby facilitate collaborations and accountability. (David Nather and Charles Piller, STAT news)

Natural Resources

Large helium reserves found in Tanzania

Everyone knows helium for one of two things: 1) keeping balloons afloat and 2) making people sound funny. Nevertheless, helium is a remarkably important gas, especially in medicine and science. To keep the magnets of an MRI machine cool, it requires helium. To keep the Large Hadron Collider at CERN running, it needs helium. Helium is also used in other industries that require superconductivity. It is a naturally occurring gas that is formed from decaying uranium and thorium, but this is a slow process. Furthermore, helium does not react with anything (ergo its important role in cooling) and is very light. As a result, helium escapes to the atmosphere quickly and cannot be retrieved. The great demand on helium has led to several moments of shortages. It has been vital to discover a new deposit on helium.

To date, helium was only extracted as a by-product of oil and gas drilling, but these deposits only contain a small amount of helium. By understanding how helium is released from rocks, a team of researchers have devised a method to explore for helium in a new and specific way. Just like other gasses, released helium has to be trapped by underground formations. Using the same kind of seismic studies in oil and gas exploration, helium can be recovered. An area in the Tanzanian part of the East African Rift was proposed to be a prime candidate region to find helium. Indeed, a large amount of helium was discovered there. As much as 1.5 billion cubic meter of helium is thought to be trapped. This is more than twice the amount that is currently stocked at the Federal Helium Reserve near Amarillo, TX. This reserve supplies 40% of the helium used in the U.S. (Henry Fountain, NY Times)

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July 1, 2016 at 2:00 pm

Global disparities in cancer treatment and recent policies to address cancer care

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By: Nivedita Sengupta, Ph.D.

photo credit: phalinn via photopin cc

According to American Cancer Society more than 8 million people worldwide die from cancer every year. The number of deaths worldwide from communicable diseases like malaria, HIV and AIDS is insignificant compared to the number of global deaths from cancers which is expected to cross the 13 million mark by 2030, making cancer the leading cause of death worldwide. Cancer as a non-communicable disease has long been considered a disease of developed countries, where people are more likely to succumb to long-term chronic diseases rather than dying from infectious diseases. However, according to statistics from the World Health Organization (WHO) and American Cancer Society, of the 14.1 million new cancer cases reported worldwide in 2012, 6.1 million were from developed countries compared to 8 million in developing countries – and these numbers are still rising. The number of new cancer cases in developing countries is predicted to rise to 13.1 million by 2030. These discrepancies between developed and developing countries are also apparent in childhood cancers. Childhood cancers account for less than 1% of the total cases in developed countries but about 4% in developing countries. Considering that reliable data on incidence are only available for a fifth of the world population consisting of people in mostly high-income countries, the actual statistics on cancer in developing countries may be even higher making cancer a significant and growing health burden in developing countries.

Escalation of cancer cases in developing countries over the past years has resulted in an increase in cancer-related health care costs, building up a global financial burden due to cancer. In 2010, $290 billion was spent to treat 13.2 million new cancer cases worldwide and this spending is projected to increase to $458 billion by 2030. Despite a wealth of data on how to diagnose and treat cancer, funding for cancer remains a low priority in context of health spending for both developing countries and for the nations providing donations. Only 5% of global resources devoted to cancer are spent in developing countries. In 2014, total global funding for development assistance for health was $35.9 billion, and only 2% of that amount was allocated for assistance in the area of non-communicable diseases of which cancer is only one aspect. This sets up an untenable situation as developing countries do not have the resources to tackle the rising human cost of cancer within their borders and necessitates significant global interventions and funding.

One potential in-country way to combat and prevent many of the deaths from cancer could be by raising awareness of the signs and symptoms of cancer among the general population, as well of awareness of proven ways to prevent cancer. A 2007 study on breast cancer in Malaysia found that 52.2% of newly diagnosed patients have stage III and IV cancers due to a lack of awareness of the signs and symptoms of cancer leaving them to seek treatment further into the disease progression. Most of these women were from rural Malaysia, with little or no education. Earlier screening for these and other cancers could help prevent cancer deaths. The major cancer types found in the developing countries are breast, cervical and colorectal cancer. Many of these cancers respond to treatment if detected early and treated adequately. However due to lack of cancer diagnosis facilities, by the time cancer is detected in these poor people it progresses to a stage where palliative care becomes the only option. In another example, potentially up to 20% of cancer deaths in developing countries could be prevented by immunization against HBV and HPV infections. Public-private global health partnerships like GAVI Alliance have partly facilitated the availability of HPV vaccines in the poor countries such as Kenya, Ghana, Madagascar, Malawi, Niger, Sierra Leone and the United Republic of Tanzaniato. However, poor people living in the middle income countries like China, Malaysia, India and Brazil are excluded from this initiative due to their country’s slightly higher income.

Another significant problem needing attention is a lack of proper infrastructure (in terms of equipment and people) for cancer treatment in developing countries. Currently, treatment options in developing countries are very limited and expensive. In developed countries people can have better health care coverage and access to up-to-date cancer care facilities and treatment, in addition to dedicated cancer research centers and specialists. Most developing countries have limited treatment centers with proper infrastructure and oncologists. According to the International Atomic Energy Agency (IAEA), even though 85% of the world’s population resides in developing countries, the average number of pieces of therapy radiation equipment in developing countries is only 0.4 units per million inhabitants, compared to more than six units per million inhabitants in developed countries. The few developing countries who are privileged enough to have access to radiotherapy equipment face considerable financial burdens in then providing the necessary training, equipment set-up and maintenance, protocols and quality control for proper usage of these machines for cancer treatment. Oncology and palliative care training is limited in medical schools and very few doctors and nurses can afford to have training outside their country resulting in lack of sufficiently trained staff in developing countries to deal with the increasing load of cancer cases.

Even treating cancer patients at all can be difficult in developing countries. Apart from expensive cancer drugs themselves, pain medications for palliative care like morphine are not easily available in these countries. Statistics show that 99.9% of cancer patients in developing countries are dying with untreated pain. 84% of the morphine used globally goes to the developed countries, leaving just 16% for the rest of the world. This is not because of limited morphine production but rather mainly because of onerously complicated and expensive narcotic supply regulations set by the International Narcotics Control Board (INCB). The structure of surveillance and accountability requirements implemented by INCB makes it almost impossible for poor nations to comply because of poor infrastructure and lack of educated people to handle issues necessary to comply with the regulatory needs. Moreover, country specific regulatory laws make it harder for the doctors to prescribe these medicines. All patients in need of pain relief could be helped if proper laws are implemented to gain access to pain medication and palliative care.

Drug companies themselves can help to address these health disparities in developing countries. On March 31st 2016, GlaxoSmithKline (GSK) CEO Andrew Witty announced a series of new patent policies designed to make innovative GSK medicines available to more people living in under-developed and developing countries. The new polices have a special focus on improving access to cancer drugs specifically. In the policy, GSK plans to stop filing for patents on its molecules in 50 of the least developed and low-income countries. In developing lower-middle-income countries, GSK will continue to file for patents but will grant licenses to generics manufacturers. This will enable easier access to cheaper generic versions of GSK’s drugs in those countries for the treatment of cancer. Furthermore, GSK will submit patents on future cancer drugs it develops to the United Nations-backed Medicines Patent Pool (MPP). The MPP deals in large-scale licensing agreements between drug developing companies and generics manufacturers thus enabling greater access to medicines in up to 127 developing countries. GSK has been applauded for this venture and the initiative also reveals the growing awareness among people regarding the magnitude of disparities in cancer care around the world. However experts says that a lot more still needs to be done in terms of improving access to needed medications. Ironically, most of the world’s poor live in ‘middle income’ countries such as China, India and Brazil that are not included in these polices and therefore will not gain anything from these new measures.

To reduce the death burden due to cancer in developing countries significant funding is needed, and one key challenge is how to obtain that funding. International advocacy is required to mobilize the international community and individual governments to take action. A number of influential international advocates like the UN, WHO and IARC are already active and trying to form partnerships with international health professionals, non-government organizations (NGOs), and funding organizations to bridge the gap between funding and treatment. By taking the necessary steps in proper direction to strengthen cancer prevention, early detection, treatment and palliation, much can be done to help improve cancer control in developing countries.

Written by sciencepolicyforall

May 23, 2016 at 9:00 am