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Posts Tagged ‘genetic testing

Science Policy Around the Web – March 18, 2017

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By: Joel Adu-Brimpong, BS

By James Tourtellotte, CBP Today [Public domain], via Wikimedia Commons

Public Health Policy

Missing the Brush Strokes while Gazing at the Bigger Picture

Last Wednesday, the House Committee on Education and the Workforce approved a little-advertised bill called HR 1313, or the genetic testing bill, with partisan-line voting (all 22 republicans in favor and all 17 democrats opposed). Overshadowed by the highly publicized, contentious debate over the Affordable Care Act repeal-and-replace efforts, this bill has remained largely undetected by the media as it traverses congress. This genetic testing bill would not only enable employers to require their employees to undergo genetic testing but also allow employers access to the genetic information, according to an article by STAT news. Employees refusing such requests could be at risk for thousands of dollars in penalties.

Current legislation, including the Americans with Disabilities Act (ADA) and the 2008 Genetic Information Nondiscrimination Act (GINA), prohibit such authority by employers, preventing requests by employers for “underwriting purposes”, which include “basing insurance deductibles, rebates, rewards, or other financial incentives on completing a health risk assessment or health screenings.” Additionally, genetic information provided to employers must be de-identified and aggregated to protect individual identities.

The HR 1313 bill would circumvent current legislation by nullifying these protections as long as the genetic test requests are part of “workplace wellness programs.” Employers purport that the ADA and GINA are “not consistent with the well-established and employee protective wellness program regulatory framework under HIPAA.” They argue that the House bill will aid in aligning the ADA and GINA with laws about workplace wellness programs. Conversely, experts including Jennifer Mathis, director of policy and legal advocacy at the Bazelon Center for Mental Health Law, and Nancy Cox, president of the American Society of Human Genetics, have come out against the bill. In an opposition letter to chairwoman Representative Virginia Foxx (R-N.C.), and ranking member, Robert Scott, of the U.S. House Committee on Education and the Workforce, critics of the bill state that “Workplace wellness programs are fully able to encourage healthy behaviors within the current legal framework: they need not collect and retain private genetic and medical information to be effective. Individuals ought not to be subject to steep financial pressures by their health plans or employers to disclose their own or their families’ genetic and medical information.” Nonetheless, with the possibility of such infringement, we remain lost in the bigger debate surrounding Affordable Care Act repeal-and-replace efforts with little regard for subtle components like HR 1313. (Sharon Begley, STAT news)

Infectious Diseases

Here We Go Again? The Re-emergence of Yet Again, Another Arbovirus

The recent resurgence of arboviruses, or ARthropod-BOrne viruses, in the Americas is concerning. While the 1990’s saw the reemergence of Dengue and the West Nile, Chikungunya resurfaced in 2013 and, recently, Zika in 2015. With South and Central America and the Caribbean still reeling from the reemergence of these viruses, another arbovirus appears to be making a comeback. Over the past weeks, a fifth arbovirus has been detected. Per a perspective piece co-authored by Dr. Anthony Fauci, infectious disease expert and director of the National Institute of Allergy and Infectious Diseases, there are on-going outbreaks of yellow fever in Brazil.

As of February 2017, there have been 234 reported cases and 80 confirmed deaths, with many other infections pending investigation. In context, the number of reported cases currently exceeds previously observed rates of infection for this time of the year. Regionally, the reported cases appear localized to rural areas in southeastern Brazil, chiefly Sao Paulo, Espirito Santo and Minas Gerais. According to the article, current cases appear to be “sylvatic” or jungle cases, with transmission occurring primarily between forest mosquitoes and non-human primates. Thus far, there is no evidence to suggest human-to-human transmission via the infamous Aedes aeqypti mosquito. Humans currently serve as “incidental hosts.” However, the propinquity of the affected areas to major urban centers in Brazil, where routine coverage of yellow fever vaccination is low, is alarming.

Experts posit that the likelihood of spread to the continental United States is low. However, they caution, “In an era of frequent international travel, any marked increase in domestic cases in Brazil raises the possibility of travel-related cases [anywhere].” A particularly poignant example in the article is the December 2015 large urban yellow fever outbreak in Angola and subsequent spread to the Congo. This led to an exhaustion of the world’s emergency supply of vaccines for epidemic response, “prompting health authorities to immunize inhabitants in some areas using one fifth of the standard does in order to extend vaccine supply.” Amidst these critical times of global health crises, threatened cuts to U.S. global health support will likely be catastrophic for developing nations. (Madison Park, CNN)

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March 18, 2017 at 9:31 pm

Science Policy Around the Web – October 16, 2015

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By: Sylvina Raver, Ph.D.

Photo source: pixabay.com

Nutrition Policy

How agriculture controls nutrition guidelines

Every five years, the nutritional recommendations that help Americans make healthy dietary choices are revised to reflect the current state of nutritional and health science. Although only 4% of Americans adhere to these Dietary Guidelines for Americans (DGAs), DGAs have a huge impact. For example, physicians routinely use them to advise patients on how to stay healthy. DGAs also affect billions of dollars in government spending as they inform meal content for military personnel, those helped through the Women, Infants and Children (WIC) program and the Supplemental Nutrition Assistance Program (SNAP), and US children who are served public school lunches.

The process of updating DGAs involves compiling the recommendations of the Dietary Guidelines Advisory Committee (DGAC), a panel of scientific experts who distill thousands of scientific studies into an advisory report, with comments from the public and input from federal agencies. For the first time, the 2015 DGAC report recommended that sustainability of food sources be considered in the final 2015 DGAs. Sustainable diets are defined by the United Nations as those with “low environmental impacts which contribute to food and nutrition security and healthy life for present and future generations,” and the recommendation to consider sustainability is within the statutory bounds of the DGAC as defined in 1990. Proponents of the sustainability language emphasize the importance of considering the environmental impact of food production, and argue that nutrition is influenced by agricultural practices; for example, wild-caught fish or grass-fed beef is generally more nutritious than farm-raised fish or corn-fed beef. Opponents argue that sustainability is beyond the scope of the DGAC and accuses the committee of writing the recommendations from a political perspective rather than a scientific one.

Unsurprisingly, considering the extent of government funding that is influenced by the DGAs, the 2015 DGA revision process has come under constant attack by the agricultural industry. On Wednesday October 7, during a meeting of the House Committee on Agriculture, chaired by Representative Mike Conaway of Texas, Secretary of Health and Human Services Sylvia Burwell and Secretary of Agriculture Tom Vilsack conceded that the 2015 DGAs were not “…the appropriate vehicle for this important policy conversation about sustainability” as a “matter of scope,” and that sustainability would not be a factor in the 2015 DGAs. The sustainability debate will likely resume in 2020 when the DGAs are next revised.  (James Hamblin, The Atlantic; Kathleen Merrigan et al., Science; Sandra Hassink & Steven Stack, The Hill)

Scientific Funding

Neuroscientist team calls for a National Brain Observatory

A team of six influential neuroscientists has proposed the creation of a national network of neurotechnology centers that they’re calling the National Brain Observatory. The same group of scientists, dubbed “the Kavli six” due to their affiliation with The Kavli Foundation, is credited with drafting a proposal to map the activity of the living brain that would become President Obama’s Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative announced in Spring 2013. The first round of BRAIN funding was awarded mostly to individual labs or multi-lab research teams. In an opinion article published October 15 in the journal Neuron, the Kavli six call for the next step in the BRAIN initiative: a coordinated effort to synergize the discoveries made by the multiple individual laboratories funded by BRAIN. The scientists believe that the technological challenges facing neuroscience necessitate large investments in advanced technologies that are beyond the scope of any individual lab or research institution, similar to the national telescopes and particle accelerators used in the fields of astronomy and physics.

The goal of the National Brain Observatory proposal would be to expand shared access to four types of expensive technologies required to map the brain’s structure and activity: 1) large scale electron microscopes, capable of magnifying objects by more than 10 million times; 2) fabrication facilities to develop nanosized electrode systems capable of recording the activity of large networks of neurons with minimal damage to brain tissue; 3) new optical and magnetic resonance imaging (MRI) facilities to monitor the dynamics of neural circuits in real time; and 4) advanced electronic storage and computational data mining to collect and analyze vast amounts of data.

The Kavli six suggests that such technologies could arise from existing Department of Energy (DOE) National Labs around the country, such as Argonne National Laboratory in Illinois, or they could be housed in newly created facilities. The group argues that the experimental challenges being undertaken by the BRAIN Initiative, and by the neuroscience field at large, can only be surmounted through “highly coordinated, multi-investigator, cross-disciplinary efforts” such that a National Brain Observatory would permit. (Emily Underwood, ScienceInsider)

Genetic Testing

The crowdsourcing site that wants to pool our genomes

Two geneticists have launched a new crowdsourcing science project to collect the genetic data generated by direct-to-consumer (DTC) companies like Ancestry.com and 23andme.com. The project, called DNA.LAND, is a non-profit website created by Drs. Yaniv Erlich and Joe Pickrell and is affiliated with the New York Genome Center of Columbia University. DNA.LAND urges potential users to “Know your genome; Help science,” and the platform is designed to give participants ancestry and relationship data, as well as help to fill in missing sequences of DNA overlooked by DTC companies through a method called imputation. Although some of these functions are already provided by DTC companies, these companies compare users’ genetic information within individual company databases, and customers may miss out on connecting with relatives who have had their genetic information sequenced elsewhere. DNA.LAND compiles genetic information from multiple DTC companies, thus creating a dataset that is beyond the scope of anything amassed to date. To the extent to which users consent, scientists can then use this vast pool of genetic data to tackle research questions that require very large sample sizes. The project’s founders also envision linking DNA.LAND data with that from other sources, such as from activity tracking devices like Fitbits, or from social media activity that might indicate someone’s sleep patterns or mood fluctuations.

Privacy concerns are obvious. The site’s consent form contains minimal medical and legal jargon to describe guidelines that the founders say should lessen many of the privacy risks, such as not sharing personal identification information or genetic data with third parties without the user’s explicit permission. Still, the form contains the important caveat that the chance of a confidentiality breech is not zero and sharing data of this type carries inherent risks. Indeed, in 2013, Dr. Erlich and colleagues authored a study that revealed that men who have had their full genomes sequenced could be re-identified based on short DNA sequences found on their sex chromosomes.  To help ease users’ privacy concerns, both of DNA.LAND’s Principal Investigators adopt a “skin in the game” philosophy by making their own personal genomes publicly available. They are not alone; by October 15, less than a week after the site went live, nearly 6,000 genomes have already been uploaded. (Ed Yong, The Atlantic; Erika Check Hayden, Nature; Andrea Anderson, GenomeWeb)

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Written by sciencepolicyforall

October 16, 2015 at 9:00 am

Science Policy Around the Web – October 14, 2015

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By: Amy Kullas, Ph.D.

photo credit: Cell Culture via photopin (license)

Reproducibility in science

Researchers do not bother verifying the identity of their cell lines

Despite being warned years ago, more than 50% of biomedical researchers admitted in a recent survey that they do not confirm the identity of their established cell lines. The confirmation process includes validating the species, tissue-type, and gender of the cells. Even those researchers that had confirmed their cells were labeled correctly, most did not use the ‘gold-standard DNA-based testing method.’ Contaminated cell lines waste valuable research funds and undermine research findings.

Unfortunately, not much has changed in cell line validation or cell culture practices in the past decade. Dr. Leonard Freedman, president of the Global Biological Standards Institute, said that “while support for change is strengthening, the scientific community has still not embraced cell authentication as an expected part of the research process.” He pointed to the issue of how cell identity directly contributes to data irreproducibility and encourages journals to refuse to publish manuscripts unless the authors describe how they validated cell lines used. Nature conducted an analysis from 60 manuscripts and found that only 10% of authors had validated their cell lines. Following that dismal finding, Nature and its associated research journals implemented a policy in May requiring “authors to check the cell lines used against a database of almost 500 known misidentified cell lines and to provide details about the source and testing of the cells.” (Declan Butler, Nature News)

Biomedical funding

NIH continues to reduce award funding

The National Institutes of Health (NIH) released a notice at the beginning of October, that continuing awards for fiscal year 2016 will be funded at a lower level than previously committed (approximately 90%). However given the NIH has been slated for a billion-dollar increase, the agency may return funding to 100% of the awarded amount after a final appropriation.

Global health

Polio remains endemic only in Pakistan and Afghanistan

On September 25, 2015, the World Health Organization announced that polio is no longer endemic in Nigeria, leaving wild poliovirus only spreading in Pakistan and Afghanistan. July 2015 marked one full year without a new case of polio being reported in Nigeria, taking the country and Africa close to being ‘certified polio-free’. This was a monumental accomplishment for Nigeria because as recently as 2012, Nigeria was credited for over half of all polio cases globally. The WHO wrote: “Eradicating polio will be one of the greatest achievements in human history, and have a positive impact on global health for generations to come.” (Sona Bari, Oliver Rosenbauer, and John Butler, World Health Organization News Release)

Genetic testing and scientific patents

Australia rules a genetic sequence is not a “patentable invention”

On October 6, 2015, Australia’s highest court ruled that “an isolated gene sequence is not a ‘patentable invention.’” This ruling mirrors legislation established in the United States, South America, and most of Asia. The European Union and Canada allow human gene patenting if the biological material has been isolated by a ‘technical process’.

In 2010 a cancer survivor, Yvonne D’Arcy, challenged patents over the BRCA1 and BRCA2 genes held by the Melbourne-based Genetic Technologies and the U.S. firm Myriad Genetics. BRCA1 and BRCA2 are human genes that encode tumor suppressor proteins, which can help repair damaged DNA and contribute to the stability of a cell’s genetic material. If mutations are present in one or both of these genes, the cells are more likely to divide and rapidly change, significantly increasing a woman’s likelihood of developing breast and ovarian cancers. Myriad had used the genetic information to develop diagnostic tests over which it and its international counterpart had a monopoly.

This decision allows hospitals in Australia to be free to perform genetics testing, perhaps even to develop their own assays, without many consequences from large biotech companies. However the biotech community feels differently and views the ruling as ‘blow to innovation’ while predicting the decision to have ‘significant negative impact’ on new and innovative medicines and innovations. Though Myriad’s patents have expired, the company estimates it had spent more than $1 billion over 25 years to develop its facilities and resources and the tests used on 2 million patients. (Leigh Dayton, ScienceInsider)

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October 14, 2015 at 9:00 am

Regulating laboratory tests for accuracy and patient safety

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By: Cheryl Jacobs Smith, PhD

On June 13, 2013, the Supreme Court ruled that Myriad Genetics did not own the sole rights to the genetic testing of genes involved in breast cancer susceptibility, BRCA1 and/or BRCA2 (1). Therefore, diagnostic companies and academic institutions could then create their own diagnostic tests surrounding BRCA1 and BRCA2. However, since the ruling, as more and more companies and academic centers are taking advantage of the “open market” on diagnostic tests, a question arises: Are all of these diagnostic tests appropriate for the clinic and safe for patient use?

The Food and Drug Administration (FDA) would certainly say no. In a document issued on October 3, 2014, the FDA outlined a draft guidance addressing gaps and areas of improvement related to the regulatory oversight of diagnostic tests (2). In the draft guidance, the FDA emphasized that the subset of in vitro diagnostic devices (IVDs) referred to as laboratory developed tests (LDTs), should have additional regulatory oversight to assure their safety and efficacy. Some recommendations include: adverse event reporting, an option to remove unsafe LDTs, critical evaluation of clinical validity and reproducibility of LDTs, and structured guidelines for informed consent.

Since 1976, the Medical Device Amendments (MDA), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), established a rubric for the regulation of medical devices intended for human use (3)(4). It was amended to make explicit that the act include IVDs, and thus, LDTs. The definition of an IVD applies equally whether it is manufactured by conventional manufacturers or by individual laboratories. However, since the implementation of the MDA of 1976, the FDA has enforced applicable provisions with respect to LDTs under the FD&C Act at the manufacturer’s discretion. Thus, enforcement discretion for LDTs developed as a matter of general practice rather than by law.

The Centers for Medicare and Medicaid Services (CMS) has regulated LDTs (with research LDTs exempt) since 1988 under the Clinical Laboratory Improvement Amendments (CLIA—42 U.S.C. 263a) (5). Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct responsibilities to either Medicare or Medicaid. CLIA governs the accreditation, inspection, and certification process for laboratories. However, the statutes of CLIA do not evaluate test validity prior to marketing, nor do they assess the clinical validity of a LDT. This regulatory gray area poses a couple of questions: Can the LDTs actually identify the biological events that the manufacturers claim? And, if so, with what accuracy in the tested population? These are very important questions when the result of a particular test could determine medical treatment. Therefore, although CLIA oversight is important, it alone does not ensure that LDTs are properly designed, appropriately manufactured, and are safe and effective for patient use. With the large regulatory gaps that still exist in the LDT market, how is it that this has gone on for so long without being addressed?

Initially, when LDTs were used to measure blood type or one or two biological markers at a time, CLIA accreditation was sufficient. However, due to changes in the complexity and use of LDTs, and with the advent of complex algorithms accompanied by computational analysis, CLIA requirements alone have become inadequate. Learning this information may make consumers uneasy to have any sort of test done by a medical office in the near future. Yet, is the current state of affairs of LDTs this dire?

I have been fortunate to witness the process by which an LDT is developed. From what I observed, the process appeared highly regimented, rigorous, and repeated to ensure accuracy and specificity of both the test and the instrument running the test. The diagnostic laboratory was not only CLIA-certified but was also certified by the College of American Pathologists (CAP) Laboratory Accreditation Program that “[…] test disciplines with the most scientifically rigorous customized checklist requirements.” (6) Under CAP-certification, laboratories must maintain the accuracy of test results and ensure accurate patient diagnosis, as well as have mechanisms in place to correct cited deficiencies. In that setting, the manufactured LDTs met the CLIA and CAP-certification requirements and included data on LDT specificity, accuracy, and clinical validity to discern between various biological conditions. Consequently, for this laboratory and others with CLIA and CAP-certification, additional oversight by the FDA could prove to be redundant and burdensome slowing down LDT production and availability, in turn potentially negatively impacting patient care. However, not every laboratory that manufactures LDTs conforms to this high level of scientific and medical integrity. Therefore, how can LDTs be regulated so that consumers can be confident in the methodology and reliability of LDTs without stifling LDT production and innovation?

The FDA proposes to amend the regulations surrounding LDTs by implementing a risk-based approach toward oversight of LDTs. Similar to how other medical devices are categorized into risk classes (I-III with I being the lowest risk and III the highest risk), LDTs would be classified based on risk to the patient and/or user and receive appropriate regulations commensurate to the risk level. With the exception of some LDTs solely used for forensic purposes and those used in CLIA-certified, high-complexity histocompatibility laboratories, those laboratories with high, moderate, and low risk LDTs would be required to enforce applicable regulatory requirements that include registration and listing, adverse event reporting, pre-market review, and quality system requirements. If the FDA guidelines become regulatory law for LDTs, patients would gain a comprehensive database of reliable LDTs increasing patient flexibility with whom they choose to do the LDTs and perhaps reduce costs if saturated markets are filled with reliable LDTs rather than a mixture of quality. Additionally, LDT manufacturers would be able to scrutinize tests more comprehensively instead of relying on word-of-mouth or anecdotal evidence to improve unreliable tests.

The suggested increased regulation of LDTs by the FDA may seem burdensome but would achieve a more comprehensive manner to regulate and equalize the validity of LDTs on the market. If anything, it would be helpful to have LDT pre- and post-market evaluations standardized as these measures uncover important medical device mishaps that frequently save patients from unnecessary harm or distress (7). The Diagnostic Test Working Group (DTWG), an independent group consisting of representatives from diagnostic manufacturers and clinical laboratories, suggested adopting some, but not all, of the FDA’s recommendations. Most importantly, the group stressed that this new legislation should require LDT manufacturers to register the LDT with the FDA but that additional oversight concerning sensitivity, specificity, and validity should be applied to LDTs only in the high risk class. Furthermore, DTWG suggested that the FDA should create an additional center for LDTs (8). The later should be seriously considered as FDA is excellent in drafting regulatory frameworks that ensure patient safety, but frankly lack the money and thus, people power to execute its regulations effectively. New LDT regulation may be needed, but without increasing the FDA’s budget to allow swift and effective execution of the FDA’s recommendations, this LDT legislation could ultimately just be black ink on white paper.

Written by sciencepolicyforall

June 10, 2015 at 9:00 am

Science Policy Around the Web – June 2, 2015

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By: Kaitlyn Morabito, Ph.D.

photo credit: GENE A101 via photopin (license)

Genetic Information Non-discrimination Act (GINA)

Test for ‘devious defecator’ was unlawful, judge rules

The Genetic Information Non-discrimination Act (GINA), which protects people from health care and employment discrimination based on their DNA, is being used in court for an unlikely case. A mysterious person had been leaving feces in a warehouse run by Atlas Logistics Group Retail Services near Atlanta. In an effort to solve the mystery, two employees suspected of being involved were threatened with losing their jobs if they did not take a DNA test. The DNA was then compared to the DNA in the fecal sample. The samples were not a match showing that these employees did not commit the crime. Despite being cleared, the employees sued the company citing humiliation. The employees won the lawsuit with the judge ruling that using a DNA test to identify the employees was a violation of GINA, even though there were no disclosure of medical information. In this case, the judge argued that even though they weren’t using the test to check for genetic disorders, the information they received could have been used for this purpose. This case suggests that GINA can be more far-reaching than originally intended. (Nita Farahany, The Washington Post)

GMO Debate

A proposal to modify plants gives GMO debate new life

A process dubbed “rewilding” where scientists re-introduce genes lost through years of breeding back into plants is sparking a new debate in the labeling of genetically modified organisms (GMO). This technique may be used to bolster fragile organic crops using “precision breeding” where modern molecular biology techniques are used to insert or delete genes. By US law, organic non-GMO foods cannot contain any “foreign” genes which could not have occurred in nature in that organism. Since rewilding is introducing genes, which have previously been in the plant, this may not be considered GMO by US standards. The EU, however, uses a different definition. The EU’s definition revolves around the process of genetic engineering to introduce genes, making rewilding a GMO in the EU. Regardless of whether rewilding would be considered GMO, opponents of GMO would likely not accept precision breeding since it involves genetic engineering. (Gina Kolata, The New York Times)

Biosecurity

Anthrax inquiry widens to 24 labs in 11 states, two foreign countries

A military lab at Dugway Proving Ground outside of Salt Lake City accidentally sent live Bacillus anthracis, Anthrax, spores to 24 labs inside and outside the US. The samples were supposed to have been inactivated prior to shipment. The army lab sent samples to laboratories that were testing a new diagnostic for anthrax. The error was discovered when a private lab in Maryland was able to culture the anthrax bacteria. The CDC and other agencies are working to determine how the samples were shipped and whether all the labs received live anthrax samples. 26 people are currently being treated for potential exposure, but no infections have been confirmed.   The public is not at risk for exposure. This recent breach of biosecurity is not an isolated incident. Last year, the CDC’s Bioterror Rapid Response and Advanced Technology laboratory also failed to properly inactivate anthrax before releasing it to another CDC laboratory. (W.J. Hennigan, The LA Times)

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June 2, 2015 at 9:00 am

Science Policy Around the Web – September 12, 2014

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By: Bethanie L. Morrison, Ph.D.

photo credit: ynse via photopin cc

Genetic Testing

Lasker Winner Calls for More Genetic Testing for Cancer
Dr. Mary-Claire King, 2014 Lasker award winner and the woman who discovered the BRCA1 gene, has boldly proposed that all women over the age of 30 be screened for cancer-causing genetic mutations. The details of Dr. King’s proposal were published this week in JAMA. The current guidelines for cancer screenings suggest evaluating only those women who have a family history of breast or ovarian cancer and are in a very high risk pool. Dr. King argues that women will be better off in the future if they have this information at their disposal. They will be in a better position to make life decisions that may prevent the possible onset of breast or ovarian cancer, unlike the current practice of treating the cancer once it appears. Dr. King did make a distinction between receiving genetic screens for known cancer-causing mutations, and general genetic screens. She does not believe that women should be screened for mutations for which function is not well-defined. (Lawrence K. Altman and Roni Caryn Rabin, The New York Times)

 

Regulatory Policy

23andMe CEO navigates health regulation

Anne Wojcicki, CEO of the DNA testing firm 23andMe, recently spoke with the Associated Press about keeping a health care business afloat under the oversight of the FDA. The primary goal of 23andMe is to make genetic testing available and affordable to the general public. Furthermore, they use the testing to create a massive archive of DNA results for use in medical research. In November, the FDA issued a warning to 23andMe to stop marketing its personalized health reports, which indicate to customers any possible genetic predisposition to various medical conditions. This issuance by the FDA caused a dramatic downswing in sales, although the company is still able to sell ancestral and unprocessed DNA data. As a result, 23andMe has hired 4 new health care executives and decided to pursue FDA regulatory approval on each individual health test, a process which could take years.  Ms. Wojcicki indicated that such heavy and constantly changing FDA regulations are very scary for health technology start-up companies, a sentiment held by most of Silicon Valley, whose investors are hesitant to back health technology ventures. (Matthew Perrone, (AP), The Washington Times)

 

Ebola Outbreak

Ebola: ‘Wow, that is really tough’
In an interview with Science, Bruce Aylward, an assistant director-general at the World Health Organization (WHO), responded to the criticism that the WHO has been too slow in its response to the Ebola outbreak in West Africa. “Foreign medical teams and NGOs [nongovernmental organizations] are used to dealing with trauma and primary health care; they’re not trained to deal with pathogens,” remarked Aylward when asked why the WHO appears to have underestimated the severity of the outbreak. The WHO has put more people in the field than has ever been heard of in an Ebola outbreak. The main problem lies in the inexperience of field staff and the lack of funding for proper field hospitals required for containment of the outbreak. The notion of vaccine trials and new therapies being introduced is promising for those who would otherwise not be willing to subject themselves to this dangerous pathogen, but the WHO cannot sit back and wait for the therapies to be approved. They must act now, according to Aylward. The WHO is asking foreign medical teams, primarily from the U.S., France, and the U.K., to stop just thinking of how to help and mobilize their troops before many more people have to die. (Leslie Roberts, ScienceInsider)

 

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September 12, 2014 at 6:00 am

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Science Policy Around the Web – February 16, 2014

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photo credit: sarihuella via photopin cc

photo credit: sarihuella via photopin cc

By: Kaitlyn Morabito

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

U.S. launches new global initiative to prevent infectious disease threats  – Participants from 26 countries, including the U.S., met on Thursday to launch a new world-wide public health program.  The focus of this initiative is to detect, treat, and contain newly emerging and known infectious disease agents where the outbreak starts to prevent global spreading of diseases such as West Nile virus, Dengue virus, tuberculosis and polio virus.  This program involves establishing a network of disease detecting laboratories, increasing vaccination campaigns and setting up emergency response teams. This global strategy of rapid detection, treatment and containment is more cost efficient than efforts by individual counties once the disease has spread. (Lena H. Sun)

Myriad Wins First Round in Cancer Gene Testing Battle  – Last June, the Supreme Court ruled that companies can not patent naturally occurring human genes, challenging Myriad’s patents on the BRCA genes used in breast cancer screening tests.  Following this ruling, many competitors released their own tests for the BRCA genes, prompting lawsuits from Myraid.  Myraid argues that the ruling does not apply to the related patents on the BRCA testing kits.  Last week, one of the competitors, Gene By Gene, settled with Myraid, agreeing to stop selling the kits within the US.  Lawsuits against other competitors are still pending. (Eliot Marshall)

Fusion energy milestone reported by California scientists  – Scientists at the National Ignition Facility, part of the Lawrence Livermore National Laboratory, are a step closer to creating a fusion reactor.  In their experiment, more energy was released from the fuel core than went into the fuel core.  However, there is still a long way to go before scientists create a fusion reactor.  The fuel core absorbed only a small fraction (about 1%) of the energy from the lasers, so the overall input energy is more than the output energy. (Joel Achenbach)

 

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February 16, 2014 at 10:27 am