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Archive for April 2015

“Hell No GMO”? Fact vs. fiction in the fight over genetically engineered foods

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By: Kimberly Leblanc, PhD

 

Last month, the Food and Drug Administration (FDA) issued a press release announcing the approval of genetically engineered (GE) apples that have reduced browning and potatoes that exhibit reduced black spots and bruising. There are more of these compositionally changed GE foods awaiting FDA approval — among many others, a pink pineapple that includes lycopene, and a tomato that has high levels of anthocyanins, which could lower the risk of cardiovascular disease and cancer. With the increasing prevalence of GE foods, public concern has risen. An Associated Press-GfK poll last December found that 66 percent of Americans want genetically engineered foods to be labeled. Furthermore, a poll from the New Pew Research Center revealed that only 37% of U.S. adults believing that GE foods are generally safe to eat. The question is, are these concerns warranted? In the same Pew poll, 88% of scientists reported that they believe it is safe to eat GE foods. This is greater than the percentage of scientists who believe that climate change is mostly due to human activity (87%) or that the growing world population will be a major problem (82%). This gap between scientists and the public on the issue of GE foods is the largest gap of all issues studied, greater than the difference for climate change, human evolution, or the use of animals in research. What’s the reason for this dramatic difference? One possibility is that 67% of U.S. adults felt that scientists do not have a clear understanding about the health effects of GE foods. But is the science really still out on the issue?

The recombinant DNA techniques used in genetic engineering involve the modification of a single or a select number of genes, allowing the transfer of desirable traits to occur more rapidly, predictably, and precisely than when using traditional agricultural methods, such as selective breeding. The FDA regulates the safety of foods and food products from all plant sources including GE plants, and GE foods must meet the same safety requirements as foods from traditionally bred plants. The FDA addresses nutritional composition to ensure that the nutrition in GE crops is substantially equivalent to the non-GE crop. This means that there are no significant differences in the levels of nutrients (including fiber, protein, fat, vitamins, and minerals), toxic components, or chemical composition in the new GE plant compared to the range of values found in traditionally bred plants. In addition to this regulatory oversight, studies so far have supported the substantial equivalence of GE foods.1,2 The FDA also assesses the potential toxic or allergenic properties of GE crops, and so far any crops that have been shown to be potentially allergenic have halted development before the crops have made it to market,3,4 or been pulled from the market (in the case of Starlink corn) even though there was no evidence that it caused an allergic reaction. So far, the scientific evidence has largely shown that GE foods are safe to consume. In a review of 1,783 studies on the safety and environmental impacts of GE foods, the researchers concluded that “the scientific research conducted so far has not detected any significant hazards directly connected with the use of GE crops”. This is all the more impressive since the authors of the above mentioned review are from Italy and European Union may have the most stringent GMO regulations in the world. However, even a report from the European commission looking at ten years (2001 – 2010) of GMO research concluded that GE foods are safe. Currently there is overwhelming scientific evidence that GE foods are safe to consume, at least in the sense that they are no more dangerous, toxic, or allergenic than non-GE foods, and they have substantial equivalence in terms of nutrition and chemical composition.

There is also considerable concern over possible indirect health impacts of GE foods through increased exposure to pesticides and herbicide. So, do GE crops increase our exposure to harmful pesticides? Insect resistant crops, produced through the expression of Bacillus thuringiensis (Bt) genes, reduced exposure to pesticides in the first ten or so years. Between 1996 and 2011, Bt crops have reduced insecticide applications by 56 million kilograms (123 million pounds). Insecticide use has also declined for both Bt crop growers and non-Bt crop growers, with essentially no difference in pesticide use between Bt corn adopters and non-adopters as of 2010. However, this is likely due to area-wide suppression of certain insects through the adoption of Bt crops, as has been shown in multiple studies. If anything, GE crops have had a positive impact on reducing the amount of pesticides used.

Herbicide usage is more controversial.  Although there were initial decreases in herbicide usage in herbicide-tolerant (HT) crops, herbicide resistance among weed populations may have induced farmers to raise application rates in recent years according to the USDA. One study found that herbicide-resistant crop technology has led to a 239 million kilogram (527 million pound) increase in herbicide use since 1996. This increase is largely due to an increase in the use of glyphosphate, the active ingredient in Roundup®, which is classified as a non-toxic herbicide. The National Research Council and the World Health Organization point out that this may be beneficial because glyphosphate is less toxic and less persistent than traditional herbicides like atrazine. While the International Agency for Research on Cancer proposes that glyphosphate increases the risk of cancer, the Seralini et al. (2012) study that claimed that GE corn could induce tumors in rats has largely been discredited by the European Food Safety Authority. A meta-analysis of human and non-human animal research found no significant effects of glyphosphate on neurotoxicity, immunological diseases, or endocrine disruption, and numerous safety evaluations have concluded that glyphosphate does not pose a health risk to humans. However, the USDA warns that herbicide toxicity may be on the rise (compared to glyphosate) by the introduction of crops tolerant to the herbicides dicamba and 2,4-D.

All of this discussion about GMOs leads to the question: should GE foods be labelled? Or more specifically, should the federal or state governments make laws concerning the labeling of GE foods? Rep. Mike Pompeo (R-Kan.) along with co-sponsor Rep. G.K. Butterfield (D-N.C.) recently introduced the Safe and Accurate Food Labeling Act of 2015 (H.R. 1599), which would create a voluntary federal labeling standard while pre-empting states from passing their own mandatory labeling laws for GE foods. In February, the Genetically Engineered Food Right-to-Know Act was introduced in the House (H.R. 913) by Rep. Peter DeFazio (D-Ore.) and in the Senate (S. 511) by Sen. Barbara Boxer (D-Calif.). Their bill would require labels for all foods produced using genetically engineered ingredients and would prohibit manufacturers from labeling genetically modified foods as “natural.” The FDA has issued draft guidance on voluntary labeling. Essentially, unless there is a “material” fact that is different about GE foods – information that is material in light of statements made or suggested on the label, or material with respect to consequences that may result from the use of the food – the producers don’t need to label it. The American Association for the Advancement of Science (AAAS) has stated that mandatory labeling “can only serve to mislead and falsely alarm consumers”, and the American Medical Association has declared that voluntary labeling is misleading unless accompanied by focused consumer education. It is important to note that environmental and social factors also matter to consumer’s decisions, and so these issues must also be considered when debating labeling.

The basis of the question may come down to whether or not citizens have a right to information on what they consume, even if that information might lead to decisions that are not based on scientific evidence.

Additional sources:

  1. Batista, R., & Oliveira, M. M. (2009). Facts and fiction of genetically engineered food. Trends in Biotechnology, 27(5), 277-286.
  2. Kuiper HA, Kleter GA, Noteborn HP, Kok EJ (December 2002). “Substantial equivalence–an appropriate paradigm for the safety assessment of genetically modified foods?”. Toxicology. 181-182: 427–31. doi:10.1016/S0300-483X(02)00488-2. PMID 12505347
  3. Lehrer SB, Bannon GA (May 2005). “Risks of allergic reactions to biotech proteins in foods: perception and reality”. Allergy 60 (5): 559–64. doi:10.1111/j.1398-9995.2005.00704.x. PMID 15813800.
  4. Key S, Ma JK, Drake PM (June 2008). “Genetically modified plants and human health”. J R Soc Med 101 (6): 290–8. doi:10.1258/jrsm.2008.070372. PMC 2408621. PMID 18515776
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Written by sciencepolicyforall

April 29, 2015 at 3:09 pm

Science Policy Around the Web – April 28, 2015

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By: Sylvina Raver, Ph.D.

Biotechnology and Bioethics

Scientists edit the genome in human embryos for the first time

Scientists now have access to technologies that allow them to edit DNA sequences in human tissue with relative ease. As has been discussed in detail previously, the safety and ethical considerations of permanently altering the human genome are considerable. Genetic modifications, however well intentioned, may be unsafe and result in unintended consequences in the embryo. And because these alterations can be passed on to subsequent generations of people, the far-reaching effects are substantial as well. In light of the many concerns raised by these technological advances, the scientific community has been nearly unanimous in calling for a temporary moratorium on genetic engineering in human embryos until the technical, safety, and bioethical concerns can be more fully understood. However, not all scientists are adhering to this temporary ban. This week a team of researchers at Sun Yat-sen University in Guangzhou, China published a report in the online journal Protein & Cell describing how they were able to successfully modify the genetic code in human embryos. The scientists, led by Dr. Junjiu Huang, performed experiments in non-viable human embryos using the CRISPR-Cas9 technology to modify a gene called HBB, mutations of which can lead to the fatal blood disorder beta-thalassemia. The scientists found that the rate of successful editing was quite low; only 28 of the 86 very early embryos studied demonstrated successful repair of the HBB gene. In addition to the relatively low efficacy of this technique, the paper also reported that embryos contained multiple unintended changes to their DNA. The authors state that their results highlight the need to improve the fidelity and efficacy of the CRISPR-Cas9 platform if it is to be applied in clinical settings in the future. Despite these qualifications, responses to the report by the international scientific community have been swift and mostly critical. Many scientists and watchdog groups argue that these experiments underscore the need for a moratorium on germline gene modification. However, other prominent voices in the bioethical and stem cell communities praise the value of basic research aimed at improving genetic engineering methods. A wave of similar research reports may be on the horizon as multiple Chinese research teams are rumored to be conducting ongoing experiments to edit the genome of human embryos. (David Cyranoski & Sara Reardon, Nature; Rob Stein, NPR; Jocelyn Kaiser & Dennis Normile, ScienceInsider)

Public Health

Contraceptive implants could decrease the rate of unplanned teenage pregnancies in the US

The rate of unplanned pregnancies in the United States is nearly 50%, and since 2001 the US made no substantial progress toward reduce this number. In teenage women between the ages of 15-19, the rate of unintended pregnancy is nearly seven times higher than in countries like Switzerland or the Netherlands. Many of these pregnancies could be averted through more widespread use of highly effective forms of birth control, including hormonal implants (miniature plastic rods inserted under the skin) or intrauterine devices (IUDs). The failure rate for these forms of contraception is only about 0.2%, which is remarkably lower than those for more commonly used methods like the pill (9%) or condoms (18%). Furthermore, because implants and IUDs are inserted and then remain stable for multiple years, they remove the need for women to remember to take a daily pill, or to rely on her partner to use a condom. Long-term contraception essentially changes the default, so that instead of actively preventing pregnancy, women can instead consciously decide when to conceive. Yet despite these clear advantages, only 7% of American teenage women use implants or IUDs, compared to nearly 40% of women in China. A primary reason for the limited use may be lack of information. A recent survey by the National Campaign to Prevent Teen and Unplanned Pregnancy found that nearly 77% of American women knew “little to nothing” about implantable birth control. Misconceptions about the safety and efficacy of these devices are also prevalent, possibly due to a lingering collective memory of a defective IUD that caused infections in some women and was removed from the market in the 1970’s. However, a lack of adequate information concerning implants does not lie solely with patients. Despite guidelines that require medical providers to recommend implants and IUDs as the “first-line” method of birth control for teenagers, many practitioners are not trained to insert these devices or worry that they are not suitable for teenagers. Medical providers, including pediatricians, who many teenagers first approach for birth control, must be reminded of the benefits of recommending IUDs and implants, and must be trained to properly insert and remove these devices. Increased promotion of IUDs and implants by public health agencies is also warranted. States that have increased the prevalence of these devices have seen both their birth rates and abortion rates fall dramatically among teens, particularly those in lower socioeconomic brackets. (The Economist)

Natural Disasters

Major earthquake devastates Nepal, may herald more Himalayan tremors

A 7.8 magnitude earthquake struck late in the morning of Saturday April 25, 2015 and has devastated a large portion of central Nepal, including the capital city of Kathmandu and the mountaineering destination of Mount Everest. At least 3,800 people are dead in what may prove to be one of the most deadly natural disasters to strike the Himalayas in years. Sadly, an earthquake of this magnitude was not unexpected, as the tectonic plates underneath Nepal have been close to the breaking point for centuries. The same geological forces that cause the Himalayan Mountains to reach such towering heights cause this region to be one of the most seismically active in the world. While seismic events are not unexpected in Nepal, the socioeconomic situations of many Nepalese citizens, combined with a rapid rate of urbanization, contribute to the devastation wrought by the April 25th quake. Much of the older infrastructure in villages and cities like Kathmandu has not been upgraded to withstand earthquakes. And as the country becomes more urbanized, new construction that lacks structural reinforcement often occurs hastily in dense and impoverished neighborhoods. Earthquake recovery, rather than prevention, will likely dominate Nepal for the foreseeable future. While the April 25 quake released much of the strain accumulating within the faults in the region, many experts feel that this earthquake was not sufficient to relieve all of the building pressure, and predict more than 30 aftershocks greater than magnitude 5 in the coming weeks. (Matt Schiavenza, The Atlantic; Alexandra Witze, Nature; Priyanka Pulla, ScienceInsider)

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April 28, 2015 at 9:00 am

Science Policy Around the Web – April 24, 2015

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By: Danielle Friend, PhD

photo credit: DSC03602.JPG via photopin (license)

Genetic-based Drug Discovery

23andMe will invent drugs using customer data

As of March 2015, 23andMe will no longer simply be known for direct-to-consumer genetic tests. 23andMe has now made progress toward their long-term goal of influencing drug discovery. 23andMe claims to have collected DNA from approximately 850,000 consumers through marketing of their $99 kit, and the company plans to use this genetic information to identify new drug targets. Additionally, 23andMe reports that approximately 80% of the consumers that purchase the kits have agreed to allow 23andMe to use their genetic information for this research. To help lead these discovery efforts, 23andMe recently hired Richard Scheller, who formerly lead research and development at Genetech, as the chief scientific director and head of operations. In addition to these in-house efforts, 23andMe has also recently formed partnerships with pharmaceutical companies, including both Pfizer and Genetech who plan to use the genetic information to develop drugs for diseases like Parkinson’s disease. Although the partnerships with companies like Pfizer and Genetech are clearly defined to help identify drug targets for particular diseases, 23andMe plans to organize their in-house research as a broad sweep through their databases without a particular disease in mind. However, 23andMe has mentioned that they have a particular interest in metabolic and immune system disorders, eye disease, and cancer. (Mathew Harper, Forbes; Ron Winslow, Wall Street Journal)

Transparency in Clinical Trial Data

World Health Organization calls for increased transparency in clinical trials

In mid-April, the World Health Organization (WHO) released a statement recommending that findings from all clinical trials be made public regardless of the results of the study. Dr. Marie-Paule Kieny, the assistant director-general for health systems and innovation with the WHO, stated that the goals of this new mandate are to “…promote the sharing of scientific knowledge in order to advance public health.” Additionally, Dr. Kieny also stated that, “failure to publicly disclose trial results engenders misinformation, leading to skewed priorities for both [research and development] and public health interventions,” and that “it creates indirect costs for public and private entities, including patients themselves, who pay for sub-optimal or harmful treatments.” Several factors may come between completed research and the publication of results. However, unpublished results (even if negative) can lead to the perception that treatments are more or less effective than they are. The WHO mandate requires that results from clinical studies be submitted to peer-reviewed journals within 1 year after the completion of data collection, and that the work should be published within 24 months in an open access journal. The WHO also asks that “key outcomes” — limited details of the study including the number of participants, main findings, and adverse events — be made available online within a year of study completion. Although these new requirements are a step in the right direction for clinical trial transparency, it remains unclear just how the WHO plans to enforce these recommendations. (Chris Whoolston, Nature Research Highlights; Martin Enserink, Science Insider; The World Health Organization)

Ebola Clinical Trials

Lack of patients hampers Ebola drug and vaccine testing

As attention on the Ebola outbreak in Africa has increased, more resources and medical assistance have been provided. Although the number of Ebola cases has significantly decreased due to these interventions, an unexpected troubling scenario has developed: Ebola vaccine clinical trials are now having trouble testing the efficacy of their vaccines due to the lack patient populations. In fact, one company has altogether halted their trial. Chimerix, a company running a trial for their antiviral drug, brincidofovir, has decided to end the trial altogether due to a lack of patients. In fact, the World Health Organization’s weekly report from April 19 states that new cases of Ebola are now down to a total of 33. Because of the dramatic decrease in Ebola cases, the public health community faces ethical issues regarding whether more promising drugs should be prioritized and given preferential access to patients and geographical regions. (Andrew Pollack, The New York Times; Richard Harris, National Public Radio; The World Health Organization; Kai Kupferschmidt, Science)

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April 24, 2015 at 9:00 am

Science Policy Around the Web – April 17, 2015

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By: Cheryl Jacobs Smith, Ph.D.

photo credit: MJ/TR (´・ω・) via photo pin cc

Genomics in Medicine

Personalizing Cancer Treatment With Genetic Tests Can Be Tricky

Since the New Year, President Obama, backed by National Institutes of Health Director, Dr. Francis Collins, has rejuvenated an initiative to use the human genome to make more informed medical decisions in health care. Since the completed endeavor to sequence the human genome was published in 2001, scientists and physicians have used this information to better understand the underlying complexities of human behavior, health, and disease. As a consequence, many areas in medicine use human genetic information as a diagnostic to guide treatment regimens.

More and more oncologists, or cancer doctors, are relying on genetic tests of a patients’ tumor to help guide cancer treatment. However, given the complexity of our genome coupled with our limited understanding of the millions of A, T, C, and G’s encoding our genetic information, oftentimes much of the information generated from genetic tests can be ambiguous. Researchers writing in Science Translational Medicine say there is a way to make these tests more meaningful.

One of the main issues with genetic testing of tumors is that they harbor mutations and it is unclear which mutation is the key to killing the cancer cell, thus, making a therapeutic decision difficult. In this regard, the researchers suggest not only conducting genetic tests on the cancer of the patient, but also conducting genetic tests on healthy, normal tissue of the patient. In this way, physicians and researchers can detect cancer-specific mutations as these mutations would only be present in the cancer, but not the normal, healthy tissue.

This is not to say that current genetic tests conducted on cancer are not trustworthy. They, indeed, are quite reliable at identifying mutations that are clearly linked to certain cancers. This group asserts that in those cases where this approach does not work, that additional sequencing of the normal, healthy tissue as a means of comparison may help improve the diagnostic quality of those tumors that produce ambiguous results. The future of cancer diagnostics is a booming, changing, field and much is to remain to be seen in regards to consistency of tactic used. (Richard Harris, NPR)

Federal Research Funding

Controversy awaits as House Republicans roll out long-awaited bill to revamp U.S. research policy

The America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science Act of 2007, or America COMPETES Act, was signed by President Bush in 2007 and it became law on August 9, 2007. The COMPETES Act sets funding targets for select physical science agencies: the National Science Foundation (NSF), the National Institute of Standards and Technology (NIST), and two offices with the Department of Energy (DOE): the Office of Science, and the Advanced Research Projects Agency-Energy, or ARPA-E.

Authored by the panel’s chair, Representative Lamar Smith (R–TX), there are provisions to the reauthorization act that scientists are likely to find interesting.

  • NSF spending: The bill would authorize $126 million less than President Obama requested but $253 more than NSF’s current budget. It relocates NSF’s budget to the natural sciences and engineering at the expense of the geosciences and the social and behavioral sciences. To add injury to insult, additional cuts from the geosciences and the social and behavioral sciences are expected.
  • DOE R&D: At least in 2016, the bill funds most Office of Science programs but the budget remains flat in 2017. Cuts will occur in the more applied renewable energy programs and new energy technologies. Interestingly, funding will boost in the areas on fossil and nuclear energy.
  • Peer review: Since Smith became chair in 2013, this has been a major area of debate regarding how NSF reviews the 50,000 or so requests for funding it receives from scientists every year. Apparently Smith and the NSF Director, France Córdova, have agreed upon legislation that will not “[…]alter[ing] the Foundation’s intellectual merit or broader impacts criteria for evaluating grant applications.”
  • NSF’s portfolio: This section of the bill gives NSF the responsibility “to evaluate scientific research programs undertaken by [other] agencies of the federal government.” This language apparently wants NSF to judge other research agencies about how they are facilitating their research programs. This is quite an awkward and broad demand. It still remains to be seen how this will play out.
  • Large new facilities: This section of the bill tries to rein in “wasteful spending” by requiring the NSF to correct any problems identified by an independent audit on a project’s expected cost before starting construction. However, the bill also restricts spending from contingency funds “[…] to those occurrences that are foreseeable with certainty … and supported by verifiable cost data.” This is interesting language given the need of a contingency fund is to fund unexpected occurrences.
  • Administrative burden: This part of the bill supports reducing administrative oversight in the form of government oversight and regulations. The bill argues that administrative costs are high and costly and these monies could be used to fund research. Instead, the bill will have the White House science advisor convene an inter-agency panel.
  • NIST: The bill increases NIST’s budget; however, falls short of President Obama’s request.

The good news is that the COMPETES bill has finally been reauthorized. However, controversy awaits as to the effectiveness of the reauthorized bill. (Jeffrey Mervis and David Malakoff, ScienceInsider)

Climate Policy

Climate change: Embed the social sciences in climate policy

The Intergovernmental Panel on Climate Change (IPCC) needs to broaden its perspective by adding more social scientists. The organization is akin to a moth to a flame— focusing attention on a well-lit pool of the brightest climate science. But the insights that matter are not readily viewed and are far from the bright light of the debate. The IPCC has involved only a narrow slice of social-sciences disciplines: economics. The other social sciences were mostly absent. Bringing the broader social sciences into the IPCC may prove challenging, but it is achievable if they adapt a strategy that reflects how the fields are organized and which policy-relevant questions these disciplines know well. The IPCC has proved to be important. But presently, it is too narrow and must not monopolize climate assessment. In the future, reforming the organization will benefit the conversation surrounding climate change greatly and move contentious work into other forums. (David Victor, Nature)

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April 17, 2015 at 9:00 am

Is the human germline off limits?

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By: Thomas Calder, Ph.D.

Licensed via Creative Commons

A new genetic engineering technology, known as CRISPR-Cas9, is allowing scientists to edit the human genome faster and easier than ever thought possible. This technology has the potential to treat and even cure several major diseases such as sickle-cell anemia, HIV, and many forms of cancer. As a result, many labs around the world are rushing to better understand the CRISPR-Cas9 system so they can eventually advance the technology into the clinic. However, such unparalleled potential comes with a risk. CRISPR-Cas9 could be used to alter the genetic code of germline cells, which are reproductive cells that could then pass these alterations onto further generations. This has scientists and the public asking the controversial question: is editing the human germline ethical?

This controversy is not new, as genetic engineering technologies have been around since the 1980’s. Zinc-finger nucleases (ZFNs) were discovered in the 1980’s and were determined to have genome-editing capabilities during 1996-2003. ZFNs are DNA cutting enzymes that can be engineered to target specific segments of DNA, and can thus alter sections of the human genome. Designing ZFNs proved to be difficult, so many scientists were excited when different genome-editing enzymes, TAL effector nucleases (TALENs), were found in 2009-2010 to be easier to engineer than ZFNs. Both ZFNs and TALENs have the same shortcoming though. They require scientists to design proteins specifically for a targeted segment of DNA, which then requires validation of each newly designed protein. Thus, these technologies are highly impractical for editing the genome on a large-scale.

The CRISPR-Cas9 system was first discovered in 1987 by a Japanese lab, but it was not well understood until recent years. Scientists determined in 2005-2007 that bacteria harbor this DNA editing system to digest foreign viral DNA. In 2011-2012, scientists began to understand the basic essentials of this system so they could utilize it for genetic engineering. They discovered that Cas9 is a DNA cutting enzyme that can be targeted to specific DNA fragments with the help of a specially designed guide-RNA molecule. This system proved to be much easier to use that ZFNs and TALENs, because scientists did not have to design different enzymes for each targeted DNA fragment. Instead, they only had to engineer RNA molecules to match with targeted DNA fragments. With this approach, CRISPR-Cas9 can be used to target and alter any gene based on its genetic code, and it can even be used for genome-wide studies.

With the recent characterization of CRISPR-Cas9, a new frontier in science has begun. Scientists have designed guide-RNA molecules for every gene in the genome to determine which genes are essential for various diseases, such as many forms of cancer. This approach is exciting because it may lead to the discovery of new targets for drug-based therapy. Scientists are also creating animal models of various genetic diseases by causing disease-specific alterations in the genome of animals such as mice and monkeys. For humans, this research has focused on non-reproductive cells, but the efficacy of this technology is making the human germline a tempting target. Theoretically, scientists could use CRISPR-Cas9 in an embryo to remove a disease-causing gene and replace it with a healthy version of the gene. This approach has the potential to ward off deadly diseases—but is it ethical? Most importantly, is it safe?

Both questions are controversial. In terms of safety, many scientists currently agree that it is not safe to create a permanent genetic alteration that can be passed onto future children. One concern is that Cas9 could have off-target effects that could damage the human genome in unpredictable ways. Another concern is that scientists do not understand the genome well enough to start making changes to the code. According to a Perspective article in the journal Science, by scientists that attended an ethics discussion in January on the topic of editing the human germline, “there are limits to our knowledge of human genetics, gene-environment interactions, and the pathways of diseases (including the interplay between one disease and other conditions or diseases in the same patient).” Also, side-effects from altering the genetic code of an embryo might not be noticeable until that embryo turns into a grown child, many years into the future. Therefore, more information on the human genome is necessary before genetic engineering of the human germline can be considered safe.

These safety concerns factor into the ethics debate, but other concerns are also drawing attention. While CRISPR-Cas9 is currently being proposed to prevent debilitating diseases, the use of this technology might start a slippery slope that could lead to the creation of “designer-babies.” For example, the genome of an embryo could be altered to impart a different eye color, hair color, or higher level of intelligence. These changes are certainly not worth the risk of side-effects, but some parents might pursue these options to provide their child with a “leg up”. Other ethical questions include:

  • Would the use of this technology be regulated?
  • Would a child be monitored if he/she was genetically modified as an embryo? Would the child’s future offspring be monitored?
  • Which parts of society would have access to this technology? Would use of this technology lead to a greater divide between the poor and wealthy?

The CRISPR-Cas9 technology is advancing quickly, so scientists need to act now to reach a consensus on these ethical issues. Many scientists have already called for a moratorium on editing the human germline in the short-term. This would provide time for scientists to engage with the bioethics community and the public to discuss the ethical, social, and legal implications of altering the human genome.

The genetic engineering capabilities of CRISPR-Cas9 is exciting. Millions of lives could benefit from this new technology. It could cure certain cancers, prevent diabetes, ward of many age-related diseases, and even stop HIV from causing AIDS. But scientists must use extra caution when editing the human germline, because any negative effects that arise could last for many generations into the future.

Sources:

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April 15, 2015 at 11:02 am

Science Policy Around the Web – April 14, 2015

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By: Elisavet Serti, Ph.D.

Ebola and Public Health

After Ebola devastation, a measles outbreak threatens West Africa

A second health crisis, after the most widespread Ebola epidemic in history, is threatening thousands of people in West Africa. The Ebola crisis has devastated public health systems and, as a result, has slowed down measles immunizations, a viral lethal disease that could affect the region even worse than Ebola. Even before Ebola hit, only an estimated 62% to 79% of children were vaccinated against measles in Liberia, Guinea, and Sierra in 2012 and 2013, according to the Demographic and Health Surveys — and that was with only one dose of the vaccine. Because the virus is so exquisitely transmissible, 95% of the population must be protected with two doses of vaccine to stop measles. “The secondary effects of Ebola are likely to be as bad as or worse than the direct effects,” says epidemiologist Justin Lessler of Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, who with his collaborators warned about a potential post-Ebola measles outbreak.

The symptoms of measles generally appear about seven to 14 days after a person is infected and include fever, runny nose, cough, red eyes, and sore throat, followed by a rash that spreads over the body. The measles virus is highly contagious and spreads through the air through coughing and sneezing. Common measles complications include ear infections and diarrhea but some people may suffer from severe complications, such as pneumonia and encephalitis that could be lethal. In the United States, as many as one out of every 20 children with measles gets pneumonia, the most common cause of death from measles in young children. Encephalitis is less common (1 out every 1000 children), which can leave the child deaf, or with intellectual disability. Measles is characterized as one of the most contagious viruses on Earth — five to 10 times more infectious than Ebola — and is among the first diseases to erupt in the wake of a disaster. In humanitarian crises in poor countries, it can kill up to 20% of those infected; usually those weakened by malnutrition and vitamin A deficiency.

Dr. Lessler and his collaborators estimated in a new study that a regional post-Ebola measles epidemic would strike roughly twice as many people as a pre-Ebola epidemic; an estimated 227,000 of infections compared with 127,000, and cause 2000 to 16,000 additional deaths. At the high end, the death toll could exceed the nearly 10,000 people killed by Ebola to date. However, nearly all of those deaths could be avoided by effective mass vaccination campaigns. That is why Liberia, with help from Centers for Disease Control and other international partners, is trying to launch a measles campaign as early as May that will target all children between 9 months and 5 years of age. Sierra Leone and Guinea are still affected by the Ebola disease so planning for measles vaccination is not considered a priority for the time being. (Leslie Roberts, Science)

Federal Biomedical Research

National Cancer Institute Director steps down

Harold E. Varmus, the Nobel Prize winner cancer biologist who has led the the National Cancer Institute (NCI) at the National Institutes of Health for nearly five years, stepped down from his post on March 31st. Dr. Varmus was co-recipient of the 1989 Nobel Prize for Physiology or Medicine for research into the cellular origins of cancer while conducting research at the University of California, San Francisco, where he joined the faculty in 1971. He was director of the entire NIH under President Bill Clinton from 1993 to 1999. Dr. Collins, the current NIH director, praised Dr. Varmus as being gifted with “unparalleled expertise.”

In his farewell letter to NCI staff, Dr. Varmus stressed the advances in oncology that NCI researchers led during his time as the NCI director in spite of the congressionally imposed budget cuts and budget sequestration that his institute and the entire NIH have had to endure in recent years. He wrote that his years at NCI “have not been easy ones for managing this large enterprise” and that “we have endured losses in real as well as adjusted dollars, survived the threats and reality of government shutdowns and have not yet recovered all the funds that sequestration has taken away.” He noted a range of scientific breakthroughs that have stemmed in part from NCI investments in recent years, from more widespread use of the HPV vaccine to greater acceptance of imaging tests in heavy smokers to pinpoint lung cancer, based on an NCI trial.

Dr. Varmus plans to return to New York and will head a laboratory in the Meyer Cancer Center at Weill-Cornell Medical College and also work with the New York Genome Center. Dr. Douglas Lowy, currently deputy director of the NCI and a researcher whose work led to development of the HPV vaccine to prevent cervical cancer, will become acting director April 1. (Thomas M Burton, Wall Street Journal)

Emergency Medicine Response

Having a companion is associated with faster treatment of stroke victims

The human element is much more significant in emergency medicine than initially believed by researchers. Dr. Gal Ifergane, a neurologist at Soroka University Medical Centre in southern Israel recently published in Medicine a striking story about the positive impact that relatives and friends have in the care and treatment of stroke victims when they accompany them to the ER. The most common stroke involves a clot blocking blood vessels in the brain, which causes almost immediate brain cell death because of the absence of oxygen transport. Thrombolytic therapy is very effective and uses drugs to dissolve the clot and restore the flow of blood. If started within a couple of hours of a stroke occurring, it can limit brain damage and reduce long-term disability. Time is a matter of life and death for these patients. Another key step is using a computed tomography (CT) scanner to ensure that there has been no bleeding in the brain, in which case thrombolytic drugs would cause excessive bleeding and would probably be lethal for the patient. In order to reduce the time to CT scan and correct treatment, paramedics have been trained to recognize strokes and warn hospitals in advance so that the medical team prepares accordingly.

Evidence for the significance of the human element in this case of emergency medicine came from 15 months of observation at Soroka Medical Center, where the ER staff recorded the number of companions escorting each stroke sufferer (over 700 in all) and monitored their progress. The results of this study showed that stroke victims arriving with someone were more than twice as likely to be correctly diagnosed by the triage nurse, and had their CT scans performed earlier. Patients eligible for thrombolytic medication also received treatment much faster if accompanied; although the patient sample was too small for the researchers to be sure it was because they had relatives or friends bringing them into the ER. The differences between the two groups cannot go unnoticed; patients with one companion had CT scans an average of 15 minutes sooner than those unaccompanied. A second companion reduced this time wait 20 minutes more; however, three or more companions did not confer any additional benefit. Dr. Ifergane believes that this is probably a combination of focusing the attention of clinical staff on their loved ones, and providing basic care when they initially arrive at the hospital. (The Economist)

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Written by sciencepolicyforall

April 14, 2015 at 11:36 am