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Science Policy Around the Web – October 24, 2014

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By: Amie D. Moody, Ph.D.

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Congress

Congressman continues inquiry into National Science Foundation grant decisions

Members of Congress have been known to call out specific grants awarded by government funding agencies that they deem unworthy of the hard-earned tax payers’ dollars. On August 27th of this year, Congressman Lamar Smith (R-TX), who is the House Science, Space, and Technology Committee Chairman, wrote a letter to the National Science Foundation (NSF) requesting “all official documents pertaining to 20 NSF-approved research projects.” Although the Committee has the authority to oversee government appropriations, he cited no specific reason for the inquiry. In a letter responding to Mr. Smith, the senior Democrat on the Committee, Eddie Bernice (D-TX), argued that this is a “fishing expedition, pure and simple.” Her letter voiced concern that the inquiry is jeopardizing the NSF’s merit-review process and mentioned that a media report contained confidential material that should have only been known to Committee members. In response, Mr. Smith stated, “Our efforts will continue until NSF agrees to only award grants that are in the national interest.” But, to what end? Richard M. Jones, American Institute of Physics

 

Health

To beat once more – surgeons successfully transplant “dead hearts”

Historically, the heart was the only organ not used after it has stopped beating. But now a team of surgeons at St. Vincent’s Hospital in Sydney, Australia, has successfully transplanted three hearts that had stopped beating for up to 20 minutes. The doctors utilized a machine known as a “heart-in-a-box” to revive a stopped heart, and then flush the organ with a nourishing fluid. Similar tactics are used to improve the success of liver and lung transplants. Although the exact data to estimate how many more lives could be saved with these new protocols, one estimate places that number around 30%. No matter what the exact number is, the ability to save even more lives each year is a great achievement. James Gallagher, BBC News Health

 

Genetics

The oldest man

This week, Nature published an article reporting on the completed sequence from a man who lived 45,000 years ago in Siberia. It is the oldest reconstructed sequence from a modern human. A Russian fossil collector, Nikolai V. Peristov, found the bone in 2008 while looking for mammoth tusks in Siberia. He took it to the Russian Academy of Sciences, where researchers dated the thighbone. They ran the tests twice to ensure they were right. Next, a team of scientists led by Dr. Svate Paabo at the Max Planck Institute for Evolutionary Anthropology took samples of the bone and found enough DNA for sequencing. Dr. Paabo’s group has made a name for themselves by deriving highly refined sequencing methods, specifically designed to sequence ancient DNA. They published an entire Neanderthal genome in December 2013. These findings add amazing new insight into modern human migration out of Africa, and place a more precise time frame for how long ago Neanderthals and humans interbred (roughly 50K-60K years ago). Carl Zimmer, New York Times

 

 

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October 24, 2014 at 2:16 pm

Science Policy Around the Web – October 21, 2014

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By: Jennifer E. Seedorff, Ph.D.

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Ebola Outbreak – Public Health

In the US, fear spreads faster than Ebola

Ebola is a scary, lethal virus. Luckily, “There’s a reason it’s not everywhere. It’s just not as easy to transmit as people think.” said CDC epidemiologist, Michael Kinzer. So far, the only people to become infected while living in the US are two health-care works that treated the initial patient while he was having severe symptoms, including vomiting and diarrhea. In Ebola, the amount of virus in the body is not the same throughout the course of the infection. As the disease progresses, the amount of Ebola virus present in the body and bodily fluids increases dramatically. Since Ebola is transmitted through direct contact with bodily fluids, individuals without symptoms are not contagious despite being infected with Ebola. However, fears of Ebola have led to what some believe to be overreactions, including a cruise ship that was turned away from port or a school that temporarily closed because an employee had traveled on a different flight that used the same airplane as an Ebola infected health-care worker. As Kinzer told the Guinea media this summer, “Ebola’s not transmitted by the air. Fear and ignorance are transmitted by the air.” (Joel Achenbach and Brady Dennis, Washington Post)

 

Infectious Diseases

US pauses new funding for controversial virus research

The White House has announced that it is pausing any funding for new Gain-of-Function studies on viruses, like influenza, MERS, or SARS, and has called for a voluntary moratorium on existing research projects. Gain-of-Function studies have been controversial both inside and outside the scientific community. These types of studies seek to understand what kinds of mutations are necessary for a virus to evolve to become more pathogenic or to be more easily transmitted in humans or mammels. Proponents argue that these studies help in pandemic planning and strategies for vaccine development. Opponents argue that these studies are generating viruses that have the potential to cause a pandemic if accidentally or intentionally released from the labs. Concerns have been elevated due to recent concerns over safety at high-level containment research labs. US policy for determining the risk/benefits and approval process for these types of gain-of-function will be evaluated by both the National Science Advisory Board for Biosecurity and by the National Academy of Sciences over the next year. (Jocelyn Kaiser and David Malakoff, ScienceInsider)

 

Cancer Research – Precision Medicine

Cancer Immunotherapy successful in Phase I/IIA clinical trial

Cancer Immunotherapy is a promising precision medicine approach for treating cancer, and was named Science magazine’s breakthrough of the year in 2013.   In a recent study, cancer immunotherapy was shown to be an effective treatment for acute lymphoblastic leukemia, a cancer of B-cells. This treatment worked well in patients who had failed traditional therapies, including some whose cancer had previously returned even after stem cell transplants. This study reported impressive, durable results six months after therapy, with 23 of 30 patients alive, 19 of 30 in complete remission, and with 15 of 30 receiving no additional therapy. In this particular version of cancer immunotherapy, a patient’s own T-cells were harvested, then genetic bits of information are added to their T-cells to help them recognize B-cells (which are the source of the cancer), the modified T-cells are given back to the patient, and then these genetically modified T-cells hunt and kill the cancerous B-cells. As with any therapy, this treatment does have side effects most, including destruction of healthy B-cells and Cytokine release syndrome, a systematic inflammatory response that can cause a high fever, a drop in blood pressure, and difficulty breathing. This study was published in the New England Journal of Medicine and was partially sponsored by Novartis which holds the license to develop this therapy. In July, the FDA designated this engineered T-cell treatment as a “breakthrough therapy” which should help expedite the development and regulatory review of this therapy. (Denise Grady, New York Times)

 

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October 22, 2014 at 3:20 pm

Science Policy Around the Web – October 17, 2014

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By: Thomas Calder, Ph.D.

“photo credit:CDC Global Health via photopin cc

Ebola Outbreak – Public Health

New Ebola Case Confirmed, U.S. Vows Vigilance

Amber Joy Vinson, the second nurse found to be infected with the Ebola virus, was discovered to have flown on a commercial plane the day before showing symptoms. Ms. Vinson had been caring for the Ebola victim Thomas Eric Duncan, and was therefore exposed to the virus. According to Dr. Tom Frieden, the director of the CDC, “Because at that point she was in a group of individuals known to have exposure to Ebola, she should not have traveled on a commercial airline.” Family members and flight crew are now being asked to stay home. Ms. Vinson, and the other infected nurse Nina Pham, may have been exposed to Ebola due to insufficient safety gear. To address this issue, the CDC announced changes to the required protected gear used by health workers when caring for Ebola patients in the U.S. The new stringent guidelines require hoods that cover the neck along and the addition of shoe and leg coverings. While there is concern among some of the general public about the government’s response to the Ebola crisis, President Obama provided this reassurance on Wednesday: “I want people to understand that the dangers of you contracting Ebola, the dangers of a serious outbreak, are extraordinarily low, but we are taking this very seriously at the highest level of government.” (Manny Fernandez and Jack Healy, The New York Times)

 

Science Publication and Communication

Copycat papers flag continuing headache in China

An article published in Science last year uncovered dozens of China paper-selling companies. These companies were exposed for fabricating data, adding authors to accepted manuscripts, and selling entire publications. Recently, a similar China-based company was discovered by two computational biologists: Guillaume Filion from the Centre for Genomic Regulation and Lucas Carey from Pompeu Fabra University. These researchers were originally mining Pubmed publication records from 2012-2014 to uncover new hot topics based on commonly used words. From their big data analysis approach, they found 32 papers that were meta-analysis or review articles with, as Filion describes, “disturbingly similar” wording. For example, one paper states, “Importantly, the inclusion criteria of cases and controls were not well defined in all included studies and thus might have influenced our results,” and another paper states, “Importantly, the inclusion criteria of cases and controls were not well defined in all included studies, which might also have influenced our results.” From their investigation, they found these papers originated from a website that sold papers with an impact factor of 2-3 for approximately $10,000. This big data analysis technique may be useful for uncovering other paper-selling companies in the future. (Mara Hvistendahl, ScienceInsider)

 

Science, Religion, and Education

Seminaries awarded $1.5 million to include science in coursework

The American Association for the Advancement of Science (AAAS) is striving to bridge the gap between religion and science by providing $1.5 million in grants to 10 U.S. seminaries with the goal of providing greater science education. According to Jennifer Wiseman, the director for AAAS Dialogue on Science, Ethics and Religion, “Many (religious leaders) don’t get a lot of science in their training and yet they become the authority figures that many people in society look up to for advice for all kinds of things, including issues related to science and technology.” The seminaries receiving these grants will engage in a pilot program to incorporate curriculum that includes science educational videos, events, guest speakers, and other science resources. Additionally, AAAS is coordinating with surrounding universities to provide science advisors. This pilot program hopes to educate seminarians and reduce any perceived hostility between scientists and the religious. (Sarah Pulliam Bailey, The Washington Post)

 

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October 17, 2014 at 12:00 pm

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Science Policy Around the Web – October 3, 2014

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By: Bethanie L. Morrison, Ph.D.

photo credit: Xavier Donat via photopin cc

  EBOLA

 

When Ebola protection fails

“Working in an Ebola treatment unit need not be a life-threatening endeavor. Otherwise, I wouldn’t do it myself and it wouldn’t be ethical for me to counsel other people to do it,” says epidemiologist Daniel Bausch of Tulane University, who worked in Ebola units in Guinea and Sierra Leone at the beginning of the Ebola outbreak. Health care workers who have survived an Ebola infection have recently shared their stories with Science and all admit to being unsure of the source of their infection. Interestingly, the health care workers do not think they were infected by patients in the Ebola treatment units (ETUs) where safety precautions are the most stringent, but most likely in the emergency rooms and clinics. They all say that the greatest danger lies with patients whose status is unknown.  According to Senga Omeonga, an Ebola survivor and doctor working in Sierra Leone, “a lot of them were lying when they came to the hospital,” he says. “They didn’t even tell you they’re having fevers. They’d say they fell down or were on a motorbike or someone pushed them or they went to work and passed out.” The Centers for Disease Control and Prevention (CDC) is currently running 3-day training sessions for health care workers. These sessions are meant to closely mimic the environment where the workers will be helping patients in Africa. Thus far, nearly every trainee has had a breach of protocol. However, it is better to catch these breaches now, in the U.S., instead of in the middle of a treatment center in Africa.  (Jon Cohen, Science Magazine)

 

Could Ebola virus become ‘bioterrorist threat’?

While lawmakers and experts are investigating the possibility of the weaponization of Ebola, they say it is more likely that the highly pathogenic virus will spread through accidental and crude means. Dr. Anthony Fauci, head of the National Institute of Allergies and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), says that any real attempt at weaponizing Ebola would “have to be a state thing. I don’t think you’re going to get some rogue person being able to do that.” While it is not impossible, enhancing the pathogenicity of Ebola would, “require experts with advanced training and equipment that would be difficult for any but a state actor to obtain,” said Sen. Tom Coburn, R-Okla, ranking member of the Senate Homeland Security and Governmental Affairs Committee. On the other hand, it would not take a lot of sophistication to spread the disease via infected suicide bomber, who would be willing to put him/herself in danger in order to harm others. Scott Gottlieb, a physician and former Food and Drug Administration official is confident that appropriate government agencies “have thought through these scenarios and are well aware of the risks.” (Kelley Beaucar Vlahos, Fox News)

 

A Liberian doctor is using HIV drugs to treat Ebola victims. The NIH is intrigued.

At least 15 people infected with the Ebola virus in Liberia have been given lamivudine, and all but 2 of them have survived, according to Dr. Gorbee Logan, the doctor administering this controversial therapy. Lamivudine is an effective long-term drug used to treat people with HIV. According to Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), it is not unbelievable that this treatment would be effective. Lamivudine is a type of nucleoside analog, a class of drugs that alter the replication ability of certain viruses. Dr. Fauci said that as of yet, scientists at the NIH have not been able to see a reaction between lamivudine and the Ebola virus, but they will try it again, “to see if there’s even slight activity against Ebola.” If so, the NIH may be prepared to move to trial stage, according to Dr. Fauci. The most positive thing about lamivudine is that is an agent already approved by the U.S. Food and Drug Administration (FDA) and can therefore be much more easily distributed than a newly developed agent. In the meantime, Dr. Logan is concerned that the trial stage is too lengthy of a process. He is trying to save lives and is willing to try any therapy he thinks may work in order to do so. “Our people are dying and you’re talking about studies?” Logan said to CNN. “It’s a matter of doing all that I can do as a doctor to save some people’s lives.” (Elahe Izadi, The Washington Post)

 

 

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October 3, 2014 at 4:22 pm

Science Policy Around the Web – September 26, 2014

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By: Bethanie L. Morrison, Ph.D.

photo credit: Rusty Russ via photopin cc

Ebola Outbreak – Public Health

The Ebola Emergency — Immediate Action, Ongoing Strategy

The Ebola epidemic is still expanding, according to newly published epidemiological data from the World Health Organization’s Ebola Response Team. An increasing epidemic, one that may in fact become endemic, will lead to a disintegration of an already dysfunctional health care system in Africa. The WHO has estimated that there will be 20,000 cases of Ebola infection by early November.  Hospitals will become overwhelmed with Ebola patients and will no longer be able to care for those afflicted with malaria, HIV/AIDS, cancer, or even for women who have complications during childbirth. However, the current Ebola epidemic must take center stage in respect to where our efforts lie. There is a critical need for a massive increase in the current response levels. The questions asked are whether an outbreak of this magnitude could have been prevented and how? According to the report, the slow response time is to blame for letting the epidemic get out of control. Meanwhile, now that the response and relief efforts are underway, it is critical to analyze the response to this outbreak in order to prevent another one from occurring. There is a need for better surveillance, sharing data in real time, and rapid action based on available information. In general, we must learn to work more effectively. (Jeremy J. Farrar and Peter Piot, The New England Journal of Medicine)

 

Ebola Outbreak – Regulatory Policy

FDA OKs siRNA Ebola Drug

Dr. Richard Sacra, a U.S. physician infected with the most recent Ebola virus, has been given a new therapeutic not yet approved by the FDA called TKM-Ebola. TKM-Ebola is a short-interfering RNA (siRNA)developed by Tekmira that has thus far only been tested in animals, but has been given the green light by the FDA for “compassionate use” as medication in more patients. The compassionate use of this therapy cannot be considered a valid clinical trial, however, and the vetting and thorough FDA review must continue in order for TKM-Ebola to be approved for more widespread use in Ebola patients. (Kerry Grens, The Scientist)

 

Federal Science Policy

U.S. asks universities to flag risky pathogen experiments

New U.S. government policies released this week call for scientists to flag experiments that employ the use of any of 15 select toxins or dangerous microbes. White House officials are said to be open to engaging in a dialogue with the public regarding the possibility of expanding the list of agents, as some researchers are concerned that certain pathogens have not been included, such as those causing MERS and SARS. The new policies insist that researchers receiving federal funding notify an institutional review board if they are working with one of the 15 pathogens in experiments referred to as dual-use research of concern (DURC). DURC studies may include enhancing the virulence potential of a pathogen while at the same time studying mechanisms by which to kill the organism. The institutional committee then has 30 days to report the activity to the federal funding agency, and 90 days to submit a risk mitigation plan. These new policies are updated from those released in March 2012 and February 2013 identifying the 15 select agents and the need to screen DURC experiments. Research universities believe that the new regulations that include the tight deadlines overlap with other previously released regulations and are unnecessary. The White House Office of Science and Technology Policy (OSTP) claims that the new policies are an “additional and important component” of an overall framework, said Andrew Hebbeler, assistant director for biological and chemical threats in the OSTP. (Jocelyn Kaiser, ScienceInsider)

 

 

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September 26, 2014 at 6:00 am

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Science Policy Around the Web – September 19, 2014

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By: Bethanie L. Morrison, Ph.D.

photo credit: Newport Geographic via photopin cc

Ebola Outbreak

Obama says world has responsibility to act; Ebola to “get worse before it gets better”

The World Health Organization, this week, has called for at least $1 billion in foreign aid in order to keep the people infected with the Ebola virus in the tens of thousands. The United States has promised to lend a considerable amount of aid to the countries in Africa most affected by the Ebola outbreak; Sierra Leone, Liberia, and Guinea. The plan, laid out by President Obama this week during a press conference at the Centers for Disease Control and Prevention (CDC) headquarters, calls for a significant military presence in Africa to help organize and engineer the process of setting up containment centers and hospitals, bringing in and training health care workers, and distributing medical equipment, among others. The Pentagon announced that it will be setting up additional treatment centers in Senegal, a country not as hard hit by the deadly virus, and will train at least 500 health care workers per week. In addition to the efforts by the United States, the World Bank has issued a $105 million emergency grant to the countries most affected by the outbreak. While the effort is necessary and appreciated by the African nations and the World Health Organization (WHO), concerns about the efficacy of the plans have been raised by public health officials. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, has suggested that one organization in charge of the entire operation will be more effective than many different organizations all trying to do the same thing, but in different ways. Protocols for containment must be perfectly executed everywhere. In addition, the majority of the grant money and foreign aid is being funneled to Liberia, the country hit the hardest thus far. According to Osterholm, this is like, “fixing one of three screen doors on the submarine.”  (Juliet Eilperin and Lena H. Sun, The Washington Post)

 

Grant Funding

#IceBucketChallenge Highlights Difficult Funding Decisions

While there are plenty of opinions voiced in every social media outlet about whether the #IceBucketChallenge to support ALS research and patients is a reasonable thing, the effectiveness of the campaign cannot be argued, at least in the short term. The challenge has raised more than twice the NIH’s budget for ALS research. The ALS Association (ALSA), the non-profit organization receiving the majority of the donations, has reported contributions of $106 million, $103 million more than had been received at the same time point last year. Questions are beginning to arise as to how ALSA plans to use the newly acquired funds. ALSA spokesperson Carrie Munk told TheScientist, “It’s $100 million dollars; with that money comes tremendous responsibility.” The organization is dedicated to ensuring that the wishes of the donors regarding how the money is to be spent will be honored. They not only have added selection boxes to their website for current donation earmarks, but are also allowing for retrospective restrictions on the use of past #IceBucketChallenge gifts. While the majority of donations will likely go to basic research, some scientists and physicians are concerned about the stability of the funding. “Most research doesn’t go for only two years,” said ALS physician-researcher Jeff Rothstein. “So any program that invests money has to be cognizant [of that]. . . . When that money [runs] out, what happens?”  (Jef Akst, TheScientist)

 

Regulatory Policy

F.D.A. Panel Weighs Restrictions on Testosterone Drugs

“Is it O.K. to give testosterone without any limits to all older men with low testosterone levels?” asked Dr. Brad Anawalt of the University of Washington in Seattle. This is the question being posed to an FDA advisory committee this week in order to determine if further regulations should be put in place for the marketing of and prescription of testosterone as a therapeutic. Currently, testosterone therapy is a $2 billion industry, with 2.3 million Americans having received testosterone in 2013. Experts in the field are raising questions about the long term effects and risks associated with testosterone therapy. Testosterone is prescribed by doctors primarily for middle aged to older men experiencing low libido, low energy levels, and/or other natural symptoms associated with aging. The marketing for the treatment of “Low T,” or low testosterone levels, is somewhat reminiscent of that for the prescription of hormone-replacement therapy for menopausal women, which has since been deemed risky as it can lead to higher risks of breast cancer, blood clots, and strokes in these women. The FDA is seeking advice from the expert advisory panel as to whether the long term risks associated with testosterone use outweigh the benefits for men without any other medical conditions, as well as what information is appropriate to add to the drug labels.  (Sabrina Tavernise, The New York Times)

 

Cancer Research

American Association for Cancer Research Releases 2014 Cancer Progress Report: Research is Transforming Lives

“Cancer survivors …, as well as those who are projected to receive a cancer diagnosis in the future, are depending on our nation’s policymakers to make funding for biomedical research a national priority,” according to Margaret Foti, PhD, MD, CEO of the American Association for Cancer Research (AACR), which just released its annual cancer progress report this week. The AACR Cancer Progress Report 2014 is an annual document that details the progress made in basic and epidemiological cancer research, clinical research, and therapeutic development for the year. It serves to highlight the importance of federal investment in the NIH and NCI and ultimately calls on Congress and the administration to grow the funding for the NIH and NCI at predictable and sufficient rates that are at least that of biomedical inflation. While Americans are far more likely to survive a cancer diagnosis today than any time prior, the population is aging and thus annual cancer diagnoses will only continue to rise. The disease and its treatments are a hefty burden on the economy, both nationally and internationally. “If we are to fully realize the promise of science to transform cancer care, it will require leadership in Congress and within the administration to ensure that biomedical research in cancer becomes a major priority for our nation,” said Carlos Arteaga, MD, president of the AACR.  (AACR Newsroom)

 

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September 19, 2014 at 6:00 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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