Science Policy For All

Because science policy affects everyone.

Posts Tagged ‘FDA

Science Policy Around the Web – January 17, 2016

leave a comment »

By: Kseniya Golovnina, PhD

Source: Wikimedia Commons, by Copyright (c) 2004 Richard Ling, under Creative Commons

Biodiversity

The Mysterious World of Antarctica is More than Penguins

On December 21, 2016 the Australian Antarctic Division (AAD) released a video, which was made under the sea ice in O’Brien Bay, south of Casey research station in East Antarctica. This was the last part of the Australian Antarctic program, led by Dr. Johnny Stark, with the aim to observe the effect of climate change and ocean acidification due to increased carbon dioxide emissions on the Southern Ocean seafloor communities.

AAD biologist Dr. Glenn Johnstone and his team launched a remotely operated vehicle (ROV) through the small hole drilled in the ice and captured a rare glimpse of wonderful colorful Antarctic underwater world. They discovered a flourishing community of sea life below the massive ice sheet, at 30 meters below the surface, where the water temperature is −1.5°C year round, and the sea is covered by ice that is 1.5 meters thick for more than 10 months of the year. The video surprisingly revealed “a habitat that is productive, colorful, dynamic and full of a wide variety of biodiversity, including sponges, sea spiders, urchins, sea cucumbers and sea stars.”

About 30% of the carbon dioxide emitted into the atmosphere is absorbed by the ocean and increases its acidity. According to NASA Earth Observatory, increased acidity will increase the ocean’s ability to absorb carbon dioxide, making the carbonate shells of marine organisms such as corals thinner and more fragile. Higher water temperatures would also decrease the abundance of phytoplanktons, which play an important role in the carbon cycle absorbing excess carbon dioxide from the atmosphere. The increased carbon dioxide in the ocean might facilitate the growth of a few species of phyplanktons that take carbon dioxide directly from the water, but overall excess carbon would be detrimental to most ocean species.

Scientists are only now beginning to understand the complex underwater Antarctic ecosystem. Antarctica may be one of the first places where the detrimental effects of ocean acidification are seen, says Dr. Stark. These studies could be a good future indicator of the effects of climate change and ocean acidification on ocean ecosystems. (Australian Antarctic Division)

Food Policy

One or Two Tablespoons of Nutella?

The Food and Drug Administration (FDA) has closed collecting public comments about a regulatory change that would cut Nutella’s labeled serving size by half. More than 650 comments were collected. “One tablespoon or two tablespoons?” – The Washington Post explains the difference. The issue was about the appropriate reference amount customarily consumed (RACC) and product category. Nutella is classified as a dessert topping, with a RACC of two tablespoons. The serving size typically indicates how much Americans consume at a time and not how much they should, to make it easy for people to compare different products.

Its manufacturer, Ferrero, has asked that Nutella be reclassified as a jam or put in a different product category. This would cut the serving size that Nutella displays on its labels to one tablespoon, which would also decrease the sugar and calorie counts. It is already the second request from Nutella’s company since 2014. As they said to the Washington Post “it was simply seeking clarity as it and other companies prepare their new Nutrition Facts labels, slated for release in 2018”. However, critics of Nutella’s FDA petition including Lindsay Moyer, a senior nutritionist at the Center for Science in the Public Interest, warn people about the marketing ploy to trick people into thinking that it has less calories. If Nutella’s serving size is changed to one tablespoon, it could advertise a mere 100 calories per serving — versus roughly 188 calories for two tablespoons of peanut butter, or 196 calories for almond.

At the same time the question of one or two tablespoons seems not so relevant if one takes a look at the company’s website, where they say “you could circle the world with the amount of Nutella produced every year”. U.S. sales of Nutella are up 39% — from $161.4 million to $224.3 million — in the past five years in comparison with 5% for other nut butters. (Caitlin Dewey, The Washington Post)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

January 17, 2017 at 12:09 pm

Science Policy Around the Web – November 25, 2016

leave a comment »

By: Alida Palmisano, PhD

Source: pixabay

Climate Change

2016 Set to Break Heat Record Despite Slowdown in Emissions

An article published in the Washington Post discusses recent news about climate change. Temperatures around the globe are reaching a record high this year, according to a report from the U.N. weather agency. Another report from the World Meteorological Organization showed that while emissions of a key global warming gas have flattened out in the past three years, preliminary data through October showed that world temperatures are 1.2 degrees Celsius (2.2 degrees Fahrenheit) above pre-industrial levels. That’s getting close to the limit set by the global climate agreement adopted in Paris last year. It calls for limiting the temperature rise since the industrial revolution to 2 degrees C or even 1.5 degrees C. Environmental groups and climate scientists said the report underscores the need to quickly reduce emissions of carbon dioxide and other greenhouse gases blamed for warming the planet.

Another recent report delivered some positive news, showing global CO2 emissions have flattened out in the past three years. However, the authors of the study cautioned that it is far too early to declare that the slowdown, mainly caused by declining coal use in China, is a permanent trend. Even if China’s emissions have stabilized, growth in India and other developing countries could push global CO2 levels higher again. Even the recent election in the United States — the world’s No. 2 carbon polluter — could also have a significant impact.

Some researchers stressed that it’s not enough for global emissions to stabilize, saying they need to drop toward zero for the world to meet the goals of the Paris deal. “Worryingly, the reductions pledged by the nations under the Paris Agreement are not sufficient to achieve this,” said climate scientist Chris Rapley of University College London. (Karl Ritter, Washington Post)

Information and Technology

Facebook, Google Take Steps To Confront Fake News

Are we, as a society, really prepared for today’s way of receiving information from the web? In a recent article, NPR reporter Aarti Shahani talks about the issues related to viral fake news.

Facebook CEO Mark Zuckerberg has addressed (multiple times) the issue of fake news, which are inaccurate or simply false information that appears on the Web in the guise of journalism. Zuckerberg said that the notion that fake news on his platform influenced the election in any way is “a pretty crazy idea.” But many disagree; and as a former employee, Antonio Garcia-Martinez says Zuckerberg’s comment sounds “more than a little disingenuous here.” Facebook makes money by selling ad space inside its news feed. It also makes money as a broker between its advertisers and other online companies. A company spokesperson told NPR that it is not doing business with fake news apps as these outside parties are not allowed to use the ad network. But the company did not address the reality that fake news in the Facebook news feed attract people and clicks, which translate to money.

Google, another tech giant, said that it is working on a policy to keep its ads off fake news sites. Garcia-Martinez says that it’s “ambitious” of Google to make this promise. “Where does it end? Are they just going to limit it to advertising?” he asks. “Are they not going to show search results of things that are obviously false? I mean, even false content itself is free speech, even though it’s false speech.”

These issues are emerging in today’s society because of technological advances; however policy and legislation struggle to keep up with the evolving way we interact with the world. (Aarti Shahani, NPR)

Public Health

Could the FDA be Dismantled Under Trump?

A recent article reflects on how the President-elect may change the work of the Food and Drug Administration (FDA). Public health policies shift may include a surrender of the FDA’s rules for off-label promotion of drugs, the importation of more drugs from other countries, and fewer requirements for clinical trials (the gold standard for determining whether medicines are safe and effective). “Between a Trump presidency and a radically pro-business Congress, the next few years may see a removal of numerous consumer protections,” said Michael Jacobson, co-founder and president of the Center for Science in the Public Interest.

The FDA’s balancing act between patient protection and the drug and device industry’s push for a quicker path to market has never been easy. Over the past few years, spurred by patient advocacy groups and much of the pharmaceutical industry, lawmakers have fought over bills that would change how the country regulates prescription drugs and medical devices. Regardless of whether that legislation advances, Trump’s presidency is likely to enable the industry to get much of what it wants in terms of deregulation. “At the very least, President-elect Trump will support ‘Right-to-try’ laws that attempt to provide access to unapproved drugs,” the authors wrote.

One former FDA official, who spoke anonymously, said that the support for the right to try movement signals a broader disapproval of regulation. “The people who believe in that don’t believe there should be an FDA,” the former official said. Jacobson, of the Center for Science in the Public Interest, said that Congress could easily cut the FDA’s budget thereby “crippling programs to prevent foodborne infections, prevent dishonest food labels, and keep unsafe additives out of the food supply.” Others said even if he intends to overhaul the FDA, Trump may be surprised to find that there are limits to what he can do. “You can be against regulation all you want but the Food, Drug and Cosmetic Act is not something that is malleable within executive orders,” said Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group, which has long battled the agency for better patient protection. “There are laws, many laws, and it took a long time to get them.” (Sheila Kaplan, STAT)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

November 25, 2016 at 9:00 am

Science Policy Around the Web – October 4, 2016

leave a comment »

By: Cheryl Smith, PhD

Source: Flickr, under Creative Commons

Health Policy

FDA approves first drug for Duchenne muscular dystrophy

The Food and Drug Administration (FDA) approved a drug, Exondys 51, to treat Duchenne muscular dystrophy, a rare, debilitative disease that destroys muscle and confines boys to wheelchairs and eventually death. The decision was made by the FDA in opposition to its own medical staffers who questioned the effectiveness of the drug. One of the key issues medical staffers were concerned about was whether the drug can produce a sufficient amount of a protein called dystrophin to reverse muscle damage and, as a consequence, overall mobility and strength.

However, patients and their families lobbied hard for drug approval. Laura McLinn, an Indiana mother whose 7-year-old son has Duchenne muscular dystrophy, was in tears Monday when she heard the news of the drug’s approval. “I’m really overwhelmed,” McLinn said. “We’ve been waiting a long time to hear this.”

In reaching its decision, the agency essentially overruled its own medical staffers, who earlier this year questioned the effectiveness of the drug over concerns about a small clinical trial. The wrangling raised still larger questions about standards for approving a drug, but some FDA officials also acknowledged that unmet medical needs for patients with some rare diseases warranted endorsement under a program known as accelerated approval. (Ed Silverman, Scientific American)

Biotechnology and Forensics

DNA breakthrough finally gives ‘a face to this crime.’ But can it solve a woman’s 1992 murder?

Lisa Ziegert was murdered in 1992 and her killer was not found, however, a sliver of her attacker’s DNA was recovered. But that DNA lead went cold – like all the other evidence in the case. Now, prosecutors say that the DNA left by Ms. Ziegert’s attacker has given them a new lead in the case as well as a face. The Reston-based company Parabon Nanolabs has developed a new technology that uses DNA to make predictions about the suspect’s ancestry, eye color, hair color, skin color, freckling, and face shape. The DNA technology uses these characteristics to reconstruct faces based on DNA characteristics.

In the past, DNA has typically been used as a biometric identifier capable of identifying individuals with great certainty. Now, this technology can literally put a face to a crime.

Ms. Ziegert’s killer, according to Parabon, was likely a man of European descent with hazel eyes and brown or black hair. For the first time in twenty-four years, we have a face to this crime,” Hampden District Attorney Anthony Gulluni said in a statement released Wednesday. “The technology we have put to use is at the leading edge of the industry. No expense, effort, or means will be spared to bring the person(s) to justice who killed Lisa. We will never forget her.” (Cleve R. Wootson Jr., The Washington Post)

Biomedical Research

Yoshinori Ohsumi of Japan wins Nobel prize for study of ‘self-eating’ cells

Dr. Yoshinori Ohsumi, a Japanese cell biologist, was awarded the Nobel Prize in Physiology or Medicine on October 3, 2016 for his discovery of autophagy – a Greek term for “self-eating”. It is a crucial process for cellular survival. During starvation, cells are able to break down proteins and reuse them for energy internally running their recycling plant for survival. Autophagy is also critical during infections and can serve to protect the cell by destroying invading viruses or bacteria and then sending them for recycling. Cells can also use autophagy to get rid of damaged protein structures. In diseases such as cancer, neurodegenerative disorders, or immunological diseases, autophagy is thought to be defective. The importance of this cellular recycling mechanism was not known until Dr. Ohsumi studied the process in baker’s yeast in the 1990s.

Dr. Ohsumi received his Ph.D. from the University of Tokyo in 1974 in molecular biology. His ‘unimpressive’ Ph.D. thesis made it difficult for him to find a job. His advisor suggested a postdoctoral position at Rockefeller University in New York where he was to study in vitro fertilization in mice. Because Dr. Ohsumi grew ‘very frustrated’ he switched to studying the duplication of DNA in yeast. This work led him to a junior professorship at the University of Tokyo where he began his autophagy work. Dr. Ohsumi later moved to the National Institute for Basic Biology, in Okazaki, and since 2009, has been a professor at the Tokyo Institute of Technology.

“All I can say is, it’s such an honor,” Dr. Ohsumi told reporters at the Tokyo Institute of Technology after learning he had been awarded the Nobel, according to the Japanese broadcaster NHK. “I’d like to tell young people that not all can be successful in science, but it’s important to rise to the challenge.” (Gina Kolata and Sewell Chan, New York Times)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

October 4, 2016 at 9:02 am

Science Policy Around the Web – July 8, 2016

leave a comment »

By: Valerie Miller, Ph.D.

Photo source

Federal Regulatory Policy

To keep the blood supply safe, screening blood is more important than banning donors

With the recent mass shooting at Pulse, a gay night club in Orlando, many members of the LGBT community were outraged that gay men were unable to donate blood to help victims of the massacre. The federal ban on blood donations from men who have sex with men, instituted by the Food and Drug Administration (FDA), has been in place since 1983, after scientists understood the HIV disease and how it was spreading. This rule was recently scaled back in December 2015, when the FDA determined that men who have sex with men can donate, but not if they have had sexual contact with other men in the past year. The FDA continues to support a ban on men who have sex with men, because this demographic has the highest incidence of HIV infection.

Receiving a blood transfusion is extremely safe. Statistically, the risk of contracting HIV from a blood transfusion is 1 in 2 million, according to the National Institutes of Health. However, the actual incidence is much lower. Each year, more than 15 million donated pints of blood are transfused into patients. The last time anyone was known to have contracted HIV from a blood transfusion was 2008. However, experts believe this this success has little to do with donor bans, and is instead a result of advances in blood screening technology. All blood donated in the United States is federally regulated, and has been tested for HIV since 1985. Currently, donated blood is subjected to two tests for HIV, both of which are highly accurate. In a typical year, there are a few hundred cases in which donated blood tests positive for HIV.

Researchers at the FDA recently published a paper concluding that relying solely on blood testing would result in an additional 31 pints of HIV infected blood to get past the screening process, because there is a window following HIV infection and when it becomes detectible by today’s technologies, which is currently nine days. However, the FDA model is based on a complete lack of a ban, and doesn’t take into account the fact that donors themselves who participate in risky behaviors may practice self-selection. Instead, evidence suggests that it may be possible to ban donors based on risky behaviors such as unprotected sex with multiple partners, instead of focusing on the gender of sexual partners. From 2010-2013, researchers conducted a pilot study that collected information about every donor who tested positive for HIV, and found that 76% of HIV-positive donors were male, and 52.4% of those men had had sex with another man in the past year. This study indicated that men who have sex with men are already donating blood, and that half of the men whose blood tested positive had not had sex with another man in the past year. In the study, men who had sex with women were found to have a higher number of lifetime partners than men who had sex with men. At this point, no questions are asked about heterosexual partnerships during the blood donation process. A possible solution would be to make donor bans based on risky sexual behavior that apply to everyone. However, the Canadian Blood Services performed a survey of sexual behaviors on potential donors and found that many would be excluded, leading to potential blood shortages, indicating that careful consideration must be given to any potential new bans. In the meantime, the FDA recently approved the Intercept Blood System, which can reduce viruses, bacteria and pathogens that contaminate platelets, making the blood supply even safer. (Maggie Koerth-Baker, FiveThirtyEight)

Drug Legalization

Now we know what happens to teens when you make pot legal

The Colorado Department of Public Health and Environment has published the results of a new survey showing that following legalization in 2012, the rate of marijuana use among Colorado teens has remained unchanged. This survey, based on a random sample of 17,000 middle and high school students, showed that in 2015, 21% of Colorado students used marijuana in the past 30 days, which is lower than the national average, and is a slight decrease from the 25% of Colorado students who reported using marijuana in the past 30 days in 2009.

The results of these surveys are being monitored closely by policymakers on both sides of the legalization debate. Opponents of legalization have feared that more kids would smoke pot following legalization, due to increased availability. However, the data from Colorado, which includes two full years following the legalization of marijuana, indicates that adolescent use has not increased in this state. One explanation for why legalization is not increasing pot smoking among teenagers is that adolescents report that marijuana is widely available. Nationally, nearly 80% of high-school seniors report that pot is easy to obtain, indicating that those who want to smoke marijuana probably already are, which would change little following legalization. (Christopher Ingraham, The Washington Post)

NASA

Jupiter, meet Juno: NASA spacecraft settles in to begin its mission

Juno, NASA’s planetary probe sent to investigate Jupiter, has safely entered Jupiter’s orbit. NASA received confirmation of the successful orbit entry in the form of three tones, at 11:53 pm EDT on the 4th of July, following a 35-minute engine burn to slow the speed of the probe. Now that Juno has arrived at Jupiter after a 5-year journey from Earth, it will investigate the planet at 4000 kilometers above its outer veil of clouds, more closely than any spacecraft before. Juno’s mission will be to attempt to shed light on the origin and evolution of Jupiter by investigating questions such as: what structures are present below the surface clouds? Does Jupiter have a solid core? And how far do the surface stripes and storms extend into the center of the planet? Juno will begin observations in August after a 53-day orbit, and will then will orbit Jupiter 33 times over the next year and a half. At the end the mission, Juno will crash into Jupiter and disintegrate, in order to prevent accidental collision with one of Jupiter’s potentially habitable moons, which could cause contamination with microbes from Earth. (Daniel Clery, Science Magazine)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

July 8, 2016 at 9:00 am

Science Policy Around the Web – May 27, 2016

leave a comment »

By: Sophia Jeon, Ph.D.

Photo source: pixabay.com

Drug regulation and rare diseases

FDA delays decision on whether to approve Sarepta drug for Duchenne

The Food and Drug Administration (FDA) is wedged between a rock and a hard place to decide whether or not the agency should approve the controversial drug, eteplirsen, for Duchenne muscular dystrophy (DMD). DMD mainly affects boys and is considered a rare disease as it affects fewer than 200,000 US cases per year. As the name implies, it is a neuromuscular condition in which symptoms include frequent falling, trouble getting up or running, and learning disabilities. Average life expectancy for those afflicted with DMD is about 25, and there is no treatment. Considering these devastating factors, it is easy to understand why DMD patients, and their parents would want to hasten the approval of a drug that could potentially save their lives.

On the other hand, it is also easy to understand why the FDA is hesitant to approve this drug. The FDA is a regulatory agency and one of their missions is to evaluate drugs to determine whether or not they are safe and effective to be in the market. The issue is with a Phase III study that Sarepta Therapeutics did to test the efficacy of eteplirsen – that the trial was not well-designed making it difficult to come to a definitive conclusion that this drug works. The trial only involved 12 patients, without a placebo control group. If the FDA makes a decision to approve this drug under political pressure from various stakeholders, a drug that potentially could be ineffective for many kids with DMD only gives them and their family false hope and decreases the motivation for pharmaceutical companies to develop more effective DMD drugs.

Understanding patients’ needs, FDA has an expanded access program that, with the FDA’s approval, allows patients to try experimental drugs. In addition, the Orphan Drug Act gives pharmaceutical companies more incentive to develop drugs for rare diseases. However, it is clear that patients whose lives are on the line do not think the drug development is happening fast enough and are willing to try any option they have available. In 2015, there was even a bill introduced, called Right to Try Act that allows patients to have access to an experimental drug without the FDA’s approval. How much should public input or influence be taken into account in a drug approval process? Should FDA have better strategies in effectively communicating and engaging with patient groups? These are some good questions without definitive answers. (Ed Silverman, STATnews)

Research evaluation and bibliometrics

The pressure to publish pushes down quality

Let’s look at our current research culture. Whether or not you get an academic position, a grant, or a renewal of a grant all depends on how much you publish. “Publish or perish” is a phrase that is frequently used in academic science and it definitely rings true for many researchers in the US. People evaluate your research and productivity based on the number of your publications and the impact factor of the journals you publish in. Daniel Sarewitz recently wrote in Nature about the negative consequences of promoting this “publish or perish” culture.

The first problem is that increasingly everyone in research, whether conscious of it or not, seems to be contributing to this culture, and we need a cultural shift, which does not happen overnight. However, there are efforts to change the way we evaluate science. For instance, Declaration on Research Assessment (DORA) was initiated by the American Society for Cell Biology with a group of editors and journal publishers to try to make that cultural shift and start the movement for everyone in science to realize that merely an impact factor or how many times your paper has been cited should not and cannot accurately reflect your productivity, assess your work’s value or even define your career.

The second problem that Daniel talks more about in this article is the problem of rigor. Some researchers are so pressured to publish that they end up do things that are unethical or produce hard-to-replicate findings by experiments that are not rigorously designed. Researchers also sometimes exaggerate the importance of their findings in order to publish or hand-wave at any inconsistencies in their discussion sections. The real harm is done not only when other researchers waste time trying to chase a false lead but also when these not-rigorously-tested studies accumulate to adversely affect public health. A popular example is the study done by Andrew Wakefield who published his (false) claim linking the MMR vaccine to autism. These problems should not just stop at being “concerns,” instead it is time to re-think the strategies of evaluating science and doing science. Scientists could do better quality science by spending more time thinking and rigorously testing hypotheses than strategizing how to write an attractive story to publish more in a “high impact” journal. (Daniel Sarewitz, Nature Comments)

Clinical trial design and personalized medicine

Personalized medicine: Time for one-person trials

Biomedical research is in a very unique position right now. Recent technological advances have allowed scientists to easily and economically perform activities such as whole genome sequencing (WGS), big data analysis, mobile health data tracking and tissue and cell engineering. These technologies, especially when used in combination, can be a powerful tool that not only offers scientific insight into human biology but also brings up a number of exciting opportunities for prevention and treatment of diseases. These are a few of many reasons the President’s Precision Medicine Initiative (PMI) is gaining much attention.

With these advanced technologies, scientists are beginning to realize that personalized medicine, not just genetic counseling but one that includes a number of other measures, such as your metabolic profile, lifestyle factors, environmental exposures, etc., is the future of biomedical science. One-person trials hope to address a number of issues that the current clinical research or trial designs cannot address sufficiently such as the fact that people have different responses to drugs, and that there has been a lack of inclusion of minority or health disparities populations in many clinical trials taking place in the US. N-of-1 trials would not only address that issue but also could reduce any ethical concerns for placing patients in a randomized placebo control group especially when there is no standard-of-care, because everyone in the trial would be getting the experimental drug for a certain period of time, wait for the effects to wear off, and then a placebo for another to examine their responses to the drug. (Nicholas J. Schork, Nature Comment)

 

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

May 27, 2016 at 1:30 pm

Science Policy Around the Web – May 13, 2016

leave a comment »

By: Danielle Friend, Ph.D.

Gene Therapy Treatment

Gene Therapy Effective in Treating Rare Brain Disorder

A recent study has shown promising results using gene therapy to treat andrenoleukodystrophy (ALD), a genetic disorder that occurs in approximately 1 in 18,000 individuals and is caused by a mutation in a gene on the X chromosome. With ALD, individuals lose the myelin sheath that protects and allows brain cells to function properly. Symptoms of ALD begin between the ages of four and ten and include behavioral issues. Symptoms progress with individuals developing blindness, deafness, seizures, loss of muscle control, and dementia, ultimately leading to death. Until now the only treatment for ALD was a bone marrow transplantation that includes problems related to immune rejections and difficulty matching donors.

Researchers at Bluebird Bio have now tested a gene therapy approach in a trial including 17 children with ALD. Blood from the affected children was removed, the blood cells treated with a virus that expressed the normal ALD protein, and the blood was then reinfused into the patients. According to the report, within 6 months, 16 of the 17 patients symptoms had stabilized. Brains scans conducted 2 years after the reinfusion indicate that the myelin loss stopped progressing. Importantly, none of the patients have shown signs that the gene was inserted into an inappropriate location on the genome, causing serious side effects seen with other gene therapies.

Although these results have lead to a possible therapeutic for halting symptoms, the treatment is unable to reverse the damage to the myelin and thus reverse symptoms that have already manifested. However, the hope is that in the future gene therapy to treat ALD could be used as soon as patients are diagnosed, thus ideally preventing the progression and development of the more severe symptoms.

Bluebird Bio will soon be applying for approval from U.S. Food and Drug Administration (FDA), however a long road to treatment of patients in the United States could be ahead. While authorities in Europe have given approval for the use of gene therapy for rare disorders, the FDA has yet to approved a single gene therapy. This hesitancy from the FDA likely stems from previous side effects and the unfortunately death of Jesse Gelsinger resulting from gene therapy treatment. In addition to the development of an effect means for treating ALD, these gene therapy findings also provide hope for gene therapy techniques in safely treating other diseases in the future. (Jocelyn Kaiser, Science)

Zika Virus

Rapid, Cost Efficient Diagnostic for Zika Coming Soon

Until recently the only means for determining if an individual was infected with Zika was to use a technique known as the Polymerase Chain Reaction (PCR) or antibody detection. Unfortunately the resources to perform these tests are unavailable in many areas. Furthermore, antibodies produced against Zika may cross react with those produced against other similar viruses, thus limiting the specificity of the results. For an example, an individual whom was infected with dengue, when tested using the antibody method, may also test positive for Zika despite never having been infected with Zika. Since the rise in Zika spread there has been an emphasis on the development of a diagnostic test that would allow individuals all over the country (and world) to easily and quickly be tested for the virus.

Last week, a consortium of researchers including scientists from Harvard, Massachusetts Institute of Technology, Cornell, Arizona State, and Boston University all led by Dr. James Collins, a synthetic biologist at Harvard announced that they may developed such a test. The new test, which can develop results in two to three hours is not only faster and potentially more accurate than current methods but is also much cheaper and the result can be easily read. The test is paper-based and consists of a series of yellow dots that change to the color purple when placed in contact with Zika virus RNA.

While the test has not yet been tested with human samples, it has successfully detected Zika virus in the blood of infected monkeys. Dr. Francis Collins, the director of the National Institutes of Health stated that they are now working with groups in Colombia and Brazil to test the diagnostic in the field. Additionally the researchers state that they hope the new test will not only reduce future spread of Zika but other possible diseases as well by paving the way for a rapid, low-cost diagnostics. (Donald McNeil Jr., New York Times)

Public Health Policy

Food and Drug Administration Begins Regulating E-Cigarettes

The first piece of legislation aimed at regulating e-cigarettes was issued last week when the Food and Drug Administration (FDA) made the sale of e-cigarettes illegal to those under the age of 18. According to the Center for Disease Control and Prevention, approximately 5.3 percent of middle school and 16 percent of high school students reported using e-cigarettes in the past 30 days, a statistic that has risen in the last couple of years.

While public health experts support the new regulations, they also call for the FDA to do much more, suggesting that increased regulation on advertising for e-cigarettes and the ban of e-cigarette flavors that appeal to children including bubble gum, chocolate, and cotton candy should be put in place. In contrast, the e-cigarette industry and others are concerned that the new regulations will make it harder for consumers to obtain less harmful alternatives to traditional cigarettes. In fact, David Levy, professor in the department of oncology at Georgetown Lombardi Comprehensive Cancer Center believes that there is strong evidence that e-cigarettes may help addicted individuals stop smoking and the new regulations may be prohibitive for individual who use traditional cigarettes from quitting.

In addition to banning sales for individuals under 18, the new regulations also call for e-cigarette manufactures whose products went on sale after February 15th 2007 to seek approval from the FDA before they begin selling their products. The FDA also states that the new approval requirement will allow the FDA to verify e-cigarette ingredients and evaluate possible health risks. The American Vaping Association stated in response “This is not regulation — it is prohibition,” further emphasizing that submitting an application for approval takes more than 1,700 hours and cost upwards of $1 million. Retailers are also banned from selling e-cigarettes in vending machines that minors have access to and from distributing free e-cigarette samples. The FDA also suggests that they may soon ban e-cigarette flavors that are specifically targeted to children.

No doubt this will not be the last we hear of this battle between the e-cigarette industry and the FDA, Nicopure Labs LLC, a manufacturer of e-cigarette products, announced Tuesday that it has filed a lawsuit in the federal district court in Washington, D.C., challenging the FDA’s regulations. (Laurie McGinley and Brady Dennis, Washington Post)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

May 13, 2016 at 9:00 am

Posted in Linkposts

Tagged with , , , ,

Science Policy Around the Web – February 26, 2016

leave a comment »

By: Kimberly Leblanc, Ph.D.

photo credit: Alex E. Proimos via photo pin cc

Precision Medicine Initiative

NIH’s 1-million-volunteer precision medicine study announces first pilot projects

On Thursday, the President participated in a panel discussion at the White House Precision Medicine Initiative (PMI) Summit, marking the one year anniversary of the announcement of the Precision Medicine Initiative, which attempts to tailor medical treatments to individuals. The White House and the National Institutes of Health (NIH) announced several pilot projects, including one to work out how to recruit hundreds of thousands of volunteers online. The cohort program is the largest piece of the PMI: A 1-million-volunteer health study that will probe the interplay among genetics, lifestyle factors, and health. Vanderbilt University Medical Center (VUMC) will lead the Direct Volunteers Pilot Studies under the first grant to be awarded in the federal PMI Cohort Program. The university will work out how to engage participants with a website and a phone line for signing up. Verily, formerly Google Life Sciences (renamed in December 2015), in Mountain View, California, will advise the project. To facilitate the contribution of volunteer data, the NIH is launching a program called Sync for Science, added Francis Collins, M.D., Ph.D., director of the NIH, which will “pilot the use of open, standardized applications that will give individuals the opportunity to contribute their data to research, including for the PMI cohort.” Sync for Science will include participation by electronic health records firms Allscripts, Athenahealth, Cerner, Drchrono, Epic, and McKesson, which have committed to deploying the applications required for individuals to donate their health data directly to the PMI cohort, he said. Such technologies will enable individuals to “control and manage their data … coordinate their care among their healthcare providers, and submit their data to researchers if they choose.” The White House also announced a batch of projects being launched by some 40 universities, patient groups, companies, and others to promote personalized medicine. The PMI “is an all-hands-on-deck operation,” John Holdren, director of the White House Office of Science and Technology Policy, said during the press briefing. “We really need the participation of all of these groups to realize the potential of precision medicine.” (Jocelyn Kaiser, ScienceInsider; a genome web staff reporter, genomeweb)

Public Health and Nutrition

Judge upholds NYC rule on restaurant salt warnings

Justice Eileen Rakower of the New York state Supreme Court ruled to uphold a recent regulation in New York City, requiring restaurants with 15 or more locations nationwide as well as concession stands at some movie theaters and sports stadiums to post a salt-shaker warning symbol next to menu items with more than 2,300 milligrams of sodium. That’s the recommended daily limit proposed in the latest Dietary Guidelines for Americans, released in January. Yet Americans are consuming close to 3,440 milligrams a day on average. Most of the sodium we consume is already added to our food, whether its in the processed foods we buy in the grocery or the meals we’re served in restaurants. Mandated salt warnings on menus are intended to make New Yorkers more aware of the link between excessive salt in their diets and high blood pressure, heart disease and stroke, according to health officials.

“I believe that the New York City salt label [on menus] does protect public health,” said Thomas Merrill of the Department of Health & Mental Hygiene. He says it gives people the information they need to make informed choices. New York City adopted the rule in December, and the National Restaurant Association then sued the city’s Board of Health saying the rule unfairly burdened restaurant owners. In court on Wednesday, Rakower denied the restaurant group’s motion for a preliminary injunction to stop enforcement of the rule. Starting March 1, violators will be punished by $200 fines. Unlike the city’s unsuccessful large-soda ban, she said, the rule did not restrict the use of sodium. S. Preston Ricardo, a lawyer for the restaurant group, said the association intended to appeal. Overall, health officials are happy with the judges’ decision. “This is really good news for the health of New Yorkers,” said Dr. Mary Travis Bassett, the city’s health commissioner. (Karen Freifeld with additional reporting by Jonathan Stempel, Reuters; Allison Aubrey, NPR)

FDA Leadership

Robert Califf confirmed as new FDA head

On Wednesday, after 4 months of delay, the U.S. Senate approved cardiologist Robert Califf, President Obama’s pick to head the Food and Drug Administration (FDA) by a vote of 89 to four. The nomination, announced last September, has faced significant opposition. Senators Edward Markey (D–MA) and Joe Manchin (D–WV) have both used the nomination as a chance to express frustration with the FDA over its response to the epidemic of opioid abuse—to argue that the agency has been too permissive in its approval of prescription opioids, and has failed to consult its scientific advisory board in those decisions. Ill will toward the agency over its approval of genetically modified salmon last November led Senator Lisa Murkoswki (R–AK) to block the nomination and demand that FDA put out guidelines requiring the fish to be labeled (Murkowski later lifted her hold.) And Senator Bernie Sanders (D–VT) also blocked the nomination, citing concerns that Califf wouldn’t be motivated to help combat the rising cost of prescription drugs. There were also personal concerns about Califf and his long-standing ties to the pharmaceutical industry — which funded many clinical trials he oversaw as an academic — and questioned whether his interests lay more with drug companies than with ordinary patients. In a confirmation hearing last fall, Califf defended his past work and said he had no intentions of lowering the FDA’s standards for safety and effectiveness of drugs and devices. After winning confirmation Wednesday, he spoke in a brief interview with the Washington Post about his priorities as FDA commissioner, including a desire to better explain to the public how the agency operates. (Kelly Servik, Science Insider; Brady Dennis, Washington Post)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

February 26, 2016 at 9:00 am