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Posts Tagged ‘FDA

Growing Need for More Clinical Trials in Pediatrics

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By: Erin Turbitt, PhD

Source: Flickr by Claudia Seidensticker via Creative Commons

      There have been substantial advances in biomedical research in recent decades in the US, yet children have not benefited through improvements in health and well-being to the same degree as adults. An illustrative example is that many drugs used to treat children have not been approved for use by the Food and Drug Administration (FDA). Comparatively, many more drugs have been approved for use in adult populations. As a result, some drugs are prescribed to pediatric patients outside the specifications for which they have been approved for use, referred to as ‘off-label’ prescribing. For example, some drugs approved for Alzheimer’s Disease are used to treat Autism in children. The drug donepezil used to treat dementia in Alzheimer’s patients is used to improve sleep quality in children with Autism. Another example is the use of the pain medication paracetamol in premature infants in the absence of the knowledge on the effects among this population. While decisions about off-label prescribing are usually informed by scientific evidence and professional judgement, there may be associated harms. There is growing recognition that children are not ‘little adults’ and their developing brains and bodies may react differently to those of fully developed adults. While doses for children are often calculated by scaling from adult dosing after adjusting for body weight, the stage of development of the child also affects responses to drugs. Babies have difficulties breaking down drugs due to the immaturity of the kidneys and liver, whereas toddlers are able to more effectively breakdown drugs.

The FDA requires data about drug safety and efficacy in children before issuing approvals for the use of drugs in pediatric populations. The best way to produce this evidence is through clinical drug trials. Historically, the use of children in research has been ethically fraught, with some of the early examples from vaccine trials, such as the development of the smallpox vaccine in the 1790s. Edward Jenner, who developed the smallpox vaccine, has famously been reported to have tested the vaccine on several young children including his own without consent from the children’s families. Over the next few centuries, many researchers would test new treatments including drugs and surgical procedures on institutionalized children. It was not until the early 20th century that these practices were criticized and debate began over the ethical use of children in research. Today, in general, the ethical guidance for inclusion of children in research specifies that individuals unable to exercise informed consent (including minors) are permitted to participate in research providing informed consent is gained from their parent or legal guardian. In addition to a guardian’s informed consent, assent (‘affirmative agreement’) of the child is also required where appropriate. Furthermore, research protocols involving children must be subject to rigorous evaluation by Institutional Review Boards to allow researchers to conduct their research.

Contributing to the lack of evidence of the effects of drugs in children is that fewer clinical trials are conducted in children than adults. One study reports that from 2005-2010, there were 10x fewer trials registered in the US for children compared to trials registered for adults. Recognizing the need to increase the number of pediatric clinical trials, the FDA introduced incentives to encourage the study of interventions in pediatric populations: the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). The BPCA delays approval of competing generic drugs by six months and encourages NIH to prioritize pediatric clinical trials for drugs that require further evidence in children. The PREA requires more companies to have pediatric-focused drugs assessed in children. Combined, these initiatives have resulted in benefits such as improving the labeling of over 600 drugs to include pediatric safety information, such as approved use and dosing information. Noteworthy examples include two asthma medications, four influenza vaccines, six medications for seizure disorders and two products for treating migraines. However, downsides to these incentives have also been reported. Pediatricians have voiced concern over the increasing cost of some these drugs developed specifically for children, which have involved minimal innovation. For example, approval of liquid formulations of a drug used to treat heart problems in children has resulted in this formulation costing 700 times more than the tablet equivalent.

A further aspect that must be considered when conducting pediatric clinical trials is the large dropout rates of participants, and difficulty recruiting adequate numbers of children (especially for trials including rare disease populations) sometimes leading to discontinuation of trials. A recent report indicates that 19% of trials were discontinued early from 2008-2010 with an estimated 8,369 children enrolled in these trials that were never completed. While some trials are discontinued for safety reasons or efficacy findings that suggest changes in standard of care, many (37%) are discontinued due to poor patient accrual. There is insufficient research on the factors influencing parental decision-making for entering their child to a clinical trial and research into this area may lead to improvements in patient recruitment for these trials. This research must include or be informed by members of the community, such as parents of children deciding whether to enroll their child in a clinical trial, and disease advocacy groups. The FDA has an initiative to support the inclusion of community members in the drug development process. Through the Patient-Focused Drug Development initiative, patient perspectives are sought of the benefit-risk assessment process. For example, patients are asked to comment on what worries them the most about their condition, what they would consider to be meaningful improvement, and how they would weigh potential benefits of treatments with common side-effects. This initiative involves public meetings held from 2013-2017 focused on over 20 disease areas. While the majority of the diseases selected more commonly affect adults than children, some child-specific disease areas are included. For example, on May 4, 2017 public meeting was held on Patient-Focused Drug Development for Autism. The meeting included discussions from a panel of caregivers about the significant health effects and daily impacts of autism and current approaches to treatment.

While it is encouraging that the number of pediatric trials are increasing, ultimately leading to improved treatments and outcomes for children, there remain many challenges ahead for pediatric drug research. Future research in this area must explore parental decision-making and experiences, which can inform of the motivations and risk tolerances of parents considering entering their child to a clinical trial and potentially improve trial recruitment rates. This research can also contribute to ensuring that clinical trials are ethically conducted; adequately balancing the need for more research with the potential for harms to pediatric research participants.

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May 24, 2017 at 5:04 pm

Science Policy Around the Web – May 2, 2017

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By: Allison Dennis, BS

Public Health

You Can’t See What You Don’t Test For

The CDC relies on blood testing by pediatric health care providers to monitor lead exposure in children nationwide. However, many doctors may not be prompted to seek a test. According to a recent study, only half of estimated cases of elevated blood lead levels were reported to the CDC. From 1999 to 2010 an estimated 1.2 million cases of elevated lead blood level counts were predicted by state-by-state surveys conducted by the CDC. In contrast, only 607,000 cases were reported to the CDC by the 39 states that report elevated blood lead levels.

There is no safe threshold for lead exposure, however the CDC moved to revise the acceptable limit to 5ug/dL from 10ug/dL in 2012. Currently all doctors who treat children receiving Medicaid benefits are required to submit lead level tests for children at age 12 and 24 months or for those who have not received a test by the age of 7 years to meet formal eligibility. However, the number of tests performed annually falls short of those expected if doctors were following the rules. Each state maintains its own guidelines for when doctors should request testing and report to the CDC. And 12 states do not submit data to the CDC.

The greatest discrepancies between numbers predicted from survey data compared with state reported values were observed in Western states. When diagnosing lead exposure doctors may overlook environmental risk factors when treating patients in communities where lead has not been an issue historically. While public housing in Northeast cities like Baltimore have been recognized as a systemic source of lead exposure, the risk may not be so obvious in communities in California where buildings are assumed to be newer than 1978 when lead paint was banned nationally. (Susan Scutti, CNN)

Drug Policy

Access To Lethal Injection Drugs Challenges States To Get Creative

The FDA ruled on Thursday, April 20th that the Texas Department of Criminal Justice and the Arizona Department of Corrections have 90 days to destroy or return a batch of execution drugs imported from India. The Texas bound shipment seized by the FDA in July 2015 consisted of a thousand or more vials of sodium thiopental, which is used as the anesthetic in three-drug lethal injection protocols. While the FDA had abstained from enforcing a law preventing the import of sodium thiopental, which has no approved use in the United States, a US District Court permanently ordered the FDA to impose the ban.

Implementation of the import ban on sodium thiopental follows a long line of restricted access to lethal injection drugs. Political pressure on drug manufacturers has dramatically reduced the availability of products appropriate for use in lethal injection protocols. The last US manufacturer of sodium thiopental, Hospira, discontinued its production in 2011. In 2012, the European Commission blocked the export of drug for lethal injection to the United States. In May 2016, Pfizer announced it would end the use of its products in lethal injections, making it the final FDA approved manufacturer of potential drugs to do so. States have been responding by adapting protocols to meet drug availability or seeking third-party suppliers.

The modern use of lethal injections for corporate punishment were proposed in 1977 by the Oklahoma state medical examiner as being more humane and was first executed in Texas in 1982. While the practice is associated with drugs and medical professionals, it has never been subject to clinical trials or peer review. (Susan Scutti, CNN)

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May 2, 2017 at 10:08 am

Science Policy Around the Web – April 25, 2017

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By: Eric Cheng, PhD

Photo source: pixabay.com

FDA

FDA Nominee Gottlieb Tackles Vaccines, Trial Design at Hearing

The President’s nominee to head the FDA, Scott Gottlieb, MD, sat before lawmakers for his confirmation hearing before the Senate’s health committee. Gottlieb, a hospitalist and former FDA official, was questioned on many controversial topics on health.  On the topic of vaccines and autism, Gottlieb said, “I think we need to come to the point where we can accept ‘No’ for an answer, and come to the conclusion that there is no causal link between vaccinations and autism.”

On the topic of double-blind randomized trials as the “gold standard” for medical treatment research, Gottlieb was more cautious. He believed that there are more “opportunities to modernize how we do clinical trials in ways that aren’t going to sacrifice on the gold standard of safety and effectiveness. Perhaps there are ways to think of clinical trial constructs that don’t require the tight randomization that current clinical trials do.” What this suggests is a push towards more adaptive trials that would allow researchers to review results before a study’s endpoint and would allow changes to treatment groups in a study, which is in contrast to traditional randomized controlled trials.

Another less controversial but popular topic in the hearing was on opioid abuse. Gottlieb believed that opioid abuse is “a public health emergency on the order of Ebola and Zika” and that bolder steps will be needed to address this issue.

The committee will vote on whether to move Gottlieb’s nomination to the Senate floor after the Senate returns in late April from a 2-week recess. (Joyce Frieden, MedPage Today)

Healthcare Policy

Trump Administration Still Plans to Undo Parts of the ACA, Tom Price Testifies

Health and Human Services Secretary Tom Price made one thing clear during his testimony to the House appropriations committee: “The administration is still intent on dismantling parts of the Affordable Care Act even if Republicans lack the votes to rewrite it.”

Price discussed how, as the Health and Human Services Secretary, his department could scale back several federal mandates that include “essential benefits” in coverage to make insurance plans cheaper. He did not say if the administration will continue to provide cost-sharing subsidies for insurers, which has been a topic of discussion on items to change in the Affordable Care Act. However, removing subsidies will bring “significant premium increases,” said Michael Adelberg, a health-care principal at FaegreBD Consulting. He predicts that the removal of these subsidies will cause some insurers to drop out while the remaining insurers will seek rate increases to compensate.

Regardless of these discussions, the individual mandate remains in place with Price telling the panel, “So long as the law’s on the books, we at the department are obliged to uphold the law.” (Juliet Eilperin and Mike DeBonis, Washington Post)

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April 25, 2017 at 9:53 am

Science Policy Around the Web – January 17, 2017

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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)

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January 17, 2017 at 12:09 pm

Science Policy Around the Web – November 25, 2016

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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)

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November 25, 2016 at 9:00 am

Science Policy Around the Web – October 4, 2016

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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)

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October 4, 2016 at 9:02 am

Science Policy Around the Web – July 8, 2016

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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)

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July 8, 2016 at 9:00 am