AngelMD Friday Roundup – October 13, 2017

The Friday Roundup is a collection of five stories that you need to know about each week. From policy, to innovations, look to us to keep you up to date on what’s happening in the healthcare industry.

Will Your Next Pharmacy Visit Be Virtual?

E-commerce giant Amazon is reportedly still considering selling prescription drugs on its site, with a possible announcement expected in a year or two. Recently, Amazon has made a sprinkling of healthcare hires, oh, and they also have a super secret healthcare lab.

Bezos and his empire were previously tied to pharmacy when he invested in Drugtore.com before it was bought and then subsequently shut down by Walgreens. Like with any other industry Amazon enters, they would be perceived as a potential threat, or “disruptor.” However, selling prescription drugs will be a bit more difficult to implement because of its complicated supply chain.

The Evolution Inside You

Immunologist Gabriel Victora was recently awarded a MacArthur Genius Grant for his research on how cells respond to infection in the body, specifically the evolutionary development of antibodies.

Victora and his team have developed an imaging and modeling system so they can nearly visualize the process, which produces valuable data. He doesn’t yet know what he’s going to do with his $625,000, but we’re looking forward to finding out.

Executive Order Takes Aim at ACA

After several failed attempts at repealing and replacing the Affordable Care Act (AKA Obamacare) in Congress, President Trump has signed an executive order removing some regulations the ACA put in place.

Under the new order, fewer benefits and protections are required for customers and small companies can group together to buy “association plans” which do not have to adhere to guidelines laid out by the ACA.

VOX has an interesting look at what the association plans might do to the overall ACA market. Tennessee, where the plans already exist because of a loophole, holds some of the highest average ACA plan pricing in the nation.

NIH Partners with Big Pharma

In a $215 million collaboration, the National Institute of Health announced the start of a five-year research initiative in partnership with 11 pharmaceutical companies to support the Cancer Moonshot program.

The project with a focus on immunotherapy and why certain cancers do or do not respond to the treatment. The collaboration will be known as the Partnership for Accelerating Cancer Therapies, or PACT, and NIH director Dr. Francis Collins has high hope for the initiative.

“A systematic approach like PACT will help us to achieve success faster,” Collins said in a statement.

Another Gene Therapy Moves Forward

A treatment for a rare form of childhood blindness has been unanimously recommended for approval by the FDA. Developed by Spark Therapeutics, the therapy treats Leber congenital amaurosis a disorder with 13 different types depending on cause, amount of vision loss, and other eye abnormalities.

The treatment is called Luxturna, and was previously predicted to be the first gene therapy in the U.S. market before CAR-T claimed that prize earlier this year.

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Friday roundup – October 6

The Friday Roundup is a collection of five stories that you need to know about each week. From policy, to innovations, look to us to keep you up to date on what’s happening in the healthcare industry.

Americans Awarded Nobel Prize in Medicine

Jeffrey C. Hall, Michael Rosbash, and Michael W. Young won the prize for their work about the molecular functions behind the circadian rhythm, a powerful element of our biological clocks.

 

Using fruit flies, the trio isolated a gene which encoded a protein that gathers in cells at night, but degrades during the daytime. This degradation of the protein corresponds with the insect’s sleep-wake cycle. The honorees also discovered other contributors in their research which has led to a better understanding of our body clocks and what impacts them.

Do Let it Get Under your Skin

Last week, I wrote about the FDA’s approval of the first prick-free continuous glucose monitor. This week, MIT Technology Review profiled a team of University of Chicago researchers who a working to turn YOU into a continuous glucose monitor.

 

The team has genetically engineering mice skin cells to detect glucose, which can be grafted on the animal and monitor levels 24/7 with no battery or other upkeep. The process definitely needs to be refined, as currently the sensor can only be read using a laser and microscope. So, how’d they do it? CRISPR, of course.

CDC Links US Cancer Diagnoses to Obesity

The Center for Disease Control found that 40 percent of all cancer diagnoses in America are for those affiliated with obesity and being overweight. There are 13 different types of cancer that patients who are overweight are at an increased risk for.

 

Though overall cancer diagnoses in the U.S. have decreased since the ’90s, between 2005 and 2014 rates of cancer linked to obesity rose seven percent. Researchers are not yet sure why obesity is a factor in certain cancers or why the risk associated is not equal across all 13 cancers.

Sharing is Caring

Unless you are an EMR, that is. According to a recent study, only one of three hospitals in the US can send, receive, and find EMRs for patients that receive care elsewhere.

 

There was only about a five percent gain in interoperability between 2014 and 2015, which is slow growth for something that is supposedly going to revolutionize a patient’s care experience. This puts the burden on the patient, as they then need to print out and bring records with them from hospital to hospital.

Gene Therapy Still Debated

In a JAMA study, a child with ALD, a disease which causes nerves in the brain to die, was successfully treated with gene therapy. The typical treatment for ALD is a bone marrow transplant, but at a 20 percent mortality rate, it’s incredibly risky and often difficult to find a donor.

 

The news complicates the narrative surrounding gene therapy, which has been historically negative since the death of Jesse Gelsinger due to an experimental treatment in 1999. A recent death in a CAR-T trial also caused concern, however the FDA’s approval of the gene therapy shows progress.

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Friday Roundup – September 29

The Friday Roundup is a collection of five stories that you need to know about each week. From policy, to innovations, look to us to keep you up to date on what’s happening in the healthcare industry.

The Gears of Government Grind … Fast?

On Tuesday, the FDA announced that nine tech companies, including Samsung, Apple, and FitBit, will be put into a program that would reduce regulations on health software development. Companies in the program will have their software evaluated to verify it meets quality standards, and if they pass these audits, would be pre-certified and face a shorter approval process, or none at all.

 

Verily Life Sciences, Johnson & Johnson, and Roche Holding AG are also a part of the program, which commissioner Scott Gottlieb hopes will streamline the process to market, and therefore increase access to theses health products.

Floodwaters Bring Dangerous Disease

Flooding is typically associated with a higher risk of infection, but this can be significantly lowered by minimizing the amount of people displaced and ensuring sanitation systems are function and water sources remain uncompromised. Unfortunately, this isn’t always doable.

 

Harvey brought skin and gastrointestinal infections to Houston along with devastating property damage. Earlier this week, a Texas woman died as a result of a more serious and rare infection: necrotizing fasciitis, a flesh-eating bacteria. Fortunately, no other infections have been identified.

No Need to be Pricky

This week the FDA approved the first ever glucose monitor that does not require a blood sample. Made by Abbott, the FreeStyle Libre Flash Glucose Monitoring System uses a sensor that is implanted under the skin and remains on at all times. Users can view their blood-glucose level by waving a reader over the sensor site. The sensor needs to be replaced every two weeks.

 

The device was only approved for patients 18 and up and Abbott has not yet released pricing information. The company has said pricing should be similar to that of the product in Europe: $69 for the reader and $69 for each sensor.

Still No Official Declaration on Opioid Epidemic

This summer, the Commission on Combating Drug Addiction and Opioid Crisis recommended that the opioid epidemic be declared a national emergency. In August, President Donald Trump did just that, or did he?

 

Despite the verbal declaration, nothing official has come from the White House, which means none of the financial resources given by such an act can be distributed or used. According to the New York Times, the White House is reviewing options to expedite the process.

 

Meanwhile, the commission met on Wednesday and was join by PhRMA CEO Stephen Ubl, who announced they support a reduction in dose dispensing from 30 days down to 7.. The move was applauded by commission head Chris Christie, who is expected to release the commission’s final report on November 1.

Bad Things Come in Threes

APOE4, the genetic marker linked to the development of brain plaques which lead to Alzheimer’s disease, has been found to affect two other characteristics of the disease as well.

 

Researchers at the Washington University School of Medicine discovered that the gene also makes tau tangles and increases brain inflammation which leads to cell death. This information gives scientists a much better understanding of the disease and its potential causes.

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Friday Roundup – September 15, 2017

The Friday Roundup is a collection of five stories that you need to know about each week. From policy, to innovations, look to us to keep you up to date on what’s happening in the healthcare industry.

Apple Continues to Target Health with Flair

If you somehow avoided the flurry of tweets, photos, and articles coming out of the Steve Jobs Theater, Apple hosted their product announcement this week on their shiny new campus. The Apple team introduced the Series 3 Apple Watch, and emphasized the health impact the watch has already had by using consumer feedback.

 

To build on this, Apple has launched a study with Stanford to determine if the Apple watch could accurately identify heart abnormalities like arrhythmias. Though arrhythmias aren’t always threatening, this could be used as a detection and prevention measure for patients at high-risk for heart conditions.

FitBit Teams with Dexcom for Glucose Monitoring

Not to be outdone by the Apple Watch, FitBit announced a collaboration with Dexcom to bring a glucose level display to their Ionic smartwatch. Essentially, the data from Dexcom’s continuous glucose monitoring device will populate onto the Ionic’s screen. The data is already available to be viewed on a smartphone or the Apple Watch.

 

This partnership already showed its value for FitBit as it cause their previously faltering stock to take a jump. Consumers will have to wait a bit though, the new function won’t be available until early 2018.

Tackling Addiction One App at a Time

In a landmark decision, the FDA has approved the marketing of the reSET app to treat substance use disorders (SUDs).

 

“More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder,” said Carlos Peña, director of the Division of Neurological and Physical Medicine Devices.

 

Created by Pear Therapeutics, the app has a patient-facing and physician-facing interface. In a study across 10 U.S. treatment centers, reSET was found to be effective. About 58 percent of patients who were dependent on stimulants, marijuana, cocaine, or alcohol were abstinent in weeks 9-12 compared to only 29.8 percent of those receiving face-to-face therapy.

It’s a Bird! It’s a Plane! It’s a Blood-Carrying Drone!

One of the most promising applications of healthcare tech has been better care access for rural areas, but there’s only so much a doctor can do via telehealth. Enter drones.

 

A Johns Hopkins University professor set a record by flying blood samples 160 miles across the Arizona desert and kept them viable. Timothy Amukele, the professor behind the drone, wants to do more trial flights, some with less healthy blood to see glucose levels would impact the blood’s ability to remain viable.

Patent Politics

In an unusual (and possibly never-done-before) move, drugmaker Allergan transferred one of its patents to the Saint Regis Mohawk Tribe of New York. This legal maneuver would protect the drug in question from any patent disputes because the tribe can claim sovereign immunity.

 

The tribe will lease the patent back to Allergan and in return, the tribe will receive a $13.75 million payment and $15 million in annual royalties while it remains valid. It’s certainly an unorthodox approach and one that has the pharmaceutical community buzzing.

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What You Need to Know: CRISPR Gene Editing

Chances are, you’ve already heard about the groundbreaking gene editing technology known as CRISPR. The technique has been in the headlines a lot lately due to its controversial function and plethora of research opportunities it presents. The prospective uses for CRISPR have captured the attention of the scientific community and general public. Here’s what you should know about CRISPR and its progress so far.

The Background

CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeats. The technology was discovered as a foundational part of bacterial organism’s immune system and modified to be used for genomic engineering in 2013. Generally, when someone refers to CRISPR, they are likely talking about CRISPR-Cas9, where Cas9 is the protein that does the actual “snipping” of the DNA.

 

Since its identification, CRISPR has faced quite a few controversies, including speculation that use of the technique would lead to “designer babies,” or parents selecting for specific characteristics like hair or eye color.

 

That future won’t come fast however, as the FDA has kept a watchful eye on CRISPR and the research projects it chooses to approve using the tech. Currently, CRISPR-edited embryos are only allowed to mature for a few days in the U.S., though more ambitious research with embryos has taken place in China.

The Potential

Armed with the power of gene editing, there’s a lot you can do. Though the technique was only discovered a few years ago, several research products have been conducted with drastically different goals, but equally exciting results, here are just a few:

  • Removing a viral gene in pigs – At the beginning of August, Science published a study detailing the successful use of CRISPR to remove PERVs (genes that contain dangerous viral infections) from piglets. This success is a step toward xenotransplantation, or the transfer of organs across species. Pig organs are similar in size to human organs and parts of pig organs are already used in some surgeries like valve replacement. Currently, about 22 people die daily waiting for an organ transplant. Xenotransplantation still has a ways to go, but CRISPR presents a promising solution to the problems it has faced in the past.
  • More accurate mutation removal – Researchers in Oregon recently conducted an experiment to remove a genetic mutation that affects the heart and the results are promising. Chinese scientists conducted a similar study in 2015, but CRISPR was found to have unintended effects on the genome, such as removal or mutations of genes it was meant not to target. The Oregon scientists seems to have limited that effect as according to their release, “there were no off-target mutations.”
  • Storage space … in your genes – Back in July, Harvard researchers published a paper about storing a gif of a galloping horse in bacterial DNA using CRISPR. The study was largely a proof of concept as the researchers end goal is to code cells to take in information about themselves and store it in the genome for scientists to review. The researchers are most interested in gathering information from brain cells to understand the process by which they become a neuron.
  • No more sickle cell – The ability to edit genes means the ability to eradicate genetic disease altogether. Since sickle cell is caused by a single mutation, it makes an optimal candidate for the use CRISPR.  U.S. clinical trials have yet to begin, but the NIH is set to launch a study later this month.

There’s plenty of other research on CRISPR going on right now and more studies are coming. What do you think about the use of this technology? Are scientists being cautious enough about how and what they use CRISPR for? Where do you see the future of gene editing going? Let us know on social media by using #angelMDCRISPR in your post.

Further reading

The Gene: An Intimate History by Siddhartha Mukherjee – If you’re as interested in the genome and genetics as I am, then this is a must-read. Mukherjee chronicles the entire exciting, and at times frightening, history of genetic research from Mendel’s pea plants to a tragic death as a result of gene therapy. Mukherjee interweaves his own family’s genetic history with schizophrenia in an enlightening explanation of the impacts of genetic research.

A Crack in Creation: Gene Editing and the Unthinkable Power to Control Evolution by Jennifer Doudna and Samuel Sternberg – If Doudna’s name looks familiar to you, it’s because she is one of the scientists who first discovered and popularized CRISPR. In her new book (which I am anxiously awaiting to come off hold at the library), she grapples with the consequences of her discovery, something she also discussed with Wired earlier in the summer.

Epigenetics: How Environment Shapes our Genes by Richard Francis – First published in 2011, there are now multiple editions of this dive into a fascinating subsection of genetics. Francis explains the different aspects of epigenetics, including how the idea came to be and how it can be observed throughout history and today.

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