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Health officials, politicians, business owners and apprehensive residents have a healthy fear about the spread of coronavirus, or COVID-19, in the Tampa area.

Tampa Mayor Jane Castor is one of those concerned citizens, and she addressed her concerns alongside Hillsborough County Commissioner Chair Les Miller in downtown Tampa in a Thursday afternoon press conference.

Were here to address a global issue that has the potential to impact our entire communitythe coronavirus, or COVID-19, Miller said to start the conference. But let me make one thing clearthere are no reported cases in Hillsborough County, or in the state of Florida.

Throughout the press conference, Castorwith the help of Dr. Charles Lockwood, USFs Health Dean of the Morsani College of Medicinestressed that Bay area officials are continuously preparing for the unfortunate day that coronavirus might make its way into the Bay area.

Were here to ensure our residents that we are as prepared as possible to deal with this disease if and when it arrives in our community, Castor said.

Castor urged Tampa residents to obtain their information from reputable sources and to not fall victim to online rumors, like the paranoid South Floridians who bought all of the face masks in their area. Dr. Lockwood said face masks dont prevent the spread of coronavirus.

Tampa Bays aggressive preventative and prepared measures are similar to that of Floridas approach to coronavirus as a whole. Although some Floridians may worry about the heavy international tourism surrounding Disney World, Gov. Ron DeSantis squashed anxieties in a his own Thursday press conference, stating that the state of Florida is fully committed, and is doing everything we can to prepare and respond to coronavirus.

Earlier this month, US. Rep. Charlie Christ wrote a letter to the Center for Disease Control and Prevention (CDCP), stating that there should be more of an emphasis on transparency about how coronavirus is spread. But Florida health officials arent currently revealing information about monitoring possible cases since the virus has yet to be declared a public health crisis.

Perhaps the scariest thing about coronavirus is the fact that it is so contagious, and one can be infected without showing symptoms. Concerned citizens can meet that challenge with strong preventative measures, like simply washing their hands, and education about the virus. In the Thursday press conference Dr. Lockwood said that 80% of people with coronavirus are asymptomatic or only show mild symptoms.

RELATED:Wash your damn hands, Tampa Bay

It's probably also worth pointing out that a different virus, influenza (aka the flu), has already sickened at least 13 million Americans this winter and killed 6,600 people.

The first cases of the coronavirus were reported in Wuhan City, Hubei Province, China in late December 2019, and now there are 48 countries reporting infections, according to live updates from the New York Times.

According to the CDCP, various symptoms associated with coronavirus are fever, cough and shortness of breath.

Although there are no reported cases of coronavirus in Florida, Mayor Castor and the rest of Tampa Bay are making sure the Bay area is prepared if the unfortunate day ever comes. In the spirit of preparedness, Castor promises minute-by-minute updates on any further news surrounding coronavirus.

Miller added Floridians and Tampeos alike should not fear the coronavirus at this point because states health officials have not yet declared it acrisisbut that might change very soon.

Early on Thursday, the state of California reported the first instance of a community-transferred infection. All other reported cases in the U.S. have been obtained overseas.

But in the meantime, wash your damn hands and chill out.

Follow @cl_tampabay on Twitter to get the most up-to-date news + views. Subscribe to our newsletter, too.

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Mayor Castor eases Tampa Bay's coronavirus worries by talking prevention and preparation in Thursday's press conference - Creative Loafing Tampa

ROCHESTER, N.Y. (WROC) Dr. Jeff Harp of Highland Family Medicine discussed the Coronavirus, its spread, and what you need to know about it Thursday during News 8 at Sunrise.

Actually, theres not one coronavirus, theres a whole bunch of coronaviruses, explained Dr. Harp. They basically range from the common cold to very serious diseases like this SARS thing that just happened, MERS, and what were having right now. So, its a whole family of one type of virus.

The current strain, COVID-19, originated in China. When it comes to symptoms, Dr. Harp said theyre not dissimilar to the common cold. So look for cough, fever, and trouble breathing. But the trouble is with some of these viruses, like the one that were seeing here, it can go on to very serious diseases like pneumonia, kidney failure, and even death.

Dr. Harp said this strain of Coronavirus, COVID-19, has been identified in 32 countries. Were learning more about exactly how deadly it is at this point. So at one point, it seemed like a lot of people who were getting it were getting very seriously ill. Now, it looks like perhaps about 2% of the people who get the disease will eventually succumb to it, die from it, which is a lot less serious. For example, the Middle Eastern virus that was around a couple years ago, it was about a third of people that got it would die from it.

Fear of Coronavirus and its impact has been reflected across the global economy and in the actions of individual people. Some have taken to wearing masks as a preventative measure. Its serious if ones exposed to it, noted Dr. Harp. Its not as contagious as many viruses, but its also preventable through the same kind of way that you would prevent the common cold. So we recommend that people take precautions. Obviously, traveling to China right now is not really the thing to do. Dont go outside when youre sick. Dont hang around sick people. If youre sneezing or someones sneezing, you know, cover the sneeze. Throw out the stuff that you use to clean it up. And then just use common sense in terms of, you know, touching objects, cleaning surfaces, that sort of thing.

If you want to learn more about Coronavirus and the current strain, COVID-19, Dr. Harp said go online to cdc.gov/coronavirus.

Read the rest here:
Highland Family Medicine doctor helps us understand the threat of Coronavirus - RochesterFirst

(MENAFN - Somali Land Sun)

Somalilandsun : It is estimated that every year more than 300 young cheetahs are illegally snatched from Ethiopia, northern Kenya, Somalia and Somaliland.

Illegal wildlife trafficking is an ever-increasing problem for the conservation of species in the wild, and the trafficking of cheetahs is no exception. It is estimated that every year more than 300 young cheetahs are illegally snatched from Ethiopia, northern Kenya, Somalia and Somaliland, then smuggled out of Somaliland to be sent across the Gulf of Aden to the Arabian Peninsula where they are bought and sold in illegal online sales to the wealthy.

Most of these cubs are pulled from their mothers prematurely and kept in poor conditions with inadequate food and water. Less than 25% of these captured cheetah survive to the buyers. And those that do survive are often in poor health, with fractured bones, infections and malnutrition.

Of those that are sold, the average lifespan is only 5 years of age, and most die due to causes related to stress and malnutrition. With less than 7,500 cheetahs surviving in the wild, compiled with the low reproductive rates of wild cheetahs, these numbers are unsustainable. Experts estimate that, than in less than 10 years, the cheetah could be extinct in Northern Africa.

The Cheetah Conservation Center (CCF) led by Dr. Laurie Marker, along with the Somaliland government's Ministry of Environment and Rural Development (MoERD), has been working since 2011 to set up a task force to help rescue confiscated cheetah cubs. Rescued cubs were initially sent out to sanctuaries in Ethiopia and Djibouti. After the laws changed in Somaliland, a cheetah sanctuary was started in the capital city of Hargeisa in 2017. Currently there are more than 45 cheetah cubs at the cheetah safe house, with more than 30 of those arriving in 2019.

Most of the confiscated cubs come into the safe house in critical condition, including severe dehydration, injuries and infectious diseases and require intensive care. Needless to say, in-country resources for cheetah care are very limited.

Because of the scarce in-country resources, CCF contacted Dr. Margarita Woc Colburn to help assist with the cheetahs. Dr. Woc Colburn assisted with the care of these confiscated cheetahs by acting as one of the veterinary consultants, utilizing her cheetah expertise.

Overall, Nashville Zoo has been supporting the Somaliland-CCF cheetah efforts through donations of medications and equipment, but last September, the Zoo sent Dr. Woc Colburn to Somaliland to assist with the health assessment of 30 cheetahs.

She worked in conjunction with Laurie Marker and a South African veterinary team led by Dr. Peter Cadwell. During her time there, the team fully examined the cheetahs at the safe house, as well as evaluated and developed preventative care protocols and assisted in the training of local veterinarians. Based on the findings of the exams, improved nutrition and preventative medicine protocols were set in place. Dr. Woc Colburn continues to be a core veterinary consultant for the project.

Future plans include the building of a cheetah conservation center outside of Hargeisa, where the cheetahs will have room to roam and breed, as well as creating a main education center to help educate the public about cheetahs and how to stop illegal wildlife trade. Nashville Zoo continues to support these efforts by ongoing donations of medications and medical equipment, as well as allowing Dr. Woc Colburn to provide veterinary expertise via telecommunication consults with Somaliland.

This press release was produced by the Nashville Zoo . The views expressed here are the author's own.

By. Press Release Desk, News Partner

MENAFN2702202001620000ID1099767727

The rest is here:
Working To Stop Illegal Wildlife Trade Of Cheetahs In Somaliland - MENAFN.COM

February 25, 2020

Today is the Canadian Federation of Medical Students National Day of Education and the Max Rady College of Medicines Global Health Portfolio is highlighting an initiative by students involved with the reproductive and sexual health component of their portfolio. The group is hoping to fill in the gaps in Manitobas current sexual education curriculum by training medical students to deliver workshops to high school students.

After the groups successful campaign last year for universal coverage of the abortion pill Mifegymiso in Manitoba, this year its focus is on preventative medicine, including the prevention of unplanned pregnancy and sexually transmitted infections (STIs) and an overall emphasis on sexual health and well-being.

They have planned training sessions for interested medical students to gain the skills they need to effectively lead formal and engaging sexual health education workshops in the community. The group is working with the Womens Health Clinic and is receiving guidance from the Clinic in designing the program. They hope to collaborate with local high schools and begin delivering the workshops in the spring or fall of this year.

We caught up with Jacqueline Donner, a second-year medical student and a local officer of reproductive and sexual health with the Global Health portfolio to talk about this project.

How did this initiative come about?

I think many Manitobans feel theres a big gap in the sexual health component of our school system. A lot of our peers feel that they didnt really get a comprehensive education, and certainly not a sex positive one. We realized as future physicians, we will have the privilege and responsibility at times of playing the role of sexual health educator for people, so we wanted to be as well-equipped as possible.

Why do you think sexual education is important?

Sexual health is all-encompassing. It plays into many aspects of our life. Many people in our community feel excluded by the way sexual health is currently taught. Sexual health is not just for people who are cis and straight. Were being very careful about our terminology so everybody feels included. When you have a good knowledge of sexual health and are able to take some ownership of your own sexual health, its very liberating, and allows you to enter other parts of your life feeling autonomous and independent.

How will you train medical students to deliver this information?

Were working with the Womens Health Clinic to do a series of three workshops that will provide us with legitimate training to enter schools and educate young people. We had our first workshop this past Sunday.

The format that Womens Health Clinic uses, that we will emulate, is using interactive, group-based activities for students of all ages to break down those barriers to talking about sex and sexual health. It looks at the different components of sexual health from a more holistic approach. It doesnt just involve the biology of sex, but everything from body positivity to self-love to the role of media in our perception of ourselves and our sexuality.

What are some of the things you learned about in the workshop?

We did some exercises that broke down basic terminology. We also talked about body image, body positivity and the harms of dieting. They do a cool activity using skittles to help visualize the spread of STIs. The visualization of these issues translates well into a classroom environment, especially since we are trying to reach youth.

Do you hope that once established, these workshops will continue on an on-going basis?

We want to establish a long-standing relationship with Womens Health Clinic and also hope that it becomes something that can perpetuate on its own. Once we gain this training, we can continue to train our fellow students. I hope theres a snowball effect and more students can be involved in coming years.

CHANTAL SKRABA

See original here:
Med students aim to fill in sexual education gaps in high schools with new initiative - UM Today

All over New Zealand, prisoners are breaking out of their cells and the Department of Corrections is quite happy about it.

The freedom the prisoners are finding has nothing to do with the physical bars that contain them they are escaping their mental prisons, using the keys of meditation to open the door.

For more than three years, Ishaya monks of the Bright Path have been teaching ascension meditation techniques in prisons around the country. This follows a successful trial at Rimutaka Prison.

Savitri and Prasada Ishaya first approached Corrections in 2016 to volunteer as meditation teachers in prison, inspired byA Mindful Choice a documentary film made by two Kiwi colleagues about the positive power of ascension meditation including in one of Mexico's most notorious prisons.

Chris McKeen/Stuff

For more than three years, Savitri Ishaya and other monks have been teaching ascension meditation techniques in prisons around the country.

"I was so impressed and inspired by the fact that people who had suffered terribly traumatic lives and experiences were able to find peace even in a prison environment," Savitri says.

She showed the film to Corrections and they decided to trial meditation at the Drug Treatment Unit (DTU) at Rimutaka Prison.

Since then, the teachers have returned for many block courses and the teaching of ascension meditation has expanded to six prisons across the country. Last year, 46 courses were delivered in prisons teaching about 400 people, including some Corrections staff.

Chris McKeen/Stuff

The main benefit to inmates from ascension meditation is in the way they're able to stop themselves from falling back into old behaviour patterns.

Frith Dunlop, clinical manager at the Rimutaka DTU, says the men come to the high security unit through a dual mechanism first their case manager will recommend the DTU as part of their rehabilitation but the prisoners also have to agree to it, so there is an element of self-selection.

Then as part of their course they are offered the opportunity to take the ascension meditation course. Dunlop says around half the inmates in each intake put up their hands.

"There are always people in the group who are motivated and are willing to try anything. We do a lot of preparation before the coursewhat's involved, what to expect and, basically asking them: 'What have you got to lose?"'

Dunlop said the main benefit she's seen from ascension meditation is the way the inmates are able to stop themselves from falling back into old behaviour patterns they are less reactionary.

"When they start falling back into old thinking patterns, they've got a simple way to find a moment to pause to reset themselves and put themselves back on track we see that all the time, right in front of our eyes: you can see they are going down a certain path and they just stop. And then they have the time to rationalise what they are doing and get back on the right track."

Chris McKeen/Fairfax NZ

Savitri says her students are motivated because they are "hungry for peace".

And she's seen success where she least expected it, recalling one prisoner who grudgingly volunteered for the programme.

"One that I'm thinking of, I really didn't expect him to be interested, I didn't expect him to last the first day," she says.

"But after the first session he started to make noises that showed something was changing in him. And then he started to talk about how he suddenly realised that he was in charge of his thoughts. We encourage our guys to journal and he started journalling about how his reality has changed because he's been able to change the way he thinks.

"That was a huge revelation for him because he was at the start of a long sentence and was quite depressed about it he made it clear that he feels positive [now] about doing the rest of the sentence and that he can handle anything he can just practise his techniques at any time when things get hard or he gets frustrated or overwhelmed. And this is a person I didn't expect to last the first day."

Savitri says some of the changes she's witnessed in the prisoners have been profound.

"These guys are interested because they are hungry for peace they have got powerful motivation to drop their thoughts and they are very interested in learning how to drop emotions particularly anger.

"They know that when the red mist comes they often can't control what happens next. So, to have a tool that allows them to notice when they are starting to get triggered into traditional patterns of behaviour and to use the technique as a circuit breaker is great," she says.

"The guys who are ready to change areso good at putting this into practice that the change can happen rapidly because they really want it."

She says it's amazing to see the difference in the individuals and the group from the beginning to the end of the course.

One of the reasons a depressed or angry prisoner can make a sudden change within a few days is because the ascension meditation techniques are simple and easy to practise, says Savitri.

Chris McKeen/Stuff

Ascension meditation enables you to release stress through the day. "I call it preventative medicine if you're doing it every day, the stress levels don't overflow. You're much more resilient, calm and coming from a much more present place."

"It's a simple tool that allows us to let go of our thoughts and emotions there are lots of patterns of behaviour that come about through the way people relate to their thoughts, and when we are always focused on our thoughts and believing them, we don't realise how they often drive our actions."

Corrections lists the benefits of the meditation programmes as: managing anger, stress, tension and trauma; improved communication with others, including whnau and Corrections staff; motivation to participate in rehabilitation programmes to address offending, and education and offender employment activities.

There has been a lot of research on what is known as emotional contagion, the transfer of moods among people in a group. The basic premise is summed up in the old quote "misery loves company" one person's negative mood can influence others in a family, workplace or group. And the reverse is true a positive mood is equally catchy; it can increase co-operation and decrease conflict important in a prison setting.

It's something Dunlop has noticed within Rimutaka's DTU, with a ripple effect based on how many men in the unit have taken the course.

"The last time that Savitri and Prasadacame through was the most powerful I've seenwe noticed a real shift," Dunlop says.

"We noticed significant shifts in behaviour, compliance and morale. It changed the whole unit even when the whole unit didn't undertake the programme. But those who did brought peace back to the unit with them."

Dunlop speculates that because the unit always has some inmates who have been there for a while, they can positively affect newcomers by talking up meditation and continuing to practise it themselves.

"We've always got a few people left from the last intake that have done the ascension course. This is about the fourth or fifth time in the past two years that we've had them in so there's a number of people who have done it, so when we are trying to encourage newcomers to give it a shot, we've got men saying, 'This is really valuable."'

Those who have already learned are keen to resit the course and the new students come more willingly because their peers have recommended it, she says.

"We've got another course coming up in March and we will have even more people in the unit who have done it once or twice before, so we expect the next time around will be a more powerful effect."

This doesn't surprise Savitri her experience is that the prisoners who embrace the techniques are strong advocates for its power.

"The guys who get keen on it are very good at passing on their experience to others they all like to talk about it and how they are changing.

"It takes a while for them to trust us and then to be willing to open up and try the techniques and sometimes people aren't ready to do that but for those who are ready, once they've done the first couple of lessons they start to meditate in their cells and they get quite enthusiastic."

She likens regular practice of meditation to a pressure valve that can release stress, a huge benefit in a prison where anger and quick tempers can cause trouble.

"It enables you to release a lot of stress through the day so it's not building up. I call it preventative medicine if you're doing it every day, the stress levels don't overflow. You're much more resilient, calm and coming from a much more present place.

"A guy might have someone say something to him and in the past he would have flared up or even given him the bash but, after learning to meditate, they say things like. 'I just used my technique and I was able to let it go.' That might seem like a small thing, but it's huge to these guys. For them to be able to let that stuff go is just amazing."

The next step in the programme, besides spreading to other prisons beyond the current six, is to get some real measurement of what until nowhas been anecdotal success stories.

Dunlop says thereare national statistics available on what's calledRQthe rehabilitation quotient of all the DTUs around the country, but there are no site-specific stats held, so it's hard to pull out variables such as what difference meditation has had on prisoners once they are released.

But Dunlop is a believer and it seems Corrections can see the benefits too.

"I can't speak for Corrections but I can speak for the support they've shown the programme they believe in and want it to keep happening.

"I've sat in on a few of the courses with the men and it's something I practise several times daily and this is what people don't understand: it doesn't have to take time if you're busy.

"I sometimes do just a couple of minutes four times a day like when I'm shifting from one job to another it's like getting closure in my mind about what I've just been working on and freshen up for the next step.

"Definitely before I get out of the car and walk into the prison, I do a quick session and if something particularly stressful is going on, I use it as a strategy."

Another measure of success is that the rest of the world is starting to take notice of what is happening in some New Zealand prisons.

Since prisons in Mexico and New Zealand began offering ascension meditation, their counterparts in other countries are also getting involved. The Ishaya monks have started going into prisons in Norway and Spain and the first course is about to be taught in a facility near Perth, Australia.

"We want to wake people up to know that peace is possible," says Savitri.

FINDING YOUR PEACE: TESTIMONIALS FROM PRISON STUDENTS

"Like many other men in my situation, I wasn't granted the luxury of a healthy upbringing. [This] led me to develop many very negative unhelpful views about myself, others and the world. These views and beliefs are the bricks and mortar of my internal mental prison, far more secure and complex than any maximum security prison and until now I considered it escape-proof.

"I was blown back in my seat at the first class when [the teacher] said it's all too often that we think we are just bad or broken. And that's exactly what my beliefs tell me. That's what all the drug use and looking for love and acceptance outside myself has been all about. The downside to that antisocial lifestyle has been making poor choices and bad decisions in which people have been hurt. I can't undo that tragedy. However, with your knowledge and teachings of meditation I can start to break down the beliefs and views that created the thoughts... I can't thank you enough for the keys to my prison... Just know that there are others like me serving life sentences who need this."

Testimonial from a prison student

"I was burdened by raging thoughts, irregular sleep patterns and general anxiety. However by using the meditation techniques I have been able to really calm my mind. I have been experiencing deep, peaceful sleep and have noticed that my general anxiety has been reduced significantly."

Testimonial from a prison student

Mindfulness versus meditation

Mindfulness is a bit of a buzzword, butwhat's the difference between that andmeditation?

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Meditation in NZ prisons offering keys to freedom - Stuff.co.nz

Feb. 25, 2020

WASHINGTON Although the immediate side effects of antimalarial drugs are widely recognized, few studies were designed specifically to examine health problems that might occur or persist months or years after people stopped taking them. For this reason, a new report from the National Academies of Sciences, Engineering, and Medicine finds there is currently insufficient evidence to determine whether there is an association between antimalarial use and neurologic and psychiatric outcomes, including anxiety, depression, and the development of symptoms that mimic post-traumatic stress disorder (PTSD). Further research is warranted because existing studies are limited in their design.

As of 2019, six drugs have been approved by the U.S. Food and Drug Administration (FDA) for prevention of malaria and are available by prescription: tafenoquine, atovaquone/proguanil (A/P), doxycycline, mefloquine, primaquine, and chloroquine. The report examines the possible long-term health effects of these six drugs, with a particular focus on the neurologic and psychiatric effects of mefloquine, which was widely prescribed to U.S. troops until 2009; and tafenoquine, a newly approved drug. It contains 31 conclusions regarding the level of association between the antimalarial use and persistent or latent adverse events.

The committee that wrote the report defined persistent events as those that start while the drug is being taken and continue at least 28 days after the drug is stopped. Latent events are not apparent while the drug is being taken, but present any time at least 28 days after cessation.

The report also presents strategies for designing and conducting studies that would advance the understanding of possible persistent and latent events associated with antimalarial drugs.

The committee recognized that adverse events while taking some antimalarial drugs are quite common, but the pressing, well-justified question of whether health problems continue after use has simply not generated the rigorous research needed to answer it, said committee chair David Savitz, professor of epidemiology at the Brown University School of Public Health. The absence of evidence on long-term health effects of these drugs does not mean the link doesnt exist, only that there is a critical need for well-designed studies to answer important safety questions.

In 2018, there were 228 million cases of malaria worldwide, with 405,000 resulting in death. Malaria has affected nearly every U.S. military deployment since the Civil War, and it remains an ongoing threat to those involved in the current conflicts in the Middle East. In addition to U.S. service members and veterans, the report also examines the adverse events and health outcomes experienced by populations including Peace Corps volunteers, travelers, people living in malaria-endemic areas, and research volunteers. While travelers are encouraged to take an antimalarial drug as a preventative treatment, military personnel are required to do so under proper medical supervision.

Limitations of Existing Research Some of the currently available antimalarials have been in use since the 1940s, but after an extensive literature review, the committee found only 21 epidemiological studies that examined adverse events occurring at least 28 days after the final dose. The studies conducted to gain FDA approval are generally limited by small sample sizes and short follow-up periods, making it difficult to identify persistent or latent effects. In other studies, adherence rates may be inflated, as people are often reluctant to report when they modify a dose or stop taking a medication altogether.

Furthermore, because of the many other factors and stresses associated with deployed environments, like combat, it is challenging to attribute specific health effects to the use of an antimalarial drug. For a diagnosis of PTSD, the person should have directly experienced a traumatic event; the medication itself is not the traumatic event, as the diagnostic criteria explicitly state, the report says.

Conclusions on Association Between Antimalarial Use and Health Outcomes For each of the six approved drugs, the committee examined adverse events categorized by body system: neurologic, psychiatric, gastrointestinal, eye, cardiovascular, and other disorders.

There is a sufficient level of evidence of an association between tafenoquine and vortex keratopathy, a condition that involves asymptomatic deposits in the cornea, the committee found. While it was found to persist beyond 28 days, it was also found to resolve within 3 to 12 months and not result in clinical outcomes, such as loss of vision.

While the committee found little evidence for associations between the drugs and most outcome categories, it also found the evidence provides a basis for additional research into an association between the following antimalarial drugs and health outcomes:

Advancing Research on Antimalarials Given the billions of people at risk for malaria and the severity of the disease, there will be a continuing need for people to take antimalarials, the report emphasizes. The threat of drug-resistant parasites also necessitates research into new preventatives.

To establish causal links between taking antimalarial drugs and persistent or latent adverse health effects, the committee recognized the need for a series of randomized trials and multiple well-designed observational studies of varying types. Ideally, these studies would:

Researchers could also conduct studies using health care databases that cover a large number of individuals who used antimalarial drugs and reported their subsequent health experiences. Such data sources might include Department of Veterans Affairs (VA) and Department of Defense (DOD) health care databases, existing DOD and VA registries, Medicare, FDA Sentinel, commercially available claims databases, and national health care data from other countries. Adverse event registries, such as that used by FDA, would not be informative, since they do not provide comparative data, the committee concluded.

The study undertaken by the Committee to Review Long-Term Health Effects of Antimalarial Drugs was sponsored by the U.S. Department of Veterans Affairs. The National Academies are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine. They operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln. For more information, visitnationalacademies.org.

Follow us:Twitter@theNASEMInstagram@thenasemFacebook@NationalAcademies Contact:Stephanie Miceli, Media Relations Officer Office of News and Public Information202-334-2138; e-mailnews@nas.edu

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Determining Whether There Is a Link Between Antimalarial Drugs and Persistent Health Effects Requires More Rigorous Studies - National Academies of...

Lead contamination in hunted meat has the potential to impact the health of millions of people in the U.S. who are connected to the hunting community, including low-income recipients of venison donations.

However, a lack of communication from public health agencies and health professionals leaves people who eat hunted meat without a trusted source of information about the health risks and advice for reducing exposure to lead.

An investigation of dozens of studies about lead in hunted meat, preventative information about lead, and questionnaires used to identify patients at high risk for lead exposure, along with hours of interviews with hunters who use lead ammunition, revealed a concerning disparity between what is known about risks of exposure to lead in hunted meat, and what is shared with the hunting community. Hunters reported either never hearing about this topic, or hearing about it from perceived anti-hunting sources, resulting in a deep mistrust about the topic of lead. In addition, healthcare providers and health departments are not including the dangers of lead in wild game in their preventative information or questionnaires to identify children and pregnant women at risk for lead exposure.

There is no safe level of lead in the blood. Levels above 5 micrograms/deciliter (g/dL) are considered elevated and have been associated with Attention Deficit Hyperactivity Disorder (ADHD) and decreased IQ. However, developing brains exposed to even lower levels are at risk for attention-related behavioral problems, decreased cognitive performance, and increased incidence of problem behaviors.

Althoughneurotoxiceffects of lead may be the most widely-known, low levels of lead in the blood have been associated with a range of serious health effects, includingkidney diseaseand impacts to thecardiovascular system. The mechanisms behind the toxic effects of lead are not fully understood.

As lead ammunition use continues to be widespread among U.S. hunters, experts say it is crucial that health officials get a message out to hunting communities, including useful advice for hunters who will continue to use lead. Hunters want to know what the risks are and what options they have to keep their families safe.

This is also an issue of environmental reproductive justice for girls and women who, with each meal of contaminated meat, add to the burden of lead in their bones that can affect the outcomes of their future pregnancies.

Dr. Ned Ketyer, Washington County, Pennsylvania-based pediatrician, told EHN, Were learning more every day about the significant adverse health impacts of lead on human health, especially childrens health.

As we continue putting more lead into the environment, and continue to expose ourselves and our children to lead, at some point it makes sense to say, Wait a minute, what are we doing?'

Researchers found lead ammunition fired from high-powered rifles contaminated carcasses more than slower-moving lead slugs fired from shotguns. (Credit: mr.smashy/flickr)

While lead was banned from waterfowl ammunition in the U.S. in 1991, the majority of people who hunt other types of game use lead ammunition.

Upon impact, a lead bullet can fragment into tiny microparticles, too small to see with the naked eye or sense when eating. A deer processor in Pennsylvania who requested anonymity shared his first-hand experience. Seventy-five percent of the time when I find a bullet in the carcass, I only find the base. I know the lead is all in the meat somewhere, he told EHN.

Scientists have used X-rays to visualize andcountsometimes hundreds of minute lead particles in hunted meat, and have detected high concentrations of lead in hunted carcasses using chemical analysis. Although the U.S. Food and Drug Administrationdoes not recognizea safe limit for the amount of lead in meat, the European Commissionsetmaximum levels at 0.1 parts per million (ppm).

Concentrations of lead more than 100 times this limit have beendetectedin the meat of lead-shot carcasses as far as six inches from the entry wound.

In 2009, biologists from the Minnesota Department of Natural Resources x-rayed deer and sheep carcasses that were shot with lead ammunition to make any lead fragments visible. Theyfoundsome types of lead bullets fragmented more than others, and that fragmentation was more extensive when poorly-placed shots struck large bones.

They also found that lead ammunition fired from high-powered rifles contaminated carcasses more than slower-moving lead slugs fired from shotguns.

For most people, lead exposure occurs primarily through eating, drinking, or inhalation. While inhaling airborne lead from gun smoke produced by a firearm is arecognizedrisk factor for lead exposure, eating lead-contaminated meat is widely ignored, despite scientific evidence.

Multiple studies have found a direct link between game harvested with lead ammunition and spikes in blood lead.

Three studies about consumption of lead-hunted meat were published in 2018.

Hunted venison is typically part of the menu at the Tent, an annual event for hunters in the Allegheny National Forest since 1947. (Credit: Mike Bleech)

After an adults digestive system absorbs lead from a meal, the resulting concentration of lead in the blood typicallydecreasesby approximately 50 percent every month. But that doesnt mean all the lead has left the body. Instead, some lead moves from the blood to the skeleton, where it remains for decades.

As a result, blood-lead levels can be deceivingly low months after peak consumption of lead-hunted meat. For example, astudyin Greenland identified a clear seasonal variation in blood lead levels, with peaks during the months when consumption of hunted meat was highest, and decreases during months of lower consumption.

No study has been conducted in the U.S. to understand monthly patterns of blood-lead levels among people who eat lead-hunted meat. Yet the National Shooting Sports Foundationstates, A study from 2008 by the U.S. Centers for Disease Control and Prevention (CDC) on blood- lead levels of North Dakota hunters confirmed that consuming game harvested with traditional ammunition does not pose a human health risk.

However, the referencedstudycollected blood samples five months after the hunting season, and reported results for people who ate wild game in general it was not determined whether the meat was hunted with archery, non-lead ammunition, or lead ammunition. A significant difference of 0.30 g/dL was observed between the average concentration of lead in the blood of people who reported eating wild game compared to those who did not.

Children hunters. (Credit: U.S. Army Corps of Engineers Savannah District)

There are some potential consequences of lead exposure unique to women and their fetuses. Due to hormonal changes during pregnancy, lead that has been stored in the skeleton is released into the blood, exposing both mother and fetus. As a result, high levels of lead in mothers bones have beenidentifiedas a risk factor for impaired mental development in infants.

In addition to neurotoxic effects, potential consequences to the fetus or infant includelow birthweightandspontaneous abortion.

Onestudyof pregnant women found the odds of a spontaneous abortion nearly doubled for each 5 g/dL increase in blood lead. Lead is also amajor risk factorfor preeclampsia, a high-blood pressure condition that can have severe consequences for the mother and infant. Women who experience adverse pregnancy outcomes such as preeclampsiafaceincreased risk of cardiovascular and metabolic diseases as they age.

Many pregnant and breastfeeding women arent receiving recommended screening for lead exposure, and even those who are screened may not be asked the right questions to detect all potential sources of exposure, Dr. Jennifer Braverman, assistant professor in the Division of Maternal Fetal Medicine at University of Colorado, told EHN. Asking women about consumption of lead-hunted meat may identify women at risk of adverse outcomes who are currently being missed.

Doctors decide whether to test a pregnant womans blood based on answers to a questionnaire about exposure to lead. However, consumption of hunted meat is not included in any of the 12 risk factors for lead exposure recognized by theAmerican College of Obstetricians and Gynecologists, and is also absent from the U.S. Centers for Disease Control and Preventions (CDC)Guidelinesfor the identification of lead exposure in pregnant and lactating women.

Even though some parts of a lead-hunted carcass may be free of lead and safe for pregnant women to eat, it is not possible to identify contaminated meat with the naked eye, and levels of contamination vary from carcass to carcass.

Dr. Braverman told EHN that since its not clear how to choose safe portions of lead-hunted meat, preventative information about lead-hunted meat could be provided along with other nutritional advice. We provide education about mercury. We talk about how to avoid listeria. I think its reasonable to add to that, dont eat lead-hunted meat.'

Braverman also emphasized that even if women avoid ingesting lead during pregnancy, the lead they accumulated before pregnancy can still pose risks.

Certainly it would be better to avoid lead exposure for your whole life.

Childhood prevention information related to hunted meat is absent from theAmerican Academy of Pediatrics, theCDC,EPA, and guidance from state health departments such as thisbrochurefrom the Pennsylvania Department of Health. Although the New York Department of Health issued the followingstatement, people who eat game harvested with lead shot may be exposed to lead.

This is of greatest concern for young children because they are particularly susceptible to the toxic effects of lead, the topic is absent from the departments advice onChildhood Lead Poisoning Prevention. The Wisconsin Department of Health Services acknowledges concerns about lead exposure from eating hunted meat, andrecommendsuse of non-lead ammunition. However, the topic is absent from the departments lead prevention information, Feeding Your Child.

The most common policy in the U.S. is for children to have their blood-lead levels tested by the age of two, before they are likely to consume large amounts of hunted meat. But exposure to lead after the age of two matters. Blood-lead levels of 6-year-olds have been more stronglyassociatedwith impaired cognitive and behavioral development compared to blood-lead levels measured earlier in childhood. This highlights the importance of questionnaires for identifying older children at high risk of lead exposure, and the need for a question about consuming hunted meat.

Its something pediatricians should be asking. Do you eat venison or other locally hunted meat? it might be useful to add this question to the lead questionnaire we give to parents of infants and toddlers, Dr. Ketyer told EHN.

Venison meat. (Credit: Chris Davies/flickr)

These concerns extend to those who eat venison donated to food pantries.

Venison donation programs have provided millions of meals to food banks across the country. States with venison donation programs include those that also harvest themost deer: Texas, Michigan, Pennsylvania, Wisconsin, and Georgia. None of these five states require x-ray inspection of meat for lead contamination.

In 2008, astudyanalyzed nearly 200 packages of venison from food pantries in Wisconsin, but it is unknown how many packages contained meat that was hunted with firearms. Lead was detected in 15 percent of packages; the average level in lead-contaminated meat was 160 ppm. At this concentration of lead, the study predicted 81 percent of children who consumed just two meals of venison per month would experience blood-lead levels above 10 ug/dL.

In terms of other states, Minnesota requires x-rayinspectiondue to documented lead contamination of donated venison. However, North Dakota and Iowa currently accept venison donations to food banks without lead inspection, despite previous findings of lead contamination.

The Iowa Department of Public Health hasresponded, pointing out that no cases of concerning blood-lead levels in the states children have ever been attributed to lead in venison. However, this fails to recognize that most children tested in Iowas program are tested from ages 0-3. This also fails to take into consideration that blood-lead levels tested several months after the hunting season may be deceptively low.

Evidence of lead contamination in donated venison first came to light in 2008. North Dakota hunter and physician Dr. William Cornatzer saw an x-ray image of a lead-contaminated carcass during a board meeting of the Peregrine Fund, a conservation organization focused on birds of prey. Soon after, he led a project to x-ray packages of venison donated to the states food banks. The images revealed lead contamination in 60 percent of samples. I about fell out of my chair. he told EHN. He realized his children and pregnant wife had likely been exposed to lead from his own hunted venison.

I dont think humans should be eating lead-contaminated meat, and I dont think we should be donating it to people who cant afford alternatives, he said. Unfortunately, a lot of people took this as, Somebodys trying to take my bullets away, somebodys trying to take my guns away.'

The Peregrine Fund issued a statement in response to accusations directed at Dr. Cornatzer and characterizations of the organization as anti-hunting extremists: To build support for their own agenda, special interest groups have deliberately tried to smear the integrity of thoughtful, dedicated health and wildlife professionals and create fear of losing hunting and gun rights among their constituents. Smear and fear is a well-known technique for manipulating public opinion when facts are absent. Their action is disingenuous and not in the interests of wildlife or human health, including the health of their own constituents.

Across the state line, Lou Cornicelli, Wildlife Research Manager and author of the Minnesota Department of Natural Resources specialreporton lead contamination of hunted meat, had a similar experience.

I got crazy accusations just because we described what might happen if you shoot a lead bullet, Cornicelli told EHN. It evoked a strong reaction from people, like The next thing youre going to do is take my guns away.'

At the time Cornicelli ran the states big game program and was responsible for regulation-setting, the annual harvest was roughly a quarter of a million deer per year. And yet he received accusations of being a secret agent for the organization People for the Ethical Treatment of Animals (PETA).

People would ask, Are you an anti-hunter? No. Just because I dont want to eat lead doesnt mean Im against hunting, he said.

When asked for a comment regarding lead-contaminated meat, the National Shooting Sports Foundation (NSSF) sent a link to theirfactsheeton lead-based ammunition, which claims the lead detected in North Dakotas donated meat was part of the Peregrine Funds agenda to ban lead ammunition. In reality, the stated mission of the Peregrine Fund is to preserve our wildlife conservation and hunting heritage through voluntary incentive-based outreach and education aimed at increasing the use of non-lead alternatives.

The NSSF also told EHN that their support for educating hunters extends to discussing options hunters have for limiting exposure such as burying entrails after field dressing and careful meat processing.

Group of deer hunters. (Credit: Florida Fish and Wildlife/flickr)

Natural resources officials may be appropriate messengers to discuss lead-contaminated meat, however, there are two problems. Elaboration on potential health effects is often avoided, viewed as the domain of health departments. Second, many hunters strongly disagree with their states deer management decisions, and view any information from the responsible department with deep suspicion.

Kevin, Perry, and brothers Robert and Gary have been hunting together with lead ammunition for decades, since they were 12. We met with them in November and they requested EHN use their first names only. They believe that advice about how to avoid the potential health effects of consuming lead-shot meat should be more accessible to the hunting community.

According to Kevin, lead exposure is not a topic of conversation among hunters.

Its not really brought up. People in the hunting community dont really know about it, he told EHN.

Robert believes this should change, and emphasized the need for information to be free of anti-hunting or anti-ammunition agendas.

I think its important not just for hunters to understand it, but for people who are ingesting the meat from hunters, whether its their families or people eating whats been donated, that they understand there are potential consequences, he told EHN. But it has to be clear theres no hidden agenda It needs to be pure, science-driven, here are the facts, were not legislating anything, just saying heres what the issues are.'

Gary sees opportunities for communication by healthcare providers. He told EHN, I was in the doctors office today, my heart doctor. You go in, just like when you go to the diagnostic center, and they have those pamphlets Are you a lady of childbearing years? Are you a pre-diabetic?' He suggested that information about lead-hunted meat be presented similarly, Why cant that information be funneled through the health industry into pamphlets?

For Perry, the issue centers on information parents should receive before their child is old enough to start eating lead-shot meat. I would say one of the biggest possibilities is a pediatrician. The biggest. Because youre feeding that baby deer meat once it gets older, he told EHN. Somebodys going to come in there with their baby, and the pediatrician will check it all over, and then say Oh here, this is what I want you to read. The doctors have to get it out there.

Dr. Ketyer emphasized that its not just about what is being communicated, but the way it is communicated.

How we communicate is the key. This is not about challenging the hunting lifestyle we need to consider what would be most useful for families that hunt, he said. People should have an opportunity to understand the risks to themselves and their children. I didnt know is not acceptable to a pediatrician.

While switching to alternative ammunition is the most effective way to eliminate lead contamination of hunted meat, Cornicelli said he understands why many hunters choose to continue using lead ammunition. There are real reasons why people dont switch the commercial availability of copper is lower, and the price is higher, he said. A large shift to copper is going to be predicated on manufacturers ramping up production, driving costs down, and making availability more broad.

As a result, Minnesotas DNR provided hunters with examples of ways to reduce lead exposure, even if they continue to use lead ammunition. These include selecting shotguns instead of high-powered rifles, and avoiding acidic cooking ingredients, since acids can dissolve even more of the lead into the food.

Additional advice for hunters who use lead ammunition is to avoid shooting the deer in regions of the body with heavy bones, such as shoulders and hips, where the resulting impact scatters more lead into the meat. The anonymous deer processor in Pennsylvania told EHN he cautions his customers, Pick your shots. If youre not comfortable shooting at a running deer, dont do it. Wait for a better shot. And its not just to have meat thats not contaminated with lead. Its also better for the animal you dont want the animal to suffer.

Dr. Braverman pointed out the need to include hunters in the process of identifying strategies to reduce lead exposure,

We need more research about what effective interventions are for people eating a lot of hunted meat, she said. Its important to ask, culturally, what works for people in their life? What do they think about this?

Gary summed up the challenge of communicating about lead exposure from hunted meat, Its easy to say, Well, its not going to happen to me. That lead, it didnt bother my dad or my grandfather, or my aunt, or my uncle, so its not going to happen to me.'

His brother Robert added, But we dont know that it didnt affect them. Now the science could exist to say, you know Grandpa had this, and this, and lead could have contributed.

Sam Totoni is a graduate student in Environmental and Occupational Health at the University of Pittsburgh Graduate School of Public Health.

James Fabisiak is an Associate Professor of Environmental Health and Director of the Center for Healthy Environments and Communities at the University of Pittsburgh Graduate School of Public Health.

Martha Ann Terry is a faculty member in the Department of Behavioral and Community Health Sciences at Pitts Graduate School of Public Health.

This article originally appeared in Environmental Heath News. It was republished under a Creative Commons license.

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Lead in hunted meat: Who's telling hunters and their families? - UPMC

As disease-wary stock markets tumble, the outbreak of the novel coronavirus, COVID-19, has continued to see global death tolls rise rapidly spreading from its Wuhan roots to gain a foothold in countries as diverse as Italy and Iran.

But virus outbreaks are nothing new: in just the past 10 years, the world has been plagued with the H1N1 pandemic of 2009 and a resurgence of the Ebola virus from 2014 to 2016 and it seems like such epidemics will continue for years to come.

Which begs the question, can scientists predict if, and when, we will see another new virus strike within the next several years?

But despite advancements in virus detection technology, according to Prof. Roy Gulick, medicine, chief of the division of infectious diseases at Weill Cornell, it is often difficult to predict when and how often such outbreaks will occur.

These difficulties are compounded by the fact that viruses cannot be singularly categorized instead, representing a wide range of illnesses, which vary considerably in both symptoms and manner of transmission.

However, the medical community is increasingly equipped with more advanced technology that can more quickly discover new viruses, though challenges still loom.

Were much better at discovering, tracking, and characterizing new viruses, Gulick said. Given that we have much better tools today to analyze these [viruses], were going to continue to discover more viruses and microorganisms and that will help us do genetic analyses and develop vaccines and medications.

For instance, a new virus, Yaravirus brasiliensis, which was discovered at the end of January in Brazil, is a testament to the gap in knowledge in the world of viruses.

Over 90 percent of the virus genome has never been seen in other organisms, and bears no resemblance to any genome cataloged in over 8,500 publicly available metagenomes, genetic samples recovered from the environment.

In fact, the virus is so foriegn it actually represents an entirely new group of viruses based on current classification protocols, the Yaravirus would not even be considered a virus.

The novel virus does not cause human disease, but its exact effects still remain unknown.

For a virus to cause diseases in humans, it has to be able to recognize a cell and target that cell, Gulick said. Different viruses target different cells in the body the cold and flu virus tend to target cells of the upper airways, nose, mouth, and the throat.

Another reason that makes viruses so difficult to track and contain is the vast variety in the way they are transmitted.

For instance, some viruses, like the common cold, spread through nasal or oral secretions that are passed from one individual to another through contact, while others, like measles, can spread through mere proximity, moving through coughs or sneezes near others.

In a type of illness Gulick called zoonosis, humans can contract viruses not only from other humans, but animals as well, such as in the case of SARS.

The occurrence and severity of outbreaks, Gulick explained, depends on which of these modes of transmission a virus uses to spread. This, in turn, affects what preventative measures are recommended by healthcare professionals to halt a virus contagion.

Typically, around cold and flu season, we remind people to wash [their] hands frequently, Gulick said. If someone is admitted to the hospital for measles, we put a mask over them and anybody entering their rooms so that measles is not transmitted through the air from one person to another.

While the nature of the next viral outbreak is uncertain, significant medical advancements, such as vaccines, have improved the treatment of viruses and the state of public health as a whole, according to Gulick.

Were much better, particularly in the last five years, about being able to develop vaccines in a rapid way, Gulick said.

Vaccines are not available for all viral ailments, but advancements in antivirals have significantly improved treatments for viral infections within the past few decades, Gulick said. Gulick explained that antivirals are commonly used for influenza and Hepatitis C.

Overall, the trend of new virus outbreaks doesnt seem to be slowing down any time soon, but preventive measures are crucial for avoiding infection.

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Evolving Viruses: What Does the Future Hold? - Cornell University The Cornell Daily Sun

The Most Recent study on the Hematopoietic Stem Cell Transplantation (HSCT) Market Research provides a profound comprehension of the various market dynamics like trends, drivers, the challenges, and opportunities. The report further elaborates on the micro and macro-economic elements that are predicted to shape the increase of the Hematopoietic Stem Cell Transplantation (HSCT) market throughout the forecast period (2019-2029).

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Hematopoietic Stem Cell Transplantation (HSCT) Market Research report explores the Market for the forecast period, 2018-2026 - Keep Reading

Global Smart Street Lighting MarketThis research report provides detailed study accumulated to offer Latest insights about acute features of the Smart Street Lighting Market. The report contains different market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market. It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary and SWOT analysis.It presents the 360-degree overview of the competitive landscape of the industries. Smart Street Lighting Market is showing steady growthand CAGR is expected to improve during the forecast period.

Manufacturer DetailCCBCCBRViaCordEsperiteVcanbioBoyalifeLifeCellCrioestaminalRMS RegrowCordlife GroupPBKM FamiCordcells4lifeBeikebiotechStemCyteCryo-cellCellsafe Biotech GroupPacifiCordAmericordKrioFamilycordCryo StemcellStemade Biotech

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Smart Street Lighting Market 2020: Industry Share, Size, Emerging Technologies, Future Trends, Competitive Analysis and Segments Poised for Strong...

Global Progenitor Cell Product Market research report gives a comprehensive outlook of the markets 2019-2026 and offers an in-depth summary of the current market status, historic, and expected way forward for the Progenitor Cell Product Market. Additionally, to this, the report provides data on the restraints negatively impacting the markets growth. The report includes valuable information to assist new entrants, as well as established players, to understand the prevailing trends in the Market.

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Progenitor Cell Product Market Report by Manufacturers, Regions, Type and Application Forecast 2019 2026 - News Times

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Newswise CLEVELANDResearchers at Case Western Reserve University have used a unique method to safely deliver gene therapy to fight a rare, but irreversible, genetic eye disorder known as Stargardt disease.

By using chemically modified lipidsinstead of the viruses most commonly used as carriersStargardt disease did not return in animal models for up to eight months after treatment, said lead researcher Zheng-Rong Lu, the M. Frank Rudy and MargaretDomiter Rudy Professor ofBiomedical Engineering at the Case School of Engineering, with a dual appointment at the School of Medicine.

Lus research, recently published in the journal Molecular Therapy, was funded in part through a Gund-Harrington Scholar grant, a partnership between Harrington Discovery Institute at University Hospitals and the Foundation Fighting Blindness.

This grant provides innovative scientists like Dr. Lu both funding and drug development expertise to advance research that will defeat diseases that limit millions of people from experiencing the gift of sight, said Jonathan S. Stamler, MD, President, Harrington Discovery Institute and Robert S. and Sylvia K. Reitman Family Foundation Distinguished Chair of Cardiovascular Innovation at University Hospitals and Case Western Reserve University School of Medicine. It is very encouraging to see Dr. Lus work move closer to human trials.

A so-far incurable disorder

The research may give some hope to people with Stargardt disease, an inherited disorder of the retina also known as macular dystrophy or juvenile macular degeneration because it often surfaces during childhood or adolescence.

Although individuals with Stargardt disease rarely go completely blind, they progressively lose vision in both eyes, become very sensitive to light and, in some cases, develop color blindness.

Were really excited because there is a potential to help people with Stargardt, Lu said. But we believe this success could also apply to other disorders as a platform therapy for delivering other genes through the use of the lipids.

Lipids are simple organic compounds, or fatty acids, that are insoluble in water, including various natural oils, waxes and steroids.

Because they are basically unsaturated oil, the likelihood of damage to the eye is low, which isnt always true with the viral gene therapy, Lu said.

Gene therapy offers best hope

There are a lot of researchers trying to figure out how to treat this disease right now with little success, Lu said. The best hope is gene therapy.

Gene therapy is the technology in which genetic material is introduced into cells by an engineered carrier to compensate for abnormal genes or to make a beneficial protein.

The most successful gene therapy carriers so far have been certain viruses (the AAV, or adeno-associated virus, especially) because they can deliver the new gene by infecting the target cell.

But the Stargardt-associated gene, known as the ABCA4 gene, turns out to be too large to fit within that popular virus, Lu said.

Lu said other researchers have attempted to remedy that problem by splitting ABCA4 into pieces and then trying to reassemble it inside the eyewith limited success.

Other researchers have modified a larger virus to carry ABCA4 into the eyes, a technology tested in human trials as far back as 2011, but which still hasnt been fully commercialized.

He said he and his collaborators have also already met with investors to expedite the commercialization of the platform used for Stargardt.

Further, this gene therapy product could be classified as an orphan drug by the U.S. Food and Drug Administration (FDA) because Stargardt is a rare disease, increasing the likelihood of faster FDA approval after clinical trials, Lu said.

The non-viral gene therapy is also much more cost-effective for production than the virus-based therapy and has a potential to significantly reduce the high price of gene therapy in the eye, he said.

We think that within two to three years we could really be helping people after further demonstration of its safety and efficacy, Lu said.

MEDIA CONTACTS:

Michael Scott, Case Western Reserve University

216.368.1004, mike.scott@case.edu

Carly Belsterling, University Hospitals

412.889.8866, carly.belsterling@uhhospitals.org

###

Case Western Reserve University

Case Western Reserve University is one of the country's leading private research institutions. Located in Cleveland, we offer a unique combination of forward-thinking educational opportunities in an inspiring cultural setting. Our leading-edge faculty engage in teaching and research in a collaborative, hands-on environment. Our nationally recognized programs include arts and sciences, dental medicine, engineering, law, management, medicine, nursing and social work. About 5,100 undergraduate and 6,200 graduate students comprise our student body. Visit case.edu to see how Case Western Reserve thinks beyond the possible.

Harrington Discovery Institute

The Harrington Discovery Institute at University Hospitals in Cleveland, OHpart of The Harrington Project for Discovery & Developmentaims to advance medicine and society by enabling our nations most inventive scientists to turn their discoveries into medicines that improve human health.The institute was created in 2012 with a $50 million founding gift from the Harrington family and instantiates the commitment they share with University Hospitals to a Vision for a Better World.

The Harrington Project for Discovery & Development

The Harrington Project for Discovery & Development (The Harrington Project), founded in 2012 by the Harrington Family and University Hospitals of Cleveland, is a $300 million national initiative built to bridge the translational valley of death. It includes the Harrington Discovery Institute and BioMotiv, a for-profit, mission-aligned drug development company that accelerates early discovery into pharma pipelines. For more information, visit:HarringtonDiscovery.org.

Read more:
Scientists successfully test new way to deliver gene therapy - Newswise

A health ministry panel approved Wednesday the production and sale of a gene therapy for treating spinal muscular atrophy, a rare incurable disease that destroys muscle function through a decrease in motor neuron cells.

The health minister is expected to formally approve the drug, Zolgensma, by the end of March, with public health insurance coverage seen starting this summer.

The one-time-only gene therapy, developed by Swiss drug giant Novartis AG, will cover patients below 2 years old with abnormalities in their genes to make proteins necessary for maintaining motor nerves. Novartis estimates 15 to 20 children a year are likely to receive treatment using the drug in Japan.

In the therapy, proteins are created after the genes, carried by adeno-associated viruses, are delivered to motor nerves through intravenous drips. In an overseas clinical trial, all of the 15 severe SMA patients who used the therapy were able to live without an artificial ventilator. If no treatment is offered, about 75 percent of such patients are expected to die or need an artificial ventilator before they reach the age of 13.6 months.

The therapy, which has already been approved in the United States, is expensive, costing the dollar equivalent of 230 million for a one-time infusion.

View original post here:
Japanese government panel OKs expensive gene therapy for rare disease - The Japan Times

TrakCel and Ori Biotech have announced a new non-exclusive strategic partnership to "achieve supply chain orchestration within closed system manufacturing for the cell and gene therapy sector.

The Ori platform enables therapy developers and contract manufacturers to achieve automated CGT manufacturing in a closed platform, and so the collaboration aims to enable users of the Ori Biotech manufacturing platform to benefit from live supply chain visibility through TrakCel software.

The companies plan to work together to give TrakCel customers greater visibility into the manufacturing process via data services within the Ori platform, and to develop suitable points of integration in order for a shared data platform to be available to partners.

TrakCel has developed an extensive partnership network with contract manufacturers and companies across the cell and gene therapy sector. This enables therapeutic developers to be supported by more standardised and integrated solutions, said Fiona Withey, co-founder and chief executive officer, TrakCel.

Fiona continued, Closed system manufacturing is becoming progressively more important for the ongoing future of the cell and gene therapy sector, and we look forward to working with Ori to offer more integrated solutions to the wider industry.

TrakCel was created in 2012 in order to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. Its platform accelerates global scale-up and scale-out of cell and gene therapy products, aiming to increase efficiency and decrease complexity.

See original here:
TrakCel, Ori Biotech ink supply chain deal for cell and gene therapy - PharmaTimes

For the cell and gene therapy revolution to be fullyrealized, physicians, research scientists, biomanufacturing experts, advocacygroups, regulatory bodies like the Food & Drug Administration (FDA) andother key stakeholders have to Think Different, as Apple famously encouraged.

The vein-to-vein, one batch to one patientformula of personalized medicine is radically and rapidly forcing changes onbiomanufacturing where cell and gene therapy best practices are not yetcalcified and are changing as we speak. Personalized medicine supply chainchallenges are emerging and still being worked through and the high cost ofthese therapies remains a daunting challenge for life science companies andpatients.

Cell and gene therapy challenges across R&D, manufacturing, commercialization, and supply chain as well as bioethical challenges yet to be fully confronted or resolved have been well documented and discussed by experts across the BioHealth Capital Region (BHCR).

One company Jeeva InformaticsSolutions, Inc. (Jeeva) in Herndon, Virginia is developing BigData solutions for a less publicized but equally urgent cell and gene therapychallenge: How to manage a radically new form of clinical trial that could spandecades. Founder and CEO of Jeeva, Harsha K. Rajasimha, is building a companythat leverages Big Data, AI and mobile tech to decentralize clinical trials.Jeevas goal is to make it easier for biotech companies to collect, aggregate,analyze and report required clinical trial data while helping patients stayenrolled and compliant over longer periods of time with little travel from theconvenience of their homes.

The FDA recently passed newindustry guidelines requiring long-term follow up (LTFU) periods ofup to 15 years for gene and cell therapies, representing a sea change for howclinical trials will operate in the future.

The cell and gene therapy space provides significant hope for cures that can reverse genetic mutations. This space is growing. There are more than 900 clinical trials ongoing. Hundreds if not thousands of genetic diseases are likely to have therapies for the first time in our lifetime, stated Rajasimha.

At Jeeva, we are trying to solve a number ofissues but have focused on one particular problem that needs to be addressed ifthese cell and gene therapies are going to be delivered to patients: No oneknows the long term implications of these therapies because they are a one anddone type treatment. If a patient receives therapy today, they are done, and sothe FDA has mandated that recipients need to be monitored for up to 15 years.We are looking to address this issue with digital health technologies and AI,he added.

Jeeva believes that these long-term monitoringchallenges can be managed by making clinical trial participation easier viamobile applications, video conferencing consultations and centralizedscheduling, to name just a few of Jeevas product features. Leveraging digitalhealth tech can reduce the need for travel and eliminate inconveniences thatmight cause a patient to become non-compliant or, worse, drop out of a trialaltogether.

Decentralized clinical trials eliminate the heavy burden of patient travel and makes the process simpler and more efficient. Utilizing a Bring-Your-Own-Device (BYOD) approach and an eVisit consultation model to create decentralized trials can reduce brick and mortar visits by 20% to 80%, according to Jeeva.

Thenew FDA guidelines is the latest attempt to grapple with unchartedsafety protocols for cell and gene therapies. Clinical trial challenges are notnew to the biotechnology industry, however; rather, the approach to clinicaltrials has been inefficient and static for decades, leading to industry-wideproblems with clinical trial enrollment and recruitment that has a dominoeffect that lengthens the commercialization process and increases drugdevelopment costs.

We want to be a catalyst for accelerating thedrug development and delivery process. Patient recruitment is a huge barrierand has made the biopharmaceutical industry unsustainable. The average cost ofbringing a drug to market is $2.5B and takes 10-15 years to get to market. Wefeel that by educating and informing the global community about clinical trialsand enrollment opportunities using AI and digital health tech, we can help allstakeholders in getting people earlier access to treatments and getting thetreatments to markets faster, Rajasimha said.

Jeeva not only can help small to midsize biotechs improve trial recruitment and longer-term safety monitoring, but the company uses AI to improve clinical trial operations. By using AI and high tech tools, biotech companies can leverage historical trial data to shape new trials while empowering real-time adjustments to trials based on real-time monitoring to improve overall success rates.

Rajasimha continued, We have been building AItools to solve our customers specific needs, not just for AIs sake. Wesurveyed our customers last year and they told us Every single clinical trialseems like the first trial ever conducted by mankind. Even companies likePfizer and Novartis, which have been conducting hundreds of trials for decades,feel that when they launch a new trialit is no more efficient than theprevious trial.

So, we have been building an AI assistant that learns from past clinical trials data to make the next trial more efficient, he added. Rajasimha quickly reinforced patient centricity by saying it is not something you fix with an all technology solution, unless the robustly tested technology solution is combined with the human elements and focus on patients perspectives. Having been a global patient advocate in the U.S. over the past six years has given me a unique perspective on how to integrate technology in the lives of patients and caregivers. Moreover, a growing number of trials are recruiting patients from multiple countries and reducing international travel burden on patients over extended durations will be critical to achieve enrollment.

While the concept of virtual clinical trialsmight seem futuristic, Rajasimha and the Jeeva team believe the market is readyfor change.

A number of pilot projects or proof of concept clinical trials, about 20 of them, have been published where patients didnt go to the clinic at all. The feasibility of conducting such remote patients studies has been validated multiple times by the industry now. The tipping point has arrived. One of the key barriers for widespread adoption of decentralized clinical trials was a lack of FDA guidelines. Now the FDA has clarified its expectations about how the industry and stakeholders can share the responsibility to reduce the burden on patients. Enough validation and regulatory guidelines have put us in a position to give our customers what they need, stated Rajasimha.

Rajasimha sees partnering with smaller to midsize biotechs early on in the drug development process meaning well before the start of Phase II or III trials as an inflection point where it can deliver the greatest impact. In addition, we are seeing some initial interest from the Medical Cannabis industry, opioid crisis intervention for chronic pain management, and patient advocacy groups, where patients often live in remote, rural areas, can also benefit from decentralized, hybrid virtual clinical trials. Finally, real-world evidence studies, or longitudinal cohort studies, is also a growing market because companies need to collect and manage patients across longer time horizons, which is Jeevas sweet spot.

Rajasimha and Jeeva are starting to see this growing market interest manifest itself in new funding partnerships. Jeeva recently announced that CIT GAP Funds had invested in the company. Jeeva is currently in an early-stage investment round and the company is in active product development with a validated prototype. Jeeva is seeking new customer pilot projects to add to its ongoing pilots, which include chronic pain, medical cannabis, oncology and cell, and gene therapy products. Later this year, the company plans to complete multiple pilot projects and have validation in Good Clinical Practices (GCP) settings.

Rajasimha and his Jeeva team are certainlyembracing a think different approach to the future of clinical trials. Jeevaand its AI-driven, virtual clinical trial model is poised to help biotechcompanies thrive and meet the unmet medical needs of more patients across theglobe.

You can listen to Rajasimhas interviewwith podcast host Daniel Levine earlier this month on iheart radio here.

Team Jeeva is seeking customer pilot projectsand strategic partners to join the journey and will be exhibiting at the NationalInstitutes of Health Rare Disease Day event on Feb 28, 2020.Rajasimha will also be delivering a keynote speech on AI in rare diseases atthe BIO-IT World West Conference at San Franciscoon March 3rd, 2020.

Steve has over 20 years experience in copywriting, developing brand messaging and creating marketing strategies across a wide range of industries, including the biopharmaceutical, senior living, commercial real estate, IT and renewable energy sectors, among others. He is currently the Principal/Owner of StoryCore, a Frederick, Maryland-based content creation and execution consultancy focused on telling the unique stories of Maryland organizations.

Originally posted here:
This Startup is on a Mission to Decentralize Cell and Gene Therapy Clinical Trials - BioBuzz

The excitement about cell and gene therapies is almost tangible within the biotech and pharma industry. Over 950 companies are actively developing advanced therapies, which are expected to make exceptional improvements to peoples lives in the next decade. Although hopes are high, the industry still faces a number of challenges in cell and gene therapy manufacturing, mainly around being able to deliver these often difficult to make, complex treatments at the scale needed to meet patient demand.

The unprecedented growth of the industry, alongside the need to develop scalable manufacturing strategies, has led to a number of challenges that need to be addressed urgently. Previously, patient numbers were so small that processes were highly manual and required numerous skilled operators. However, the recent success of early gene therapy trials means upscaling now needs to be considered right from the start.

In the early days the aim was just to get to the clinic, said Lindsey Clarke, Head of Cell and Gene Therapy EMEA at Bio-Techne. Scale didnt come into it so much, but now the conversations we are having focus much more on making these complex therapies at a scale needed for a commercial medicine. There are increased efforts on finding solutions that dont just work for trials with 10 patients, but will still work at 1000 times that scale.

Life science tools and technology provider, Bio-Techne, has made it its mission to further support the cell and gene therapy industry by channeling its expertise into developing technologies that can help to scale manufacturing processes. The companys commitment is highlighted by its recent investment into a new good manufacturing practice (GMP) manufacturing facility in St Paul, Minnesota, US, that will focus on producing raw materials for use in cell and gene therapy applications.

We have realized that if all our customers are to be successful with their therapies then there will be a huge demand for raw materials, Clarke explained. So weve started building that capability, ahead of time. But its not just about supply, we are also innovating, from simple things like looking closely at the format our products come in and making them more compatible with large-scale manufacturing to whole new product ranges.

Bio-Technes investment in the new GMP manufacturing facility is a solution to meet the growing demand for raw materials needed for cell and gene therapy manufacturing. But its just one piece of a large puzzle: cell and gene therapy developers also need to consider the complex logistics required to deliver their therapies to the clinic, particularly when its an autologous therapy.

The process from the patient to the clinician, to the apheresis collection, to the manufacturing site, then the complex manufacturing process and then delivery back to the patient is highly complex.

Another key challenge closely related to upscaling is the great risk of human error in manual processes. Many of the cell and gene manufacturing processes currently in place have been developed with small patient numbers in mind and involve manual steps.

Humans are an excellent source of variability and risk, explained Clarke. When youre manufacturing in a GMP environment, you need highly-skilled, trained operators and there is a shortage of them out there. Automation is going to be key to address this issue. Not only does it reduce the manpower that is required, but it can also streamline the processes and make them less risky, more scalable, and reproducible as well, Clarke added.

With cell and gene therapy products, various analytical methods are used to assess critical quality attributes during development and manufacturing. These reflect the identity, potency, purity, safety, and stability of the product. However, such methods are frequently complex, non-standardized, time-consuming, and performed manually by trained operators.

Organizations such as Cell and Gene Therapy Catapult have called for the development of new analytical solutions for quality testing of advanced therapies throughout the manufacturing process. More automated analytical technologies have the potential to increase facility throughput and make quality control (QC) faster, less error-prone, more reproducible, and more GMP compliant.

Although Bio-Techne has a long-standing history of developing quality proteins, antibodies, small molecules, and immunoassays, it has expanded into automated protein analytical technologies in recent years.

For viral and non-viral vectors, Bio-Technes ProteinSimple branded platforms are rapidly being adopted by cell and gene therapy developers for assessment of vector identity, purity, and stability. Compared to traditional methods like Western blot, SDS-PAGE, and ELISA, ProteinSimples technology platform is based on capillary electrophoresis and microfluidics and provides a fully automated and accurate quantitative analysis of vectors.

We are also seeing Micro-Flow Imaging (MFI), a more common image-based analytical platform in biologics, used to characterize subvisible particles for quality control of cell and gene therapy products, explained Kamar Johnson, Commercial Development Manager in Cell and Gene Therapy at Bio-Techne. These robust automated platforms offer ease of use, rapid time to result, and software that meets GMP requirements.

Collaboration lies at the heart of successful innovation. It is especially important at the interface between process development and manufacturing, said Johnson.

Not everyone is an expert in everything, we all have our particular niches of expertise, added Clarke. We believe that we need to collaborate to get the innovation that will help change the way we manufacture cell and gene therapies. Collaboration is the key to solving the challenges of the cell and gene therapy industry.

On that note, Bio-Techne recently partnered with Fresenius Kabi and Wilson Wolf to form a new joint venture that provides manufacturing technologies and processes for the development and commercialization of new cell and gene therapies.

The collaboration combines Bio-Technes expertise of proteins, reagents, media, and gene editing technologies with Fresenius Kabis Lovo cell processing system and the bioreactor expertise from Wilson Wolf with its G-Rex technology that is designed as a scalable platform for personalized cell therapies.

As processes develop and technologies evolve, the cell and gene therapy space will be confronted with new challenges. At Bio-Techne, the team is keeping an eye out for interesting trends that might affect the industry.

I see the induced pluripotent stem cell (iPSC) therapy field continuing to grow with more allogeneic cell therapies being developed, says Johnson. Allogeneic manufacturing is potentially less complicated than autologous manufacturing due to the ability to provide off-the-shelf products when patients need them.

Although the challenges in cell and gene therapy manufacturing remain a problem, companies like Bio-Techne are establishing quicker, simpler, and more automated options within quality control, manufacturing, and process development.

Wherever we go, we see newer technologies supporting cell and gene therapy manufacturing, says Clarke. Within our industry, changes come so rapidly and the treatments have shown so much promise that there is a lot of focus on cell and gene therapies. This puts a lot of pressure on us as an industry to provide these treatments. I believe that collaboration is the key to tackling this problem.

To learn more about the challenges in cell and gene therapy manufacturing and how to solve them, visit Bio-Technes website or get in touch with the experts here!

Images via Shutterstock.com

Author: Larissa Warneck

See more here:
Tackling the Challenges in Cell and Gene Therapy... - Labiotech.eu

Biomarin(BMRN) just recently announced that the FDA has accepted for Priority Review the BLA for ValRox (valoctocogene roxaparvovec) for adults with hemophilia A, notes biotech expertJohn McCamant, editor ofThe Medical Technology Stock Letter.

This constructive action by the FDA marks the first marketing application accepted for a gene therapy (GT) product for any type of hemophilia in the United States.The PDUFA date is August 21, 2020.

More from John McCamant: Alkermes Targets Bipolar Disorder and Schizophrenia

For the past 2+ years, we have known that the FDA has been proactive with gene therapy companies with an emphasis on hemophilia. Hence, the recent news may not be the biggest surprise.

However, with specific issues of variability and durability relating to ValRox data to date, the BLA acceptance is absolutely good news. Moreover, the agency also stated that, as of now they do not expect to convene an outside Advisory panel before the PDUFA. This tells us that a few things.

First, the agency believes it has enough information to make decision on its own. And second, the agency has beefed up its own internal gene therapy (and likely gene editing) efforts since ~2018.

Of course, we wont know the final answer until this summer. In the meantime, investors will continue to not only assess the likelihood of ValRox approval but also the potential market size and competitive landscape.

We know Biomarin has a major lead time over the other players in hem A GT. The company has made enormous investments in gene therapy manufacturing and in our view, bodes incredibly well for ValRox and the company with regards to the FDA acceptance of its application.

Either way, the floodgates for hem A gene therapy are open once more. As a reminder, back in January the EMA also validated the firm's ValRox application and that, too, is scheduled for an accelerated review.

See also: Taxable Bonds: An Income Strategy

This is important positive news for Biomarin and the revolutionary advances for patients via biotechnology. We believe the stock is undervalued at current levels, and remains ripe for an acquisition. The latest news should help that process along.

More From MoneyShow.com:

More:
Biomarin- Gene Therapy and Hemophilia - Yahoo Finance

BioMarins hemophilia A drug has been set an Aug. 21 PDUFA date as the California biotech looks to gain a speedy approval for the first-ever gene therapy for the bleeding disease.

The company said Friday morning the FDA had granted its AAV5 gene therapy, valoctocogene roxaparvovec, a quick review and that, at the moment at least, it didnt see the need for an expert committee to assess the drug, giving it a smoother path to a potential approval.

The FDA has also accepted the premarket approval application for a companion diagnostic test for valoctocogene roxaparvovec, helping identify the patients it can treat. The test is made by ARUP Laboratories, a nonprofit enterprise of the University of Utah and its department of pathology, it said in a statement.

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The drug is also under a speedy review in Europe.

Its not all been smooth sailing: Three-year data on its candidate were reported last May but sparked concerns about the durability of the therapy, also known as "valrox," after factor VIII levels seemed to fall off after 12 to 18 months, raising the possibility that patients might need to be re-dosed to maintain protection against bleeds.

Its main competition could come from Pfizer and Sangamo Therapeutics hemophilia A gene therapy SB-525, which reported positive data late last year, with Roche/Spark Therapeutics also in contention with SPK-8011.

Spark, however, suffered a setback after two patients treated with SPK-8011 developed immune reactions, one of which had to be treated in a hospital, but reported encouraging results with its therapy last February. It has since been snapped up in a (protracted) $4.3 billion takeover by Swiss major Roche.

RELATED: BioMarin drops lower dose of its hemophilia gene therapy as it eyes submissions by year-end

The hemophilia community has been waiting for decades for gene therapies. The FDA acceptance of the filing and initiation of review for the first gene therapy for hemophilia A builds on years of scientific achievements in improving the standard of care for people with bleeding disorders, said Doris Quon, M.D., medical director at the Orthopaedic Hemophilia Treatment Center at the Orthopaedic Institute for Children.

As a treating physician, I look forward to the possibility of having more treatment options for people with hemophilia.

Continued here:
BioMarin gene therapy won't need an AdComm as it nabs speedy FDA review - FierceBiotech

Supplies of Zolgensma, the gene therapy approved last year for spinal muscular atrophy, are tight.

Novartis, which sells the one-time treatment, can currently make about 700 to 800 doses a year at its manufacturing plant in Libertyville, Illinois. That's enough to cover the infants in the U.S. currently eligible to receive Zolgensma but leaves little room for treating a wider group of patients, which the Swiss drugmaker aims to do.

On Thursday, executives from AveXis, the Novartis unit that developed Zolgensma, opened a new facility in Durham, North Carolina, that the company views as a critical cog in its plans to expand supply of the gene therapy.

Initial production will begin this spring. But until the Food and Drug Administration licenses the plant, Novartis won't be able to use product made there for commercial sale. The company expects to gain approval next year.

Between now and then, Novartis also hopes to secure regulatory OKs for manufacturing Zolgensma at a site in Longmont, Colorado, bought last year, and through the contract manufacturer Catalent.

"There is a short-term challenge over the next six to nine months to make sure that we can manage the supplies that are out there," said David Lennon, president of Novartis' AveXis unit, in an interview.

"We feel comfortable where we are, but we'd love to have these other sites onboard to make sure we're really robust and don't face any risks of shutdowns or anything that could impact supply."

Limited supply has also kept Novartis from widening a program set up to make the gene therapy available free of charge to patients in countries where it's not yet approved. The "expanded access" scheme, which was launched in January, randomly allocates doses of Zolgensma for participating patients under the age of two with genetically confirmed spinal muscular atrophy.

This year, Novartis plans to distribute 100 doses through the lottery, which has been criticized as putting a child's life to chance.

"We obviously know that not everyone is happy with the program," said Lennon. "We're still considering what we might do, but we're open to making changes if it makes sense for the community and to meet the goals of the program."

Lennon said he hoped to expand the program as more manufacturing capacity for Zolgensma becomes available.

Novartis has committed upwards of $200 million to building out the site in Durham, which will employ about 400 staff by the end of the year.

Spanning 170,000 square feet, the facility will be used for both commercial Zolgensma manufacturing as well as to support clinical production of other gene therapies that Novartis is developing.

"This is as much an investment in the short term in building out our supply for Zolgensma, as it is for the long term to have the flexibility to deliver on a robust pipeline," said Lennon.

Novartis currently expects to treat about 100 infants every three months in the U.S. under Zolgensma's current label. But it's also working to expand the therapy's approval to treat older children over two using a spinal injection rather than an infusion.

That patient population is significantly larger and will test Novartis' ability to produce a steady supply of the drug, although the FDA has placed a partial "hold" on the study testing the new dosing.

Novartis' launch of Zolgensma is under significant scrutiny, both because of the $2.1 million price tag the drugmaker put on the therapy and due to a data manipulation scandal that engulfed the company last year.

Despite the high cost, insurers have largely covered treatment, leading to strong sales of Zolgensma in its first three quarters on the market.

Here is the original post:
With supply tight, Novartis readies gene therapy plant for production - BioPharma Dive