Seven drugs of the current top-10 best selling drugs are biologics, the penetration of biologic drugs is expected to reach 30% by 2020 of the global pharmaceutical market and some of the key modalities include monoclonal antibodies, recombinant proteins, peptides, cell and gene therapy products.

Dr Subir Basak Chief Business Officer, GVK Biosciences

Over the last two decades, the Pharmaceutical industry has seen a radical change. The unprecedented downsizing of the internal discovery of big pharmaceuticals, patent expiration, shift towards biologics have seen a surge in the externalization and outsourcing activities. As the industry is looking for new sources of discovery and innovation with limited resources, there is a growing preference to move towards externalization and willingness to embrace the concept of outsourcing.

Seven drugs of the current top- 10 best selling drugs are biologics, the penetration of biologic drugs is expected to reach 30% by 2020 of the global pharmaceutical market and some of the key modalities include monoclonal antibodies, recombinant proteins, peptides, cell and gene therapy products. Global R&D spend in the biopharmaceutical industry is estimated to be $194 billion in 2016 and according to industry experts, 75-80% of the expenses can be outsourced. However, current penetration rate is around 58% which presents a huge opportunity for the CROs to tap the Trends in Drug Discovery Outsourcing: A Perspective market. The global pharmaceutical outsourcing market was estimated to be $113.7 billion in 2016 and out of which 49% is accounted for CROs. Among the $55.7 billion CRO market, 31.2% accounts for discovery-based service i.e. $17.4 billion in 2016 and the remaining 68.8% accounts for Preclinical and clinical services.

Biology related services segment is a high growth area with huge potential and expected to grow faster at a CAGR of 17.2% compared to the small molecules segment due to increase in budget allocations for R&D by biopharmaceutical companies.

The drug discovery CRO industry is witnessing increased consolidation. Many Asia-based companies are increasing their foothold in Europe and North America. GVK BIO, a Contract Research & Development Organization (CRDO) from India has taken over Aragen Bioscience. Aragen has early stage discovery biologics capabilities and played a leading role in oncology and fibrosis based animal models for preclinical biotechs in bay area. Similarly, ChemPartner established research facility in South San Francisco. Also, WuXi AppTec acquired HD Biosciences (HDB), a biology focused preclinical drug discovery CRO.

Advancement in drug discovery technologies such as iPS cells, automated high content screening, patch clamp, gene editing and DNAencoded libraries have expedited the drug discovery process with increased efficiency. There is an increased interest in the use of DNAencoded libraries (small molecules tagged with DNAs) by major pharma companies.Majority of the companies offering DNA-encoded library services are from US (DiCE, X-Chem, Ensemble therapeutics) and Europe (Nuevolution, Vipergen, Cominnex, Philochem). Thereseems to be very little competition in APAC. This trend should push some of the CROs from APAC region to acquire companies with proprietary technology in DNA-encoded libraries or to build capabilities and this seems likely to be a focus point for majority of the CROs especially from APAC.

Evolving business models including risk-based and insourcing are facilitating better collaboration between pharmaceutical companies and CROs. Some of the companies established a new business model known as insourcing which is a new sourcing for pharma where CROs work on-site at customer location in an integrated fashion. This new model provides outstanding performance with efficient cost and time.

CROs should build capabilities to differentiate in the area of Target Identification/Target Validation on how to use human disease pathology knowledge/primary tissues from humans clubbed with Omics knowledge to further validate the concepts. As most of the CROs propose targets from literature and sponsor companies consider it as risky option to invest in such projects without substantial evidences. As a de-risking strategy some CROs are investing internally and validating the concept by siRNA, knockdown approaches and take the concept to a level-up and then approach the sponsors companies who are working in similar area. This approach would increase the sponsor confidence in the CRO program.

There is a huge demand for the novel therapeutics addressing the unmet needs, for example, there are no FDA approved drugs or any therapies for NASH treatment and there is a tremendous opportunity for CROs to work on novel targets, preclinical models and biomarker to come-up with some early stage assets for partnering. Owing to market attractiveness, there is funding provided by venture capitalists to promising players, while some investors are even launching new companies to specifically work on NASH projects. For instance in February 2017, Versant Ventures formed Jecure Therapeutics through $20 million investment for NASH program development. Similarly, Third Rock Ventures formed Pliant Therapeutics with $45 million investment for TGF- signaling based NASH treatment. These companies could potentially outsource majority of the work to CROs in APAC region.

Asia is emerging as a preferred destination for outsourcing drug discovery activities due to the vast availability of skilled manpower, lower costs, favorable regulatory environment and quality data. In addition the local governments are focusing on development of healthcare and pharmaceutical industryby ensuring focus on high quality & compliance in terms of higher regulatory surveillance and training programs. Japan being the second largest pharmaceutical market in the world provides huge opportunity for CROs from APAC. Chinese and Indian pharmaceutical markets are one of the fastest growing in the world and are considered to be the preferred locations for drug discovery outsourcing primarily because of the end-to-end technological capabilities developed over several years. Asian CROs have strong capabilities in biologics research services and built new technology platforms for high-throughput screening, genomics and proteomics research panel screening, enzymatic, and binding assays. They are also well equipped with transgenic and disease animal models that have been developed for target validation, efficacy, and safety studies, thereby providing clients with end-to-end services. Indian CROs typically focus more on new chemical entities and offer integrated discovery services at much lower cost.

Therapeutic area gap analysis research indicates that the key contract research organizations in Asia pacific region are majorly focusing on Oncology, metabolic diseases, Inflammation and CNS. However, majority of Pharma companies in addition to the above therapeutic areas are also focusing on other areas like cardiovascular, immunology, infectious diseases. Since there is a high gap in these therapeutic areas, the CROs should increase their focus in order to tap the opportunity.

Growth in biologics research and orphan drugs, innovative technological platforms and evolving business models encourage pharma and biotech companies to outsource. Even though, big pharma is moving towards research institutions and academia to accelerate knowledge and leverage innovation and technology platforms, they lack the infrastructure to move the drugs from early stages of drug discovery. These factors are expected to enhance drug discovery outsourcing market in APAC region for the coming years.

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Trends in Drug Discovery Outsourcing: A Perspective - BSA bureau (press release)

Recommendation and review posted by sam

In Brief The CRISPR process will be used inside the human body for the first time on July 15th to combat HPV, which impacts millions of people worldwide. And this is just one of a huge amount of proposed CRISPR studies occurring soon. Uninvasive CRISPR

A new CRISPR trial, which hopes to eliminate thehuman papillomavirus (HPV), is set to be the first to attempt to use thetechnique inside the human body. In the non-invasive treatment, scientists will apply a gel that carries the necessary DNA coding for the CRISPR machinery to the cervixes of 60 women between the ages of 18 and 50. The team aims to disable the tumor growth mechanism in HPV cells.

The trial stands in contradistinction to the usual CRISPR method of extracting cells and re-injecting them into the affected area; although it will still use the Cas9 enzyme (which acts as a pair of molecular scissors) and guiding RNA that is typical of the process.

20 trials are set to begin in the rest of 2017 and early 2018. Most of the research will occur in China, and will focus on disabling cancers PD-1 gene that fools the human immune system into not attacking the cells. Different trials are focusing on different types of cancer including breast, bladder, esophageal, kidney, and prostate cancers.

The study, if it succeeds, will be promising for sufferers of HPV and act as a milestone in the CRISPR process. Although HPV is not necessarily cancerous, it cancause cervical cancer. In the U.S. alone, there are more than 3 million new infections every year.Although there is a vaccine for the virus, currently, once you have it you can never get rid of it.

More generally, the CRISPR process could be nothing short of a miracle: if it passes all medical tests it wouldnt just make medicine a whole new kettle of fish, it would reinvent the kettleand the fish, for almost any field. It is cheaper than other gene editing therapies, and could potentially save millions of lives by curing diseases we can only deal with therapeutically like cancer, diabetes and cystic-fibrosis. Crops could be altered more effectively using the process. Drugs and materials that were never possible before could be pioneered.

However, it is still extremely nascent technology, and many fear that there could also be a host of unexpected consequences. Recently, it has been found that it causes hundreds of unexpected mutations in DNA. While these concerns are valid, more research is necessary. Which is why the upcoming studies over the next few years are so vital to the future of our health.

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A World First CRISPR Trial Will Edit Genes Inside the Human Body - Futurism

Recommendation and review posted by Bethany Smith

All pipelines showed that F03 harbored 164 indels and 1,736 SNVs (63 and 885 of these, respectively, associated with known genes). F05 harbored 128 indels and 1,696 SNVs (51 and 865 of these, respectively, associated with known genes). . .The same 117 indels and 1,397 SNVs were detected in both of the CRISPR-treated mice, which indicated nonrandom targeting. . .The mutation rate detected in CRISPR- treated mice was substantially higher than that generated by spontaneous germline mutations (3 to 4 indels and 90 to 100 SNVs, de novo, per generation).

Oh dear. If that holds up, thats clearly going to be a major difficulty in bringing CRISPR-based therapeutics forward, at least with the current state of the art. Just as worrisome, if not more, is that fact that software predictions of the fifty most likely off-target sites of action did not match any of the variants that were actually seen. So it would appear that we have no idea of whats going on here. As the paper says, with great restraint, The unpredictable generation of these variants is of concern.

Now we get to the arguing, though, because the big question is whether these results are correct. They do not match up well with whats already in the literature on the subject, thats for sure. On Twitter, Nicolas Bray brought up one of the concerns. His question is a simple one, but it needs to be answered: The two treated mice were siblings, while the control was (apparently) more distantly related. How many of these variations, then, can be ascribed to what the mice started out with?

The control animal was from the same inbred strain, but still the number of variations seen in this paper is way off what others have reported. Sam Sternberg noted that the paper (and its supplementary information) is not very clear about the relationship between the mice, and also suspects that many of these mutations are from the founders and not the CRISPR treatment per se. Meanwhile, Gaetan Burgio pointed out that the experimental details say:

Briefly, an sgRNA-expressing plasmid had been co-injected, into FVB/NJ zygotes, with the single-stranded oligodeoxynucleotide (ssODN) donor template and Cas9 protein to generate mosaic F0 founders.

Plasmids themselves, he notes, are known to cause mutations, since they have much longer half-lives than RNA or protein, and he says his own labs work with direct injection of sgRNA and Cas9 protein showed far fewer mutations, in keeping with the rest of the literature. Another potential problem has been brought up by many observers: This study has an n of 2, with one control animal. Thats a pretty thin platform on which to build the CRISPR Is Doomed! monument.

So there are a number of reasons to wonder if these results are real. If they are, other questions arise about the newer Cas9 variant enzymes and various sgRNA designs, but Im not even going to think about those, to be honest, until this result has been replicated and given a thorough going over. The implications are too big to start running around in circles just yet. There will be time for that, if needed...

Update, in the interests of full disclosure: After publishing this post and looking at the moves in the stock prices of both EDIT and CRSP yesterday and today, I found my own doubts convincing enough to have bought some of both as a short-term trade. I have no idea what their long-term prospects are, but their sudden drops due to this news may not be justified. On the rare occasions that Ive taken a position in any sort of individual biopharma stock, Ive noted it on the blog, and will continue to do so. Now you all can watch me lose money in real time...

Disclosure: I am long EDIT and CRSP.

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Trouble With CRISPR? Maybe - But Maybe Not - Seeking Alpha

Recommendation and review posted by simmons

Michael J. Wade. Credit: James Brosher, IU Communications

Researchers are exploring the use of the revolutionary gene-editing tool CRISPR-Cas9 to fight human disease and agricultural blight. But a study from Indiana University has found several challenges to the method's use in saving lives and crops.

The research, reported today in the journal Science Advances, combines advanced genetic and statistical analyses to show how certain genetic and behavioral qualities in disease-carrying insects, like mosquitoes, make these species resistant to genetic manipulation.

This resistance could complicate attempts to use CRISPR-Cas9 in the fight against malaria -- a deadly mosquito-borne disease that threatens over 3 billion people worldwide -- or crop blights such as the western corn rootworm, an invasive species that costs the U.S. about $1 billion in lost crops each year.

The discovery of the CRISPR-Cas9 system -- or simply "CRISPR" -- in the early 2010s introduced an unprecedented level of accuracy in genetic editing. Scientists can use the method to design highly precise genetic "scissors" that snip out and replace specific parts of the genome with sequences of their choosing. Two English scientists were the first to show the method could spread infertility in disease-carrying mosquitoes in late 2015.

"We found that small genetic variation within species -- as well as many insects' tendency to inbreed -- can seriously impact the effectiveness of attempts to reduce their numbers using CRISPR technology," said Michael J. Wade, Distinguished Professor of Biology at IU Bloomington. "Although rare, these naturally occurring genetic variants resistant to CRISPR are enough to halt attempts at population control using genetic technology, quickly returning wild populations to their earlier, 'pre-CRISPR' numbers."

This means costly and time-consuming efforts to introduce genes that could control insect populations -- such as a trait that causes female mosquitoes to lay fewer eggs -- would disappear in a few months. This is because male mosquitoes -- used to transmit new genes since they don't bite -- only live about 10 days.

The protective effect of naturally occurring genetic variation is strong enough to overcome the use of "gene drives" based on CRISPR-based technology -- unless a gene drive is matched to the genetic background of a specific target population, Wade added. Gene drives refer to genes that spread at a rate of nearly 90 percent -- significantly higher than the normal 50 percent chance of inherence that occurs in sexually reproducing organisms.

Wade, an expert in "selfish genes" that function similarly to gene drives due to their "super-Darwinian" ability to rapidly spread throughout a population, teamed up with colleagues at IU -- including Gabriel E. Zentner, an expert in CRISPR-based genetic tools and assistant professor in the Department of Biology -- to explore the effectiveness of CRISPR-based population control in flour beetles, a species estimated to destroy 20 percent of the world's grain after harvest.

The team designed CRISPR-based interventions that targeted three segments in the genome of the flour beetle from four parts of the world: India, Spain, Peru and Indiana. They then analyzed the DNA of all four varieties of beetle and found naturally occurring variants in the targeted gene sequence, the presence of which would impact the effectiveness of the CRISPR-based technology.

The analysis revealed genetic variation in all four species at nearly every analyzed DNA segment, including a variance rate as high as 28 percent in the Peruvian beetles. Significantly, Wade's statistical analysis found that a genetic variation rate as low as 1 percent -- combined with a rate of inbreeding typical to mosquitos in the wild -- was enough to eliminate any CRISPR-based population-control methods in six generations.

The results suggest that a careful analysis of genetic variation in the target population must precede efforts to control disease-carrying insects using CRISPR technology. They also suggest that the unintended spread of modified genes across the globe is highly unlikely since typical levels of genetic variation place a natural roadblock on spread between regions or species.

"Based on this study, anyone trying to reduce insect populations through this method should conduct a thorough genetic analysis of the target gene region to assess variation rates," Wade said. "This will help predict the effectiveness of the method, as well as provide insight into ways to circumvent natural genetic variation through the use of Cas9 variants with an altered sequence specificity."

This article has been republished frommaterialsprovided by Indiana University. Note: material may have been edited for length and content. For further information, please contact the cited source.

Reference

Drury, D. W., Dapper, A. L., Siniard, D. J., Zentner, G. E., & Wade, M. J. (2017). CRISPR/Cas9 gene drives in genetically variable and nonrandomly mating wild populations. Science Advances, 3(5), e1601910.

More:

CRISPR Gene Drives May Not Be As Effective As Once Hoped - Technology Networks

Recommendation and review posted by Bethany Smith

Skip to content On November 4 2016, the Eiffel Tower was illuminated in green to celebrate the entry into the Paris Agreement. Credit: U.S. Department of State

This week, President Trump pulled the U.S. from the Paris Climate Agreement, which 195 countries had signed in 2015, pledging to reduce greenhouse emissions. Trump said that the agreement imposed draconian financial burdens on the U.S. and that he would negotiate for a deal that is fair. Maggie Koerth-Baker, senior science reporter at Fivethirtyeight.com, fills us in on the announcement. Plus, she talks about new CRISPR clinical trials, and NASAs Parker Probe Plus, a mission to explore the sun.

[What happens if the U.S. leaves the Paris climate deal?]

Maggie Koerth-Baker

Maggie Koerth-Baker is a senior science reporter with FiveThirtyEight.com.Shes based inMinneapolis, Minnesota.

Alexa Lim is a producer for Science Friday. Her favorite stories involve space, sound, and strange animal discoveries.

One way is fast and dramatic. The other is slower and leaves wiggle room.

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Science Friday is produced by the Science Friday Initiative, a 501(c)(3) nonprofit organization. Created by Bluecadet

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Trump Pulls US From Climate Agreement, CRISPR Human Trials, And A NASA Sun Orbiter - Science Friday

Recommendation and review posted by Bethany Smith

Bacteria genomes have repeating sequences of DNA with bits of other DNA sandwiched between them. These are the "clustered regularly interspaced short palindromic repeats" that give CRISPR its name. What scientists eventually discovered is that those sequences of unique DNA, in between the repeating bits, matched the DNA of viruses. Basically, it's a gallery of Bacteria's Most Wanted.

A set of enzymes called CRISPR-associated proteins, or Cas for short, looks for these bits of DNA as a way to identify danger when an intruder is detected. When a virus is spotted, the proteins act like assassins, snipping out those offending bits of DNA, rendering the virus harmless. More important, it turns out, you can basically train these Cas proteins to look for any sequence of DNA you want. Then they can replace it with another piece of genetic code.

This all sounds pretty complicated, but you can actually do it in your kitchen with a $160 kit from a company called The Odin. The particular kit I used includes everything you need to make baking or brewing yeast glow green under a black light.

To start, I prepared a whole bunch of agar plates -- petri dishes filled with a nutrient-rich gel for the yeast to grow on. Then I had to wake up my dried French Saison yeast with a little bit of water and "streak" the little guys out on the plates and put aside for about 24 hours to let them grow.

Once the yeast was healthy and I had full cultures, it was time to prep them for their transformation. I introduced them to a solution of chemicals and salts that weakened the cell walls so that our new DNA can enter more easily. Then it was time to introduce the plasmid (a small molecule of DNA) carrying the genes I want the yeast to adopt. The genetic code introduced in this case tells the yeast to produce green fluorescent protein, which is what causes it to glow. Basically, we're tricking the yeast into thinking the DNA we introduced is its own so that it makes the Cas proteins that will cut out the parts we want to replace.

Once it's all combined, the mixture gets incubated in a warm water bath for about an hour, before adding nutrients to the solution and putting the whole thing back in a warm-water bath for another four hours. This gives the yeast time to recover and replicate the DNA that will make it fluoresce. Then it's time to streak the modified yeast on some new agar plates and wait again for them to grow into thriving colonies.

A few days later, I had yeast that glowed green under a black light.

Now, a petri dish worth of yeast isn't nearly enough to brew a beer with. So I had to make a starter -- a weak proto-beer on which the yeast can feast and build its strength. Eventually, I had a 1 liter Erlenmeyer flask filled with fluorescent French Saison yeast.

Brewing beer itself is pretty straightforward but here's the TL;DR version of how it works: Grains, such as barley, are steeped in hot water to extract their sugars. This creates a liquid called wort, which is then boiled to sterilize it, break down and remove unwanted proteins, and extract flavors from additives like hops -- the little green cones that deliver all that lovely beer flavor and aroma.

Then the wort is cooled and the yeast is added, and it becomes a waiting game. The yeast eats away at the sugar, converting it to carbon dioxide and delicious, delicious alcohol.

The results of my grand experiment were successful ... ish.

The yeast certainly glowed and the first couple of samples pulled from the fermenter did as well. But, as the beer settled and the yeast dropped out of my brew, the glow became fainter and fainter. By the end, it was a pale glimmer rather than a blinding glare.

At the end of the day, my glowing beer was a strange novelty; it's merely meant to show off the power and simplicity of CRISPR. It's a technology that could one day lead to a cure for diseases like sickle cell or AIDS, or be used to breed drought-resistant plants. But that's still a ways off. Right now, CRISPR is in its infancy, so I'll just have to settle for yeast that can brew unique-looking (if not particularly unique-tasting) beer.

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I bio-engineered glowing beer and it hasn't killed me (yet) - Engadget - Engadget

Recommendation and review posted by simmons

BBC News

Hair loss: What is female-pattern baldness? BBC News Hayley Jennings, who set up the Yorkshire Hair Loss Clinic, said the majority of her clients were women - especially mothers - in their 30s and 40s with female pattern hair loss. "This effects one ... Dihydrotestosterone (DHT) is the main hormone ... and more »

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Hair loss: What is female-pattern baldness? - BBC News

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Breast cancer is thought of as a womens disease, with less than 1 percent of breast cancers affecting men, according to breastcancer.org. Because of that, there is a lack of awareness about the disease in males, which leads to late diagnoses and lower chances of survival.

As part of Mens Health Month in June, learn the facts about male breast cancer and what can be done to treat it.

Everyone has breast tissue

Male bodies dont make as much of the hormone that stimulates breast growth as female bodies, but men still have breast tissue and can even develop medium or large breasts, according to breastcancer.org.

Usually these breasts are just mounds of fat, the website says. But sometimes men can develop real breast gland tissue because they take certain medicines or have abnormal hormone levels.

While testosterone in men and estrogen in women controls their sex characteristics, those hormones are found in both sexes.

Most people think of estrogen as an exclusively female hormone, but men also produce it though normally in small quantities, the Mayo Clinic says. However, male estrogen levels that are too high or are out of balance with testosterone levels can cause gynecomastia."

Gynecomastia happens when males have swollen breast tissue which, on its own, is not a serious problem but, because both the condition and breast cancer are related to more breast tissue, one could be a sign of the other.

Male breast cancer is usually advanced

Although breast cancer in men is uncommon, its usually diagnosed late, meaning the cancer is more advanced.

Overall survival is shorter in men, possibly because they tend to be older and have more comorbid conditions, according to research in medical journal the BMJ.

Having comorbid conditions means a person has more than one disease or condition at a time. Men may also have advanced stages of breast cancer because they ignore symptoms.

Men carry a higher mortality than women do, primarily because awareness among men is less and they are less likely to assume a lump is breast cancer, which can cause a delay in seeking treatment, the National Breast Cancer Foundation says.

Men can check for symptoms, at home

Men with a family history of breast cancer are at a higher risk of developing it, but all men should tell their doctor if they have any of these symptoms:

Before going to the doctor, men can perform a self-check, something they should do every month. That may sound like a lot, but it takes less than 30 seconds and is simple, involving looking for changes on or around the nipple and feeling in the area for lumps or discharge. Detailed instructions are available from multiple online resources.

Men can treat and beat breast cancer

If a biopsy confirms a man has cancer cells in his breast, medical tests will determine the stage. As with other cancers, a lower stage means the cancer has not progressed as far.

Treatment options could include surgery, chemotherapy, hormone therapy, radiation therapy and targeted therapy, according to the National Cancer Institute.

Men's and womens breast cancer survival rates are the same, so the stage is more important. For example, if men visit the doctor early, and the breast cancer is caught and treated at stage 0 or 1, there is a 100 percent survival rate, according to the American Cancer Society. That rate drops for every subsequent stage until stage 4, which has a 20 percent survival rate.

The best thing a man with a family history or symptoms of breast cancer can do is visit his doctor right away for diagnosis and treatment.

Sinclair Broadcasting is committed to the health and well-being of our viewers, which is why were introducing Sinclair Cares. Every month well bring you information about the Cause of the Month, including topical information, education, awareness and prevention.

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Here Are The Facts About Male Breast Cancer - KUTV 2News

Recommendation and review posted by sam

A federal judge in Minnesota dealt a devastating blow to parental rights last week. Senior U.S. District Judge Paul Magnuson dismissed a lawsuit brought by a mother who accused school officials, healthcare providers, and doctors of violating her parental rights by assisting her son with gender transition without the mothers consent.

Anmarie Calgaros case made international headlines last year when she sued her teenage son known only as EKJ for undergoing a sex change through hormonal therapy without her permission, as well as numerous state agencies for the role they played in helping him to transition from male to female. Calgaros lawsuit claimed that she was neither consulted nor informed about the transition, thereby stripping her of her constitutionally protected parental rights.

The U.S. Constitution says that parental rights are fundamental rights, that cant be terminated without due process, said Calgaros attorney, Erick Kaardal of the Thomas More Society.

At particular issue in Calgaros lawsuit was a Minnesota law that allows minors to undergo medical care and procedures without parental consent. According to Calgaros suit, Park Nicollet and Fairview Health Services began providing hormone therapy to her son in November without consulting Calgaro or even informing her about it. Calgaro also argued that St. Louis County violated her parental rights by providing government assistance in the form of medical payments to cover the costs of the childs transition.

Calgaro indicates she is fighting for parents to be included in their minors medical decisions.

"I'm also taking this action for the benefit of all parents and families, who may be facing the same violation of their rights so that they and others in the future may be spared from the same tragic events," she opined.

Sadly, some media outlets portrayed Calgaro less as a champion of parental rights and more as an anti-LGBTQ activist, even quoting critics who took issue with Calgaros and her attorneys repeated references to her son as male, which of course squares with reality, but not with her sons desire to be acknowledged as female.

For Calgaro, however, the case is not about her son's transgenderism, but with his ability to obtain medical treatment without her knowledge or consent, particularly potentially harmful treatment. At a press conference, Calgaro told reporters that "The transitioning thing isn't even the issue, the issue is that he's able to make these [medical] decisions."

In fact, scientists suggest that it is psychologically harmful for adolescents to undergo hormonal therapy in the name of transgenderism, as most children outgrow gender confusion.

"Children are a special case when addressing transgender issues. Only a minority of children who experience cross-gender identification will continue to do so into adolescence or adulthood, a study in The New Atlantis reads.

There is little scientific evidence for the therapeutic value of interventions that delay puberty or modify the secondary sex characteristics of adolescents, although some children may have improved psychological well-being if they are encouraged and supported in their cross-gender identification," it continues. "There is no evidence that all children who express gender-atypical thoughts or behavior should be encouraged to become transgender."

The study argues that enabling acceptance of transgenderism through medical intervention is particularly harmful. An area of particular concern involves medical interventions for gender-nonconforming youth. They are increasingly receiving therapies that affirm their felt genders, and even hormone treatments or surgical modifications at young ages, the authors observe.

Calgaros lawsuit also focused on the absence of an official legal process in the state for the emancipation of minors, and this absence served to create considerable confusion and inconsistencies in Calgaros case. Some of the agencies involved considered the teenage boy to be emancipated from his mother based on the grounds that he no longer lived with Calgaro and was not financially supported by her. EKJ reportedly moved out of his mothers home in 2015 to move in with his father so that he could attend a better school and has not returned since. He eventually moved in with friends until he finally began living on his own.

EKJ also filled out an emancipation form with the help of a homosexual advocacy group without Calgaros knowledge. In the lawsuit, Calgaro notes that the emancipation form was riddled with falsehoods. For example, the form claimed that Calgaro failed to report her teen son as a runaway and made no attempt to bring him home, thereby concluding that she wished to have no contact with him, all of which Calgaro denies.

The Minneapolis Star Tribune reports that an attorney with the Mid-Minnesota Legal Aid clinic then provided EJK with a letter that concluded the teen was legally emancipated under Minnesota law.

Meanwhile, Calgaros attorney noted at a news conference last year that Calgaro was never given notice that her child was seeking emancipation and the emancipation determination was reached without a hearing or court order.

"If there had been a court order of emancipation, then Anmarie would have received notice and an opportunity to be heard," said Kaardal.

Once it was determined that EKJ was emancipated, the school then refused to provide Calgaro her sons medical records, and the Department of Human Services refused to provide her information about her sons hormonal therapy, Life Site News reports.

Yet, while these particular agencies accepted EKJs emancipation determination, the St. Louis County District Court had rejected the teens application for a name change because of the lack of any adjudication relative to emancipation, underscoring the flimsy legal grounds on which the defendants case stood.

Calgaro turned to the federal court to intervene, and asked the court to stop the teens hormone treatment and award her financial damages.

But Judge Magnuson determined on Tuesday that Calgaros claims were meritless.

Magnuson admitted that the boy was not legally emancipated, and that Calgaro's parental right "remain[ed] intact." However, he decided that the defendants could not be held liable because they did not act under color of state law. Without evidence that the school and agencies violated a law or a policy or custom, Calgaro had no claim, he determined.

Magnuson revealed his flagrant disregard for parental rights by going so far as to question whether those include access to school records.

Furthermore, Kaardal asserts that Judge Magnusons decision has done little to clarify the states emancipation issue.

On the legislative front, people on the left and on the right believed that emancipation procedures in Minnesota should be put in statutes and codified, Kaardal said. But until then, its confusing and the courts decision hasnt cleared up that confusion.

NBC News notes the potential impact that a decision on the states emancipation process could have on abortion in Minnesota, since current statute mandates that a non-emancipated minor cannot access an abortion until 48 hours after parental notification has taken place.

Predictably, EJKs attorneys welcomed the judges decision, saying it shows the resilience of transgender youth and the importance of access to appropriate health care.

The law protects all young people, including transgender young people, and we are pleased that this outcome supports her access to essential health care and other critical service, said Asaf Orr, a staff attorney for the National Center for Lesbian Rights Transgender Youth Project in San Francisco.

According to theMinneapolis Star Tribune, Kaardal and Calgaro are considering an appeal.

Anmarie Calgaro is living a parents worst nightmare," Kaardalsaid. "Her minor child has been piloted by third parties through a life-changing, permanent body altering process by organizations that have no legal authority over him, and that have denied his own mother access.

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Judge Dismisses Mother's Lawsuit Over Her Son's Transition to a "Girl" - The New American

Recommendation and review posted by simmons

Illustration of the heart patch using artificial capillaries.

Editors note: This is a guest post by Frances Ligler, Lampe Distinguished Professor in the Joint Department of Biomedical Engineering (BME) at NC State and UNC-Chapel Hill. This is one of a series of posts from NC State researchers that address the value of science, technology, engineering and mathematics.

Judging from evidence provided by Star Wars and The Six Million Dollar Man, repairing body parts seems to require a screwdriver. However, teams of scientists and engineers are exploring other ways to repair our bodies and NC State faculty and students are collaborating across colleges to perform cutting-edge experiments to further regenerative medicine therapeutics.

Before joining NC State, Michael Daniele (an assistant professor of BME and electrical and computer engineering) and I invented a method of making long strings of artificial blood capillaries by creating soft walls in between fluids streaming through a small channel. Cells present in the streams were incorporated into the capillaries to mimic the 3-D architecture of your capillaries and veins.

At NC State, we joined forces with Ke Cheng, an expert in stem cells and cardiology from the College of Veterinary Medicine, to incorporate these artificial capillaries into a degradable patch containing cardiac stem cells. Postdoctoral fellow Teng Su placed the patches on damaged areas of rat hearts and showed both repair of the rat heart tissue and return of the pumping capacity of the heart (which does not happen under the untreated condition where scar tissue forms in the damaged heart).

In another exciting collaboration, Matt Fisher from BME, Rohan Shirwaiker (an associate professor of industrial and systems engineering) and Behnam Pourdeyhimi from the College of Textiles are teaming up to reconstruct damaged knees. They are recreating the underlying fibrous scaffolds that support the cartilage in a manner that better mimics the original knee and supports the growth of the normal cell type within the new scaffolds which should improve healing and support a return to normal function in the knee.

The variety of skills required for this project include designing an entirely new device for printing fibers, understanding how to arrange the fibers and change their composition to accommodate bone or cartilage-forming cells, and learning how the new tissue develops to accommodate physical motion.

The lure of replacement body parts is widespread. There are far more people waiting for replacement organs than can be accommodated by human donors. Learning to use an individuals own cells to trigger tissue regeneration has far more long-term potential to address the ever-growing needs of accident victims and an aging population.

The key to success lies with teams of dedicated scientists, engineers, medical professionals and financial supporters that are focused on using the lessons learned across many fields to solve this grand challenge.

Original post:
Can Tiny Plumbing Fix Broken Hearts? - NC State News

Recommendation and review posted by simmons

The Expedition 51 crew members are awaiting a new space shipment and getting ready for new science experiments. The crew is also preparing for the departure of a pair of International Space Station flight engineers.

The Falcon 9 rocket that will launch the SpaceX Dragon cargo craft to space is resting at its launch pad today at the Kennedy Space Center in Florida. Dragon will lift off Thursday at 5:55 p.m. EDT on a three-day trip to the stations Harmony module.

Inside the commercial space freighter is nearly 6,000 pounds of crew supplies, station hardware and science experiments. One of those experiments, Cardiac Stem Cells, will research how stem cells affect cardiac biology and tissue regeneration in space. The stations Microgravity Science Glovebox is being readied for the study which may provide insight into accelerated aging due to living in microgravity.

On Friday, cosmonaut Oleg Novitskiy will command the Soyuz MS-03 spacecraft to return him and European Space Agency astronaut Thomas Pesquet back to Earth after 196 days in space. The two crew members are packing their spacecraft with research samples, hardware and personal items for the near 3.5 hour ride home. The duo will undock from the Rassvet module at 6:47 a.m. EDT. They will then parachute to a landing in Kazakhstan at 10:10 a.m. (8:10 p.m. Kazakh time).

See the article here:
Station Ramps Up for Cardiac Research Loaded on Dragon - Space Fellowship

Recommendation and review posted by sam

Friday November 20 2009

Human embryonic stem cells

Stem cells could create new skin to help burn victims, BBC News reported. It said that French researchers have duplicated the biological steps that occur during skin formation in embryos. This could potentially provide an unlimited source of temporary skin replacements for burn victims while they wait for grafts from their own skin.

The study in mice behind this report used human embryonic stem cells to make keratinocytes (the most common cell types in the skin). These cultured cells were used to create skin equivalents, which grew successfully when they were grafted onto the backs of mice.

This well-conducted research has potentially developed a successful method of culturing tissue in the laboratory that resembles human skin. Only human trials of the technology will show whether such grafts will be accepted (i.e. not rejected by human patients) as permanent transplants or can provide a temporary skin replacement before grafting.

The research was carried out by Dr Hind Guenou and colleagues from the Institute for Stem Cell Therapy and Exploration of Monogenic disease, and BIOalternatives SAS in France along with colleagues in Madrid. The research was funded by the Institut National de la Sant et de la Recherche Mdicale, University Evry Val dEssonne, Association Franaise contre les Myopathies, Fondation Ren Touraine, and Genopole. The authors declare that they have no conflicts of interest and say that the funders had no role in the studys design, analysis or write-up.

The research was published in thepeer-reviewed medical journal the Lancet.

BBC News has covered this research in a balanced way, pointing out that thiswas animal research and that human studies will follow.

This well-conducted research involved laboratory and animal research which investigated whether epidermal stem cells could be cultured in the laboratory and used in skin grafts.

Burn patients are often treated using autologous skin grafts. These involve a section of healthy skin being removed from another part of the body to harvest the patients own skin cells for culture. A graft for the burn site is produced from this culture. There is a delay of about three weeks between the harvesting of the skin and the graft to allow the cells to grow. During this time, the patient is at risk of dehydration and infection.

Having a ready source of skin cells for temporary grafts while patients are waiting for their autologous grafts would improve the outcome of treatment. With this in mind, the researchers investigated whether keratinocytes (the major cell constituent of the outer layer of the skin, or epidermis) could be derived from human embryonic stem cells.

The researchers began by culturing embryonic stem cells in a specialised medium that encourages cell differentiation (the process whereby cells become specialised). Embryonic stem cells can renew themselves and also have the potential to develop into any type of specialised cell.

Cultures of human embryonic stem cells were then grown on a framework made of fibroblast cells and collagen (a fibrous protein that can form a mesh-like structure) made by fibroblasts. Fibroblasts are the cells that form the underlying structure of tissues and are involved in healing.

The stem cells were manipulated so that they developed into epidermal cells, and monitored throughout their specialisation process to make sure the cells were developing into skin cells. The researchers named the cells keratinocytes derived from human embryonic stem cells (K-hESCs).

After several rounds of subculturing and replication, the cells could be frozen and used in further experiments. Bioengineered skin equivalents were then created by growing the K-hESCs on an artificial matrix. These were then grafted onto the backs of five six-week-old immunodeficient female mice. After 10 to 12 weeks, samples were taken from the implants for analysis.

The researchers confirmed thatthe embryonic stem cells differentiated into keratinocytes, which could be grown in culture medium and which replicated well. These derived skin cells were structurally and functionally similar to normal skin cells in that they could be grown on an artificial matrix using classic techniques.

After 12 weeks of growth on immunodeficient mice, the grafted epidermis had developed into a structure that was consistent with mature human skin.

The researchers concluded that their findings build on previous research and show that K-hESCs can develop into a multi-layer epithelium. This epithelium resembles normal human skin both in cell cultures (in vitro) and following grafting onto live animals (in vivo).

They say that growing human skin from human embryonic stem cells could provide an unlimited resource for temporary skin replacement in patients with large burns who are waiting for autologous skin grafts.

If it can be demonstrated that it works in humans, this technology could improve outcomes for burns patients. The researchers report that the first human trial is currently underway.

At present, skin from deceased donors is used to treat burns patients while they wait for their own skin transplant, but there are often problems with rejection. The researchers highlight several potential benefits of an epidermis reconstructed using K-hESCs, including:

It is important to note that, at present, the researchers are only investigating this technology for providing temporary grafts. They say that whether it can be used for permanent grafts for patients who cant use their own cells needs further investigation. They say that for temporary use, the grafts would only be used for the three-week period while the patients permanent graft is grown.

This is a good study and the findings are exciting in this field, but only human research will tell whether it will have a wider application in the treatment of burns patients.

The rest is here:
Skin grafts from stem cells - NHS

Recommendation and review posted by sam

In experiments in mice, UC San Francisco researchers have discovered that regulatory T cells (Tregs; pronounced tee-regs), a type of immune cell generally associated with controlling inflammation,directly trigger stem cells in the skin to promote healthy hair growth. Without these immune cells as partners, the researchers found, the stem cells cannot regenerate hair follicles, leading to baldness.

Our hair follicles are constantly recycling: when a hair falls out, a portion of the hair follicle has to grow back, saidMichael Rosenblum, M.D., an assistant professor of dermatology at UCSF and senior author on the new paper. This has been thought to be an entirely stem cell-dependent process, but it turns out Tregs are essential. If you knock out this one immune cell type, hair just doesnt grow.

The new study published online May 26 inCell suggests that defects in Tregs could be responsible for alopecia areata, a common autoimmune disorder that causes hair loss, and could potentially play a role in other forms of baldness, including male pattern baldness, Rosenblum said. Since the same stem cells are responsible for helping heal the skin after injury, the study raises the possibility that Tregs may play a key role in wound repair as well.

Normally Tregs act as peacekeepers and diplomats, informing the rest of the immune system of the difference between friend and foe. When Tregs dont function properly, we may develop allergies to harmless substances like peanut protein or cat dander, or suffer from autoimmune disorders in which the immune system turns on the bodys own tissues.

Like other immune cells, most Tregs reside in the bodys lymph nodes, but some live permanently in other tissues, where they seem to have evolved to assist with local metabolic functions as well as playing their normal anti-inflammatory role. In the skin, for example, Rosenblum and colleagues have previously shown that Tregs help establish immune tolerance to healthy skin microbes in newborn mice, and these cells also secrete molecules that help with wound healing into adulthood.

Rosenblum, who is both an immunologist and a dermatologist, wanted to better understand the role of these resident immune cells in skin health. To do this, he and his team developed a technique for temporarily removing Tregs from the skin. But when they shaved patches of hair from these mice to make observations of the affected skin, they made a surprising discovery. We quickly noticed that the shaved patches of hair never grew back, and we thought, Hmm, now thats interesting, Rosenblum said. We realized we had to delve into this further.

In the new research, led by UCSF postdoctoral fellow and first authorNiwa Ali,several lines of evidence suggested that Tregs play a role in triggering hair follicle regeneration.

First, imaging experiments revealed that Tregs have a close relationship with the stem cells that reside within hair follicles and allow them to regenerate: the number of active Tregs clustering around follicle stem cells typically swells by three-fold as follicles enter the growth phase of their regular cycle of rest and regeneration. Also, removing Tregs from the skin blocked hair regrowth only if this was done within the first three days after shaving a patch of skin, when follicle regeneration would normally be activated. Getting rid of Tregs later on, once the regeneration had already begun, had no effect on hair regrowth.

Tregs role in triggering hair growth did not appear related to their normal ability to tamp down tissue inflammation, the researchers found. Instead, they discovered that Tregs trigger stem cell activation directly through a common cell-cell communication system known as the Notch pathway. First, the team demonstrated that Tregs in the skin express unusually high levels of a Notch signaling protein called Jagged 1 (Jag1), compared to Tregs elsewhere in the body. They then showed that removing Tregs from the skin significantly reduced Notch signaling in follicle stem cells, and that replacing Tregs with microscopic beads covered in Jag1 protein restored Notch signaling in the stem cells and successfully activated follicle regeneration.

Its as if the skin stem cells and Tregs have co-evolved, so that the Tregs not only guard the stem cells against inflammation but also take part in their regenerative work, Rosenblum said. Now the stem cells rely on the Tregs completely to know when its time to start regenerating.

Rosenblum said the findings may have implications for alopecia areata, an autoimmune disease that interferes with hair follicle regeneration and causes patients to lose hair in patches from their scalp, eyebrows, and faces. Alopecia is among the most common human autoimmune diseases its as common as rheumatoid arthritis, and more common than type 1 diabetes but scientists have little idea what causes it.

After his team first observed hair loss in Treg-deficient mice, Rosenblum learned that the genes associated with alopecia in previous studies are almost all related to Tregs, and treatments that boost Treg function have been shown to be an effective treatment for the disease. Rosenblum speculates that better understanding Tregs critical role in hair growth could lead to improved treatments for hair loss more generally.

The study also adds to a growing sense that immune cells play much broader roles in tissue biology than had previously been appreciated, said Rosenblum, who plans to explore whether Tregs in the skin also play a role in wound healing, since the same follicle stem cells are involved in regenerating skin following injury.

We think of immune cells as coming into a tissue to fight infection, while stem cells are there to regenerate the tissue after its damaged, he said. But what we found here is that stem cells and immune cells have to work together to make regeneration possible.

Niwa Aliof UCSF was the lead author on the new study. Additional authors were Bahar Zirak,Robert Sanchez Rodriguez, Mariela L. Pauli,Hong-An Truong, Kevin Lai,Richard Ahn, Kaitlin Corbin, Margaret M. Lowe, PharmD,Tiffany C. Scharschmidt, M.D., Keyon Taravati, Madeleine R. Tan,Roberto R. Ricardo-Gonzalez, M.D., Audrey Nosbaum, M.D.,Wilson Liao, M.D., andAbul K. Abbas, MBBS, of UCSF; Frank O. Nestle, M.D., of Kings College London; Marta Bertoliniand Ralf Paus, M.D., of the University of Mnster in Germany; and George Cotsarelis, M.D., of the University of Pennsylvanias Perelman School of Medicine.

The work was primarily supported by the U.S. National Institutes of Health (K08-AR062064, DP2-AR068130, R21-AR066821), the Burroughs Wellcome Fund, a Scleroderma Research Foundation grant, the National Psoriasis Foundation and the Dermatology Foundation.

Here is the original post:
A new baldness treatment? | University of California - University of California

Recommendation and review posted by Bethany Smith

By Ian Haydon 3 minute Read

A new research paper is stirring up controversy among scientists interested in using DNA editing to treat disease.

In a two-page article published in the journal Nature Methods on May 30, a group of six scientists report an alarming number of so-called off-target mutations in mice that underwent an experimental gene repair therapy.

CRISPR, the hot new gene-editing technique thats taken biology by storm, is no stranger to headlines. What is unusual, however, is a scientific article so clearly describing a potentially fatal shortcoming of this promising technology.

The research community is digesting this newswith many experts suggesting flaws with the experiment, not the revolutionary technique.

The research team sought to repair a genetic mutation known to cause a form of blindness in mice. This could be accomplished, they showed, by changing just one DNA letter in the mouse genome.

They were able to successfully correct the targeted mutation in each of the two mice they treated. But they also observed an alarming number of additional DNA changesmore than 1,600 per mousein areas of the genome they did not intend to modify.

The authors attribute these unintended mutations to the experimental CRISPR-based gene-editing therapy they used.

Cas9, the CRISPR enzyme that snips DNA, in contact with its target. [Graph: via rcsb.org]A central promise of CRISPR-based gene editing is its ability to pinpoint particular genes. But if this technology produces dangerous side effects by creating unexpected and unwanted mutations across the genome, that could hamper or even derail many of its applications.Several previous research articles have reported off-target effects of CRISPR, but far fewer than this group found.

The publicly traded biotech companies seeking to commercialize CRISPR-based gene therapiesEditas Medicine, Intellia Therapeutics, and Crispr Therapeuticsall took immediate stock market hits based on the news.

Experts in the field quickly responded.

Either the enzyme is acting at near optimal efficiency or something fishy is going on here, tweeted Matthew Taliaferro, a postdoctoral fellow at MIT who studies gene expression and genetic disease.

The Cas9 enzyme in the CRISPR system is what actually cuts DNA, leading to genetic changes. Unusually high levels of enzyme activity could account for the observed off-target mutationsmore cutting equals more chances for the cell to mutate its DNA. Different labs use slightly different methods to try to ensure the right amount of cuts happen only where intended.

Gatan Burgio, whose laboratory at the Australian National University is working to understand the role that cellular context plays on CRISPR efficiency, believes the papers central claim that CRISPR caused such an alarming number of off-target mutations is not substantiated.

Burgio says there could be a range of reasons for seeing so many unexpected changes in the mice, including problems with accurately detecting DNA variation, the extremely small number of mice used, random events happening after Cas9 acted, or, he concedes, problems with CRISPR itself.

Burgio has been editing the DNA of mice using CRISPR since 2014 and has never seen a comparable level of off-target mutation. He says hes confident that additional research will refute these recent findings.

Although the news of this two-mouse experiment fired up the science-focused parts of the Twittersphere, the issue it raises is not new to the field.

Researchers have known for a few years now that off-target mutations are likely given certain CRISPR protocols. More precise variants of the Cas9 enzyme have been shown to improve targeting in human tissue in the lab.

Researchers have also focused on developing methods to more efficiently locate off-target mutations in the animals they study.

As scientists continue to hone the gene-editing technique, we recognize theres still a way to go before CRISPR will be ready for safe and effective gene therapy in humans.

Ian Haydon is a doctoral student in Biochemistry at the University of Washington. This story originally appeared at The Conversation.

See the original post here:

Unraveling The Controversy Over The CRISPR Mutations Study - Fast Company

Recommendation and review posted by sam

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More here:

CRISPR stocks sank on news the gene editing tool can veer off target. But that's hardly news - STAT

Recommendation and review posted by sam

CRISPR-Cas9 is the gene editing tool that promised to change the world.

In the short time since its discovery, it has snipped HIVout of human immune cells, sparked a biomedical race between the US and China to work towardbioengineered humans, and now scientists have used CRISPR-Cas9 to slow the spread of cancer.

Every living cell goes through a reproduction cycle, known as the 'cell cycle' a sequence of events that result in cell growth and division.

When this cycle gets out of hand, it becomes a serious and life-threatening problem.Once a cell becomes cancerous it will divide without stopping and quickly invade surrounding the tissue.

And trying to stop cancer is no easy feat. Scientists have used a range of approaches to try to stop it from forming and spreading.

A previous study has turned the body's own immune systemagainst cancer cells, and another team of researchers has created an artificial organthat can pump out cancer-fighting T-cells.

We've even worked out a way to cause particularly aggressiveforms of cancer to self-destruct.

In the latest study, scientists from the University of Rochester have interrupted the cell cycle by targeting a protein responsible for preparing the cell for division, called Tudor-SN.

Tudor-SN influences the cell cycle by controlling microRNA, which are the molecules that fine tune the expression of thousands of genes.

"We know that Tudor-SN is more abundant in cancer cells than healthy cells, and our study suggests that targeting this protein could inhibit fast-growing cancer cells," says lead researcher,Reyad A. Elbarbary.

When Tudor-SN was removed from human cells, using CRISPR-Cas9, the level of microRNAs increases.

With more microRNAs in the mix, it slows down the genes that encourage cell growth. With these genes hindered, the cell transitions slowly to the cell division phase of the cell cycle.

The researchers used this approach to slow the growth of kidney and cervical cancer cells.

"Because cancer cells have a faulty cell cycle, pursuing factors involved in the cell cycle is a promising avenue for cancer treatment," said Lynne E. Maquat, senior researcher on the paper.

The next step for the research is to work out how Tudor-SN functions in combination with other molecules and proteins. That way, scientists may be able to identify the most appropriate drugs to target it.

While the researchers admit that they have a long way to go before we see this technology being used in humans, any new approach that could provide a cure to the millions ofpeople living with cancer is always welcome.

The findings have been reported in Science.

See more here:

Scientists have used CRISPR to slow the spread of cancer cells ... - ScienceAlert

Recommendation and review posted by sam

A new research paper is stirring up controversy among scientists interested in using DNA editing to treat disease.

In a two-page article published in the journal Nature Methods on May 30, a group of six scientists report an alarming number of so-called off-target mutations in mice that underwent an experimental gene repair therapy.

CRISPR, the hot new gene-editing technique thats taken biology by storm, is no stranger to headlines. What is unusual, however, is a scientific article so clearly describing a potentially fatal shortcoming of this promising technology.

The research community is digesting this news with many experts suggesting flaws with the experiment, not the revolutionary technique.

The research team sought to repair a genetic mutation known to cause a form of blindness in mice. This could be accomplished, they showed, by changing just one DNA letter in the mouse genome.

They were able to successfully correct the targeted mutation in each of the two mice they treated. But they also observed an alarming number of additional DNA changes more than 1,600 per mouse in areas of the genome they did not intend to modify.

The authors attribute these unintended mutations to the experimental CRISPR-based gene editing therapy they used.

A central promise of CRISPR-based gene editing is its ability to pinpoint particular genes. But if this technology produces dangerous side effects by creating unexpected and unwanted mutations across the genome, that could hamper or even derail many of its applications.

Several previous research articles have reported off-target effects of CRISPR, but far fewer than this group found.

The publicly traded biotech companies seeking to commercialize CRISPR-based gene therapies Editas Medicine, Intellia Therapeutics and Crispr Therapeutics all took immediate stock market hits based on the news.

Experts in the field quickly responded.

Either the enzyme is acting at near optimal efficiency or something fishy is going on here, tweeted Matthew Taliaferro, a postdoctoral fellow at MIT who studies gene expression and genetic disease.

The Cas9 enzyme in the CRISPR system is what actually cuts DNA, leading to genetic changes. Unusually high levels of enzyme activity could account for the observed off-target mutations more cutting equals more chances for the cell to mutate its DNA. Different labs use slightly different methods to try to ensure the right amount of cuts happen only where intended.

Unusual methods were used, https://twitter.com/LluisMontoliu/status/869705549453119489">tweeted Lluis Montoliu, who runs a lab at the Spanish National Centre for Biotechnology that specializes in editing mice genes using CRISPR. He believes the authors used suboptimal molecular components in their injected CRISPR therapies specifically a plasmid that causes cells to produce too much Cas9 enzyme likely leading to the off-target effects they observed.

Gatan Burgio, whose laboratory at the Australian National University is working to understand the role that cellular context plays on CRISPR efficiency, believes the papers central claim that CRISPR caused such an alarming number of off-target mutations is not substantiated.

Burgio says there could be a range of reasons for seeing so many unexpected changes in the mice, including problems with accurately detecting DNA variation, the extremely small number of mice used, random events happening after Cas9 acted or, he concedes, problems with CRISPR itself.

Burgio has been editing the DNA of mice using CRISPR since 2014 and has never seen a comparable level of off-target mutation. He says hes confident that additional research will refute these recent findings.

Although the news of this two-mouse experiment fired up the science-focused parts of the Twittersphere, the issue it raises is not new to the field.

Researchers have known for a few years now that off-target mutations are likely given certain CRISPR protocols. More precise variants of the Cas9 enzyme have been shown to improve targeting in human tissue the lab.

Researchers have also focused on developing methods to more efficiently locate off-target mutations in the animals they study.

As scientists continue to hone the gene-editing technique, we recognize theres still a way to go before CRISPR will be ready for safe and effective gene therapy in humans.

This article was originally published on The Conversation. Read the original article.

Ian Haydon does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond the academic appointment above.

See the original post here:

CRISPR controversy raises questions about gene-editing technique - Joplin Globe

Recommendation and review posted by sam

Associate biology and microbiology professor Wanlong Li assesses the growth of two-week-old wheat seedlings. Credit: South Dakota State University

Larger, heavier wheat kernelsthats how associate professor Wanlong Li of the SDSU Department of Biology and Microbiology seeks to increase wheat production. Through a three-year, $930,000 U.S. Department of Agriculture grant, Li is collaborating with Bing Yang, an associate professor in genetics, development and cell biology at Iowa State, to increase wheat grain size and weight using a precise gene-editing tool known as CRISPR/Cas9.

South Dakota State is one of seven universities nationwide to receive funding to develop new wheat varieties as part of the National Institute of Food and Agricultures International Wheat Yield Partnership (IWYP) Program. The program supports the G20s Wheat Initiative, which seeks to enhance the genetics related to yield and develop varieties adapted to different regions and environmental conditions.

The goal of IWYP, which was formed in 2014, is to increase wheat yields by 50 percent in 20 years. Currently, the yearly yield gain is less than1 percent, but to meet the IWYP goal wheat yields must increase 1.7 percent per year. Its a quantum leap, he said. We need a lot of work to reach this.

Humans consume more than 500 million tons of wheat per year, according to Li. However, United States wheat production is decreasing, because farmers can make more money growing other crops. He hopes that increasing the yield potential will make wheat more profitable.

First, the researchers will identify genes that control grain size and weight in bread wheat using the rice genome as a model.

The CRISPR editing tool allows the researchers to knockout each negatively regulating gene and thus study its function, according to Li. CRISPR is both fast and precise, he added. It can produce very accurate mutations.

This technique will be used to create 30 constructs that target 20 genes that negatively impact wheat grain size and weight. From these, the University of California Davis Plant Transformation Facility, through a service contract, will produce 150 first-generation transgenic plants and the SDSU researchers will then identify which ones yield larger seeds. One graduate student and a research assistant will work on the project.

The end products are not genetically modified organisms, Li emphasized. When we transfer one of the CRISPR genes to wheat, its transgenic. That then produces a mutation in a different genomic region. When the plants are then self-pollinated or backcrossed, the transgene and the mutation are separated.

The researchers then screen the plants to select those that carry the desired mutations. This is null transgenic, Li said, noting USDA has approved this process in other organisms. Yang used this technique to develop bacterial blight-resistant rice.

As part of the project, the researchers will also transfer the mutations into durum wheat. Ultimately, these yield-increasing mutations, along with the markers to identify the traits, can be transferred to spring and winter wheat.

This article has been republished frommaterialsprovided by South Dakota State University. Note: material may have been edited for length and content. For further information, please contact the cited source.

Read the rest here:

Increasing Wheat Yields with CRISPR - Technology Networks

Recommendation and review posted by simmons

To Be a Machine: Adventures among Cyborgs, Utopians, Hackers, and the Futurists Solving the Modest Problem of Death Mark O'Connell Granta 242 pages ISBN: 978-1-78378-196-6 12.99

"We built ingenious devices and we destroyed things." These words are easy to imagine carved on the tombstone of the human race. In To Be a Machine, where these words appear after an alarming session with people working on artificial intelligence, they're just one of the many possible futures that Dublin journalist Mark O'Connell visits. None seem to appeal to him much.

A friend once observed that anyone who had ever watched a baby could see how limited AI really is. Here, O'Connell's new baby son helpfully provides him with a grounding biological balance as he ponders the work of people who, in one way or another, all want to transcend biology.

Many of the ideas O'Connell explores, and some of the people he interviews, will be familiar to those who who've read prior efforts, beginning with Ed Regis's Great Mambo Chicken and the Transhuman Condition. It's probably a mark of some kind of social change that Regis, writing 26 years ago, couldn't avoid -- or rather, embraced -- a certain, "Oh, my God, are these people nuts or what?" tone, while O'Connell, writing now, can be more soberly reflective. The Singularity, mind uploading, cryonics, whole-brain emulation, real-life 'cyborgs', and escaping the surly bonds of Earth to colonise distant planets and save the future of humanity may be no closer to reality than they were in 1991, but the ideas are more familiar: twenty-five years of Wired magazine and Silicon Valley hegemony have had their effect.

Today, when Nick Bostrom predicts (in his book Superintelligence) that an AI might turn all the Earth's resources to making paper clips he may still seem crazy -- but he's an Oxford University professor and director of the Future of Humanity Institute. Colonizing space to save the human race may be a fringe notion -- but it's also been embraced by the physicist Stephen Hawking.

To embrace biology, O'Connell is told during his study of cryonics, is to buy into "deathist ideology". I sympathize here: visiting the leading cryonics company, Alcor, and learning the details of cryopreservation can make death seem almost cuddly. Cryonicists themselves admit that revival is a very long shot -- but it's the only non-zero option.

The one overtly comic section of To Be a Machine, therefore, is the one that's most embodied: O'Connell watches as robots try to complete DARPA's 2015 challenge -- there's a collection of the best pratfalls at Popular Mechanics. The hardest things to automate are the things humans learn earliest: the 2015 state of the art, after millions of dollars and millions of hours of human engineering, couldn't climb stairs or open doors as well as a two-year-old. So in that area, at least, we can feel smug.

Given that the technology industry famously loves disruption, it should be no surprise that it attracts people who favour disrupting life itself. In the end, however, O'Connell favours blood and bone.

Read more book reviews

Read the rest here:
To Be a Machine, book review: Disrupting life itself - ZDNet

Recommendation and review posted by Bethany Smith

Aging is a normal process the body goes through, but not all of the symptoms that are frequently attributed to the normal aging process should be directly connected to aging some may be associated with other illnesses such as hyperthyroidism or hypothyroidism.

Hyperthyroidism, or too much thyroid hormone, in the elderly is often difficult to diagnosis. While multiple symptoms may be present in a younger population, the elderly may only present with one or two symptoms. According to the Cleveland Clinic, in the elderly population, "typical symptoms (such as weight loss, fatigue, tremors, palpitations, atrial fibrillation, anxiety, depression, shortness of breath, heat intolerance, eye symptoms and anemia) may be absent or attributed to aging or another chronic illness." As such, subtle signs should be looked for.

symptoms

Symptoms and signs of hypothyroidism may include weight gain, sleepiness, dry skin and constipation; however, a lack of these symptoms does not negate a diagnosis. To make a diagnosis in the elderly patient, doctors often need a high index of suspicion.

When attempting to diagnosis hypothyroidism in the elderly, doctors often look at a person's family history of thyroid disease, past treatment for hyperthyroidism or a history of extensive surgery and/or radiotherapy to the neck.

Due to the high incidence and prevalence of irregular heart rhythms, congestive heart failure, weight loss, nervousness and muscle weakness in our elderly, it is wise to carefully review with a physician the possibility of such illness being related to hypothyroidism.

Knowledge is the key. Tests, such as T4 and T3U (or T3 Uptake), can be performed to help evaluate the presence of either hyper or hypothyroidism. Replacement hormone therapy (L-T4) is effective in hypothyroidism, whereas in hyperthyroidism (the over production of thyroid hormone) an antithyroid medication is often prescribed to reduce production of the thyroid hormone with sedatives and beta-blockers utilized to treat the associated rapid heart rate and nervousness.

talk to your doctor

The issue here is that many seniors are never diagnosed properly as having hyper or hypothyroidism but, rather, are told their symptoms are typical of anyone in their stage of the aging process. It requires both the family and the physician of the elder to carefully review the mishmash of symptoms that plague us as we age, sort out what is "normal" in the aging process and what might be associated with some other diagnosis (such as hypothyroidism).

Simple tests can determine if the suspicions are valid. Treatment is relatively benign and, in the case of hyperthyroidism, can often be normalized in three to six months with subsequent medication therapy less aggressive in nature.

Bottom line: Don't simply assume that when a physician proclaims that you have an issue (i.e., high cholesterol) that you should begin to receive medication therapy to help reduce those cholesterol levels (given that diet and exercise did not lower the levels significantly); ask why the cholesterol is high to begin with you may find it's high due to hypothyroidism. Remember, knowledge is power.

Judson Haims is the owner of Visiting Angels Home Care in Eagle County. Contact him at 970-328-5526 or visit http://www.visitingangels.com/comtns.

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Silicon Valley thinks our bodies need a reboot. PayPal founder and Donald Trump booster Peter Thiel, who plans to live for 120 years, has publicly discussed taking human-growth hormone (and expressed interest in blood transplants from young people). Google spun off Calico in 2013 to defeat the inevitability of aging. Software engineers fast for days and order custom stacks of nootropics, or brain-enhancing substances, to gain a cognitive edge. One venture capitalist, requesting anonymity, said at a dinner he recently attended several people opened up boxes to pop nootropic pills before the first course.

Theres no end to the experimentation people will undertake in pursuit of productivity, even if most treatments and supplements dont yet have strong evidence or FDA approval. That hasnt phased the patients that Dr. Molly Maloof sees in her Silicon Valley practice. This is a place where people dont give a flying fuck what they do with their minds and bodies, she said.

The general practitioner wants to see real medical rigor behind people trying to hack their health. Her concierge medicine practice in San Francisco serves a small number of patients for anywhere from $5,000 for an initial assessment to upwards of $40,000 per year for comprehensive care (every patient has a second, primary care physician as well). Her clients are often engineers and executives looking to hit peak performance, or recover from an over-stressed work-life. Maloof, who earned her medical degree from the University in Illinois in 2011, sees part of her work as ensuring they they are doing it safely, backed up by the maximum amount of evidence.

Too often, she says, executives and entrepreneurs place performance above health. All these people are not stupid but what used to be domain expertise is now everyone claiming to be the expert, she says.

Maloofs data-heavy approach begins with a battery of testsmeasuring thousands of biomarkers in allto understand her patients at the cellular level. By analyzing the results, she can prescribe food and lifestyle tailored to every individual, alongside standard western therapies. Only then does she consider pharmaceutical-grade supplements. If needed, she helps patients practice harm reduction with performance-enhancing substances from nootropics to micro-dosing LSD. Her philosophy, she says, is to do more than cure sickness, but to enhance health.

Investors are betting this approachoptimizing ones health through deep analysis of their genetics, physiology, and psychologybecomes the standard of care. Technology, they argue, will ultimately bring down prices so its affordable for almost everyone. Today, Maloof estimates less the 1% of private medical practices take this approach, but companies like Color Genomics, Forward, Nootrobox, Arivale, Metabolic Code, Habit, and Viome are already aiming to go mainstream.

Maloof is surprised at the cavalier acceptance of DIY health at the intersection of technology and personalized medicine. People will spend months researching which computer they will buy and then two minutes researching the nootropic brand theyre about to put into their body, she says.

Maloof sat down with Quartz to talk about her work and the future of personalized medicine. The interview was condensed and edited for clarity.

Can you describe your practice?

My practice has basically been an emergent phenomena: What if a doctor decided to optimize health instead of just fixing illness? The first thing Ive done differently is Ive positioned myself as a doctor who is aiming to improve the human condition rather than just get you from sick to not-sick.

Theres this spectrum of disease. Most people are in the sick-to-average part of that spectrum. The athletes and movie stars of the world are at the opposite end at the optimal part of the spectrum.

Theres this space between average and optimal that is a very grey area. Its been sort of commandeered by the wellness industry: the people who perpetuate mindfulness, fitness, and nutrition, but maybe dont have any rigorous medical training. And, as such, havent actually learned the basic science of the human body and how biology, physics, and chemistry works.

How did your practice begin?

I thought, if I was in a perfect world, What would I want my health experience to look like? I basically decided I would want a doctor to listen to me, and listen for a long time. In an ideal situation, it takes about two hours to ask all the questions I would want.

In a perfect world, your body is like the airplane and Im the co-pilot

The second thing is that, typically when you get blood drawn from a doctor, you might get 10 biomarkers or lab [tests]. Thats just not very much information. And they dont usually tell you theres something wrong with you unless its really wrong. In my practice, Im looking at 170 chemical biomarkers. Instead of normal or abnormal, Im looking at a range of whats good.

Instead of just looking at blood, Im looking at blood, urine, stool and saliva. Instead of just chemistry markers, Im looking at chemistry, metabolomics (chemical fingerprints of cellular processes), genomics, microbiome (microorganisms), hormone tests, and Im starting to look at immunology markers.

Thats a very different experience. In a perfect world, your body is like the airplane and Im the co-pilot and were using all these tools to identify if there are issues going wrong with the engine.

How does your typical day go? How would a patients visit to your office be different?

A typical patient is first going to have a meeting with me to go through all these questions, Ill gather all the data and then send a phlebotomist to their house [to draw blood].

I get all the information back and then I sit back down with the patient and we will go over all of the report together. And that will take up to an hour and a half.

At the end of that, we edit the decision together. So we decide what we we want to do. I come up with a summary, a one- to two-page summary, and then create a schedule for all their supplements and their nutrition, and then basically hand off the recommendations to any staff they have to help implement it, or just to them.

Then Ill check in with them in a couple weeks via text or via email or the phone and then well repeat the process. Well take some of the labs that we did and then well repeat that on a quarterly basis. And then well go over the changes we see over time.

Q: How long would a typical patient be with you?

The real benefit comes after working for a year. Six months to a year is the minimum amount of time that we should be working together. And the patients who tend to go off the program, they come back to me eventually and theyre like, Yeah, I fell off the wagon and I want to jump back on. But it takes some commitment because you want to optimize health.

The patients that dont do the best are the ones that think that everything is about the supplements, and everything is about the right supplements. Supplements are like the last mile of optimization.

The first and foremost thing you need to do is recognize that this is not an overnight fix. Youre not just going to feel amazing overnight. Its actually about building these changes over time, and it makes a lot of difference if you recognize its like compounding interest.

And the thing about it is that its not rocket science, but a lot of it is actually knowing what is right for your body and your lifestyle. And thats going to be different for different people.

Q: Thats tough what youre describing. How many stick with it?

I work with mostly entrepreneurs, investors, and executives. So I tend to work with people who, when I first evaluate whether or not theyre a fit for my practice, I can assess how willing are they to do the things that Im asking them to do? If theyre a six out of 10, then Im not going to ask them to do that.

The patients that dont do the best are the ones that think that everything is about the supplements, and everything is about the right supplements. Supplements are like the last mile of optimization. They can make a really big difference. But fundamentally, if your lifestyle is a disaster, for those people its about actually showing them whats happening in their lifestyle and showing them how food is affecting them, giving them continuous glucose monitors, getting them heart-rate variability monitors, so they can glean some real insight around whats happening day-to-day.

Q: What are some of the more dangerous things patients come in doing?

A big problem I see people buying everything they read on Bulletproof Coffee. Im just like, Guys, [Bulletproofs founder] Dave Asprey has not figured everything out. First and foremost hes a salesman and a marketer. And secondly he is a bio-hacker, and so lets get real.

Everything hes recommending! Bulletproof Coffee [which has as much as 4 tablespoons of fat or oil per cup) is probably the worst idea that a person can do in terms of their health. The problem is theres a large number of people that will have much higher rates of cholesterol, and some people will be fine on it. And people do it wrong: they add sugar to it, or eat sugary things, or dont have the right genetics for that level of fat consumption.

Ive seen three patients now with really, really high cholesterol levels. Way, way above normal. Im like, What are you drinking in the morning? What does your routine look like? They say, You know, I start my day with Bulletproof Coffee And Im like, Are you? Oh no.

Is what youre doing scalable?

What Im doing right now is not scalable at all. Ive been doing this practice in order to figure out what does scale. Because if you look at all this information, youll start to see things that make sense for larger populations of people, and I think this is where medicine could go if we had more convenience.

Can this become a standard of care for most people, or will it be concierge medicine forever?

Here are few things that have to happen.

The health care system needs to recognize that what they are doing isnt working for chronic disease, first and foremost. Second of all, we need large-scale studies on this kind of medicine.

Im looking at interventions from the perspective of what is the most sound, evidence-based recommendation I can make for this individual. If it doesnt have evidence, why doesnt it. Chinese medicine may not have much evidence in the western model but it has thousand of years of people using it. The question is, Is it totally bullshit? Well, probably not. Theres probably some truth in it.

Then we need doctors who want to learn how to do this. We have to be able to train them how to do this. When I was in med school, I thought there was a lot missing from my education: what about lifestyle, what about what happens after the patient goes home after the visit to the hospital?

The kitchen is no longer the medicine cabinet. The kitchen is now the place of ultra-toxicity and disease.

I saw this giant problem in my education, and I actually designed a course called, Physician Heal Thyself, Evidence-based lifestyle. I brought in all these doctors who are experts in sleep medicine, sleep, fitness nutrition, food as medicine, functional medicine, integrative medicine, osteopathy and acupuncture. I got them all in a room and said I want you to teach students what were missing. We need to make this medical school education and have to implement this into the board certification programs as well as board exams. If its not required, its not going to be taught.

Finally, we need to be able to prescribe these things. We need food companies to do the research to show their food has outcomes that can improve human health. If we believe its medicine, then we need to study food as medicine. And we have to put it through the same rigor that we put drugs through. Thats going to happen. Were not that far way, but one of the biggest things that needs to happen is a culture shift.

Where do you think a practice like yours will be in five years?

The way to explain this question is actually to look to the past. When I was trying to figure out if what I was doing was special, I started doing some research on doctors in antiquity. I found an interesting pattern.

Most people in Greek and Roman times considered their kitchen to be their medicine cabinet. The women of the world were responsible for managing a lot of illness through food. So food as medicine was fairly widespread, but the wealthy and the gladiators and the kings, all of these people had special doctors.

Theres always been doctors working with the elite and working with the athletes of the world. But the difference between now and then, is that the kitchen is no longer the medicine cabinet. The kitchen is now the place of ultra-toxicity and disease.

I think in five years, Im going to be, hopefully, speaking to the entire country through media and through public health campaigns (Im going to build a platform around this) trying to bring back what we knew for thousands of years about how food can treat our disease and how plants are a source of healing and how the way that we are living our lives in modern times is antithetical to optimal health.

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according to the doctors statement, the procedure is quick, painless, and doesnt require stitches. The pellets are inserted under the skin just above the hip, and will last three to four months.

The doctors office statement said that Forbes magazine recently reported on several studies regarding the effects of adding testosterone pellets to conventional hormone replacement therapy.

Researchers found that women taking testosterone have reduced incidences of breast cancer, and that testosterone can suppress breast cell proliferation and improve the common symptoms of menopause.

One patient, 44, had surgically induced menopause through a hysterectomy when she was 35.

I would say truthfully I felt a little dead inside, the doctors statement quoted her as saying.Nothing seemed fun anymore. I slept a lot. I had spurts of memory loss. I was just miserable.

That patient has been receiving both testosterone and estrogen pellets for nearly six years, and said its changed her life.

After the pellets are inserted, within 48 hours, I will wake up, and I will know my system has taken it in, she said. My brain fog is gone. I sleep better. You dont have the dips that come with oral medications. Its a more consistent release. The pellets have helped me with anxiety, weight loss, libido, mental clarity. Its like night and day.

Without hormone replacement therapy, Savage said, women are increasingly at risk for serious health consequences that also include osteoporosis, heart disease, Alzheimers and diabetes. The doctors statement came with the usual disclaimers making no promises and providing appropriate warnings.

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A new research study out of Brigham and Womens Hospital in Boston, Massachusetts, found a possible connection between hormones and hearing loss among menopausal women.

The study, which will be published in Menopause, the journal of the North American Menopause Society, focused on data collected from 80,972 postmenopausal women. The self-reported study indicated that menopausal women who undergo hormone therapy for extended periods of time are at a greater risk for hearing loss.

More: Is Hormone Replacement Therapy Right for You?

Previously, it was believed that hormone therapy would actually improve hearing loss in menopausal women.

The finding from this observational study that women who underwent menopause at a later age and used oral hormone therapy had greater hearing loss was unexpected but should lead to more testing in a randomized, clinical trial,says Dr. JoAnn Pinkerton, executive director of NAMS.

Menopause usually occurs in women over the age of 45 and brings with it symptoms like vaginal dryness, hot flashes and mood swings.

While the Brigham and Womens Hospital-led study does present a comprehensive set of facts supporting hearing loss among women who use HRT, the overall benefits and risks of undergoing hormone replacement therapy should be discussed with a physician.

More: It's Super-Common to Miss These Symptoms of Hormonal Imbalance

In an effort to make the conversation about menopause a more exhaustive one, the JAMA network published a one-sheet that can help women when speaking to their physicians.

By Vivian Nunez

Originally published on HelloFlo

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By Cara Rosner, Conn. Health I-Team Writer

A genetic test that helps doctors determine how best to treat breast cancer and whether chemotherapy is likely to help is significantly more likely to be administered to white women than blacks or Hispanics, a Yale University study has found.

The test, called Oncotype Dx, uses gene expression to gauge how early-stage breast cancer is affecting patients gene activity. It uses the information to determine how likely cancer recurrence would be, and physicians and their patients can use that knowledge to decide how to proceed with treatment.

Yale researchers analyzed a group of more than 8,000 Connecticut women who were diagnosed with hormone receptor positive breast cancer between 2011 and 2013, and found significant racial and ethnic disparities in use of this new gene test, said study leader Dr. Cary Gross, a member of Yale Cancer Center and professor of medicine and epidemiology at Yale School of Medicine.

It reinforces that, at the same time we are investing in developing new treatments and new testing strategies and were promoting them with great excitement, we really need to double-down our efforts to eliminate disparity, Gross said.

Breast test disparity

Here are some key statistics from a Yale University study about Oncotype Dx, a genetic test for breast cancer patients.

The study from that, among the Connecticut women for whom the test was recommended under national guidelines:

51.4 percent of white women received it

44.6 percent of black women received it and

47.7 percent of Hispanic women received it.

Among women for whom national guidelines did not recommend the test:

21.2 percent of white women received it

9 percent of black women received it and

9.7 percent of Hispanic women received it.

Among the Connecticut women for whom the test was recommended, Yale researchers found 51.4 percent of white women received it, compared with 44.6 percent of black women or 47.7 percent of Hispanic women.

One local doctor said the findings are disconcerting, but not surprising. Its long been known that women of color have lower rates of breast cancer screening, and are less likely to have mastectomies or breast reconstruction surgery, typically because they dont have access to or cant afford the services, said Dr. Denise Barajas, medical director of Griffin Hospitals Hewitt Center for Breast Wellness in Derby.

Research has also shown that minority women also are more likely to die from breast cancer.

This is just another area where were unfortunately seeing that certain groups dont have the same access, Barajas said.

Disparities found

The study also found disparity among women for whom national guidelines did not recommend the test. In that group, 21.2 percent of white women, 9 percent of black women and 9.7 percent of Hispanic women received it.

The findings were unsurprising not just to Barajas, but also to Dr. K. M. Steve Lo, a hematology oncologist and breast cancer expert at Stamford Hospitals Dorothy Bennett Cancer Center.

Its part of the overall problem with our health care system, Lo said. Minority women are less insured, underinsured, and have more out-of-pocket expenses to put out in one way or another. As a result, there will be less use of technology across the board. It needs to change but, unfortunately, I dont see a movement toward that in the near future. Its a systemic problem, and its a problem that we as a society need to address.

Barajas said that one of the most upsetting things about the Yale study, is that its first breast cancer-related disparity shes aware of involving a physician-led treatment. Mostly, Barajas said, its patients who opt not to have the treatment.

This test is offered by oncologists, for the most part," she said. Youd like to think that an oncologist would treat all women the same.

The only reason Barajas could think of for a woman who is eligible for the test not being offered it is that shes said she isnt interested in chemotherapy.

Removing guesswork

Having access to Oncotype Dx can greatly impact womens outcomes, Gross said. Even after a biopsy or tumor removal, he said, its still difficult to know which patients are at higher risk for their cancer coming back again. There are many, many subtypes of breast cancer. (The test) takes some of the guesswork out of it.

The test has become the standard of care for certain types of early-stage cancer, Lo said.

It helps physicians narrow down those women who really do benefit from treatments like chemotherapy, he said. That is crucial, he added, because it means many women who would not benefit from chemotherapy no longer are subjected to the process, the expense and the side effects.

Oncotype Dx is most frequently used on women who have stage 1 cancer that has not spread to the lymph nodes, Lo said, but its likely it will be used on women whose cancer has attached to lymph nodes.

In light of the studys findings, Gross team plans to examine data from a broader group of women to see why the disparities exist. Researchers will look at whether women are more or less likely to get the test depending on which hospital treats them, or whether there are disparities within hospitals.

Gross also said research should be done to determine if the tests $4,000 price tag though covered by many insurance companies is a barrier to some patients, and more breast cancer patients should be educated about national guidelines and recommendations.

This story was reported under a partnership with the Connecticut Health I-Team (www.c-hit.org)

Hearst Connecticut Media staff writer Amanda Cuda contributed to this report.

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"I thought it was, what's the right word, ill-conceived, shall we say? And merciless as well. Particularly in the way it treats the poor and the disabled in our society."

Crist chats with James Keane, Metros fundraising and events manager.Kate BradshawAs we wrote about last year, Metro Wellness is a nonprofit that offers specialized care and advocacy for the region's LGBT residents everything from HIV tests to hormone replacement therapy for gender transition to counseling for gay and trans youth. It's headquartered on the western edge of St. Petersburg's Kenwood neighborhood in an area where new apartment buildings seem to be going up by the month.

They're in the middle of a massive expansion officials with the organization say will better equip them to meet the needs of the community. And with any luck, event and retail space they plan on renting out will boost their revenue.

July of 2018 their target for cutting the proverbial ribbon is a long way off.

But with the looming (though uncertain) repeal and replacement of the Affordable Care Act and a spike in new HIV cases (largely among gay minority men under 30), demand for what they do will probably go up well before then.

On Wednesday morning, former Governor and current Congressman Charlie Crist, D-St. Petersburg, checked out the facility for the first time.

He did his usual thing introducing himself to the dozens of staff members going about their day, making conversation about sports and hometowns.

Crist speaks to Metro's CEO, who was home recovering from knee surgery, as Priya Rajkumar looks on.Kate Bradshaw

He was there to show his support for Metro and to find out more about what they do. As a Democrat in Congress, it doesn't seem likely that Crist could do all that much in D.C. in terms of pulling down federal money.

Metro doesn't get much in the way of federal funding anyway, beyond grants and savings on medications it doles out via the 340B Prescription Drug Program. Many of the services they provide are free, and they take insurance when it's applicable.

But if millions of people lose their health care under the Republicans' Affordable Health Care Act, that could put a huge burden on health nonprofits like Metro.

The health care act is going to be pretty crucial for us in terms of our ability to move forward as an organization, said Priya Rajkumar, Metro's chief operating officer, as she and her colleagues gave Crist the grand tour.

Needless to say, Crist wasn't a fan of the GOP plan, either.

I thought it was, what's the right word, ill-conceived, shall we say? And merciless as well. Particularly in the way it treats the poor and the disabled in our society. I think it's on its way to nowhere. I hope, he told Metro CEO Lorraine Langlois, who was at home recovering from a knee surgery at the time of the tour, during a phone call in which he congratulated her on Metro's success.

Notably, the tour took place the day before Pride Month starts. In June, St. Petersburg hosts the biggest Pride festival in the state. Metro has long been something of a hub during the event, as an adjacent parking lot served the parade's staging area for years. This year, the event's parade portion will take place in downtown St. Pete and the former staging area now belongs to a developer. There was controversy over the move, especially since Kenwood and the Grand Central District, where the parade has taken place for over a decade, make up the city's first gay-friendly area.

Perhaps the downtown move is a sign of how mainstream Pride has become, and how welcoming St. Pete is. Even so, given the political climate and the ideological bent that's helping shape federal and state health care policy, the need for services that cater to the LGBT community like the ones Metro provides isn't going anywhere.

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