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Stem Cell Research For Cancer, Alzheimer’s And More

Posted: September 23, 2017 at 11:54 am

Stem cell treatment: The stem cells are returned to the patients body through an intravenous infusion or an injection directly into the joints, tendons or ligaments.

Hope has fueled the mushrooming growth of private stem cell clinics. The industry has been aided by stories like those of Laurie Hanna.

A skiing accident in the mid-1990s had shredded the cartilage in Hannas knee. Surgery helped the damaged joint, but it still deteriorated over the years, drastically limiting her mobility. When I walked, my knee sounded like crunchy granola, says the 52-year-old nurse anesthetist, who lives in Los Angeles with her son.

When one of the plastic surgeons Hanna worked for, Mark Berman, talked about doing stem cell therapy, she jumped at the chance. What did I have to lose? Hanna says. My only other option was knee replacement surgery.

One morning in January 2010, Hanna arrived at Bermans expansive Beverly Hills office, with comfy leather couches in the waiting room and a state-of-the-art surgical suite. Berman, working in tandem with an orthopedic surgeon, removed fat tissue from her hip, separated out the stem cells and injected those cells into her left knee. After two treatments, Hanna noticed a significant improvement and was able to ski again for the first time in 10 years. I called him on the phone, crying, Hanna recalls. I had back my quality of life.

This is the front edge of a new era of medicine, says Berman, who has expanded the use of stem cell procedures within his broader plastic surgery practice in California and has helped establish a nationwide network of clinics called the Cell Surgical Network. Berman has even performed stem cell treatments on himself and his wife. He says he finds the procedures work best for orthopedic conditions, such as arthritis and hip, back and joint pain. Were using the bodys natural repair mechanisms to reverse cell damage.

While there havent been many reports about serious complications at clinics in the U.S., the lack of oversight does allow abuses. Two patients in Florida died after receiving stem cell injections, and a California woman developed bone fragments in her eyelids after a stem cell face-lift.

In another incident, three older women, paying to participate in what was described as a clinical trial, were blinded after being injected with stem cells at a South Florida clinic to treat their macular degeneration. All three patients had functional vision they could watch TV and get around unassisted, but they worried about the prospect of further deterioration and the potential loss of their drivers licenses. Lured by claims on the clinic website, they each paid $5,000 for injections in both eyes. The turnaround time was about 30 minutes from harvesting the tissue to the injection of stem cells into the vitreous cavity of both eyes, which was done by a nurse without the direct supervision of a doctor.

Within a few days, it was obvious something was wrong they ended up in the ER in severe pain and complained of vision loss. Two of them were referred to Thomas Albini, an ophthalmologist at the University of Miami. He speculates that when the stem cells started dividing, they caused the retina to detach. There was nothing we could do to bring their vision back, Albini says. All three are now legally blind and unable to live independently.

The FDA is struggling with how to police these clinics. The agency held hearings last September and has sent warning letters for safety violations to a handful of the worst offenders. The agency would also like to classify stem cell treatments as drugs, which would mean they would have to go through years of human tests before they could be used commercially.

Beyond isolated horror stories, there are concerns about the treatments performed by certain clinics. Theyre basically fraudulent, says Larry Goldstein, M.D., director of the Stem Cell program at the University of California, San Diego, and scientific director of the Sanford Consortium for Regenerative Medicine. They take advantage of the average persons lack of sophisticated medical information andjudgmentandpromiseimprovements indiseasethat are not reasonable.

But the industry has grown so rapidly in the past several years that its going to require a lot of firepower from government and other regulatory agencies to rein it in, says Turner, the bioethicist at the University of Minnesota. In the meantime, its a Wild West marketplace where anything goes.

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Stem Cell Research For Cancer, Alzheimer’s And More

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Adult Stem Cell Foundation

Posted: September 21, 2017 at 6:48 am

The Foundation is a privately funded philanthropic (non profit) organization advising un-well people about how to gain access to Adult Stem Cell Therapy (ASCT). The Foundation is also promoting a plan to its members on how to prevent or limit the progression of degenerative diseases and other conditions. Degenerative disease is an escalating world problem that, if not controlled, could bankrupt our health systems.

A major objective of the Foundation is to highlight that people suffering from degenerative conditions now have the option of considering Adult Stem Cell Therapy. This therapy may improve quality of life for sufferers of Arthritis, MS, Parkinsons, Diabetes, Stroke, Alzheimers, Spinal Cord injuries, Cancer or Chronic Pain to name a few. A stem cell transplant, instead of a joint replacement, is fast becoming the preferred first option for orthopedic surgeons.

The Foundation intends to educate parents/carers of children suffering from a debilitating or degenerative condition like Cerebral Palsy, Muscular Dystrophy, Autism, Spinal injuries, Cystic fibrosis, ADHD etc. Stem cell treatments have progressed in leaps and bounds for these conditions. There are now state of the art clinics that specialize in treating the afore-mentioned conditions. Children can usually benefit substantially from an early intervention by stem cell therapies and other protocols because they are still growing. As an example: spending time in a mild hyperbaric chamber (HBO) can also be beneficial. Just fill out the Application Form for an experimental transplant and we will be only too happy to advise.

The ASCF has become a global Information Centre for stem cell therapy. The centre will only support clinics that have demonstrated they abide by the highest medical standards and have a proven track record of administering these types of therapies, in Australia and overseas. We can now advise locally which gives peace of mind to our members who are contemplating a procedure of this nature.

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Government sets out aims for science post-Brexit | Cancer Research … – Cancer Research UK

Posted: September 7, 2017 at 12:48 pm

The Government has set out its aims for the UKs scientific relationship with the EU following Brexit.

The Department for Exiting the European Union has published a report outlining how it still wants collaboration on issues including clinical trials and research funding.

When scientists from the UK and the EU work together they have greater impact, which ultimately benefits patients across the EU and beyond. – Emma Greenwood, Cancer Research UK

While the focus on science was welcomed, many in the sector called for more detail.

Emma Greenwood, Cancer Research UKs director of policy, said that the reports focus on scientific collaboration is essential, and that details of future clinical trials and immigration should be agreed quickly.

Clear priorities must be an aligned regulatory system for clinical trials, and a migration system that attracts global scientific talent and supports collaboration,” she added.

The report is one of a series setting out the Governments position on key areas being negotiated around Brexit.

It follows calls from members of the scientific community to protect rules that allow researcher migration, funding agreements and partnership with regulatory bodies, so that the sectors positive contribution to the economy and patients can continue.

When scientists from the UK and the EU work together they have greater impact, particularly in medical research, which ultimately benefits patients across the EU and beyond, said Greenwood.

The report recognises the importance of funding programmes such as Horizon 2020, and again commits to funding applications submitted while the UK is part of the EU, if necessary.

Collaboration on clinical trials and a strong relationship with the European Medicines Agency (EMA), the EU body that ensures the safety and quality of medicines, are also vital to ensure that patients get access to the best treatments.

On these points, the report states an aim to continue to work closely with the EMA and other international partners, in place of our current status as a member.

Greenwood added that more than a quarter of Cancer Research UKs clinical trials involve a European partner.

This is important for trials testing new treatments for rare or childhood cancers where studies require a cross-EU approach, she said. So its critical that our ability to participate and lead international research projects is upheld as negotiations on our future relationship with the EU continue.

Professor Venki Ramakrishnan, president of the Royal Society, said that while the paper is just a first step, it was encouraging in both its tone and aspiration.

Much needs to be done to work out the conditions that ensure our continued close collaboration with the EU, he said. That is necessary to dispel the uncertainty that continues to pose a threat to our position as a global scientific power.

He also said that there should be a commitment to future funding programmes, as well as guarantees about the status of the highly skilled EU researchers already working here.

Professor Sir Robert Lechler, president of the Academy of Medical Sciences, also called for further detail as soon as possible to ensure UK science and innovation doesnt suffer.

Funding is only one part of the picture. Arguably the most important factor in determining the strength of UK science is our ability to recruit and retain the brightest and best minds and to collaborate effectively across borders, he said.

In addition, in a post-Brexit era we will need a regulatory system that facilitates collaboration between the UK and Europe across discovery science, clinical trials and beyond, and ensures that patients continue to benefit from new discoveries.

In response the EUs research commissioner, Carlos Moedas, said that he was sure that solutions would be found in science, as well as other areas. We have to have a relationship that works.

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How a cancer research and treatment center used hybrid cloud to modernize its data center – TechRepublic

Posted: at 12:48 pm

At the 2017 VMworld conference in Las Vegas, Moffitt Cancer Center CTO Tom Hull spoke with TechRepublic about how the company used hybrid cloud to modernize its data center infrastructure.

“We had to assess our current data center situation,” Hull said. “We’re coming from a legacy data center scenario where on-premise, we have older technology [and] we have a data center that has infrastructure that’s aging.”

After looking at the latest options available, a hybrid cloud approach that included on- and off-premise capabilities seemed like the right fit, he said. “What we were able to do is balance our workload from a legacy data center to a partner colocation.”

SEE: Research: Cloud vs. data center adoption rates, usage, and migration plans (Tech Pro Research)

Before transforming their resiliency and disaster recovery model, Hull and his team had to consider what their data center architecture and location was going to look like. Taking that into consideration, MCC had to design that resiliency in a hybrid cloud approach.

Because so many people rely on MCC’s data, server, and network, they had to make sure they weren’t taking from the legacy and creating new risks. “In defining what our data center architecture was going to look like, we had to make sure that we were going to serve each one of [our seven corporate entities],” he said.

Since switching to a hybrid cloud approach, the company has achieved a more balanced workload across environments in the case an issue occurs in their remaining legacy data center. And their security became more modernized by using VMware products, and taking physical servers and virtualizing them.

Hull said MCC partnered with VMware and Dell EMC, and “bought into SDDC.” “It’s been a great partnership so far,” he said.

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Keyhole oesophageal cancer surgery as good as more invasive operations – Cancer Research UK

Posted: at 12:48 pm

Keyhole surgery for oesophageal cancer is as good as more invasive surgery in terms of survival, according to unpublished clinical trial results.

There may also be benefits in reducing complications for patients after surgery.

This well-conducted study shows that keyhole surgery for oesophageal cancer is at least as good as open surgery in terms of long term survival. There may also be a benefit by reducing complications after surgery. -Professor Tim Underwood, Cancer Research UK.

Professor Rebecca Fitzgerald, a Cancer Research UK-funded expert in oesophageal cancer at the University of Cambridge, said the study should give reassurance that keyhole surgery is just as good an operation, which should be better for patient recovery.

The unpublished results from the phase 3 European MIRO trial were presented to the ESMO 2017 Congress in Madrid.

The study included 207 patients who were followed for an average of more than 4 years. Half had keyhole surgery and half had more invasive open surgery, which is standard treatment.

After 3 years 67% of keyhole surgery patients were alive, compared to 55% of open surgery patients.

Just over a third of keyhole surgery patients (36%) had major complications after their operation, compared to just under two thirds of patients (64%) who had problems after open surgery.

Professor Tim Underwood, a Cancer Research UK-funded expert in gastrointestinal surgery at the University of Southampton, said: This well-conducted study shows that keyhole surgery for oesophageal cancer is at least as good as open surgery in terms of long term survival. There may also be a benefit by reducing complications after surgery.

In comparing surgical approaches its important to measure the success in removing as much of the tumour as possible, while reducing the amount of normal tissue affected.

These factors affect whether or not the patient will require further surgery and the time taken to recover.

These results suggest that patient safety is not compromised by the keyhole approach, and that patients have reduced surgical trauma.

Removing all or part of the oesophagus is a very invasive procedure with significant quality of life issues, said Fitzgerald. Anything that can be done to improve patient experience and reduce hospital and recovery time after surgery is ideal.

Patients included in the MIRO trial had cancers affecting the middle or lower third of the oesophagus.

Before we know if these results are true in the UK population we need to see the results of the UK ROMIO study, which is currently recruiting, added Underwood.

Lead investigator Dr Guillaume Piessen, from University Hospital C. Huriez Place de Verdun in Lille, said that the results show that keyhole surgery is a clinically sound procedure for oesophageal cancer.

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Physicists develop new tool that could improve cancer research – Phys.Org

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University of Arkansas physicists have developed a new way for quantifying data from microscopic observations that could help scientists better study how cancer cells respond to treatment, among other benefits. The research, recently published in the journal PLOS ONE, was carried out by Shenghang Jiang, at the time a Fayetteville High School student who was working with Department of Physics assistant professor Yong Wang.

The finding is a novel method of analyzing experimental data obtained by a technique called single-molecule localization microscopy, an advance that allows scientists to see things as small as individual molecules in biological systems such as bacteria and animal cells.

The method is robust, said Wang, and does not require any input parameters from the observer, which can introduce inaccuracy or bias. With it, researchers can accurately estimate the clustering density of biological molecules. Clustering of biological molecules is a process that is important for proper synaptic function in the brain, for example. It is also related to gene regulation in cells, and mistakes in gene regulation can lead to cancers.

“With this capability, one can quantitatively study the response of cancer cells to different drugs by examining how the clustering density of certain proteins changes,” said Wang. “Previously, there were methods for estimating the clustering densities of molecules. But those methods usually require human inputs, which possibly introduces human bias. In contrast, no human inputs or parameters are needed in our method, and thus biases are minimized.”

Jiang, who has since graduated from Fayetteville High School and is now at the University of California at Berkeley, ran about 11,000 numerical simulations for the study, said Wang, producing 135 gigabytes of data, the equivalent of about 25,000 songs or 60 hours of high-definition video.

Explore further: A metabolic pathway that feeds liver cancer

Journal reference: PLoS ONE

Provided by: University of Arkansas

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Weill Cornell Medicine awarded $11.3M grant for prostate cancer research – Cornell Chronicle

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Neuroendocrine prostate cancer cells from a patient biopsy.

Weill Cornell Medicine has been awarded a five-year, $11.3 million Specialized Programs of Research Excellence (SPORE) grant from the National Cancer Institute (NCI), part of the National Institutes of Health, to improve detection, diagnosis and treatment of prostate cancer a disease that affects one in six men.

The NCI offers SPORE grants that focus on cancers associated with 19 specific organ sites, groups of highly related cancers or diseases that share a common pathway. The SPORE grant is the first awarded to Weill Cornell Medicine and will expand the prostate cancer basic and translational research program at the institutions Sandra and Edward Meyer Cancer Center and the Caryl and Israel Englander Institute for Precision Medicine.

We are extremely proud to join an elite group of institutions working toward decreasing the suffering caused by prostate cancer, said principal investigator Dr. Mark Rubin, founding director of the Englander Institute for Precision Medicine and a professor of pathology and laboratory medicine and of pathology in urology at Weill Cornell Medicine, and director of the Department for Biomedical Research and leader of precision medicine at the University of Bern, Switzerland. Despite years of effort trying to understand the biology of this disease, we still have many fundamental challenges to address, including why African-American men develop a more aggressive form of prostate cancer and why some patients develop a rare subtype that is resistant to therapy.

The grant, which Dr. Himisha Beltran, assistant professor of medicine at Weill Cornell Medicine, will co-lead, will support four research projects focused on highly translational areas relevant to the detection and treatment of aggressive prostate cancer, each led by a basic scientist and translational clinical investigator.

Projects will be aimed at improving the detection and treatment of a rare, treatment-resistant form of prostate cancer called neuroendocrine prostate cancer; exploring a molecular subtype of prostate cancer characterized by mutations in a gene called SPOP, which occurs in 10 to 15 percent of prostate cancers; and improving the understanding molecular variations in prostate cancer tumors. The SPORE grant will have significant infrastructural support for big data management, featuring a team of computational biologists and biostatisticians. It will also provide dedicated resources for tissue collection, organoid creation and molecular studies on patient samples.

In addition, the grant includes yearly funding to jump-start new high-risk and high-reward studies led by Weill Cornell Medicine researchers, as well as a career enhancement program to support junior investigators who seek to enter the field of prostate cancer research. We are excited that matching institutional funds will help us recruit leading scientists into the field of prostate cancer research, Rubin said.

This work and resulting findings will enable Weill Cornell Medicine researchers to develop an approach to treating prostate cancer that aligns their expertise in translational and genomic research with the care of men, Rubin said. Early detection of aggressive prostate cancer could improve clinical risk assessment and reduce overtreatment, and the development of unique biomarkers and treatment strategies could reduce the probability of drug resistance and disease progression, improving outcomes for men with metastatic disease.

This prestigious grant will enable us to enhance our innovative, translational research into prostate cancer and inspire new collaborations as we work together to find a cure for this disease, said Dr. Augustine M.K. Choi, the Stephen and Suzanne Weiss Dean of Weill Cornell Medicine. The team of SPORE investigators is exceptional, and its groundbreaking work will undoubtedly advance our mission of scientific discovery and patient care, reinforcing Weill Cornell Medicines reputation as a leader in research.

Lewis Cantley, Ph.D. 75, who has many years of experience working with or co-leading SPORE grants, will work closely with the Weill Cornell Medicine SPORE team.

This is an amazing accomplishment and a major milestone for Weill Cornell Medicine, said Cantley, the Meyer Director of the Sandra and Edward Meyer Cancer Center and a professor of cancer biology in medicine at Weill Cornell Medicine. It will provide dedicated support for prostate cancer research that can be leveraged to help develop other types of program projects and grants. We believe this will yield some of the best research at our institution, inspiring our top investigators to consider how their science might be applied to address the challenges of understanding prostate cancer.

The SPORE grant will facilitate collaboration and accelerate the translation of scientific discoveries into the clinic, said Beltran, who is director of clinical activities at the Englander Institute for Precision Medicine at Weill Cornell Medicine and an oncologist at NewYork-Presbyterian/Weill Cornell Medical Center. The grants focus is translational research, which means our projects have a higher likelihood of going from bench to bedside and impacting patients.

Weill Cornell Medicine investigators have developed their research projects with the support of the Prostate Cancer Foundation, priming them for SPORE funding.

Additional investigators on the SPORE grant include Karla Ballman, Dr. Chris Barbieri, Julie Boyer, Olivier Elemento, Paraskevi Giannakakou, Lorraine Gudas, Dr. Juan Miguel Mosquera, Dr. David Nanus, David Rickman, Dr. Brian D. Robinson, Dr. Douglas Scherr, Michael Shen and Ronglai Shen at Weill Cornell Medicine; Dr. Scott Tomlins at the University of Michigan; and Francesca Demichelis from the University of Trento, Italy.

Kathryn Inman is a writer for Weill Cornell Medicine. Joseph Bonner is a freelance writer for Weill Cornell Medicine.

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Concern Rises Over $475000 Price Tag for Breakthrough Cancer Treatment – Healthline

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The immunotherapy drug Kymriah from Novartis has been hailed as a breakthrough in cancer treatment. But is its cost justified?

The announcement that an immunotherapy treatment using engineered versions of patients own cells recently approved by the Food and Drug Administration (FDA) has been heralded as a real breakthrough in cancer treatment.

But amid the celebration is the concern that the cost for the drug ringing in at $475,000 could be financially damaging for patients who pursue this treatment.

There is also a worry that the new drug could usher in an unsustainable rise in cancer treatment costs.

The drug is called Kymriah, and it was developed by Novartis.

Kymriah uses a patients own immune cells and reengineers them to fight cancer. It helps patients fight a kind of leukemia called B-cell acute lymphoblastic leukemia (ALL).

The Leukemia and Lymphoma Society (LLS) declared the FDA approval of Kymriah a new era in cancer treatment.

This is truly an exciting new day for cancer patients, Louis J. DeGennaro, PhD, LLS president and chief executive officer, said in a statement.

The LLS noted they have spent $20 million in funding CAR-T cell therapy research that helped contribute to Kymriah.

Every year an estimated 3,100 young people are diagnosed with ALL.

While children with the disease have an overall survival rate of 85 percent with traditional chemotherapy treatments, those who dont respond or relapse face a poor outlook.

Kymriah reengineers a patients cells through a process called CAR-T cell (chimeric antigen receptor T-cell) therapy so they are primed to attack the cancer.

In a clinical trial, people with ALL who had relapsed and then given Kymriah showed an 83 percent remission rate.

The treatment has only been approved for children and young adults under the age of 25.

Dr. Gwen Nichols, the chief medical officer at the Leukemia and Lymphoma Society, said she is concerned about the growing costs for cancer treatment.

However, she said that Kymriah does not cost significantly more than a bone marrow transplant or intense hospitalization for multiple chemotherapy treatments.

While this is an expensive therapy, so would be the treatment these children would be getting if they didnt get this therapy, she said. The cost for just keeping them alive is exorbitant.

Nichols said there needs to be more attention paid to rising cancer treatment costs in general, but Kymriah despite its price tag is different.

The idea of being able to give a child their life back, the value here is so great, I think that focusing just on [the cost] isnt focusing on the bigger problems, she said.

However, some patient groups disagree that the drugs price is acceptable.

Will Holley, spokesman at Campaign for Sustainable Rx Pricing, said the treatment is absolutely a breakthrough, but its pricing highlights how drug and medical treatment costs have escalated in recent years.

Ten years ago, we had the thousand-dollar-a-month drug and their jaw dropped, Holley told Healthline. Now, half-a-million dollars for a drug. It’s this ever-increasing trend.

Holley said if costs dont come under control, people will be unable to access these breakthrough therapies.

At a certain point, access becomes just as large an issue as innovation, he said. If the patients who need these therapies don’t have access to them… then what have we ended up with?

David Mitchell, founder and president of Patients for Affordable Drugs, said in a statement that price tags perpetuate a cycle that hurts patients.

While Novartis decision to set a price at $475,000 per treatment may be seen by some as restraint, we believe it is excessive, Mitchell said in a statement. Novartis should not get credit for bringing a $475,000 drug to market and claiming they could have charged people a lot more.

Mitchell said $200 million in funding from the National Institutes of Health has gone to CAR-T cell research that helped lead to Kymriah.

However, Novartis Chief Executive Officer, Joseph Jimenez, told Forbes that number was overblown and that only $16 million had been put towards CAR-T cell funding when they came onboard.

Jimenez said Novartis has spent $1 billion bringing the drug to market.

Novartis officials said in a statement they are working with the Centers for Medicare and Medicaid Services, and the company will only get reimbursed by the centers if patients show a response to the drug.

This means even if a patient gets the full treatment, there will be no cost if they do not go into remission.

In addition, Novartis has created Kymriah Cares to help patients afford the drug. The company has pledged to offer an access program for eligible uninsured and underinsured patients.

This program includes copay assistance as well as travel assistance for eligible patients, Novartis officials said. The travel assistance program will arrange and cover air and ground transportation, accommodations, and meals for the eligible patient and up to two caregivers.

For those in the field, the increasing cost of drugs has taken a toll in how they work with patients.

Dr. Craig Devoe, acting chief at the Don Monti Division of Medical Oncology & Hematology at Northwell Health, said pharmaceutical costs have been increasing, even for therapies that have been around for years.

He estimated hes seen costs go up by around 10 percent year over year for many cancer treatments.

As a result, Devoe said hes had more and more issues keeping patients protected from financial strain while getting treatment.

There’s a whole other toxicity now called financial toxicity, Devoe said. [Patients] are struggling with out-of-pocket expenditures.

He said they now have teams of people to help patients get through the maze of copayment assistance programs and insurance authorization.

In regard to Kymriah, Devoe acknowledged that this is a big step in a new kind of treatment, but he is concerned about what it means for cancer treatment in the future.

This is a breakthrough, it’s important and everybody gets that, he said. The issue is that overall this is just emblematic of skyrocketing costs of cancer drugs in general.

Devoe said its true that Kymriah might cost as much as a bone marrow transplant, but he worries that some people may eventually relapse and then need a transplant later as well.

There has to be more of a reasonable and fair profit that pharma can derive from these kinds of treatments, he said. That word reasonable is where the gray is and where the debate lies.

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A bioethicist’s take on child cancer treatment that uses gene therapy … – Catholic News Agency

Posted: at 12:47 pm

Washington D.C., Sep 7, 2017 / 03:02 am (CNA/EWTN News).- A genetic modification therapy designed for treating pediatric leukemia has drawn both praise and caution from a Catholic bioethicist, after recently being approved by the Food and Drug Administration.

While a promising use of gene modification technology, the treatment still has potentially deadly side effects – which could make the risks outweigh the benefits, says Fr. Tadeusz Pacholczyk, Ph.D., of the National Catholic Bioethics Center.

Gene therapies have garnered public attention for their potential medical significance, and because of problematic research procedures surrounding their development and the moral questions they raise.

However, the new treatment, called Kymriah, is a hopeful development and a morally licit use of genetic modifications in medicine, Fr. Pacholczyk told CNA.

Because the therapy only uses matured cells from the patient, Fr. Pacholczyk explained, it does not entail the same ethical problems as other forms of gene therapy under investigation including therapies which destroy human embryos or make modifications of cells which can be passed onto future generations. Instead, developing therapies which make genetic changes to help our immune system do better what it is supposed to do, namely identifying and eliminating various dangers from the body, is a praiseworthy goal, he said.

To the extent that side effects can be limited or controlled, the therapy appears to be very promising, with reports of high success rates in slowing or even eliminating certain childhood cancers like pediatric acute lymphoblastic lymphoblastic leukemia, Fr. Pacholczyk said.

Kymriah, developed by drug company Novartis, is a highly personalized form of immunotherapy called CAR T-cell therapy. The procedure, short for Chimeric Antigen Receptor T-cell Therapy, takes a persons T-cell a kind of white blood cell and genetically modifies it to contain a new kind of protein.

This protein, called a chimeric antigen receptor, or CAR, helps detect certain kinds of cancer cells. When the bodys T-cells are reintroduced to the body, they are now able to find and kill the cancer cells.

The treatment is specialized to attack a kind of pediatric cancer called acute lymphoblastic lymphoblastic leukemia, or ALL. ALL is a bone marrow and blood cancer, and is one of the most common childhood cancers in the United States.

According to the FDA, over 3,000 patients under the age of 20 are diagnosed with ALL each year. The treatment will be offered to patients who have not responded to other existing treatments, or those whose cancer has returned after initial treatment.

Fr. Pacholczyk emphasized that there are some ethical concerns doctors and patients considering this treatment should investigate, particularly the potential for side effects the treatment can cause in some individuals.

One ethical concern raised by this therapy centers on the question of whether the risks may be greater than the benefits for particular patients, he said.

In some patients, treatment with Kymriah can cause a severe immune response. Sometimes, when the white blood cells are rewritten, they can lead to a severe immune response called cytokine release syndrome, or CRS, when they are reintroduced. Symptoms of this syndrome can include high fever, flu symptoms, dangerously low blood pressure, and organ damage. It can also cause neurological symptoms, including swelling of the brain, which can be fatal.

In light of these dangerous side effects, the FDA also approved the expansion of use of an immune suppressing drug for treatment for CRS. The drug has shown to be an effective treatment for CRS after treatment with CAR-T cells. The FDA will also require Novartis to continue monitoring Kymriah after its release for long-term side effects and other harmful side effects.

With the control of the dangerous side effects, and weighing the risks of the treatment against its benefits, however, the new gene therapy looks promising, Fr. Pacholczyk said.

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Discussing cancer costs can reduce treatment expenses – Reuters

Posted: at 12:47 pm

(Reuters Health) – Even brief conversations between oncologists and patients about cancer costs can help reduce treatment expenses, a new study suggests.

Increasingly in oncology there are many therapeutic options and they all differ slightly from one another. Where there is a huge difference, a doctor is going to recommend the best one that is the best hope for the patient. When there is a small difference and the big issue is cost, I think its relevant to discuss it with patients since they are going to bear some financial burden, said Dr. Richard Schilsky, chief medical officer of The American Society of Clinical Oncology (ASCO).

I am hopeful that as doctors read about studies like this they realize that its feasible to discuss cost in patient encounters, said Schilsky, who was not involved in the research.

Researchers analyzed 677 transcripts of conversations taped in 2010-2013, between 56 oncologists in private practice clinics across the country and patients with breast cancer. Most patients were 55 to 74 years old and insured.

Cost came up in only 147 conversations, or 22 percent. When it did come up, oncologists were the ones who raised it 59 percent of the time, the research team reported in the Journal of Oncology Practice.

Half of the discussions lasted only about 33 seconds. But even though the discussions were brief, they were substantive enough to lead to helpful and creative solutions for patients in most cases, said lead author Dr. Wynn Hunter of the Duke University School of Medicine in Durham, North Carolina.

After these conversations, oncologists switched patients to lower-cost medications, ordered different diagnostic tests, changed the dose or frequency of medication, facilitated copay assistance, gave patients free samples or changed the logistics of intervention by, for example, rescheduling tests before the patient had to pay a new deductible.

Hunter told Reuters by phone, Finances have to be a part of the equation when we think about the therapies that we give. One part of the Hippocratic Oath is that we do no harm to patients. If we just treat disease and two or three years later it causes financial hardship and marital strife, then its not necessarily a victory.

In 2009, ASCO recommended that physicians discuss the costs of cancer treatment with patients, because they can become a tremendous financial burden. One-third of working-age cancer survivors go into debt, and 3 percent of patients go bankrupt from cancer care costs.

This study is encouraging because it documents real doctor-patient encounters that were meaningful and demonstrated that doctors are knowledgeable about how to identify alternatives for patients that are less costly, Schilsky said in a telephone interview.

Hunter told Reuters Health, It used to be taboo to talk about finances in the clinic and no one was doing it. This study proves its happening more frequently than people thought, and it can be done in a way thats non-confrontational and non-biased. It can be as simple as asking a patient if they are having any difficulties obtaining their medications.

Patients also need to be empowered to bring up costs with their oncologist, Hunter emphasized.

In the study, Caucasian patients initiated cost conversations 12 percent of the time while African American patients had these conversations 3 percent of the time.

One of the limitations of the study is that it analyzed cost discussions only for patients with breast cancer. Its not clear if patients with other cancers engage in similar discussions.

Schilsky said, One of the challenges is we dont understand if its necessary, appropriate or feasible to have had discussions in all 677 encounters. Sometimes patients have an acute medical problem, and we have to be focused on that. Sometimes there isnt an issue of cost for the patient. We dont know what the denominator is in a sense. Is it likely these discussions could be held more frequently? Almost for sure, he said. But there are many nuances to this.

Schilsky warned that one discussion of costs is often insufficient. Multiple discussions with multiple levels of a patients health care team are usually needed.

SOURCE: Journal of Oncology Practice, online August 23, 2017.

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Discussing cancer costs can reduce treatment expenses – Reuters

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