Exciting New Treatments in Medicine and How Not to Treat Our Nurses!

20915645_1286250984837891_7362681283119444727_nThis week I want to take a break from what is wrong with our system and focus on some really great advances in medicine. I was amazed and excited when I heard the announcement this week that the FDA on Wednesday approved a chimeric antigen receptor (CAR) T-cell therapy for treatment of certain pediatric and young adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. John Gever the managing editor of MedPage wrote that the agency is calling it a “historic action,” and the approval marks the “first gene therapy available in the United States.”

I have been following these patient studies for a number of months and was thrilled that the FDA had approved this therapy. How cool!

The treatment, to be trade named Kymriah and carrying the generic name tisagenlecleucel, is sold by Novartis. The company said it would charge $475,000 for the one-time treatment.

In this type of therapy, patients’ own immune cells are modified ex vivo to include a gene for the CAR protein, which directs them to attack leukemia cells carrying the CD19 antigen.

An FDA advisory committee had unanimously recommended the approval at a meeting last month.

However, tisagenlecleucel (also known as CTL019) can cause severe side effects, particularly a condition called cytokine release syndrome (CRS) that can become life threatening.

The FDA is including a boxed warning for CRS and, in an unusual move, also approved a new indication for the rheumatologic drug tocilizumab (Actemra) as a treatment for CRS. The agency said that 69% of patients developing the condition during CAR T-cell trials “had complete resolution of CRS within 2 weeks following one or two doses” of tocilizumab, which inhibits interleukin-6.

In a call with the media, FDA Commissioner Scott Gottlieb, MD, discussed the “cross-agency approach” involved in this approval, with both the Oncology Center for Excellence and the Center for Biologics Evaluation and Research collaborating. Gottlieb said that this “more collaborative scientific model for review” will be employed in the future, as the agency is committing to “expediting new and groundbreaking therapies.”

Gottlieb noted that there are currently more than 550 investigational new drug applications for gene therapy products, including 76 related to CAR T-cells.

Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA, said that CAR T-cells may have the potential to treat different types of diseases and cancers, including solid tumors, certain infections, and autoimmune disease. He added that potential use of these treatments to treat hematologic malignancies, adult forms of leukemia and certain types of non-Hodgkins lymphoma is “not yet approved and are currently investigational.”

In a statement, the American Hematology Society’s president, Kenneth Anderson, MD, applauded the approval but noted that it’s just the first step down a long road.

“While the importance of CAR-T cannot be overstated, this approval only pertains to a small population of children,” Anderson said. “More research is needed to make this therapy more effective for a broader population, to reduce the severe side effects that patients experience during treatment, and ultimately to find a broader application beyond blood cancers. Continued research will also lead to improved manufacturing of large numbers of cells, which is necessary to make this therapy accessible to more patients.”

Gottlieb said that a post-marketing study would be required for tisagenlecleucel and called it a crucial part of the “new, accelerated pathways to approval.” He said he is “very confident” that the FDA has the resources to ensure that companies fulfill their post-marketing commitments.

In addition to the boxed warning and post-marketing study, the FDA is also requiring a Risk Evaluation and Mitigation Strategy that includes mandatory training in CRS and its management for all personnel “involved in the prescribing, dispensing, or administering” tisagenlecleucel. Clinics must also certify that they have tocilizumab on hand for immediate administration.

Novartis had received breakthrough therapy and priority review designations on tisagenlecleucel.

However, this is just the beginning of a new era in medicine. I have been working with oncologists and companies developing biomarkers to predict recurrence of disease, as well as new immunotherapy and special antibodies to “kill” tumor cells, which we are finding, are safer for the patients.

Also, I find it exciting that scientists have discovered a new process to kill cancer cells, called Caspase Independent Cell Death (CICD), that can get rid of tumors, and decrease the risk of both side effects and recurrence. In experimental models, CICD removed tumors completely — killing all cancer cells.

Current treatments such as chemotherapy, immunotherapy, and radiation all carry risks of side effects, and they frequently fail to kill all cancer cells, which leads to recurrence. These treatments all work through apoptosis, the process of activating proteins called caspases to cause cell death.

Dr. Stephen Tait, the researcher who led the University of Glasgow team in the work on the CICD technique, told Sky News the new method “often led to complete tumor regression” and “may be a more effective way to treat cancer” than apoptosis. He added: “In essence, this mechanism has the potential to dramatically improve the effectiveness of anti-cancer therapy and reduce unwanted toxicity. Taking into consideration our findings, we propose that engaging CICD as a means of anti-cancer therapy warrants further investigation.”

It is so exciting that we are in the next level of cancer treatment. Think about it. Cancer is one of the leading causes of death globally. Worldwide, there were 14 million new cases of cancer and 8.2 million cancer-related deaths in 2012. Within the next 20 years, the number of new cancer cases will rise to 22 million worldwide.

In the United States alone, an estimated 1,685,210 new cases of cancer were diagnosed in 2016, and 595,690 people died. Every year in the U.S .there is about 454.8 new cases of cancer for every 100,000 adults — and 171.2 cancer deaths per 100,000 adults. About 39.6 percent of people in the U.S. will be diagnosed with cancer at some time in their lives. As a country, the U.S.’s annual national expenditures on cancer care have been estimated to reach up to $156 billion by 2020.

Cancer is a disease that science is eager to better understand so that it can be better prevented, treated, and perhaps even one day cured. Current treatment methods are only partially effective (and are typically specific to the type of cancer, of which there are many). They also make even healthy cells sick, which further wreaks havoc on the rest of the body, not just the cancerous tumors. In contrast, when the CICD technique kills cancer cells, those cells release inflammatory proteins which alert the immune system to ramp up the body’s own natural defenses, which then attack any remaining tumor cells missed during the initial treatment.

Work remains for the researchers, as they have not yet successfully triggered the CICD response in humans. They hope that achievement will be possible as their research continues and they experiment with a wider range of cancer cells (the current work focused solely on colorectal cancer cells). Still, these initial results are very promising.

“Although many cancer treatments work by triggering apoptosis, that method sometimes fails to finish the job and instead may lead to the tumor becoming harder to treat,” spokesperson Dr. Justine Alford told Sky News. “This new research suggests there could be a better way to kill cancer cells which, as an added bonus, also activates the immune system.”

We have heard about nanomachines in science and science fiction but now we discover that nanomachines can be used to treat cancer that drill into cancer cells killing them in just 60 seconds developed by scientists. What I am talking about is nanomachines, which can drill into cancer cells, killing them in just 60 seconds, have been developed by scientists.

The tiny spinning molecules are driven by light and spin so quickly that they can burrow their way through cell linings when activated.

In one test conducted at Durham University, the nanomachines took between one and three minutes to break through the outer membrane of prostate cancer cell, killing it instantly.

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The ‘motor’ is a rotor-like chain of atoms that can be prompted to move in one direction, causing the molecule to rotate at high speed.

Dr. Robert Pal of Durham University said: “We are moving towards realizing our ambition to be able to use light-activated nanomachines to target cancer cells such as those in breast tumors and skin melanomas, including those that are resistant to existing chemotherapy.

“Once developed, this approach could provide a potential step change in noninvasive cancer treatment and greatly improve survival rates and patient welfare globally.”

Motorised molecules that target diseased cells may deliver drugs or kill the cells by drilling into the cell membranes.

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The scientists, whose work is reported in the journal Nature, created several different light-activated motorized molecules designed to home in on specific cells.

They found that the nanomachines needed to spin at two to three million times per second to overcome nearby obstacles and outpace natural Brownian motion, the erratic movement of microscopic particles suspended in fluid.

The molecules could be used either to tunnel into cells carrying therapeutic agents or to act as killer weapons that blast open tumor membranes.

Without an ultraviolet trigger, the motor molecules located target cells but then remained harmlessly on their surfaces.

The prostate cancer cells start to ‘bleb’ or disintegrate after just 60 seconds, as seen in the bottom image Credit: Robert Pal/Durham University)

When triggered, the molecules rapidly drilled through the cell membranes.

Dr James Tour, a member of the international team from Rice University in Houston, US, said: “These nanomachines are so small that we could park 50,000 of them across the diameter of a human hair, yet they have the targeting and actuating components combined in that diminutive package to make molecular machines a reality for treating disease.

“In this study, we have shown that we can drill into cells, animal cells, human cells using these nanomachines, they will attach to the surface and then a light will be shone upon them and they will drill right into the cell.

“For many years I never had envisioned the nanomachines being used medically, I thought they were way too small, because they are much smaller than a cell, but now this work has really changed my thoughts on this and I think therapeutically this will be a whole new way to treat patients, it’s going to be an excellent application for cancer treatment, not just for killing of cells but for the treatment of cells, interacting with the human body using molecular machines.”

The researchers are already proceeding with experiments in microorganisms and small fish and hope to move to rodents soon, ahead of clinical trials in humans if animal testing is successful. How cool to have all of these and other advances in treating cancers in our lifetime!! My only reservation is the cost of all these new treatments and how are we going to pay for it all? Back to the basics of finance and economics.

And now there is something very important but truly disturbing to report, the video of the detective in Utah arresting a nurse for doing her job in protecting a patient’s rights. On July 26th, the head nurse at the University of Utah Hospital’s burn unit was wrongly arrested when she refused to collect a blood sample from an unconscious patient. As seen in the video, taken by Payne’s body camera, Wubbels, the head nurse of the University of Utah Hospital’s burn unit, remains calm as she explains policy after Payne insists on collecting the blood sample of an unconscious patient, according to The Salt Lake Tribune.

Wubbels explains she is simply trying to her job, telling the detective “three things that allow us to [give blood samples] are if you have an electronic warrant, patient consent or patient under arrest, and neither of those things … the patient can’t consent. He told me repeatedly that he doesn’t have a warrant and the patient is not under arrest.”

The footage of the arrest shows Payne interrupting Wubbels as she continues to explain the policy to him before placing her in handcuffs, which causes a brief scuffle between the two.

The video, made public Friday, sparked a wave of criticism over Payne’s confrontation with a nurse who appears to be following hospital protocol.

Salt Lake City Mayor Jackie Biskupski and Police Chief Mike Brown apologized for Payne’s actions and promised investigations from Internal Affairs and the Civilian Review Board.

“I was alarmed by what I saw in the video with our officer” and Wubbels, Brown said in a joint statement. “I am sad at the rift this has caused between law-enforcement and the nurses we work so closely with. I want to be clear, we take this very seriously.”

After Payne placed Wubbels in handcuffs, the nurse was released without being charged for anything. In fact, a 2016 Supreme Court ruling suggests that the nurse was right to not allow Payne to obtain a blood alcohol test without a warrant.

According to Payne’s report obtained by the Tribune, the detective said his watch commander, Lt. James Tracy, advised him to arrest Wubbels for interfering with a police investigation. He also said he needed the blood sample to protect, not punish, the patient.

After seeing the video, National Nurses United, which is currently sponsoring a campaign to raise awareness of hospital workplace violence, publicly denounced Payne and the Salt Lake City Police Department.

“As the videos and news accounts make clear, there is no excuse for this assault, or her arrest, which sends a chilling message about the safety of nurses and the rights of patients,” said Jean Ross, the organization’s co-president.

Police spokeswoman Christina Judd told AP that the police department initiated an internal investigation within hours of the July 26 confrontation. Since the arrest, Payne has been suspended from the department’s blood draw unit.

 

Salt Lake County District Attorney Sim Gill ordered a criminal investigation Friday into the actions of Detective Jeff Payne who aggressively arrested nurse Alex Wubbels on July 26 for refusing to draw blood from a severely injured patient.

Payne has been placed on administrative leave, The Associated Press reported. The Salt Lake City Police Department also said Friday that two of its employees have been placed on administrative leave while the investigation is underway. It is unclear if Payne is one of the employees mentioned in the agency’s statement.

This situation is clearly an abuse of power by Detective Payne. We believe it is an example of a much larger issue. Too often have we seen cases of officers abusing their power, whether it is at traffic stops or within low-income communities. Instead of embodying the principles of public service, many officers act inappropriately, which ultimately harms their community. This is not a case of a few bad apples, but instead proof that the whole barrel is rotten.                                                                     Under the current system of policing, officers are unable to succeed at serving the people, as they have forced into us vs. them methodology. This is further complicated in cities across the country with the system actively enabling officers to feel like they are above the law. Despite all of the reforms Salt Lake City has worked to implement, Detective Payne still felt he was above the law and therefore took it upon himself to enact his own ‘justice’ in that hospital.

I’m going to take a position that I usually don’t agree with, that is taking legal action against this detective, his supervisor, and the whole department. If the nurse and the hospital don’t then this could happen again and my concern is that patients and nurses and physicians rights could be violated again and again. Take a stand!

Next Happy Labor day to all and sincere best wishes for strength and resolve to all affected recovering from the severe hurricane Harvey and the havoc it spread across Texas and its residents. We the people of this nation stand strong with you in your road to recovery and rebuilding.

 

 

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