The United States Food and Drug Administration announced, this week, the approval of Pfizer Inc’s new acute meyloid leukemia treatmetn, Mylotarg (gentuzumab ozagamicin).
Now, this medicine will not treat all patients; it is mostly effective on newly diagnosed AML who also have tumors that express the CD33 antigen, and could also treat patients—ages 2 and older—who have relapsed CD33+ AML or did not respond a different initial treatment.
The drug had actually received accelerated FDA approval back in 2000 as a potential standalone treatment for older, relapsed CD33+ AML patients. Ten years later, however, the drug was voluntarily withdrawn—via FDA request—when later confirmatory trials did not verify any clinical benefit while demonstrating potential safety issues. Particularly, there was great concern over a potential elevation of early death risk.
Fortunately for Pfizer, though, more clinical trials have taken place since then and shown there is some benefit.
FDA Oncology Center of Excellence director, Richard Pazdur, MD, comments, ”
“We are approving Mylotarg after a careful review of the new dosing regimen, which has shown that the benefits of this treatment outweigh the risk. Mylotarg’s history underscores the importance of examining alternative dosing, scheduling, and administration of therapies for patients with cancer, especially in those who may be most vulnerable to the side effects of treatment.”
Also the acting director of the FDA Center for Drug Evaluation and Research Office of Hematology and Oncology Products, Pazdur assures that the FDA approval comes only after “a careful review of the new dosing regimen, which has shown that the benefits of this treatment outweigh the risk.”
AML is a form of rapidly-progressing cancer in the bone marrow which results in a higher than usual white blood cell count in the bloodstream. According to the National Cancer Institute and the National Institutes of Health, we will see an estimated 21,380 cases diagnoses this year; and nearly half as many deaths.
The most common side effects of this drug include fever, vomiting, nausea, infection, and bleeding. This medication can also result in low blood platelets, swelling in the mouth and mouth sores, constipation, rash, and headache. Severe side effects can include liver damage, infusion-related infections, severe bleeding, and hepatic veno-occlusive disease. Also, women who are pregnant or breastfeeding should be wary that the drug could harm a developing fetus or newborn baby.
Indicators on MRI Scans May Provide Tips on Multiple Sclerosis Development
A tremendous discovery possibly has been made to help predict what type of Multiple Sclerosis (MS) may develop up to one year after the first attack. MS is a tricky disease where the body’s own immune system attacks the protective layers of nerves within the central nervous system. There is no simple way of diagnosing MS as doctors have to rely on symptoms and tests to eliminate other diseases. It is a disease which leaves its victims in the dark as its progression and severity are extremely unpredictable. MRIs have been used extensively to study the effects of MS on the brain.
MRIs are a valuable tool to allow doctors to visually see lesions within the central nervous system which could indicate the presence of MS. Even though not all lesions which appear on an MRI are due to MS, the imaging tool can be used by doctors to determine future treatment options.
Researchers are now becoming craftier in their analysis of MRI results to determine what the future may hold for an individual with an MS diagnosis. A formula based on the number, size, and length of lesions on the first MRI after the onset of MS can potentially allow doctors to determine the prognosis of a patient.
There are numerous types of MS and, on occasion, demyelinating incidents may have no future attack. This is known as clinically isolated syndrome (CIS). This can sometimes delay the decision of what type of treatment to utilize and when to apply it.
In an effort to put their theory to the test, researchers studied patients with a CIS. They measured their lesions after the first attack and took the same measurements over the course of one year.
The study looked at 46 patients and 25 (54%) of them progressed to MS after the completion of one year. It was noted that individuals who had lesions that were temporal, occipital, or perpendicular to the corpus callosum on the initial MRI had an increased risk for another attack.
Any patient who displayed greater than 13 lesions, a largest lesion of more than 0.75cm in length, and a lesion perpendicular to the corpus callosum was at a 19 times greater risk of conversion MS.
A closer look at these indicating factors can help doctors determine which patients are less likely to experience a future attack within the next year and patients who should be on high alert.
The results of the study were invigorating in scientists’ quest to shorten the time it takes to diagnose MS and to deliver proper treatment. However, further research is required to determine if this method is the proper tool to predict the prognosis of everyone who suffers from a CIS.
“It was a fine study, intriguing, interesting, and adds to what we know about the imaging factor, but it’s not actionable yet,” said Bruce Bebo, executive vice president of research at the National Multiple Sclerosis Society.
Until then, doctors will utilize their knowledge of what MRIs reveal after an initial CIS to make an accurate prediction of the likelihood it develops into MS.
Group of Doctors Mobilized by a City to Treat Addiction at any Location on the Street
The mayor of San Francisco, Mark Farrell, has organized a unique medical team to tackle the growing opioidcrisis in the city. The 10-person medical team was given $6 million in funding to locate homeless citizens and heroin addicts to prescribe them the medication buprenorphine. The program is a pioneering initiative to assist those suffering from opioid addiction who would otherwise fail to get treatment. The team’s goal is to prescribe the medication to at least 250 addicts over the course of their program as first reported by the San Francisco Chronicle. Doctors are working mercilessly to provide access to the medication to the homeless who suffer from addiction.
“The consequences of standing still on this issue are unacceptable,” Farrell told TheChronicle. “Drug abuse is rampant on our streets, and the recipe of waiting for addicts to come into a clinic voluntarily is not working. Plain and simple. So we’re going to take a different approach.”
Buprenorphine is known by the brand name Suboxone. It has shown to be more effective at limiting urges and the effects of withdrawal symptoms than methadone. Patients can take buprenorphine as a daily pill or a dissolvable strip.
The Department of Public Health first got the idea for the program back in 2016 when they prescribed buprenorphine in tent camps. They noticed a remarkable trend of nearly 60 percent of the roughly 200 individuals prescribed the medication still making positive steps to stay away from opioids.
The encouraging trend of the one-year pilot study inspired the health department to take things a step further with the street program. “Homeless people who use drugs are especially vulnerable and our health system is adapting by going directly to them with compassionate outreach and expertise,” DPH Director Barbara Garcia said.
Many people are afraid to seek treatment for opioid addiction at clinics due to either a degrading social stigma or the fear of being sent to jail. The street program aims to find people, wherever they may be located, before they fall victim to overdose.
Mayor Farrell believes the investment into the program will pay dividends. “When you think about it, we’re doing a couple things, one saving lives with this program and second, the reduction of emergency costs for individuals who are in our ambulances, emergency rooms and hospitals,” Farrell said.
The one of a kind program by the San Francisco DPH team has been praised by drug addiction experts. Dr. Alex Stalcup, who leads a clinic in the Bay area and is a nationally renowned expert on addiction treatment, is enthusiastic about the program. He stated buprenorphine as “blindingly effective.”
“It clearly saves lives. It ought to be part of the national program. And people who go into tents, like San Francisco has done to distribute Suboxone, they are my heroes,” Stalcup stated.
The DPH hopes to see a resounding change in the city’s opioid addiction epidemic. The department believes there to be roughly 11,000 heroin addicts in the city who utilize needles and a sizable portion of that figure are expected to be homeless.
Post Operative Care: Groundbreaking sensor for analyze patient’s rehab
Groundbreaking sensor could potentially allow doctors to analyze patient’s rehab from afar. Researchers at the University of Waterloo have constructed an innovative self-powered sensor which could enable doctors to oversee their patients’ post-surgery rehabilitation or post surgery care or Post Operative Care thousands of miles away.
Hassan Askari, a Ph.D. engineering student at Waterloo University, and his teambelieve there is a vast array of applications for their new sensor. Askari’s team included Ph.D. student Ehsan Asadi, doctoral student Zia Saadatnia, professors at Waterloo Amir Khajepour and Mir Behrad Khamesee, and professor at the University of Toronto Jean Zu.
The primary application of their tube-shaped sensor is to be connected to orthopedic braces patients wear after an operation and feed data to easily accessible devices such as a smartphone. The sensors use for knee rehabilitation in particular was studied by the research team. Doctors can analyze crucial identifiers of improvement after joint procedures such as range of motion from the comforts of home. Adjustments that need to be made to a patient’s rehabilitation program post-surgery can be spotted immediately by doctors with the sensor to avoid further disruption to the patient’s progress.
“That data would be continuously collected, so it would be as though the physician or physiotherapist was always there, always observing the patient,” said Hassan Askari.
The same sensor utilized for patient rehabilitation after surgery can potentially be used in the tires of autonomous vehicles to spot and adjust to dangerous driving conditions such as icy roads.
The research team performed tests on a model of the sensor by combining triboelectric and electromagnetic generators to produce a current.
The sensor produces an ample amount of electricity to power electronic circuits for wireless signal transmissions when twisted.
“The aim was to develop a sensor that works without having a battery attached to it,” said Askari. “It is its own power source.”
This device would be a tremendous fit for scenarios where dependability is critical as replacing worn out batteries would be a costly and tedious task.
The sensorsmeasure roughly six centimetres long and one centimetre wide and likely can be assembled for $5 to $10 per unit.
Using solely triboelectricity, researchers are now focusing on reducing the size of the sensor even more. Askari’s team is researching tremendously for technology to utilize the sensor’s use in tires.
When the sensor is fitted to the inside of car tires, it could have the capacity to detect changes in road conditions, including dangers like icy roads, and send the data to the computer of a self-driving vehicle so it can make proper modifications in driving patterns.
“Based on the forces, the interaction between the road and the tires, we could actually detect ice or rain,” said Askari. “That is extremely important information for autonomous driving.”
A study which outlines their research, A flexible tube-based triboelectric–electromagnetic sensor for knee rehabilitation assessment, was published in the journal Sensors and Actuators A: Physical.
Sources: Waterloo, Waterloo Engineering, Science Direct