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Wednesday, January 23, 2019

Good News, Bad News on Levodopa for Parkinson’s


The most potent drug available for Parkinson’s disease, levodopa, treats symptoms of the disease but does nothing to either ease or increase its still-mysterious underlying causes, a new clinical trial has concluded.
Doctors often delay prescribing levodopa, or L-dopa, to Parkinson’s patients for fear that the drug might have toxic effects that produce jerky involuntary body movements over time.
But patients started on L-dopa nearly a year earlier than a second group did not develop significantly different rates of involuntary movement, results from the new trial show.
“The current study bolsters our confidence that levodopa is safe even in early Parkinson’s disease and that patients should not fear it,” said Dr. Michael Okun. He’s the national medical director of the Parkinson’s Foundation and chairman of neurology at the University of Florida in Gainesville.
There’s disappointment here as well. While levodopa isn’t toxic, it also doesn’t appear to provide any protection against progression of Parkinson’s in the brain, said Dr. Susan Bressman, co-director of the Mount Sinai Parkinson and Movement Disorders Center in New York City.
“The bottom line is they couldn’t show neuroprotection,” Bressman said. “Using this very normal dose we normally use, they couldn’t show it slows the progression of the disease.”
Parkinson’s disease is a progressive nervous system disorder. One of its hallmarks is the loss of neurons that produce a brain chemical called dopamine. Low dopamine levels affect a person’s control over their movements, causing tremors, rigid muscles and slowness.
Developed more than 50 years ago, L-dopa eases these muscular and movement symptoms. The brain synthesizes levodopa into dopamine and then puts the neurotransmitter to good use.
“Levodopa remains the most important and effective treatment for Parkinson’s disease and its introduction has undoubtedly improved morbidity, mortality and quality of life,” said Okun, who wasn’t part of the trial.
But side effects in some patients cause concern that the drug might have a toxic effect on the brain, researchers noted.
A clinical trial 14 years ago that aimed to clear up the matter only muddied the waters, Bressman said.
The earlier trial found that people taking L-dopa showed improvement even after they stopped taking it, raising hopes that it might be somehow be stemming the progression of Parkinson’s.
But brain scans of those patients showed some evidence that levodopa was causing potentially harmful changes to dopamine receptors in the brain, Bressman said.
“We couldn’t really prove one way or the other if it’s good or bad for the brain,” Bressman said. “But the bottom line — people need it. We don’t have a better drug. It’s the most potent drug for the symptoms, so you’ve got to use it, but you don’t use a high dose.”
The new clinical trial, led by Dr. Rob de Bie from the University of Amsterdam, hoped to clarify results of the older study.
A group of 445 early Parkinson’s patients in the Netherlands were randomly assigned to either start levodopa therapy right away, or wait 40 weeks and then start taking the drug.
“The theory is if you get those extra 40 weeks of exposure to levodopa and it’s neuroprotective, the earlier group will be in a better place and the late group will never catch up,” Bressman said. “They’ll always be a little worse because the first group got more of this neuroprotective effect.”
But both groups wound up in the same place by week 80 of the trial, with essentially the same rate of disease progression, the Dutch researchers found. The drug didn’t provide people in the earlier group any extra protection.
At the same time, neither group suffered greater rates of jerky movements or levodopa-related fluctuations in motor response, discounting concerns over toxic effects.
“Basically, it confirms what we currently do,” said Bressman, co-author of an editorial accompanying the study. Both were published in the Jan. 24 issue of New England Journal of Medicine.
“Most people don’t start levodopa at first diagnosis, when they have hardly any symptoms, because they don’t need it. We don’t think the drug is protecting the brain, so we don’t start it right away, because it’s not going to change what they’re going to look like 10 years down the pike,” she noted.
“But as soon as they do start to need it, we start it. We use it. And we’re judicious in how we use it,” Bressman continued.
Hopes for a drug that will directly treat or perhaps even cure Parkinson’s now rest on research being done into suspected causes of the disease, she said.
Experts now think Parkinson’s is a related group of diseases, each subtype potentially triggered by a different cause, Bressman said.
Drugs are being developed to target genes that have been implicated in Parkinson’s for some patients. Future drugs might target inflammation in the brain or other potential causes.
“I think ultimately between the genetics and other biomarkers we find in the spinal fluid or in the blood, we’re going to be able to group patients better and figure out the disease mechanisms,” Bressman said.
More information
The Michael J. Fox Foundation for Parkinson’s Research has more about myths surrounding levodopa.
SOURCES: Michael Okun, M.D., national medical director, Parkinson’s Foundation, and chairman, neurology, and co-director, Movement Disorders Center, University of Florida, Gainesville; Susan Bressman, M.D., co-director, Mount Sinai Parkinson and Movement Disorders Center, New York City; New England Journal of Medicine, Jan. 23, 2019

Fried Food May Shorten Your Life


 Fried chicken, french fries and chicken-fried steak might be delicious, but treating yourself to such fare regularly could be deadly, a new study warns.
Women who eat more than one serving a week of fried chicken or fried fish have an increased risk of heart disease and death, researchers report.
“Overall, we found that total fried food consumption is related to higher risk of all-cause death, and also death from cardiovascular disease,” said senior researcher Dr. Wei Bao. He’s an assistant professor of epidemiology with the University of Iowa’s College of Public Health.
The results are not surprising “given the association of fried food to weight gain and obesity, as well as elevation of cholesterol and triglycerides,” said Dr. Guy Mintz, who was not part of the study. He directs cardiovascular health and lipidology at Northwell Health’s Sandra Atlas Bass Heart Hospital in Manhasset, N.Y.
“Poor decisions lead to poor outcomes. We have the opportunity to help ourselves live healthier and longer with lifestyle changes,” Mintz said. “It is time we own what we eat and realize our dietary choices have consequences.”
For the study, Bao and his colleagues relied on data from the Women’s Health Initiative, a long-running federally funded study focused on heart disease, cancer and other health problems in postmenopausal women.
Nearly 107,000 women between ages 50 and 79 were quizzed on their diets and other health problems. These women enrolled in the study between 1993 and 1998, and researchers followed them up to February 2017.
During those two decades, 31,588 women died, including 9,320 heart-related deaths, 8,358 cancer deaths and 13,880 deaths from other causes.
The researchers found that women who ate a lot of fried foods also had other problems that could affect their heart health, Mintz said.
One-third of participants who ate one or more fried meals per week were obese, as were 44 percent of the patients who consumed more than one fried food meal per day, Mintz noted.
“More than half of these patients achieved less than the recommended 150 minutes of exercise per week,” Mintz continued. About 40 percent of the patients were former smokers.
But even after researchers controlled for these risk factors, fried foods were independently associated with an increased risk of death:
  • Women who ate one or more servings a day had an 8 percent higher risk of death compared with those who didn’t eat fried food.
  • One or more servings of fried chicken a day was linked to a 13 percent higher risk of death from any cause and a 12 percent higher risk of heart-related death.
  • One or more servings of fried fish or shellfish a day was linked to a 7 percent higher risk of death from any cause and a 13 percent higher risk of heart-related death.
The researchers found no evidence linking fried food to an increased risk of cancer death, and the study did not prove a cause-and-effect link between fried foods and early death.
The findings were published Jan. 23 in the BMJ.
Even though the study focused on women, Bao said it’s very likely that men would be similarly affected by a diet heavy in fried foods.
Obesity probably plays a part in the increased risk of death, he said. Women who ate fried food regularly had a much larger daily calorie intake than those who didn’t eat fried food.
But other factors could play a role as well, Bao said.
People in Spain often eat fried foods, but a previous study found that fried foods were not associated with an increased risk of death in that country, he noted.
Spanish fried food lovers regularly use olive oil for their frying, and more often they cook their fried foods in their own kitchens, Bao explained. By comparison, people in the United States tend to eat fried foods from restaurants, where they are often cooked in deep fryers using peanut or canola oils.
“The frying process at home could be different from the frying process away from home,” Bao said. “A notable thing is when we fry at home, we don’t reuse the oil many times.”
In the meantime, people shouldn’t downplay the affect high fat intake has on heart health, said Dr. Satjit Bhusri, a cardiologist with Lenox Hill Hospital in New York City. He was not part of the study.
“Heart attacks occur from cholesterol plaques building up in the coronary arteries,” Bhusri said. “Consuming fats from fried food directly impacts the burden of this disease. A cholesterol plaque rupture in the artery will cause a heart attack.
“This study emphasizes that there is no ‘maybe’ — fried food and fat have a direct relation to heart disease,” he said.
More information
The American Heart Association has more about a heart-healthy diet.
SOURCES: Wei Bao, M.D., Ph.D., assistant professor, epidemiology, University of Iowa College of Public Health, Iowa City; Guy Mintz, M.D., director, cardiovascular health and lipidology, Northwell Health’s Sandra Atlas Bass Heart Hospital, Manhasset, N.Y.; Satjit Bhusri, M.D., cardiologist, Lenox Hill Hospital, New York City; Jan. 23, 2019, BMJ

Medical device makes muscle recovery easier for patients


Non-invasive magnetic stimulation ‘tricks’ muscle cells into thinking that they are exercising, and amplifies the biological effect to promote muscle regeneration
The journey of muscle rehabilitation can be long and arduous, and requires strong perseverance from the patient. Now, researchers from the National University of Singapore (NUS) are making the recovery process much easier for patients with an ingenious medical device capable of regenerating muscles in a non-invasive and painless manner. The device, named MRegen, makes use of specific magnetic field to trigger and amplify the biological effect of exercise, hence accelerating muscle recovery.
The earth is cloaked in a protective magnetic field which is believed to have enabled life to evolve. Its ability to influence human development has prompted scientists and biomedical companies to seek ways to harness magnetic fields for therapeutic purposes. While creating a magnetic field is simple, the ability to generate the appropriate magnetic stimulation that triggers a positive therapeutic effect is technologically challenging.
A team of NUS researchers led by Associate Professor Alfredo Franco-Obregón studied the effects of magnetic fields on muscle cells. By coupling two fundamental concepts – firstly, muscle development is regulated by energy production; and secondly, energy management is extremely sensitive to magnetic fields – the researchers developed MRegen which makes use of a unique magnetic field to activate energy production and trigger muscle regeneration. The energy produced via the magnetic stimulation ‘tricks’ muscle cells into thinking that they are exercising, hence activating them to adapt and improve at an accelerated speed.
Assoc Prof Franco-Obregón, who is from the Department of Surgery at Yong Loo Lin School of Medicine and the Biomedical Institute for Global Health Research and Technology at NUS, explained, “The device provides a uniform electromagnetic field to a muscle area at a magnitude and pulse duration that reproduces the same regenerative, energetic and metabolic responses as physical activity. The duration of use for the device has been optimised for providing the largest therapeutic effect in terms of muscle equality, function and metabolic stability. The device is especially useful in reducing muscle degradation in periods when physical activity is not possible.”

Promising results in two clinical trials

MRegen has shown promising results in two human trials conducted between 2015 and 2017.
The first human trial examined the effects of MRegen on healthy individuals by giving 10 recruited healthy individuals the magnetic field treatment in either their left or right leg. The researchers found that those who received 10 minutes of magnetic stimulation by MRegen once a week for five consecutive weeks showed an average of 30 to 40 per cent improvement in muscle strength, in both legs.
The second human trial examined the effectiveness of MRegen in accelerating the muscle recovery of patients who had undergone anterior cruciate ligament (ACL) knee surgery at a local hospital. In this trial, 10 recruited patients were given the normal rehabilitation therapy while 10 other patients were given the magnetic field treatment with MRegen in addition to the rehabilitation therapy. It was observed that the patients who were treated with MRegen experienced a recovery in muscle size and strength in their operated leg four weeks earlier than those who had undergone only the normal rehabilitation procedures. Most notably, Magnetic Resonance Imaging measurements showed that muscle metabolism, one of the strongest indicators of muscle health and regenerative capacity, improved by up to 50 percent in the patients who had undergone MRegen’s magnetic field treatment.
Field treatment in one leg has also consistently appeared to have positively influenced the health of the other leg in both trials, demonstrating what is known as a contralateral effect. Such an effect has been described in the sports science field, but not as strongly observed as with MRegen’s magnetic field therapy. Furthermore, those who received the magnetic field treatment showed no sign of discomfort or adverse consequences, proving the treatment to be a painless procedure. This breakthrough medical device could therefore shift the paradigm of current muscle rehabilitation routine and make the road to recovery shorter and more comfortable for patients.
The researchers filed a patent for this novel technology and have since spun off a company, QuantumTX, to commercialize it. They believe that the technology holds great promise for slowing muscle loss and maintaining healthy muscle metabolism in the frail and elderly, as well as helping to maintain muscle mass for professional athletes during detraining. The NUS team is also looking into applying the same technology for treating other health conditions such as obesity and diabetes, and early stages of their research have already shown encouraging results.
“Muscle makes up 40 per cent of an average person’s body mass, and plays a major role in regulating one’s body, health and longevity. If we can harness the ability to regulate muscle development, we may gain greater control of the overall human health. MRegen, which has proven to be non-invasive and effective in regenerating muscles, can be easily modified to treat other human diseases. We foresee this technology playing an important role in disease treatment in the future,” said Assoc Prof Franco-Obregón.

Fate of DNA derived from genetically modified food


An international group of toxicologists, which includes scientists from Far Eastern Federal University (FEFU), continues to study the potential risks of genetically modified (GM) products. Scientists have published a review of research papers on the fate of the DNA derived from GM food and feed entering the human body and animals. The article published in the journal Food and Chemical Toxicology.
According to the review data, the DNA of GM products can survive harsh processing and digestive conditions. Some of them can get into the human body, combining with the DNA of bacteria in the gastrointestinal tract (GIT). Scientists have discovered the presence of such DNA in the blood stream and tissues of humans and animals.
“We are talking just about the limited pieces of evidence of this process, including because this area studied insufficiently. Although we have not found evidence of any effect of DNA of GM products on the human genome, we can safely say that micro-ribonucleic acid (one of the main molecules in cells of living organisms, in addition to DNA and proteins) of the plant food treated with insecticides and antiviral sprays, enters the body of its consumers and can affect genetic processes. This question would be worth exploring further. ” – Commented on the results of the review one of its authors, Dr. Muhammad Amjad Nawaz, a visiting scientist at the “Nanotechnology” Research and Education Center (REC) operating at FEFU. The scientist continues to study the effects of GM products on human and animal health, working in a group of colleagues from FEFU and other Russian and foreign universities, led by a foreign member of the Russian Academy of Sciences, chief researcher of the “Nanotechnology” REC Aristides M. Tsatsakis.
In the review, scientists examine the ways and mechanisms by which foreign DNA can survive during digestion and penetrate into the cells of the body of their consumer. In particular, researchers are interested in the region of the gastrointestinal tract as the hot spot for horizontal gene transfer of GM crop DNA into gut-bacteria. Such a transfer can potentially lead to dysbacteriosis and ill-health, as well as subsequent mutations. Scientists pay attention to the contradictions that arise around the topic of the presence of DNA of consumed products in the blood and organs of their consumers and declare the failure to prove their effect on the human body. They are also discussing the possibility of integrating genomes and the expression of foreign DNA in the tissues of the consumer. In conclusion, researchers consider the potential for penetration of micro-RNA of GM plant food into the human body cells.
In 2017, the same group of researchers had published two reviews of the scientific papers on the GM crop cultivation impact on the environment, ecosystem, diversity and the health of animals and humans.
As of 2016, the global production of genetically modified cereals for food and feed is set at 185.1 million hectares and makes a profit of about 150 billion US dollars. With such production volumes, research on the potential effects of genetically modified products on human health remains relevant in the future.

Incyte upgraded to Buy from Hold at Gabelli


https://thefly.com/landingPageNews.php?id=2852775

Hologic says FDA grants clearance for Aptima Mycoplasma genitalium assay


Hologic announced that the FDA has granted clearance for its Aptima Mycoplasma genitalium assay, the first and only FDA-cleared test to detect this under-recognized but increasingly common sexually transmitted infection, or STI. This newest Aptima assay joins a growing suite of market-leading tests offered by Hologic to help combat the rise of STIs in the U.S.
https://thefly.com/landingPageNews.php?id=2852785

Measles Causes Public Health Emergency in Washington State


measles outbreak in 23 largely unvaccinated individuals in Washington state since the beginning of the year has led public health officials to declare a public health emergency, according to a January 22 statement from the Clark County, Washington, Public Health Department. The department is investigating two other “suspect cases.”
Measles was confirmed in 18 children aged 1 to 10 years, four children aged 11 to 18 years, and one adult aged 19 to 29 years.
The Clark County Public Health Department statement includes a list of 36 public places where exposure to the infection may have occurred and the list is being updated regularly.
These locations include eight healthcare facilities, 12 schools, and 16 other locations including stores, churches, a Portland Trail Blazers basketball game at the Moda Center, and the Portland International Airport in Oregon — located across the Columbia River from Clark County, Washington. Numerous locations on the list had potential exposures on more than 1 day.
“Measles is so contagious that if one person has it, 90% of the people close to that person who are not immune will also become infected,” according to the Centers for Disease Control and Prevention (CDC).
Twenty of the sickened individuals were unvaccinated and vaccination status is unknown for the other three. One person is reportedly hospitalized.
Portland is one of several “hotspot” metropolitan areas in the United States with high numbers of nonmedical exemptions from vaccines, according to a study published online June 12, 2018, in PLOS Medicine. Others include Seattle and Spokane in Washington; Phoenix, Arizona; Salt Lake City and Provo in Utah; Houston, Fort Worth, Plano, and Austin in Texas; Troy, Warren, and Detroit in Michigan; Kansas City, Missouri; and Pittsburgh, Pennsylvania. Additional smaller counties, particularly in Idaho, Wisconsin, and Utah, also have high exemption rates.

Call Before Seeking Medical Care, Officials Stress

Because the disease is so contagious, those who have been exposed or who believe they have the infection should call their healthcare provider before going to medical offices, urgent care centers, or emergency departments, unless they are having a medical emergency, officials say.
Calling ahead will give healthcare providers an opportunity to ensure no other patients are exposed in the waiting room.
Students and staff without documented measles immunity are being excluded from schools where exposures may have occurred; these individuals are also excluded from other schools, child care locations, and other settings where people gather. These exclusions do not apply to students and staff at schools where exposure to measles has not occurred.
The measles virus can survive for as long as 2 hours in the air where an infected individual has coughed or sneezed. Others can become infected if they “breathe the contaminated air or touch the infected surface, then touch their eyes, noses, or mouths,” the CDC explains. Individuals with measles can spread the disease to others from 4 days before the rash appears through 4 days after it appears.
The Clark County Public Health Department will update their web page with additional information as it becomes available.
Those with questions about the investigation or about public exposures should call Public Health’s call line at 360-397-8021.