FDA panel endorses Johnson & Johnson ketamine nasal spray for treatment-resistant depression

MJ_Prototype/iStock BY: DR. THERESA SCOTT

(NEW YORK) — Ketamine is often used in hospitals as an anesthetic, but it’s also well known as a street drug. Now, an expert panel wants to convince the Food and Drug Administration that ketamine may help treat severe depression when no other drugs work.

Tests for ketamine as a depression treatment began in the late 1990s, when psychiatrist Dr. Dennis Charney and a team of researchers saw that patients with severe depression, who were undergoing operations, were given ketamine and subsequently experienced fewer symptoms. The team quickly got to work on a study, which was published in 2000 and found similar results.

The only problem with the study was that “no one cared,” Charney told ABC News.

That was not the case for the next study on ketamine’s effects on people with depression, which was sponsored by the National Institute of Mental Health. After it showed that patients with major depression benefited from two ketamine treatments a week apart from each other, doctors who didn’t have anything else to offer patients with severe depression began treatment with the drug.

Several other studies since then have also found success in treating depressed patients with ketamine. Most recently, Johnson & Johnson has developed a ketamine-based nasal spray called esketamine. On Feb. 12, an advisory committee at the FDA voted in favor of approving the nasal spray, an action that the FDA will decide on by March 4.

What is esketamine and what would it be used for?

Esketamine is a nasal spray derived from ketamine, a medication most commonly used to put people to sleep during an operation. Ketamine has also been given off-label intravenously to people with severe depression for over a decade now. Both physicians and patients have reported rapid improvement in their depression symptoms, sometimes within hours of taking their first dose, Charney said.

While Charney said it’s still unclear how the drug fights depression so well, he said it might involve restoring brain cell connections through totally different neurotransmitters than conventional antidepressants.

Charney said that based on his study of ketamine, side effects are generally mild, with the most common ones being dizziness, increased blood pressure, sleepiness, and dissociative symptoms (feelings of being “detached” from one’s surroundings). If esketamine is approved, Charney said that a ketamine nasal spray would have to be administered in a doctor’s office so that patients could be monitored.

Will it be approved?

Esketamine is currently undergoing human clinical trials, but preliminary data has been so promising that the FDA assembled that panel of experts to see if it should be made available to the public immediately. Dr. Charney is “very optimistic,” and that recent vote, 14 to 2 in favor, is also promising. They haven’t mentioned how much the treatment would cost, but if it’s FDA approved, it often means that insurance companies will begin to cover it.

Why is it controversial?

Ketamine is used for anesthesia, but it also has a reputation as a “club drug” that alters consciousness by distorting vision and sound as well as causing feelings of being detached from one’s environment.

That said, there is currently no evidence that people can become addicted to treatment doses of ketamine, which are much lower than they would be for recreational or anesthetic use. The longest study on its effects against depression show that it can be taken safely for up to a year, however, that’s only because the drug hasn’t been studied for a longer period of time. Charney said that it’s possible the drug could be used for longer than a year, but that patients could probably be tapered off of it over time or use it as a “bridge” while waiting for more conventional antidepressants to work. It is unclear at this time if patients will require ongoing, lifelong treatment, he said.

As a fierce supporter of using the drug’s in people with depression for almost 30 years, Charney is optimistic as he waits for the FDA to make a decision.

“For those patients who have had depression for years and have never responded to treatment,” he said, “there is now hope.”

Theresa Scott, DO, MS, is a pediatric resident and member of the ABC News Medical Unit.

Copyright © 2019, ABC Radio. All rights reserved.

‘Young blood’ treatments to stop aging, disease are a ‘significant public health concern’: FDA

toeytoey2530/iStock(NEW YORK) — It sounds like science fiction, but some companies are promoting the infusion of “young blood” into older people. Now, the Food and Drug Administration has gone on the record saying there is no evidence that these treatments have any effect on signs of aging or diseases, and it is warning people about getting transfusions from companies, calling them “unscrupulous actors.”

Start-up companies like Ambrosia have received a lot of attention for promises about the benefits of transfusing plasma from young donors (ages 16-25). It has claimed that the transfusions can combat memory loss from aging, Alzheimer’s disease, heart disease, multiple sclerosis and post-traumatic stress disorder.

FDA Commissioner Scott Gottlieb and Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release that they have “significant public health concerns about the promotion and use of plasma” for the aforementioned purposes.

Plasma is the clear, liquid part of blood that moves blood cells around the body. It is rich in proteins that help clot blood and fight infection. Currently, plasma transfusions are used in serious medical situations, such as traumas and bleeding disorders, but even in these cases, a transfusion carries the risk of complications, most notably new infections, allergic reactions, and lung injuries.

“There is no proven clinical benefit of infusion of plasma from young donors to cure, mitigate, treat, or prevent these conditions, and there are risks associated with the use of any plasma product,” they said in their statement.

Despite possible adverse reactions to another person’s plasma, Ambrosia, specifically, allowed people to purchase one unit of plasma for $8,000 directly from its homepage, without even going through a medical assessment or examination. The company noted that “checks and money wires are accepted” and “laboratory fees may be extra.” This service has since been removed after the FDA statement was released on Feb. 19.

Ambrosia did not respond to ABC News’ request for comment on Tuesday.

The FDA statement says there is no clinical evidence that infusions of young plasma are effective and there are no official regulations on dosing, frequency or recommended monitoring associated with the transfusion.

“Today, we’re alerting consumers and health care providers that treatments using plasma from young donors have not gone through the rigorous testing that the FDA normally requires in order to confirm the therapeutic benefit of a product and to ensure its safety,” the statement said. “As a result, the reported uses of these products should not be assumed to be safe or effective. We strongly discourage consumers from pursuing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight.”

“Simply put, we’re concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies,” the statement continued. “Such treatments have no proven clinical benefits for the uses for which these clinics are advertising them and are potentially harmful. There are reports of bad actors charging thousands of dollars for infusions that are unproven and not guided by evidence from adequate and well-controlled trials.”

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‘Zombie deer’ disease is spreading across the US: What you should know


(NEW YORK) — Is there such a thing as “zombie deer?” The answer is yes, and they may be your newest neighbors.

Since the first report of “zombie deer” about 50 years ago, sightings of the deer have spread to several parts of the United States, mostly because the cause of the disease has spread as well. “Zombie deer,” of course, have more to do with a fatal disease than with any kind of zombie flick.

What is ‘zombie deer’ disease?

“Zombie deer” disease, also known as chronic wasting disease, is a type of prion disease that affects deer, elk, and moose. Prions are small, abnormal, infectious proteins that cause proteins in the body to fold abnormally, especially in the brain and spinal cord. The disease gets more serious as it progresses, and it is always fatal.

“A lot of the concern [about chronic wasting disease] is based on something that occurred years ago,” Ryan Maddox, Ph.D., epidemiologist at the Centers for Disease Control and Prevention, told ABC News.

Maddox was referring to fears from another prion disease, “mad cow,” which was first found in England, where it spread to humans as the rare variant Creutzfeldt-Jakob disease. “Mad cow” disease is not what is affecting the deer.

Where can chronic wasting disease be found?

According to the CDC, this disease is present in at least 24 states in the United States and two provinces in Canada. Cases have also been reported in Norway, Finland and South Korea. Chronic wasting disease was first reported in Colorado in the late 1960s. Since then, the disease has spread to involve states in the Midwest, Southeast and east coast. There may be even more cases that we do not yet know about.

How is chronic wasting disease spread and how common is it?

Chronic wasting disease is spread between animals through direct contact with contaminated body tissue or fluids (blood, saliva, urine or feces), or through indirect contact with infected soil, water or food. Once introduced to an area, this disease can spread quickly among animals. Even after an infected animal dies, the risk of it spreading to other animals can last a long time. Although the overall rate of infection in deer, elk and moose across the country is low, infection rates may be as high as 10 to 25 percent in places where it is common.

What are signs of chronic wasting disease?

Animals with chronic wasting disease may not show it for several months to years. But slowly, signs of the disease may develop, including dramatic weight loss, impaired coordination, stumbling, drooling, excessive thirst or urination and aggression. Infected animals may also display a lack of fear of people and may be more out in the open, making them more susceptible to hunting.

Can chronic wasting disease spread to humans?

According to the CDC, there is no evidence that chronic wasting disease occurs in humans or that humans can even get infected. Current studies have also shown no evidence to support the possibility of it spreading to humans. However, one experiment showed that this disease can affect macaques, monkeys that have close genetic similarities to humans.

“There is concern about the potential for the disease to transmit to humans” said Maddox.

If the disease were able to spread to people, the most likely way would be through eating infected deer or elk, and many people eat these animals. In areas where the disease is common, the CDC recommends that hunters strongly consider testing the animals before eating their meat and/or checking with local wildlife or public health departments regarding their testing policies. If animal tests positive, meat from that animal should not be eaten.

Again, the disease, while deadly for animals, has not been known to infect humans. Regardless, proper precautions should be taken in areas where this disease is common.

Amrit K. Kamboj, MD, is an internal medicine resident and member of the ABC News Medical Unit.

Copyright © 2019, ABC Radio. All rights reserved.

New report recommends ways to prevent depression during pregnancy and postpartum for new moms

kieferpix/iStock(NEW YORK) — Perinatal depression – which affects women during pregnancy and up to a year after delivery – can be prevented with counseling, according to a new report.

The report from the U.S. Preventive Services Task Force (USPSTF) is a hopeful sign for women, one in seven of whom are affected by perinatal depression. Despite major medical organizations recommending screening for it over the past several years, half of all women in the U.S. remain undiagnosed and untreated, studies show.

The task force found that women who are at risk for depression (those with socioeconomic risk factors, a history of depression or current depressive symptoms) are most likely to benefit from counseling interventions, specifically cognitive behavioral therapy and interpersonal therapy.

Cognitive behavioral therapy (CBT) focuses on changing negative thinking patterns and changing behavioral patterns, according to the American Psychological Association (APA). Interpersonal therapy (IPT) works to improve relationships and social functioning through techniques like role-playing to help reduce distress.

The USPSTF found those two forms of counseling were more effective than other options for women like physical activity, dietary supplements and medicine. The counseling sessions could be done either one-on-one or in group settings.

The USPSTF’s report comes just two months after the American Academy of Pediatrics (AAP) issued a call for increased screenings of women for perinatal depression.

The AAP now recommends doctors screen mothers for depression once during pregnancy and again at each of their baby’s 1, 2, 4 and 6-month checkups. The organization also encourages pediatricians to identify community resources that can help mothers who screen positive for the condition.

Symptoms of perinatal depression include “loss of interest and energy, depressed mood, fluctuations in sleep or eating patterns, reduced ability to think or concentrate, feelings of worthlessness, and recurrent suicidal ideation,” according to the USPSTF.

Symptoms must be present for at least two weeks for the diagnosis. The task force stressed that receiving a diagnosis of perinatal depression is not the same as suffering from “baby blues,” or feelings of fatigue, crying and irritability that usually goes away 10 days or less after delivery.

Moms may want to keep a written diary or even document symptoms in a calendar on their smartphone so that they can discuss them with their doctor. Having a journal of how a patient is feeling helps with the diagnosis, experts say.

The task force singled out two counseling programs for women in its findings: the Mothers and Babies Program, which offers a cognitive behavioral therapy approach, and the Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program, which offers an interpersonal therapy approach.

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Antonio Brown, Steelers president, agree it is ‘time to move on’

Sports News Antonio Brown, Steelers president, agree it is 'time to move on' https://linewsradio.com/antonio-brown-steelers-president-agree-it-is-time-to-move-on/ http://abcnewsradioonline.com/sports-news/

iStock/Thinkstock(PITTSBURGH) — Pittsburgh Steelers wide receiver Antonio Brown, who has had nine wildly successful seasons with the organization, says he and the team have decided to “move on.”

Brown posted a picture with his arm around the shoulder of Steelers president, Art Rooney II, writing:

“we discussed a lot of things and we cleared the air on several issues! We both agreed that it is time to move on but I’ll always have appreciation and gratitude towards the Rooney family and @steelers organization!”

ESPN NFL Insider Adam Schefter reported
that after the meeting, a source told him “everyone agreed the trade will be for the best.”

The tweet comes after Brown publicly requested a trade in January. He then posted an Instagram video in which he said he will not play without more guaranteed money, reinforcing his desire for a trade.

ESPN reports Brown has no guarantees left on his current five-year-deal with the Steelers, which he signed in 2017. Rooney previously stated he wanted to meet with Brown to “clear the air.”

Brown publicly put pressure on the Steelers to trade him on several occasions. He thanked fans and fielded questions on Twitter, saying quarterback Ben Roethlisberger has an “owner mentality,” and criticized head coach Mike Tomlin.

Brown holds an NFL-record six consecutive seasons with 100 or more catches. He has led the league in receiving yards and receptions twice.

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Posted On 19 Feb 2019

Manny Machado reaches deal to join San Diego Padres

Sports News Manny Machado reaches deal to join San Diego Padres https://linewsradio.com/manny-machado-reaches-deal-to-join-san-diego-padres/ http://abcnewsradioonline.com/sports-news/

Willard/iStock(NEW YORK) — ESPN reports Manny Machado, regarded as one of the top free agents in all of baseball this offseason, has reached a record deal to join the San Diego Padres. The contract is the biggest in American sports history, worth $300 million over ten years.

Machado split time with the Baltimore Orioles and Los Angeles Dodgers in 2018, hitting .297/.367/.538 with 37 home runs and 107 RBI. The 26-year-old was traded to Los Angeles ahead of last season’s trade deadline in a blockbuster transaction.

He had many big moments for the Dodgers and helped lift the team to a World Series appearance, but drew harsh criticism from fans and the media about hustling. He told Fox Sports during the 2018 postseason, after being chastised for not running full speed down to first base on plays, that hustling was “not my cup of tea.”

Machado is a four-time All-Star and two-time Gold Glove Award winner at third base, though his preferred position is shortstop.

The 26-year-old former top draft pick played five full seasons in Baltimore before last year’s trade. He is the second high profile free agent to join the Padres in the past two winters, joining first baseman Eric Hosmer, who agreed to an eight-year, $144 million contract last year.

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Posted On 19 Feb 2019

Hank Sheinkopf of Sheinkopf Communications LIVE on LI in the AM w/ Jay Oliver!


Posted On 19 Feb 2019