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Patients With Hard-To-Treat Depression, A New Drug ‘Special K’ At Rescue

Depression is among the leading causes of disability in the U.S. and is being closely monitored by health authorities amid rising suicides nationwide.

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Depression
A vial of ketamine, which is normally stored in a locked cabinet, is seen in Chicago, July 25, 2018. VOA

A mind-altering medication related to the club drug Special K won U.S. approval Tuesday for patients with hard-to-treat depression, the first in a series of long-overlooked substances being reconsidered for severe forms of mental illness.

The nasal spray from Johnson & Johnson is a chemical cousin of ketamine, which has been used for decades as a powerful anesthetic to prepare patients for surgery. In the 1990s, the medication was adopted as a party drug by the underground rave culture due to its ability to produce psychedelic, out-of-body experiences. More recently, some doctors have given ketamine to people with depression without formal FDA approval.

The Food and Drug Administration approved Spravato as a fast-acting treatment for patients who have failed to find relief with at least two antidepressants. Up to 7.4 million American adults suffer from so-called treatment-resistant depression, which heightens the risk of suicide, hospitalization and other serious harm, according to the FDA.

The drug will cost between $590 and $885 depending on the dosage and before various insurance discounts and rebates.

There have been no major pharmaceutical innovations for depression since the launch of Prozac and related antidepressants in the late 1980s. Those drugs target the feel-good brain chemical serotonin, and can take weeks or months to kick in.

Ketamine and J&J’s version work differently than those drugs, targeting a chemical called glutamate that is thought to restore brain connections that help relieve depression.

When the drug works, its effect is almost immediate. That speed “is a huge thing because depressed patients are very disabled and suffer enormously,” said Dr. John Mann, a psychiatrist and researcher at Columbia University. If the drug doesn’t work, physicians can quickly switch to other options, he noted.

The FDA approved Spravato, known chemically as esketamine, based on study results that showed patients taking the drug experienced a bigger improvement in their depression levels than patients taking a sham treatment, when measured with a psychiatric questionnaire.

The drug is designed to be lower-dose and easier to use than ketamine, which is normally given as an intravenous infusion.

Robin Prothro, 60, began taking antidepressants more than 20 years ago. But she says none of the five medications she tried relieved the depression that has stymied her personal and professional life.

Since enrolling in a Spravato trial two years ago, Prothro says her depression has lifted and she’s returned to hobbies she abandoned years ago, like gardening.

She takes the drug every two weeks at her psychiatrist’s office while reclining in a comfortable chair.

“You can feel it coming on, it’s a strong drug,” she said, describing colors and shapes that drift before her eyes. “I just let the drug work. I close my eyes and my mind is amazingly quiet.”

Psychedelics reconsidered

The ketamine-like drug is the first of several psychoactive substances making their way through the U.S. regulatory process as physicians search further afield for new therapies. Researchers are conducting late-stage trials of psilocybin, the active ingredient in magic mushrooms, and MDMA, a euphoria-inducing club drug, as potential treatments for depression and post-traumatic stress disorder.

Lauren Pestikas sits as she receives an infusion of the drug ketamine during a 45-minute session at an outpatient clinic in Chicago, July 25, 2018.
Lauren Pestikas sits as she receives an infusion of the drug ketamine during a 45-minute session at an outpatient clinic in Chicago, July 25, 2018. VOA

“Substantially different agents are only rarely appearing from pharmaceutical companies or other laboratories,” said Dr. Paul Summergrad, a psychiatrist at Tufts University. “That’s prompting people to investigate other compounds.”

Unlike ketamine, psilocybin and MDMA have no legal medical use. Classified in the same category as heroin and LSD, they are tightly restricted by the federal government. But the FDA’s approval of esketamine could smooth their path.

Burden of depression

Depression is among the leading causes of disability in the U.S. and is being closely monitored by health authorities amid rising suicides nationwide. In 2017, the U.S. suicide rate rose to 14 deaths per 100,000 people, the highest rate in at least 50 years, according to federal records.

Government officials haven’t suggested an explanation for the trend, though academic researchers point to the nation’s widening income gap, financial struggles and divisive politics.

J&J’s drug will be subject to a number of restrictions due to its abuse potential, side effects and lingering safety questions.

The drug will only be given by accredited specialists who must monitor patients for at least two hours after administration, due to its trippy, disorienting effects. Additionally, all patients will be tracked in a registry to monitor long-term safety and effectiveness.

The immediate impact of ketamine is thought to last just four to seven days and there’s no consensus yet on how long patients can benefit from ongoing treatment.

sad
Depression is among the leading causes of disability in the U.S. and is being closely monitored by health authorities amid rising suicides nationwide. Pixabay

Still, there are few other options for patients who fail to respond to antidepressants. The most effective treatment in such cases, electroshock therapy, requires patients to be fully sedated and can cause persistent memory loss.

Wall Street has high expectations for J&J’s medication, with analysts predicting more than $600 million in annual sales by 2022. But J&J will face competition in the marketplace.

A decades-old drug, ketamine is already used off-label to treat depression by some doctors. At least 150 clinics around the U.S. provide treatment with various forms of the drug, which is available as a low-cost generic. Patients often pay hundreds or thousands of dollars for intravenous infusions of the drug over several weeks or months. Such therapies are generally not covered by insurance because they haven’t been approved as safe and effective by FDA regulators.

Also Read: Hospital in Jordan Gives War Victims New Hope, Develops 3D-printed Prosthetics for War Victims

Some doctors plan to offer both ketamine and the new J&J drug.

Dr. Steve Levine says having FDA-approved standards for dosing and administering the new drug should raise standards in the field and drive out some of the bad actors who are not qualified to treat depression.

“This is going to bring in some standards, regulation and it’s going to make it safer and more accessible to patients,” said Levine, who serves as vice president of the American Society of Ketamine Physicians, a group representing doctors, nurses and others using ketamine for treating depression or other non-approved uses. (VOA)

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Story Of Pakistani Immigrant Who Came To U.S. Helps Feed The Homeless

“I have a deep interest in social justice, Catholic social teaching … and so to be part of something bigger than myself, my son and I chose to come to lunch here today to support and be a small part of a great thing."

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Food
Sakina Halal Grill serves a hot luncheon buffet to paying as well as non-paying guests. (J.Taboh) VOA

When Pakistani immigrant Kazi Mannan came to the U.S. in 1996 as an impoverished young adult, he could only dream about success. He worked long hours in a series of tough jobs, saved money and learned everything he could about working and living in America.

His hard work paid off. After more than 20 years, he’s now a successful entrepreneur and owner of a popular Pakistani-Indian restaurant just a few blocks from the White House.

But what’s most remarkable about his story is what he’s doing in his restaurant every day.

Kazi Mannan speaks with two of his regular homeless guests at his restaurant, which welcomes paying and non-paying customers. (J. Taboh/VOA)
Kazi Mannan speaks with two of his regular homeless guests at his restaurant, which welcomes paying and non-paying customers. (J. Taboh) . VOA

Mannan offers free meals to the homeless and anyone else in need.

Paying it forward

He says it’s his way of heeding the principles of his Muslim faith.

“I know God is happy with me, what I do, because I do it with my pure heart, with my pure intention, to uplift others without seeking any reward, any recognition,” he says. “I don’t need any awards, I don’t need any money. I just want to please Him.”

Mannan helps the needy he says, because growing up poor in Pakistan, he knows what it’s like to be hungry.

“I have nine siblings and [we didn’t have] much to eat … when you are poor and you [don’t] have things that other people have, when you get it, you want to appreciate, you want to share with others,” he said.

His desire to share deepened as he worked as a limousine driver in the nation’s capital. He saw homeless people on the street, day and night, in all kinds of weather — looking for food in trash cans.

The experience had an impact.

“I don’t want to see another human being going through the poverty that I went through. I don’t want to see another human being going through the hunger that I went through. I want them to have that feeling that they were being accepted, so they can come and sit here and eat with respect,” he says.

Just like family

His message is simple. Come to Sakina Halal Grill, which is named after his late mother, ask for food, use the restroom, and sit for as long as you want.

“We will love you and respect you the same way we respect a paying guest. We will treat you like family,” he said.

Members of the homeless community are welcome at Sakina Halal Grill restaurant anytime for a free meal. (J. Taboh/VOA)
Members of the homeless community are welcome at Sakina Halal Grill restaurant anytime for a free meal. (J. Taboh). VOA

Marchellor Lesueur, who is homeless, has been coming to the restaurant every day for the past eight months.

“I think that he’s a saint. He’s a beautiful man,” he says about Mannan. “My stomach was growling, I was looking for a blessing, then he popped up, gave me a card and invited me to a restaurant for lunch. And I was so overwhelmed and happy I couldn’t wait to get here, and ever since then I’ve been coming.”

Hegehiah Griakley is also a regular. He was finishing up a generous portion of rice and chicken, which he described as two meals in one.

“This is more than lunch,” he said. “They give you enough to feed you for the rest of the day I think. The food is great, the people are nice. I wouldn’t mind working here!”

Griakley says he once asked Mannan what he could give him in return for the free food. “Because most people expect you to give back.”

“But he said ‘no, no, no, no, no!’ He just wanted me to have a good meal,” he recalls. “I couldn’t believe that. It was so nice. I loved it.”

Compassionate immigrant

Mannan estimates that he’s provided more than 80,000 free meals since the restaurant opened in 2013.

And when he’s not feeding the needy in his restaurant, Mannan delivers meals to local shelters and churches, and organizes food and clothing drives at nearby parks.

Kazi Mannan distributes food to the needy at a local food and coat drive -- one of many he organizes every year. (K.Mannan)
Kazi Mannan distributes food to the needy at a local food and coat drive — one of many he organizes every year. (K.Mannan). VOA

“Some people tell me ‘homeless people are using drugs and you’re feeding them; that’s bad.’” To which he responds, “For you, it’s bad, for me, it’s joy. … I see a person who’s fallen to the ground. Whatever problem they went through to become homeless, it’s not my job to judge — my job is to give them respect and love.”

His paying customers are still his main business. Many of them contribute towards the free meals… and support his cause.

First time customer Geralyn Nathe-Evans was visiting from Minnesota when she read about Mannan’s mission in an article.

“I have a deep interest in social justice, Catholic social teaching … and so to be part of something bigger than myself, my son and I chose to come to lunch here today to support and be a small part of a great thing,” she said.

Mannan uses food as a way to help his fellow man, in practice of his faith. He urges others to do the same with their talents.

“If you’re a medical doctor, can you love him through your practice? If you are a lawyer, can you love him through your practice? Be kind and be compassionate to your client?” he asks.

In doing so, he believes “we will all prosper and flourish” as a society.

Also Read: Apple Watch Can Detect And Notify Users Irregular Heart Rhythms

Meantime, he says he will continue to nourish both body and soul of all who walk through the door of his restaurant.

“Just uplifting others is a joy for me. It doesn’t matter [what] color, religion you belong to. We are all human. I am focusing on humanity. I’m bringing humanity together and this is my mission.” (VOA)