Monthly Archives: May 2020

If you think this can help you, Austin Wolff said earnestly into the camera, its worth a shot .It can only help.

Wolff was speaking on a YouTube video produced for the Novus Center, a Studio City business run by his mother, Stephanie, selling stem cell-related products said to treat chronic pain, sexual performance issues and the effects of aging.

In recent weeks, Novus has begun directing its pitch at potential customers fearful about the effects of the novel coronavirus, implying that its stem cell exosome vapor the supplies for which can be shipped overnight to customers homes can improve lung strength, the immune system and ward off viruses and disease. (Exosomes are a form of cellular secretion.)

These are opportunistic businesses, and COVID-19 for them is an opportunity.

Novus videos bristle with formal disclaimers. Its not going to cure anything, Austin Wolff says on one video. You should only do this if you want to try it.

But the videos seem aimed at viewers desperate for any possible defense against a pandemic whose implacable spread seem to grow more frightening with every passing day.

Novus charges $10,000 for the shipment of vials containing the exosomes and nebulizing equipment. Stephanie Wolff says the business, which has been open for four years, has served about a dozen customers worried about COVID-19 in the last month or two.

Promoters of untested and unlicensed stem cell treatments have jumped into the coronavirus market with both feet, says Leigh Turner, a bioethicist at the University of Minnesota who has been tracking the spread of clinics pitching these treatments to consumers for years.

The direct-to-consumer clinics have pivoted their marketing message to treating or preventing COVID-19, Turner told me. Thats not really shocking, in a way; these are opportunistic businesses, and COVID-19 for them is an opportunity.

In a paper scheduled to be published shortly in the prestigious journal Cell Stem Cell, Turner examines how these businesses are preying on public fears and anxieties about the pandemic.

Typically, their claims fall short of actually promising cures or even specific treatments; that holds at bay the Food and Drug Administration, which has sought to shut down clinics offering unproven therapies for conditions such as Alzheimers, diabetes, multiple sclerosis and erectile dysfunction.

Some use the language of immune booster or preventive intervention, Turner says. Theyre not trying to treat somebody whos in an ICU bed. Its more the worried well theyre going after people who are anxious, fearful of the pandemic, and susceptible to claims that a stem cell procedure will reduce their chance of becoming infected.

These treatments can come with a healthy price tag, ranging hundreds to thousands of dollars. But they run up against one indisputable fact: There are no approved stem cell treatments for COVID-19.

Those are the words of Martin F. Pera, a leading stem cell researcher who is editor-in-chief of Stem Cell Reports, the open-access journal of the International Society for Stem Cell Research. The society issued a stern warning March 6 against claims that stem cells can be used to treat people infected with COVID-19.

As for the products sold by Novus, the FDA warned consumers in December that there are currently no FDA-approved exosome products. The agency stated that certain clinics across the country offering such products to patients deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions.

Weve reported for years on the proliferation of clinics selling purported therapies based on stem cell injections costing as much as $15,000 each.

These treatments arent supported by scientific research, typically arent covered by insurance, and have been targets of an FDA crackdown. (Turner did groundbreaking work with UC Davis biologist Paul Knoepfler in 2016, sounding the alarm about the spread of these clinics.)

In early April, the FDA sent letters to two stem cell firms, Dynamic Stem Cell Therapy of Henderson, Nev., and Kimera Labs of Miramar, Fla., that it said had been marketing their products for the treatment or prevention of COVID-19 and warning them that any such products would have to meet regulatory standards for drugs. But the agency didnt explicitly threaten them with legal consequences. Kimera is the supplier of exosomes to Novus.

Frightened laypersons arent the only targets of claims for cellular treatments for COVID-19. So are decision-makers and government regulators.

The FDA came under fire in March when it issued an emergency use authorization to allow the prescribing of two antimalarial drugs, chloroquine and hydroxychloroquine, for COVID-19 patients. The action came after President Trump had been relentlessly promoting the drugs as potential game changers in the battle against COVID-19.

Less than a month later, the FDA issued a warning against using the drugs against COVID-19 because of reports of serious heart problems in COVID-19 patients who had taken them, as well as the absence of evidence that they were safe and effective for treating the disease.

It wouldnt be surprising to see more companies and clinics showing up in the media and on cable television hawking unsubstantiated stem cell treatments for COVID-19. On May 4, the San Diego stem cell firm Giostar issued a news release asserting that it had received approval for a COVID-19 clinical trial using stem cells to treat COVID-19 patients, under the approval of the United States Food and Drug Administration (FDA) expanded access for compassionate use program.

Is this plausible? Weve reported before that Giostar had made untrue claims about its scientific connections: Several legitimate stem cell scientists the firm listed as members of its scientific advisory board said they had no connection with Giostar and had repeatedly asked that their names be removed from its website. The company has also acknowledged that it had exaggerated the professional credentials of its co-founder and chairman, Anand Srivastava.

Giostars claim in its news release that it would conduct the clinical trial under the FDAs expanded access for compassionate use program is curious. That program, which allows doctors to prescribe unapproved drugs as a last resort for people suffering from life-threatening diseases with no established cure, covers patients for whom enrollment in a clinical trial is not possible.

In other words, there doesnt seem to be such a thing as a clinical trial conducted subject to the expanded access program.

Giostar didnt respond to our request for comment. The FDA would say only that it generally cannot disclose information about an unapproved application, which certainly suggests that Giostar hasnt won the approval it claims.

In the frenzied search for COVID-19 treatments, it may be difficult to distinguish promising efforts from those just grasping at the main chance.

What we have right now is a COVID-19 gold rush, Turner says. Businesses are seeing this as a terrific opportunity to get their applications for investigative new drug trials approved by the FDA a process that can take years and generally requires the submission of extensive evidence from lab and animal studies.

The direct-to-consumer pitches by clinics reviewed in Turners paper typically fuse pseudoscience, which is what theyre offering, with more credible forms of science. He found numerous references in these pitches to research from China, often of doubtful scientific significance.

A Pennsylvania clinic offering stem cell treatment to support lung health during COVID-19, for example, cited a report from a Beijing hospital where seven patients were injected with stem cells all saw significant improvement in COVID-19 related pneumonia, according to the clinics press news . It quoted its CEO stating, This goes to support the wide range of healing and restoration that can be provided by (stem cell) therapy.

However, as Turner observes, the report didnt specify the severity of the subjects pneumonia, the source of the stem cells, or results from a control group. At best you can say that no one seemed to be harmed, but its hard to draw any firm conclusions about efficacy.

The Novus Center hangs its pitch on what Stephanie Wolff describes as a study thats ongoing in China right now using exosomes to help with viral load, to help with inflammation of the lung, to help with pneumonia, to help with infection.

The reference, however, is to a clinical trial in Wuhan that had not even begun to recruit test subjects at the time of its latest public report, which is dated Feb. 25. The researchers didnt expect their trial to be completed until July 31.

As weve written before, the proliferation of stem cell clinics selling untested and unlicensed therapies has been a public health crisis for years. The COVID-19 pandemic will only deepen the crisis as clinics add the coronavirus to their menu of treatment claims.

Despite its crackdown campaign, the FDA has never taken strong enough action against this corner of the healthcare industry. It should act without delay to shut down opportunistic initiatives, or more innocent Americans will find their health, and their pocketbooks, at ever greater risk.

2020 Los Angeles Times

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Distributed by Tribune Content Agency, LLC.

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Michael Hiltzik: Don't be taken in by stem cell firms offering unsubstantiated therapies for COVID-19 - Rome News-Tribune

The revival of Company was in previews and 10 days from opening when Broadway shut down. And opening night was meant to be especially special, timed to the 90th birthday of the musicals composer Stephen Sondheim. Soon after, the shows director, Marianne Elliott, returned to her husband and producing partner, Nick Sidi, and their daughter in London, while one of its stars, Patti LuPone, headed to the Connecticut home she shares with her husband, Matthew Johnston, and their son.

Prompted by The New York Times, they agreed to share their email exchanges during those first weeks, a conversation that touched on plans for the show and for Elliott & Harper, its production company (optimistic); their respective nations leaders (pessimistic); a former colleagues health (worrisome); and how family, friends and members of the current cast, including Katrina Lenk, were keeping in touch (Zoom parties). An edited selection of their emails follows, with Elliott kicking things off the day after the canceled opening night.

My dear friend,

Its amazing, isnt it, how ones life is now recalibrated. All things I took for granted are now long-lost treasures.

Ive been clearing everything in this house, ready for God knows what, but its easier than sitting at a desk and doing concentrated work. I like a pair of yellow rubber gloves, and I love to throw things into the rubbish heap. So theres truly satisfaction of sorts here. And it channels my energies. But it also means Ive been going through old drawers of long-kept items or piles of faded photos even from my 20s and looking at how young and happy we looked.

I had to throw out Eves school uniform the other day. As she had her last day of school on Friday. Shes been there since she was four! I found myself burying my head and sobbing into an old skirt of hers. That uniform that always went missing, nobody liked, was thrown into heaps every day as she entered the house, that never seemed very durable, was usually hitched way too high up her legs, and was far too expensive for its own good. And yet there I was, crying over it as though it was born from my very own limbs.

Yesterday was tough, wasnt it? Im truly not sentimental about shows, and certainly not about opening nights because they are usually so pressurized about other things. But I really, really, and, yes, really missed ours yesterday. It felt like a huge hole. And all that publicity for Sondheims birthday was wonderful on one level, but kind of bleak on another, because Elliott & Harper had been working so hard to make sure we could be open on that very day, with Steve with us all celebrating!

However, the sun is shining here in England. So Im feeling hopeful.

Nick and [co-producer] Chris are working like buzzing bees, trying to decipher what is to happen to our work force, our employees, our future shows, most of which are probably going by the wayside. Though we are fighting tooth and nail to keep our staff. The government is offering help, but its vague how much and when. Its hard not to catastrophize when you hear some of the stories out there. Some being very gloomy about the future of theater at all.

But the one thing we all agree on, and that we all KNOW, is that by hook or by crook Company is coming back! We need it, we love it, the theater community needs it, and New York needs its story. Theater has always been and will always be vital. We humans are creatures that survive as a togetherness. And we need stories to make sense of things.

I look forward to that moment with all of my being. And I look forward to being in a room with you again Patti, to be sharing a G & T and to be screaming with laughter over some silly thing or other.

It seems far away now, but its only round the corner really!

Until then

Keep bleaching!

Love you so much

Girl!

That was quite a missive. You put down the rubber gloves and wrote a monologue!

Its so wacky and disjointed and at the same time kind of wonderful to be home with our loved ones and really grasping time. Whoever has the time to really understand time in the fullness of the word? My problem is structure. I want to be very disciplined, but I cant figure out how to structure the time. Im cleaning house like you, but I do that a lot. Im the Delete Queen. I actually threw out the elusive, desperately needed mask only a month ago. I have no idea why I had a box of them, but I looked at them and tossed them in the bin. Well done, Patti! Now I go to the market looking like a madwoman with scarves wrapped around my nose and mouth with fogged-up glasses.

I wonder if well come back. The uncertainty is the killer. I went through the polio scare, but there was a plan in place! I can still see the vaccination administered in my arm in the gymnasium of the elementary school. We had to suck on pink sugar cubes or Im making the whole thing up.

I think about you every day. Stay safe, healthy, warm, and know you are LOVED by so many of us.

XOXOXOXOXO

Hi P,

Gosh, it was good to see your face last night. And everyones. Poignant too, because you all felt so near via Zoom, and yet, you werent!

What a bunch of gorgeous people, our cast of Company. And how bonded we all seem. Now more than ever. Everyone cheery and happy to be connected again. It was three weeks to the day of our last performance, did you know that? Feels more like three years, doesnt it?

But the quirks that everyone displayed in just their little close-ups: Jen [Simard] and her gratefulness, Etai [Benson] with his dry humor, Matt [Doyle] recovering from Covid but actually looking more like George Michael every day, Chris [Sieber] dressed up in his beautiful blazer for our cocktail party, Chris [Fitzgerald] with his sons Trump impressions. Amazing.

And then there was you, dancing at the jukebox. Oh, and then mooning at us all! Brilliant. Not a dry eye in the house! You were always the very soul of the party and Zoom, Im so happy to learn, has lessened none of that!

By the way, have you got Judy Garlands Life is Just a Bowl of Cherries on that old jukebox? I was listening to it this morning (regarding another project I might do when and if I ever get out of this house!), and I thought Id love to hear you sing it! Go on give me a rendition. Your Twitter feed would go mad!!

I heard, two days ago, of a good friend of mine in dire straits in a New Jersey hospital. Hes been there a few weeks. Still on a ventilator. That made my head spin, and I took myself to bed and started visualizing him well and happy and going for dinner and a good big drink, of course, with me in some packed restaurant in the future.

I feel pretty lucky, though. Were safe and together here in the house. My sister had it pretty bad (and did get the test), but shes bounced right back. But I feel sorry for Eve, my teenager, the most. I think shes picking up more than she shows actually. But she mostly doesnt watch the news. Who can blame her?

However, shes getting Nick and I doing Tic Tok (Im too old to know the right blinking spelling) challenges to our neighbors across the road. Ill learn to body-pop yet!!

Im trying to run most days, while were still allowed. And I do a Pilates session and arm exercises (with lots of serious swearing I turn the air blue!) most days too. I tell you, I shall come out of this looking young and beautiful and with incredibly sculpted arms. And watch me wear that opening night dress! Come on!

Keep safe my lovely friend,

And Ill see you on the other side!

Meantime, heres a photo of you and Katrina in our show. Glorious!

PS: How is that Katrina STILL looks beautiful on Zoom and with no [expletive] make up!!?! Ugh.

M

The Zoom cocktail party left me drunk on my ass. Matt said I was shout-singing Blue Moon in bed. I think its just the release. Our collective energy shot through those funny little boxes.

We are all doing our best to be positive, mentally and emotionally. I think, I hope, we find a way to blow back all the negative energy in the world. This reset is good. Its forcing us to slow down, reflect, look out and see, really see, whats in front of us. Im continually fascinated with the birds, squirrels and chipmunks at our bird feeder. The birds are singing and nesting, the squirrels are demanding more peanuts. Theyre so bold as to come to the door, raise up on their hind legs, peer in the glass imploring Farmer Matt to FEED ME!

I feel for Eve. For all the youth in the world. What have we left them?

Im trying to remember 16 years old, in my high school on Long Island. There were those of us in the music department in joyous harmony with our teachers, our various choruses, our instruments, our summer band retreat with a high school from another county (a different set of boys in my case ). We were the outcasts, the oddballs, the bohemians.

Ill bet that division still exists. Its prevalent in our society as adults. The arts are superfluous. I am always made to feel like a third-class citizen in this country. They are NOT superfluous. They are an inherent human right. Games and storytelling have been our lifes force for as long as theyve been writing on walls. Eve will have a story to tell, a story shell tell her children who I hope will have a more peaceful Mother Earth.

We must get rid of the current politicians on both sides of the Atlantic. We are stuck with a clown and his clown car of clowns. And while Im raging, there has to be term limits for Supreme and federal court judges, the generals in the war room and Broadway musicals.

Sending you dear friend BIG LOVE.

Your pal, Patti

Hi P!

That article you sent from the NY Times was amazing: Come Back, New York, All Is Forgiven. Thank you. It sums up just exactly what I feel about that splendid city. It made me grieve for that beautiful volcano of craziness and brilliance. Well now, what to report in this weird cave of an existence over here?

Boris Johnson seems to be out of hospital. But dont ask me whos running the country. Our press conferences sort of lack a leader and a driver. They are dry, boring, staid affairs. And the same things get repeated and repeated: Not enough tests! Not enough protective equipment for our health workers! It kind of drives you mad after a while.

My friend who has been on a ventilator for nearly four weeks now is part of a very new drug trial, Pluristem. Hes just gone on it, and hes making the news! The new drug is a sort of stem-cell therapy. It comes from placentas! Can you believe it?

Hes doing well! Its literally Day Two on the drug, but he had a few hours yesterday off the ventilator and breathing himself! Im praying. Every time I go jogging, I fill my lungs as I run, as though I was teaching him how to breathe again. I dunno. Anything. Im trying anything. Ridiculous, but what can you do?

We still watch movies most nights, which is highly educational for all of us! And we look forward to it each day. Although we realized the other night that the dog had pissed on the sofa. It slowly started to seep into Nicks trousers during Whats Eating Gilbert Grape. In the morning I took the cushions outside to properly clean and realized that clearly the dog had been using the sofa as a toilet for some time. It was full of stains! I wonder, if there had been no quarantine, we would have EVER discovered this?

So maybe this is a metaphor for unearthing what was always beneath the surface? Well all emerge from this cleansed and illuminated. Ha! Or Im just looking for meaning and stories in every little thing? Directing and analyzing the text as ever!

Dearest Marianne,

I just reread your email. You are eternal sunshine. Im a black cloud. Its harder and harder to maintain equilibrium.

Im loving Madame Bovary, but I find my mind scanning, not absorbing, Lydia Daviss beautiful translation (a quarantine gift from my dear friend Jeffrey Lane. When you return you must come to Salon de Jeff. Hes a monster cook, and his dinner parties are Bacchanalian events.)

I cant watch any more videos, because its just too late at night, even though its only 8 p.m. The daytime seems to slip through my fingers, and Ive done next to nothing. I dont mean for this to sound like a bitch fest. I think Im verbalizing my anxiety. Im sorry.

The one great treasure for me is being somewhere to really experience the blossoming of spring. The birds are in full cacophony, occasionally full harmony. The squirrels are demanding and trusting. The bear woke up and destroyed our bird feeder. Its all glorious nature. Virus? What virus?

Its Sunday. What will I do? I think I shall drive to Farmer Randy, get the best eggs in the Western Hemisphere and attempt a souffl. I had a moral dilemma. Randy is a BIG TIME Trump supporter. There were signs all over his barn. What to do? Boycott his eggs? I just couldnt. Theyre too damn delicious.

Its time for me to get out of bed. I wake up early, very early. Ill attempt to change my attitude today and make something of myself. But what will it end up being? A restless, unfocused energy? Or maybe a pensive, dreamy organism? Or maybe a housewife dusting?

Dear pal o mine, I wish you sanity, safety, health and peace.

Your loving friend,

OXP

Hi Patti,

I have to tell you that my friend, the one that was on the ventilator for FIVE weeks, has made an amazing recovery. You may know him, Eddie Pierce? He codesigned my set of Angels in America on Broadway. Such an amazing guy and so talented. Younger than me and no complicated health circumstances that I know of. Anyway, hed been through so much in hospital, was sedated most of the time, caught other infections while in hospital, and they even thought at one time that hed had a stroke! It was not looking good, P.

Well, he came home yesterday! His wife sent a video of him leaving the hospital. With all the staff, standing in awe, clapping as he left the front entrance, and his children running to hug him. Then there was another video of his friends welcoming him arriving at the house. It was incredible. They had gathered in their cars, in a nearby parking lot, and then PROCESSED together down his street, honking their horns. They couldnt get out, obviously, so they held out huge, homemade, colored signs to be read as they passed. Some had painted their cars, some had got dressed up in fancy dress, some stood on their car doors. It was like watching a carnival.

Hell need a bit of physio, but otherwise hes totally on the mend. Seems like a miracle. Things that you cant believe can ever come about can indeed occur. Keep the faith.

Read the original here:
The Shows Delayed, but Theyre Still Keeping Company - The New York Times