The family of a 34-year-old father in a 2-week coma with COVID-19 says a 'bureaucratic glitch' has kept him from accessing potentially life-saving treatment

• Michael Goldsmith, a 34-year-old husband, dad, and IT professional in New Jersey, has been on a respirator and in a medically induced coma from COVID-19 for two weeks.
• His doctors first said he'd be able to try remdesivir, a drug the World Health organization has called the "most promising" treatment for the disease, under a compassionate use program.
• But the pharmaceutical company that makes remdesivir, Gilead, pulled back that program right before Goldsmith was sick enough to qualify.
• Doctors thought they could get him on the drug through Gilead's new program, but ultimately Gilead denied him the drug that way too due to what can only be understood as a beurocratic glitch.
• The family continues to advocate, and pray, for Gilead to give Goldsmith and other patients in his shoes what could be his only chance to recover.
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Every Friday afternoon, without fail, Michael Goldsmith calls his grandmother-in-law just to check in.

But today, April 3, will be the third in a row that the 34-year-old IT professional, husband, and father of two in Bergenfield, New Jersey, doesn't ring.

He's been in a medically-induced coma and on a respirator since Friday, March 20, due to COVID-19, which prior to his hospital stay left the "big, powerful, strong" man so winded he could barely speak when he was on the phone to his cardiologist father-in-law, Dr. Jack Stroh.

"He told me just walking to the bathroom he was short of breath," Stroh told Business Insider.

Now Goldsmith is not only unable to speak to his family, but the family's best hope for his recovery -an experimental antiviral drug called remdesivir - has been dangled, and retracted, from their reach due to what they see as an ironic lack of compassion and bureaucratic red type from the drug company, Gilead.

Business Insider talked to Stroh about the family's journey so far, and their ongoing battle against Gilead. If Goldsmith could talk, Stroh said, he would encourage just that.

"He would say, 'keep fighting,' which we are; we're not resting," Stroh said. "And he would also show concern for all the other people that are in the same boat. We didn't start the fight to try to get medication for one person. We started that fight to try to right the wrong."

Goldsmith's sickness progressed a day too slowly to get remdesivir under compassionate use

After Goldsmith came down with a fever and dizziness on March 11, Stroh advised him to go to his nearest hospital, Hackensack University Medical Center.

After staying several days to get treatment for dehydration, clinicians tested him for COVID-19 just in case, which by March 16 came back positive. "He got sent down to the basement for quarantine," said Stroh, who thinks Goldsmith may have picked up the virus at a social gathering after prayer.

That breathless phone call came two days later, March 18, and Goldsmith's wife, Elana, took him back to the hospital. He was treated with several therapies including the malaria drug hydroxychloroquine and antibiotics.

By March 19, Goldsmith had pneumonia and doctors prepared to put him on respirator, which they did Friday morning, March 20.

"I spoke to Michael just a few minutes before they put him on the machine," Stroh said. The family felt "horrible," he added, "but we were hopeful because his physicians were telling us there should be no problem applying for this life-saving medication or that he would get it."

The WHO has called remdesivir has been called the 'most promising' candidate therapy

That life-saving medication was remdesivir, a drug the World Health Organization has called "the most promising" potential coronavirus treatment. The antiviral was shown to be safe, though not entirely effective, in Ebola patients, and research in test tubes and monkeys suggest it may help fight COVID-19.

The first known person with COVID-19 in the US also began to improve the day after receiving remdesivir, Business Insider previously reported.

But the drug has not yet proven to be safe and effective against COVID-19 in clinical trials, and so the only way to access it is by enrolling in such a trial, some led by Gilead, or through a "compassionate use" program, which loosens restrictions on drug access when other treatment options aren't available.

At Hackensack, a study center for the medication, plenty of patients were already on the drug there under compassionate use, Stroh said. Goldsmith's doctors had even prepped the application prior to putting him on the respirator to waste no time.

Little did they know that over at Gilead, the compassionate use program was being revoked at precisely the same time.

"Who knew that if they intubated him that [Thursday] night, he would have gotten the remdesivir under compassionate use?" Stroh said. "But because he wasn't quite sick enough until Friday morning, he missed the boat."

After being told Goldsmith could enroll in a new program to access the drug, that option was rescinded too

Goldsmith's physicians, who, along with the whole hospital staff, has been "unbelievably great throughout this whole thing," Stroh said, quickly implemented plan B: Contact Gilead and ask if Goldsmith could access the drug as part of its new "expanded access" program that's mostly replacing compassionate use.

Gilead said yes - if Goldsmith still tested positive for COVID-19, which he did (again) on March 24. Within a day or two, the hospital approved the research protocol and filed the paperwork including Goldsmith's positive test results, to Gilead. "We were excited," Stroh said.

But on March 27, the family was told Goldsmith would not have access to the drug due to a reason Stroh can only understand as a "beaurocratic glitch" that "makes no sense." It seems that because Goldsmith was a patient at a hospital that was an established, rather than new, study center for Gilead, he was shut out of the company's new program.

"They expanded the program at other hospitals and would not make an exception or an expansion for Michael, even though originally they said they would. So as you can imagine, it was devastating to me," Stroh said. "I'm a cardiologist at a different hospital system, and people all around me were all of a sudden getting the medication my son-in-law needed to help him fight this virus, and he was being denied."

Gilead says it wishes it could help every patient in need

Gilead stopped the compassionate use program Goldsmith's family and others had counted on because it couldn't "support and process the overwhelming number of applications" it received, according to a March 28 open letter from Gilead's CEO and chairman Daniel O'Day.

In its place, the company is transitioning to "expanded access" programs, through which hospitals or physicians can apply for "emergency use" of the drug for multiple severely ill patients at once. "While it will take some time to build a network of active sites, this approach will ultimately accelerate emergency access for more people," O'Day wrote.

Meanwhile, children and pregnant women are still able to access the drug under compassionate use, and company continues to work "at unprecedented speed to enroll patients in clinical trials," the letter said.

O'Day also addressed people like the friends and family of Goldsmith, who've been pressing the company to give their loved ones access to remdesivir during this transition.

"We are used to seeing numbers and statistics in the news on a daily basis but we all know that behind each of those numbers is a real and often heartbreaking human story," he said. "I know I speak for everyone at Gilead when I say how much we all wish we could help every patient in need."

The explanations don't match Goldsmith's supporters' definition of compassion, though. "All of the press releases that they put out saying that they're doing what they can are worthless if they can let people like my son-in-law languish on a machine."

Gilead did not respond to Business Insider's request for comment.

'There's a lot of praying going on'

Earlier this week, Goldsmith's cousin Adam Holzer, a physician who's currently abroad, started a Physician's Petition calling on President Trump to invoke the Defense Production Act to require Gilead Sciences to provide a solution for severely ill young patients that don't meet criteria for a remdesivir clinical trial.

As of the night of April 2, more than 1,300 physicians had signed on to the petition that's been sent, via various channels, to the White House, Stroh said. New Jersey Representative Josh Gottheimer has also advocated on Goldsmith's behalf. The hashtag #SaveMichaelGoldsmith is circulating on Facebook and Twitter.

"We've tried to marshal the forces of government officials, biopharma, and the financial world to try to put pressure on Gilead to look at this sanely and logically, and realize that there's a gap here and that innocent lives are gonna be endangered because of this bureaucratic decision," Stroh said. "So far, it has failed."

Meantime, Goldsmith's community is marshalling another force - faith - as he continues to be sustained on oxygen and a cocktail of IVs and nasal tubes that give him nourishment, fluids, and intermittent medications to prevent infections. Elana has "visited" him once via Facetime.

"Anyone that has patients or family member in this situation, they know it's a roller coaster - it's up, it's down, one day better, one day worse. Even within minutes, the condition can change," Stroh said. "And I will say that besides excellent medicine going on, there's a lot of praying going on as well."

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