Treatment and trials go on, but Michigan doctors split on coronavirus drug

A dearth of reliable information about hydroxychloroquine’s safety and effectiveness has forced doctors to make judgement calls about whether or not to use the drug to treat COVID-19, leading to stark contrasts in treatment protocols from one hospital system to the next. (Shutterstock image)

Thousands of people are being recruited to participate in southeast Michigan clinical trials — touted as among the largest in the country — to test the effectiveness of hydroxychloroquine in the battle against COVID-19.

But since a 3,000-person Detroit trial was announced April 2, an increasing number of reports have shed doubt not only on the drug’s effectiveness, but also its safety. Some warn of potentially deadly changes to the heart’s rhythm — an alarming side effect so widespread the U.S. Food and Drug Administration last month warned against the use of hydroxychloroquine outside of a closely-monitored hospital setting or clinical trial. 

Those concerns, along with growing skepticism about hydrochloroquine’s effectiveness, have fueled a sharp decrease in U.S. hospital orders of the drug. Some hospitals are even pulling the drug from treatment.

“There was a lot of hope for [hydroxychloroquine] initially, but it has not panned out,” said Dr. Dennis Cunningham, medical director of infection control at McLaren Health Care.

A preliminary review of COVID-19 patients at U.S. Veterans Health Administration hospitals found that those who took hydroxychloroquine had higher death rates than patients who didn’t take the drug. Additionally, they were no less likely to end up on a ventilator. 

Meanwhile, case reports began building in the FDA Adverse Event Reporting System that raised concerns about serious health problems tied to hydroxychloroquine and related drugs in 2020. In some cases, the results were deadly.

Last week, a research team led by a Harvard Medical School doctor published a review of several studies, raising concerns about whether the drug might actually impair the body’s ability to fight the COVID-19 virus. The review called for limiting the drug to COVID-19 patients in a “carefully constructed randomized clinical trial.”

As the virus began burning through southeast Michigan in March and April, the 14-hospital McLaren system added hydroxychloroquine to its treatment for COVID-19 patients, and a few doctors said there might be “some benefit in some patients,” Cunningham said.

But by this week?

“I have to say that doctors are moving away from using it. It’s just not effective,” he said Wednesday.

Health systems split over safety, effectiveness 

The stakes are high to find an effective treatment against the virus, which has sickened more than 45,000 Michigan residents, with a death toll of 4,343 as of Thursday. 

There’s no vaccine yet to prevent infection, and medical experts worry about a second wave of the virus as social-distancing rules are relaxed. Hence, the scramble to find an effective treatment.

Related:

Just one drug, Remdesivir, was fast-tracked to approval, but results even there have been short of stellar.

That leaves doctors at each health system to make their own decisions, based not only on what the research indicates, but also on results among their own patients. It’s a judgment call that has begun to create stark contrasts in treatment protocols from one hospital system to the next.

At Detroit Medical Center, Dr. Teena Chopra said doctors believe the drug may be helping keep some COVID inpatients off ventilators.

Detroit Medical Center doctors continue to prescribe hydroxychloroquine, but they are monitoring its use closely, said Dr. Teena Chopra, DMC’s medical director of infection prevention.

“We haven't seen any harm,” said Chopra, who oversees DMC’s infection prevention efforts. “And we've been able to take patients, use this [drug] and delayed the need for ventilation in some category of our patients.”

Still, she said, doctors are closely watching its use.

Beaumont Health doctors, like those at Ascension healthcare system,  have been less impressed.
“I don't think [it] is hurting anything, but we don't feel that it's been helpful,”  said Heidi Pillen, director of pharmacy for medication use policy at Beaumont. 

Michigan Medicine also has stopped using hydroxychloroquine to treat COVID, unless the patient is enrolled in a clinical trial. That’s because of side effects ranging from vomiting to heart and liver problems, said Dr. Vineet Chopra, Michigan Medicine’s Chief of Hospital Medicine.

“I remember that the first few patients we gave it to were just sick to their stomach with nausea and vomiting,” Michigan Medicine’s Chopra said. “...And here’s somebody who's having a hard time breathing, and now they're throwing up."

Stories from the front  

Bridge Magazine, the Detroit Free Press and Michigan Radio are teaming up to report on Michigan hospitals during the coronavirus pandemic. We will be sharing accounts of the challenges doctors, nurses and other hospital personnel face as they work to treat patients and save lives. 

If you work in a Michigan hospital, we would love to hear from you. You can contact Robin Erb rerb@bridgemi.comat Bridge, Kristen Jordan Shamus kshamus@freepress.com at the Free Press and Kate Wells katwells@umich.edu at Michigan Radio.

Dr. Geoff Barnes, a Michigan Medicine cardiologist, said he frequently prescribes hydroxychloroquine for reasons other than COVID. 

“We actually use it a lot in outpatient settings for other conditions, like rheumatoid arthritis.”

But Barnes said it’s crucial to first screen patients for underlying heart issues with an electrocardium, or EKG test (the test that shows a patient’s heart rate as a wavy line fluctuating with each heartbeat). 

Whether hydroxychloroquine helped Sam Washington fight his COVID-19 infection in early April, he’s not sure, but Washington, 73, is feeling better these days.

The Detroit resident said he was prescribed a dose of hydroxychloroquine and four doses of azithromycin, an antibiotic, at Beaumont Hospital’s emergency room in Dearborn. He’d felt ill, and emergency room doctors told him he’d tested positive for the virus. Medical staff monitored him for several hours, he said.

“Then they called my daughter and told me I could go” home. 

If anyone mentioned the possible risks of the medications he’d been given, Washington said he doesn’t remember it. “They said ‘Here, take these.’” 

Once home, he started improving. “I got better,” Washington said.

Thousands enrolling in ongoing trial 

In mid-April, Michigan Medicine announced it would be enrolling participants in a massive, multi-site research pool of healthcare workers run by Duke University, including a 15,000-person study into whether hydroxychloroquine prevents or reduces the effects of COVID. 

 Meanwhile, Henry Ford Health System, one of dozens of hospitals across the country studying the drug’s potential, said it will continue a similar  clinical trial.

It’s recruiting 3,000 healthy health care workers, first responders and bus drivers for the trial, to find out whether daily doses of hydroxychloroquine taken at home, can help people avoid contracting COVID-19. Participants won’t know whether they’re receiving a regimen of hydroxychloroquine or a placebo, allowing researchers to tease out from the comparison groups whether the drug had an impact.

In announcing the trial, Henry Ford CEO Dr. Steven Kalkanis called first responders and hospital workers “heroes.”

“And while this is only a study of an unproven medication — there are no proven cures or preventative treatments for COVID-19 — we owe it to them to look for ways to protect them.”

People with “significant heart or retinal disease” and those who are pregnant or nursing can’t join the study. 

Once enrolled, participants are assessed three times and give five vials of blood over the course of 8 weeks.They also receive weekly phone calls “to see how you have been feeling,” according to the study’s guidelines.

But unlike hospitalized patients, trial participants won’t have the protections of constant monitoring. If a hospitalized patient develops an irregular heartbeat (one of the drug’s potential side effects) doctors can spot it instantly.

“The biggest concern is, if you have a complication … [like a] life-threatening arrhythmia, the only way to treat somebody is to shock somebody,” says Barnes, the Michigan Medicine cardiologist, referring to defibrillation.

“We use the paddles you see on TV. If that happens in a hospital setting, you can do that almost immediately. If you’re out in the community, we may not know that’s happening. Again, it’s a rare complication, but it does at least raise concern.”

According to records on public file, both the Henry Ford Health System and Michigan Medicine studies would exclude anyone with a history of QT prolongation, a “heart rhythm condition that can potentially cause fast, chaotic heartbeats” and can be deadly if left untreated, according to the Mayo Clinic.

But it’s not clear whether researchers are screening for that condition with an EKG test — something Dr. Barnes, the Michigan Medicine cardiologist, said is critical. 

And as first responders and health care workers, they’re already at higher risk of contracting the virus, raising additional concerns about the possibility of the drug impairing the immune system. 

“There is some association with COVID and heart tissues from the virus itself,” Barnes says. “If you were on hydroxychloroquine and you had [underlying issues] and you developed a heart condition from covid, there could be issues there.”

Participants in the Henry Ford trial are required to sign an “informed consent” form that warns about “rare but serious” side effects, including reduced counts of the white blood cells that help fight infections and potentially deadly heartbeat abnormalities. 

Such complications are “only likely to happen in fewer than 1% of those who take the study drug,” according to the form.

But a recent study at Boston’s Beth Israel Deaconess Medical Center found that 19 percent of COVID patients treated with hydroxychloroquine “were at increased risk of electrical changes to the heart and cardiac arrhythmias.”

However, patients in that study already had COVID, potentially increasing their risks of heart issues to begin with.

It’s a tricky ethical question, said Kayte Spector-Bagdady, chief of Michigan Medicine’s Research Ethics Service: What should researchers do when new information about potential risks of the medication they’re studying only becomes available after the trial has already started?

“Do you need to update your consent form going forward? And do you need to go back and tell all your [already enrolled] participants, ‘Hey we have this information, do you still want to continue?’ I don’t think it’s clear, but I think it’s an important issue.’”

Even if participants are given that new information, they’re still in a tough spot: Spector-Bagdady says if she were a participant in the study, even she wouldn’t know how to process all this new information and wrap her mind around the risks. 

“As a professional research ethicist focusing on COVID...I wouldn’t know how to translate that risk myself. I wouldn't know what to do with that information.” 

A spokesperson for Henry Ford declined to say whether participants in its study have experienced any side effects thus far, or whether the emerging concerns about hydroxychloroquine may influence its study, other than to say participants are being closely monitored. Michigan Medicine did not immediately respond to similar requests.

“We've communicated information quite extensively already,” Henry Ford spokeswoman Tammy Battaglia said in an email. Battaglia added that Henry Ford is “looking forward to having study results with solid insight to share.”

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Comments

Revere
Fri, 05/08/2020 - 8:45am

Nice attempt at a Trump hit piece, Bridge. You "partisans" (LOL). Trials have found up to 90% success rate with this drug. I know you hate Trump, I don't love the guy in any way but this is a pretty pathetic hit piece.

Rick
Fri, 05/08/2020 - 11:15am

'Trials have found up to 90% success rate with this drug.'
How about a link to this 'trial' (I notice you're not saying 'study' because it wasn't and was largely anecdotal)?
You know more than we or The Bridge know so let's see your evidence.

Terry Fitzgerald
Fri, 05/08/2020 - 8:51pm

Before you get bucked off your high horse, please take the time and research the so-called study that was released by some people at the VA. It is as anecdotal as you can get with nothing close to controlled research. I do not know anymore than you, the writer of the article, or even the expert medical people do whether or not this drug in conjunction with zinc can be effective. What I do know is that it has been around for a very long time without the degree of dreaded side effects that are now being touted. It’s biggest problem is that when The President said that it MIGHT be a game changer the Trump haters suddenly could not allow him to be right.

Revere
Sun, 05/10/2020 - 10:54am

Terry Fitzgerald has TDS baaaaaaad.... Get help!

Anonymous
Fri, 05/08/2020 - 10:14pm

I went to bing and typed in my search "90 percent success rate with hydroxychloroquine" and the first result was the story "Hydroxychloroquine Has about 90 Percent Chance of Helping COVID-19 Patients, States Association of American Physicians and Surgeons (AAPS)"- I think that's the one he is referring to. Maybe though he is wrong- this story says it is 91% success rate- "Professor Didier Raoult Releases the Results of a New Hydroxychloroquine Treatment Study on 1061 Patients". He might have gotten it very wrong though- the story "Doctor treated 350 Cov-19 patients with 100% success using the drug the media hates" suggests that he's understating how successful the drug is. Typical Trump supporter- bragging about a treatment that he says is only 90% successful when in reality it might be higher yet.

Revere
Sat, 05/09/2020 - 12:16am

Rick,
I know this was bait to attempt and force an Orange Man vs. person suffering from TDS(you) debate.
I won't dignify it with a response.
Remember when your grandparents told you that if you kept making that face, it would stay that way? If you keep letting this TDS drive you, you'll stay crazy.
You have google.
Find the evidence, look at it yourself, and decide - i.e. think for yourself for once!

Exactly...
Fri, 05/08/2020 - 2:49pm

I get emails from these folks claiming to be unbiased and bipartisan, asking me to donate to their cause. I would like to donate to these causes but not to those who knowingly lie and refuse to be fair and balanced. Bridge is not fair, honest, or balanced.

Todd
Fri, 05/08/2020 - 2:47pm

It's simple. Follow the money. Whichever generates more of it will be backed and just as long as Trump doesn't endorse it. Had Obama endorsed this med, all would be good and especially if they could make more money from it. Make no mistake folks. This is NOT about care or concern for us but more about power and money. Money is power.

middle of the mit
Fri, 05/08/2020 - 9:06pm

Ahh yes!

When even a drug to treat an "non existent virus" or "nothing worse than flu virus" is made political.

And when that cure starts killing people because it co-constrains with heart problems of the virus and the "experts" are split while people die,

the rest of us cry.

bh
Fri, 05/08/2020 - 10:22pm

I don't know if HCQ works or does not work. But I admit that the testing thus far does not make much sense to me. I would liken it to this:
"A group of farmers recently ran a study that shows that shuting the door to the barn is of no benefit once the horse has left the barn.
Therefore it was decided that having doors on barns is useless and should be abandoned. In addition the use of doors on barns must be prohibited
except in cases where the horse has already left the barn." From what I have read HCQ prevents the virus from replicating. Once the virus has spread throughout
the body HCQ is of little value. Yet they keep giving HCQ to patients in the hospital who are too sick and then comming to the conclusion that the drug is useless.
And to make it worse they discourage or prohibit the use of HCQ before a patient is admitted to the hospital. Tests are beginning that will
test HCQ for prophylaxis of COVID-19. I know of no tests of HCQ effectiveness in early use to keep people out of the hospital in the first place. Doctors have used HCQ
to help keep patients out of the hospital and they feel they have had success. But this is called anecdotal and is therefore invalid.