Facing shortages, Michigan asks feds for experimental coronavirus drugs

Michigan Gov. Gretchen Whitmer’s administration is “pursuing a request” for hydroxychloroquine or chloroquine from the federal government’s Strategic National Stockpile. (Shutterstock)

Mary Louise Luczkowski phoned her local pharmacy this month to refill a prescription she needs to keep her autoimmune disease at bay.

Then the Detroit resident got a jolt — her pharmacy was out of hydroxychloroquine, a medication she’s taken for lupus since 2010 that is suddenly in high demand as an experimental treatment for a deadly coronavirus that has swept the state and the country. 

Medical experts say there is no conclusive evidence the drug, also widely used to treat and prevent malaria, improves outcomes for COVID-19 patients despite anecdotal success stories and claims of “tremendous promise” by President Donald Trump. 

There is hope and demand, however, and the Michigan Department of Licensing and Regulatory Affairs said last week there are “multiple allegations” of physicians inappropriately prescribing hydroxychloroquine or chloroquine to themselves, family, friends or coworkers.

Luczkowski figured she had enough left to last for maybe a month, if she cut her prescribed dose in half.

“I’m keeping my fingers crossed,” she told Bridge, adding that running out of medicine “would mean I would probably become sick.”

With heightened demand prompting worldwide shortages, Gov. Gretchen Whitmer’s administration last week warned Michigan medical providers against stockpiling hydroxychloroquine or chloroquine, antimalarial drugs that are effective to treat lupus, rheumatoid arthritis and other ailments.

But those supply concerns appear to be fading after drug maker Sandoz donated 30 million doses of hydroxychloroquine sulfate to the federal government’s Strategic National Stockpile and Bayer Pharmaceutical donated another 1 million doses of chloroquine phosphate.

The U.S. Food and Drug Administration on Sunday granted emergency authorization for the federal government to distribute the donated drugs to states, where doctors can prescribe them in limited circumstances: for hospitalized teens and adult patients with COVID-19. 

The Whitmer administration is “pursuing a request” for the drugs from the Strategic National Stockpile, Michigan Department of Health and Human Services spokeswoman Lynn Sutfin told Bridge Magazine late Monday. It’s not immediately clear how many doses the administration seeks.

The state’s earlier advisory urging pharmacists to take “special care” to examine the “legitimacy” of  chloroquine and hydroxychloroquine prescriptions was supported by the Michigan State Medical Society and the Michigan Pharmacists Association. 

The groups warned of shortages for patients with conditions like lupus and suggested “any prescription medicine that may be effective in treating COVID-19 must be reserved for Michigan’s sickest and most vulnerable patients.”

But the government advisory sparked blowback from the political right. In tweets later deleted for violating Twitter rules, conservative activist Charlie Kirk and Rudy Guiliani, Trump’s personal attorney, accused Whitmer of “threatening doctors” and risking lives to oppose the president. 

State officials have pushed back against similar claims, arguing Michigan is simply urging doctors to adhere to traditional standards of practice and exercise appropriate professional judgement. 

“Prescribers and dispensers have a responsibility to apply the best standards of care and use their clinical judgment when prescribing and dispensing these and any other drugs to treat patients with legitimate medical conditions,” said David Harns, a spokesman for the Department of Licensing and Regulatory Affairs. 

“Hoarding and stockpiling drugs for one’s own personal use is inappropriate.”

Whitmer said Monday the state wants to be “nimble” in the crisis and is continually updating and adjusting policies to meet the moment.

“We want to ensure that doctors have the ability to prescribe these medicines,” the governor said in a press briefing. “We also want to make sure that the people who have prescriptions that predated COVID-19 have access to the medication they need. And so all of the work that we’ve done is trying to strike that balance.”

Several Michigan hospitals are using chloroquine and hydroxychloroquine on COVID-19 patients, but even some experts who have used the drugs caution that there is not enough scientific evidence to prove their efficacy.

“We don’t know if these agents will work, and if they do, we don’t know the ideal patients that will benefit from them,” said Jason Pogue, a clinical professor at the University of Michigan College of Pharmacy and an infectious disease clinical pharmacist at Michigan Medicine.  

That’s because scientists have not yet completed rigorous clinical trials to determine if COVID-19 patients who use chloroquine and hydroxychloroquine have better outcomes than those who do not.

There’s a laundry list of reasons that that study (of using hydroxychloroquine and Z-Pak for COVID-19) is flawed.” - Jason Pogue, a clinical professor at U-M

Test-tube studies suggest hydroxychloroquine may have an “inhibitor” effect against the virus, and China announced in mid-February that chloroquine could help mitigate symptoms and shorten hospital stays. But six weeks later, Chinese researchers have not released data to support their claims, Pogue said. 

There is no vaccine for the virus, although separate research is underway. Patients with mild symptoms are typically quarantined, while those with more serious respiratory issues receive supplemental oxygen treatments or are placed on mechanical ventilators to help them breathe. 

At Michigan Medicine, medical providers have given chloroquine or hydroxychloroquine to a handful of patients with COVID-19. 

That’s a “reasonable” approach given available evidence, Pogue said, but “I honestly don’t know” how effective it will be and “that recommendation could change any day.”

Hydroxychloroquine may not be a “miracle cure,” but there is enough evidence to “justify its use” at this point, said Dr. Marcus Zervos, head of the infectious diseases division at Henry Ford Health System.

The Detroit-based hospital system is using hydroxychloroquine in combination with other therapies in an attempt to reduce the likelihood of complications, Zervos said Tuesday in a video chat with reporters. About 800 patients half in Detroit have been treated with the drug since March 1 at various Henry Ford hospitals, according to a spokeswoman. 

“We have had a number of success stories — patients that have been severely ill, we’ve gotten them off the ventilator and out of the hospital,” Zervos said. But hydroxychloroquine appears to have greater benefits “if we’re able to start the therapy earlier,” he added.

More recently, French researchers published a study suggesting COVID-19 patients could benefit from a combination of both hydroxychloroquine and azithromycin, an antibiotic marketed as Z-Pak.

Trump has suggested the combination could be “one of the biggest game changers in the history of medicine,” and at least one Michigan man claims the drugs aided his recovery from COVID-19. 

But the initial French research was based on only six patients who were tested after six days, and one of them tested positive for the virus on day eight, Pogue said. “There’s a laundry list of reasons that that study is flawed.”

Dr. Mohammed Arsiwala, president of the Michigan State Medical Society, said he has personally used a combination of hydroxychloroquine and azithromycin on one COVID-19 patient, but without clinical testing he does not have confidence in the approach. 

“The patient did recover, but I don’t know if that worked or the patient recovered on their own,” he said. “It’s hard to say.”

Ariswala runs Michigan Urgent Care, a chain of facilities in southeast Michigan that as of Monday had reported 24 confirmed cases of COVID-19. 

He said he tried to prescribe hydroxychloroquine and azithromycin to a second patient but was denied the hydroxychloroquine request by a pharmacist because of shortages. 

Michigan Medicine is now recommending against the routine use of azithromycin. 

“One of the big concerns that I have is that both of those agents share a similar toxicity, which can be additive, so it can cause some cardiac issues in patients,” Pogue said. “So you’re giving this combination therapy with really no data to support it, but definitely a risk for adverse outcomes.”

Michigan Urgent Care is only willing to try the drug on younger and otherwise healthier patients because of the associated toxicity, Ariswala said. 

“According to what we know right now, based on all the scientific evidence, there is actually no treatment that really directly works against COVID-19,” he said.

Henry Ford hospitals using hydroxychloroquine to treat COVID-19 patients are typically using it in combination with azithromycin, according to Zervos. He said the health system is also using hydroxychloroquine with another antibiotic called doxycycline, which appears to have fewer side effects.

“One of the reasons that the virus can be so deadly is it activates the immune system— there’s an overreaction of the immune system — and the azithromycin may also help to reduce some of that over activity of the immune system,” he said.  

“The small risk of having an issue with some sort of a cardiac problem can be mitigated by us monitoring the patient in the hospital.”

Pogue said he understands the hope for an effective treatment but cautioned residents against believing everything they read on the internet or trying to practice “Twitter- or Facebook-based medicine.”

“We’re also clamoring for positive outcomes right now,” he said. “Every one of us who takes care of patients wants a therapeutic option to work. That’s our goal. That’s our hope. That’s what we want to occur. But we can’t manufacture science to get to that endpoint.”

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Comments

Kevin Grand
Tue, 03/31/2020 - 1:07pm

Your Orange Man Bad bias has absolutely no place in a "non-partisan" new organization, Mr. Oosting.

And, I wouldn't be so quick to use the PRC has a reliable source of information regarding the efficacy of any new treatments.

Their widespread incompetence aside, too many people who were critical of their government's handling have either "disappeared" or have died.

https://www.theguardian.com/world/2020/jan/31/help-or-hindrance-how-chin...

https://www.nytimes.com/2020/03/14/world/asia/china-ren-zhiqiang.html

https://www.globaltimes.cn/content/1178814.shtml

Hopefully, the results of the FDA trials will replicate the successful results of Michiganian Jim Santilli's experience with that drug.

https://townhall.com/tipsheet/bronsonstocking/2020/03/30/hydroxychloroqu...

https://www.stevegruber.com/2020/03/covid-19-survivor-praises-president-...

And if Dr. Fauci (the same person Gov. Whitmer says she'll only listen to on the federal level as a reliable source), says that it's worth trying, what more do you really need?

https://www.breitbart.com/politics/2020/03/25/dr-anthony-fauci-of-course...

duane
Tue, 03/31/2020 - 2:28pm

With our Governor requesting drugs from the federal government [why not directly from the manufacturer?] and doctors saying there needs to be much more detailed testing to ensure its efficacy for Covid 19 it can cause one to wonder if the Governor has any type of advisory team on this pandemic, if she is even asking virus knowledge medical professionals for their thinking and recommendations.
We know President Trump has a panel of experts [including Drs. Fauci and Birx] that he listens to for establishing federal government policies and practices. The President has his team out front making their thinking public and keeping the public informed plans and actions. Since our state is unique I would like to hear how the plan and actions for Michigan customized for our needs, I would like to hear resources we have and how individuals can help in this effort, I would like to hear that the Governor was using team that included medical professionals to make these plans and monitoring the effectiveness of the plans, I would like to hear from this special team and how we are applying their expertise. I hope the Governor is only relying on her political experience and advisors.

President Trump through out this crisis has elevated the value of the medical experts and the private medical companies [even to bring back the pharma manufactures], I wish the Governor saw her role similarly.

Mitten Girl
Fri, 04/03/2020 - 11:56am

“COVID 19 is a hoax”
I rest my case.

middle of the mit
Wed, 04/01/2020 - 12:40am

Take note of what I am about to say. Listen to what Kevin and Duane are saying. Know that both of these individuals are against cannabis.

Know also that they are FOR EXPERIMENTAL DRUGS THAT MAY SAVE LIVES! (but we don't know the side effects of) UNLIKE CANNABIS!

Also, know this-- https://www.nbcnews.com/health/health-news/man-dies-after-ingesting-chlo...

I am not saying there is a good about it or not. It's NOT my place to decide that. You don't ask a fabricator how to prevent a disease just like you wouldn't ask a CEO to weld a couple of metal pieces together for you. NO! It doesn't happen that way! The CEO directs you to t he proper person that will weld those parts together for you.

But don't look to the experts! They are stoooopid, and they can't tell you how families want to raise their children!

Fine then! We now see that conservatives are reluctant that they can actually do the jobs of teachers! Look down a few posts. You will see it.

Kevin still thinks this a big "coup" on the President. Did he shirk responsibility for Governor Snyder? H e double hockey sticks no he didn't! The FEDS were responsible! Specifically the EPA! Even though the EPA is an advisory role via the 1984 clean air and drinking water act. They literally need permission to come into your State. That is my problem with the professor from VA. He wouldn't acknowledge that, I do and so does the law. And what do you think MI would be doing under a Gov Bill Shcuettte? That is also what Jason Chaffetz said when he blamed the stoopid dumb and dangerous lead and copper rules. Then when the EPA administrator said that the stoopid dumb and dangerous lead a copper rules were put in place and voted for under Jason Chaffetz and the Bush administration? Why are you blaming Bush for the stoopid dumb and dangerous copper rules?

She said; "BECAUSE YOU WROTE THE STOOPID DUMB AND DANGEROUS LEAD AND COPPER RULES! AND WE WEREN'T ALLOWED TO REWRITE THEM"!

When are you conservatives GOING TO TAKE PERSONAL RESPONSIBILITY FOR THE LAWS THAT YOU WRITE AND THE LIVES THAT YOU THINK ARE WORTH LESS THAN MAMMON?

The time IS here. It IS now.

The funny thing is, the religious seem to think it is a hoax. HAVE YA ALL READ REVELATIONS? Then why is this so hard to believe?

And if Duane or Kevin think that Gov Whitmer has done anything but look to the experts, and we know that Donald J Trump has succumbed to elite medical authorities (even though in his own words his uncle was an instructor at MIT and he has his uncles jeans, so that means that Donald isA jenious) A jenious that doesn't trust the elites.

And the elites includes doctors, nurses, and anyone that has any expertise in any industry! So we can now do what Duane has been telling us we should have been doing for decades, and (yet apparently Duane never followed his own advice on) we can all be Jacks of all Trades and masters of none.

See where that gets us Duane.

We are on the conservative path. Make no mistakes about that.

What? You think monarchy is a liberal thing?

This time and this age should allow us a more liberal , via Matthew 25 , even Christian nation. But it won't. And it won't be the progressives that side with the regressives.

Fellow readers, there are many on this board who think I am a troll. And to be honest, for a while I was a troll. That doesn't mean that I am not speaking what needs to be spoke.

These are new times to all of us. We can ask elders what has happened in the past, but none of them ever had the circumstances that we have today.

We have a global epidemic. We are going to have to come together. WE are going to have to rely on eachother. We are going to have to forgo the individual for a moment. And if we don't. I don't know what will happen. I am just hoping there are more people out there with some common sense and sympathy, let alone empathy.

I know... I just have hope.

https://talkingpointsmemo.com/news/taxpayers-paid-millions-to-design-a-l...

Catapult
Wed, 04/01/2020 - 3:33pm

So are you suggesting that the ne wonder drug, cannabis, will defeat COVID-19 or just that you can stay stoned while you're dying?

middle of the mit
Fri, 04/03/2020 - 2:41am

Why am I surprised that is the only thing you got from that post? OH wait! Even though I do use cannabis, I am NOT surprised.

You do know that says more about you than it does about me, don't ya?

And since YOU said I claimed that cannabis could cure Covid-19 and since you don't use drugs, could you show me anywhere in my post where I claimed such things? Cause I looked and I looked again and I just couldn't find it.

So once again, I need people who don't use cannabis to show me where in my posts what they claim I am saying is actually what I said.

If you have reading comprehension problems, I would suggest a grade school teacher to supplement your comprehension problem. If need be, I could probably direct you to some help.

Let me know if you need it.

Richard Miller
Wed, 04/01/2020 - 8:01am

This just a bunch liberal whining. Pogue is a Trump hating Marxist from Ann Arbor. Piss on him and piss on clinical trials. This stuff is going to save alot of lives. Not the least bit concerned about lupus or rheumatoid arthritis patients right now. Sorry, but we've got far bigger problems.

John Steele
Wed, 04/01/2020 - 10:02am

President Trump should make the Michigan Governor publicly apologize for such stupidly as all she did was try to take cheap shots at the President.. NOW... they want it..

George
Wed, 04/01/2020 - 10:04am

There is enough anecdotal evidence coming out of multiple countries that the drug does seem to help. In these days of crisis, hiding behind the statements that there have not been rigorous trials done so we should not use it to treat covid is tone deaf in so many ways. You dont immediately die from arthritis or lupus though they are painful. The use of the drug, even if experimental, to prevent someone from dying, seems like it should be the primary use.

Constituents know full well that the Governor went all out in her TDS - interfering with doctor's ability to prescribe what they feel best for their patients in order to make a political statement. Its not like her base was not screaming and hollering about how the President caused the death of people who treated themselves with aquarium cleaner. This is the same lady who ranted in her anti-state of the union message. Of course we buy the lie that she was just looking out for the people in her state.

JScott
Wed, 04/01/2020 - 11:53am

"experts say there is no conclusive evidence the drug, . . . improves outcomes for COVID-19 patients despite anecdotal success stories"
In other words, we cannot even try it until there is 'conclusive' evidence
However, we must upend our lives to save the planet from man-made global warming because there is a so-called 'consensus' - basically the conclusions of some scientists vs. the opposite conclusion (other causes) from other scientists.
Hmmmmm.

ModerateGuy
Wed, 04/01/2020 - 3:06pm

Demokrats happen, people die

J W
Wed, 04/01/2020 - 3:29pm

I'm don't think it would be possible to present this issue in a more biased way, or to carry any more water for the State officials.

You should be ashamed. Absolutely embarrassing. It seems your ability to think critically and attack arguments works in precisely one direction.

People see right through it.

G T
Wed, 04/01/2020 - 3:41pm

Whitmer is guilty of fraud and practicing medicine without a license...and possibly numerous cases of manslaughter.

G T
Wed, 04/01/2020 - 3:43pm

Whitmer is guilty of fraud and practicing medicine without a license...and possibly numerous cases of manslaughter.

Tom Freaking Brady!
Wed, 04/01/2020 - 5:20pm

I hope Trump fraks her up her bum so hard you'd think John Holmes came back to life.

David D.
Wed, 04/01/2020 - 5:40pm

I guess those that oppose the use of "experimental" FDA Approved drugs should just keep denying the use when they get the Chinese-Wuhan Flu (good riddance). Personally I find the results from Stanford pretty conclusive. Too bad Orange Man Bad partisan politics and journalism delayed action. I'll take the (RED) pill and hopefully live to fight another day. #WalkedAway

TrumpCure+
Wed, 04/01/2020 - 8:48pm

Thank god that Michigan's Governor has reversed her policy of denying the TrumpCure+ to sick Michigan citizens. Hydroxychloroquine, Zinc, and Vitamin C- one can only hope that this cure works.

Dave Neamo
Thu, 04/02/2020 - 10:50am

If the author of this article and the UM doctor feels the HCQ treatments are unwarranted, then I encourage them along with all of the Witless supporters to make a public pledge that they will not take the drug (and their families) in the event they contract the virus, or until such time as a long term study is completed. If the HCQ treatment is even partially effective at earlier stages of the disease and there are no other short term options, why wouldn’t we use it? What is Witless’s plan now? She’s completely reactive. A well thought out plan of testing and HCQ could at least mitigate the loss of human life in our state. Instead we have hack reporters, political ideologues and a governor and staff without a clue.

Publius
Thu, 04/02/2020 - 11:43am

Reporters, a couple questions you might have asked:
1) what other drugs were included since this was intended to prevent hoarding? Only this particular drug was of concern to Whitmer and no others? Sure.
2) if supply was a potential issue, why didn’t Whitmer seek out additional sources?
If the governor wants to carpet Michigan with the corpses of her empty headed supporters, go ahead. Unfortunately not all of us are willing to die for her political ideology. She needs to be removed and replaced by someone with common sense if nothing else. UM medical system goes down a big notch if this doctor is representative of their physicians and I’m a long term patient of UMHS. I hope he’s an outlier, at the left end of the curve.

Steve
Thu, 04/02/2020 - 2:08pm

Stop it libs, it works...

Todd
Thu, 04/02/2020 - 6:00pm

Cracks me up how Bridge claims no bias.

Anonymos
Mon, 04/06/2020 - 1:56pm

I think the government should revisit old school Respiratory medicine that has proven to work...In Pneumonia patients and other upper respiratory infections.
Why throw out there a Malaria drug with a ton of side effects....give everyone hope...and who knows if it's really going to help anyone .
There mixing it with Zithromax and also using doxycline...both are killer antibiotics in there own right and cause alot of stomach distress but work well On upper respiratory infections....if they need an anti viral pill to boost the power then utilize Diflucan....which is totally antiviral and has been around a very long time....why spend all the money to give people hope in a pill that has never been used for this disease?????
Government isn't using there brain in this one ...the chemists out there should have there input listened too...they would know a lot better then anyone else.
To scramble to get a stock of pills that have no guarantee and put in jeopardy all the nurses and drs on the front lines is just ludicros!!!!

Anonymous
Mon, 04/13/2020 - 10:33am

But the government advisory sparked blowback from the political right. In tweets later deleted for violating Twitter rules, conservative activist Charlie Kirk and Rudy Guiliani, Trump’s personal attorney, accused Whitmer of “threatening doctors” and risking lives to oppose the president.
But the government advisory sparked healthcare workers from the political( Left). In tweets later deleted for violating Twitter rules, (liberal) activist Hillary Clinton and Andrew Coumo , Trump’s personal attorney, accused Whitmer of threatening doctors and risking lives to help the president.