Lupus Patients Can’t Get Crucial Medication After President Trump Pushes Unproven Coronavirus Treatment

22 Mar

by Charles Ornstein

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The drug Plaquenil keeps Anna Valdez’s lupus in check.

Late last week, as she sheltered in place at her home outside Santa Rosa, California, Valdez called her local pharmacy and ordered a refill to treat her autoimmune disorder, thinking a 90-day supply would help her ride out the coronavirus outbreak.

But the pharmacy told her it had only 10 pills left. Valdez called other pharmacies. They, too, had run out.

Valdez and lupus patients around the country have learned in recent days that an extraordinary force has upended the supply chain they all rely on: President Donald Trump.

These days, Plaquenil is better known by its generic name, hydroxychloroquine. It is the medication Trump has been hyping as a potential treatment for the novel coronavirus, even though it is not approved for this use and there is scant medical evidence so far that it works to treat the virus.

HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains – Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents)…..

— Donald J. Trump (@realDonaldTrump) March 21, 2020

Trump’s push to use hydroxychloroquine to treat COVID-19 has triggered a run on the drug. Healthy people are stocking up just in case they come down with the disease. That has left lupus patients like Valdez and those with rheumatoid arthritis suddenly confronting a lack of medication that safeguards them, and not only from the effects of those conditions. If they were required to take stronger drugs to suppress their immune systems, it could render them susceptible to more serious consequences should they get COVID-19.

The shortages have caught the attention of the Lupus Foundation of America, which said it is working “to take steps that ensure people with lupus will be protected from a disruption in access to critical medications.”

Lupus afflicts about 1.5 million Americans, and women and African Americans are disproportionately affected. The immune system of a lupus patient attacks its own tissues, causing inflammation and tissue damage in an array of organs, from the joints to the kidneys and lungs.

Many lupus patients use Plaquenil to combat these effects and have taken to Twitter with their fears for what the Trump-driven run on the drug means for them:

Hi – lupus patients like myself need help. Pharmacies are out of stock of plaquenil. I personally called dozens of pharmacies in NYC and had friends calling in Boston. This is endangering lives. There must be something to ensure we can get this drug that we have to take daily.

— cat (@schrodingercat) March 22, 2020

Valdez, 49, has been taking Plaquenil for 15 years, and it has enabled her to work and lead a relatively normal life. Here’s what she said on Twitter on Saturday, referring to Lupus as SLE, which stands for systemic lupus erythematosus.

Please do not misuse hydroxychloroquine. This med is critical for people who have SLE, like me. I was told today that my prescription cannot be filled because the suppliers are completely out. Now I do not have the meds I actually need for an incurable disease I actually have. 🤬

— Anna Valdez, Ph.D., RN (@drannamvaldez) March 21, 2020

Valdez was diagnosed with lupus when she was 31 or 32, in the early 2000s. She was working 12-hour shifts as an emergency room nurse and felt sick all the time. She chalked it up to working hard and maybe being a little overweight. “When I really started to worry is when I had a hard time gripping a soda can or managing a syringe. That’s what drove me to get seen and get a lot of testing.”

Lupus isn’t easy to diagnose, and doctors typically work to rule out other conditions first.

The first medicine Valdez’s doctor put her on was Plaquenil, a mainstay for decades that is also used as an anti-malaria drug. “Most everybody that has lupus takes Plaquenil unless they can’t tolerate it,” she said. “It’s usually the first medication that anybody with lupus is put on. It can be protective for us. It can protect our immune system from attacking our own organs. It’s the least severe of all of the medicines that are out there.”

In Valdez’s case, Plaquenil was not enough. She takes the steroid prednisone every day, as well as CellCept, an immunosuppressant drug that reduces rejection in transplant recipients and others, in addition to a weekly injection of Benlysta, which reduces her lymphocytes, the part of white blood cells that fight the immune system.

What happens if she runs out? “I am likely going to go into a flare or I am going to have to increase other, more dangerous medicines to keep me out of a flare. I take a bunch of medicines to keep my immune system from working so it doesn’t harm me. If I have to replace it [Plaquenil] by increasing my CellCept, which is a more powerful immune suppressant, I am basically putting myself at a higher risk. I am basically increasing my risk of having very serious complications of coronavirus. I already have that risk.

“When I think about the other people out there with lupus and other autoimmune disorders, we’re all really scared right now. I haven’t left my house in nine days. I’m working completely remotely. If I get coronavirus, unlike someone else my age, almost 50 years old, who is likely to recover and will be fine, I will likely end up in the ICU.”

Making Valdez even more nervous is that her 32-year-old daughter, who lives with her and has diabetes, has come down with symptoms consistent with COVID-19: fever, shortness of breath and a cough. The daughter has quarantined herself in a bedroom and uses a bathroom that no one else uses, but Valdez worries.

“She’s not here in our area,” Valdez said. “She’s not sick enough that we feel it warrants taking her to the ER to get a test. … We’re doing everything that we can but there’s no guarantee that I won’t get it.”

Valdez is angry at Trump for recommending a drug that is unproven for COVID-19, upending the way medicine has been practiced and taking a medicine that works away from her.

“When the president stands on the stage and he makes uninformed statements that are not backed by science and are not vetted by professionals who have expertise in that area, he leads an entire massive nation to think what he says is true,” she said. “You have people running around thinking there’s a cure for coronavirus, that there’s medicine.”

Some medical researchers have raised concerns about a recently published study about the use of hydroxychloroquine in coronavirus patients, and even the nation’s top infectious disease specialist has said there is no evidence, beyond anecdotes, that it works.

More robust studies are already underway. The University of Minnesota began enrolling patients in a clinical trial last week. New York State is also going to study using hydroxychloroquine in combination with the antibiotic azithromycin to treat COVID-19 patients. New York Gov. Andrew Cuomo announced Saturday that the U.S. Food and Drug Administration is acquiring 10,000 doses of azithromycin and hydroxychloroquine to be used by New York on a trial basis.

“I spoke to the president, he spoke to this drug therapy in his press conference yesterday and I spoke to him afterward,” Cuomo said Saturday. “I said that New York would be interested and we have the most number of cases and health professionals have all recommended to me that we try it, so we’ll try it.”

As of Saturday afternoon, Valdez had 27 pills left. Now she has 25.

I asked why she didn’t just take the 10 pills the pharmacy had left.

“If I were completely out, I would have driven down there and gotten those 10,” she said. “We only take what we need, and that’s true of everything. Only take as much toilet paper as you need. Only take as much milk as you need. Or only take as much medicine as you need.”

No, President Trump, the Coronavirus Is Nothing Like H1N1 Swine Flu Either

19 Mar

by Charles Ornstein

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published.

As the coronavirus threat has escalated in recent weeks, President Donald Trump has repeatedly compared it to the U.S. handling of the H1N1 swine flu outbreak of 2009.

In three press briefings and five tweets since March 1, the president has compared his administration’s handling of the coronavirus favorably to the way President Barack Obama’s team dealt with the H1N1 outbreak, which infected 60 million Americans. This comes after Trump spent weeks saying the coronavirus paled in comparison to the seasonal flu, a comparison we debunked over the weekend.

“Interestingly, if you go back — please — if you go back to the swine flu, it was nothing like this. They didn’t do testing like this. And actually, they lost approximately 14,000 people. And they didn’t do the testing. They started thinking about testing when it was far too late,” the president said at a press briefing on March 13.

Or this on March 15:

….The USA was never set up for this, just look at the catastrophe of the H1N1 Swine Flu (Biden in charge, 17,000 people lost, very late response time), but it soon will be. Great decision to close our China, and other, borders early. Saved many lives!

— Donald J. Trump (@realDonaldTrump) March 15, 2020

The president is wrong in multiple ways.

First, the swine flu did not kill 17,000 people, as Trump maintained in his tweet. Nor did it kill 14,000, the figure he cited days earlier. The U.S. Centers for Disease Control and Prevention has estimated that H1N1 killed about 12,500 Americans between April 2009 and 2010, far fewer people than typically die each year from the flu. (Trump has gotten this figure right on other occasions.)

Second, the president’s characterization of the government’s response does not match reality. If anything, the response to H1N1 was swift in comparison to the current administration’s handling of the coronavirus.

“I assume what he’s trying to say is somehow he’s doing a much better job,” Kathleen Sebelius, secretary of health and human services under Obama, said in an interview Wednesday. “I just find that totally baffling. Anybody who looks at the comparisons very quickly understands that this is not the case.”

From First Case to Approved Test: Two Weeks

Though the H1N1 virus had begun spreading in Mexico, the first case in the United States was detected on April 15, 2009, in a 10-year-old patient in California. Two days later, CDC laboratory testing confirmed a second infection in an 8-year-old also living in California. Within one week, the CDC had activated its Emergency Operations Center to respond to what it had identified as an emerging public health threat.

Before the end of April, the government had declared a public health emergency and started releasing medical supplies and drugs from the CDC’s Strategic National Stockpile. “The real-time PCR test developed by CDC was cleared for use by diagnostic laboratories by FDA under an Emergency Use Authorization (EUA) on April 28, 2009, less than two weeks after identification of the new pandemic virus,” the CDC notes on its website.

Sebelius remembers that date well. It was the day she was sworn in as HHS secretary.

The test developed by the CDC was created quickly. It was accurate. And it was shared with governments around the world, she said. “The capacity of CDC at that point to make and develop and quickly turn out a test was vastly different than what we saw occurring” with the coronavirus, Sebelius said.

In an interview, Dr. Tom Frieden, who was CDC director under Obama, said testing for H1N1 and the United States’ willingness to share its test with other countries was a success. “I traveled all over the world and for years afterward even very hostile governments were saying thank you for sending it to us.”

Coronavirus testing, on the other hand, remains mired in delays. Though the first person in the United States was confirmed to have the virus on Jan. 20, a series of problems have kept testing out of reach for many patients with telltale symptoms of the virus. The CDC designed a flawed test for COVID-19, then it took weeks to figure out a fix so state and local labs could use it, ProPublica found. Trump said on March 6 that “anybody who wants a test gets a test,” but many doctors, patients and public health leaders say that is not the case.

On Wednesday, Ohio Gov. Mike DeWine, a Republican, said: “Testing is limited. It will, in all likelihood, remain limited.”

#COVID19 Testing: Testing is limited. It will, in all likelihood, remain limited. But please, do not fixate on testing. The vast majority of Ohioans who have symptoms do not need to be tested for the virus. If you are feeling symptoms, you should act like you have it.

— Governor Mike DeWine (@GovMikeDeWine) March 18, 2020

Vaccine Successes and Weaknesses

Almost from the day the H1N1 strain of flu was identified, researchers set out to develop a vaccine for it. Six days after the first case was identified in April 2009, the CDC began working to develop a candidate vaccine virus. Clinical trials began in July. And on Sept. 15, the Food and Drug Administration approved four 2009 H1N1 influenza vaccines. The first doses of the vaccine were available in October, and by December, 100 million doses were available to be ordered.

The vaccine production didn’t go as smoothly as officials had hoped. In October, the CDC and Frieden were called to task about the pace of the manufacturing process.

“We are now in a period where the vaccine availability is increasing steadily but far too slowly,” Frieden said at a press briefing in October 2009. “It’s frustrating to all of us. We wish there were more vaccine available. … Manufacturers are working hard to get as much vaccine out safely as possible. The vaccine strains of the virus grow and that’s how we develop vaccine. Even if you yell at them, they don’t grow faster.”

Once it was manufactured, the vaccine was distributed widely. CDC arranged for 126.9 million doses of the vaccine to be shipped to tens of thousands of medical providers. All told, about 81 million U.S. residents were vaccinated, and the strain is now a regular part of annual flu shots. I remember waiting in line with my family at a school in Bergen County, New Jersey, to get my shot. The line was long but orderly.

“The biggest problem with the H1N1 [response] is that the vaccine didn’t come on time,” Frieden said.

President Barack Obama is vaccinated against H1N1 by a White House nurse on Dec. 21, 2009.
(Pete Souza/The White House/AP)

There is no vaccine yet for the coronavirus. The disease is novel and appears to behave differently than the flu, so it will likely take longer to develop a vaccine, which would not be the fault of the Trump administration. The first patients in a clinical trial of a vaccine were given shots this week. But Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, cautioned that the process may take a year or more.

“We’re close to starting a phase 1 trial to determine safety,” Fauci said recently on CNN. “We’re going to do that in about one and a half to two months. But that doesn’t mean you have a vaccine. In order to get a vaccine that’s practically deployable for people to use, it’s going to be at least a year to a year and a half at best.”

If Trump wants to learn from H1N1, he could start readying manufacturing capabilities right now, so once the coronavirus vaccine is proven to be safe and effective, there won’t be any delay.

Coronavirus Is Not H1N1

The coronavirus that causes COVID-19 is different from the H1N1 swine flu.

Though we are still learning a lot about the coronavirus, the biggest difference appears to be the difference in mortality between the two viruses. The death rate of H1N1 was just 0.02%. By comparison, the data to date seems to indicate that the case fatality rate (the number of reported deaths divided by the reported cases) for the coronavirus is 3% to 4%, the World Health Organization reported this month. Researchers have acknowledged that number may fall over time.

Moreover, the coronavirus appears to spread more easily than H1N1. What that means is that each person who is infected will likely infect more people than a patient who had H1N1.

And who is affected by the coronavirus is also different from the patients most susceptible to death from H1N1. Deaths from COVID-19 have been concentrated in those over age 65. By comparison, H1N1 struck children and young and middle-aged adults the hardest.

It remains unclear how many people will ultimately become infected by the coronavirus, but experts at Harvard have said 20% of adults is a conservative estimate based on other pandemics and its spread so far, though many will not be tested or will have only mild symptoms. Because of its virulence, that could overwhelm hospitals and has prompted widespread calls for people to stay home. In 2009, those calls were largely confined to schools that had outbreaks of H1N1.

Lessons From H1N1

Both Sebelius and Frieden said one of the key lessons from H1N1 was the need for clear and honest communication, something they both faulted in the current coronavirus response.

Obama’s administration reacted with alarm as cases of H1N1 were initially reported. Trump, by comparison, repeatedly reassured the public that everything was under control.

“From Day 1, [Obama] said: ‘We will be led by the facts. We need to tell people what we know and what we don’t know,’” Sebelius said. She said she and her team held twice-a-day press conferences to do that.

At one point, in June 2009, Obama invited experts who helped respond to the 1976 swine flu outbreak to a private meeting at the White House. He wanted to know “what went right and what went wrong. What do we need to learn, how do we need to do this,” Sebelius said.

“I haven’t seen any of that go on with this,” she added, referring to the coronavirus.

Asked to rate his response to the crisis on a scale of 1 to 10, Trump said on March 16: “I’d rate it a 10. I think we’ve done a great job. … We were very, very, early with respect to China. And we would have a whole different situation in this country if we didn’t do that.”

Frieden said he’s been troubled by the fact that CDC officials haven’t played a more visible role in the crisis response. Instead of briefings led by CDC leaders, Trump, Vice President Mike Pence and others brief the media each day.

“The biggest concern that I see now is the lack of CDC at the table when decisions are being made and at the podium when they’re being communicated,” Frieden said. “That is a really big mistake. That has not happened before.”

“This is not the way to run a railroad. It might get better. We’ll see. I hope so. We all want them to succeed.”