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SD Hydroxychloroquine Trial Sputtering: Lack of Interest or Leadership?

When Governor Kristi Noem announced that South Dakota would conduct a statewide trial of hydroxychloroquine, she rushed to her private Fox News remote studio to tell Neil Cavuto that the big experiment was about her being “a lot better being on offense than I am on defense.”

More than three weeks later, Noem looks like a quarterback who can’t inspire much offense. The number of South Dakotans trying Trump’s wonder pills remains pretty low:

Remember the South Dakota clinical trial of the antimalarial drug hydroxychloroquine? It’s off to a slow start, with just an estimated 270 COVID-19 patients signed up.

The trial, lead by Sanford Health and involving all healthcare systems in the state, was supposed to initially include 2,000 patients [“South Dakota Hydroxychloroquine Clinical Trial Off to Slow Start,” KOTA-TV, 2020.05.06].

Since Noem’s announcement last month, the Food and Drug Administration has warned that hydroxychloroquine can cause serious side effects and death. Could South Dakotans be taking seriously Donald Trump’s regular admonition that the cure shouldn’t be worse than the disease? No way, says Noem’s Health Secretary Kim Malsam-Rysdon:

“I think the numbers are low because we don’t have that many people impacted by COVID, which is a great problem to have,” Malsam-Rysdon said.

The clinical trial includes in- and outpatients throughout South Dakota and patients in other states where Sanford operates. It is primarily geared toward people who are hospitalized. In South Dakota Wednesday, just 72 people were in the hospital due to the coronavirus [KOTA-TV, 2020.05.06].

Geared toward people who are hospitalized? On April 20, Sanford Health published this article explaining that the trial wasn’t meant for people who already have COVID-19, and it wasn’t focused on hospitalized people:

This is a research study looking at whether the drug hydroxychloroquine can help prevent an individual from getting sick after they have been exposed to someone who tested positive for COVID-19.

This trial is not for people who already have COVID-19. Instead, this trial focuses on health care workers or individuals who are considered high-risk, who may have been exposed at work or in the community. People enrolled in the trial will be given either hydroxychloroquine or a placebo.

…Participants will include health care workers and high-risk individuals who have been exposed to someone with a confirmed COVID-19 positive test within the past seven days, either as close contact in the community or as a health care worker. They include:

  • Employees of any health care organization in South Dakota, with direct patient contact
  • Residents of South Dakota, regardless of health care provider
  • Any Sanford Health employee with direct patient contact, regardless of the state
  • Any patient of Sanford Health, regardless of the state

Other requirements include:

  • No known COVID-19 symptoms (fever, cough, difficulty breathing, sore throat)
  • Must be at least 18 years old
  • Non-health care workers must have one or more of the risk factors listed below.

…A study team member will review your medical history to see if you qualify, but risk factors will include:

  • Congestive heart failure
  • Asthma, COPD, emphysema
  • Organ transplant
  • Currently on immuno-suppressive drugs such as chemotherapy
  • Kidney disease
  • Cardiovascular disease such as hypertension
  • Smoking or vaping
  • Obesity
  • High cholesterol
  • Over 80 years of age [Courtney Collen, “COVID-19 FAQs: Your Clinical Trial Questions Answered,” Sanford Health, 2020.04.20]

As of yesterday, there have been 3,144 confirmed cases of coronavirus in South Dakota, with 247 people hospitalized. On Friday there were 1,044 active cases in South Dakota and 76 people hospitalized. Even if each of those currently coronavirus-stricken individuals has encountered only a quarter of the number of fellow citizens we normally meet each day, and even if we pare down the non-health care workers to only those with one of the listed risk factors (smoking? obesity? high cholesterol? high blood pressure? plenty of that in South Dakota), we should be able to identify of a pool of well over 2,000 people who’d be eligible for participation.

Either Team Noem is having trouble identifying people who are eligible for the trial suggesting that, like Trump, anti-government Noem leapt out with a splashy initiative without a real plan for effective ongoing testing and tracing, or South Dakotans are showing some good gosh-darn sense and choosing social distancing and personal restraint over quack medicine.

Related Research: An observational (i.e., not randomized, so not as solid) study conducted on 1,376 patients at a large New York City hospital and published yesterday concludes that “hydroxychloroquine administration was not associated with either a greatly lowered or an increased risk of the composite end point of intubation or death.” The hospital has updated its clinical guidance “to remove the suggestion that patients with Covid-19 be treated with hydroxychloroquine,” and the authors conclude HCQ should not be used “outside randomized clinical trials testing its efficacy.”

29 Comments

  1. Eve Fisher 2020-05-09 09:24

    Or it’s possible that the money for the study was yet another too-ripe fruit for the plucking by the various people in our state who always manage somehow to siphon it off… somewhere else. The flat out lie that “it was geared towards people who were hospitalized” tells me that right now the Health Secretary (who’s looking a little worn out these days) is tap-dancing around, hoping that no one will ask questions to which she has no answers.

  2. leslie 2020-05-09 09:35

    Trump’s “brain” should be left for medical science, like Kristi’s. Am a little worried about her quoted adviser here too. Trump had just watched addict character Al Pacino (Two for the Money 2005) for his lines: “Try it, what have you got to loose?” ANYONE following Trump’s lead on ANYTHING except grifting, has no excuse
    .

    The sooner we throw out these partisan jokes, including McConnell Kavanaugh and Gorsuch the better for this nation and the planet.

  3. Donald Pay 2020-05-09 09:43

    My supposition would be that reality intervened and medical and scientific experts and ethicists, not Trump, not Noem, not some Sanford flunky, decided the parameters and protocols for the clinical study after all. A doctor named Mengele might engage in the sort of speculative and unethical liberal experimentation described Noem, Trump and their team of sycophants, but science is fairly conservative and ethical in how it approaches such matters. Doctors, in particular, are concerned with “doing no harm,” You don’t give a powerful medication with documented potential for life-threatening side-effects without having some seriously sick people to funnel into the clinical trial.

  4. Alan Peterson 2020-05-09 10:10

    Where was this drug manufactured? Is this part of the drugs Dr. Rick Bright (whistleblower) previous head of the Biomedical Advanced Research and Development Authority, a unit of Department of Health and Human Services commented about? “I witnessed government leadership rushing blindly into a potentially dangerous situation by bringing in a non-FDA approved chloroquine from Pakistan and India, from facilities that had never been approved by the FDA,” Bright said on a call with reporters earlier this week.

  5. Dana P 2020-05-09 10:31

    ‘Self Promotion and Auditioning for Trump Cabinet Position’ —- She’s on it!

    and the statement by Noem’s supposed health secretary –“I think the numbers are low because we don’t have that many people impacted by COVID, which is a great problem to have,” Malsam-Rysdon said.

    oofdah. Dear Kim, it is because we aren’t doing enough testing.

  6. Loren 2020-05-09 10:43

    Kristi, a true Trumpette, following the path of her heroes… Fire…Aim…Ready!

  7. Francis Schaffer 2020-05-09 11:59

    Well, she didn’t latch onto the medical study for injecting of disinfectant, or UV light bulbs

  8. mike from iowa 2020-05-09 12:12

    https://time.com/5833945/hydroxychloroquine-coronavirus-study/

    Hydroxychloroquine Fails to Help Coronavirus Patients in Largest Study of the Drug to Date

    Fullscreen
    BY ALICE PARK
    MAY 7, 2020 7:21 PM EDT
    In a study published in the New England Journal of Medicine, scientists led by a team at Columbia University found that people infected with COVID-19 taking hydroxychloroquine do not fare better than those not receiving the drug.

  9. mike from iowa 2020-05-09 12:25

    71.9k deaths so far. someone better find something quick. Get rid of drumpf and criminal en terprise first.

  10. o 2020-05-09 12:59

    But this is how GOP rhetoric process always works: shoot an outrageous claim from the hip; a claim that you have no authority of expertise to make (a claim real experts in the feild do NOT make); the claim gets tested in the real world and bears out to be untrue; stay the course and just don’t talk about it.

    It works for GOP economics; it works for GOP foreign policy; why wouldn’t it work for GOP medicine?

  11. Donald Pay 2020-05-09 13:21

    o,

    Science involves testing out someone’s hypothesis, even what seem to be crackpot ideas, so I don’t have a problem with the clinical trials. DNA as the genetic material was considered a bit crackpot at one point. The problem I have is pushing snake oil when it hasn’t been tested, or pushing it in the face of repeated failures. I also don’t like politicians pushing pet theories over other hypotheses that are more soundly science-based.

  12. jerry 2020-05-09 14:03

    Plus, Sanford gets big bucks for this. Important as their elective surgery’s (the money makers) have dried up due to the virus. And you thought it was just NOem who was in on the grift. Wait until the first of June when all bets are off on charging for Covid19.

  13. Moses6 2020-05-09 16:15

    I laugh every time she talks about people like she really cares what a joke as a leader.

  14. Debbo 2020-05-09 16:27

    Kruel Kristi is following her Sugar Daddy. It’s not about the truth of the matter. Just make the outrageous claim and move on. Brainless Bozo does it all the time. “I’m going to do this thing, I’m going to do that thing, etc.” Doesn’t matter that he never even begins. He just states it for the sound bite.

    That’s exactly what Kruel Kristi has done here. When questioned, stick a subordinate’s face in front of the camera to make excuses and otherwise lie while she moves on to the next $hitshow.

  15. Robin Friday 2020-05-09 16:47

    I have hypothesized all along that this “study” in SD was a quid pro quo. It happened about the time that Noem was talking to the White House, begging for testing, tracing and PPE, and Trump was pushing HCQ as a treatment. I can visualize Trump saying, “we need a little favor, though”. Hence the “studies” in SD of HCQ.

  16. mike from iowa 2020-05-09 17:19

    With such a small pool of usable volunteers this study is bound to fail.

  17. Robin Friday 2020-05-09 18:20

    yes, indeed, Mike, but Trump is too ignorant to know that, and Noem probably had that premonition, but she’ll go along with him, whatever he wants.

  18. jerry 2020-05-09 18:48

    The trumpian republican death star now says 100,000 American dead is cool with them. I’m sure we’ll be hearing an earful about abortion coming into the election cycle right soon like. Nothing like war crimes against your own people to seal the deal though.

  19. John 2020-05-09 21:26

    The orange man and NOEM cannot protect us. The virus is running in the White House: presidential valet, VP spokeswoman – spouse to POTUS advisor Stephen Miller, Ivanka’s personal assistant, over 12 Secret Service agents are self-quarenteening, heads of the FDA, CDC, and even Dr. Fauci are self-quarenteening, and South Dakota hit a new daily high of cases. Couple the Sioux Falls area cases with the Sioux City area cases — and Noem has a problem she’s unfit to address.
    https://www.cnn.com/2020/05/09/opinions/coronavirus-cases-in-the-white-house-presidential-weekly-briefing-vinograd/index.html
    https://kdat.com/county-in-western-iowa-named-national-coronavirus-hotspot/

  20. John 2020-05-09 23:35

    Meanwhile . . . there are pork shortages in the US while the US exports pork hand over fist to China.
    https://www.reuters.com/article/us-usa-pork-braun/us-faces-meat-shortage-while-its-pork-exports-to-china-soar-braun-idUSKBN22H2Q6
    You can’t make this stuff up.

    Meanwhile, the orange man wants to take control of the board for the federal retirement Thrift Savings Program because . . . they have investments in the world’s second largest economy.
    Federal retirees and workers should consider transferring their funds to an IRA or Roth IRA from the TSP.
    Politicizing pensions and retirement accounts always ends badly for the retirees.
    https://www.govexec.com/pay-benefits/2020/05/trump-moves-replace-tsp-board-members-prompting-concerns-politicization/165196/

  21. Moses6 2020-05-09 23:43

    this fizzled about like her meth ads can we do better than this.

  22. Eve Fisher 2020-05-10 07:57

    Meanwhile, the latest photograph of the President with military leaders was of them all sitting, less than 6 feet apart, in a relatively small room, with no masks anywhere in sight. I know, real men don’t wear masks. But they do wear ventilators.

  23. mike from iowa 2020-05-10 08:43

    Body count for drumpf passed 80k overnight. Will hit 100k long before August ever gets here. And the Hydroxyhoax will still be a jokeless hoax pushed by the worst czarina ever.

  24. Cory Allen Heidelberger Post author | 2020-05-10 11:00

    We need serious accounting for this HCQ trial. Where did the money come from, exactly how much money was allocated, and where exactly did the money go? If we don’t get 2,000 volunteers, will money be refunded?

  25. grudznick 2020-05-10 11:09

    Indeed. How much does this HCQ cost and will be be at Walgreens soon?

  26. Peg Detmers 2020-05-10 12:17

    As a biologist I have been keeping tract of the trials on Hydroxychloroquine on the NIH.gov website. The level that is needed to arrest the virus is a dose much higher than the dose needed to arrest malaria. The high dose causes heart damage, and other serious health threats in many of the “test subjects”, i.e. human beings. That is what the trials show and why the NIH advised against it BEFORE Noem’s SD trials!

  27. chris 2020-05-11 01:54

    MIight’ve worked, who knows? The theory was HClQ was a zinc ionosphore which meant that it would let zinc into the cell membrane to interfere with viral reproduction. Impossible to run a study with 2 variables. The word was it worked in S. Korea at first. Sorry to see Sanford dragged into a scam meant to vindicate Trump’s mafia. Maybe test it out in Russia…

  28. Debbo 2020-05-25 17:23

    “The World Health Organization cited a scientific study published last week suggesting that proposed COVID-19 drug hydroxychloroqine may do more harm than good in halting its study to review data. The medical journal The Lancet reported on Friday that patients getting hydroxychloroquine were dying at higher rates than other coronavirus patients. The WHO’s trial had involved 3,500 patients from 17 countries.”

    NPR

  29. Darla Gay 2020-06-22 15:58

    I was not aware of your paper. Thank you for facts l was looking for.
    I will be following your paper, with much enthusiasm. I am from Ct. & moved here in 2000.
    Being retired l am careful with my budget. I love seeing likeminded people here in SD.
    Thanks again.

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