Tagged CDC

Robin in the Coal Mine

            “‘Michigan is an outlier that’s profound,’ said Dr. Eric Topol, a professor of molecular medicine at Scripps Research in La Jolla, Calif. ‘This is a precedent in the country. It’s about plasticity, flexibility in responding, in being able to pivot.’ He added that tens of millions of doses were sitting unused across the country, and ‘in some states, you can’t even give them away…’ Vaccines could have been surged to Michigan weeks ago when signs of its new wave of infections were appearing, he said, like signs that are now showing up in other states, such as Minnesota. ‘We have this incredibly powerful tool, and we’re not using it…And it’s just an outright shame.’” The New York Times, April 13, 2021

            “Hi this is Michael Moore and this is an Emergency Podcast System episode… I appeal to my friends across this country and across this world: please stand for Michigan. Please come to our aid. The level of COVID cases has doubled, then it tripled, then it quadrupled…  We need to act immediately. This is a surge that’s out of control… Sadly the CDC has decided, the Biden administration has decided, not to give Michigan any more vaccines during this very sad turn of events. Now I think that’s wrong. And I think that we need to demand that the vaccine—the Pfizer vaccine that is made in Michigan, in Kalamazoo Michigan—that we get as many of these vaccines into as many arms as possible…to help put a stop to this UK variant. But if it gets ahead of the number of vaccinations…we may not catch up. And believe me there’s no Covid border around the state of Michigan. This…will happen where you live… So number one, the CDC needs to send more of the vaccine to Michigan, in hospitals, doctors, clinics, every pharmacy…This needs to happen in the next few days, not next week, not next month. The Governor of Michigan has to shut the state down…just for a little bit, this is not some long-term thing here this is just right now, immediately, to try and bring an end to this rapid, rapid epidemic in Michigan… Both are wrong; the CDC is wrong, the governor of Michigan is wrong. Let’s get this fixed right now. Please call your Congress people and your Senators at their switchboard on Capitol Hill 202-224-3121. Please contact the governors office…in Lansing, Michigan, and please go on WhiteHouse.gov and send a note to President Biden and ask him to please increase the amount of doses to the state of Michigan this week, right now, let’s not let this thing grow…it’s critical right now, this doesn’t need to happen… This just has to end. Everybody get your shot, everybody wear a mask, everybody keep your social distance and wash your hands. Be kind to each other. And politicians, the Governor, please, please…close it down just for a little bit. And the CDC: you’ve got to send us more vaccine…” Documentary filmmaker Michael Moore, Podcast #182, April 12, 2021

            “[Michigan] State Representative Steve Johnson, a Republican, said he doubted that many people would comply with a lockdown order. ‘For [Governor Whitmer] to try to continue those measures would have been political suicide,’ he said.” The New York Times, April 13, 2021

Dear Students,

The American Robin is the State Bird of Michigan, and it’s shown here singing its heart out on the graph of the new massive surge in the state. Michigan’s coal mines were tapped out decades ago, but there’s a saying about “the canary in the coal mine” that warns miners of toxic gas, not by singing but by dying.

Plenty of people in Michigan are doing that job for us in America, where we just keep digging ourselves deeper into a hole that the Michigan Robin is trying to warn us about. Of course, it’s just the Michigan population of the American Robin, just as the Michigan virus is part and parcel of good ol’ American SARS-CoV-2.

Michael Moore is right to say that Michigan’s Governor Gretchen Whitmer should ideally shut down the state again. But as that state legislator Steve Johnson points out, it would be political suicide.

If only that were the worst form of suicide it could be.

Last spring lockdowns led a Trumpist mob to stage an armed coup in the State Capitol building, a coup that actually succeeded in shutting down the legislature for several days. Obviously it was another robin in the coal mine, warning us of a similar coup attempt on our nation’s Capitol on January 6th. We have not seen the last of these.

But meanwhile, a group of deadly serious armed plotters were planning to kidnap Governor Whitmer, ending her administration, and some of them were planning to kill her. This planned assasination and coup was aborted by the FBI, but the next one may succeed. That doesn’t mean that she doesn’t have a duty to keep the people of Michigan safe, she still does.

But it’s pretty sickening when CDC Director Rochelle Walensky sits in the complete safety of her office in Washington and turns down a threatened and vulnerable Governor who is begging for vaccines. Walensky and President Biden have miserably failed the people of Michigan, and they will soon be failing much larger swaths of America, by insisting on a pigheaded policy of distributing vaccines exactly in proportion to a state’s population.

That means not only the Michigan surge but other state and regional surges to come will be ignored while millions of doses of vaccine sit unused. Biden and Walensky are already planning how to distribute internationally hundreds of millions of doses that will comprise a huge American surplus in a few weeks time.

Do I understand that vaccines take weeks to start working? Yes I do, and you know I do if you’ve been following what I’ve said all along about them. But that just means that Biden and Walensky failed Michigan weeks ago as well. Dr. Ashish Jha, one of the leading public health voices throughout the pandemic, tweeted on April 8, “This is very upsetting. Michigan is struggling. We need to be surging tests, vaccines to the state.” The idea that it is too late now is in my view absurd. Vaccines now could prevent millions of Michigan cases a few weeks down the road, even with one dose of a two-vaccine regimen.

What Walensky and others are saying to justify not doing this is a disgusting evasion. They are playing a political game. You can be that if this surge were in Texas or Florida they would not be withholding vaccine. Michigan is a blue state, like the color of the sky behind the robin. Biden’s people are afraid of seeming to favor Democrats, so they are letting Michigan and its Democratic Governor twist in the wind.

That’s the game—avoiding blame—instead of avoiding illness and death.

Walensky said, “The answer is not necessarily to give vaccine.” Not necessarily? What kind of mealy-mouthed answer is that? And, “The answer to that is to really close things down, to go back to our basics, to go back to where we were last spring, last summer, and to shut things down.”

So, Dr. Walensky, is your boss going to send troops to protect Governor Whitmer and her family? Are you going to stand beside her in Lansing when she faces another anti-lockdown mob that wants to kill her?

Michael Moore understands the value of “everybody wear a mask…keep your distance, and wash your hands.” He is also, like Governor Whitmer, begging, begging for a surge of vaccines for Michigan.

Dr. Eric Topol, whose twitter feed has been a vital source of information for me and thousands of others throughout the pandemic, thoroughly understands and promotes the tried-and-true precautionary measures, and knows, as I do, that they would be a faster response to the Michigan crisis than additional vaccines would.

He also said about extra vaccines for Michigan, “We have this incredibly powerful tool, and we’re not using it…And it’s just an outright shame.”

Where Dr. Walensky or anyone else gets the idea that vaccines and masks are substitutes for each other is beyond me. I do think however that we are watching a political game run by Biden in his Michigan vaccine-refusal gambit, just as we so often watched Trump play as President.

The irony is that Trump’s political game worked against blue states like New York and Biden’s political game is working against the blue state of Michigan.

Good News

  1. Biden’s performance in rolling out the vaccination program nationally, despite my grave reservations expressed above, has more than met expectations. I criticized him for thinking at first that a million shots in arms a day was an achievement, at a time when experts were saying 3 million a day were needed. Biden deserves credit for getting to that number as an average, with maximums up to 4.6 million. We will have 200 million jabs by the end of Biden’s first 100 days, double his original goal.
  2. Biden and his associates frequently wear masks in public and preserve social distance, setting desperately needed examples for the American people—examples which, very happily, are the opposite of what we had for the previous first year of the pandemic. Biden takes frequent opportunities to encourage these measures as well as thinking about ways to address the looming problem of vaccine hesitancy.
  3. Data continue to emerge confirming the safety and effectiveness of the two mRNA vaccines, which represent a completely novel kind of vaccine science and one of the greatest achievements in the history of medical science. In addition to safety and efficacy, the mRNA technology afforded an unprecedented platform for speed in development of the original vaccines without compromising safety, and it will continue to provide a platform for speed in the relentless arms race against new variants of the virus, allowing for the development of variant-specific new vaccines and boosters with unprecedented speed. (Read the moving story of Dr. Kati Kariko, the brilliant and heroically self-sacrificing lab-science gypsy who helped lay the mRNA groundwork.)
  4. Just in the last few weeks some uncertainty has been removed about whether fully vaccinated people can contract, carry, and pass on the virus asymptomatically. The answer increasingly appears to be, for the most part, no, even with the much more transmissable and more virulent UK variant. Also, current protection against hospitalization and death, at least with the UK variant and the main one preceding it, appears to approach 100 percent.
  5. Monoclonal antibodies (aka passive vaccinations) have continued to prove themselves as useful if not magical. They still require intravenous infusions but are increasingly doable in outpatient settings, and they prevent early cases from progressing to hospitalization. Increasingly too, they are being introduced for people who have no symptoms but positive tests for active virus and even for people who just have known exposure. Vaccines are not much use in these situations. Research on intramuscular injection of monoclonals is under way, and if successful would greatly enhance the deployment of this lifesaving technology.

Bad News

  1. The Johnson & Johnson (Janssen) vaccine has been halted because of a blood clotting problem affecting about one in a million vaccinated people (6 in the US; one died and one is gravely ill). This is a similar adverse effect to that suspected with the AstraZeneca vaccine. In both cases the nature of the clotting disorder is unusual, and so unlikely to be part of the background clotting problems expectable in such a large population. The J&J patients were women of reproductive age, suggesting an immune system problem. The halt, if it has to continue, removes a single-dose vaccine from the toolkit, a loss for the US but a much more important loss for the world.
  2. 200 million doses in American arms by the end of April (Biden’s 100 days) means 100 million people fully vaccinated, approximately 30 percent of the US population, or less than half of the level needed for herd immunity. Even adding the immunity of people who’ve had the virus doesn’t get us near herd immunity, which is at best months away—without taking the newest variants into account, with their potential for resistance against immunity and vaccines.
  3. Vaccine hesitancy, particularly common among Republican men, will play an increasingly large role as more of the country is vaccinated. Children will not even begin to be vaccinated until late summer at the earliest. Herd immunity is not a slam-dunk; it will be an increasingly uphill slog as long as vaccine acceptance is politicized.
  4. I have become increasingly convinced, thanks to Michael Osterholm who along with a few others has been arguing this for months, that we should be using our vaccine doses very differently. Namely, we should administer twice as many first doses of the two-dose vaccines rather than insisting that people get a second dose within a few weeks of the first. As Osterholm cogently argues, using two doses to give two people first doses results in 80 percent protection for both, while giving two to one person and none to the second person results in an average of 47.5 percent protection, since the two-dose person has 95 percent protection and the other has zero. Mathematical models easily show that Osterholm’s strategy gets to herd immunity faster.
  5. Last, and most important, the pandemic is not an American problem or a developed world problem but a global one, including a general threat of global instability. We have not even begun to fight the global war against the virus. Herd immunity for the world will take years to achieve. You don’t need to care about humanity, just the long-term repercussions for you. The virus loves the global stage, which is its evolutionary playground. We already have growing numbers in our country of the South Africa variant (B.1.351) and the Brazil variant (P.1). What new variants will evolve in the slowly vaccinated populations of poor countries and bounce back to us in ’22 or ’23? Stay tuned.

Michigan, the robin in the coal mine, represents what much more of America will be facing in the months ahead. If the Biden administration does not drop its political games and surge vaccine supplies to states and regions that have surging virus—whether blue or red—we will be wasting time and vaccine doses and causing preventable deaths. The time may come soon to tally up the deaths cause by the Biden administration’s sometimes willful errors, just as we have done with Trump. They won’t be as many, but they will be substantial. Biden doesn’t get a pass on a bad decision because it followed two good ones.

Also, we need to look at the evidence for Osterholm’s claim that vaccinating twice as many people once would save many thousands of lives. We only found out recently how much protection one dose of the two-dose vaccines gives us. As Dr. Topol said, “It’s about plasticity, flexibility in responding, in being able to pivot.” New knowledge brings new responsibility.

Old knowledge helps too. Mask up. Keep your distance. Avoid gatherings. Use caution until we see what the new variants can do. This is not over, not even close.

Stay safe,

Dr. K

PS: Please don’t just rely on me. The most important recent addition I have is Dr. Michael Osterholm’s weekly podcast from CIDRAP, the Center for Infectious Disease Research and Policy of the University of Minnesota; it drops on Thursdays. He combines realistic assessments and warnings with uplifting stories about how people are finding light and small victories in the pandemic. The best resource on what is happening specifically in the state of Georgia is Dr. Amber Schmidtke’s Daily Digest. More generally, I recommend the following: The Bill & Melinda Gates Foundation COVID-19 Update, aka The Optimist; for the science of viruses, especially the new coronavirus, This Week in Virology (TWiV) podcast; Dr. Sanjay Gupta’s podcast, Coronavirus: Fact vs. Fiction; COVID-19 UpToDate for medical professionals; and for the current numbers: Johns Hopkins University (JHU); Institute for Health Metrics and Evaluation (IHME); Our World in Data (OWiD); The New York Times Coronavirus Resource Center (NYT). For uncannily accurate warnings, follow @Laurie_Garrett on Twitter. I also recommend this COVID-19 Forecast Hub, which aggregates the data from dozens of mathematical models, and this integrative model based on machine learning. For an antidote to my gloom, check out the updates of Dr. Lucy McBride, who doesn’t see different facts but accentuates the positive.  

 

 

 

 

 

 

TETRIS Is Dead. So Is the CDC. And the FDA. And 188,000 Americans.

            “We are not anywhere near done with this and I think we have more days ahead of us than we have behind us.”

            Ashish Jha, MD, Harvard School of Public Health, August 28

            “The problem here is the credibility of the FDA is crumbling before our eyes. This is an agency that so many of us in the scientific world have looked up to, trusted it, we know that they have these really rigorous scientific protocols, but that’s all changed this year.”

                        Seema Yasmin, MD, Stanford University, September 2

            “Obviously there are places around the world that have been able to control this. What I’m starting to feel is the existential threat is the human behavior. I’m discouraged and frustrated… Other countries are essentially vaccinated right now, not because they have a vaccine, but because they did these things, they are back to normal. They reduced their death rates into the dozens or hundreds, not the hundreds of thousands.”

                        Sanjay Gupta, MD, Emory University, September 4

Dear Students,

You remember what TETRIS is, right?

TEsting. Contact TRacing. ISolation.

Those are the “these things” Dr. Gupta is referring to above, along with mask wearing and social distancing, that have enabled other advanced countries with large populations to have hundreds of deaths from COVID-19, while we have hundreds of thousands of deaths.

Good News:

  1. Many other countries have got this under control, and they are immediately using TETRIS to bring any new breakouts under control. Per capita hospitalizations and deaths are a tiny fraction of what they are here now, and that gap will only widen as they prevent and control their second wave—which we won’t have because never controlled the first wave, only smushed it down and smeared it, and that only a little. Our second wave will come on top of an enduring first wave.
  2. Cases per week have gone steadily down in the U.S. for at least a month, and that is good news if real. As you know I was skeptical of case rates when they were going up because politicians were saying daily that the rise was only because of more testing. Now when we know testing is going down, because it was badmouthed by politicians and the CDC recommended doing less of it. You don’t hear politicians saying one reason for the decline in case rates is less testing. Deaths, being a lagging indicator, have gone down only slightly. Also, the southern states are doing somewhat better while the midwest is having its big first wave, and the northeast is rising but from very low levels.
  3. Vaccine development is proceeding around the world. Phase III testing is going slowly and will be difficult to interpret because of marked underrecruitment of minority people, who are way overrepresented among the cases, hospitalizations, and illnesses.
  4. Finally, the sum total of well-designed research has shown that steroid treatment (like dexamethasone) reduces deaths in patients severely ill with the virus. Death rate for 1,700 people across 12 countries was 32% with steroid treatment and 40% with placebo. That amounts to saving 1 in 5 very sick COVID-19 patients who would otherwise have died.
  5. There is a lot of talk about, and even some progress in, cheap rapid testing, but the deployment of these tests has been slow due to manufacturing bottlenecks and general badmouthing of testing by politicians. Nevertheless as these tests become more available, we should make progress against our U.S. pandemic (near the world’s worst), but that would require a revival of TETRIS and a modification of behavior based on test results.
  6. The CDC has issued a mandate against evictions until January 1, as a public health measure. But the CDC does not have a police department and it will leave enforcement to local authorities. There are many exceptions that would still allow people to be evicted, and after January 1 all those protected will owe all back rent. Perhaps there will be another Congressional stimulus package by then to soften that blow.

Bad News

  1. The latest models from IHME and Johns Hopkins agree on where we are now, and the graph shows three projections as to where we are going, depending on one of threee assumptions. The most likely scenario (dark blue line) shows where we will be on January 1 if we keep on doing what we’re doing: 300,000 deaths total, and adding about 3,000 deaths a day. If we had universal mask use, that total would be around 230,000 and the daily deaths would stay under a thousand for a while in the fall before doubling or tripling again with the cold weather (more time indoors) and the flu season giving many both viruses. If we continue to have easing of social distancing mandates, we are expected to have 600,000 total deaths and almost 12,000 cases a day by years end. You will hear some politicians say that these projections have been wrong throughout in overestimating the future damage. This is a lie. Except for the very beginning when nobody knew anything, the IHME reference scenario has been too optimistic. Testing is going down or staying at low levels in most states, contact tracing is beyond inadequate, and isolation is accordingly moot.
  2. We’ve learned that infected people are most likely to infect others during the first week or ten days of significant viral load, which is why superspreader events attended by healthy people are the major U.S. source of viral spread right now. These are most likely to be indoor, largely unmasked, crowded events. Viruses linger in the air for hours in many such spaces. These superspreader events have included Mardi Gras, church services in Arkansas and elsewhere, funerals in Georgia and Ohio, and a Boston meeting of executives at Biogen, a large molecular technology company, among many others. The Sturgis motorcycle rally in South Dakota in early August has resulted in at least 70 cases so far (it’s difficult of course to track folks from an event like that). These are in addition to the well known virus petri dishes known as cruise ships, prisons, nursing homes, meatpacking plants, choir practices, and now colleges and universities. Luck matters, since one person can be a key superspreader, and neither you nor they know which one in the crowd they may be.
  3. In the past month or two there has been a wave of oh-so-careful openings of colleges and universities, and now there is a national wave of even faster closings. (See my update predicting this and explaining why it was inevitable.) Despite evidence of universities acting to cover up coronavirus cases, we know that there have been outbreaks at many, and they are rapidly spreading the virus to the local communities. As of September 3, “More than 100 colleges have reported at least 100 cases over the course of the pandemic, including dozens that have seen spikes in recent weeks as dorms have reopened and classes have started. Many of the metro areas with the most cases per capita in recent days — including Auburn, Ala.; Ames, Iowa; and Statesboro, Ga. — have hundreds of cases at universities.” Thousands upon thousands of students are now being sent home, where they will bring virus to their communities. (See my update on “Bye-Bye Grannie.”)
  4. “Sloppy coronavirus immunity” is a term that has been used to describe the handful of documented cases of people getting the virus twice (it also applies to other coronaviruses, like the common cold). At least one of the reinfected patients caught a different strain, so as you know viral evolution will play a role. It should also apply to the question of how effective any immunity from a future vaccine will be, and how long it will last. Vaccine refusal in the U.S. has been at high levels for decades, and this vaccine will be no exception, unless the rushing of it and the prior erosion of public trust swells the ranks of anti-vaxxers to unprecedented levels (especially if, as is likely, it requires two shots). Imagine a COVID-19 vaccine that gives us about the same level of protection as the seasonal flu vaccine (~50%), lasts about as long (<1 year), and is accepted by 50% of the population. So we’d have seasonal protection for a quarter of the population, have to repeat the shots every year, and we’d still have to have over a hundred million more cases and hundreds of thousands more deaths to get to herd immunity.
  5. Harold Varmus, a Nobel Laureate and former National Institutes of Health head, and Rajiv Shah, president of the Rockefeller Foundation, published an article on August 31 called, “It Has Come to This: Ignore the CDC.” Their statement is based on the latest of a series of false, incompetent, and frankly craven pronouncements of “advice” issued or changed by the political appointee at the top of that organization, obviously in response to pressure from those who appointed him, non-doctors and non-scientists all. When Stanford’s Dr. Seema Yasmin said (above), “the credibility of the FDA is crumbling before our eyes,” she was likewise referring to the latest of multiple instances of knuckling under by the political appointee directing that organization. This would be (together with the CDC) following orders from non-doctors and non-scientists in the White House to order states to prepare for widespread distribution of a vaccine by November 1 or sooner. These non-experts say that it is purely coincidental that this is two days before our national election on November 3. The vaccine will be deployed with great fanfare on the basis of far-from-complete Phase III trials, it will put minority people at greatest risk, and there will no time to find out what damage is done by this half-baked but highly touted vaccine before people vote.
  6. The principal advisor on the pandemic in the White House is now Scott Atlas, MD, a neuroradiologist and health policy wonk at Stanford’s right-wing Hoover Institution. Dr. Atlas has no qualifications in infectious disease, epidemiology, or virology, but he is happy to parrot the long-standing White House views playing down the virus. He has denied reports by several reliable sources that he argues openly in Task Force meetings with Dr. Fauci and Dr. Birx (the real experts) and he has more than hinted that he favors “herd immunity” as a strategy, which would entail far more American deaths than the huge numbers projected above. Like an overpopulated herd of deer, we would be culled.

I must say it surprised me to see the expression on Dr. Gupta’s face and hear him say he is “discouraged and frustrated.” I am too, and that’s why it’s been so long since my last update. Frankly, I expected more from him. He’s one of my greatest heros—a top-flight brain surgeon and medical school professor, the most inspired and gifted medical broadcast journalist who ever lived, and, I’m proud to say, our colleague at Emory.

My expectations for him were totally unfair. Unlike me, he has rubbed his nose in this stinking situation all day every day for eight months. Also unlike me, he probably has not had a dark view of human nature lasting a lifetime, based on a different branch of science—behavioral biology. So yes, he has a right to see the “existential threat” in “human behavior,” and he has more right than me to feel discouraged and frustrated, having worked his heart out 24/7 to prevent things from getting anywhere near this bad. Which it wouldn’t have if people had listened to him. It will still save many lives if people start listening now.

Mardi Gras: outbreaks. Memorial Day Weekend: big outbreaks. July 4th weekend: ditto.

So we’re in the Labor Day Weekend now.

What do I think is going to happen?

What do you think is going to happen?

Stay safe,

Dr. K

PPS: Please don’t rely just on me. The best resource on what is happening specifically in the state of Georgia is Dr. Amber Schmidtke’s Daily Digest. More generally, I recommend the following: The Bill & Melinda Gates Foundation COVID-19 Update, aka The Optimist; for the science of viruses, especially the new coronavirus, This Week in Virology (TWiV) podcast; Dr. Sanjay Gupta’s podcast, Coronavirus: Fact vs. Fiction; COVID-19 UpToDate for medical professionals; and for the current numbers: Johns Hopkins University (JHU); Institute for Health Metrics and Evaluation (IHME); Our World in Data (OWiD); The New York TimesCoronavirus Resource Center (NYT). For uncannily accurate warnings, follow @Laurie_Garrett on Twitter.