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j/c...

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Two P.R. Experts at F.D.A. Have Been Ousted After Blood Plasma Fiasco

The agency’s chief spokeswoman, Emily Miller, was removed from her position just 11 days into the job. And the contract was terminated of a consultant who had advised the F.D.A. chief to correct misleading claims about plasma’s benefits.

By Sheila Kaplan and Katie Thomas

Aug. 28, 2020
link

The head of the Food and Drug Administration ousted its top spokeswoman from her position on Friday in an urgent bid to restore the tarnished credibility of the agency after he made erroneous claims that overstated the benefits of plasma treatments for Covid-19 at a news conference with President Trump.

The decision came just a day after the F.D.A.’s parent agency, the Department of Health and Human Services, terminated the contract of a public relations consultant who had advised the F.D.A. commissioner, Dr. Stephen M. Hahn, to correct his misleading claims that 35 out of 100 Covid-19 patients “would have been saved because of the administration of plasma.”

The removals come at a moment when the agency, which will be making critical decisions about whether to approve coronavirus vaccines and treatments, is struggling to salvage its reputation as a neutral scientific arbiter.

The ousted spokeswoman, Emily Miller, had little experience in health care. She had spent years working in Washington for Republicans, including the former Texas Congressman Tom DeLay and Senator Ted Cruz of Texas, and as a journalist for One America News, the conservative cable network. She was in her agency post for just 11 days.

“This is a low moment for the F.D.A. in at least a generation,” Daniel Carpenter, a professor at Harvard University who studies the agency, said of Dr. Hahn’s failure to control the public message about the plasma authorization. “This was a major self-inflicted wound.”

The most recent controversy over plasma follows a series of missteps by the F.D.A. that have fueled concerns that the agency is losing the public’s trust as the nation faces a presidential election in November and a pandemic that has taken more than 180,000 American lives.

Also this week, the nation’s premier public health agency, the Centers for Disease Control and Prevention, was accused of bowing to political pressure after it revised its testing guidelines to say people without symptoms of the virus didn’t need to get tested.

Dr. Hahn has already been criticized for a series of worrisome actions, including authorizing the emergency use of two malaria drugs Mr. Trump had favored — a decision that was later revoked — and for having allowed the sale of shoddy antibody tests early in the U.S. outbreak.

“The agency needs to work very hard to regain the trust of the American people — there have been too many unforced errors,” said Dr. David A. Kessler, who was F.D.A. commissioner under Presidents George Bush and Clinton, and is advising Joseph R. Biden Jr.’s presidential campaign. “It needs to focus on what it does best, which is to put the data in front of the medical and scientific community and the American public, and stick with the data.”

Dr. Hahn notified senior leadership at the F.D.A. on Friday that Ms. Miller would no longer be the official spokeswoman for the agency, and that he would be appointing someone to replace her in an interim capacity. Ms. Miller could not be reached for comment.

The consultant who was removed by the health and human services department, Wayne L. Pines, said he wasn’t told why his contract was severed.

“I did recommend that he correct the record,” he said. “If a federal official doesn’t say something right, and chooses to clarify and say that the criticism is justified, that’s refreshing.”

The Department of Health and Human Services denied that Mr. Pines’s contract was terminated because of his involvement in the plasma messaging.

It was “100 percent coincidence,” said Brian Harrison, the department’s chief of staff. “H.H.S. has been reviewing and canceling similar contracts, so I had it sent to our lawyers, who recommended termination. This was routine,” he said.

Nevertheless, the decision by Dr. Hahn to clarify his remarks and to grant a series of media interviews appears to have rankled H.H.S. officials, who saw it as ill-timed, given that the Republican convention was underway. Trump administration officials are often reluctant to publicly admit error out of concern that doing so provides political ammunition to their critics.

Mr. Pines is president of the large health care practice at APCO Worldwide, a public relations and lobbying firm that represents health companies that do business before the F.D.A. He said he did this work on his own, outside of his APCO practice. He would not say how much he was paid, but noted that as a friend to Dr. Hahn, he is willing to continue advising him for free.

Meredith McGehee, executive director of Issue One, which promotes bipartisan political reform, was critical of the contract, noting the potential for conflicts of interest in Mr. Pines’s work for the F.D.A., and his company’s health care client base.

“This notion that, ‘Oh, I’m doing it in my private capacity, on the one hand, and I’m representing health care interests, on the other,’ it doesn’t pass the smell test,” said Ms. McGehee.

The F.D.A. did not respond to requests for comment on Friday about Mr. Pines’s contract or whether it was vetted for conflicts of interest.

Ms. Miller started at the agency on Aug. 17 after a career in both politics and journalism. In 2004, while working for the Department of State, she made headlines after she apparently cut off an interview for a taped segment between Tim Russert, the host of NBC’s “Meet the Press,” and her boss, the then Secretary of State Colin L. Powell, who could be heard apologizing to Mr. Russert and saying “Emily, get out of the way.” In 2015, reporters cast doubt on whether Ms. Miller had been a victim of a home invasion, a story that she had repeatedly included in public remarks and in a book, “Emily Gets Her Gun: But Obama Wants to Take Yours.”

The decision to hire Ms. Miller as the agency’s top spokeswoman was seen as puzzling by outside observers, given that she had little experience in health care. On May 30, Ms. Miller tweeted, “Remember coronavirus?”

The F.D.A. had been considering allowing the use of convalescent plasma as a treatment for Covid-19 on an emergency basis, but last week The New York Times reported that the decision had been delayed after top health officials Dr. Francis S. Collins and Dr. Anthony S. Fauci intervened and expressed concern that the available evidence on the effectiveness of the treatment was too weak. F.D.A. officials argued that although the data was preliminary and needed continued analysis as more patients are treated, plasma still met the agency’s standard for emergency use authorization.

On Saturday morning, Mr. Trump tweeted that the “deep state” at the F.D.A. was slowing drug development. Late that night, the White House press secretary tweeted that the president would have a news conference the next day “concerning a major therapeutic breakthrough.”

The announcement should have been a rare win for the F.D.A., which for months had fended off criticism of its track record on the pandemic, and questions about the independence of Dr. Hahn, who was previously pressured by Mr. Trump to authorize malaria drugs that turned out to be ineffective for Covid-19 and carried risks of harmful side effects. But last weekend, finally, the agency could reveal some legitimate good news: convalescent plasma, the antibody-rich plasma donated by Covid-19 survivors, showed promise for a subset of patients when given early.

The announcement, made at the White House on Sunday, has instead spurred a week of recriminations, anger and mistrust between the F.D.A. and H.H.S. The officials’ statements Sunday cast nuanced and preliminary data as “a very historic breakthrough,” as Mr. Trump put it. The exaggerated statements drew criticism from scientists and at least three former agency commissioners.

Within the F.D.A. and H.H.S., officials have offered conflicting accounts for how a single misleading statistic — that plasma led to a 35 percent reduction in deaths — appeared in the remarks of Mr. Trump, Dr. Hahn and Alex. M. Azar II, the health and human services secretary. It was also unclear why Dr. Hahn, a longtime cancer doctor, and Mr. Azar, a former pharmaceutical executive, did not themselves catch the overstated statistic. No randomized trials have found a survival benefit for convalescent plasma. The 35 percent number referred to a tiny subset of patients, and was a relative comparison between two groups, not an absolute reduction in deaths.

At a speech at the convention on Thursday evening, the president again overstated what’s known about the benefits of plasma, promising it “will save thousands and thousands of lives.”

Missteps by the F.D.A., a federal agency that has long prided itself on its scientific independence, have heightened concerns that the American public may not be willing to take a vaccine approved by the agency, particularly if the decision is seen as having been made under pressure from Mr. Trump.

“It’s very important for the leadership of the agency, especially the commissioner, to be accurate about the information he’s providing and to do it in a way that really sticks to the facts,” said Dr. Mark McClellan, who was F.D.A. commissioner under President George W. Bush.

“There’s almost not enough adjectives to describe how appalling this is,” said Emily K. Brunson, a medical anthropologist at Texas State University. Opinion polls have shown that many Americans are already wary of taking a vaccine for the virus.

If approval of a vaccine is viewed as politically motivated, she said, “it has the potential to really make this a disastrous situation.”

Sharon LaFraniere and Maggie Haberman contributed reporting.

Damn the WH has more turnover than a fast food restaurant.

Or a strip club.

I don't go to fast food joints or strip clubs, so I don't know if you mean that's a lot of turnover or not. Care to educate us about the inner-workings of those places?

What a coincidence... my favorite dancer was named "Cherry Turnover"...

Like

Just think 40. How disappointed the dem party would be if we beat covid19 cause their counting on it to win the election for pres in November watta a sad group of people...IMO

Of the sales staff at a car dealership

I liked her sister.

Pop Tart

Somebody would have to form an actual plan for that to happen. We've been waiting for that since February. It would have been nice because that would have saved thousands upon thousands of Americans. But it didn't.

You can quit pointing the finger at everyone else for that. Trump is doing a great job of that all by himself.

Being on the front lines you must know the Covid numbers are being played and hyped. Perhaps your bias won't allow you to see it.

I talk to a lot of medical people on a regular basis, family friends acquaintance, Doctors Surgeons Nurses Medical Billing Specialists.

They tell me the numbers are being hyped as hospitals get paid more for Covid patients than regular patients.

They tell me of those who tested positive and were retested later, 2 or 3 times, one woman retested 6 times, and each further positive test is listed as a new positive for the records.

Even a news story of 30 people catching the virus when they attended an event and no one, not one, ever developed more than the sniffles.

183,000 deaths and climbing. And this is the BS we still have to hear.

I'll not comment on the fact that you think that through "extensivve talks" that you claim to have with all levels of medical professionals is supposed to make you more knowledgeable or credible than the guy who is working it every day ... and I'll set aside the idea that as one of the most impartial posters ever to hit a keyboard stroke on this board you could possibly question another posters impartiality, one who has demonstrated a consistent ability to think for himself instead of spew party line propaganda ....

Leaving that aside - it appears you think that the reporting of positive CV-19 is over reported and that actual cases are lower? If so I find it odd that a lot of what I read (from the scientists) talks about how long the virus has been here, undetected before we caught on. A lot of what I read (from the scientists) tends to suggest that the numbers are probably significantly under reported.

I don't know the validity of testing someone 7 times and reporting the 7 tests as 7 positive results instead of a single case. That would be flat wrong. Maybe someone can supply proof of such a wild claim? Or did that tidbit come from your wife's, cousin's, brother's stepson's, schoolteacher's sister?

Fact Check: Ohio does not count multiple positive coronavirus tests as new cases
Jackie Borchardt
Cincinnati Enquirer
Ohio is not counting multiple positive coronavirus tests as new cases, an Ohio Department of Health spokeswoman confirmed to The Enquirer.
A theory has been circulating social media in recent weeks that Ohio’s surge in coronavirus cases is due to people taking multiple tests and having those positive results count as new cases.

But the Ohio Department of Health says there's no evidence to support that.

The claim made it to cable TV on Wednesday, when a guest on Fox News’ The Ingraham Angle repeated it and cited a "Twitter exchange" that included inaccurate information. And Ohio House Speaker Larry Householder mentioned the double-counting theory to reporters on Thursday as an example of how people are questioning state data.

What happens if a person takes multiple tests? Those tests are added to the person's case file; not as new separate cases, health department spokeswoman Melanie Amato told The Enquirer.


Case data and test data are reported to the agency separately, she said, and epidemiologists also review cases and will merge records, if appropriate.

How positive tests are reported
When someone tests positive for the virus the first time, the result must be reported to the Ohio Department of Health within 24 hours. The test is reported with the person’s name, birth date, address and other information in the Ohio Disease Reporting System and that person becomes a confirmed case.


If that person takes another test for active infection in three weeks, maybe as part of a return-to-work protocol, and gets a positive result, the result would be recorded as a multiple test in the person’s case file but not as a new case.

[ The Enquirer is providing most of its coronavirus-related stories free to readers. We can’t do this work without your support. Please consider a digital subscription to Cincinnati.com. ]

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The test would separately be reported to the state as part of the labs’ daily test reports. It would be displayed on the state’s website in the cumulative “total tests administered” number as well as in the testing and percent positive chart.

Both numbers lag two days to allow for more complete collection. Through July 12, the state reports there were 68,202 positive test results. Separately, the cumulative confirmed case count reported July 12 was nearly 7,000 less: 61,669.

Negative tests are not required to be reported for each case. But each day's number of negatives is reported. Amato said the agency is working with labs to get individual-level data on negative tests, tests not performed and indeterminate tests.

Multiples in the state’s spreadsheet?
One of the reasons people suspected double counting, and cited by Ingraham’s guest, is the way the data is exported to a public spreadsheet on the state's coronavirus website.

Instead of showing one row for each case, cases are consolidated within the row if they share common characteristics such as the same county, age group and date they became ill or were hospitalized.

The example mentioned on Fox News by Phil Kerpen, of the conservative economic advocacy group Committee to Unleash Prosperity, was 15 cases counted on one line for individuals of unknown gender age 80+ in Mahoning County.

The Ohio Department of Health's public coronavirus data file consolidates coronavirus patients who share criteria such as age range, sex and date tested.
That does not mean one person has had 15 positive coronavirus tests.

What actually happened: 15 Mahoning County residents around the same age were tested on the same day and received positive results, according to Mahoning County Public Health. They were likely nursing home residents participating in mass testing.

The Twitter user, Ohio sports podcaster Kyle Lamb, later deleted his tweet about the multiple count.

That blew up yet another conspiracy theory.

But damn it sounded good to the Trump supporters to repeat those lies. #itsafactthatfactsdonotmatter

https://www.foxnews.com/media/ingraham-angle-coronavirus-repeat-tests-double-counting

https://www.wthr.com/article/news/health...8f-d0df32c834c1

This link goes to the covid death rate possibly being inflated: https://www.realclearpolitics.com/articles/2020/05/29/us_covid-19_death_toll_is_inflated.html#!


As to your other point/question about covid possibly being over reported. I don't think it is over reported - as far as number of cases.

In fact, a few weeks ago, someone from I believe the cdc stated that there may be as many as 10-15 times MORE cases than have been reported.

I believe that sincerely. In Dec, my daughter, and 2 friends, had what was then called "the crud", the 2 friends even went to a doctor. Lasted about 3-4 weeks.

I got "the crud" in January. Symptoms? Exhausted. stuffy nose way up in the sinus cavity, dry throat so bad I'd wake up at night feeling like I couldn't breath. Sore throat, had the craps, wake up literally drenched in sweat, appetite gone - not a single thing sounded or tasted good. Many other symptoms also.

I didn't go to a doctor, because I figured I got 'the crud' from my daughter, and she had gotten it from college. (she had the same symptoms as me. She's young, healthy, etc). We don't have a thermometer, so neither of us took our temps.

Yeah, I sincerely believe the number of cases is much higher than the reported number. I also believe covid deaths are, and here's where it gets tricky: Over counted as "died from covid" as opposed to "died WITH covid". And I say tricky because depending on one's view, 'from' or 'with' can mean different things. As in, the person that had cancer and was dying anyway, sure, covid was a contributor. The obese 65 year old high blood pressure having, heart disease having, diabetic.....did covid contribute? Yeah, probably. Was covid the true CAUSE? Hard to say.

Yes, I'm sure the number of cases is actually much higher - which is actually good news.

Well, that clears up the first link I had. Thanks.

"Possibly".

Well the response was to 40 ... who seemed to imply the opposite of what you and I both believe. As Pit mentioned - the big thing in that article is "Possibly" ... we've seen a post and a flat denial that double (and 7 times counting) is definitely not happening in Ohio. Who knows - it seems completely obvious to anyone and everyone that if you test someone 4 times and get 4 positive results ... that is ONE positive 'case'. To count it any other way is flat wrong.

As for under-counting being good - I'm not sure. If we were aiming for herd immunity, then maybe... probably. But we've seen a strong amount of science pointing to immunity being short lived. So maybe it makes no difference. From the mortality rate? Maybe that would be a positive. Personally I still think the more accurate date you have on everyone - sick or asymptomatic - the better. I'd like the clearest insight possible for those that study these things to make the best forecasts and predictions.

I don't see any POSSIBLE way that the numbers of cases is accurate. I think it's way higher. And that's a good thing. If the actual numbers are even 10 times higher........look what that does to the hospitalization rate, what it does to the death rate.

As for what pit says? If I said 1+1=2, pit would find some way to attempt to prove me wrong, or attempt to belittle me.

There is zero chance the numbers are accurate.

If I had to guess, I agree with you. The number of cases is actually higher and the number of deaths is actually lower.

I'm sorry you can't comprehend what "possibly" means. Speaking of the pot calling the kettle black.

I think the number of infected is higher. I don't know by what factor.

I do not agree the number of deaths is lower ... or if the death rate is inaccurate it single percentage point(s) and could be a little higher or lower.

It's just like I don't believe that this whole thing and the reporting of it is a Democratic manipulation to suppress the economy and oust Trump. For either of those things to be true - then the entire world would need to be coordinating their efforts. I think the death rate is about right and is about what we see in most countries. Media coverage is 24/7 in every country. Economies are crushed everywhere.

Dude, there is NO doubt the number of cases is much, much higher than reported. NO doubt. If you doubt that, you probably believe China's reported numbers.


The point is, with the total actual cases being as much as 15% higher, or even 10% higher, the hospitalization rates and death rates are much, much lower.

Doesn't mean to not take this seriously, ok? But I guarantee the numbers of infected/were infected is much much higher.

Again I agree. And if anything I would think the number of infected is more than that 15-20% you quoted in your post. Just opinion, but I think the differential is more than that, maybe as much as 50-100% .... yes it impacts a number of things and probably in a favorable light, but we still don't know enough.

Every single model that anybody uses in the literature has a huge number of "dark cases" - unless you are arguing that the dark case number is wrong, then this is not exactly news.

The best guess should be around 30-35M cases in the US thus far. Reasonable uncertainty on that could put you in the 20-50M range, I think it is very unlikely that you are outside of that.

But ~200,000 deaths seems pretty accurate. If anything, the total mortality this year (compared to previous years) indicates that we are undercounting deaths, rather than overcounting.

I saw / heard the same report. Interesting how they have that much data/statistics/analytics to predict/review something like that. Ha, we have managed to bring Analytics to the PP forum!

j/c:

Here's the Shockingly Small Number of People Who Died From Only the Coronavirus

The Centers for Disease Control and Prevention (CDC) website disclosed the shockingly small number of people who died from only the Wuhan coronavirus, with no other cause of death mentioned. Hold on to your hat because here it is: out of the 161,392 deaths in the CDC data, just six percent, about 9,700 deaths, were attributed to the coronavirus alone. According to the CDC, the other 94 percent had an average of 2.6 additional conditions or causes of deaths, such as heart disease, diabetes, and sepsis.

https://townhall.com/tipsheet/bronsonsto...avirus-n2575306

Kinda what I've been saying, but, politically, those facts don't condemn trump. Therefore, the loudmouths on here won't believe it.

Since that aligns with what I believe, I am giving it max credibility.

This is the table to look at (scroll down a bit)

https://www.cdc.gov/nchs/nvss/vsrr/covid19/excess_deaths.htm

J/C

People don't die from AIDS. People die from complications due to AIDS.

Covid works the same way.

Please educate yourselves.

I copied the most relevant part of the CDC data here:

https://imgur.com/vIjRDMj

For some reason the upper limits are listed separately below.

What you should do is take Observed Deaths - ATTR, to get the excess number of deaths compared to a typical year.

If I can type numbers into a calculator correctly (always a risk) then that is:


1292343 Observed Deaths between March 21 - August 8
1071981 Expected Deaths between March 21 - August 8 (based on previous years, and differences in population)

= 220,362 Excess Deaths between March 21 and August 8 this year compared to a typical year


===============

60640+61749+62177+61321+61145+59924+58956+58349+58432+59252+60071+62049+64953+67278+69668+74186+77086+79360+72525+63222 = 1292343

51695+51751+51912+52076+52204+52331+52313+52670+52710+52890+53054+53254+53564+53950+54420+55076+55683+56258+56809+57361 = 1071981

FDA chief walks back comments on effectiveness of coronavirus plasma treatment

https://www.cnbc.com/2020/08/25/fda-chie...-treatment.html

j/c

U.S. Won’t Join Global Coronavirus Vaccine Effort Because It’s Led By The WHO

https://www.forbes.com/sites/tommybeer/2...o/#3cfb92c75876