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Trouble at the FDA and CDC

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That title is the only way that I can describe the events of the last few days. Like so many other things this year, what we’re seeing now at the top of the drug regulatory structure is unprecedented, and not in a good way at all. Let’s recap.

A few days ago, HHS Secretary Alex Azar sent out what has to be considered a very unusual memo. Its key point (as written) is:

The authority to sign and issue any rule for which notice and comment would normally be required, irrespective of whether notice and comment is waived, is reserved for the Secretary. Any prior delegation of rulemaking authority, including the authority to sign or issue a rule or a proposed rule, is rescinded

Now, there’s a lot of disagreement about just what that means. The New York Times, in that link above, says that this change has been talked about for some time and is an assertion of HHS power over FDA decisions – and furthermore says that former FDA head Scott Gottlieb was fighting against such a change during his tenure. HHS has gone so far as to issue a statement trying to clarify this, saying that “The memo should have no effect on operational work and does not pertain in any way to guidances or any vaccine or drug approval or authorization. This action will not slow any HHS agencies’ work. It is simply the ministerial, administrative act of attaching a signature to a document“. The statement goes on to say that this will forestall challenges to regulations on the basis that the people issuing them did not have the proper authority to do so.

How often has that happened, exactly? And doesn’t that mean that any FDA approvals or rule changes will have no force unless the Secretary sees fit to attach that signature? Giving that Secretary that power to overrule them as he or she sees fit? And even if that’s not the memo’s intention – and I’m not convinced that it isn’t – wouldn’t this seem to be a very funny time to be promulgating such a rule, what with so many people worrying about what has been obvious political interference in the work of the FDA and CDC? And yes, I know that there will be people who will say that they haven’t seen evidence of such interference, but I’m not having it – look at the position the CDC has been put in, more than once, of having to say what the White House wants rather than what their own staff recommend.

And then there’s the case of Michael Caputo. He’s a political ally of the President who was put in as chief spokesman for HHS and is now taking medical leave after a bizarre Facebook rant where he accused the CDC of committing “sedition” against the president, that “the deep state scientists want America sick through November” and had earlier made comments about “ulterior deep state motives in the bowels of CDC”. I was actually not going to comment on this weird situation, figuring that Caputo himself had had some sort of breakdown, had apologized, and deserved a respite, but now I see that he’s publicly standing by his remarks and resents the idea that he has any sort of mental problems. So we should let him own this crap.

But why stop there when talking about political interference? The Times has also reported that the FDA is planning stricter guidelines for coronavirus vaccine approval, including clearer cutoffs for efficacy, separate advisory committee meetings for each vaccine, etc. But yesterday, the president let it be known that he doesn’t necessarily want anything of the kind:

That has to be approved by the White House,” he said, adding, “We may or may not approve it.” Raising questions about why vaccine makers would want to delay the process, he said, “We are looking at that, but I think that was a political move more than anything else.”

“We are looking at that” is one of Trump’s tropes, along with “many people are saying” and how everything is coming in two weeks, etc. But the suggestion that the FDA (and the drug companies themselves?) are deliberately dragging their feet on a vaccine is (A) wrong, (B) extremely harmful to public perception of the whole effort and to its eventual success, and (C) an insult that it itself beneath contempt. Oh yeah, and it’s (D) a direct slap in the face to Trump’s own FDA Commissioner, Stephen Hahn.

Earlier in the day, Hahn (and the heads of other agencies) had been in front of Congress, saying that they would not allow political pressure to take over from a scientific evaluation of the vaccine work. And Trump’s statement is what he gets for his trouble. The honorable thing to do would be to resign, honestly, but working for Donald Trump often seems to put people in a position where they feel that doing the honorable thing is an option that’s been closed off. Will Hahn stick up for his agency now? Or can he, since Sec. Azar has said that he has to sign off on anything of any importance? What a mess. What an absolute mess, and it didn’t have to be this way. None of it had to be this way.

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petrilli
4 days ago
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Honorable people do not choose to work for Trump.
Arlington, VA
acdha
3 days ago
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Washington, DC
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Convalescent Plasma: The Science and the Politics

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I suppose that I’m going to have to say something about yesterday’s convalescent plasma announcement. First, the medical aspects: in my view, for what that’s worth, convalescent plasma is likely to be at least somewhat helpful to hospitalized coronavirus patients. I think that its safety profile is likely to be good as well, and I really have no problem with it being used.

There are downsides. It’s labor-intensive, since it needs blood donation from recovered patients, processing of their blood to obtain the plasma, pooling of these plasma samples and re-portioning all this for dosing, and finally i.v. administration to the current patients themselves. None of these are onerous by themselves, but it does add up, and remember that you need plenty of donors to make an impact, given how much plasma needs to be dosed. Another problem: as we have seen from the convalescent plasma comparators in the vaccine trial data, the antibody levels in these plasma donations is quite variable. Thus the need for pooling, because otherwise you would have a wildly differing product. Many of the convalescent plasma antibodies that will be given to the current patients will be of no use against the coronavirus (they’re random or targeted to other pathogens entirely, so ideally you’d want donors who are still showing a high neutralizing titer. What I don’t know is whether every donor is going to be screened in this way (which adds more to the labor, of course). You run the risk of having a few donors who have a great antibody profile being diluted down by a larger number of people with low titers, of course.

All of these considerations are taken care of by dosing monoclonal antibodies instead of the isolated antibody fractions, and as mAbs become more available, I would expect convalescent plasma to become less widely used. There are costs and production aspects to rolling out mAbs, but biologically, they are the perfected version of what convalescent plasma is trying to achieve.

But that brings up the second topic, the regulatory and organizational aspects of all this. It’s nearly September. We’ve been dealing with this pandemic for months now in the US, and let’s be honest: convalescent plasma is generally considered an emergency stopgap while you try to come up with something else. The problem is that we still haven’t generated any controlled clinical data on how useful it is. The Mayo-led data that were talked about during yesterday’s press conference had no control group, making that key question impossible to really answer. This shows the perverse danger of being too free with emergency use. If you just turn everyone loose on a bunch of therapies, they will be used under all sorts of conditions and the chances of getting a useful read on any of them go down. Look at our current situation: we have data on over 35,000 patients who have received convalescent plasma, but we still don’t have a good comparison to not receiving it. It shouldn’t have happened this way.

I know that there was a figure of 35% being helped/saved by the plasma treatment being used at yesterday’s press conference, but unfortunately, that’s just plain wrong. FDA Commissioner Hahn used the phrase “35% improvement in survival”, but that merely makes him look like a fool (and like someone trying to keep his boss smiling) to anyone who’s capable of reading the actual paper, which is another nasty side effect of this whole affair. See this for more, and this: since the data do not have a control comparison group, we can make no firm statements about the benefit of the treatment, and the 35% number is a misunderstanding of what data we have. Sad but true.

Finally, that leads us to the political aspect of this, damn it all. Yesterday’s press conference was announced the night before by the White House as concerning “a major therapeutic breakthrough”. The president and his allies echoed this language, with phrases like “historic breakthrough”, “a truly historic announcement”, and so on. It wasn’t. Convalescent plasma has been used for many decades in other infectious diseases, and it was tried very early on in the first countries affected by the coronavirus. Announcing an Emergency Use Authorization this late in the game for it in the US is, as I tried to convey in the above paragraph, closer to being something that we should be vaguely ashamed about.

The hype is not helpful. The preannouncement about a major breakthrough, the apparent need for the President himself to step up and give the news (alongside the heads of HHS and the FDA, yet) – all of this is sheer public relations, and that’s not what we need to beat down this pandemic. The virus does not care about press conferences, breathless tweets, and fawning statements about leadership and vision. I’ll be up front about this: the way that President Obama inserted himself into events used to get on my nerves, but I had no idea what was coming and how bad it could get. A big effect of this plasma announcement, as far as I can tell, was to sow doubt about what the administration considers a breakthrough and what its intentions are about authorizing a vaccine before the November election. And before anyone jumps on me for that insinuation, allow me to remind you that the President himself, in his Sunday morning Twitter duties, accused the so-called “deep state” at the FDA of literally dragging their feet in trying to not get a vaccine before the election. Which was a suggestion I found false, infuriating, and as harmful as such a short statement could be to the chances of rolling out a vaccine in an orderly and medically justified way. Trump himself, in his press conference, said that it was his “very strong opinion” that the FDA had delayed a plasma EUA for political reasons. So no, we don’t need the whole process tied to electoral politics, but guess who’s losing no chances to do just that?

And guess who’s lost no chances, with these statements and more, to give the impression that he’s leaning hard on the FDA to do what he wants it to do, science be damned? Have a look at the statements by former FDA scientists in this Biocentury article on the affair: they believe that the agency is being suborned. Commissioner Hahn’s and Sec. Azar’s obsequious statements yesterday (and the mangling of the statistics to make everything look rosier) were terrible to see. And the FDA’s own web site announcement includes the phrase “Another Achievement in Administration’s Fight Against Pandemic” in the headline, which is a first, to the best of my knowledge, since the FDA is not supposed to be tied to any particular presidential administration and is not supposed to be shining anyone’s shoes. But hey, if you’re going to have someone licking them, someone else has to step in with the rag right afterwards, and they’d better snap the thing so the big guy can hear it.

Comments will be turned off on this post, for obvious reasons. We’ll get back to some science tomorrow.

 

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acdha
34 days ago
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This explains the push to re-open schools and increase the number of potential donors
Washington, DC
petrilli
35 days ago
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Ask yourself: what would they do differently if the main intention was to undermine the validity of the US government for the next 20 years?
Arlington, VA
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Medical Debt Collection Firm R1 RCM Hit in Ransomware Attack

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R1 RCM Inc. [NASDAQ:RCM], one of the nation’s largest medical debt collection companies, has been hit in a ransomware attack.

Formerly known as Accretive Health Inc., Chicago-based R1 RCM brought in revenues of $1.18 billion in 2019. The company has more than 19,000 employees and contracts with at least 750 healthcare organizations nationwide.

R1 RCM acknowledged taking down its systems in response to a ransomware attack, but otherwise declined to comment for this story.

The “RCM” portion of its name refers to “revenue cycle management,” an industry which tracks profits throughout the life cycle of each patient, including patient registration, insurance and benefit verification, medical treatment documentation, and bill preparation and collection from patients.

The company has access to a wealth of personal, financial and medical information on tens of millions of patients, including names, dates of birth, Social Security numbers, billing information and medical diagnostic data.

It’s unclear when the intruders first breached R1’s networks, but the ransomware was unleashed more than a week ago, right around the time the company was set to release its 2nd quarter financial results for 2020.

R1 RCM declined to discuss the strain of ransomware it is battling or how it was compromised. Sources close to the investigation tell KrebsOnSecurity the malware is known as Defray.

Defray was first spotted in 2017, and its purveyors have a history of specifically targeting companies in the healthcare space. According to Trend Micro, Defray usually is spread via booby-trapped Microsoft Office documents sent via email.

“The phishing emails the authors use are well-crafted,” Trend Micro wrote. For example, in an attack targeting a hospital, the phishing email was made to look like it came from a hospital IT manager, with the malicious files disguised as patient reports.

Email security company Proofpoint says the Defray ransomware is somewhat unusual in that it is typically deployed in small, targeted attacks as opposed to large-scale “spray and pray” email malware campaigns.

“It appears that Defray may be for the personal use of specific threat actors, making its continued distribution in small, targeted attacks more likely,” Proofpoint observed.

A recent report (PDF) from Corvus Insurance notes that ransomware attacks on companies in the healthcare industry have slowed in recent months, with some malware groups even dubiously pledging they would refrain from targeting these firms during the COVID-19 pandemic. But Corvus says that trend is likely to reverse in the second half of 2020 as the United States moves cautiously toward reopening.

Corvus found that while services that scan and filter incoming email for malicious threats can catch many ransomware lures, an estimated 75 percent of healthcare companies do not use this technology.

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acdha
43 days ago
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This is like when the mafia and cartels fight. A pox on both their houses.
Washington, DC
petrilli
44 days ago
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Finally, a positive side of ransomware?
Arlington, VA
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dreadhead
45 days ago
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I want to say ransomware is always bad but...
Vancouver Island, Canada

tech brain

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"an addiction to easy answers combined with a wholesale cultural resistance to any kind of complexity"
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petrilli
44 days ago
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rosskarchner
48 days ago
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DC-ish
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The heirloom tomato problem

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There’s something romantic about heirloom tomatoes. People wax poetic about them, write songs about them, pine for them. That’s one of the reasons I emphasized them when we started growing for market: I figured it was just good business to provide a thing that people say they crave.

Three years later, I understand why it ISN’T good business. Everybody wants “a great tomato.” But most of y’all don’t really know what makes a good tomato, much less a great one. And that basic lack of consumer knowledge is the problem.

You can probably conjure up an image of the perfect heirloom: Bright, unusual colors. Oddly shaped. Firm. Huge. Fragrant. Flawless. The center slices extend beyond the crusts of your tomato sandwich.

Such tomatoes exist — but only briefly, and by briefly I’m not even talking about days. I’m talking about hours.

We grow more than 200 tomato vines a year. Most vines will probably produce between 5 to 10 pounds of fruit, and a few will produce at least twice that amount. I figure we probably “harvest” give or take about thousand pounds over the course of five to six weeks.

But probably a quarter to a third of that “harvest” is just tossed into the woods as soon as it comes off the vine — because we’re non-certified organic. So our tomatoes are under attack from all sorts of things: Bugs, caterpillars, fungi, diseases, blights, squirrels, woodchucks, dogs, coyotes, raccoons. And the varieties we grow are typically prized heirlooms, selected for taste over durability.

By the time we get down to the “marketable heirlooms,” we’re usually talking about no more than a quarter of the harvest. How many of those are “perfect?” It depends on the variety — but the bigger and more irregularly shaped that variety, the less likely perfection becomes.

Even if the pests miss them, a “big ugly” tomato — no matter how beautiful — is doomed to fail. All tomatoes are vulnerable to light and air and temperature and microbes, but the less uniform the structure, the more likely it is to fail in some spot before it reaches perfect ripeness.

Some — miraculously — get to dead ripe fully intact and flawless. But if you succeed in buying that fully ripe, perfect, dream heirloom, you’d better plan on eating it THAT DAY.

Because unlike supermarket tomatoes — which are bred for every trait except taste — a dead-ripe heirloom is going to start deteriorating within hours.

And after talking to customers and retailers and gardeners for the last three years, what I’ve figured out is that most consumers — even tomato lovers — expect their heirlooms to be as perfect, and to last as long, as those cardboard supermarket tomatoes.

You can hardly blame them. Local, organic heirloom tomatoes are so expensive that they’re a luxury item for all but the wealthiest of shoppers.

And, of course, most of y’all buy the wrong tomatoes anyway.

What you really need (for most tomato recipes, anyway) are paste tomatoes.

That’s why we planted no more than 10 vines of any heirloom this year, but grew almost 90 paste tomato plants. And we rarely even offer those for sale — because that harvest is mostly reserved for us, our friends and families.

Love marinara sauce? Picante sauce? Pico de Gallo? Salsa Fresca? All based on simple, unpretentious paste tomatoes. Delicious on their own — but what sends those recipes into the culinary stratosphere is the inclusion of just a few “slicers” for flavor.

Why not sell paste tomatoes? In part because we need so many of them for the things we’ll preserve for later. Depending on the day’s recipe, it takes us between two to five pounds of tomatoes to make one quart of sauce. If you’re buying those retail, that quart of sauce if going to be expensive.

What we learned last year — and we’re benefiting from it even more in 2020 — is that the true value of growing heirloom slicers is the flavor they add to tomato-based sauces, soups and juices. You simply can’t buy commercial products with real heirloom flavor at the grocery. The difference is mind-blowing.

But capturing that flavor means you have to cook with heirlooms. And to preserve the taste of July past the first week of August means you have to can what you cook. And most people just … don’t.

After all, there are all sorts of gourmet prepared Italian sauces you can buy for $5 or $6 a jar. Some of them are quite good, and they’ll stay stable on your shelf for years. Home-preserved tomato sauces are usually good for about a year to 18 months. Why take on the task of cooking and canning your own?

And that’s the story. Americans love heirloom tomatoes, but like most fresh produce, we tend to want them out of season. When we find them for sale, we want them to look perfect and last on the kitchen counter for a few days. When they don’t, and go soft in spots, we feel like we’ve been duped out of $4 — even if the rest of the fruit is firm and delicious.

I made a chicken dish earlier this week that called for a can of tomato paste and a can of diced tomatoes. I substituted about four pounds of fresh heirlooms, which I cooked down to sauce in the skillet. Depending on how you shop, those canned tomatoes would have cost you between $2 and $5 at the grocery.

If you’d substituted fresh but tasteless supermarket tomatoes you’d have paid about $8. And if you’d bought real, in-season fresh heirlooms at some bougie organic fresh market, you’d have paid $12 to $16.

That’s about three to four times what the chicken cost.

Which is why heirloom tomatoes aren’t good business.

Most people don’t understand them.

Most people can’t afford them.

Most people don’t know how to use them.

I know there are plenty of exceptions, and I understand the passion people feel for this mysterious fruit. I share it. But I doubt this basic equation is ever likely to change.

And I’m OK with that.

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acdha
57 days ago
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Washington, DC
petrilli
58 days ago
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Arlington, VA
rosskarchner
58 days ago
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DC-ish
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1 public comment
fxer
57 days ago
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If you can only grow one thing, even if you’ve just got room for a pot on a doorstep, grow yourself a tomato plant for that fleeting 2 weeks of bliss having BLTs for every meal.
Bend, Oregon
tingham
57 days ago
Or just slicers on a plate with a dallop of hellman's and some black pepper. I came to tomatoes too late in life.

AirBNB asks for handouts to help support lazy landlords

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Twitter user @olenskae shared this email from AirBNB:

Business Insider reported on the cringeworthy request, and even got a comment from AirBNB:

The new tool [Kindness Cards] appears to be another effort to assuage hosts' financial concerns, this time by soliciting contributions from former guests. An Airbnb spokesperson told Business Insider that 100% of the proceeds from the kindness cards would go to the hosts.

"In the spirit of rekindling connections, we developed a new feature that allows guests to send virtual cards with messages of support and encouragement to hosts who provided excellent hospitality. If they wish, guests have the option to add a voluntary financial contribution," the spokesperson said.

At press time, it wasn't clear if these lazy slumlords could pull themselves up by their bootstraps and find something new, so they can stop begging for handouts.

Airbnb is getting ripped apart for asking guests to donate money to hosts [Aaron Holmes / Business Insider]

Image: Public Domain via NeedPix

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petrilli
70 days ago
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