Clement and Tribe Predicted the FDA Catastrophe

by Alex Tabarrok October 27, 2021 at 7:24 am in
Paul Clement and Laurence Tribe

Laboratory developed tests are not FDA regulated–never have been–instead the labs are regulated under the Clinical Laboratory Improvement Amendments (CLIA) as overseen by the CMS. Laboratory developed tests are the kind your doctor orders, they are a service not a product and are not sold directly to patients. Labs develop new tests routinely and they do not apply to the FDA for approval. Despite this long history, the FDA has claimed that it has the right to regulate lab tests and they have merely chosen not to exercise this right for forty years. In 2015, Paul Clement the former US Solicitor General under George W. Bush and Laurence Tribe, considered by many to be the leading constitutional lawyer in the United States, wrote an article that rejected the FDA’s claims writing that the "FDA’s assertion of authority over laboratory-developed testing services is clearly foreclosed by the FDA’s own authorizing statute" and "by the broader statutory context."

Despite lacking statutory authority, the FDA has continued to claim it is authorized to regulate laboratory tests. Indeed, a key failure in the pandemic happened when the FDA issued so-called "guidance documents" saying that any SARS-CoV-II test had to be pre-approved by the FDA. Thus, the FDA reversed the logic of emergency. In ordinary times, pre-approval was not necessary but when speed was of the essence it became necessary to get FDA pre-approval. The FDA’s pre-approval process slowed down testing in the United States and it wasn’t until after the FDA lifted its restrictions in March that tests from the big labs became available.

Clement and Tribe rejected the FDA claims of regulatory authority over laboratory developed tests on historical, statutory, and legal grounds but they also argued that letting the FDA regulate laboratory tests was a dangerous idea. In a remarkably prescient passage, Clement and Tribe (2015, p. 18) warned:

The FDA approval process is protracted and not designed for the rapid clearance of tests. Many clinical laboratories track world trends regarding infectious diseases ranging from SARS to H1N1 and Avian Influenza. In these fast-moving, life-or-death situations, awaiting the development of manufactured test kits and the completion of FDA’s clearance procedures could entail potentially catastrophic delays, with disastrous consequences for patient care.

Clement and Tribe nailed it. Catastrophic delays, with disastrous consequences for patient care is exactly what happened.

Addendum: See also my pre-pandemic piece on this issue, Our DNA, Our Selves.

Comments

Dennis P Waters

2021-10-27 08:21:27
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There is an important distinction that is glossed over here. Tests developed by a lab and run only in that lab ("homebrew tests") are overseen by CLIA. And only the most sophisticated labs ("high complexity") are permitted to do this. However, tests that are marketed to labs or physician offices as complete turnkey kits are overseen by FDA, as are diagnostic kits sold directly to consumers.

Vivian Darkbloom

2021-10-27 08:46:35
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Good point, Dennis P Waters. Clement and Tribe (both paid by the laboratory industry to write that article) admit as much:

"With the FDCA, Congress authorized FDA to protect the public health by regulating the safety and effectiveness of "any food, drug, device, tobacco product, or cosmetic" that is "introduc[ed] into interstate commerce." 21 U.S.C. §331(a). Under the FDCA, therefore, FDA has authority to regulate manufacturers only of commercially distributed medical "devices," including devices used to perform standardized clinical tests (so-called "test kits"). But laboratory-developed testing services are processes and methodologies that are qualitatively and categorically different from the tangible goods that FDA may regulate as "devices." Statutory text, basic principles of interpretation, and common sense leave no doubt that laboratory- developed testing services are not medical "devices" under the FDCA."

This distinction between "testing kits" and "laboratory testing services" seems to be lost on Mr Tabarrok, who links to a New Yorker article discussion testing kits.

None of this is to say that the FDA is not overstepping its authority in regulating laboratory testing services or that they should not more quickly issue decisions on testing kits over which they do have authority, but bloggers should do their homework better (I hope this is not being "scathing").

I wish that Messrs Baird and Tribe had spent some of their legal capital on addressing the CDC's lack of authority to determine who has to pay rent...

EdR

2021-10-27 14:54:22
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Excellent post. The difference in policy for testing kits and testing services was new to me.

"I wish that Messrs Baird and Tribe had spent some of their legal capital on addressing the CDC's lack of authority to determine who has to pay rent..."

Well, the CDC may not have done a good job at controlling the disease but they sure did help to break the economy.

Why do you think the distinction was lost on Alex?

2021-10-27 11:46:55
1 -2
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He likely just hoped it would be lost for his readers.

Paid to write, you say?

2021-10-27 09:24:21
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The Bartley J. Madden Chair in Economics at the Mercatus Center is all ears.

Tim

2021-10-27 08:52:08
1 -13
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Tabarrok says "Laboratory developed tests are the kind your doctor orders, they are a service not a product and are not sold directly to patients."

Vivian Darkbloom

2021-10-27 09:05:21
18 -1
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Sure, that's simply a paraphrase from the first three paragraphs of the Baird/Tribe article. As I said, he then goes on to link to an article on testing kits for support in the same paragraph discussing the pre-approval of *laboratory tests*, which are a different animal .

JWatts

2021-10-27 10:37:21
2 -1
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"However, tests that are marketed to labs or physician offices as complete turnkey kits are overseen by FDA, as are diagnostic kits sold directly to consumers."

Would this have included the early Covid test that was developed to be run in house that the FDA sent out a cease and desist order for last year?

Scipio Assayicus

2021-10-27 20:01:48
1 0
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The earliest molecular (PCR) covid tests were laboratory developed tests (LDTs) and regulated CLIA/CMS. That's hard to scale -- the authorization is limited to the lab that developed the tests. Rutgers & Yale did an early collaboration and some scaling by "teaching" other labs to use their test.

There was a second wave under the FDA EUA in April/May 2020 extending to late summer 2020 where IVD test manufacturers produced their own tests. This scales better because the test manufacturer sells the test kit plus often an automated apparatus to run it on.

OldCurmudgeon

2021-10-27 21:16:11
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The early PCR kits were the problem. During the key time period in Feb/March 2020, the FDA produced their own PCR kits, which were apparently flawed. The FDA then blocked private labs from pushing out their own PCR kits for paperwork reasons (IIRC, because the data wasn't properly certified). The whole debacle delayed testing for about 6 weeks.

David Manheim

2021-10-28 04:56:34
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You presumably mean that the CDC produced the kits which were flawed, since that's what happened.

dearieme

2021-10-27 08:22:10
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"catastrophic delays, with disastrous consequences for patient care": but there's endless noise about catastrophic this and disastrous that. Think of all the Global Warming catastrophes that were predicted to happen in 2000 and 2005 and 2010 and ...

Anti-Gnostic

2021-10-27 09:10:42
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Indeed. What "disastrous consequences" for patient care? If you test positive, you are going to be told to get the hell out of their pristine medical clinic and wait at home to see if you get sick enough to be hospitalized. (Fortunately, most won't).

OldCurmudgeon

2021-10-27 09:46:43
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IDK. The theory is that, had the tests been available earlier (i.e., Jan 2020, a few days after the virus was sequenced), we could have done better at contact tracing/quarantining.

And, even if it wouldn't have stopped this particular virus, it probably would have bought us "two weeks to flatten the curve" a heck of a lot cheaper than shutting down the economy (admittedly, damning with faint praise there).

carlospln

2021-10-27 21:53:00
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#

If testing had begun in January extrapolation would have revealed that the virus was endemic in the US in September, 2019.

That's why it was banned.

StillGeorge

2021-10-27 10:06:52
0 -3
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Then why wasn't there an Operation Warp Speed to get us there?

This is a point that T&A have glossed over repeatedly, if rapid accurate tests were so critical (which I agree they would have been helpful), then where was the Apollo program to get us there?

Why wasn't there a sustained high-level campaign to un-stuck the FDA back then? Where was the billion in subsidies and guaranteed markets? Why wasn't Trump pounding the podium about the need for testing and launching a Saturday Night Massacre at FDA?

Mark Bahner

2021-10-27 12:54:56
5 -4
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Why wasn't Trump pounding the podium about the need for testing...

Because positive tests reveal a COVID-19 problem. That's very inconvenient to a person assuring people that COVID-19 isn't a problem.

JWatts

2021-10-27 10:32:18
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There probably should have been. It was a failure on the part of the Trump administration to push back against the over reach at the FDA.

OldCurmudgeon

2021-10-27 10:46:37
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>It was a failure on the part of the Trump administration to push back against the over reach at the FDA.

Politically impossible imho; he would have gotten excoriated by the Press for "interfering with the career Scientists"

Continue this thread →

EdR

2021-10-27 16:00:31
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You don't get it, do you?

Have you ever been a high level or even mid level manager? It is the role of the leaders of the alphabet bureaucracies, (CDC,FDA), to scream at the president that these kits need to be distributed NOW.

They didn't do that.

They failed.

Heads should role.

The POTUS wasted much time and energy fighting off a fraudulent campaign based on a political document when he could have been leading us out of this dog's breakfast.

StillGeorge

2021-10-27 17:00:07
2 -1
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I award you three internet style points for that 180 spin-jitsu attempt

Roll tape, press play, click the mouse, whatever

2021-10-27 10:41:16
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While president, Donald Trump reportedly yelled at aides to shut down testing for Covid-19 in the United States, fearing the growing number of infections and deaths due to the virus would cost him his re-election.

"Testing is killing me!" he allegedly yelled at Alex Azar, who was secretary of Health and Human Services at the time. "I’m going to lose the election because of testing! What idiot had the federal government do testing?"

The tantrum is just one of many chronicled in an upcoming book, Nightmare Scenario: Inside the Trump Administration’s Response to the Pandemic That Changed History, by Washington Post reporters Yasmeen Abutaleb and Damian Paletta. On Monday, the Post published excerpts of the book, which chronicles the United States’ early, bungled handling of the virus.

According to the authors, Mr Azar was baffled by the former president’s outburst.

"Uh, do you mean Jared?" he allegedly replied. Jared Kushner, Mr Trump’s son-in-law, had just taken over the national testing strategy.

Mr Trump evidently thought the whole effort was a mistake. In conversations with his aides, he appears to have been more bothered by the Covid statistics themselves – which he called "my numbers" – than on the actual illnesses and deaths they represented.

"This was gross incompetence to let CDC develop a test," the former president reportedly told Mr Azar.

Mr Trump didn’t just oppose testing in his private conversations. He repeatedly complained about it in public, falsely claiming that the United States only had the world’s highest Covid caseload because it did the most testing. At a rally in Tulsa, Oklahoma in June 2020, he admitted he’d asked his staff to cut down on the tests.

"When you do testing to that extent, you're going to find more people, you're going to find more cases," Mr Trump told the crowd. "So I said to my people, slow the testing down please."

EdR

2021-10-27 15:42:01
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'"Testing is killing me ...'"

TDS is killing you.

The CDC and the FDA utterly failed at their core missions. The only thing the 'orange goblin' (h/t Sam Harris) could have done was fire the incompetent asses in charge of those massively expensive bureaucracies and the middle of a pandemic is not the time.

We should be having some public and humiliating hang ... er ... I mean firings soon. If not, we have much bigger systemic problems to worry about.

Grow up!

Continue this thread →

StillGeorge

2021-10-27 10:45:46
4 -5
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zactly. The President was vehemently opposed to testing, and so we got very little testing.

I haven't seen T&A talk about this much. By that I mean, at all.

Tom T.

2021-10-27 09:23:44
1 0
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Besides which, why would anyone be expected to afford any particular weight to some lawyers' opinions on good vs. bad patient care? Certainly, they turned out to be right in this case, but they have no medical or scientific expertise to back up those assertions.

Hey now

2021-10-27 09:53:17
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Have you looked at their GRE scores before beinf so dismissive of their lack of medical or scientific expertise?

OldCurmudgeon

2021-10-27 10:06:43
1 0
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OTOH, the FDA is mostly lawyers and quasi-lawyers (i.e., bureaucrats). Given a choice, I'd go with my doctor's opinion over theirs.

Maxwell Smartass

2021-10-27 15:30:31
0 0
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"Think of all the Global Warming catastrophes that were predicted to happen in 2000 and 2005 and 2010 and ..."

Would you believe 2035?

Steven

2021-10-27 09:15:40
4 0
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From this I understand that there were people who have been aware that the FDA's claimed authority was unlawful for the past 2 years and were aware of the disastrous consequences.

Why didn't they sue the FDA?

The FDA is still holding up rapid tests. Why don't they sue the FDA now?

Garth Wood

2021-10-27 09:42:41
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Sue the FDA?

Why the Hell don't they just tell the FDA to F*CK RIGHT OFF?

Honest to God, I don't understand this absurd deference to people/groups that are exceeding their legal authority. What's the FDA gonna do if a rapid test gets developed by The Very Big Corporate Lab of America and they start selling it at Home Depot or Walmart — send in their statutorily-mandated 101st Airborne to stop them?

Sure

2021-10-27 10:37:44
6 0
#

Open an investigation, tank the parent company's stock, and destroy a small percentage of the market cap of the stock.

This in turn will result in any but the most highly protected employers being reprimanded or terminated.

And perhaps the insurers may get involved. There is no safe harbor for "standard of care" when you do things that nobody else has done and it gets particularly dicey for settlement size when you have a regulatory (even if an invalid one) to whom the jury might defer blasting your process.

Labs live in fear of creating scandal that is more costly than their annual profits. Having a "highly respected" public body weigh in opposing some major initiative is generally looked at as highly risky even absent statutory authority.

Maybe Very Big Corporate Lab can self-insure. Maybe the company is private and does not have to worry about short term fluctuations in market cap. Maybe their corporate partners will be willing to share lawsuit risks.

But the same risk aversion that makes globe spanning corporations tremble before random TikToks alleging racism or whatever dominates their thinking when it comes to regulators. The PR damage possible from defying the regulator is simply massive. And if your firm happens to have actual interests that might ever benefit from friendlier relations with the FDA? Forget it.

Modern business is a complicated web of fear surrounding lawsuits, insurance, regulation, and PR. The actual value of the product rarely outweighs the potential hit from any even theoretical scandal.

OldCurmudgeon

2021-10-27 09:51:00
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You'd need an actual plaintiff i.e., someone directly hurt. And the only entities that are likely to qualify are large labs with billions of dollars in government grants/contracts and/or will want to get FDA approval on something else soon and/or will get inspected soon c.f., how the Feds control the financial sector.

Steven

2021-10-27 10:47:56
0 0
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Sure, I understand your point and, while not a laywer, I am vaguely aware that there are these issues of standing. But, such issues always exist and yet a lot of these kinds of things do get brought to court. It seems like there are a public interest organizations that specialize in finding nominal plaintiff's who have standing in order formally resolve the standing issues.

My, possibly naive, impression is that if someone wanted to fight the FDA on this, they could find a way.

OldCurmudgeon

2021-10-27 11:27:58
2 0
#

>public interest organizations that specialize in finding nominal plaintiff's who have standing in order formally resolve the standing issues.

It's a fair point, but normally those organizations aren't trying to win as-such; they are just trying to delay action. Years of procedural wrangling is fine with them.

Side note: standing rules have been increasingly weaponized by the Feds over the last decade or two e.g., President Obama's whole "pen and phone" strategy revolved around finding things for which there wasn't a natural plaintiff.

StillGeorge

2021-10-27 09:49:04
1 -2
#

Consider the possibility... just for a moment; that both parties in Washington - including the famous swamp-draining anti-deep state warrior Trump - actually want it this way.

Could be a variety of reasons, perhaps corruption, perhaps socialism, perhaps cronyism, perhaps CIA blackmail dark ops, or, perhaps, we need someone on that wall to sort out the unscrupulous, reckless, and incompetent makers of medical products and devices.

Because, well, follow the incentives.

Huh

2021-10-27 14:09:08
0 0
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So medical device makers dont want to sell medical devices?

StillGeorge

2021-10-27 14:34:43
0 -1
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Oh yes they do. Indeed they do.

To a fault at times.

Bob

2021-10-27 10:53:52
4 0
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I used to work for a major Electronic Health Record vendor. In a meeting with the FDA about whether they could/would regulate EHRs, an FDA rep said they could if they wanted to, and in fact they could regulate the pencil in your hand if it was used to write medical information, if they wanted to.

It's funny when people write things like:

2021-10-27 09:01:58
4 -2
#

"considered by many to be the leading constitutional lawyer in the United States" which mostly means that he has the same knowledge of countless constitutional lawyers but sold his soul so many times that he ended up working for presidents.

Tom T.

2021-10-27 09:19:44
5 -1
#

Moreover, constitutional law is largely irrelevant here; they're construing a specialized statute.

PHinton

2021-10-27 10:11:05
14 -16
#

Yes, Lawrence Tribe, the man who proclaimed the Trump's 4th of July celebration reminded him of Tianamen Square should not be listened to as a serious adult.

The man who said white supremacists oppose abortion because it will reduce the number of white infants (ignoring the 40M black babies aborted) should not be listened to as a serious adult.

Yes, let's now take this man at his word on other topics...

Rich Berger

2021-10-27 11:51:58
3 -1
#

You speak the truth and you have the downvotes to prove it.

cornpopsrustyrazor

2021-10-27 12:21:11
3 -2
#

to be fair
the harvard sociologists implausible response to their replication crisis was to declare - education="signaling"
then critical race grifters came up with a education curriculum that was pure signaling
its a grifty grift

Dallas Weaver Ph.D.

2021-10-27 15:45:27
1 0
#

It is silly to make a big distinction between a "test kit" and a service. A service may provide you with instructions and a kit for many tests, think fecal iron tests. A service provider buys samples of target DNA that are really kits of reagents to run in his machines.

The observable fact that government monopoly institutions like the FDA always want to expand their scope of control, power, and influence is just the way institutions work. The prime directive of any institution is growth and survival and if it doesn't follow that directive it dies.

Why private institutions in competitive markets often succeed more than government monopoly institutions is because they have a failure mechanism (bankruptcy).

Thanatos Savehn

2021-10-27 22:31:05
1 0
#

Public health needs to be divorced from medicine. Though they've been a spectacular boon to public health toilets require neither a prescription nor the FDA's blessing. The same is true for countless other measures including tooth brushes and toothpaste, folic acid for pregnant women, etc.

That the administrative branches of government have themselves become rent seekers ought to be enough to rein them in.

Yawn

2021-10-27 08:20:12
16 -16
#

"Despite lacking statutory authority, the FDA has continued to "

My my, in year 2021 we're nitpicking about basic FDA legal authorities.

That battle was lost a century ago.
The Federal government can regulate anything it feels like regulating, in any manner it wants, at any time.
FDA bureaucrats can do what they want despite supposed legalities.

Of course as some prissy Neanderthals annoyingly note, there is zero Constitutional legal basis for the FDA to even exist.
Such quaint legalities carry no weight in modern America.

superdestroyer

2021-10-27 09:42:35
0 0
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At one time there was the term "waive test" such as would be administered by a nurse or non-physicians and the result would be used for treatment decisions. That would be an example of an FDA regulated item.

There are also lab tests are are not directly controlled by CLIA such as VA/DOD medical labs. They have their own accreditation programs that follow CLIA since neither group is under the authority of CMS.

Dr. joe bidens alsatian, ph.d

2021-10-27 11:24:10
3 -3
#

controlling the narrative satire
the nih is currently arguing with the nih over whether the nih funded gain of function research
-according to expert cnn journalers
this makes rand paul an" asshole"

RAD

2021-10-27 11:44:30
0 0
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From the Clements and Tribe warning (emphasis mine):

Many clinical laboratories track world trends regarding infectious diseases ranging from SARS to H1N1 and Avian Influenza.

A comparative analysis with other nation-states seems in order, especially considering the equipment is manufactured and distributed by large multinationals. It is also important, IMO, to carefully correlate the impact on a pandemic timeline; the testing failure significantly impacted the degree of the first-wave in the U.S. but it was quickly corrected.

Dr. Bonnie Henry's book Be Kind, Be Calm, Be Safe: Four Weeks that Shaped a Pandemic explains that one of the key problems with our collective preparedness plans was the assumption that the next pandemic would be caused by an influenza strain. Influenza, with its short incubation period, underemphasizes the need for scalable Test-Trace-and-Isolate programs.

The next pandemic may not have the same characteristics associated with this specific coronavirus; we should be careful not to prepare for the last war.

rayward

2021-10-27 12:28:47
0 0
#

What's the larger risk: false negative or false positive? From a public health perspective it's a false negative, but from a freedom perspective, it's a false positive. I don't know which is a greater concern to the FDA in implementing stricter requirements for testing. Mask mandates raise a similar question. Down here the new director of public health believes the infringement on his personal liberty of a mask mandate, even a very narrow one (such as attending a meeting with a state senator who has cancer), outweighs public health, even the public health of the state senator. I suspect the disagreement is partly attributable to the signaling school of economics, which attributes most everything we do to signaling, including testing and mask-wearing. Signaling may seem like a great insight but taken to the extreme (which is where all great insights are taken) it's dangerous.

Sara

2021-10-27 12:08:21
1 -4
#

Single Mom Makes $89,844/Yr in Her Spare Time on The Computer Without Selling Anything. you can bring from $5000-$8000 of extra income every month. working at home for 4 hours a day, and earning could be even bigger.

The potential with this is endless... Www.Findpay.com

StillGeorge

2021-10-27 09:16:24
0 -4
#

Imagine how much better off we’d be if we had simply left the pandemic response unregulated, and instead focussed on distributing billions in blank check subsidies and market guarantees.

A sick mash up of Randian wankery, methanol hand sanitizer, and Newsmax advertised supplements. All funded by the taxpayers

So Much For Subtlety

2021-10-27 07:40:23
17 -22
#

And yet this is only coming out now? Clement and Tribe knew this was a problem in 2015? Before Trump was elected. But they did not go on CNN to tell the world when hundreds of thousands were dying?

Frankly I am disappointed in Tribe. He displayed serious issues over Trump. Apparently the rule of law is dead because Trump was not jailed or something. It is enough to raise questions about why he did not raise the issue when the Bad Orange Man controlled the White House.

Rich Berger

2021-10-27 11:50:10
1 0
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Yeah, they wrote an article. OTOh, Trump went to the CDC on 3/6/2020 (IIRC), checked it out himself and enlisted private labs to conduct tests. Soon thereafter, the daily tests rose from a few hundred to 100,000 within a month.

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