Amazon Loophole Is Driving the Fentanyl Crisis

 One of the more frustrating things about public policy in the United States is how the dominance of corporate interests makes simple reforms that could save thousands of lives impossible. To wit: Here is the story of how Amazon and other retailers are facilitating the epidemic of deaths from fentanyl.

We know that fentanyl deaths rose 279 percent from 2016 to 2022. Two-thirds of the 110,000-plus overdose deaths in America last year were due to fentanyl. It is the leading killer of Americans aged 18 to 49, and it has devastated communities across the country.

Drug enforcement efforts in the U.S. have historically targeted supply through a so-called “war on drugs.” But reducing the amount of fentanyl on the street need not involve military-style operations in Central and South America. China is the source of most of the chemical compounds that cartels use to make fentanyl in illicit drug labs. Without these raw materials, much of the fentanyl trade would be stopped.

Now, of course this would not halt opioid addiction or use by itself; traditional smuggled heroin would likely fill in the gap. But fentanyl is orders of magnitude more dangerous than heroin thanks to its extreme potency, which is a principal cause of the overdose epidemic. The tiniest of measurement errors can lead to an overdose, and black-market drug dealers are not exactly known for their responsible metrology.

Customs enforcement officials have begun to charge Chinese firms that produce and ship these precursor chemicals (and produced fentanyl as well), and President Biden, in a summit earlier this month, pressured Chinese President Xi Jinping on the matter. The U.S. and China agreed in principle to a deal where China would limit the flow of fentanyl in exchange for the U.S. rolling back restrictions on China’s forensic police institute.

But while Chinese cooperation is welcome, the bigger problem is that the vast majority of fentanyl chemicals sent from China are not inspected at all. That’s because of something called the “de minimis” rule.

Section 321 of the Tariff Act of 1930 allows for goods under a certain value to be shipped into the U.S. without tariffs, fees, or inspections. Anyone who has flown on international travel is familiar with this from their declaration card when they return to the U.S.; if you got some trinkets from abroad that are of a nominal value, you don’t have to submit them to customs officials.

In 2016, that nominal, or de minimis, value, went up from $200 to $800. There are only two countries in the world that have a higher de minimis value than the U.S.; China’s de minimis value is less than $10.

It was not the original intention of de minimis rules to build a parallel, off-the-books customs system, used often for illegal goods shipping.

Why did this change happen? Because e-commerce firms, primarily Amazon, wanted to be able to bring in goods from China to their warehouses or even directly to their customers without any taxes or tariffs. In fact, it’s often been characterized as the “Amazon loophole.”

Chinese shippers have been known to package shipments in separate boxes to keep under the $800 threshold, or send goods to distribution centers just outside the United States, where packages are broken up to get under the de minimis threshold and sent into the country.

These small shipments have exploded in frequency. In fiscal year 2018, 410.5 million de minimis packages were sent. By fiscal year 2022, that number was up to 685.1 million. Some experts put that number much higher. One analysis estimates that the official figure for the trade deficit with China last year was short by $188 billion after accounting for de minimis shipments.

While there’s practically no information available about these shipments (many have no data at all except for a mailing label), there is mounting evidence that one of the most common de minimis items is fentanyl, as Michael Stumo of the Coalition for a Prosperous America has written. This stands to reason, as fentanyl’s potency means it is highly valuable by weight. “The overwhelming volume of small packages and lack of actionable data,” the U.S. Office of Customs and Border Protection wrote earlier this year, “impacts CBP’s ability to identify and interdict high-risk shipments that may contain narcotics, merchandise that poses a risk to public safety, counterfeits, or other contraband.” It’s highly likely that precursor chemicals are moving from China to Mexico under de minimis rules as well.

It was not the original intention of de minimis rules to build a parallel, off-the-books customs system, used often for illegal goods shipping. But that’s what the Amazon loophole has facilitated. Congress is aware of the problem. A bill from Sens. Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) would reduce de minimis thresholds to the level of trading partners (meaning that the de minimis threshold on Chinese goods would fall to under $10). A separate bipartisan, bicameral bill would simply ban de minimis shipments from “non-market” economies, as well as countries on a priority watch list for using de minimis, which would target China.

The House Select Committee on China has investigated rampant use of the Amazon loophole from fast-fashion companies using forced labor. One textile industry official described de minimis as akin to “handing a free trade agreement to China and the rest of the world.” The chairman of the China committee, Rep. Mike Gallagher (R-WI), has expressed optimism that legislation reforming de minimis would pass this year (though passing anything in Congress is incredibly optimistic).

Of course, this is terrible news for the companies exploiting the loophole for tax benefits, like Amazon and other online retailers. So they are firing up their lobbying engines. The U.S. Chamber of Commerce and the National Foreign Trade Council (a trade group of importers) deny that counterfeit goods or fentanyl enter the U.S. through de minimis shipments at all, while arguing that CBP gets plenty of information about what’s in the packages. Lobbyists and their allies are also complaining about higher CBP costs for inspections of small packages, while not mentioning that it would be the importer who would have to pay those charges.

Keep in mind that when indictments were handed down on the companies sending precursor chemicals for fentanyl to drug cartels, they were reportedly packaged to appear as dog food, nuts, or motor oil. The “benefits of free trade” are hard to discern in a recently expanded loophole intended mostly to save Amazon money that is now facilitating the fentanyl crisis.

There’s another beneficiary of the de minimis loophole: digital advertising companies, which benefit from ads from Chinese fast-fashion firms like Shein and Temu that make liberal use of the loophole. Financial Times reporter Rana Foroohar reported recently that one-third of the revenue growth from Meta this year is due to these two fast-fashion firms.

The Biden administration could actually use executive authority to remove certain de minimis exceptions. But in a meeting last week about combating the entry of fentanyl, administration officials actually claimed that reauthorizing the warrantless spying provisions of the Foreign Intelligence Surveillance Act was critical to stopping the supply. There isn’t much evidence that surveillance dragnets would deal with the fentanyl trade, and Congress is highly unlikely to rubber-stamp government spying once again.

Drug addiction is largely a medical issue, and expanding treatment is likely to pay higher dividends than a loser’s game of trying to stem the flow of supply. But the fact that fentanyl is coming in through ordinary shipping services without inspection seems to be the low-hanging fruit here. The process of customs inspection has been almost totally circumvented, to the benefit of two groups: e-commerce companies raking in cheap goods from China, and drug traffickers. The latter may be a universally hated scourge, but the former is quite powerful. And so abuse of the loophole continues.

The question for lawmakers and the White House then becomes: How many Americans are they willing to sacrifice so Amazon doesn’t have to pay a little bit in import fees?

https://prospect.org/economy/2023-11-27-amazon-loophole-fentanyl-crisis/

Gifts Under the Tree, for Johnny, Suzie, and Chairman Xi

 I don’t often take advantage of Black Friday deals, but I needed a set of tires, so I steeled myself for battle, and entered the hunt.

The one thing most shops don’t advertise online is the country of origin (I wonder why), so I handled that part by phone.  I called the shop, identified the deal I was looking for, and asked them to check the country of manufacture (as far as I’m concerned, USA would be nice, but I don’t want tires made in China).  He put me on hold while he looked at the tire, and returned with the news: Singapore!

Great, I said, we’ve got a deal.

So I looked at it when they were done, and it turns out, the tire says “Designed in Singapore.”  But I kept looking. I knew that if the tire said where it was designed, then it would also say where it was made.  Sure enough, I found, in the same small font, a few inches away: “Made in Thailand.”

I got a good deal; I’ll be safe in the snow now—and they’re not made in China.  I’m happy.

But it made me curious.  With the holiday season upon us, and everyone shopping for gifts over the next few weeks, I wonder if everyone knows the sometimes unexpected American rules that govern origin marking on our Christmas presents.

The following are the standard, with aspects enforced principally by either the Bureau of Customs and Border Protection or the Federal Trade Commission.  There are some products that depart from these rules, but these are the basics.

1. Generally speaking, there is no requirement to mark a domestic product with country of origin. This means that if you’re shopping in the USA, and something is unmarked, that should mean it was made in the USA.

2. That being said, if it were made in the USA and the seller wants to say so, then there are some very strict rules about what wording the seller can use:

   1. A product truly made or grown here of 100% domestic materials, or at least 95% domestic materials, can simply say “Made in USA,” “Manufactured in USA,” or Product of USA.”

   2. On the other hand, a product truly made here in the USA, which might have more than 5% foreign content, cannot use those terms unless they are followed with a mandatory qualifier, such as “of foreign and domestic materials.”

So, if you have ever seen a product with a mark like this: “Manufactured in USA of imported and U.S. components” or “Made in USA with global materials,” that means it’s definitely made here; it just has imported parts in it, maybe just a few, maybe a lot.  The only verb that serves as its own qualifier for this purpose is “Assembled.” You’ll therefore see “Assembled in USA” alone, but any other verb needs that additional qualifying language unless the foreign content is less than 5% of the product.

As you might imagine, a lot of companies have difficulty understanding these rules.

The Customs rules governing imports are simpler in some ways, and more difficult in others.

To begin with, Customs defines “origin” as the country in which a product “gained its essential character,” or the country in which the product underwent its “last substantial transformation.”  

Products may go through a host of different processes as they move from raw materials to components to assemblies to a final finished good.  The last “substantial transformation” for a complex manufactured good, such as a hair dryer, might be when an American housing and a Chinese heating element and a Canadian electric switch and a Japanese power cord and a Taiwanese printed circuit board and a Mexican handle are all assembled together to finally become a hair dryer.  Generally speaking, if all these parts came together to become a hair dryer in Mexico, then it’s a Mexican hair dryer. If they came together in the USA, it’s an American hair dryer. If they came together in Germany, it’s a German hair dryer.  In the modern global economy, we must assume that most manufactured products include components from multiple countries.

It does have to be a real transformation, however.  Simple finishing steps like painting, polishing or repackaging don’t change origin.  The question is, “Where did these parts come together to become a hair dryer?”

Once origin is established, this rule kicks in:  All imported products must be marked with their country of origin in a manner clear and permanent enough to convey the origin to an interested consumer, so that it can influence his purchasing decision.

1. Normally either the product or its packaging must bear this marking.  If it’s always sold in a package, then the package must be marked; if it’s always sold unpackaged, then the product itself must be marked, and if it’s sold both packaged and unpackaged, then both must be marked.

2. On the bright side, Customs doesn’t particularly care which verb is used.  So in this respect, it’s easier than the FTC rule for domestic goods.

3. Customs does, however, worry a great deal about mixed messages or confusing statements, such as my experience at the tire shop.  Customs’ rule is that a single origin statement, anywhere on the box or product, is sufficient if nothing else could possibly confuse the matter, but if there is anything misleading, then the origin statement must appear nearby, on the same side, in at least equal font size.

   1. So, if your gift says “Made in Mexico” in 12pt font on the bottom, and has no USA mention anywhere, then that’s probably enough.

   2. But if it says “Designed in USA” on top of the box, and/or it shows the company headquarters address, “Acme Stuff, Inc., Los Angeles, CA” on two sides, then all three of those sides must also bear the “Made in Mexico” statement in at least as large a font, so that nobody who looks only at one side gets the wrong idea.

There are plenty of other rules that accompany these.  Rules governing which countries are declared when a set is sold, and when the origin of small accessories need to be mentioned, and of course what kinds of products are completely exempt from origin-marking. Bureaucracies always find a way to make simple things more complicated than they need to be.

But the big picture is this: If you look hard enough, you should find an origin statement, and as long as you’re careful to watch out for misleading statements, you can make an informed purchasing decision.

Be on the lookout for terms like “Designed in USA” or “Engineered in Germany.” That usually means it was actually assembled somewhere else, and the origin statement will be nearby.  And remember too that in the modern economy, corporate headquarters are often in different countries than the companies’ factories, because some countries have more favorable tax codes for corporations and others have more favorable regulations for manufacturing.

There we go. Now we’re empowered to go shopping, and we know what to look for if we’re interested in where our Christmas gift budget is going.

And we have something else to occupy our minds, as well, while we shop:

Why are so many products made abroad? What could we do to attract more manufacturing to the United States?

Importing from other continents has certain inherent costs, after all—expensive transportation, a long lead time, costly business trips, language barriers, and an incredible upcharge when production errors necessitate rework and reshipment.

Every Christmastime, we should think about these issues, and ask ourselves what public policy changes could be effected, at the federal, state, and local level, to attract more manufacturing back home.

But more importantly, every election time, we should be electing candidates who think about these issues too.

John F. Di Leo is a Chicagoland-based international transportation professional and trade compliance consultant.  A one-time Milwaukee County Republican Party chairman, he has been writing a regular column for Illinois Review since 2009.  Read his book on vote fraud (The Tales of Little Pavel) and his political satires on the current administration (Evening Soup with Basement Joe, Volumes I and II, and the brand new Volume Three).

https://www.americanthinker.com/articles/2023/11/gifts_under_the_tree_for_johnny_suzie_and_chairman_xi.html

Not-So-Affordable Care

 In a 2022 book, Seemed Like a Good Idea, health economist Mark Pauly and his University of Pennsylvania coauthors describe how health-care policymakers “often rely on hope or conjecture, not rigorous evidence of effectiveness” when proposing and implementing new programs. Even when those programs fail, as they usually do, the authors argue that policymakers often persist in supporting them. Look no further than the Affordable Care Act, aka Obamacare or the ACA.

Obamacare’s proponents claimed that the American health-care system could and should be transformed from a fee-for-service model to one based on “value.” To make this transition, the law would promote the formation of accountable-care organizations, or ACOs—groups of health-care providers that assume responsibility and financial risk for the quality and costs of care for a defined group of patients. These groups would presumably yield superior care coordination, enhanced quality, and ultimately lower costs.

When Obamacare was enacted, commentators noted that the proposed ACOs looked like the integrated-delivery networks tried in the 1990s and the Medicare Coordinated Care Demonstration projects funded in 2002, both of which failed to lower costs and improve quality. But the health-policy community insisted that it knew better. A recent publication from the Congressional Budget Office (CBO) suggests that, as usual, they were wrong.

The federal government’s Medicare program operates ACOs through the Centers for Medicare and Medicaid Services (CMS) under two parallel tracks: the Center for Medicare and Medicaid Innovation (CMMI) and the Medicare Shared Savings Program (MSSP). Thirty-nine percent of Medicare’s fee-for-service beneficiaries are enrolled in an ACO.

CMMI was created by the Affordable Care Act in 2010 to test “innovative payment and service delivery models to reduce program expenditures . . . while preserving or enhancing the quality of care furnished to individuals” on Medicare, Medicaid, or the Children’s Health Insurance Program. CMMI operates ACOs and other value-based-care programs, such as bundled payments and medical-home models.

Obamacare appropriated $10 billion in mandatory funding for its first decade of operation, fiscal years 2011–2019—funding not provided through the annual appropriations process—to identify, develop, test, and evaluate payment models. In addition, it appropriated $10 billion for each subsequent decade. Payments for the medical services themselves, as well as for bonus payments for meeting quality and other metrics, still come out of the Medicare trust funds. These mandatory, ten-year appropriations ceded broad powers to CMMI to create programs without limits on scope and duration, free from congressional oversight.

The CBO originally projected that CMMI would save $2.8 billion from 2011 to 2020, and $77.5 billion over the next ten years. CMMI ran and published evaluations of the 49 health-care models operated by the center, nearly all of which focused on Medicare beneficiaries, during those first ten years. Only six saved money.

The CBO has found that, instead of saving money, “CMMI’s activities increased direct spending by $5.4 billion, or 0.1 percent of net spending on Medicare, between 2011 and 2020.” CMMI spent $7.9 billion to operate 49 models that reduced spending on health-care benefits by only $2.6 billion.

Why the discrepancy? The CBO’s estimate of CMMI’s expenditures on the models ($7.5 billion) was close to what the center actually spent ($7.9 billion). But the CBO’s savings estimate was way off; it predicted the center’s models would yield a $10.3 billion reduction in benefits spending, versus the actual $2.6 billion. The CBO assumed, without any detail about specific projects, that “CMMI would tend to identify models that reduced saving over time and then expand those models to produce greater savings over time.”

In fact, CMMI has certified only four models for expansion, at least one of which—the Medicare Diabetes Prevention Program—has shown no evidence of savings in Medicare expenditures in the expanded program. Another, the Pioneer Accountable Care Organization Model, began in 2012 with 32 participating ACOs and concluded with only nine participants in December 2016, after which it was incorporated into MSSP. The jury is still out on the others. Contrary to the CBO’s expectation that savings would grow as the CMMI identified and expanded the models that saved money, the CBO found that after the CMMI’s first two model certifications, its certification rates declined.

The CBO also has now updated its previous estimate that the center would save $77.5 billion over its second decade, 2021–2030. It now projects that CMMI will increase net federal spending by $1.3 billion over that period and acknowledges that CMMI might “achieve smaller savings than projected in its second decade” since the models CMMI has thus far implemented “may have already targeted the most easily addressable drivers of health care spending for providers, therefore making similar savings over the next decade more challenging to achieve.”

Other researchers have reached similar conclusions. Brad Smith, former head of CMMI, wrote in the New England Journal of Medicine that “the vast majority of the Center’s models have not saved money, with several on pace to lose billions of dollars.” Avalere, a health-care consultancy, estimates CMMI will produce $9.4 billion in net losses over the 2017–2026 budget window as “a result of models that did not generate expected savings and model savings that did not outweigh the cost of shared savings payments to participants.” Similarly, Health Management Associates, a health-care research and consulting firm, found that CMMI in its first decade showed “minimal success in fulfilling its . . . statutory criteria of lower spending or improved quality.”

The second ACO track, the Medicare Shared Savings Program, was a demonstration project that the ACA expanded and made permanent. Currently, 456 ACOs in the MSSP track provide care to 10.9 million beneficiaries.

CMS has reported savings compared with MSSP spending targets over the past six years. But as the CBO points out, these spending targets, known as benchmarks, do not approximate the counterfactual spending that ACO beneficiaries would otherwise have spent. Instead, they are administratively set objectives

for encouraging providers to participate and to reduce spending. That means that an ACO could generate savings as measured against a benchmark but generate no savings—or even have net costs—relative to an estimate of how spending would have evolved among an ACO’s patient population if the ACO had never formed.

When the CBO reviewed evidence of studies with counterfactual control groups, it found “mixed results.” While several studies identified small net savings, some failed to incorporate the costs of performance payments to the ACOs. Others found savings by assuming spillover savings from changes in the delivery of services to beneficiaries not enrolled in ACOs. But spillover effects can be positive (cost saving) or negative (cost increasing). Evidence of positive spillovers is largely confined to Medicare’s bundled payment-demonstration projects for hip- and knee-replacement surgeries, where a set amount is paid to cover all costs associated with the procedure.

Moreover, it is hard to estimate savings generated by MSSP and extrapolate them to non-MSSP participants, since providers participate on a voluntary basis—only if they think they are likely to achieve savings. If they fail to see savings, they withdraw. When the CBO reviewed three studies that tried to adjust for this provider-selection effect, it found that adjustments in two either wiped out or diminished the savings. The third study found that the adjustments had no impact on the “modest savings.”

Undeterred by these findings, CMS officials remain committed to plans that would move all Medicare fee-for-service beneficiaries into accountable-care plans. CMMI director Liz Fowler told attendees at the America’s Physician Groups conference on October 30 that “The most important driver in achieving broader health system transformation is [moving] 100 percent of beneficiaries in accountable care relationships by 2030.”

One should not be surprised by this determination to move forward. Health-policy planners rarely surrender an established program. Instead, they argue that it should be expanded with increased funding.

But the public and legislators should ask why we should fund these unsuccessful government experiments, particularly when the private market is more likely to come up with effective models for both private and government health-care programs. Private-group purchasers, such as employers and unions, have been demanding lower-cost, higher-quality health coverage for their subscribers. They have been developing lower-cost quality-improvement programs for decades. They have an important incentive to pursue value-based care: saving money.

Private-equity firms have noticed, as private investment in value-based care companies has grown more than fourfold from 2019 to 2021. Private investors and coverage providers hold an important advantage over government programs: they do not undertake and persist in coverage arrangements that lose money, and they do not double down on non-beneficial programs.

The CBO data demonstrate why we should not expand government health-reform programs launched without evidence of effectiveness. Beneficial changes to the American health-care system are far more likely to come from the private market than from unelected bureaucrats in Washington.

Joel Zinberg is a senior fellow at the Competitive Enterprise Institute, director of the Paragon Health Institute’s Public Health and American Well Being Initiative, and an associate clinical professor of surgery at the Icahn Mount Sinai School of Medicine in New York.

https://www.city-journal.org/article/not-so-affordable-care

"Two Words... Tucker Carlson": Greg Gutfeld Gores Fox After Musk Blasts Activist Advertisers

 Greg Gutfeld just took a major shot at his employer, Fox News, saying what we all knew: Tucker Carlson, the highest-rated on-air host in television history, was fired due to pressure from special interest groups.

While discussing Elon Musk's "fuck you" moment over advertiser attempts to blackmail the billionaire, Gutfeld joked that it would be like "extorting Jerry Nadler with salad, or blackmailing sports fans by threatening to cancel PBS."

He then said that Musk was the last man standing against "the censorship-industrial complex, which is made up of government, media and tech forces."

Then, Gutfeld stated what we've all suspected since it happened...

"He [Musk] realizes that advertisers have no spine and can be easily cowed by special interest groups in cahoots with political allies – if you don’t believe me I got two words for ya – Tucker Carlson."

Watch (h/t Modernity.news):

Carlson says 'global freedom hinges on Musk and X'

Meanwhile, in an interview with VC David Sacks, Tucker Carlson says he thinks that the fate of free speech hinges on X.

"I'm worried about the pressure being brought to bear on X because it's the only huge international free speech platform with hundreds of millions of people," said Carlson, adding "The existence of X where anyone around the world can get for free a whole range of opinions that aren't controlled — that changes everything."

Watch the full interview below:

https://www.zerohedge.com/political/two-words-tucker-carlson-greg-gutfeld-gores-fox-after-musk-blasts-activist-advertisers

Amgen expands pact with Amazon to usher drug manufacturing into the AI era

 Seeking to identify ways to improve the discovery and production of medicines, Amgen is expanding its partnership with tech giant Amazon.

Specifically, Amgen is growing its decade-old collaboration with Amazon Web Services (AWS)—a widely used cloud platform—to create generative AI in a bid to increase the manufacturing throughput of pharmaceuticals.

The companies aim to use the tech to boost operations and sustainability at Amgen’s upcoming assembly and final product packaging facility, which is slated to open next year in the greater Columbus, Ohio, area.

Amgen's new plant is being designed to include the latest digital and robotic technology, which will include a connected platform on AWS using Amazon SageMaker. SageMaker is used to build, train and deploy machine learning models, AWS explained in a press release.

The aim of the platform is to help reduce the need for human operators to step in during the manufacturing process, among other goals. Further, the system will allow for the collection and reporting of real-time performance metrics that will be integrated with machine learning models to predict and prevent equipment failures.

Over the past 10 years, Amgen and AWS have been experimenting with generative AI and machine learning technology across the drugmaker's R&D functions. The partners are further using Amazon platforms to explore AI opportunities in Amgen's other areas of operations.

In the biopharma world, Amgen isn't alone in leveraging AI in an increasingly digital world.

Back in June, for instance, Sanofi unveiled a new app developed with AI company Aily Labs that provides a “360” view across all Sanofi activities. At the time, Sanofi also pledged to become “the first pharma company powered by artificial intelligence at scale.”

The platform, dubbed plai, marked an important step in Sanofi’s company-wide digital transformation. Sanofi also incorporates AI across teams including research, clinical operations and manufacturing.

Germany’s Boehringer Ingelheim has also become one of the latest drugmakers to apply machine learning tools to its drug discovery efforts. Earlier this week, the company said it would harness an IBM artificial intelligence model in a bid to discover new antibody therapeutics.

Separately, Boehringer recently struck up a target identification pact with Phenomic AI. The deal features an upfront payment of $9 million and up to $500 million in potential milestones.

https://www.fiercepharma.com/pharma/amgen-expands-pact-amazon-web-services-usher-manufacturing-ai-era

As FDA probes CAR-T safety, expert meeting for Bristol's Abecma could serve as key guidepost

 The revelation of an FDA investigation into whether CAR-T treatments can cause cancer sent shockwaves across the cell therapy world Tuesday. As industry watchers deliberate the implications, one upcoming meeting could offer precious clarity from drug regulators.

The meeting of the FDA’s oncology drugs advisory committee to deliberate Bristol Myers Squibb’s application for Abecma in earlier treatment of multiple myeloma will be “an important milestone in understanding evolving regulatory stances on non-relapse risks with CAR-T” therapies, Leerink Partners analysts said in a Tuesday note.

BMS said the FDA will discuss overall survival data from Abecma’s KarMMa-3 trial during the meeting. As the FDA has yet to set a date, Leerink analysts suspected that the agency might be considering including Johnson & Johnson and Legend Biotech’s rival drug Caryvkti in the discussion, as well.

A Legend spokesperson told Fierce Pharma Wednesday that the company hasn’t received any communication from the FDA about a potential advisory committee meeting for Carvykti’s earlier-line application.

Abecma and Carvykti are BCMA-targeted CAR-T therapies that have each shown an impressive ability to prevent myeloma progression. But CAR-Ts also come with significant toxicities, and the FDA views patient survival as a measurement of both efficacy and safety.

For years, the possibility of patients developing secondary cancer has been discussed mostly as a theoretical risk for CAR-T therapies that use viral vectors as their delivery vehicles. As the Leerink team noted, rates of T-cell lymphoma in clinical trials were too low to draw any conclusions. The FDA’s investigation, unveiled Tuesday, now demonstrates actual reports of T-cell malignancies.

Across all six FDA-approved CAR-T therapies, drugmakers have reported treating about 34,400 patients worldwide. The FDA has identified 19 cases of T-cell malignancies following CAR-T treatment, although the number of CAR-positive lymphoma cases—and whether there’s any causal relationship—remains unclear.

As Legend’s spokesperson pointed out, blood cancer patients who received CAR-Ts had also received other treatments, such as chemotherapy, which is also associated with an increased risk of secondary cancer. The FDA hasn’t yet responded to a request for comment.

Given the small number of cases, analysts at Leerink and William Blair viewed the overall risk of T-cell lymphoma as low, especially for drugs that have shown a strong overall survival benefit, like Gilead Sciences’ CD19-targeted Yescarta. The FDA also said the benefits of these CAR-T products continue to outweigh their risks, but the agency is weighing potential regulatory actions.

Currently, secondary malignancies are listed in the “warnings and precautions” section of every CAR-T therapy’s label. Should the FDA take regulatory action, the Leerink team argued the agency would most likely flag the risk in a black-box warning, which is the highest level of a safety alert on a medication’s label. That wouldn’t be too big a problem, given CAR-Ts already have several boxed warnings, including for potentially life-threatening cytokine release syndrome and neuro toxicities.

Alternatively, the FDA could decide to restrict CAR-T use to high-risk patients or to later-line treatment settings, the Leerink analysts said. Such actions would limit these products’ commercial potential in a meaningful way.

“A worst-case scenario is that today’s FDA announcement portends increased scrutiny and higher risk/benefit bar for CAR-T in earlier lines and settings beyond oncology,” the Leerink analysts wrote in their note Tuesday.

What’s more, the FDA’s probe could start to shift doctors’ attention to the long-term safety profile of these drugs. For now, safety differentiation is secondary to topline efficacy results in most doctors’ evaluation of treatment choice, serving only as a “tie-breaker” between two products with comparable efficacy, the Leerink analysts observed.

As part of the initial approvals for CAR-T therapies, the FDA has required the companies to conduct 15-year follow-up studies to assess the long-term safety and the risk of secondary malignancies.  

https://www.fiercepharma.com/pharma/fda-inspects-car-ts-safety-risk-adcomm-bristols-abecma-could-offer-guidepost

If Dems can target billionaire Elon Musk to control speech, who WON’T they target?

 The Internet heated up recently when X CEO Elon Musk erupted on stage over Disney and other companies pulling advertising over alleged antisemitism on his platform.

“If someone is going to try and blackmail me with advertising? Blackmail me with money? Go f – – – yourself,” Elon Musk said, stunning both the interviewer and audience.

In case anyone missed his profane advice, Musk repeated it with a wave of his hand toward Disney’s Bob Iger, “Hey, Bob, if you’re in the audience.”

Having spoken to both Musk and his staff, after going to the company to dig through Twitter Files, I was not very shocked by his outburst.

And his anger is entirely understandable.

Democratic operatives have been targeting Musk since he took over the company and ceased censoring Americans.

Their tactic is to gin up flimsy reports that allege hate, and then scream at advertisers for supporting his company.

Think Disney’s Bob Iger is incapable of political guilt?

Take a look at his partisan bona fides.

Even before Joe Biden had been sworn in as president, Iger began angling for a position in his administration — possibly as ambassador to China.

And after claiming he didn’t want to get involved in “culture wars,” Iger hired a loyal Biden aide to run Disney’s crisis communications.

He remains a critical donor for Biden’s reelection.

In recent months Musk has sued two Democratic Party activist groups — the Center for Countering Digital Hate and Media Matters for America — for falsely accusing X of promoting hate and driving away advertisers like Disney.

Both groups claim to be nonpartisan but actually work to attack critics of Democratic Party policies.

As I documented in an investigation for Tablet, political operatives with the British Labour Party founded the CCDH in 2018.

The group’s leader, Imran Ahmed, asserts that he is now “at the forefront of reporting on the hate proliferating on X/Twitter since Musk completed his takeover in late October 2022.”

Since Ahmed moved the group to Washington, DC, one of CCDH’s main targets aside from X and Elon Musk has been presidential candidate Robert Kennedy Jr., who leads Biden among young voters and is suing the administration over censorship.

This should not surprise anyone, especially since CCDH’s chairman is Simon Clark, a former senior fellow at the Center for American Progress think tank founded by John Podesta, chairman of Hillary Clinton’s 2016 campaign against Donald Trump.

Ahmed does not disclose CCDH’s funding, but I found that 75% of it comes from dark-money sources.

After I tweeted a series of Twitter Files on Imran Ahmed’s work with the old Twitter to censor people, Musk responded, “Anyone know who is supporting this rat?”

A month later, Musk sued CCDH for “faulty reports” that were driving away advertisers.

“CCDH’s scare campaign to global advertisers . . . is an attempt to stifle freedom of speech on the X platform.”

Media Matters has a similar history.

Founded in 2004 by Democratic operative David Brock with help from the Center for American Progress, Media Matters served as part of Hillary Clinton’s 2016 election “outrage machine,” as The New York Times put it.

After Clinton’s loss, Brock retooled Media Matters to move into the digital space and attack Trump “misinformation.”

But when Biden beat Trump, this political machine pivoted to focus on Musk and Twitter, criticizing him for helping Stanford Professor Jay Bhattacharya look into the Twitter Files to see why he had been placed on a “blacklist.”

Media Matters has also attacked Musk for retweeting news about immigration problems at the southern border, but as border issues have overwhelmed the Biden administration, and with an election approaching, the group ceased making the issue a priority.

Instead, it recently published a bogus report alleging that X placed Nazi content alongside advertisements from major corporations — claims that caused multiple advertisers to freeze spending.

Musk immediately sued. “As the most prominent online platform dedicated to hosting free speech, X and its predecessor Twitter have long been the target of Media Matters,” reads the lawsuit.

Now  Musk’s legion of online supporters have renewed calls for a boycott of Disney.

But you don’t need to love the guy to be concerned.

I am grateful Musk gave me and other reporters access to Twitter’s company documents, something no other CEO has ever done in the history of our democracy.

But I’m not one of his fans.

What worries me as I watch these attacks on Musk unfold: If a political party can target the richest, most powerful man in the country, and in a bid to control speech, who might be next?

I think that’s what Musk and I agree is important.

Paul D. Thacker is an award-winning reporter and former investigator for the US Senate.

https://nypost.com/2023/12/01/opinion/if-dems-can-target-billionaire-elon-musk-to-control-speech-who-wont-they-target/