Yesterday, the Food and Drug Administration named Dr. Vinay Prasad, a San Francisco oncologist, as its top regulator for vaccines and other complex drugs called biologics.

This is a YUGE move.

I know Prasad. He is deeply thoughtful about the value and cost of new medicines. He understands the games Big Pharma plays to win approvals for expensive new drugs that all-too-often have little benefit — and hidden risks.

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Those games often rely around the design of clinical trials: keeping them short for a drug that may be used for years; including only the healthiest possible patients (for example, the Covid-19 mRNA vaccine trials included few people over 80, who should have been the focus of the trials); comparing them to other drugs that have serious side effects and are not the true “standard-of-care.”

They also include pressure campaigns to push regulators to quickly approve drugs for serious conditions like cancer on the basis of “surrogate endpoints.” Drug companies, and the desperate patients they work with and fund, argue any treatment is better than no treatment.

They’re wrong.

Even for people who are dying, they’re wrong — at least on the institutional level.

The human body is incredibly complex. Efforts to modify disease and healing processes are even more complex. Medicine is rife with stories of treatments, from bloodletting to lobotomies, that did more than harm than good but that became accepted cures for decades or centuries.

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(Less toxic than fentanyl…)

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A few weeks ago I visited a little museum in London called the Old Operating Theatre, which is just what it sounds like — a small warren of rooms built around a surgical theater that was used for hundreds of years.

I highly recommend it. You will walk out with a visceral understanding that until the 19th century, surgery was butchery and drug treatments were witchcraft. Amazingly, even the invention of anesthesia didn’t improve surgery much for decades. Ether just meant that patients died horribly of infections after their operations instead of horribly of shock during them. Only the acceptance of germ theory changed that.

But fixing the process of finding and testing curative medicines took even longer than fixing surgery. Only in the last century have physicians realized they needed to stop guessing and look instead to randomized placebo-controlled trials, where two groups of equally matched patients are given either an experimental drug or a placebo and their outcomes carefully measured.

Randomized controlled trials aren’t usually called a miracle, but they are.

They are the miracle that underlies all the other miracles in drug discovery. They aren’t perfect, but they are as close to the truth as science can get. If one group of patients gets a drug, and another equally matched group doesn’t, and they have different outcomes, it is almost certain that the drug — and not hidden factors — has caused the difference.

No other evidence is as strong, because if the two groups are not randomly separated before receiving the treatment, we can never be 100 percent sure that some hidden difference between the groups caused the difference in outcomes that occurred after taking the drug.

Of course some outcomes are so clear that randomized trials are unnecessary. An old joke explains that you don’t need a randomized trial for a parachute before jumping from a plane. To take a less fanciful example, we don’t have a randomized controlled trial showing that cigarettes cause cancer (such a trial would be both unethical and impossible), but in that case the real-world evidence is overwhelming: nearly everyone who gets lung cancer was a smoker, and rates of lung cancer have risen and fallen along with smoking.

But, in general, randomized trials are the best we’ve got, the foundation of modern medicine, the reason doctors can say, this works or this doesn’t.

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(Meet your new director of the Center for Biologics Evaluation and Research)

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But randomized trials can also be the enemy of drug approvals, and so pharmaceutical companies have been chipping away at them for decades. Most recently, they have pressed for “accelerated approvals” that show a drug may work, while promising more data once a drug is on the market.

But those approvals have too frequently led to drugs that don’t work — and that take years to withdraw. Once a company can profit from commercial sales, it will do everything it can to delay collecting data that might force it to stop selling a drug.

And even if a company has good intentions, post-approval data can be messy and hard to collect. Many people won’t enter a clinical trial where they might not receive a drug if they know they can get it outside the trial. The FDA has maximum leverage before approval.

Prasad knows all of this. And as an oncologist he has seen the harms of false hope in cancer treatment up close. He’s going to hold the companies to high standards. The right standards.

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(Boom goes the dynamite!)

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No wonder a lot of biotechnology companies plunged yesterday after word of his appointment came out. Moderna lost 10 percent of its value in two hours (and is now down a cool 95 percent from 2021).

There’s a new sheriff in town.

And the varmints are on notice.

• Chinese exporters are using third countries to avoid US tariffs on their goods.
• Social media is filled with ads offering "place-of-origin washing."
• Countries bordering China are wary of becoming staging posts for goods destined for the US.
• Businesses are shipping goods to countries like Malaysia to obtain new certificates of origin.
• US partners are concerned about the risks of altered origins and false values.

Chinese exporters are stepping up efforts to avoid tariffs imposed by US President Donald Trump by shipping their goods via third countries to conceal their true origin.

Chinese social media platforms are awash with adverts offering “place-of-origin washing”, while an inflow of goods from China has raised alarm in neighbouring countries wary of becoming staging posts for trade actually destined for the US.

The growing use of the tactic underlines exporters’ fears that new tariffs of up to 145 per cent imposed by Trump on Chinese goods will deprive them of access to one of their most important markets.

“The tariff is too high,” said Sarah Ou, a salesperson at Baitai Lighting, an exporter based in the southern Chinese city of Zhongshan. “[But] we can sell the goods to neighbouring countries, and then the neighbouring countries sell them on to the United States, and it will reduce.”

US trade laws require goods to undergo “substantial transformation” in a country, usually including processing or manufacturing that adds significant value, to qualify as originating there for tariff purposes.

But adverts on social media platforms such as Xiaohongshu offer to help exporters ship goods to countries such as Malaysia, where they will be issued with a new certificate of origin and then sent to the US.

“The US has imposed tariffs on Chinese products? Transit through Malaysia to ‘transform’ into Southeast Asian goods!” said one advert posted this week on Xiaohongshu by an account under the name of “Ruby — Third Country Transshipment”.

“The US has set limits on Chinese wooden flooring and tableware? ‘Wash the origin’ in Malaysia for smooth customs clearance!” it added. A person contacted through the details supplied in the advert declined to comment further.

South Korea’s customs agency said last month it had found foreign products worth Won29.5bn ($21mn) with falsified countries of origin in the first quarter of this year, most of them coming from China and almost all destined for the US.

“We are seeing a sharp increase in recent cases where our country is used as a bypass for products to avoid different tariffs and restrictions because of the US government’s trade policy changes,” the agency said in a statement. “We have found numerous cases where the origins of Chinese products were falsified as Korean.”

Vietnam’s industry and trade ministry last month called on local trade associations, exporters and manufacturers to strengthen checks on origins of raw materials and input goods and to prevent the issuing of counterfeit certificates.

Thailand’s foreign trade department also last month unveiled measures to tighten origin checks on products bound for the US in order to prevent tariff evasion.

Ou of Baitai said that, like many Chinese manufacturers, the company shipped goods as “free on board”, under which buyers took liability for products once they left their departure port, reducing the legal risk for the exporter.

“Customers only need to find ports in Guangzhou or Shenzhen, and as long as [the goods] go there, we have completed our mission . . . [after that] It’s none of our business,” she said.

Salespeople at two logistics companies said they could ship goods to Port Klang in Malaysia, from where they would move items into local containers and change their tags and packaging. The companies had connections with factories in Malaysia that could help issue certificates of origin, said the salespeople, who declined to be named.

“The US must know of it,” said one. “It cannot get too crazy so we are controlling the amount [of orders we take].”

“They [Malaysian customs] are not very strict,” the other salesperson said.

China’s foreign and commerce ministries, and the Malaysian government, did not immediately respond to requests for comment.

A consultant who advises companies on cross-border trade said origin-washing was one of the two main methods being employed to avoid Trump’s new levies. The other was mixing high cost items with cheaper goods, so exporters could falsely claim a lower overall cost of shipments, the consultant said. 

The owner of a consumer goods manufacturer based in the southern Chinese city of Dongguan said two domestic industry associations had introduced it to intermediaries who offered “grey area” tariff workarounds.

“Basically I only ship to a Chinese port and they take it from there,” the owner said, adding that the intermediaries had offered to arrange the workaround for just Rmb5 ($0.70) per kilogramme shipped.

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“These agencies said small- and medium-sized enterprises like us can weather the tariff hit better because there’s always grey areas,” she said. “I hope it’s true. The US is a big market — I don’t want to lose it.”

The proliferation of efforts to avoid tariffs has caused concern among US business partners. One senior executive at a top 10 independent seller on Amazon said they had observed instances where shipments’ origins had been altered, risking confiscation by US customs authorities.

The executive said they were reluctant to accept offers of assistance from their Chinese suppliers, such as having them act as the “importer of record” into the US and paying tariffs based on the cost of manufacturing rather than the retailer’s higher cost of purchase.

The executive said they worried that a supplier might report a false value. “You’re putting a lot of trust in a Chinese supplier,” they said.

• Donald Trump has proposed a budget with $163bn in cuts to federal spending, targeting programs deemed "woke" or "wasteful".
• The plan involves a 22.6% reduction in non-defense spending, the lowest since 2017, while increasing the defense budget.
• Key areas for cuts include foreign aid, healthcare, education, and environmental programs.
• The budget aims to cut funding for renewable energy, electric vehicles, and agencies like the National Institutes of Health.
• Democrats have criticized the budget, with Chuck Schumer calling it "heartless" and a "betrayal of working people."

Donald Trump has called for $163bn in cuts to federal spending in a sweeping budget proposal that guts programmes his administration deems “woke”, “wasteful” or “weaponised against ordinary working Americans”.

In a budget blueprint submitted to Congress on Friday, the US president pressed for non-defence spending to be slashed by 22.6 per cent to the lowest level since 2017 alongside a sharp increase in the defence budget.

Trump’s plan would slash billions of dollars previously spent on foreign aid, healthcare, education and the environment, codifying many of the cuts being implemented by the so-called Department of Government Efficiency.

Russ Vought, head of the Office of Management and Budget, said current expenditure was “contrary to the needs of ordinary working Americans and tilted toward funding niche non-governmental organisations and institutions of higher education committed to radical gender and climate ideologies antithetical to the American way of life”.

Trump’s budget wishlist comes as he intensifies his assault on the administrative state. Elon Musk, the world’s richest man, and Doge are leading the radical effort to shrink the size of the federal government.

The proposal outlines the president’s priorities for so-called discretionary spending, the portion of the federal budget set by appropriations bills in Congress each year. It does not include longer-term ‘mandatory’ spending such as Social Security, Medicare, and interest paid on the federal debt.

Foreign aid would be hit particularly hard under Trump’s proposal, with a $49bn cut in spending and the shuttering of USAID, which Doge has reduced to a skeleton operation.

The budget takes aim at what the administration dubbed the “globalist climate agenda”, cutting grants for renewable energy and electric vehicles.

It also slashes spending on the education department, which Trump has vowed to close. The plan takes an axe to funding for agencies including the National Institutes of Health, the Federal Emergency Management Agency and Internal Revenue Service, all of which he said have been “weaponised”.

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Contrasting the spending cuts, the plan calls for an increase in government outlay on the military and border security as part of Trump’s pledge to clamp down on illegal immigration. The defence budget would rise 13 per cent, while homeland security would be allocated another 65 per cent.

Chuck Schumer, the leading Senate Democrat, described the budget as “heartless” and said his party would fight efforts by Republican lawmakers to embed it in legislation.

“As [Trump] guts healthcare, slashes education, and hollows out programmes families rely on — he’s bankrolling tax breaks for billionaires and big corporations,” Schumer wrote on X. “It’s not just fiscally irresponsible, it’s a betrayal of working people from a morally bankrupt president.”

• The UK's Financial Conduct Authority (FCA) plans to ban retail investors from borrowing money to invest in cryptocurrencies.
• The FCA intends to expand its regulatory oversight of the crypto market, including trading platforms and lending services.
• The new rules will mandate stricter regulations for crypto services offered to retail investors compared to professional investors.
• Key concerns addressed by the FCA include market manipulation, lack of transparency, and unreliable trading systems.
• The FCA aims to balance consumer protection with encouraging growth in the crypto sector, despite acknowledging the high-risk nature of most crypto assets.

The UK financial watchdog plans to ban retail investors borrowing money to invest in cryptocurrencies like bitcoin as it seeks to bring much of the fast-growing digital assets market under regulatory supervision for the first time.

The restrictions on lending for crypto purchases are part of a sweeping set of rules outlined by the Financial Conduct Authority on Friday, a few days after the government presented its plans to legislate for the digital asset market.

“Crypto is an area of potential growth for the UK but it has to be done right,” David Geale, FCA executive director of payments and digital finance, told the Financial Times. “To do that we have to provide an appropriate level of protection.”

Dismissing claims by some crypto asset companies that the FCA is hostile to their industry, Geale said: “I would in some ways compare this to any other high-risk investments, which if anything often have less protections . . . We are open for business.”

The FCA proposals aim to bring much of the crypto market under its regulatory remit, including trading platforms, intermediaries, crypto asset lenders and borrowers, and decentralised finance systems. The plans apply a much tougher set of rules to crypto services provided to retail investors than to those dealing only with professional, or sophisticated investors.

“We started from a position of wanting to develop something that is safe and is competitive,” Geale said. “If we can get the regulatory regime right it actually becomes attractive for firms. That is what we are trying to achieve.” 

The FCA said it planned to restrict firms from lending to consumers to fund their crypto purchases — including via credit cards — due to the regulator’s concern about “unsustainable debt, particularly if the value of their crypto asset drops and they were relying on its value to repay”. 

The proportion of people in the UK funding crypto purchases by borrowing has more than doubled from 6 per cent in 2022 to 14 per cent last year, according to a recent YouGov survey.

The FCA also said it planned to block retail investors from accessing specialist crypto lenders and borrowers such as Celsius Network, which collapsed in 2022 amid a wider crisis in the sector. 

The regulator listed a number of concerns about the market for trading crypto assets including market manipulation, conflicts of interest, settlement failures, a lack of transparency, illiquidity and unreliable trading systems.

To tackle some of these, the FCA will require crypto trading platforms to treat all trades equally, to separate their own proprietary trading activities from those done for retail investors and to provide transparency on pricing and execution of trades.

It will ban trading platforms from paying intermediaries for order flow and require all companies offering crypto trading to UK consumers to operate through an authorised legal entity in the country. 

Consumers who park their crypto assets with “staking services” in exchange for a return will have to be reimbursed for any losses caused by third-party actions.

Decentralised finance systems, which have no centralised operation and run purely on lines of computer code, will be exempt from the new FCA regulations unless they have a “clear controlling person”.

While warning “the majority of crypto assets will remain high risk — speculative investments and consumers should be prepared to lose all their money if they buy them”, the FCA said its aim was “encouraging growth as far as reasonably possible”.

Crypto companies have grown frustrated with the FCA over the high level of rejections in the regulator’s registration scheme for compliance with its anti-money laundering rules.

The regulator rejected 86 per cent of such applications in the 12 months to April 2024, but in the latest fiscal year that proportion fell to 75 per cent.

Crypto executives supported the FCA’s focus on consumer protection.

“As such an internationally influential regulator, as soon as the FCA starts to regulate the crypto market they are giving it a massive stamp of approval — so I understand their caution,” said Joey Garcia, head of public affairs at Xapo Bank, a Gibraltar-based crypto custodian.

Riccardo Tordera-Ricchi, director of policy and government relations at the Payment Association, a trade body, said: “The government says it is open for business, but in practical terms it will be difficult for the FCA to implement this — they don’t have an easy job.”

Companies have until June 13 to respond to the FCA’s proposals.