EU capitals propose Chips Act for medicines

“The EU capitals point out that 40 percent of all pharmaceutical ingredients globally are sourced from China, and that production for many of these products is concentrated in just a handful of manufacturing sites. “As a result, Europe (and the world) depend on a few manufacturers for a large bulk of their medicines supply,” notes the paper.”

Prohibition Gave Us Xylazine in Fentanyl. The Solution, Drug Warriors Say, Is More Prohibition.

“The emergence of the animal tranquilizer xylazine as a fentanyl adulterant, like the emergence of fentanyl as a heroin booster and substitute, has prompted law enforcement officials to agitate for new legal restrictions and criminal penalties. That response is fundamentally misguided, because the threat it aims to address is a familiar consequence of prohibition, which creates a black market in which drug composition is highly variable and unpredictable. Instead of recognizing their complicity in maintaining and magnifying that hazard, drug warriors always think the answer is more of the same.”

“Why is xylazine showing up in fentanyl? For the same reasons fentanyl started showing up in heroin. As a 2014 literature review in Forensic Science International notes, “illicit drugs, such as cocaine and heroin, are often adulterated with other agents to increase bulk and enhance or mimic the illicit drug’s effects.” Because xylazine and heroin have “some similar pharmacologic effects,” the authors say, “synergistic effects may occur in humans when xylazine is use as an adulterant of heroin.”
Before the DEA was warning us about xylazine in fentanyl, it was warning us about fentanyl in heroin, and both hazards are the result of laws that the DEA is dedicated to enforcing. From the perspective of drug traffickers, fentanyl has several advantages over heroin. It is much more potent, which makes it easier to smuggle, and it can be produced much more cheaply and inconspicuously, since it does not require the cultivation of opium poppies. Xylazine has some of the same advantages: It is an inexpensive synthetic drug that can be produced without crops. And unlike fentanyl, it is not currently classified as a controlled substance, which makes it easier and less legally risky to obtain.”

“American drug users are not clamoring for xylazine in their fentanyl, any more than they were demanding fentanyl instead of heroin. In both cases, the use of adulterants is driven by the economics of the black market. And as usual with illegal drugs, consumers do not know what they are getting. The Times underlines that point by noting one response to the proliferation of xylazine: “Addiction medicine experts,” it says, “urged that newly introduced xylazine test strips, which people can use to check the drugs they buy, be as widely distributed as fentanyl test strips.”

The fundamental problem, of course, is the dangerous uncertainty created by prohibition. Unlike alcohol, cannabis products sold by state-licensed pot shops, or legally produced, reliably dosed pharmaceuticals, black-market drugs do not come with any assurance of quality or potency. The introduction of new adulterants like xylazine increases that hazard. We have seen this story play out many times before. Whether it is vitamin E acetate in black-market THC vapes, MDMA mixed with synthetic cathinones or butylone, levamisole in cocaine, or fentanyl pressed into ersatz pain pills, prohibition reliably makes drug use more dangerous.”

Studies Link Marijuana Legalization to All Sorts of Positive Public Health Outcomes

“Legalization linked to fewer suicides, traffic fatalities, and opioid deaths. A new paper on the public health effects of legalizing marijuana finds “little credible evidence to suggest that [medical marijuana] legalization promotes marijuana use among teenagers” and “convincing evidence that young adults consume less alcohol when medical marijuana is legalized.””

No, the U.S. Shouldn’t Wage War Against Mexican Cartels

“As Cato Institute Policy Analyst Daniel Raisbeck has written for Reason, Plan Colombia’s aid did initially “help the Colombian military to severely weaken the once-formidable [Revolutionary Armed Forces of Colombia (FARC)]. But Plan Colombia’s anti-narcotics element was an unqualified failure.” Per Raisbeck:
“By 2006, “coca cultivation and cocaine production levels (had) increased by about 15 and 4 percent, respectively.” In 2019, there were more hectares cultivated with coca leaf in Colombia (212,000) than two decades earlier (160,000).

The so-called FARC “dissidents,” thousands of fighters who did not demobilize in 2016, still control large swathes of the cocaine business. They wage constant combat over production areas and export routes against other guerrilla groups and criminal organizations, including several with links to Mexican drug cartels.”

American counternarcotics efforts yielded similarly bad results in Afghanistan. The U.S. spent about $9 billion to tackle Afghanistan’s opium and heroin production, only for the effort to be “perhaps the most feckless” of “all the failures in Afghanistan,” according to The Washington Post’s analysis of confidential government interviews and documents. By 2018, Afghan farmers were growing poppies on four times as much land as they were in 2002. Operation Iron Tempest, meant to cripple Afghanistan’s opium production labs, folded within a year. “Many of the suspected labs turned out to be empty, mud-walled compounds,” noted the Post.

The war on drugs has helped turn Latin America into the most violent region in the world. Criminalization has led to the proliferation of black market activity, a boom in many countries’ prison populations, and increased corruption across Latin America. It’s also contributed to a huge number of homicides: At least half of the violent deaths in Colombia, El Salvador, Honduras, Mexico, and Venezuela are estimated to be drug-related, according to the World Economic Forum.

Despite those failures, many Republicans still want to use war on terror tactics to fight Mexican cartels.”

“The increase in overdose deaths among Americans is tragic and obviously a problem. It isn’t one that will be solved by fighting the war on drugs just a little bit harder. It certainly isn’t one that will be solved by bombing a neighboring country against its wishes, risking further escalation. It requires being realistic about the policies that have made drug use more dangerous. “That starts with bipartisan support for prohibition,” writes Reason’s Jacob Sullum, “which creates a black market where the quality and potency of drugs are highly variable and unpredictable.”

Simply stopping the supply of drugs into the country is an impossible task, as decades of prohibition show. Republicans would be far better off embracing harm-reduction strategies rather than pushing for another episode of military adventurism that is destined to fail.”

Police Found a Blunt in Their Car. So They Seized Their Kids.

“Bianca Clayborne and Deonte Williams were driving through rural Tennessee with their five young children when they were pulled over. When police found 5 grams of marijuana in the car, Williams was arrested and the five children were seized by local child protective services. One month later, the couple is still fighting to regain custody of their children.”

The growing Chinese investment in illegal American weed

“Despite the Chinese Communist Party’s strict stance on drugs, the triads — which run global crime networks distributing chemicals needed to manufacture methamphetamine and fentanyl, among other potentially dangerous substances — often curry favor with the CCP by functioning as extralegal enforcers for the government, Felbab-Brown said. The CCP in turn often allows them to continue their operations, though it does not control them.”

“Roughly 75 percent of the $100 billion cannabis market in the U.S. remains illegal, and roughly two thirds of that illicit weed is grown domestically”

“In California, the Department of Cannabis Control says Chinese triads have been nominally involved in illegal cannabis production for decades, but that there’s been a recent increase in the number of actors and money that may have originated in China. The DCC also said that some — but not all — of the Chinese-funded grows they’ve encountered are operated by Chinese triads.”

““This notion that you now have Chinese actual funding for illicit cannabis, it’s definitely new, and it cuts directly across the interests of Mexican drug trafficking groups,” said Felbab-Brown. “It’s interesting to see whether it continues growing, [and] how that’s going to affect relations between the Mexicans and the Chinese [criminal groups].””

Need an Adderall Prescription? Good Luck Getting It Over Telehealth.

“During the early stages of the COVID pandemic, the Drug Enforcement Administration (DEA) temporarily lifted restrictions on doctors’ ability to write prescriptions for controlled drugs via telehealth. However, the agency is poised to bring telehealth under regulation again, bringing back strict limits on how and when doctors can prescribe certain drugs.

DEA officials announced the proposed regulations on Friday. The rules would render most controlled drugs ineligible for prescription via telemedicine appointment—severely restricting patients’ ability to obtain drugs without an in-person examination.”

“However, the proposal contains several carve-outs. Under the policy, Schedule III-V controlled medications can still be prescribed via telemedicine. But patients would be limited to a 30-day supply, after which the patient would be required to have an in-person visit in order to get a refill. The same exception applies to buprenorphine, a drug used to treat opioid substance abuse. Further, under the proposed rule, patients can get indefinite prescriptions for controlled substances via telehealth but only if they are referred to a telehealth physician after receiving an in-person examination by another doctor.”

“Officials justified the regulations by citing concerns over the risk of overprescription of controlled drugs. While administration officials did mention the benefits that telehealth services bring to rural Americans, there is little consideration of how these services are equally important to many who rely on controlled drugs—and the increased risk that desperate patients will turn to significantly more dangerous drugs to alleviate their symptoms.
“As a health policy lawyer w. chronic pain & ADHD, I cannot overstate how unnecessary & cruel this policy is given what visits look like in person v. Telehealth,” wrote health policy lawyer Madeline T. Morcelle on Twitter. “Or how deadly this could be for those who struggle to get to [appointments] due to disability or transport/geographic barriers.””

Insulin is way too expensive. California has a solution: Make its own.

“There are few better emblems of the failures of the US system of medical care than its inability to consistently provide insulin to Americans who need it.
The drug was discovered 100 years ago, and it provides essential and ongoing treatment for millions of people living with diabetes, one of the most common chronic diseases in the country. And yet one in six Americans with diabetes who use insulin say they ration their supply because of the cost. Some people end up spending nearly half of their disposable income on a medicine they must take to stay alive.

Though insulin generally costs less than $10 per dose to produce, some versions of the drug have a list price above $200. This is in part because, in the US, a warped market has allowed three companies to dominate the insulin business.”

“With California leading the way, a handful of states are considering trying to disrupt the market for essential medications, starting with insulin. The plan would be to manufacture and sell insulin themselves for a price that is roughly equivalent to the cost of production.”

“Medicare, the federal health insurance program for seniors, is about to institute a $35 per month cap on insulin costs for its beneficiaries, a provision of the Inflation Reduction Act that Democrats passed last year. But, because of the Senate’s arcane rules, they could not establish the same cap for private insurance, which covers more than half of Americans.”

“The main mechanism the US has for bringing down prescription drug prices is allowing generic drugs to compete with brand-name versions. When a company develops a new drug, it gets a period of exclusivity, 10 years or more, in which it is the only one able to make or sell that drug. But after that exclusivity period has passed, other companies can make a carbon copy and sell it at a lower price. Studies find that once several generic competitors come on the market, prices drop significantly.

But pharma companies are savvy about finding ways to extend their monopolies, with insulin and other drugs, by making minor tweaks to the chemical compound and asking for a patent extension. In the case of insulin, the companies can also modify the delivery device to protect their market share. Each product is meant to be used with specific, company-designed injectors. Though the patents on the artificial insulin developed in the 1990s have started expiring, these companies continue to hold and extend monopolies on either their devices or other chemical compounds, making it harder for generic competitors to enter the market.

Other federal regulations have added to the challenge. The FDA began to treat insulin as a biologic drug in 2020 — meaning it is made with living materials instead of combining chemicals like conventional pharmaceuticals — which comes with a different set of standards for generic versions, which are known as biosimilars, as well as manufacturing challenges given the precise conditions these products must be made in. Biosimilars can cost up to $250 million to produce and take up to eight years to bring to the market, versus a one-year investment of as little as $1 million for conventional generics. And unless the FDA recognizes a new generic insulin as interchangeable with the products already on the market, health insurers might not want to cover it and doctors may not be willing to prescribe it.

To add one more layer of difficulty, the current manufacturers can always decide to drop their prices to crowd out new generic competitors, given the gap between the retail price and the $10 cost of production. The first biosimilar drugs have come onto the market in the past few years, but only one of them has been deemed interchangeable with the brand-name version; ultimately, in late 2021, it was priced at only $20 less than the brand-name insulin it was competing with. More competition is needed to meaningfully depress prices.”

“If manufacturing a cheap generic insulin proves viable for California, the consequences could be enormous and stretch far beyond insulin. California would provide proof of concept, and a fledging public marketplace for public pharmaceutical production could potentially emerge.”