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The hidden link between screen time, sleep, and teen health | STAT

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With all the discussion around the adolescent mental health crisis, a prime suspect has gone relatively unnoticed: sleep. 

I have treated thousands of youths struggling with mental illness over the past 25 years. As a child and adolescent psychiatrist, I have observed a remarkable shift in their everyday habits thanks to screen time. A 2021 report from Common Sense Media found that people between the ages of 13 and 18 spend almost nine hours a day looking at screens.

These additional hours of screen time have come at the expense of a variety of other activities: socializing in person, chores, employment, reading books, physical activity, and most importantly, sleep. Studies confirm that teens now sleep less than before smartphones took over our lives, while their biological need for sleep has remained unchanged. Two-thirds of adolescents fail to get the minimum eight hours their minds need on most school nights, with Black and male teens sleeping the least. According to the National Science Foundation, 70% of American high school students get less than eight hours of sleep per night, or less time than they spend looking at screens.

Dozens of studies have proven how screen habits lead to poor sleep. Screen time impairs sleep in five ways.

First, kids stay up later because they prefer screen media over going to bed. Second, video games and social media increase autonomic arousal (it riles them up), delaying sleep onset even after the device is turned off. Third, many teens lie in bed during daylight hours to engage with their phone or tablet, deconditioning the body to fall asleep in bed when they want to. Fourth, notifications — typically messages from insomniac peers looking for company — often wake teens from sleep at night. Others plan middle-of-the-night awakenings to go online undisturbed by parents who assume they’re asleep. Fifth, the blue light emitted by screens at night tricks the suprachiasmatic nucleus into believing it is daytime, further disrupting a teen’s sensitive sleep-wake cycle. 

Sleep-deprived adolescents sometimes fall asleep in school, but more often, nap after school and crash on the weekend, temporarily meeting their sleep debt but failing to undo most of the related damage. That damage is considerable. Sleep deprivation impairs learning considerably, strongly predicting declining grades. It also predisposes youth to depression, anxiety, suicidality, and obesity. Multiple studies confirm that the relationship between screen time and poor mental health is related to its negative effect on sleep. The lack of sleep that results from teens’ nighttime social media and video game engagement may be the most important single cause of the adolescent mental health crisis. 

Why then, does adolescent sleep receive so little attention in the news media? One reason is that the effect of insomnia on mental health is insidious. Teens and their parents often fail to connect an onset of depression and anxiety with a decline in their sleep habits. Many depressed youths value time spent on screen entertainment late at night because the entertainment provides temporary relief from their growing daily distress. They are unaware, though, that their solution ultimately exacerbates the problem. 

A decade ago, it was not uncommon for teens with insomnia to ask me to prescribe sleep medication. More often than not, removing screens from their room at night resolved their insomnia without requiring pills.

But increasingly I find teens don’t really want to give sufficient time to sleep. They prefer nighttime smartphone use to a reasonable bedtime, refusing parental rules and even sleep medication lest it interfere with their favorite activity. When I was working with a boy who would stay up all night in his room playing video games, I suggested to his mother that she move his gaming console into the living room. She did it, but to my surprise, he was sleeping no better. Then she clarified what was happening: “He never goes into his room anymore, just spends all night gaming in the living room.” 

While screens may seem inseparable from modern adolescence, we must not ignore the mounting evidence that nighttime screen use exacts a terrible toll on mental health. Teens must be educated about the importance of adequate sleep, and how screens can get in the way. Many lack the insight, perspective, and willpower to manage screen time on their own, but parents can help by setting a bedtime that allows for nine hours of sleep per night and restricting all access to screens until morning. Often this means banning screens from the bedroom completely, charging phones in the parents’ bedroom overnight, and deactivating Wi-Fi automatically each evening. Parents might bristle at this because they want to use their devices, too, but this offers a chance for parents to set an example by moderating their own screen habits. Prioritizing sleep will help children and teens lead healthy lives in this media-saturated world. Sometimes the best therapy of all is a good night’s rest. 

This essay is adapted from a chapter written by Paul Weigle and edited by Naomi Schaefer Riley and Sally Satel in the edited volume “Mind the Children: How to Think About the Youth Mental Health Collapse.”

Paul Weigle, M.D., is a board-certified child and adolescent psychiatrist, associate medical director at Natchaug Hospital, and associate professor of psychiatry at UConn School of Medicine.

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sarcozona
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European tourist denied entry to US over JD Vance meme on his phone

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A visitor from Norway was reportedly denied entry to the United States after border officers found an unflattering meme of Vice President JD Vance on it. Mads Mikkelsen, 21, told his hometown newspaper that be was harassed by officers before being deported.

[He] claimed the officers then threatened him with a $5,000 fine or five years in prison if he refused to give the password to his mobile phone. The guards reportedly found a meme on the device’s camera roll showing US vice president JD Vance with a bald, egg-shaped head.Mikkelsen said after discovering the image the Officers Beforeities sent him home to Norway the same day.

U.S. officials warn visitors that they must not only hand over their devices at the border for inspection, but also access to their social media accounts. It’s not in the official guidance, but do remember to say thank you as well.…’ Rob Beschizza via Boing Boing



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sarcozona
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Trump Declares War on the Birds and the Bees

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No, not those birds and bees, ya randy bastids!

During the 2024 election, I repeatedly POASTED something along the lines of “If Trump wins, he will break things that most people didn’t even know could be broken.” With that as prelude, I give you the birds (boldface mine):

If the Trump administration gets its way, we won’t have much hope of learning more. The White House’s 2026 budget would end the annual North American Breeding Bird Survey and the Bird Banding Laboratory, programs under the U.S. Geological Survey’s Ecosystems Mission Area.

For more than a century, bird studies have operated as follows: Scientists band birds and wait to see what happens to them. Since 1920, the Bird Banding Laboratory has worked with Canadian scientists to run the North American Bird Banding Program. More than 77 million birds have been banded in the United States and Canada; more than 5 million of those birds have been “reencountered,” or found and logged by someone later on.

Bird banding might seem low-tech, but the program has provided some of the best information we have about certain species. It’s how we know about Wisdom, a Laysan albatross that lives on Midway Atoll and is the oldest confirmed wild bird in the world. She was banded in 1956 and still incubating eggs as of last year, at 74 years old. Banding is how agencies track the health of waterfowl populations and set hunting limits and seasons for the birds at sustainable levels. Wood ducks were hunted to such an extent that they were close to extinction when the North American Bird Banding Program started. Today, there are an estimated 4 million of them, and the population is increasing. Hunters are some of the most frequent loggers of banded birds.

Who would want to end such a program? If we don’t track a bird species, we’ll have no idea when it’s in jeopardy. Without the citizen-reported data, it becomes much harder to prove that a marsh where someone wants to build a parking lot or a resort or a golf course is actually vital habitat. The bird-banding program is just one part of the USGS’s Ecosystems Mission Area; the program’s $292.9 million budget in 2025 went to programs that monitor invasive species, track diseases such as avian influenza and look for ways to help ecosystems adapt to climate change. All of this is slated for defunding in the White House’s proposed 2026 budget. Hard to see how that makes America great again.

And the bees (boldface mine):

Droege, a slender 66-year-old who wears his long white hair in two neat French braids, is one of the world’s leading native bee experts, devoted to tracking and identifying the insects and the plants they help maintain. And for the first time in its more than two-decade-long history, the future of the bee lab is imperiled.

The Trump administration’s 2026 budget proposal calls for the defunding of the bee lab and other federally funded wildlife research efforts. Bracing for these cuts, priorities have shifted for the the lab, which has collected and identified more than 1 million specimens of pollinators, hundreds of thousands of which are slotted away in its modest walls. Active field work is on pause. No new research projects have begun.

Droege studies native bees, the types of pollinators that only live in the wild, as opposed to honeybees, which are farmed and bred for profit. Entomologists stress that honeybees and native bees are different — sort of like farmed chickens and wild birds. But they can be exposed to the same threats, and there are signs that both are in trouble….

Commercial and native bees can fall victim to the same hazards, including pesticides, drought and environmental pollutants, experts said. Droege is one of the only people in the country who can distinguish most native bees from their thousands of relatives — research that helps track the insects and the plants and crops they maintain.

Native bees pollinate an estimated 80 percent of flowering plants around the world, and understanding the pollinators’ behavior helps us sustain the production of our food. Forests, prairies, grasslands, deserts and wetlands rely on bees to maintain their unique biodiversity. The more we track bees, the better we can understand the role different species play in the pollination of crops such as pumpkins in the Mid-Atlantic, apples in Pennsylvania, tomatoes in California and blueberries in Oregon.

Hollis Woodard, an assistant professor focused on native bees at the University of California at Riverside, said the lab is “essentially irreplaceable.” She uses its data for her work researching native bees nearly every day. “If we lose this facility and we lose these people, the hit we’re going to take to tracking bees and trying to conserve them would be absolutely devastating,” Woodard said…

The lab’s budget is small. Droege said it includes his salary and that of his sole employee, a lab manager hired about four years ago. Otherwise, he said, they have received anywhere from $3,000 to $12,000 annually from the government. But it falls under a larger federal biological research effort that the Trump administration has proposed eliminating as of Oct. 1.

The White House wants to eliminate grants and research programs that “duplicate other Federal research programs and focus on social agendas (e.g., climate change) to instead focus on achieving dominance in energy and critical minerals,” according to its proposal, which calls for cutting $564 million from the Interior Department’s U.S. Geological Survey. The agency runs the bee lab and other programs that monitor animals including birds, butterflies and bats…

“Sam’s whole role and the role of that lab is to be in service to the American people,” said Mace Vaughan, the director of the pollinator and agriculture biodiversity program at the Xerces Society, an insect conservation organization. “They’re like a hub in a wheel supporting identification, training, research, data sharing.”

The lab has provided data for more than 800 papers over the last 20 years. It receives and identifies bees from universities and hobbyists alike. It takes the time to write identification manuals and run the sort of tests that Droege quips “will not get you tenure,” such as: Which brand of soap works best in a bee trap?

Many people who have come through my lab have either been directly trained in bee identification by Sam Droege or have used his lab’s expertise to verify species IDs,” said Scott McArt, who heads a pollinator lab at Cornell and is an assistant professor of pollinator health in the university’s department of entomology.

Is this a crisis equivalent to the slow evolution of ICE into Trump’s personal praetorian or any other number of fascist* policies? No, but it’s still stupid and wasteful, as once you destroy things like this, you can’t get them back: there’s no way to recreate the missing data or expertise, they’re just gone forever.

And, as always, these are just smaller facets of a larger, fascist and totalitarian piece.

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sarcozona
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The 2025 NSF GRFP awards, now with double the bias

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Science magazine reports a new skew in the awarding of the National Science Foundation’s Graduate Research Fellowship Program (NSF GRFP) awards.

No awards in life sciences. Zip. Zero. Zilch.

I used to joke that there was no Nobel prize for biology. Now it seems there’s no GRFPs, either. The awards are heavily skewed toward computer science, particularly artificial intelligence. 

And let’s not forget that the number of awards was cut in half.

I strongly suspected that the awards were probably heavily skewed to fancy, well funded research universities and showed little love to the larger public university systems, which has been going on for as long as I know. But I had to poke the wound and look at the award data. Currently easy to download into an Excel file.

I  posted a super quick check on the numbers in a Bluesky thread.

Harvard University, with about 25,000 students total (many who would not be eligible) gets 25 GRFP awards.

Meanwhile, the entire University of Texas system, with about 250,000 students total (again, many not eligible) gets 30.

Embattled Columbia University, about 33,000 students total, gets 29 GRFP awards.

Arizona State University, with over 183,000 students total, gets 8 GRFP awards.

MIT, which is tiny, gets 82 GRFP awards. They always get a lot of awards, but the number of awards per student has jumped. Back in 2022, MIT had 83 awards, but keep in mind that because the number of awards were halved this year, the 82 award count this year is proportionately much heftier than the 83 awards in 2022.

The University of California system, which is gigantic, gets about 147 GRFP awards. (I say “about” because I just searched the Excel spreadsheet for “University of California,” and I know some universities in that system don’t follow that naming convention.) 

Yes, I could try to figure out student enrolment numbers better so they might more accurately reflect the population of students eligible for GRFP awards, but there is no way that the overall trend would budge.

I do not believe talent to so concentrated in such a small number of institutions. It’s a Matthew effect.

A recent article by Craig McClain is also worth pointing out here. McClain points out that the current academic training system makes it extraordinarily difficult to be a career scientist unless you have money to burn. The way they NSF GRFP program runs contributes to this problem.

References

McClain CR. 2025. Too poor to science: How wealth determines who succeeds in STEM. PLoS Biology 23(6): e3003243. https://doi.org/10.1371/journal.pbio.3003243 

Related posts

The NSF GRFP problem, 2022 edition  (Links to my older rants – er, posts – about this award contained within)

External links

Prestigious NSF graduate fellowship tilts toward AI and quantum 

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Generic cancer drugs fail quality tests at alarming rate, investigation shows | STAT

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Vital chemotherapy drugs used around the world have failed quality tests, putting cancer patients in more than 100 countries at risk of ineffective treatments and potentially fatal side effects, an investigation by the Bureau of Investigative Journalism (TBIJ) reveals.

The generic drugs in question form the backbone of treatment plans for numerous common cancers — including breast, ovarian, and leukemia. Some drugs contained so little of their key ingredient that pharmacists said giving them to patients would be as good as doing nothing. Other drugs, containing too much of the active ingredient, create the risk of severe organ damage or even death. “Both scenarios are horrendous,” said one pharmacist. “It’s heartbreaking.” 

Doctors from multiple countries told TBIJ that the drugs in question didn’t work as expected, leaving patients suddenly unresponsive to treatment. Other patients suffered side effects so toxic that they could no longer tolerate the medicine. 

The variance found in the levels of active ingredients was alarming. In some cases, pills from the same blister pack contained different amounts.

These findings expose huge holes in the global safety nets intended to prevent manufacturers from cutting corners to boost profits, and to protect patients from bad drugs. All the while, patients and governments with stretched resources are paying the price for drugs that don’t work.

Cancer is one of the biggest killers worldwide, linked to around 10 million deaths every year — roughly one in six. The burden of cancer is growing, particularly in low- and middle-income regions. In sub-Saharan Africa, for example, the incidence of cancer has doubled in the last 30 years. 

Much of the global demand for treatment is met by generic drugs. These are copycat versions of a medicine that can be made once the original maker’s exclusivity rights have expired, and are typically priced far more cheaply. The bad drugs described in this investigation were all generics. 

Generics are widely used in all countries but are most crucial in those with fewer resources, where costlier treatments might be beyond reach. If generics were not available in sub-Saharan Africa, for instance, “any cancer treatment would be likely inaccessible to most of the population”, said Claudia Martínez of the Access to Medicine Foundation.

In chemotherapy drugs, the active ingredient — which fights cancer cells — is also highly toxic to normal cells. Patients need to receive enough of it to treat the cancer but not so much that they overdose and suffer damaging side effects. As such, hospital pharmacists calculate doses carefully — and in doing so, depend on the accurate labeling of active ingredients.

Research from a study published Wednesday in The Lancet Global Health examined the amount of active ingredients in seven common types of cancer drugs: cisplatin, cyclophosphamide, doxorubicin, ifosfamide, leucovorin, methotrexate, and oxaliplatin. All of them are classified as essential medicines by the World Health Organization.

Working with collaborators in Cameroon, Ethiopia, Kenya, and Malawi, researchers at the University of Notre Dame in Indiana analyzed drug samples from the four countries. 

Of 189 samples that had not expired at the time of testing, about one-fifth failed, meaning they had significantly more or less of the active ingredient than stated on the label. They consisted of 20 different generic drugs made by 17 manufacturers. (See the list here.) All but one of the companies is based in India.

“We were all taken aback when we saw the results,” said Marya Lieberman, the professor who led the research. 

More than 30 manufacturers made products that met standards. But for patients receiving poor-quality drugs, the effects could be devastating. “Once a person has been diagnosed with cancer, there’s a limited window of opportunity for treatment to work,” said Lieberman. “And if someone is treated with an ineffective product, they can lose that precious window.”

The majority of the failed drugs had too little of the active ingredient (for most, this meant less than 88% of the amount stated on the label), while some contained too much (more than 112%). Both thresholds were decided by researchers based on international standards.

“Both scenarios are horrendous in my eyes,” said Shereen Nabhani-Gebara, vice chair of the British Oncology Pharmacy Association. “It takes a lot of courage for someone with cancer to accept a diagnosis, but then to be short-changed like this when they are trying their best is heartbreaking — because this is someone’s life.”

Over the past six years, these drugs have been shipped to more than 100 countries on every populated continent. They range from low- and middle-income nations like Nepal, Ethiopia, and North Korea, to wealthy countries such as the U.S., U.K., and Saudi Arabia. 

Wondemagegnehu Tigeneh, a clinical oncologist in the Ethiopian capital Addis Ababa, told TBIJ that he has treated patients with chemotherapy drugs he believes did not work.

“I have a suspicion that the active ingredient was lower than expected,” he said, recalling a drug he gave to a recent patient who had responded well to the first three rounds of treatment. But on the next round, the patient’s progress suddenly stopped.

Because he has no means to test drugs, Tigeneh can never be sure of their quality. But in his 20 years treating cancer, he has learned to notice telltale signs. Sometimes, for instance, patients have a complete absence of common side effects, such as nausea or hair loss. “That makes it difficult to trust that particular drug,” he said.

Then there are the patients whose disease he struggles to get under control, such as a patient whose response to treatment halted without warning. Rather than reducing the size of the tumor enough to enable surgery, his team has been forced to try a second-line treatment. If that fails, the next stage is palliative care. “It’s very sad,” said Tigeneh. “We didn’t used to see things like this.”

Cancer patients in Ethiopia have far better access to treatment facilities now than they did 20 years ago. It doesn’t seem, however, that the standard of medicine has kept pace. A 2020 study of cancer drugs in Ethiopia included 20 samples of cisplatin, which were all found to be substandard, averaging just over half of the stated content. One researcher who tests the quality of drugs in the country told TBIJ that they find bad medicines wherever they go.

Ethiopia is the largest importer of the worst-performing drug in the Notre Dame study, which has been shipped to five other countries as well. Made by Indian manufacturer Venus Remedies and called cyclophosphamide, it is often used to treat cancers including lymphoma and breast cancer. All eight samples of this drug failed, with six containing less than half the amount of active ingredient claimed by the manufacturer. One contained just over a quarter of the stated dose, which according to several cancer pharmacists would be as effective as no treatment at all. 

Venus Remedies told TBIJ that the study results were “not scientifically plausible” given the company’s “validated manufacturing systems and quality controls.” The company said it has received no complaints or concerns about the batches in question and shared the results of its own testing, which suggested the drugs met quality standards. 

The company said improper storage conditions in the supply chain, which can degrade drug quality, might have affected the test results. However, the absence of similar quality issues across the entire data set suggests this is not the case. 

Venus Remedies is one of three companies or regulators that queried the methodology used by the Notre Dame lab, saying it deviated from international standards or could give erroneous results. However, Lieberman said that, although her results are not intended for regulatory purposes, her researchers’ methods are based on those used by regulatory labs and were verified for suitability, accuracy, and precision. Both the findings and methods have been scrutinized by independent academics.

Some 2,000 miles south of Addis Ababa, in Malawi, specialist cancer care has only been available for about 15 years. In one of the poorest countries in the world, patients depend on health care being free at the point of need. That means clinics have to rely on generic drugs.

Malawi has imported two Indian drugmakers’ methotrexate that the researchers in this investigation found contained too much active ingredient: Zuvitrex, made by Zuvius Lifesciences, and Unitrexate, made by United Biotech. Neither company responded to multiple requests for comment.

A pharmacist specializing in cancer care in central Malawi told TBIJ that he saw patients at his hospital overdose on methotrexate, a drug used to treat leukemia and lymphoma.

The pharmacist said these patients suffered severe vomiting and nausea after overdosing on methotrexate, while others had to be moved onto a second-line treatment, which may not be as effective. For some patients, the side effects were so severe that they had to pause treatment entirely — giving the cancer a chance to grow.

When a sample of the methotrexate used at the hospital was tested as part of a research project taking place at the time, it was found to contain too much of the active ingredient. “It’s very worrying,” the pharmacist said. The drug’s manufacturer couldn’t be confirmed.

The pharmacist told TBIJ that he and his colleagues have sometimes had to stop using an entire batch of chemotherapy medicine and send samples to the Malawi drug regulator after the medicine changed color — a sign something is wrong with it. 

“We had patients scheduled for clinic,” he said, “and then we had to break the news to them that we don’t have medicines.”

Countries all over the world have systems in place to stop bad drugs from reaching patients. However, there are huge disparities in their effectiveness. According to Chaitanya Kumar Koduri of the U.S. Pharmacopeia, an organization that sets standards for medicines in the U.S. and internationally, “70% of countries cannot take care of their own medicine quality.”

Most governments have national regulators — but their resources vary hugely. And even the better-funded regulators are far from foolproof. The U.S. Food and Drug Administration (FDA), for instance, is struggling to keep up with inspections of manufacturing plants domestically and in India and China, and has admitted that its inspections have not been a reliable indicator of drug quality. 

The FDA recently announced it would expand unannounced inspections at foreign manufacturing facilities, saying this will help expose falsified records and other violations. The FDA told TBIJ “that inspections and reviews will continue to ensure [drug] safety and efficacy.”

One of the countries where medicine regulation ranks the lowest, according to the WHO, is Nepal. It is also one of the biggest importers of the failed chemotherapy products in this investigation. 

Although more than 20,000 medicines are on the market in Nepal, the country’s drug regulator has set a target of testing just 22 drugs in the next 12 months — and none of them are chemotherapy drugs.

Narayan Prasad Dhakal, the regulator’s director general, told TBIJ that its lab cannot currently test cancer drugs and admitted that the quality-testing situation is “a concern.” He also said that while his department has the power to recall cancer drugs based on external evidence, it has never done so.

The issue is especially fraught for patients who may have traveled from remote, rural areas to get treatment that then may not work.

Laxmi Kumari, whose 2-year-old son is being treated for cancer in Kathmandu, Nepal’s capital, has had to procure chemotherapy drugs from private pharmacies. The treatment has cost the family nearly 200,000 Nepalese rupees ($1,454), equivalent to several months’ average salary in Nepal, and yet they have no assurance that it will be effective.

“We have no way of knowing the quality of the medications being used in his treatment,” said Kumari. “We rely entirely on what the doctors recommend.”

“Neither patients nor their families have any way of knowing the quality of these drugs,” said Smriti Pokharel of the Wish Nepal Foundation, which helps children from low-income families access cancer treatment. 

“Even doctors face challenges in verifying their quality. No one seems willing to take responsibility for ensuring proper treatment for cancer patients.” 

Generic drug manufacturers are operating in a global market that health care professionals and experts agree is driven by one thing: price. It’s a market in which those operating under a less watchful eye can find ways to undercut their competitors. 

This could mean scrimping on the amount or quality of the active ingredient — the most expensive component — or using cheap or outdated machinery. Research shows that problems with manufacturing, quality control, packaging, or storage are responsible for most substandard drugs.

The results can be fatal. Four children died in Colombia after being given contaminated cancer drugs in 2019. Three years later, another batch of bad medicine caused the deaths of at least 10 children in Yemen who were being treated for leukemia. 

The price-driven market creates a dangerous dynamic in which the number of companies making a particular drug shrinks and shrinks until global supply is precariously dependent on just a handful of manufacturers. Should one company slip up, thousands of patients can be left without the drugs they depend on. 

It’s a situation that played out in the U.S. recently. Between 2018 and 2022, Intas Pharmaceuticals — the parent company of Accord Healthcare, which made the worst-performing cisplatin tested in this investigation — grew its market share of cisplatin from 24% to 62%. It also increased its share of methotrexate fivefold in the same time period. All the while, prices of both these chemotherapy drugs dropped. 

Then at the end of 2022, a surprise inspection by the FDA revealed a “cascade of failure” at an Intas factory in India, where staff were seen shredding and pouring acid on quality records. The shutdown that ensued sent shockwaves across the U.S., with nearly every major cancer center reporting shortfalls in chemotherapy drugs during the spring or summer of 2023, according to the New York Times.

Accord said the batch of cisplatin that failed the researchers’ testing had met all established quality standards, and shared data from internal and external studies indicating its quality. It said it has not received any market concerns related to this batch.

In India, the world’s largest producer of generic drugs, questions have been raised over whether manufacturers are properly punished for producing substandard drugs — and whether foreign regulators have proper oversight.

“The Indian government’s interest is in trying to protect the industry,” said public health activist and former Big Pharma whistleblower Dinesh Thakur.

Sixteen of the 17 manufacturers identified in this investigation are based in India, where about 20% of the world’s generic drugs come from, and five have been previously flagged by a regulator for producing substandard batches of drugs. One of them, Zee Laboratories, has been flagged 46 times since 2018. 

India’s drug regulator told TBIJ that Zee Laboratories has been audited and given a “stop production order,” which was lifted after the company resolved the problems in question. It did not give details about when this was, which issues it covered, or whether the company faced any consequences. 

It’s also unclear whether the manufacturers exposed in TBIJ’s previous investigation into substandard asparaginase have faced any repercussions, even though 70,000 children with leukemia were at risk from the substandard drugs. 

Three of those companies — Getwell Pharmaceuticals, United Biotech, and VHB Medi Sciences — also made some of the substandard drugs revealed by the current investigation.

Thakur said there’s only one way to explain the production of weak drugs by big companies: “Somebody’s cutting corners.”

Meanwhile, these medicines continue to fill pharmacy shelves. Zuvius Lifesciences and GLS Pharma have supplied their products that failed the quality testing to over 40 countries. And in the past two years, Venus Remedies, which made the drug that pharmacists said wasn’t worth prescribing, has been awarded a series of contracts and licenses, including from the Pan American Health Organization, to supply several essential cancer drugs to Latin American countries.

While the majority of drugs made in India are safe, the country’s generics industry has long been dogged by scandal. In 2013, Indian manufacturer Ranbaxy agreed to pay a $500 million fine after its U.S. subsidiary pleaded guilty to the improper manufacturing, storing, and testing of drugs. In 2022 and 2023, Indian-made cough syrups were linked to the deaths of children in Gambia, Cameroon, and Uzbekistan. And as recently as August 2024, it was reported that the regulator had found more than 50 drugs on the market to be substandard or fake, including some paracetamol and antacids. 

India’s drug regulator defended the oversight system, saying that failing drugs are recalled and manufacturers face “either administrative penalties or legal prosecution in court.” 

Getwell Pharmaceuticals, GLS Pharma, VHB Medi Sciences, and Zee Laboratories did not respond to multiple requests for comment.

The World Health Organization has taken steps to ensure that people across the world have access to safe, effective drugs. It has compiled a list of “essential medicines” to help countries with limited resources know what to prioritize. It checks certain drugs’ active ingredients and their manufacturers to create a pre-approved list that countries can trust. 

The WHO also oversees a set of standards for manufacturers and drugs that many countries refer to when importing medicines.

However, these measures have their own limitations. 

The list of recommended medicines, for example, only expanded to include cancer drugs in 2019 and experts say WHO should include more of them on the list. Shalini Jayasekar-Zürn of the Union for International Cancer Control, a global membership organization dedicated to taking action on cancer, says the list currently only encompasses two cancer drugs, rituximab and trastuzumab. “It would be great if the list was expanded to include more essential medicines, especially for cancer,” she said.

While the WHO oversees standards for manufacturers and drugs, it’s up to the countries buying medicines to make sure those standards are met, no easy task given the resources of national regulators. 

Meanwhile, Thakur said that one WHO system — certificates that say a given drug meets various standards — has been undermined by companies that have found “workarounds” to get the paperwork without improving quality. “It’s not worth the paper it’s written on,” he said. 

The upshot, experts say, is that without the comprehensive oversight seen in countries like the U.K., the WHO’s processes don’t stop substandard medicines from making their way onto shelves.

Reflecting on TBIJ’s findings alongside his own experience, Thakur said that the WHO was “clearly not” delivering on its stated purpose: to promote health, keep the world safe, and serve the vulnerable.

The WHO did not respond to several requests for comment made by TBIJ.

The cruel irony is that in this race to the bottom, it is the cancer patients who are often left to foot the bill. And those who have the least pay the most: In low-income countries, the cost of 58% of essential cancer medicines is paid by patients, compared with 1.8% in upper-middle-income countries. 

One cancer pharmacist in Ethiopia estimated that it could take over a year for a patient to save enough money for cancer treatment. If that medicine then turns out to be faulty, they might not be able to afford to pay for another. 

“Most people believe cancer is incurable,” the pharmacist said. “When they end up with a medicine that won’t cure them, that’s another tragedy.”

“For me, it’s a question of fairness,” said Lieberman, the lead researcher. “[Patients] have the right to be treated with a medicine that actually is what it says it is. One that has the correct ingredients in it, that hasn’t degraded, and that doesn’t have things in it that will hurt them. It’s too important.”

The Access to Medicine Foundation is partly funded by the Bill & Melinda Gates Foundation, one of TBIJ’s funders. None of TBIJ’s funders has any influence over its editorial decisions or output.

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I’ve had poor responses after switching to generics. Fuck big pharma for charging so much for brand names. Fuck generics manufacturers for giving us bad drugs. And fuck or governments for their bullshit IP and regulatory regimes.
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After eight years, Canada still lacks long-term data on safer supply

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Canada lacks long-term data on safer supply programs, despite funding these programs for years.

Safer supply programs dispense pharmaceutical opioids as a replacement for toxic street drugs.

There is a growing body of research on safer supply’s short-term health effects. But there are no Canadian studies that evaluate program participants’ health impacts beyond 18 months.

The absence of research into long-term data on safer supply means policymakers do not understand how safer supply affects participants’ health, substance use or social outcomes over time. 

“Long-term data is important because it helps us understand not just short-term health outcomes like reduced overdoses, but also broader impacts on quality of life, stability and health care use,” said Farihah Ali, scientific lead at the Institute for Mental Health Policy Research at CAMH. The Centre for Addiction and Mental Health is one of Canada’s leading centres for addiction research and clinical care.

Pilot projects

Canada’s first safer supply programs were introduced in Ontario in 2016. Those programs were initially small in scope, intended for a small group of high-risk individuals.

In 2020, the federal government began funding safer supply pilot programs across the country. Provinces are responsible for the delivery and regulation of these programs. 

B.C. introduced provincewide programs in 2021. Other provinces, such as Alberta, have restricted safer supply access to a very small number of clinics, and have generally shifted away from harm reduction models in favour of recovery-oriented approaches

According to the Canadian Public Health Association, an advocacy organization, the original goal for safer supply was to reduce deaths and harms associated with the unregulated toxic drug supply. It was not meant to replace addiction treatment, but to rather act as a bridge to further care.

However, a 2023 report by researchers at McMaster University and Simon Fraser University noted safer supply “does not principally operate toward goals of treatment or recovery.” The report describes safer supply instead as an emergency intervention focused on stabilization and survival.

Evidence gaps

There is a small but growing body of short-term studies on the health effects of Canada’s safer supply programs. Most only track participants’ outcomes for up to 12 months.

Some of those studies suggest safer supply may reduce the immediate harms associated with drug use.

A 2024 study found a 91 per cent reduction in the risk of death among high-risk individuals receiving safer supply in B.C. Critics have raised concerns about the study’s methodology, sample size and confounding variables.

In contrast, a March study suggested B.C.’s safer supply and decriminalization policies may be associated with increased hospitalizations. These findings also sparked controversy, with experts debating how well the data isolate causal impacts.

And a comparative study released in April also showed some positive outcomes from safer supply. It too sparked significant expert debate.

‘Arms-length’

Of all the provinces, B.C. has implemented safer supply most broadly. The province’s health ministry did not directly respond when asked about the long-term goals of its safer supply program, or whether B.C. collects longitudinal data on program participants’ health outcomes.

“Evidence shows [safer supply] helps separate people from the unregulated drug supply, manage their substance use and withdrawal symptoms with regulated medications, and helps connect them to voluntary health and social supports,” a Ministry of Health spokesperson told Canadian Affairs in an email.

The ministry did not provide the evidence it referenced.

At the federal level, Health Canada confirmed that, to date, it has funded just two evaluations of safer supply programs, despite spending more than $100 million on safer supply since April 2023.

The first was a short-term study, funded by the federal government’s Substance Use and Addictions Program program. Conducted over four months, that study assessed 10 safer supply programs in Ontario, B.C., and New Brunswick. It documented initial impacts on participants’ lives and program delivery, primarily through qualitative methods such as interviews and surveys. 

The second study is an ongoing, “arms-length evaluation” of 11 safer supply pilot programs funded by the Canadian Institutes of Health Research (CIHR), Canada’s federal health research agency.

When asked about long-term research on safer supply, Health Canada referred Canadian Affairs to a 2022 funding announcement about this multi-year evaluation. While the evaluation is being conducted over several years, it is unclear if it includes long-term tracking of patients’ outcomes.

Barriers and resistance

There are a number of factors that make it challenging to evaluate safer supply programs over long periods.

Ali, of CAMH, says unstable, short-term funding can disrupt long-term research. 

“When programs are shut down or scaled back, we lose contact with participants and the ability to track outcomes over time,” she said. 

Program participants can also be difficult to track over long periods, she says. Many struggle with housing insecurity, health instability and criminalization. 

Frontline staff also face burnout and high turnover, she says, limiting support for such research activities. 

Additionally, there are tradeoffs between the anonymity needed to encourage patients to access safer supply programs and the ability to collect detailed data.

“Ethical concerns — like not wanting to burden participants or risk their safety or confidentiality — require us to design studies that are trauma-informed and flexible, which adds complexity to long-term data collection,” Ali said.

Julian Somers, a clinical psychologist and professor at Simon Fraser University, says B.C.’s failure to conduct long-term evaluations of its safer supply programs is not just an oversight, but an act of negligence.

“B.C. has some of the best pharmaceutical data systems in the world,” Somers said, referring to PharmaCare and PharmaNet — databases that capture every prescription drug transaction in the province. 

Somers says his team previously used PharmaNet data to examine prescribed opioids’ effects on health and social outcomes. In 2017, he proposed a long-term safer supply evaluation using these tools.

In 2017, he proposed a long-term evaluation of B.C.’s safer supply programs.

The province declined.

According to Ali, “Future research should explore how safer supply impacts people’s long-term health, stability and connection to care.” 

“We also need to listen to people’s experiences, how safer supply affects their daily lives, their sense of dignity, and their relationships with care providers through qualitative mechanisms.”

The post After eight years, Canada still lacks long-term data on safer supply appeared first on CANADIAN AFFAIRS.

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sarcozona
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