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The Guardian - US
The Guardian - US
Politics
Wilfred Chan

‘The worst it’s ever been’: mysterious US Adderall shortage puts ADHD patients at risk

collage illustration shows people closing their eyes with images of adderall pills superimposed on the pictures
ADHD persists through a patient’s lifetime and stimulant medication is the most common therapy. Illustration: Marta Parszeniew

When the last tablet of Ritalin rattled softly in the plastic vial, Faati knew that sound meant trouble. The last time, they had run out of ADHD meds for three months and struggled to remember tasks or even tell time at the Washington state cafeteria where they worked. On the day they finally got a refill, they were fired for “performance reasons”.

Erik, a 26-year-old Seattle grocery clerk, who also has attention-deficit hyperactivity disorder, has been unable to get his medications filled for months now – and he’s worried he’ll lose the first full-time job he’s ever had.

For people like Faati and Erik, ADHD medication is a prerequisite for basic functioning – and over the last year it’s become dramatically harder for patients like them to access care. Last October, the Food and Drug Administration (FDA) announced a shortage of Adderall, one of the most common stimulant medications for ADHD.

In recent months, patients have reported problems filling nearly every type of ADHD medication. What’s stranger is that no one seems to know why. Is it some kind of supply chain issue? A pandemic-era surge in demand? A government crackdown?

Official explanations have offered little clarity. The FDA’s announcement mentioned “intermittent manufacturing delays” at Teva, the producer of the branded version of Adderall, but few other details. The American Society of Health Pharmacists reports shortages of multiple ADHD drugs but says manufacturers have given no explanation.

Meanwhile, the Drug Enforcement Administration (DEA), which controls the supply of the drugs, announced last month that it would not increase manufacturing quotas for 2023, despite the shortage – again, without providing a reason. One congresswoman, Abigail Spanberger, wrote to the DEA and FDA to demand an explanation last December, but Spanberger’s staff told the Guardian she had yet to receive a response.

The situation has left patients in turmoil. Since the mid-2010s, adults have overtaken children in receiving prescriptions for ADHD drugs. Studies show stimulants offer dramatic benefits to ADHD patients, improving their performance at school and at work, and reducing their risk of depression, anxiety, substance abuse and suicide. A 2017 analysis of millions of patient records even found that adults with ADHD taking stimulant medications were far less likely to get into a car crash.

But the drugs can also give a different kind of boost to people without ADHD. Studies have found prescription stimulants have little to no effect on the cognitive performance of adults without ADHD. What they do give other people is an elevated mood – a high. And like all things that get people high, they can be addictive. The medications’ side-effects include insomnia, elevated heart rate and high blood pressure, but in larger doses they can cause panic attacks, psychosis and seizures.

adderall pills
In recent months, patients have reported problems filling nearly every type of ADHD medication. Photograph: JB Reed/Bloomberg News

That’s why amphetamine and methylphenidate are Schedule II controlled substances in the US – accepted for medical use, but with “a high potential for abuse”. The DEA controls their supply, under what it calls a “closed system of distribution”. After the agency decides its annual production quotas, manufacturers and distributors must set limits on how much of the meds each pharmacy can buy. Pharmacies must guard the substances under lock and key, and fill out forms if they lose even a single pill. Doctors, of course, must screen their patients. Every link in this supply chain must also refuse and report any “suspicious orders” of unusual size, frequency or “deviating substantially from a normal pattern”.

Violating any of the DEA’s rules can mean big trouble: anything from civil penalties to criminal prosecution. It’s a conservative system that’s designed to keep just enough medication flowing to patients while minimizing the risk of illegal diversion, an especially high-stakes task during the opioid crisis. But for ADHD medication, the balance mostly worked – until the pandemic changed everything.

‘One of the most effective treatments in all of medicine’

Studies show the pandemic has affected people with ADHD more severely than those without the condition. Several doctors and experts who spoke to the Guardian say they witnessed a surge in new ADHD patients during the pandemic, as people who had relied on the guardrails of a physical workplace or classroom realized they couldn’t regulate themselves at home. And a growing awareness of the condition has inspired previously undiagnosed people to get tested – like Shauna, a California woman in her mid-20s who was diagnosed with ADHD two years ago as she fought to stay afloat in pharmacy school. “I think I always felt like this is what was going on, in the back of my head,” she said. “But once it was confirmed, it just made a lot of sense.”

Anna Brasile started homeschooling her partner’s son during lockdown. She was familiar with ADHD – she had worked in a psychologist’s office, and had two family members with the disorder – but it wasn’t until she was teaching at home that she recognized the symptoms in her stepson. When he returned to fourth grade in person the next year, “he struggled a lot, and his grades started to dip, so we decided to get him formally evaluated”.

Attention-deficit hyperactivity disorder is a chronic impairment that persists through a patient’s lifetime and stimulant medication is the most common therapy. The treatment dates back to 1937, when a Rhode Island doctor named Charles Bradley gave benzedrine, an amphetamine-based stimulant, to schoolchildren with behavioral problems in an attempt to treat their headaches. He was stunned to discover a “spectacular improvement” in their classroom performance: many of them became calmer and showed a “definite ‘drive’ to accomplish as much as possible”, he wrote in the American Journal of Psychiatry.

Bradley had stumbled upon what today’s scientists and physicians understand as ADHD’s basic neurological principle: the disorder is a dysregulation of dopamine. For ADHD patients, symptoms such as inattention, hyperactivity, impulsivity and forgetfulness may be consequences of a brain desperately seeking out the dopamine it’s not getting enough of. That’s why using a stimulant to deliver the right amount of additional dopamine can help the brain calm down and make decisions more effectively.

Modern physicians recognize stimulants as “the No 1 evidence-based treatment for ADHD”, says Dr Owen Muir, a Brooklyn-based psychiatrist who specializes in treating the disorder. “It’s one of the most effective treatments in all of medicine, for any condition. These things work extremely well – once you get to the right dose for somebody, it’s not subtle. Like, ‘Wow, I can really focus now.’” The Guardian spoke to a dozen ADHD patients for this story and all agreed. “These meds are life-changing for us,” Erik, the Seattle grocery clerk, said.

The boom and bust of Adderall prescriptions

As the coronavirus spread in 2020, the US Department of Health and Human Services authorized an emergency suspension of the 2008 Ryan Haight Act, which had banned the prescription of controlled substances by telehealth providers without an in-person examination. That rule change enabled a wave of telemedicine companies to reach ADHD patients through convenient, mobile-friendly apps.

Shauna was one of the people who got a prescription for Adderall through an app – something that wasn’t possible before the pandemic. She said it felt like “the new cultural norm”.

triptych of ads on phones touting benefits of adhd drugs and mental health treatment
Targeted ads for the telehealth providers Cerebral and Done. Photograph: Cerebral/Done

Many patients were especially drawn to Cerebral, a telemedicine startup that offered mental health counseling and medication for an introductory price of just $30 a month. Founded by the millennial Harvard Business School graduate Kyle Robertson in 2019 and flush with investor cash, Cerebral grew rapidly in 2020 in what Robertson described as a mission to improve access to mental health care and “save lives”.

But ex-employees say Robertson was only focused on profit. He saw a golden opportunity to prescribe ADHD stimulants online, and Cerebral’s pitch deck to investors contained a image of controlled substances next to the words “Now is the time to capture growth”, the Wall Street Journal reported.

Ex-employees allege that Robertson, who has no medical background, was pushing his hired nurse practitioners to prescribe stimulants to as many 30 new patients a day, in online evaluations that lasted as little as 10 minutes.

The gambit worked. Word spread quickly about Cerebral, and by late 2021 it had served more than 200,000 patients, had signed the gymnast Simone Biles as “chief impact officer”, and was valued at an eye-popping $4.8bn.

“We’re not going to stop building and iterating until everybody has access to high-quality mental health care,” Robertson declared. Rival startups like Done and Ahead were quick to join in. If you were an ADHD patient, there had never been an easier and cheaper time to get meds.

Then things fell apart. In March 2022, a group of former staff publicly accused Cerebral of fueling a new addiction crisis by pushing the drugs. Weeks later, the former Cerebral executive Matthew Truebe sued Robertson, alleging that the founder had “directed Cerebral employees find ways to prescribe stimulants to more ADHD patients to increase retention … egregiously [putting] profits and growth before patient safety”.

Regulators responded quickly: in May, federal investigators subpoenaed Cerebral as part of an investigation into “possible violations of the Controlled Substances Act”. The Federal Trade Commission opened a civil case into whether the company used deceptive marketing practices.

Two years after it began, the explosion of online, on-demand ADHD prescriptions was over. Ahead announced it would close in April. Shortly after the investigations were announced, Cerebral said it would stop prescribing stimulants, and Robertson was forced out of the company. Days later, major pharmacies including CVS Health and Wal-Mart said they would no longer fill prescriptions for controlled substances from Cerebral and Done, and in July Wal-Mart began rejecting all telemedicine prescriptions for controlled substances from patients who had not made an in-person visit within two years, according to reports. In September, the Wall Street Journal reported that Done was also under investigation by the DEA. Last month, the DEA announced it was considering revoking the license of Truepill, Cerebral’s preferred pharmacy, alleging that Truepill had “wrongfully filled thousands of prescriptions” for ADHD medications. Cerebral, Done, and Truepill have denied wrongdoing and have said they are cooperating with investigators. Robertson has also denied wrongdoing and called his firing “illegal”. Simone Biles announced she was departing Cerebral in December.

biles with mic
Simone Biles announced she was leaving Cerebral in December. Photograph: Raquel Cunha/Reuters

The DEA declined to answer emailed questions, but the agency’s thinking was evident in a letter it sent to drugmakers last summer, saying it was scrutinizing their production requests because of “the sheer volume of ADHD medications on the market coupled with aggressive marketing practices” from certain firms, according to a recent report from the Wall Street Journal. The letter said the DEA would ensure that “the manufacturing of controlled substances used to treat ADHD is driven by a legitimate need and not improperly driven purely by profit motive, pressure from marketing firms, or a desire to obtain more market share – all factors that led to an oversupply of opioids during the prescription opioid crisis.”

Karla Palmer, a pharmaceutical industry lawyer who has reviewed the letter, says it’s clear that Cerebral’s growth-at-all-costs mentality prompted the agency to pump the brakes. Unlike the decades-long opioid crisis, “this is early in a cycle of what a crisis may become”, Palmer says, and “the DEA is trying to get ahead of it”. But the industry has grown anxious over the fallout. Palmer, who calls herself a telehealth proponent, says pharmaceutical companies have long sought a framework to allow controlled substances to be safely and legally prescribed online. “I just hope this doesn’t ruin it. And I’m afraid it will.”

‘The worst it’s ever been’

Telehealth companies botched their attempt to expand access to ADHD medication. Now that the boom has fizzled, the shortage is starker than ever. Dr Henry Hasson, a New York-based pediatric neurologist who specializes in treating ADHD, says the current medication shortage is “by far the worst that’s ever been. Almost all the meds are out of stock,” even non-stimulants like guanfacine, a non-controlled ADHD medication that’s also used to treat high blood pressure. It’s become a routine for his patients and staff to call multiple pharmacies for every order: “Every once in a while you find maybe 10 pills here, or 10 pills there, but it’s not easy.”

Prescriptions for controlled substances can’t be transferred, so Hasson has to write patients a new prescription every time another pharmacy is out of stock. Sometimes all that’s left are brand-name drugs like Vyvanse that cost as much as $300 a month.

But as ADHD care gets even harder to access, it’s marginalized people who are hit the hardest. Years of research have shown that non-male, non-white and poor children are under-diagnosed with ADHD, as their symptoms are more likely to be seen as misbehavior and punished. Even if they do get diagnosed, they’re less likely to be able to find a doctor.

Despite ADHD’s prevalence, the United States has surprisingly few physicians to treat it. “The dosage matters, the medication matters, the metabolism of that medication matters, the combination with other things matters,” says Muir, the Brooklyn psychiatrist. Because ADHD commonly co-occurs with other conditions, like OCD, depression, anxiety and bipolar disorder, “you’re not doing someone a huge favor if you only diagnose them with half of their problem. That’s why there needs to be expertise, and there isn’t.”

Many doctors only get a few lectures on the disorder in their medical training, and nurse practitioners often less. The specialists most familiar with ADHD tend to be child and adolescent psychiatrists – but according to the American Academy of Child and Adolescent Psychiatry, there are fewer than 10 of them for every 100,000 young patients in America – “one of the most underserved medical specialties that there is,” says Muir – and nearly half of them do not take insurance.

Now, wait times for ADHD specialists have stretched to as long as six months in some states, if patients can afford one. And those who don’t have private health plans often struggle to get care at all.

Faati, who was diagnosed with ADHD in 2020 after qualifying for disability-based Medicare, felt hopeful after starting Ritalin: “I was able to rely on myself in a way that I didn’t know that I could before then.” But the treatment fell through last May, when they moved to Washington state and had to begin the diagnosis process all over again. This meant Faati had to wait months for a new prescription, during which their performance at work suffered and they eventually lost their job. When their medication was finally approved, their pharmacy was completely out of stock.

“Our government and corporate overlords are just hoarding their resources,” they say. “It’s madness to not allow us to at the very least do our job.”

milgram speaks while garland listens
The DEA administrator, Anne Milgram, with the US attorney general, Merrick Garland, last year. Photograph: Shawn Thew/EPA

The crisis in ADHD care is not just about a shortage of pills. It’s also a deficit of infrastructure. Even if stimulant shortages were resolved tomorrow, there might still not be enough specialists to properly prescribe them. That’s a problem that can’t just be solved overnight by an ambitious startup or an injection of investor cash. Imagine if treating ADHD were firefighting: “You can’t just have 20,000 firetrucks and call it a success,” Muir says. “I need to actually have better outcomes when it comes to fires – because otherwise, you burn the whole fucking world down.”

The problem is there’s still uncertainty over just how many fires there are. Palmer, the pharmaceutical industry lawyer, believes that calls for better ADHD data. “Is there really a significant increase in demand from legitimate patients and good doctors that have taken time to care and evaluate and prescribe? If the DEA has appropriate and accurate data up the supply chain, they can use that data to make reasonable supply determinations,” she says. “But I don’t think they’ve gotten a handle on that. And I think it’s going to take a while.”

Until then, the DEA appears to have decided that suspicion is its safest option. The agency’s order-monitoring rules are expected to become even stricter this year. A proposed draft would expand the definition of a “suspicious order” to include unusual characteristics “of the customer submitting the order”. It means anyone requesting controlled substances could be be flagged for any reason – yet another barrier for ADHD patients.

That raises a more fundamental question: who should decide who deserves Adderall? Cerebral may have damaged the mental health profession’s credibility by overprescribing medication. But if the DEA takes the opposite tack – restricting the supply before it understands the demand – it, too, distorts patients’ access to care.

Is there a hard limit on the number of people who deserve care? How many patients is the DEA willing to refuse treatment before it considers revising its quotas?

As long as ADHD meds are considered suspicious, it will be harder to train the specialists and build the infrastructure that patients need – which could mean the shortages might never truly be resolved.

For ADHD patients, the solution is clear: when someone tells you they’re on fire, believe them. “The government is blaming us for the problems that we’re having,” says Faati, “which feels the same as when me and other kids couldn’t manage our rooms or homework, and we were punished. It’s not our fault that our lives are falling apart now that we don’t have access to our medicine.”

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