Abuse of ADHD drugs following path of opioids

Public health officials have focused on the national plague of narcotic painkillers. But another scourge is looming largely unnoticed: The drugs used to treat attention deficit hyperactivity disorder in adults.

Since 2013, there have been more than 19,000 reports of complications from ADHD drugs, most of which are stimulants like Adderall, made to the U.S. Food and Drug Administration, according to a Milwaukee Journal Sentinel/MedPage Today analysis.

Of those, adults were far more likely than children to suffer severe complications, such as death and hospitalization.

Meanwhile, among those 26 and older, recreational use of Adderall, an amphetamine, rose fourfold, from 345,000 people in 2006 to 1.4 million in 2014, according to the latest available federal data.

In emergency departments around the country, the number of cases involving two common ADHD drugs nearly quadrupled over seven years.

And at morgues in Florida, a bellwether state for drug abuse problems, overdose deaths involving amphetamines increased more than 450% between 2008 and 2014.

Taken together, the data shows the drugs —  which have been heavily promoted by the pharmaceutical industry —  have left a trail of misuse, addiction and death, a Journal Sentinel/MedPage Today investigation found.

Twenty years ago, adult ADHD was a seldom-diagnosed disorder.

But it has become a part of mainstream medicine over the past decade, fueled by relaxed standards for diagnosis and a push from drug companies, one of which helped fund a study that claimed 1 in 23 adult Americans are affected by it. That represents about 10 million people.

“The streets are awash with Adderall,” said Nicolas Rasmussen, a medical historian who has studied the history of amphetamines in the United States. "Amphetamines are grossly overused."

Independent experts question whether adult ADHD truly is a widespread condition that needs treatment with dangerous drugs.

It is among a series of conditions identified by the Journal Sentinel and MedPage Today in which diagnostic definitions were expanded —  often by experts or organizations with financial ties to drug companies —  to create a larger market for treatment with expensive, often dangerous drugs.

In the case of adult ADHD, the definition was relaxed in 2013 by the American Psychiatric Association. Under the new definition, adults need to have five of a possible nine symptoms from either of two categories, down from six of a possible nine, and the symptoms must have been present before age 12, instead of the previous age 7.

Of the experts on the panel that approved the changes, 78% had financial ties to drug companies, according to a 2012 analysis by the journal PLoS Medicine.

In a Journal Sentinel/MedPage Today investigation in May, an association spokesman said financial conflicts of interest among panel members were limited to $10,000 a year in income, such as working as industry speakers and consultants.

He also defended inclusion of the adult ADHD definition in the organization’s diagnostic manual, saying the condition is a real one that affects many adults.

The symptoms of the condition typically involve an inability to focus on tasks, fidgeting or interrupting others. Experts note the symptoms are vague, can be caused by other conditions and are easy to fake.

One study, in 2010, found that 22% of adults tested for ADHD had exaggerated their symptoms.

For years, the legitimacy of adult ADHD was based on the belief that for some it was a condition that started in childhood and persisted into adulthood.

But that belief was undermined last year, when researchers published the results of along-term study that began in the early 1970s and followed more than 1,000 New Zealand children until age 38. The study found little overlap between those who had ADHD as children and those who were diagnosed as adults.

While none of its symptoms are life-threatening, the drugs approved by the FDA to treat adult ADHD can raise heart rates and blood pressure, and have been linked to sudden death. They also carry a high potential for abuse and dependence.

The long-term risks and benefits in adults are not known. Drugs often are tested for a year or more, but rigorous clinical trials of the ADHD drugs on adults have not lasted more than a few weeks or months.

Among the reports of complications to the FDA:

• A 41-year-old woman was hospitalized with kidney failure after abusing methylphenidate, better known as the stimulant in the ADHD drug Ritalin. 
• A man on heart medications also was on two ADHD drugs, which can increase heart problems. He had a fatal heart attack at age 41. 
• A 33-year-old man on the ADHD drug Vyvanse was hospitalized after suffering a panic attack, an increased heart rate, chest pain and dizziness. 

The Journal Sentinel/MedPage Today analysis of the FDA data focused on reports of problems submitted by health care professionals and drug companies. Companies are required to report any cases they learn about. It did not include cases submitted directly by patients.

As such, the number of complications is likely much higher than the 19,000 found.

University of Wisconsin cardiologist James Stein said he has treated adult patients who developed serious problems after being misdiagnosed with ADHD and put on prescription stimulants.

One patient developed extremely high blood pressure; another developed an irregular heartbeat.

Stein, a professor of cardiovascular medicine at the UW School of Medicine and Public Health, worries about the increase in prescriptions and marketing of the drugs to patients.

“I don’t think these are the kinds of drugs that should be thrown around willy-nilly.”

More prescriptions, more problems

Between 2010 and 2015, sales of ADHD drugs jumped from $7.9 billion to $11.2 billion, according to data from IMS Health, a drug market research firm. Prescriptions increased from 67 million to 87 million.

The surge came on the heels of a pattern starting in 2008 in which prescriptions to adults jumped 53% over four years, according to Express Scripts, a national prescription benefit plan provider.

Those numbers only tell part of the story:

• In the last decade, the U.S. Drug Enforcement Administration authorized increased production of legal methylphenidate, the stimulant in Ritalin, from 38 tons to nearly 106. That’s enough to provide every man, woman and child in America with 30 tablets of Ritalin —  a month’s supply.
• Use of amphetamines is so common that in Tacoma, Wash., its presence in wastewater samples collected near college dormitories was eight times higher during final exams week than the first week of classes, according to a 2013 study. 
• On the user-driven site Reddit, nearly 5,000 readers share tips on abusing Adderall, ranging from how to convince doctors to write a prescription to dealing with skin outbreaks from snorting the drugs.

Wes Hannon, 30, of Harrisburg, Pa., is a former addict who got his first prescription for Adderall at age 24. He has tried to help others on the site overcome their own stimulant addictions.

Hannon said it’s easy to persuade doctors you have the disorder.

"I have no doubt that ADHD does exist, but not nearly the amount of people that they say have ADHD,” he said in an interview. “They're way too liberal with their diagnosis, and they're willing to prescribe this to anyone who exhibits symptoms.”

In Hannon’s case, he quickly developed a tolerance and soon switched to an illicit stimulant, methamphetamine. The street drug was cheaper, stronger and easier to get than Adderall.

After several unsuccessful attempts to stop using it, he successfully quit in 2014.

Rasmussen, the medical historian who has studied amphetamines, said the drugs are prone to abuse because “people often feel it makes their lives better. It’s an antidepressant, it offers weight loss, and it improves confidence.”

But those effects soon wear out.

“Someone might start out with methylphenidate or Vyvanse, but then their tolerance builds and they want more,” he said.

While opioids are more lethal than prescription stimulants, some experts see parallels between the opioid epidemic and the increase of problems tied to stimulants.

In the opioid epidemic, users switched from prescription narcotics to heroin and illicit fentanyl. With the ADHD drugs, patients such as Hannon have switched from legally prescribed stimulants to illicit ones, such as methamphetamine and cocaine.

Other similarities include loose criteria for diagnosing underlying conditions and large numbers of prescription drug options —  more than a dozen in the case of ADHD. The relaxed definition of adult ADHD also has played a role.

“Doctors get more patients; patients have their symptoms ‘medically explained’ and pharma has a new group of people to use their medications,” said Lewis Nelson, an emergency room physician at Rutgers New Jersey Medical School.

“Clearly it becomes a cat and mouse game of new diagnoses begetting new drugs.”

Petros Levounis, chair of psychiatry at Rutgers, said he saw an increase in people seeking help for stimulant addiction when he opened a treatment center aimed at college students.

Levounis said he believes ADHD is poorly understood, which leads to both under- and over-treatment.

In some cases, people who need treatment don’t seek help, he said. Other times, doctors are quick to diagnose ADHD when other conditions are causing the problems.

“Medicine has a huge responsibility with what happened with the prescription opioid epidemic,” Levounis said. “If there is something brewing with prescription stimulants, we should be doubly, triply concerned about it."

Drug company representatives say adult ADHD is a real and treatable medical condition affecting millions of Americans and that all medicines carry benefits and risks.

Charlie Catalano, a spokesman for Shire, which makes the ADHD drugs Vyvanse and Adderall, said the drugs have been approved by regulators around the world as safe to use.

“Our medications are proven to be effective when used according to prescribing practices of a licensed, trained health care professional,” he said.

Eric Althoff, a spokesman for Novartis, which makes Ritalin, said its drug “has been used safely and effectively for more than 60 years.”  He noted that “if used inappropriately, the results could be serious, just like with the misuse of any other medication.”

Evidence of problems mounts 

Overdoses and deaths involving prescription stimulants are not tracked by any one government entity. To assess the scope of the adult ADHD drug problem, the Journal Sentinel and MedPage Today examined data from federal, state and municipal authorities:

Reports to the FDA: The analysis of FDA adverse event reports showed more problems occurred in children, for whom ADHD has long been a common diagnosis. But when adults did report problems, they were more likely to be serious and life-threatening.

Adults accounted for just over one-third of reports, but made up more than half of all hospitalizations and 85% of deaths.

Users reported several psychological problems. Hallucinations, suicidal thoughts and depression show up in hundreds of reports. Quitting the drugs also posed a problem, as several reports indicated withdrawal symptoms.

Except for Strattera, nearly all adult ADHD drugs are stimulants. That drug has not been shown to lead to abuse, but carries the FDA’s most stringent warning because it can create suicidal thoughts in children and adolescents.

Adults are warned that it can cause serious cardiovascular problems, including strokes, heart attacks and sudden death.

Emergency room visits: In 1972, the Drug Enforcement Administration set up a system to monitor emergency room visits caused by drug abuse. Though the program, known as the Drug Abuse Warning Network, stopped collecting data in 2011, in its final years a rise in stimulant-related visits stood out.

In 2004, just two ADHD drugs played a role in 10,800 cases of emergency department visits. By 2011, the figure for those two drugs jumped to 42,000, a nearly fourfold increase in less than a decade.

The increase involved methylphenidate, the stimulant in Ritalin, and amphetamine/dextroamphetamine, the stimulant in Adderall.

New definitions or lowered thresholds mean millions more people – overnight – fit the criteria of having treatable disorders. Critics say the changes mean more patients may end up being treated with drugs that may be risky. Here is a closer look at eight psychiatric and medical conditions.

In 2004, the number of emergency amphetamine/dextroamphetamine-related visits in those 25 and older was so low it couldn't be estimated. By 2011, there were 10,000 people age 25 to 44 who went to emergency rooms after using the drug.

In the five years since the tracking program ended, the DEA has approved a 60% increase in amphetamine production and the number of prescriptions for ADHD drugs jumped 20%.

The tracking was ended due to a lack of funding, said Elizabeth Crane, an analyst at the Substance Abuse and Mental Health Services Administration, which last oversaw the program.

“It was unfortunate timing,” she acknowledged.

Death reports: The U.S. Centers for Disease Control and Prevention does not separate overdose deaths caused by prescription stimulants from those due to illicit stimulants.

Still, the number of deaths in the overall category has increased by 22%, on average, every year since 2008. In 2014, the most recent year available, there were 5,100 deaths.

Other data suggests deaths from amphetamines specifically have exploded. While a few of the drugs can be used to treat conditions such as narcolepsy and binge-eating disorder, the vast majority of their use is for ADHD.

In Florida, medical examiners found amphetamines in 1,318 cases from 2008 to 2014, ruling that the drugs contributed to 277 deaths. Florida is one of just a few states that centrally track medical examiner death data.

In 2008, the drugs led to 12 deaths. In 2014, reports reached 67 deaths.

If that rate were applied to the nation, it would mean there were more than 1,000 deaths from amphetamines in 2014.

Preliminary data indicates a substantial increase in deaths in Florida again in 2015.

“It looks to me like it’s an under-the-radar epidemic,” said psychiatrist Ken Duckworth, medical director of the National Alliance on Mental Illness. “It’s a real phenomenon.”

John Fauber is a reporter for the Milwaukee Journal Sentinel. Matthew Wynn and Kristina Fiore are reporters for MedPage Today. This story was reported as a joint project of the Journal Sentinel and MedPage Today, which provides a clinical perspective for physicians on breaking medical news at medpagetoday.com.

How do ADHD drugs work?

Stimulants often are used to treat attention deficit hyperactivity disorder. That may seem counterintuitive —  those with the condition typically are fidgety or impulsive. Wouldn’t a stimulant make the condition worse?

One theory is the drugs, which increase levels of the brain chemical dopamine, provide mental stimulation. That, in turn, allows users to become more focused and calm because they no longer need to engage in self-stimulating behavior.

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