The casino didn’t always call out to Denise
Miley.
At most, she and her husband, Brad, would drive
over to the Mystic Lake Casino Hotel, just outside Minneapolis, a few times a
year.
Then, in the fall of 2014, she got an itch to go
more often. She’d ride her bike the 35 miles down to the casino and ask her
husband to pick her up. It was just exercise, she’d tell him. Sometimes
she would start driving to the office where she worked as an accountant. But
when the freeway split off, she’d peel south and head to the slots.
“I didn’t have a word for it back then, but I
was starting to feel compulsed,” she said. “I wanted to stay longer, and
longer, and longer.”
She also had no idea her compulsion might be
linked to a drug she began taking for depression and anxiety a few weeks before
she began seriously gambling. By the time she stopped taking aripiprazole — an
antipsychotic sold under the brand name Abilify — she’d stayed in the casino
long enough to lose more than $150,000.
Miley, 41, filed a lawsuit in January 2016
against the drug makers Bristol-Myers Squibb and Otsuka, alleging the drug —
one of the best-selling in the world — caused compulsive behavior. The suit
contends that the companies knew or should have known it could create such
urges, and didn’t adequately warn the thousands of people in the U.S. who use
the medication each year.
Hundreds more people have since sued the
companies, claiming that the drug caused them to gamble, eat, or have sex
compulsively. And the Food and Drug Administration signaled its own concern in
a 2016 safety warning, saying
that uncontrollable urges to gamble, binge eat, shop, and have sex had been reported with use of the
antipsychotic.
“We have people who have lost their retirement
accounts, spent their children’s college funds, blown through a lifetime of
savings,” said Gary Wilson, an attorney with Robins Kaplan, a firm representing
some of the plaintiffs, including Miley.
Scientists haven’t figured out how, exactly, a
drug might trigger compulsive behavior. Psychiatrists say that even if Abilify
does have a role, it’s probably just part of the explanation, since millions of
people take the drug without experiencing such problems.
Otsuka, which developed the drug, and
Bristol-Myers Squibb, which marketed it jointly with Otsuka in the U.S., have
denied the allegations. Bristol-Myers Squibb referred questions about Abilify
to Otsuka, which said it could not comment on pending litigation.
The lawsuits have all been lumped together, and
the case is presided over by Judge M. Casey Rodgers in the Northern District
Court of Florida. The judge picked three bellwether lawsuits to go to trial in
a bid to spur a resolution for the other cases, but those three were settled
out of court earlier this year for an undisclosed amount.
Now, Rodgers has ordered the thousands of other
plaintiffs and the drug makers to work out a framework for a global settlement
by Sept. 1. At the same time, the court is working to pick a new group of cases
to move to trial if a settlement can’t be reached.
Blockbuster drug spurs a
safety warning
The lawsuits are the latest chapter in the
roller-coaster history of Abilify. It was approved by the FDA for schizophrenia
in 2002. It’s since been approved for treating bipolar disorder, irritability
associated with autistic disorder, Tourette’s syndrome, and major depressive
disorder.
In 2007, Bristol-Myers Squibb agreed to pay more
than $500 million to settle federal charges that it illegally marketed the drug
to pediatric physicians and nursing homes. And in 2016, the company reached a
$19.5 million settlement with 42 states and Washington, D.C., which accused the
drug maker of illegally promoting Abilify to people with Alzheimer’s disease
and other forms of dementia.
But it hasn’t all been bad news. Aripiprazole
remains one of the most-prescribed drugs on the market. And though it went generic
in the U.S. in 2015, it continues to generate big sales. The brand-name version
of the drug has raked in more than $51 billion worldwide since it was approved,
according to IQVIA, a health care
analytics company.
And in 2017, the FDA approved Abilify MyCite, a version of the
drug embedded with a sensor that can alert a patient’s physician or caregiver
when its been ingested. It was the first approval of a so-called smart pill.
As the drug grew increasingly popular, reports
kept cropping up that a small number of patients taking the drug had started
gambling uncontrollably and experiencing other compulsive behaviors. Between
November 2002 and May 2016 when the FDA issued its warning, there were 184 case
reports linking the drug to impulse control problems in the medical literature
and the FDA’s adverse event database, according to the agency.
The European Medicines Agency was the first
regulator to issue a warning, in 2012, that Abilify had been linked to
compulsive behavior. In 2015, Canadian drug regulators followed suit. Both required
the drug makers to change the labeling, but “pathological gambling” wasn’t
added as a potential adverse event to Abilify’s labeling information until
January 2016. The FDA didn’t issue a warning to the public until May 2016.
When asked about the reasons for the delay
compared with warnings issued in other countries, an FDA spokesperson said,
“Our safety signal folks are always reviewing the research.”
Otsuka maintains that there weren’t any signs
the drug might be linked to pathological gambling in its initial clinical
trials. In one large study — testing Abilify paired with the antidepressant
bupropion, the exact combination that Miley was prescribed — the drug makers
reported there weren’t any unexpected adverse events.
But Miley said that wasn’t her experience.
The itch to gamble grows
It never occurred to Miley that the drug might
be to blame for her growing urge to gamble. She started taking the drug in
September 2014, two years before the FDA went public with its warning.
Nor did it raise a red flag for her psychiatrist
when Miley mentioned offhand at an appointment that fall that she’d been
gambling more. She pitched it almost as a good thing.
“I remember saying, ‘We’re going to the casino a
lot more. We’re doing it for an excursion — we’re getting out of the house,’”
Miley said.
Miley went back to work, but only part time and
with the option to work remotely from her home in Maple Grove, Minn. That meant
she could go to the casino without anyone realizing where she’d gone. Some
days, she told herself she didn’t have that much work to do. Other days, she
just ended up there. Miley’s husband knew she sometimes went to the casino
alone — but he had no idea how often. She didn’t always tell him. She hated how
she felt: alone and ashamed.
“This whole thing snowballed extremely fast,”
she said. Looking back, she felt so distant from herself — a dedicated mom to
four kids who calls herself her family’s “rock.”
That fall, if her oldest son’s high school
basketball games were anywhere near the casino, she’d dash over during
halftime. She told her family she was popping out to do some quick Christmas
shopping.
“I had the full intention of going back to his
games,” she said. “But I’d sit there and keep gambling and gambling.”
More than once, she didn’t make it back and had
to ask someone else to drive her son home. She was losing money, and growing
more and more concerned. She finally told her husband she’d lost $10,000.
She grew increasingly desperate to win the money
back. “That was the first time I had considered or threatened suicide,” she
said.
She found herself in the same brutal spiral that
many of the other plaintiffs say they’ve found themselves in: They started
taking Abilify to grapple with depression and other serious psychiatric
conditions, but then started experiencing compulsions that crushed them with
guilt and damaged their relationships — feeding their depression.
Miley’s husband convinced her to talk to a
physician who specialized in gambling addiction and who recommended she enter
inpatient treatment. But there weren’t any openings. So her husband took her
car away, hoping to cut off her ability to get to the casino. She was supposed
to take the bus to work.
“That’s what he thought I would do,” she said.
She did take the bus to work. Then, she’d wait for the bank to open so she
could take money out of their account and hop on the lightrail to the Mall of
America, where she caught another bus to the casino. Sometimes she made it back
to work, but other times she’d miss the bus. Once, she took a taxi and had it
drop her off at the bus station, so it looked like she took the bus home from
work.
“It wasn’t me. It just wasn’t me at all during
those times,” she said.
That early interaction with her psychiatrist
still haunts her. What if he had known about the possible link to Abilify? What
if he had taken her off the drug, right then and there? Before the compulsion
had stripped her of her savings. Before it had harmed her relationships with
her family and friends. Before it had threatened her career. Before it had made
her think about suicide.
“I just look back a lot and go, ‘How this could
have been different,’” she said. “That’s where I get angry.”
Scientists stumped by a
rare link
The science on the potential link between
Abilify and impulse control problems is far from settled.
A quick biology lesson: Abilify is a partial
dopamine agonist, which means it acts on dopamine, a neurotransmitter that
ferries signals between neurons in the brain. It’s involved in multiple
pathways, including one that regulates reward processing, pleasure, and
motivation.
Both sides battled it out in court over the
question of whether Abilify is capable of causing uncontrollable impulses,
roping in a slew of experts to testify on either side. In March, Rodgers ruled
“there’s a genuine dispute of material fact.” That is, it’s not clear what
might be happening, but there isn’t enough evidence to prove it’s impossible.
Experts say the more critical question — and the
bigger mystery — is why impulse-control problems might show up in just a small
slice of the millions of patients who take Abilify each year.
“If it were as simple as it causing [the
behavior], then the streets would be filled with impulsive people,” said Dr.
Jon Grant, a psychiatrist who studies impulsive-compulsive disorders at
University of Chicago.
Answering that question would take a significant
amount of time and money, experts said. It would require a randomized trial and
a ton of baseline data from brain scans, blood tests, and detailed patient
histories to tease out what factors might be at play.
“If we stick to science, we have to say there’s
a very interesting signal there that’s worth investigating,” said Dr. Timothy
Fong, a psychiatrist who serves as the co-director of the University of
California, Los Angeles, gambling studies program. “But to do that
investigation will take a massive amount of resources,” he added.
There’s also a looming question of how
responsible the drug might be for impulse control issues in some patients, if at
all, Grant said. If it were shown that the drug causes impulse control problems
in people with a certain genetic makeup, or people who were exposed to certain
environmental factors, what percent of the blame could be placed on the drug?
“The legal system looks at it very differently,”
Grant said.
One piece of evidence cited by the plaintiffs:
When some patients started taking the drug, they experienced compulsive
behavior. When they stopped the drug, it stopped. In some cases, when a patient
started taking Abilify again, the impulses reportedly picked right back up
where they’d left off. In its 2016 warning, the FDA noted that in the majority
of case reports, the compulsions happened in people with no prior history of
impulse control problems.
It’s also not the first drug linked to such
problems. Similar issues have been seen with certain Parkinson’s drugs that
also work on the dopamine system.
“The story [about Abilify] is not a story that’s
unusual or surprising,” said Fong.
A promise to get help
One night in February 2015, Miley was supposed
to be celebrating a close friend’s 60th birthday. It was the kind of
neighborhood get-together she ordinarily gets excited about. But that morning,
she took a familiar trip — down to work and on to the casino.
A week earlier, Miley had tried to take $50,000
out of her retirement account, but was told it was going to take several days
to get the money. With the casino clawing at her brain, she instead took out a
$50,000 loan. She was winning the day of the party — up so much that she
thought she’d be able to pay off the debt.
She called her friend and told her she was
working late. It was smack in the middle of tax season, so she thought it would
be believable.
“I knew I shouldn’t be lying to people,” Miley
said. “But the power that I felt like I needed to gamble was so much more than
any of that.”
Her friend knew better. Miley was still ahead
when the girlfriend showed up with a second friend at the casino at nearly 1
a.m. By that point, Miley had moved to high-stakes poker. One friend told Miley
she looked like “a shell of [herself].”
She was embarrassed and distraught. She felt out
of control, suicidal. They wanted to drive her to the nearest treatment
facility, but Miley wanted to see her kids. So with a promise to return in the
morning, they drove her home.
Miley’s husband, meanwhile, had realized she was
gone and checked their bank accounts. To his shock, he realized she had been
withdrawing their savings. He moved most of their money to an account Miley
couldn’t access. When she arrived home, she made him the same promise: “In the
morning, we’ll go.”
The next morning, Miley wrote her husband a note
saying she was going to work to get everything in order before they went to the
treatment facility. She did go to her office. Then she drained the little bit
of money her husband had left in their bank account for making their house
payment and paying other bills, and made a beeline for the casino.
Her husband was so desperate he considered
calling the police, since she’d taken his car. He begged her to come home, and,
eventually, Miley agreed. They sped straight toward the treatment facility,
more than 100 miles from home.
“Shame. That’s all I felt, this whole time,”
Miley recalled. “Shame at what I was putting my family through. Shame at what I
was doing. Shame that I couldn’t control this.”
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