www.chicagotribune.com/health/chi-drugs-doctor-reinsteinnov10,0,4609781.story
By Christina Jewett, PROPUBLICA; and Sam Roe, TRIBUNE REPORTER
November 10, 2009
Inside
Chicago's Maxwell Manor nursing home, Dr. Michael Reinstein's patients
suffered from side effects so severe that they trembled, hallucinated
or lost control of their bladders.
Staffers told state investigators that so many patients were clamoring
to complain to Reinstein about their medications that a security guard
was assigned to accompany him on his visits. In addition, staffers said
Reinstein had induced patients to take powerful antipsychotic drugs
with the promise of passes to leave the home.
Though state officials shut that facility in 2000 for inadequate care
and wretched conditions, Reinstein, the home's lead psychiatrist,
continued to practice. Today he is one of the most prolific providers
of psychiatric care in Chicago-area nursing homes and mental health
facilities, even as he is trailed by lawsuits and complaints like the
ones at Maxwell Manor.
Neither state nor federal officials appear to have ever assembled a
complete picture of Reinstein's thriving practice, built in part within
Illinois' poorly regulated system of nursing homes serving the mentally
ill. But an investigation by ProPublica and the Tribune found that Reinstein has compiled a worrisome record, providing assembly-line care with a highly risky drug.
Searching publicly available documents, reporters discovered that
Reinstein, 66, has been accused of overmedicating his mentally ill
patients. His unusually heavy reliance on the drug clozapine -- a
potent psychotropic medication that carries five "black box" warnings
-- has been linked to at least three deaths.
In 2007 he prescribed various medications to 4,141 Medicaid
patients, including more prescriptions for clozapine than were written
by all the doctors in Texas put together, Medicaid records show.
Records also show he is getting government reimbursement for seeing an
improbably large number of patients. Documents filled out by Reinstein
suggest that if each of his patient visits lasts 10 minutes, he would
have to work 21 hours a day, seven days a week. Reinstein sees 60
patients each day, he wrote in an audit report in 2007.
Illinois provides powerful incentives for cut-rate, high-volume care in
nursing homes for the mentally ill, where Reinstein sees most of his
patients.
The state Medicaid program pays psychiatrists as little as $22 per
patient for some services, a rate drastically less than customary fees.
State lawmakers recently did not act on a bill that would have given
psychiatrists the first Medicaid fee increase in years.
Working from a strip-mall office in Uptown, Reinstein says he is
psychiatric medical director at 13 nursing facilities, seeing patients
with chronic mental illness whom few doctors will accept. Those include
people with schizophrenia, who make up the bulk of his practice. His
supporters say they admire the hardworking doctor, who makes daily
rounds in a car with 140,000 miles on the odometer. And Reinstein
maintains that clozapine was not to blame for the patient deaths.
In written statements to ProPublica
and the Tribune, Reinstein said he works long hours seven days a week,
as do his four partners, who separately also prescribe clozapine. State
records overstate his workload, he said, because of a computer system
that forces him to submit claims several times. He said he is trying to
recruit more doctors to his practice, but it has been difficult because
of low pay, high malpractice insurance rates and a perception that the
work is dangerous.
He also strongly defended his reliance on clozapine, saying the
medication is underprescribed and is the most effective in its class
for schizophrenic patients. That view is supported by a prominent study
that found clozapine helped patients more than similar, newer drugs.
Clozapine can control psychotic episodes, reduce suicide risk and help
patients live independently outside of institutions, Reinstein said.
"The most gratifying part of my day," he wrote, "(is) when patients reach this level and come to the office!!!"
Autopsy and court records show that three patients under Reinstein's
care died of clozapine intoxication. Alvin Essary died at age 50 at the
Somerset Place nursing home on the North Side in 1999. Medical records
show that when he died his blood contained five times the toxic level
of clozapine.
The plaintiff's expert in his family's medical malpractice lawsuit
contended that Reinstein was grossly negligent to give multiple
medications to a man with only one kidney. Reinstein settled the claims
against him for $85,000, but Essary's sister, Shirley Palmer, said she
can't believe he is still practicing.
"There's nothing that's been done to this doctor who's caused all these
problems," Palmer said. "It makes me mad that this keeps going on."
Reinstein has a far different view of his career.
"I am grateful for the opportunity to be of service to the patients I
treat and have treated for over 37 years," he wrote. "I take pride in
the many people I have been able to help and feel badly about those
patients who have not seen the benefits of treatment."
Drug with many warningsUse of any medication carries risks, but
clozapine stands out. It ranks just behind the more widely used
painkiller oxycodone as the medication suspected in the most patient
deaths, according to a study that examined reports to the Food and Drug
Administration.
The "black box" warnings -- the FDA's strongest -- on clozapine's
label detail serious potential side effects, from enlargement of the
heart to rapid drops in blood pressure to increased seizure risk.
Doctors also are required to take regular blood samples to ensure
patients' immune systems aren't shutting down.
The FDA approved the drug two decades ago for only a sliver of the
population: the actively suicidal or the quarter of schizophrenic
patients who do not improve on medications with lesser side effects.
Yet Reinstein last year said under oath that his practice once had more
than 300 patients among 415 in one Chicago nursing home on clozapine.
Reinstein said he completes the FDA-mandated blood tests for patients
on clozapine but calls them "excessive and severe." Although other
psychiatrists said it is crucial to discuss the numerous risks of
clozapine with patients, Reinstein said he gives them the product
insert -- and hopes they read it.
His use of clozapine is at the heart of separate lawsuits filed after
the deaths of two patients he treated: Odell Spruell and Wendy Cureton.
Reinstein took over Spruell's care in 2007 when the 54-year-old was
transferred from a nursing home to a psychiatric ward after hitting
other patients and staff, records show. A former steel mill worker,
Spruell had been stable on a low dose of clozapine for about two years.
Reinstein doubled his dose and returned him to the nursing home,
medical records show.
Spruell lived two more weeks under the care of a Reinstein partner.
During that time, he grew increasingly lethargic and suffered other
symptoms associated with overmedication. His hands shook, he drooled
and he began sleeping all the time, said his sister, Irma Spruell.
"He was too weak to get up," she said. "He tried to talk, but he couldn't."
Staff members at Spruell's nursing home also noticed his lethargy. In
response, they put him in physical therapy. Five days later, Spruell
fell unconscious and could not be revived. An autopsy showed that he
died of clozapine intoxication. A lawsuit is pending in Cook County.
Reinstein declined to comment, citing a patient privacy law.
Cureton, 27, died four years before Spruell. In 2003 she was moved from
a nursing home to the psychiatric ward at Kindred Hospital North on
Chicago's North Side.
She had grown increasingly aggressive after two of her family members
died in a house fire. Reinstein, her supervising psychiatrist, and two
partners repeatedly boosted Cureton's clozapine dose -- two times
faster than the recommended pace, according to her medical records and
guidelines published by the drug's maker. Medical staff said she
remained hostile and unpredictable, at times pounding on the wall or
laughing at it.
On the 10th day in the psychiatric ward, Cureton had trouble breathing
and was taken to the emergency room. The drug's label explicitly warns
of that adverse reaction and says doctors should not mix clozapine and
certain sedatives, as the team under Reinstein's supervision had done,
medical records show.
Reinstein saw her after she returned from the emergency room and
increased her dose of another antipsychotic, records show. Within days,
Cureton collapsed next to her bed and could not be revived.
A medical malpractice suit is pending. In a pretrial deposition,
Reinstein defended boosting the dose of the clozapine, saying Cureton
was obese and had tolerated a high amount in the past. He also said the
autopsy finding that she died of clozapine intoxication was unreliable
because research shows that clozapine levels spike after death.
The physician who performed the autopsy did not dispute that. But he
said Cureton's sudden collapse before death and the condition of her
heart and lungs afterward led him to conclude that she died of
clozapine intoxication.
'He wouldn't talk to them'Reinstein has supporters in the
medical community. Nurse Bernadette Wright lavished him with praise,
saying, "The man is a genius."
"He knows his patients," said Wright, head of nursing at Sacred Heart
Home in Chicago, where Reinstein is psychiatric medical director. "He
knows them by name and by face. When you tell him about a patient, he
knows their history."
Reinstein "would never" give risky drugs without properly monitoring patients, she said.
But one nurse who worked with Reinstein said she worried that he was too busy to give his patients the time they needed.
Former Riveredge Hospital nurse Eileen "Cookie" Kempe said in an
interview that when Reinstein visited, he went into a room and
furiously wrote on stacks of medical records as his patients lined up
in the hall. "He wouldn't talk to them," according to Kempe, who said
she worked with Reinstein for a year until 2004. "I never saw him go in
a patient room, ever. They got no therapeutic interaction with a
doctor."
Riveredge is where Reinstein treated a 27-year-old pregnant patient,
Tameka Williams, in 2007 after she had an acute schizophrenic episode.
She never signed a required form agreeing to take clozapine; nor was
her immediate family consulted, according to records and interviews.
Even though it has not been proved safe for use during pregnancy,
Reinstein prescribed clozapine, Williams' medical records show. At some
point, Williams had developed a blood clot -- a condition particularly
threatening for a patient on clozapine. She died days after being
admitted when the clot lodged in her heart. A lawsuit against Reinstein
is pending in Cook County.
State regulators inspecting Westwood Manor, a Chicago nursing home,
noted in 2003 that several of Reinstein's patients were not properly
monitored. Some showed apparent clozapine side effects. One trembled
when he walked. Another kept a cigarette butt in her mouth to prevent
her tongue from jutting out.
In a written response to the inspection, Reinstein cited a "lack of
clinical sophistication on the part of the evaluator(s) ... on
medication effectiveness." He also said in a written response to
reporters that tongue jutting and trembling "are not usual" side
effects of clozapine.
Reinstein's troubles were perhaps most dramatic at Maxwell Manor, a
South Side nursing home. The Illinois State Police and the U.S. Postal
Service began investigating Reinstein in 2000 amid accusations of
billing fraud, according to documents obtained through public records
requests.
Included in those documents is the account of a Maxwell Manor
psychiatric supervisor who said Reinstein heavily promoted Clozaril,
the original brand name for clozapine. Deborah Grier told state police
investigators that Reinstein had handed out glossy fliers to staff and
prescribed the drug to nearly all of his patients.
Grier, who has since died, said Reinstein persuaded some patients to take Clozaril by offering passes to leave the home.
She said patients often complained of hallucinations from the drug and
that she "had many conversations with Reinstein about how many patients
... had bad reactions." But she said he "very seldom" reduced doses or
switched drugs, investigators wrote.
Another Maxwell Manor worker, Engoyama Fela, told investigators that
Reinstein "would not spend more than one minute" with a patient during
his rounds, according to a summary of the interview. "Many patients
became agitated and rebellious because they knew they needed care and
they wanted to talk to Reinstein but were not allowed to," he said.
Fela said Maxwell Manor security staffers were assigned to guard Reinstein when he came to update medical records.
Reinstein, in a written response to reporters, denied the workers'
allegations, saying he spends an appropriate amount of time treating
patients in consultation with other medical staff. He agreed that
security was present at Maxwell Manor but not specifically to protect
him. "This facility had many violent and disruptive patients," he said.
Several years after regulators shut the home in 2000, the U.S. Justice
Department, in a separate civil fraud case, alleged that residents had
been routinely abused and medicated as punishment.
Reinstein, who said he saw a majority of the patients at the facility,
was not a defendant in the federal civil case. Criminal prosecutors
investigating possible billing fraud by Reinstein did not file charges
against him.
Barry Miller, the prosecutor overseeing the criminal inquiry, declined
to comment. Case records say the matter was referred to Medicare to
recover any overpayments. Agency officials declined to comment.
Reinstein said he was not sanctioned by Medicare and did not have to
reimburse the agency.
Retired state investigator Ray Lewis was unhappy to see the criminal
case closed. In a recent interview, he said that if there were one
Medicaid fraud case he could revisit, Reinstein's would be it. "I'd
investigate it for free," Lewis said.
The agency responsible for investigating physician conduct, the
Illinois Department of Financial and Professional Regulation, does not
reveal to the public the number of complaints filed against doctors,
only findings where there was formal disciplinary action. In 1997 the
agency cited Reinstein for improperly admitting a patient for
psychiatric care and ordered him to complete 50 hours of education.
Since then, the agency has received at least one other complaint about Reinstein.
In 2003, Chicago psychiatrist Dr. Mark Amdur, of the Thresholds mental
health organization, became so concerned about Reinstein's work at area
nursing homes that he asked his staff to find out how many patients
came under Reinstein's care. The number -- 2,300 -- surprised him.
"I believe that the apparent concentration of care under a single
practitioner should be a matter of concern," Amdur wrote state
regulators.
When asked what happened to his complaint, the Illinois Department of
Public Health said it was unable to find it, and the professional
regulation agency could produce no evidence of follow-up.
Amdur said he never got a response. "There ought to be some outside
review for the benefit of the people residing in these nursing homes,"
he said.
Sam Roe is a Tribune reporter. Christina Jewett is a reporter for ProPublica,
an independent, nonprofit investigative newsroom in New York. Funded
primarily by the Sandler Foundation, ProPublica publishes its work at
propublica.org and through partnerships with the Tribune and other
media.
christina.jewett@propublica.org
sroe@tribune.com
Coming this week
Copyright © 2009, Chicago Tribune