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Doctor gives risky drugs at high rate

Complaints, suits follow psychiatrist to thousands with serious mental illness

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

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