16 November 2009

From a Strip Mall, Chicago Psychiatrist Delivers High-Risk Meds, Cut-Rate Care To Elderly

by Christina Jewett, ProPublica, and Sam Roe, Chicago Tribune

Dr. Michael Reinstein is one of the most prolific providers of psychiatric care in Chicago-area nursing homes and mental health facilities. But he is trailed by lawsuits and complaints while getting government reimbursement for seeing a large number of patients.

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 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. Research has found that the typical U.S. psychiatrist sees about 35 patients per week; Reinstein sees 60 each day, he wrote in an audit report in 2007.

Illinois provides some 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 failed to 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 hard working 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 does work 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 inside 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."

Potent pill, multiple warnings

Use 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 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.
Spruell lived another two 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 into physical therapy. Five days later, Spruell fell unconscious and could not be revived. An autopsy showed that said he died of clozapine intoxication. A lawsuit is pending in Cook County Circuit Court.

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 noted that 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 boosted her dose of another antipsychotic, her medical records show. Within days, Cureton collapsed next to her bed and could not be revived.

A medical malpractice suit is pending in Cook County Circuit Court. 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 his 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," said Kempe, who 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 Circuit Court.

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 the drug 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 their 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, 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 could not be found, 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.

Researchers Lisa Schwartz and Kitty Bennett contributed to this report. This story was co-published with the Chicago Tribune.

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06 November 2009


I’ve been traveling the globe again — and beg your forgiveness as my blog has been unavoidably neglected whilst I have been away. But that doesn’t mean I’ve quit writing — oh no.

In fact, quite the opposite is true.

The beauty of email and the www is that I can check-in every so often — from remote Indian villages and other far-flung corners of North America. And when I do, your words are often the perfect salve for a tired road warrior.

Thank you.

Below are a few of the most recent comments about Generation RX — written by you. I share them with you now — and promise to be back in full swing on the blog VERY soon.

Kevin P. Miller
6 November 2009

Short sighted "solution" becomes all of our problem, and the ones lost here are our children
Review by Chris

This movie is a must view for every person on this planet. Since viewing this movie, I have made, and continue to make every reasonable effort to let my friends and family know about this movie.

My sincere hope is that we as a people, can get educated, and informed about this situation and avoid "big pharma's" short sighted "solutions" that only becomes all of our problem. The biggest victims here are of course the children, and the families are left trying to pick up the pieces and understand why things went so terribly wrong.

This movie is more than just eye opening and heart wrenching. It informs and educates on so many levels. The understanding that takes place is on the deepest levels humanity has to offer. 

While my heart goes out for all of the families who have had their children taken from them, my soul also pains for the millions of children who at this moment are still having their childhood and very make up of who they are becoming robbed from them- all in the name of "big pharma" making a buck.
Think about it.....every level of protection for the children has failed them miserably- from the parents trusting the counsel of the so called "professionals" to the governments sess pool supposed consumer watch dog the FDA. Nothing could be down right more dispicable. The fraud is perpetrated upon the parents, and in turn the children suffer. As these children suffer and are destroyed in one fashion or another, so are we.....are not children our very future?

We all owe it to ourselves to get better informed.

We owe it to our children to be their guardian angels, and to take real steps to protect them and allow them to become the people they are meant to become. How dare the FDA, the doctors, the school counselors and any one eles who would willingly participate in pushing drugs on our children- not for benefit, but for profit. 

This film exposes, promotes, and touches. There are no adequate words to describe it- you have to experience it for yourself.

Thank you Kevin Miller. Thank you for taking the time, going through the painstaking work and getting this so vital and important, life saving information out to us the public.

Critical for everyone to see
Review by Judy

This DVD needs to be placed in the hands of every person in the world.

Thank God for this information and my prayer is that I can inform all my family, friends and anyone I come into contact with to watch it and change the furture of their families.

The middle school tried to get me to put my son on meds when he was in 6th grade. I knew it was because they couldn't "control" him, but I refused. I didn't know this information at that time, I wish I had.

I will show this DVD to my daughter and son-in-law because they too have a little mover and shaker who is 6 and isn't the compliant child that most scholls expect in their classes.

Is there a way to make this more affordable so it can be mass produced and mass distributed to those who are struggling financially? I would suspect that their children are placed on these drugs at an even higher rate than those we see in the DVD!

Thank you for opening my eyes. God bless you.

Review by SamSara

this movie was grim and scary, but good!!
it's upsetting to see how the people who are supposed to be safeguarding us from drug abuse are so connected to the profits of the pharmaceutical industry. 

and everyday people are being hurt! some really tough personal stories from families who've lost a lot. 

not all the information is even new - just old stories that got buried! why are these drugs still OK? it seems crazy that the corruption described in the film is still going on, maybe even getting worse! more people sure are being medicated...

everyone should see Generation RX - tell your friends and write to congress - don't let them keep putting our kids and families at risk)

The movie is sobering, but you have to see it
Review by software geek

The drugging of children for profit is one of the most despicable crimes that is occurring in our society at this time. This movie educates and raises awareness of what is occurring right now. 

Generation RX is an extremely well-done documentary that documents the facts of how we are being used for financial gain. There are innocent victims that are being exploited - children. This was once an untapped market that the Pharmaceutical industry mines using the best talent from Madison Avenue and then spreading the wealth to others that are in a position to forward their goals (JAMA, New England Journal of Medicine, doctors, ...). 

You'll learn how we got where we are today. The DSM (Diagnostic and Statistical Manual) lists disorders, including the behavioral disorders such as ADHD, bi-polar, and so on, that enables doctors to prescribe a drug even though there is no medical test to support it. One thing I learned is that the committee / authors of the DSM have financial ties to the pharmaceutical industry. In some areas 100% of the panel members have financial ties. The corruptness of the FDA is also made clear and how we need a firewall between the regulators and those that profit from what is being regulated. Right now we have a "fox watching the hen house" scenario. 

How these drugs got approved when there was clear evidence of the harm they cause is brought out. The data of prozac was available 20+ years ago, yet these drugs were approved. 

Many have stated that ADHD is a made-up disease to collect patients that manifest the stated symptoms of ADHD. Yet when such a panel of "experts" met and a question was raised to describe the symptoms, the so-called expert could not answer the question. He yammers on for minutes making an utter fool of himself but clearing showing that ADHD is merely a four letter acronym to somehow make it seem like a disease that allows drugs to be prescribed and profits to be made while children's lives are ruined or even ended by suicide. 

Generation RX gets the point across without undue emotion. It clearly presents with facts and personal stories what the current scene is today and what occurred to get us there. We know the players that created this system. We also are challenged to do something about it. It is an ethical point and all of us need to do something to change it, even if it is writing a letter to our elected representatives. 

The movie is sobering but you have to see it. Our futures depend on our children and our children depend on us.