Healthcare Finance News reported that a long-time Chicago psychiatrist faces over 18 months in prison after he pled guilty to receiving $600,000 in kickbacks from pharmaceutical companies. Dr. Michael Reinstein also agreed to pay $3.79 million in a parallel civil lawsuit settlement for prescribing clozapine in exchange for kickbacks. His medical license has also been suspended.
In 2009, ProPublica and the Chicago Tribune reported that in one year, Reinstein prescribed more clozapine to patients in Medicaid’s Illinois program than all doctors in the Medicaid programs of Texas, Florida and North Carolina combined.
The Chicago Tribune reported that autopsy and court records show that at least three patients under Reinstein’s care died of clozapine intoxication. Medical records for a fifty-year-old man showed that he had more than five times the toxic level of clozapine in his blood when he died. A 27 year-old woman died after her dose of cloazpine was increased twice as fast as recommended. Reinstein served as the psychiatric medical director for 13 different nursing homes.
Up until 2003, the manufacturer of Clozaril (Novartis) paid Reinstein thousands of dollars for speaking engagements to promote the drug, according to Healthcare Finance News. IVAX Pharmaceuticals then began paying him $50,000 per year as a consultant, so he switched his patients to generic clozapine. That arrangement continued when Teva Pharmaceuticals acquired IVAX in 2006. In 2009, as the Tribune began to examine his prescribing habits, Reinstein asked Teva to terminate the consulting agreements. Incidentally, in March of 2014 Teva agreed to pay $27.6 million to settle federal and state claims that the company paid Reinstein to prescribe clozapine.
The actions of Dr. Reinstein were extreme, but not really those of a lone rogue psychiatrist. On March 1, 2015, Robert Pear with The New York Times wrote that federal investigators with the Government Accountability Office (GAO) would announce the next day that they had found evidence of widespread overuse of psychiatric drugs by older adults with Alzheimer’s. Not only was this a concern in nursing homes, but investigators also said officials needed to focus on the overuse of these drugs by individuals with dementia who live at home or in assisted living facilities.
The GAO found that approximately one-third of older adults with dementia who spent more than 100 days in a nursing home in 2012 were prescribed an antipsychotic (neuroleptic). Among older adults with dementia living outside of a nursing home, about 14 percent were prescribed an antipsychotic. While the Department of Health and Human Services (HHS) has taken several steps to address antipsychotic use in nursing homes, nothing has been directed to settings outside of nursing homes. Therefore, the GAO recommended that HHS expand its outreach and educational efforts to include those living outside of nursing homes.
Neuroleptic (antipsychotic) drugs are classified into two sub-groups. The older, “typical” ones were developed in the 1950s. Examples include haloperidol (Haldol) and chlorpromazine (Throazine). The second generation, “atypical” antipsychotics were developed in the 1980s and initially thought to cause fewer side effects than the older, typical antipsychotics. Examples of atypical antipsychotics include aripiprazole (Abilify) and risperidone (Risperdal). Abilify was the number 13 best selling drug for 2014, according to Genetic Engineering & Biotechnology News. Clozapine (Clozaril) is an atypical.
In 2005, the FDA required that atypical antipsychotics carry a boxed warning that they had a higher risk of death related to use among individuals with dementia. In 2008, the FDA required the same warning with typical antipsychotics.
A literature review in Health Policy looked at the extensive off-label use of antipsychotics in nursing homes for residents with dementia and behavioral problems. They were found to have mixed efficacy “with an increased risk of many adverse events, including mortality, hip fractures, thrombotic events, cardiovascular events and hospitalizations.” Non-pharmacological options were recommended as first-line treatment options. The authors also noted when studies were subsidized by the pharmaceutical industry, the studies showed more favorable outcomes with antipsychotics.
Researchers from the University of Michigan Medical School and John Hopkins University reviewed two decades worth of research and concluded: “The evidence for non-pharmaceutical approaches to the behavioral problems often seen in dementia is better than the evidence for antipsychotics.” They noted there still was a place for using antipsychotics when patients have psychosis or aggression that could lead to harming themselves or others. “But these uses should be closely monitored and ended as soon as possible.”
Another study from the University of Michigan (abstract here) examined the records of 91,000 elderly veterans with dementia and found that mortality risks increased in patients taking antipsychotics to reduce symptoms of dementia, when compared to patients not being treated. A MinnPost report of the study said the mortality risks were two to four times higher than previously cited in the medical literature. “The new analysis also revealed that the higher the dose of an antipsychotic medication, the greater the risk of premature death.” Dr. Helen Kales, one of the study’s researchers, said:
Our research indicates that antipsychotics may increase mortality more than previously realized. . . . We hope this creates a dialogue about the advantages and disadvantages of antipsychotic and other psychotropic use as first-line treatment strategies for behavioral symptoms, which are universal and require effective treatments to address serious suffering among patients, families, and caregivers.
I hope it creates a dialogue as well. Thankfully we do not have the older state hospital system where the elderly with dementia and Alzheimer’s were often warehoused. But shackling them mentally with neuroleptics so they can be managed with minimal behavior problems seems to be just about the same thing.