Helping consumers add years to their lives, II: The metabolic syndrome monitoring protocol and other tools

When the "second generation" or atypical neuroleptics (c.f. box below) were introduced into consumers' treatment regimens nearly 20 years ago, they were hailed by mental health practitioners as a significant treatment advance. They were expected to ameliorate schizophrenia's negative symptoms, i.e., withdrawal, apathy and anhedonia, and to effectively address the positive symptoms, principally hallucinations and delusions.

In contrast to their predecessor or "first generation" neuroleptics, they were not expected to inflict unpleasant or serious side effects on the persons prescribed them. At least as per the controlled studies conducted by the pharmaceutical companies to secure FDA approval.

Unfortunately, as Bob Whitaker points out in "Anatomy of an Epidemic," these controlled studies were generally short-term in length and provided little evidence of the atypicals' serious side effects and the life-threatening consequences they posed. Accordingly, practitioners, particularly prescribing psychiatrists, were slow to connect the dots; and the weight gain and insulin resistance that have become hallmarks of clozaril, risperdal, seroquel and zyprexa speedily developed into the metabolic illnesses—diabetes, heart disease and related systemic ailments—that have reduced vulnerable consumers' life expectancy to 55 years of age.

Two long-term studies conducted early in the new century corroborated the foregoing. The results of the first, the CATIE study, "Clinical Antipsychotic Trials of Intervention Effectiveness," were published in September 2005 (Phase I outcomes) and April 2006 (Phase II). While CATIE, a controlled study, supported the effectiveness of Clozaril and Zyprexa in controlling psychotic symptoms, it also revealed the high incidence of diabetes (13 percent) and hypertension (27 percent) among its study subjects.

The second key study was that undertaken by the National Association of State Mental Health Program Directors and entitled "Morbidity and Mortality in People With Serious Mental Illness," with its results published in October 2006. An overview of Medicaid data from 16 states, it reached the dramatic conclusion that persons with serious mental illnesses prescribed atypicals died 25 years earlier than members of the general population.

Moreover, it specified that persons diagnosed with schizophrenia and suffering from diabetes had mortality rates 2.7 times higher than other Americans; from cardiovascular disease 2.3 times higher; from respiratory diseases 3.2 times higher; from infectious diseases 3.4 times higher.

Prior to these studies, self-reports from consumers prompted the American Diabetes Association, the American Psychiatric Association, the American Association of Clinical Endocrinologists and the North American Association for the Study of Obesity to convene a landmark conference in 2004, the "Consensus Development Conference on Antipsychotic Drugs and Obesity and Diabetes," which endorsed the Metabolic Syndrome Monitoring Protocol (cf reference below to Drs. Newcomer and Haupt) and recommended its use by psychiatrists and primary care physicians with patients prescribed atypicals (c.f. table below).

Metabolic Syndrome Monitoring Protocol

We knew from demographic overviews of nearly 700 program consumers that we completed in June 2006 and June 2008, that approximately half of our 700 consumers had diagnosed chronic medical illnesses, including nearly 20 percent with diabetes.

We also knew from our Q1 data collected during 2007-2009, while we were in the midst of our training project and comparative study, that 18 of our consumers died of natural causes during that period, at a mean age of 55. In short, we knew that our consumers were very similar to those persons who were the subjects of the Mental Health Directors' study.

We had also learned over the 15-plus years of our case management program's existence, that psychiatrists, therapists and primary care physicians often ignored the case managers' requests for assistance and for information regarding the consumers we worked with.

We had been led to hypothesize that if consumers, supported by their case managers, took the lead in requesting treatment, particularly changes in treatment, and in requesting pertinent information, particularly test results and progress reports, and that if both consumers and case managers were prepared to make such requests, they would not be denied.

Specifically, since so many of our consumers had grown ill and died as a consequence of the medications they were being prescribed, we wanted the consumers and case managers to push their treating psychiatrists and primary care physicians to follow the Metabolic Syndrome Monitoring Protocol (MSMP) and to report the Protocol's test results to one another as well as to the consumer and her/his case manager.

When we began our Intensive Collaborative Case Management training program and demonstration project in the fall of 2007, very few psychiatrists or primary care physicians were conducting the MSMP as a matter of course. By the time we had completed our follow-up comparative study in March, 2010, by which time we had trained the remainder of our 50 case managers and more than 100 consumers, the MSMP had become, if not standard, at least a common practice among many physicians treating consumers in New York City and State.

Independent of our efforts, many of the large public and non-profit behavioral health clinics in the City and throughout the State instituted utilization of the MSMP, supplemented with Wellness training for consumers. This past December, the State Office of Mental Health introduced a quality improvement protocol to its licensed community clinics designed to reduce reliance on neuroleptics, particularly those implicated in Metabolic Syndrome, and enhance consumer choice regarding medications and dosage. Consequently, the MSMP is becoming standard practice to be used with all persons prescribed neuroleptic medications.

Nonetheless, the foregoing represents only an important first step. Will the State continue holding psychiatrists' feet to the fire until the MSMP is viewed as an essential part of a consumer's medication assessment? What about the primary care physicians (PCPs)—will they be held similarly accountable? And the results of the MSMP?

Will psychiatrists do the necessary follow-up and make whatever treatment referrals are called for? Will they communicate with the consumer's primary care physician—and vice versa—and will they make sure the consumer gets a PCP if the consumer doesn't have one? If you take a look at our ICCM study summary, published on 2/17, we had little success getting psychiatrists and PCPs to talk to one another.

From conversations I've had with prescribing practitioners in clinics in the City, those whose clinics are part of a larger medical setting will find it easier to carry out those tasks than practitioners working in free-standing clinics, largely because—an important and recent innovation—consumers' medical and behavioral health records are or soon will be electronically accessible.

Further, despite the Medicaid cuts planned for the new State budget, monies will be available to establish several "medical homes," i.e., venues where a consumer can obtain all necessary medical and behavioral health care and where her/his treating practitioners will have ready access to one another.

Models are already being tested: a State psychiatric center and a private voluntary hospital in Brooklyn established an integrated behavioral health/medical clinic over three years ago with excellent outcomes; the agency from which I recently retired, FEGS, has been collaborating for the past two years with a behavioral health managed care company in a medical home demonstration project in Nassau County, immediately adjacent to New York City.

Despite all these promising developments, I remain skeptical—and, ultimately, unconvinced. The foregoing is being done to improve the effectiveness of practitioners, but what about the consumers? Are they still to rely on the same individuals who failed them in the past? Wellness training for consumers won't cut it because treatment of any kind is relational, i.e., rooted in relationships.

When you're dealing with folks who can be easily indifferent to you because of your social status, you have to learn to be assertive, to effectively represent yourself and your interests. All I know is that when I see my physicians, I ask lots of questions and make sure they're answered.

So I still like the idea of training consumers in self-advocacy: it levels the playing field and gives the consumer a shot at getting what she/he needs. Ultimately, as I wrote in a 2/1 blog on this site ("Why big Medicaid cuts mean big changes for NY mental health system"), the biological model of treatment, with medication at its center, must be tossed out.

References

· Carney, J, "Helping Consumers Add Years To Their Lives: Training Consumers and Case Managers To Be Partners In Primary Healthcare Advocacy," posted 2/17/11 at www.behavioral.net

· Carney, J, "Why Big Medicaid Cuts Mean Big Changes For New York's Mental Health System," posted 2/1/11 at www.behavioral.net

· CATIE, Clinical Antipsychotic Trials of Intervention Effectiveness, summaries available at www.nimh.nih.gov and www.catie.unc.edu

· Newcomer, JW, Haupt, DW, "Metabolic Screening and Monitoring Form," produced by Compact Clinicals, Kansas City, Mo. 2007

· Ricketts, S., "Cardiometabolic Risk Factors and Antipsychotic Medications: Changing Prescribing Practices, Promoting Wellness," NYS Office of Mental Health, Bureau of Evidence-Based Services and Implementation Science, December, 2010, powerpoint presentation

· Smith, TE, Sederer, LI, "A New Kind of Homelessness for Individuals with Serious Mental Illness: The Need for a Mental Health Home," Psychiatric Services, April, 2009, Vol. 60, #4, pp 528-533, available at ps.psychiatryonline.org

· Whitaker, R, Anatomy of an Epidemic: The Hidden Damage of Psychiatric Drugs, Crown Publishing Group, New York 20010