New Survey Shows Product Liability Litigation May Jeopardize Treatment Outcomes for People with Severe Mental Illnesses

Relapses Seen As Patients Abandon Treatment in Response to Negative Law Firm Ads

ROCKVILLE, Md., June 13, 2007 /PRNewswire/ -- Survey results released today shed light on a new barrier to treatment affecting people with severe mental illness. The findings show fears raised by product liability litigation involving antipsychotic drugs may be putting patients with schizophrenia and bipolar disorder at risk for relapse. These fears add to the already heavy burden that patients face as they work to manage symptoms, stay on their medication and work with their treatment providers to improve their mental and physical health.

The survey, which was conducted among 402 psychiatrists who treat patients with schizophrenia and bipolar disorder, showed that, even when patients were responding well to their prescribed antipsychotic treatment, many requested a medication change because these drugs are featured in law firm advertisements. Other patients stopped taking their medication, often without telling their psychiatrist, for the same reason.

"Many of our patients already struggle with accepting their illness and staying on their prescribed treatment, and now they are experiencing new levels of fear due to the increasing incidence of these jarring advertisements," said Dr. Ralph Aquila, assistant clinical professor of psychiatry, of Physicians and Surgeons; director, residential community services, St Luke's-Roosevelt Hospital Center, New York, NY. "This irresponsible advertising is hindering the progress of therapy for many of these patients and disrupting the important relationship between them and their healthcare providers. Plaintiffs attorneys need to consider the consequences that these advertisements may have on patients."

The findings from this survey, which was commissioned by the National Council for Community Behavioral Healthcare and Eli Lilly and Company, are consistent with a Harris Interactive(R) poll of 250 physicians commissioned by the U.S. Chamber of Commerce in 2003(i) that examined how pharmaceutical litigation impacts prescribing decisions across disease states. However, this new survey went one step further by asking psychiatrists to examine the potential impact of this type of litigation on patient care. These new findings have implications for doctors who treat serious and persistent mental illnesses, and confirm trends in clinical practice that many people in the mental health community have observed, but have not been quantified until now.

Ninety-seven percent of surveyed psychiatrists had one or more patients who stopped taking medication or reduced their dosage. Of these psychiatrists, 52 percent believed patients took this action due to law firm advertisements about antipsychotic drugs, and reported the following:

-- Ninety-three percent stated that one or more of their patients made medication changes without consulting them first, and the majority of these psychiatrists (94 percent) reported patient relapse as a result of discontinuing medication.

-- The most frequent consequences of relapse were symptom recurrence (93 percent), hospitalization (75 percent), loss of an important relationship (40 percent) and suicide attempts (26 percent). Even when patients were improving on their prescribed medication, they still approached their psychiatrists about stopping or changing. Ninety-seven percent of surveyed psychiatrists received one or more patient requests to stop or switch their medication. Of these psychiatrists, 59 percent felt patients made these requests based on concerns raised by law firm advertisements about antipsychotic drugs, and reported the following:

-- The majority of these psychiatrists (93 percent) felt these patients were responding to treatment.

-- Of the patients that were responding but requested a stop or switch, 71 percent of psychiatrists reported that one or more experienced a relapse, which also led to symptom recurrence, hospitalization, loss of an important relationship and suicide attempts.

-- Half of the surveyed psychiatrists reported that patient caregivers also requested a medication switch or stop due to concerns generated by law firm advertisements, even if their loved one was responding to treatment.

"Doctors and patients need to discuss the risks and benefits of any medication in order to determine what is appropriate for each patient," said Linda Rosenberg, MSW, president and CEO of the National Council. "That assessment becomes difficult in today's atmosphere because so much of the advertising is alarmist and frightening. It's especially crucial for patients to speak with their doctor before stopping their medication. Such discussions are an important part of the therapeutic relationship."

The findings from the survey are especially pertinent given the number of barriers that already exist in helping patients adhere to their treatment. Among the many challenges psychiatrists noted they faced when selecting an antipsychotic medication to treat schizophrenia and bipolar disorder, the five most challenging issues identified were:

    -- Side effects (75%),

    -- Lack of adherence due to unwillingness to accept illness (73%),

    -- Medication costs (58%),

    -- Lack of adherence due to lack of support (50%), and

    -- Co-occurring mental illnesses (49%).

More than half (55%) of surveyed psychiatrists indicated that they had changed their prescribing practices over the last five years due to product liability cases involving antipsychotic medications - and reported frustration and concern that this type of litigation sometimes interferes with patient treatment. Furthermore, many psychiatrists (62%) reported that they know of colleagues who have made similar changes in their prescribing practices.

Resources are available for clinicians who treat severe mental illness through the National Council and Lilly. Additional survey findings are also available on the National Council's Web site.

Survey Methodology

This research was conducted via a 20-minute online survey by WebSurveyResearch on behalf of Ipsos Insight Health. The survey was conducted among 402 psychiatrists sampled from WebSurveyResearch's physician's panel. All psychiatrists practice in the U.S. and treat patients with bipolar disorder and/or schizophrenia. Eighty percent of the psychiatrists have been practicing for more than 10 years. Interviews were conducted from March 5-12, 2007.

With a pure probability sample of 402 psychiatrists, one could say with a 95 percent probability that the overall results have a sampling error of +/- five percentage points. However, that does not take other sources of error into account. This online survey is not based on a probability sample and therefore no theoretical sampling error can be calculated.

This survey was conducted by independent market research company Ipsos- Insight and commissioned by the National Council for Community Behavioral Healthcare and Lilly. The survey was funded by Lilly.

About The National Council for Community Behavioral Healthcare The National Council for Community Behavioral Healthcare is a not-for-profit association of 1,300 behavioral healthcare organizations that provide treatment and rehabilitation for mental illnesses and addiction disorders to nearly six million adults, children, and families in communities across the country. Serving as the national voice of the provider community, the National Council advocates within all levels of government to ensure that all adults, children, and their families have access to quality behavioral healthcare.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. P-LLY

(i) Pendell, Judyth. "The Adverse Side Effects of Pharmaceutical Litigation." AEI-Brookings Joint Center for Regulatory Studies. September 2003.

Posted: June 2007


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