Annelle Primm, M.D., MPH
My name is Annelle Primm. I am the Deputy Medical Director for Minority Affairs of the American Psychiatric Association and an Associate Professor of Psychiatry at the Johns Hopkins School of Medicine. Thank you for the opportunity to speak before the Committee today on behalf of the American Psychiatric Association (APA), a medical specialty organization which represents 37,000 psychiatric physicians nationwide.
APA also promotes the highest standards of care for our patients and their families, and to that end we strive for standards of excellence in psychiatric research and in the education and training of our psychiatrist workforce. Critical goals and activities of the American Psychiatric Association include:
- Advocating for patients and for the profession, and fighting discrimination against people suffering from mental illnesses, including substance use disorders.
- Supporting education, training and career development of psychiatrists and other physicians.
- Enhancing the scientific basis of psychiatric care.
- Defining and supporting professional values and ethics.
The APA vigorously advocates for immediate and seamless access to care for psychiatric and substance use disorders for America’s military and their families. We continue to staunchly support increased federal funding of psychiatric and brain injury research. We remain concerned that despite concerted efforts of the VA and DoD, stigma still shadows those who seek psychiatric care and discourages those who need care from seeking it. The unprecedented length and number of deployments of U.S. military personnel, as well as the nature of our current military engagements, have placed an enormous strain on those serving in all facets of the military as well as their families. As physicians, researchers and family members, the APA has noted with increasing concern the increase in suicide attempts and completed suicides by veterans and those currently serving, and has advocated for direct action to address this major problem.
Beginning in 2002, the suicide rate among soldiers rose significantly, reaching record levels in 2007 and again in 2008 despite the Army's major prevention and intervention efforts. In response, the Army and NIMH partnered to develop and implement “STARRS” (Study To Assess Risk and Resilience in Service members) the largest study of suicide and mental health among military personnel ever undertaken. Many APA members are involved in the NIMH- Army study which will identify–as rapidly as possible–modifiable risk and protective factors related to mental health and suicide. It also will support the Army's ongoing efforts to prevent suicide and improve soldiers' overall wellbeing. The length and scope of the study will provide vast amounts of data and allow investigators to focus on periods in a military career that are known to be high-risk for psychological problems. The information gathered throughout the study will help researchers identify not only potentially relevant risk factors but potential protective factors as well. Study investigators will move quickly to provide information that the Army can use immediately in its suicide prevention efforts and use to address psychological health issues.
Today’s invitation from the Committee requested that the APA provide its position on the effectiveness and safety of psychiatric medications. I note that many of the most dramatic improvements in the effective treatment of mental illness have come as a result of newer and better medications especially a class of antidepressants called SSRIs which can be utilized to help manage PTSD symptoms. These medications have meant remarkably positive changes in the lives of tens of millions of Americans and would not have been possible without the resources of the pharmaceutical industry to research and development.
Simply put, it is the position of the American Psychiatric Association that a patient’s decision to take a psychiatric medication should be based on the best medical advice and scientific evidence available. Medications, when utilized, should be in conjunction with supportive therapies such as cognitive behavioral therapy. The prescribing and monitoring of brain medication should, however, be overseen by those with medical education, training and clinical experience.
First, the APA would like to emphasize the importance of open access to non-individually identifiable data from clinical trials, including data from negative trials, unpublished research and post-market studies. Physicians and patients clearly need access to this kind of information in order to make fully informed decisions about treatment options. For this reason, the APA has been in the forefront of the call for the development of a national registry of clinical trials. Such a registry should be comprised of non-individually identifiable data for those with an approved need, such as physicians, researchers and clinicians. This registry needs to be carefully designed in order to avoid a huge ‘data dump’ which can lead well-intentioned reviewers to erroneous conclusions. The data in such a registry needs to be meticulously coded in the same manner across many domains in order to be truly useful.
Next, let me address medication, in general, and the SSRI antidepressants, in particular which are a class of medications often used to help manage PTSD symptoms. Research has clearly demonstrated that medication can be helpful and even lifesaving, for many people with psychiatric disorders, but medication is most effective when used as a key component of a comprehensive treatment plan, individualized to the needs of the patient.
Let me take a minute to address the complex issue of whether or not the SSRI’s increase the risk of suicidal thinking or behavior. At this point, here’s what we actually know, from a scientific perspective: Contrary to frequent reports in the popular media, there is no evidence to suggest that these medications increase the risk of actual suicide. It does appear that these medications may increase the likelihood that some patients will actually tell someone about their suicidal thoughts or even about a suicide attempt. From my perspective, as a psychiatrist, this is actually a good thing, because it means you have the opportunity to intervene and to keep the person safe. The teenage suicide rate in the country had actually declined by over 25 percent since the early 1990’s, in a manner consistent with the increased use of SSRI antidepressants.
In October of 2004, following a review of clinical trial data, the U.S. Food and Drug Administration (FDA) issued a public warning about an increased risk of suicidal thoughts or behavior in children and adolescents treated with SSRI antidepressant medications. In 2006, an advisory committee to the FDA recommended that the agency extend the warning to include young adults up to age 25 given that brain development continues well into a person’s 20s.
In the 2004 FDA review the data showed that no completed suicides occurred among nearly 2,200 children treated with SSRI medications. However, about 4 percent of those taking SSRI medications experienced suicidal thinking or behavior, including actual suicide attempts—twice the rate of those taking placebo, or sugar pills. In response, the FDA adopted a "black box" label warning indicating that antidepressants may increase the risk of suicidal thinking and behavior in some children and adolescents with major depression. A black-box warning is the most serious type of warning in prescription drug labeling.
The warning notes that children and adolescents taking SSRI medications should be closely monitored for any worsening in depression, emergence of suicidal thinking or behavior, or unusual changes in behavior, such as sleeplessness, agitation, or withdrawal from normal social situations. Close monitoring is especially important during the first four weeks of treatment. SSRI medications usually have few side effects in children and adolescents, but for unknown reasons, they may trigger agitation and abnormal behavior in certain individuals.
Following the notable 2004 black box warning there was a decrease in initial prescribing of antidepressants. The APA was concerned then and remains so that the warning has the unintended consequence of a ‘chilling effect’ on people and their families considering treatment for depression.
According to data from the Center for Disease Control and Prevention, the suicide rate for 25-34 year-olds declined an average of 0.9 percent annually, or about 17 percent when comparing 1985 with 2004. The suicide rate for teens began declining sharply in the mid-90s. During the 10 years 1994-2003, suicides dropped an average of 3.8 percent annually, or 33 percent when comparing 1994 with 2003. Rates rose in 2004: the rate of suicide in young people under 20 increased 18 percent over 2003—the first increase in 12 years. The rate decreased somewhat from 2004 levels over the past three years but has remained above the 2003 level.
Recently, results of a comprehensive review of pediatric trials conducted between 1988 and 2006 suggested that the benefits of antidepressant medications outweigh their risks to children and adolescents with major depression and anxiety disorders. The study, partially funded by the National Institute on Mental Health, was published in the April 18, 2007, issue of the Journal of the American Medical Association. In the mean time, the increase in suicides following the FDA action should serve as a very strong caution against reaching conclusion and taking action too quickly.
APA welcomes more information about how to best use these medications in the treatment of our patients. In particular, we support long-term follow up studies on both safety and efficacy. Fortunately, several such studies are currently underway, with funding from the National Institutes of Mental Health.
Finally, let me emphasize the importance of advocacy for returning military with psychiatric and substance use disorders. Families, in particular, need to be advocates for their loved ones. They need to make sure their family members has a comprehensive evaluation by a trained and qualified mental health professional and that they have access to necessary and appropriate ongoing treatment services. They should also ask lots of questions about any proposed diagnosis or treatment plan. To this end, the APA has jointly developed a website, www.Healthyminds.org to provide patients, families and physicians with as much information as possible about the evaluation and treatment of depression, PTSD and substance use disorders. Over a dozen major medical, family and patient advocacy organizations have already endorsed this collaborative effort. In addition, the APA is a proud founding partner of “Give an Hour”. This volunteer organization provides professional mental health and substance use disorder services through a network of professionals who volunteer their services for an hour a week to active and returning military, National Guard, veterans and their families. “Give an Hour” has been utilized as a portal for care for those who fear the stigma of seeking services within the VA or DoD structure.
Scientific Data and Information Available to Physicians
Over the past decade, the relationship between medicine and industry, including pharmaceutical manufacturers and medical device companies, has been under increased public scrutiny. Patients need to be able to rely on the objective recommendations of their physicians. In turn, physicians must be able to rely on the objectivity of research as it pertains to the safe and effective use of medications and medical devices.
Recognizing the necessity of managing potential conflicts of interest, the APA has been proactive in examining our relationships with the pharmaceutical industry. We have taken considerable pains to implement safeguards to reduce the risk of a conflict of interest between the industry and the provision of Continuing Medical Education. In fact, the APA received a commendation and a six year accreditation for outstanding compliance with accreditations rules and regulations-2004-2010 from the Accreditation Council for Continuing Medical Education.
The APA also has a Scientific Program Committee (SPC) which is responsible for all decisions concerning the content and format of the APA Annual Meeting, including editorial responsibility for the peer review, selection and presentation of the scientific and clinical content of the Annual Meeting. The Committee reviews all submissions for scientific and clinical merit, including those symposia seeking industry support. Members of this committee must also submit disclosure forms and recuse themselves from discussions that might involve a perceived conflict.
In March, 2009, the APA’s Board of Trustees voted to phase out industry-supported education programs and industry-supported meals served at the APA scientific meetings. As far as we know, the APA is the first professional medical specialty to end industry-sponsored symposia. As a result of the Board action, at our 2009 scientific meeting, only 11 of over 500 programs offered were supported by the pharmaceutical industry. I do want the Committee to note that the overwhelming majority of our educational activities at our annual meetings are developed by APA members as well as the National Institutes of Mental Health, National Institute on Drug Abuse and the National Institute of Alcohol Abuse and Alcoholism.
The American Psychiatric Association has long understood the need for a comprehensive disclosure policy based on clarity and transparency, particularly in the areas of publishing, research and education. APA recognizes that the ultimate success of its education enterprise rests on the public’s (and its members’) trust and confidence that the educational content is based on accepted scientific information free of any perceived marketing bias. Similarly, the success of our research enterprise rests on the public’s trust and confidence that the research is conducted and presented in an unbiased manner.
We at the APA are hopeful that today’s hearing and testimony will help promote access to information, encourage expanded support for research, and enhance the ability of returning military and their families to advocate effectively for the treatment they need and deserve.
Thank you for the opportunity to testify. I would be pleased to answer your questions.