An FDA advisory committee has given a second--and very different--opinionon the need for new warnings onattention deficit hyperactivity disorder(ADHD) drugs. The Pediatric AdvisoryCommittee recommended that the FDArequire additional label language onthese drugs to warn about potentialcardiovascular risks to children withpreexisting heart problems and the rarerisk of psychotic events. At the sametime, the committee rejected therecommendation, made 1 month previouslyby the FDA's Drug Safety and Risk Management advisory committee,to require a black box warning onADHD drugs concerning cardiovascularrisks.

The Pediatric Advisory Committeelooked at evidence that those drugscaused excessive psychotic and cardiovascularadverse events in children andadolescents. A March 3 memo by 2psychiatric drug reviewers in theagency's Office of Drug Safety statedthat since January 1, 2000, the agencyand drug companies had receivedhundreds of reports of psychosis ormanic behavior, particularly hallucinations,in patients with no known riskfactors who took the usual dose of anADHD medication. Current approvedlabeling for ADHD drugs does notclearly address the risk of drug-inducedpsychosis or symptoms of mania in suchpatients, medical epidemiologist KateGelperin, MD, MPH, and safety evaluatorKate Phelan wrote. We recommendthat these issues be addressed, they added.

Any new labeling requirementadvanced by the FDA will take intoaccount the softer recommendation ofthe Pediatric Committee, which wasbased on testimony provided by bothpsychiatrists and pharmaceuticalcompanies.

Darrel A. Regier, MD, MPH,research director for the AmericanPsychiatric Association, emphasizedthe risk of limiting access to thesevalid and effective treatments . . . whenthe FDA is asked to use non-researchstandards for warnings.

McNeil Consumer & SpecialtyPharmaceuticals submitted data onmethylphenidate (Concerta) that showedan estimated rate of sudden cardiacdeath of 0.19 per 100,000 patient-yearsin those using the drug. The rate ofsudden cardiac death in children andyoung adults in the general populationis approximately 1.3 to 8.5 per 100,000persons. Regarding psychiatric events,a postmarketing safety review for methylphenidatefound the rate of suicidalideation to be 0.65 cases per 100,000patient-years. The company stated thateven with a correction for under-reporting,the observed rate of suicidal ideationis lower than the rate of suicidal ideationin the general population.

We appreciate the careful andinformative dialogue demonstrated bythe committee and agree with thecommittee's suggestion to the FDAthat heightened awareness aroundadverse events is important but thatthe data do not support the need fora black boxtype of warning, saidMatt Cabrey, spokesman for ShirePharmaceuticals.

Articles

A second opinion on the need for new warnings on attention deficit hyperactivity disorder (ADHD) drugs from the FDA advisory committee contradicts The Pediatric Advisory Committee recommendation.

ADHD Drugs: Label Cautions, but No Black Box

According to recent estimates,chronic medical conditionsaccount for 7 of every 10 deathsin the United States and have been foundto severely limit daily functioning in morethan 1 of 10 Americans, or 25 millionpeople.

 This tremendous disease burdenaccounts for most of the dollars spenton health care annually in the UnitedStates.

 Patients with chronic medicaldiseases represent a population at particularlyhigh risk for mental disorders.

There is abundant evidence that patientswith chronic illnesses, including cardiovasculardisease, cancer, and diabetesmellitus, experience high rates of psychiatricdisorders, which range from 20%to 67%, depending on the medical illness.In addition, depression and other mentaldisorders significantly impact quality oflife and the ability of patients to adhereto treatment regimens.

However, access to and reimbursementof psychiatric and other mentalhealth services are severely limited forthese doubly burdened, comorbidly illpatients, despite abundant evidence thatpsychiatric and psychosocial interventionshave positive economic and clinicaloutcomes. Furthermore, severalfederal commissions and boards,including the President's New FreedomCommission on Mental Health, theInstitute of Medicine (IOM), and thePresident's Cancer Panel, and a nationalorganization, the National ComprehensiveCancer Network

 (NCCN)have recently called attention to theevidence and the need to deliver mentalhealth care to this population.

Why, then, is access to this care solimited? The reasons for the lack ofrecognition, diagnosis, and applicationof appropriate treatments are many: thestigma of mental illness; the busy clinicsthat reduce the physicians' time toinquire about psychiatric or psychologicalsymptoms; the reluctance ofpatients to bother the physician anddistract him or her from the primaryclinical problem; and the fact that mentalhealth services are the first to be eliminatedin budget crises and, hence, areoften unavailable.

However, leading the list of obstacles--and resulting in a cascade of barriersthat prevent the deliverance of theseservices--is the absence of an appropriateand well-articulated insurancebenefit for patients with co-occurringmental and physical illnesses. The absence of an insurance benefit and thepresence of carved-out mental healthcare have led to payment as an exceptiononly and very low reimbursementfor psychological, psychiatric, andsocial services by both private andpublic payers. When there is some reimbursementfor mental health services,it is usually administered through amental health carve-out that separatesreimbursement for these services fromthe medical care reimbursement--resulting in patients being unable toreceive care in the medical setting andnot having access to experienced professionalscapable of treating complexmedical and psychiatric conditions.

Medical benefit plans vary, but mostprivate insurance plans cover only limitedpsychiatric consultations and treatment.Mental health (behavioral) benefits arefar more limited than benefits for othermedical conditions. The Mental HealthParity Act, designed to provide mentalhealth benefits equal to those for othermedical conditions, did not affect manyself-insured and small employers.

Some employee assistance programbenefits fill gaps for psychosocial andfamily support. State Medicaidprograms cover acute care consultations,ambulatory visits, and some psychosocialneeds of patients who have seriousmedical conditions as well as mentalillnesses. The federal Medicare programcovers psychiatric consultations andpsychosocial visits with clearly delineateddiagnostic and billing codes.However, Medicare pays 80% for physicalhealth care services but only 50%for mental health services. Gaps existin free care programs unless deliveredin emergency or hospital settings.

To compound the problem, theadministration of claims under bothprivate and public insurance programsfrequently imposes a substantial documentationburden on physicians whoseek payment for psychosocial services.Many nonpsychiatric physicians (eg,oncologists) who have attempted toprovide a mental-health professional in their practice group have found that thetime and paperwork required to requestreimbursement for psychosocial servicesfar exceed the moneys paid, andhence, they cannot afford to providethese services.

While, strictly speaking, mentalhealth services may be covered in aninsurance benefit program, use of behavioralhealth benefits is controlled bymanaged care organizations. To limit use of benefits, these organizations typicallyapply a number of utilizationmanagement tools, including strictmedical necessity criteria, outpatientvisitcapitation, prior authorization forpsychiatric consultations (where noprior authorization may be required forother medical consultations), copaymentby patient (often greater than formedical illness), and prescription priorauthorization or preferred drug listrestrictions. Public insurance programsmay add other restrictions: behavioralbenefits limited to priority populations,medical and social necessity criteria,outpatient-visit limits for patients withoutchronic mental illness, and physician-consultation limits. These tools, inshort, make it difficult to obtain benefitswithout a sustained effort to challengethe application of the rules, at thevery time when an ill person is mostvulnerable and least able to do so.

Several key public health initiativeshave provided some focus to this issue.The NCCN, a group of National CancerInstitute-designated cancer centers, inits 2003 standards of care,

 addressedthe need to assess and treat distress forall patients throughout and beyond theircancer illness and, furthermore, to useevidence-based interventions wheninterventions are indicated. In 2reports,

 the IOM has affirmed thatpractice guidelines are available thatshould dictate the standard of care forboth physical and psychosocial symptoms.Care systems, payers, standardsettings, and accreditation bodiesshould strongly encourage the guidelines'expedited development, validation,and use.

The President's New FreedomCommission on Mental Health4 clearlystates that mental health must beaddressed as aggressively as physicalhealth and that meeting the mentalhealth needs of individuals with primarymedical conditions is an unfulfilled criticalissue. Furthermore, on June 4, 2004, the President's Cancer Panel, stated,The federal government should implementcomprehensive health care reform,whose provisions should include coveragefor psychosocial services bothduring and after treatment and reimbursementfor a range of follow-upcare, including that provided bynonphysicians.

 Most recently, the USCongress appropriated funds for a reportto be developed that reviews the deliveryof psychosocial services to cancerpatients, with a special focus on barriersto access.

In order to effect change in our currenthealth care system, it is critical to educateand enlist the support of policy makers,insurers, health professionals (bothmental health and non-mental health),advocates from other chronic illnessorganizations (eg, those working withcancer or diabetes), and suitable corporationsto ensure that mental health careis easily accessed by people with mentaland physical comorbidities.

In addition to the hurdles mountedby current private insurers, Medicaid,and Medicare, there are several otherchallenges that must be met for an advocacyeffort to succeed:


Convincing advocates for groupswith chronic physical illnesses thataccess to mental health care is anissue on which they should focus theirtime and resources.

Overcoming the perceived stigmaassociated with mental health conditions-forboth patients and policymakers-that is perpetuated throughthe media.

Convincing public payers and privateinsurers of the importance of providingmental health and psychosocialcare as a stated benefit for patientswith co-occurring illness.

Providing access to treatment andservices when mental health carebenefits vary by insurer and, in publicplans, by state.

Finding available federal and stategovernment resources during thecurrent fiscal crunch.

The Academy of PsychosomaticMedicine (APM) and the AmericanPsychiatric Association (APA) Councilon Psychosomatic Medicine have begunto develop a plan aimed at addressingthese basic issues (

). The planincludes development of an advocacystrategy that incorporates patient andfamily groups, testing of perceptionsregarding psychosomatic medicine andreimbursement among policy makersand other decision makers, and developmentof a legislative and regulatoryplan to help improve reimbursement.

In addition, others have begun towork successfully on the local level torestructure benefit plans so that mental health and physical health care reimbursementsare integrated. The APMand APA's attempt to prioritize andhighlight a research agenda and createappropriate guidelines and opportunitiesfor training will promote advancesin psychosomatic medicine, addressthe issue of training, and ensure thatthere are adequate numbers of appropriatelytrained professionals to providethis care.

Access to psychosocial care andadequate reimbursement are essentialcomponents of quality care. We mustrecognize that delivery of evidencebasedquality care can only be achievedwhen access and reimbursement aresecured, and we must demand that care.The IOM has proposed that 21st centuryhealth care treatment must be safe andeffective (evidence-based), patientcentered(responsive to needs), timely,efficient, and equitable.10 It also mustaddress patients' physical and mentalhealth needs in order to be truly qualitycare.

Dr Alter is associate professor and director ofpolicy and community outreach in the departmentof psychiatry at Georgetown UniversityMedical Center in Washington, DC. Dr Alterhas disclosed that she has no conflict of interestwith the subject matter of this article.

 The burden of chronic diseases and their riskfactors: national and state perspectives. Atlanta:Centers for Disease Control and Prevention; 2004.


 McKenna MT, Michaud CM, Murray CJ, Marks JS.Assessing the burden of disease in the United Statesusing disability-adjusted life years. Am J Prev Med.2005;28:415-423.


 Evans DL, Charney DS. Mood disorders andmedical illness: a major public health problem. BiolPsychiatry. 2003;54:177-180.


 President’s New Freedom Commission on MentalHealth. Achieving the Promise: Transforming MentalHealth Care in America. Final Report. Rockville, Md:US Dept of Health and Human Services; 2003.Publication SMA-03-3832.


 President’s Cancer Panel. President’s Advisory PanelReport Aimed at Improving Outcomes for CancerSurvivors. Bethesda, Md: NIH/NCI; June 4, 2004.


 Foley KM, Gelband H, eds. Improving PalliativeCare for Cancer [Report of the National Cancer PolicyBoard/Institute of Medicine and National ResearchCouncil]. Washington, DC: The National AcademiesPress; 2001.


 Improving the Quality of Health Care for Mentaland Substance-Use Conditions. Washington, DC:Institute of Medicine; 2005.


 Hewitt M, Herdman R, Holland JC, eds. MeetingPsychosocial Needs of Women With Breast Cancer[Report of the National Cancer Policy Board/Instituteof Medicine and National Research Council].Washington, DC: The National Academies Press; 2004.


 Holland JC, Andersen B, Booth-Jones M, et al.NCCN Distress Management Clinical PracticeGuidelines in Oncology. J NCCN. 2003;1:344-374.


 Committee on Quality of Health Care in America,Institute of Medicine. Crossing the Quality Chasm: ANew Health System for the 21st Century. Washington,DC: The National Academies Press; 2001.

According to recent estimates,chronic medical conditionsaccount for 7 of every 10 deathsin the United States and have been foundto severely limit daily functioning in morethan 1 of 10 Americans, or 25 millionpeople This tremendous disease burdenaccounts for most of the dollars spenton health care annually in the UnitedStates.

Psychiatric Times Vol 23 No 5

ADHD Drugs: Label Cautions, but No Black Box

Meeting the Mental Health Needs of Patients With Chronic Medical Illness: A Crisis in Access