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Statement
on the Use of SSRIs Among Adolescents
DBSA Testifies Before The FDA On SSRIs
As
a Risk for Suicide Among Youth
CHICAGO, September
13 – 14, 2004 – The Federal Drug Administration’s (FDA)
Psychopharmacologic Drugs and Pediatric Advisory Committees met today to
determine if there is an antidepressant class risk for suicide for youth
taking selective serotonin reuptake inhibitors (SSRIs). These include:
Prozac, Paxil, Luvox, Effexor, Celexa, Lexapro, Serzone, Remeron,
Wellbutrin, and Zoloft.
As the result of
yesterday’s meeting, the FDA acknowledged for the first time that
antidepressants appear to lead some children and teenagers to become
suicidal. The acknowledgement
comes a year after the agency suppressed the conclusion of its own
drug-safety analyst who first found a link between the drugs and suicide
in teenagers and children. In
internal memos, agency officials wrote that the analysis was unreliable
and they hired researchers at
Columbia
University
to re-analyze the data. That
study recently reached conclusions nearly identical to the initial report.
It was an emotional
meeting as family members of suicide victims testified, angrily denouncing
agency officials for the delay in admitting the risk of suicide for
antidepressants in children. In
Britain
, health authorities decided in December, 2003 to ban the use of most
antidepressants in children and teenagers.
DBSA
testified at the hearing before the 31 independent experts charged by the
FDA to make a recommendation about the labeling and use of the medications.
DBSA
told the committee:
- All
research data on the impact of SSRIs should be made available to the
general public and independent researchers.
- Only through readily available
information on the risks and benefits of different medications can
families and patients make informed decisions about treatments.
-
The use of SSRIs as a
treatment option should also be viewed in the context of broader
systemic corrections that need to be made to the health care system.
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Most children and
adolescents receive general medical care in a given year.
Typically, however, that does not include mental health care.
Of particular concern is the availability of mental health care
within the primary care settings.
This problem is compounded by the insufficient number of child
and adolescent mental health specialists.
-
Increased training of
both primary and mental health clinicians to recognize the symptoms of
the early onset of mental disorders in youth is needed. By providing
up-to-date data on effective treatments, parents can make informed and
effective decisions about their children’s care.
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DBSA believes that
the results of all clinical trials should be made available to the
public.
Click here to read DBSA's complete
testimony.
Officials will continue
their discussion throughout the following weeks.
Still, just how the drugs may lead some people to become suicidal
remains the subject of fierce debate.
Regarding this issue,
DBSA’s primary concern is protecting the safety of all people with
depression and bipolar disorder. Parents,
young people, physicians and other health care providers must make
informed decisions. They also
must weigh the risks and lifetime impact of not treating depression with
SSRIs vs. the risks of suicide and suicidal ideation.
Editors of the nation’s
top medical journals have said they will not accept for publication trials
that have not been publicly registered, and legislation is expected to be
offered in both the House and the Senate requiring the disclosure of the
results of all major drug tests on humans.
We will keep you updated
on new developments.
To see the FDA's Statement on
antidepressants, click here.
The Depression and Bipolar Support Alliance
(DBSA) appreciates the effort by the Food and Drug Administration (FDA) to
assess the occurrence of suicidality in clinical trials for antidepressant
drugs in pediatric patients to determine whether federal regulatory action
is needed in the clinical use of these products.
DBSA is the leading patient-directed
national organization focusing on the most prevalent mental illnesses:
depression and bipolar disorder. More than three million people annually
request and receive information on depression and bipolar disorder from
our non-profit organization. As DBSA President, I can assure the members
of these committees that our organization, with more than 1,000 peer-run
support groups across the country, has received numerous inquiries from
those we serve about possible connections between youth suicides and the
use of prescribed medications, particularly Selective Serotonin Reuptake
Inhibitors or SSRIs.
We recommend to those our non-profit
organization serves that individuals must have a full understanding of the
kinds of medication they are taking and must become partners with their
physicians in their treatment. That is also true for parents with children
who are taking SSRIs.
DBSA is concerned that a premature or
ill-founded conclusion about SSRIs could lead adolescent patients or their
parents to discontinue them without consulting their physicians. If the
FDA ultimately determines that warnings should be issued in relation to
the use of certain medications, it must make clear to physicians and
parents precisely why the warning was issued so that risks and benefits
can be thoroughly weighed.
Antidepressants and Suicide
The FDA itself has recognized that to this
point, there is no clear association between suicides and the use of
antidepressants. Unfortunately, the British Medicines and Healthcare
Products Regulatory Agency, in what I believe was a premature and hasty
decision, late last year recommended against the use of SSRIs in patients
under the age of 18. Ultimately, this decision could actually prove to be
harmful for children and adolescents with depression.
Untreated or undertreated mood disorders
are the leading cause of suicide in the United States. More than ninety
percent of people who take their own lives have suffered from depression
or bipolar disorder. Suicide will continue to be a risk for people living
with depression until more effective treatments for this highly disabling
disorder are found. The key, then, is not to hastily abandon treatments
that can help alleviate the symptoms of depression, thus helping to
prevent suicide.
The findings of the British regulatory
authorities are in direct contrast to recent studies by the American
College of Neuropsychopharmacology (ACNP). Among the clinical trials of
more than 2,000 youth reviewed by their task force, there were no findings
of any statistically significant increases in suicide attempts, self-harm
or suicidal thinking related to SSRI use.
This task force, comprised of highly
respected medical doctors, psychiatrists and clinicians, further
concluded, based on autopsy reports, that suicide was more likely to occur
in patients who failed to take their prescribed SSRIs rather than when
they were taking their medication properly.
As patients we know the danger of our
illness, medication is one of the important tools we use to stay alive in
the face of this disabling disease.
In many cases, the use of SSRIs has served
to completely turn lives from despair to hope. Take the case of one DBSA
constituent, a 22-year-old woman, who wrote this about her SSRI
medication:
"I have lived with depression since I
was nine years old. In fact, I was placed in a child psychiatric hospital
when I was 14. I have been on and off different medications throughout the
years and still have good and bad days. I have tried most of the
antidepressants out there, and know that it is through this medication
that I can survive on a day to day basis. While I still have problems
focusing and concentrating on even simple tasks, I have the ability to get
up in the morning through my antidepressant."
I believe this advisory committee’s
review will be more detailed than that conducted in the United Kingdom.
The FDA’s re-examination of twenty studies of eight antidepressants
involves more than 4,100 children. This analysis, coupled with the
findings of the ACNP, hopefully will assuage any concerns in the medical
and patient communities about the use of SSRIs.
At-Risk Youth/Recommendations
In the meantime, there is much more that we
can do as a nation to combat depression and bipolar disorder as causal
factors in suicide. We must significantly increase available services to
meet the needs of at-risk youth and those with mood disorders. The
existing level of these services is woefully inadequate. We need to
encourage the growth of the number of child psychiatrists in the country
and fund a mental health infrastructure that spans primary care, schools,
mental health facilities, foster care, social services and the juvenile
justice system. We need to better fund research at the National Institutes
of Health to find causes and cures for depression and bipolar disorder. We
need to remove the barriers that stand in the way of research specifically
for Adolescents and Children.
I recognize these issues are not the
purview of this advisory committee, but this current review and any
ultimate decision by FDA on the use of SSRIs will have a significant
impact on an already inadequate mental health care system in this country.
Should treatment options for youth with
mood disorders be reduced, particularly if based on unreliable or
incomplete data, I fear the effect on the suicide rate among this
population.
I urge the advisory committee to reach a
sound conclusion with an appreciation of the significant impact that its
recommendations will have on treatments available to our youth who live
with depression.
Position of the Depression and
Bipolar Support Alliance on Mental Health Parity
Individuals who have been diagnosed with
mood disorders or other mental illness should be afforded the same level
of insurance coverage as individuals with physical illness. Research has
shown the physiological basis for many mental illnesses, and a high
success rate when mental illness is treated. In an effort to help end
discriminatory insurance practices, the Depression and Bipolar Support
Alliance (DBSA) supports the passage of a mental health parity provision
in this Congress. We support insurance coverage for both private,
employer-provided health care coverage as well as government provided care
such as Medicare, Medicaid and federal insurance.
Parity makes sense and it is affordable.
The Congressional Budget Office (CBO) estimated that providing mental
health parity as outlined in the Domenici-Wellstone Mental Health
Equitable Treatment Act, would increase health care costs less than 1%.
DBSA believes that providing mental
health coverage is cost effective for all employers. Implementing mental
health parity legislation will help individuals access treatment and yield
healthier, more productive employees. Employers, employees, the mental
health system and the federal government will all benefit from the long
term economic savings of early intervention. Passing the Mental Health
Equitable Treatment Act is a step toward ending discriminatory practices
that seek to separate the body from the mind.
Background
- In March of 2001, Senators Pete Domenici (R-NM) and
Paul Wellstone (D-MN) introduced the Mental Health Equitable Treatment
Act (S.543).
- The Mental Health Equitable Treatment Act would
ensure full parity in the coverage of mental health benefits by
prohibiting a group health plan from treating mental health benefits
differently from the coverage of medical and surgical benefits. The
legislation does:
- apply only if the plan already provides coverage for mental health
benefits.
- contain a small business exemption for
companies with 25 or fewer employees.
The legislation does not:
- The Senate Health, Education, Labor, Pensions (HELP)
Committee unanimously approved the legislation.
- Legislation was included in the FY2002 Labor-HHS-Education
spending bill
- A House-Senate conference committee eliminated the
legislation from the Labor-HHS-Education spending bill.
- The conference committee recommended holding hearings
during the second session of 107th Congress to learn more
about the potential effect of this legislation.
- In March 2002, Representative Patrick Kennedy (D-RI)
and Marge Roukema (R-NJ) introduced a House companion bill to the
"Mental Health Equitable Treatment Act" (H.R. 4066)
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Depression and Bipolar Support Alliance
Position on Prescribing Authority
The Depression and Bipolar Support Alliance (DBSA, previously the
National Depressive and Manic-Depressive Association), the nation’s
largest patient-directed, illnesses-specific advocacy organization,
believes it is in the patient's best interest to restrict psychotropic
medication prescription to medical doctors.
To safely prescribe psychotropic medication, extensive education of the
physiology of the entire body is necessary. Safe and effective use of
medications to treat brain disorders requires medical training to ensure a
thorough understanding of physiology, chemistry, drug interactions and
medical problems that mask symptoms of mental illness. Diagnosing and
medication treatment for mental illnesses such as clinical depression and
bipolar disorder (also known as manic-depression) requires the same level
of medical skill and knowledge as diagnosing and treating all serious,
life-threatening illnesses, such as heart disease and hypertension.
The psychotropic medications used to treat depression and bipolar
disorder can have significant effects on the entire body, not just the
brain. If not appropriately prescribed and monitored, these medications
can cause potentially disabling side effects. In addition, if not
efficacious, they can create a life-threatening situation. Only medical
doctors have the education required to manage these biologically complex
medical illnesses.
As patients, we demand the safest, most tolerable and most effective
treatments available. DBSA believes:
- The best approach to the treatment of mood disorders is a
combination of psychotherapy, medication and peer support, each of
which should be managed by the appropriate professional.
- Prescribing the powerful medications used to treat mental illnesses
demand a thorough understanding of physiology, chemistry, drug
interactions and medical problems that can mask symptoms of mental
illness. An understanding of the entire body and how systems interact
with each other can only be achieved through a rigorous medical
education involving undergraduate and graduate medical training, and
an extensive residency.
- Prescriptions for psychotropic medications should be written and
monitored only by someone trained in assessing all adverse physical
reactions, drug-induced physical side effects, and drug/drug
interactions.
We advocate that physicians and mental health professionals work
together to provide the best treatment possible for patients, and call for
psychotropic prescription authority to remain the purview of medically
trained physicians and only by other professionals when under the care of
a physician.
The experience, broad knowledge base, standards of care, and expertise
make medical doctors the only professional DBSA believes should be
sanctioned to prescribe psychotropic medications.
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Increase the
protection of mental health records
Confidentiality is the foundation on which effective
patient care must be built. Confidentiality is crucial in every part of
the health care delivery system -- from first diagnosis to successful
treatment. Confidentiality is the cornerstone in the doctor - patient
relationship. The inadvertent disclosure of a patient's identity by a
doctor can have terrible repercussions for the patient. Confidentiality is
of critical importance in the management of all medical records from
hospital records, both inpatient and outpatient, to physician records and
prescription records. DBSA is firmly opposed to the commercial use of all
medical records to any government action that would have the possibility
of endangering patient confidentiality at any stage in the treatment or
research process. Protection of confidential data concerning research
subjects must be assured. It should never be permissible to submit
confidential research information to employers or insurance companies
without permission of the patient.
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Increase funding for research
Researchers are making great strides in their knowledge about the brain
and the disorders that affect it, including mood disorders. The federal
government plays a crucial, leadership role in advancing research on the
brain and its disorders through a variety of agencies -- The National
Institute of Mental Health, The National Institute on Drug Abuse, The
National Institute on Alcohol Abuse and Alcoholism and the Center for
Mental Health Services. DBSA strongly supports federal research into the
causes, effects and treatment of disorders of the brain. We believe
medical research funding should be determined by the burden of illness, as
this would substantially limit stigma. Research holds the key to winning
the battle against depression and bipolar disorder. Advances in basic
research are making possible significant improvements in treatment.
Despite its clear leadership role in funding mental health research, the
federal government spends only a fraction on mental illness research as it
spends for research on other major diseases such as heart disease or
cancer. DBSA not only supports current research efforts but also supports
increased funding for all mental health research.
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Co-Morbid Illnesses
Co-Morbid Illnesses demand more attention from both policy
makers and from the medical community. Currently, too many people believe
that depression is an inevitable part of a chronic illness. To change
that, education must take place on many levels so people learn that
depression is a separate illness that frequently co-occurs with illnesses
like diabetes and coronary disease. Research has indicated that people
with diabetes are twice as likely as non-diabetics to suffer from
depression, that depression often precedes and helps trigger the onset of
diabetes, and that diabetes treatment are not as effective for people with
depression. Similarly, The Journal of the American Medical Association
(JAMA) reports that "major depression may play a role in an
increased risk of death and hospitals readmissions for patients with
congestive heart failure." Similar statistics can be found in
relation to people diagnosed with depression and AIDS or liver, pulmonary
and Parkinson’s diseases. More research is needed to show more causal
relationships. People need to know that medical treatments have a greater
success rate if the depression is treated.
Involuntary Treatment
Central to DBSA’s core values is the belief that patients must be equal
partners with their health care professionals, making decisions in a
mutually agreed upon way and that patients must be empowered to work as a
team, along with physicians, in order to reach optimal wellness.
There are times, however, when patients may
be unable to speak or act in their own best interests because of an
episode that could put the patient in serious jeopardy.
Advance Directive
Ideally, the patient, their family, and the health care team leader have
spoken in advance about what the patient would like done in the extreme
case that he/she is unable to make an appropriate decision to protect
his/her life. This document should be on file within the patient's medical
records and easily accessible to both the healthcare team and the family
members unless the patient had indicated he/she does not want the
involvement of family members.
If this advance directive has not been
created prior to an incident, DBSA mandates that the life of the patient
be preserved at all reasonable costs while protecting the dignity of the
individual. Specifically:
- The goal of any involuntary treatment
must be to restore maximum independent living as rapidly as
possible, using the appropriate level of care for the appropriate
illness.
- Patients and their families should be
given information about the nature of their illness; the efficacy of
proposed treatments; the benefits, risks and alternatives to
proposed treatments.
- Family and friends should be closely
involved in treatment decisions so that treatment is as closely
aligned to the wishes of the patient as possible unless the patient
has indicated that there is to be no family and friends involvement.
- All reasonable options for care
outside of full time hospitalization should be explored thoroughly
before involuntary hospitalization occurs.
- Extreme sensitivity to the use of
medication must be required. The overmedication of patients as a
means of "chemical restraint" must never occur.
Timeliness in Receiving Treatment
Involuntary commitment and court-ordered treatment decisions must be made
expeditiously and simultaneously in a single hearing so that individuals
can receive treatment in a timely manner.
Involvement of the Courts
The role of courts should be limited to review to ensure that procedures
used in making these determinations comply with individual rights and due
process requirements, and not to make medical decisions.
The legal standard for states to meet in
order to justify emergency commitments for initial 24 to 72 hours should
be "information and belief." For involuntary commitments beyond
the initial period, the standard should be "clear and convincing
evidence." Involuntary commitments and/or court-ordered treatment
must be periodically subject to administrative, judicial and
medical review to ascertain whether circumstances justify the continuation
of these orders.
Insurance Coverage
Private and public health insurance plans must cover the costs of
involuntary inpatient and outpatient commitment and/or court-ordered
treatment.
Consumer Partnership: Platform for
Change
The following document is a consensus statement
developed at a forum of consumer advocates who met in November 2003 to
consider the President's New Freedom Mental Health Commission report from
a consumer perspective (a complete list of attendees is included at the
end of the document). DBSA was represented at this meeting and stands in
support of these recommendations.
The following recommendations represent
concerns and definitive action steps to increase consumer involvement and
expand peer support services; reduce discrimination and stigma; increase
opportunities for a consumer and family-driven system; protect and enhance
patient's rights; and ensure that disparities in mental health care are
eliminated. These issues mirror similar recommendations set forth in the
President's New Freedom Mental Health Commission report but are
articulated solely from a consumer perspective. These recommendations are
the result of dialogue at a historic meeting held on November 14-16, 2003
where consumer leaders were convened in Baltimore, Maryland to identify
major areas of consensus and action. DBSA was represented at this meeting
and stands in support of these recommendations.
To read the complete document, click
here.
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