Federal Investigator
FDA Issues Public Health Advisory for Strattera
On September 29 th the FDA issued a public health advisory to alert physicians of reports of suicidal ideation among children and adolescents taking Strattera.
The FDA directed Eli Lilly and Company, manufacturer of Strattera, to put out a Medication Guide for patients and caregivers. The FDA also suggested that health care providers and caregivers monitor children and adolescents taking Strattera for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed
The public health advisory was announced due to a review and analysis of 11 clinical trials of which there was one patient out of 2,200 who attempted to commit suicide. The FDA then requested a review of Eli Lilly and Company’s database and clinical trials and found that %0.4 children treated with Strattera reported suicidal ideation, whereas none were reported by children taking a placebo.
Health care professionals are encouraged to report any unexpected adverse events associated with Strattera directly to Eli Lilly, Indianapolis, Ind. at 1-800-LillyRx
or to the FDA MedWatch program at 1-800-FDA-1088;
FAX at 1-800-FDA-0178;
Mail to: MedWatch, Food and Drug Administration,
HFD-410, 5600
Fishers Lane, Rockville, MD, 20857-9787;
or online at www.fda.gov/medwatch/report.htm.
Read more about the Public Health Advisory:
http://www.fda.gov/cder/drug/infopage/atomoxetine/default.htm
To learn more about Strattera visit:
http://www.fda.gov/cder/drug/InfoSheets/patient/AtomoxetinePIS.pdf
Company Says Technology Predicts Suicidal Ideation During SSRI use
May be New Tool for Developing Depression Treatments
Aspect Medical Systems reported at a National Institute of Mental Health conference that its brain monitoring technology is able to predict changes in suicidal ideation during selective serotonin reuptake inhibitor (SSRI) treatment.
Aspect said that its technology predicted new or increased suicidal ideation in patients with 76 percent accuracy.
Brain monitoring technology analyzes the electrical activity in the brain. Researchers found that certain brain wave patterns could predict levels of suicidal ideation. Aspect began its research so that it could investigate the use of the monitoring technology to predict the treatment response to SSRI antidepressants.
“The study being presented suggests that it may be possible to identify patients who are at increased risk for adverse events during antidepressant treatment, and in particular which patients may experience worsening suicidal ideation, said Dr. Maurizio Fava, the lead investigator and associate chief of psychiatry for clinical research and the director of the Depression Clinical and Research Program at Massachusetts General Hospital. “If we can identify patients at increased risk early on, we may be able to improve the quality and safety of antidepressant therapy by closely monitoring those patients at risk,” Fava said.
The usefulness for brain monitoring technology goes beyond suicide prevention, company officials aid. Technology that analyzes electrical activity in the brain is important in discovering new information about how the brain works in depressed individuals. The technology could prove to be an important tool in developing new treatments as well as refining current antidepressant treatment.
According to Philip Devlin, the general manager of Aspect’s Neuroscience Division, "As a result of this research, we are gaining a better understanding of the link between brain function and depression, which may enable the development of new, better targeted drugs and devices to treat the estimated 19 million Americans who suffer from depression.”
To learn more visit:
Aspect Medical Systems Press Release
FDA Issues Second Adult Warning
Antidepressants May Cause Suicidality
The Food and Drug Administration recently issued a public health advisory warning that adults who use antidepressant medications should be closely monitored for warning signs of suicide. This is the second time that the FDA has issued such a warning for adults.
In its most recent warning to adults, the FDA said that adults being treated with antidepressant medications, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal behavior and thinking.
It notes that “close watching may be especially important early in treatment, or when the dose is changed, either increased or decreased.” The agency also said that adults whose symptoms worsen while being treated with antidepressants should be evaluated by their health care professional.
Some advocates fear that the warnings, though necessary, may discourage people from seeking treatment.
“ NMHA’s concern, though, is that some people with mental health needs, their family members and healthcare providers may forego treatment out of fear,” said Cynthia Folcarelli, executive vice president of the National Mental Health Association. “NMHA strongly advises against misinterpretations that could deter some people from seeking mental health treatments, including medications that have helped many individuals and even saved lives. Research demonstrates that most people with depression benefit from antidepressant medications in combination with other treatments.”
Most of the concern about the increased risk of suicidal thoughts and behavior with antidepressant use has focused on children and adolescents. Last year, the FDA directed the manufacturers of all antidepressant medications to add a black box warning that describes the increased risk of suicidal thinking and behavior in children and adolescents, and emphasizes the need for close monitoring of patients who start the medications. A black box warning is the most serious warning placed in the labeling of a prescription medication.
The adult antidepressant warning will be serving a purpose, but may not mean that practices will change from patient to patient.
“ NMHA commends the Food and Drug Administration for emphasizing that good clinical practice, such as closer monitoring, should be the norm in providing care to both adults and children who take antidepressant medications,” said Cynthia Folcarelli, executive vice president for the National Mental Health Association. “The sad reality is that in many health care settings, even this fundamental knowledge about appropriate care does not translate into clinical practice,” she said.
The FDA said people should be on the lookout for the following symptoms in adults taking antidepressants: anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (psychomotor restlessness) or severe restlessness.
Although the FDA has not concluded that these symptoms are a precursor to either worsening of depression or the emergence of suicidal impulses, there is some concern that patients who experience one or more of these symptoms may be at increased risk for worsening depression or suicidality. FDA suggests that medication may need to be discontinued, when symptoms are severe, abrupt in onset, or were not part of patients’ presenting symptoms.
The FDA acknowledged that there have been several new studies that have been published in medical journals that suggest an increased risk for adults, but maintains that it began a complete review of all available data last year when it issued its first warning for adults. The review, involving hundreds of individual trials and many thousands of adult patients, will require a year or more to complete.
Bipolar Consumers Face Additional Risks
People with bipolar disorder -- a chronic mental illness characterized by extreme highs (mania) and extreme lows (depression) -- have additional risks. Because antidepressants are believed to have the potential for inducing manic episodes in people with bipolar disorder, the FDA said there is a concern about using antidepressants alone in this population.
In its 2004 warning about antidepressants and suicidal tendencies, the agency said that patients should be adequately screened to determine if they are a risk for bipolar disorder before initiating antidepressant treatment, so that they can be appropriately monitored during treatment.
The treatment should entail a detailed psychiatric history, including family history of suicide, bipolar disorder and depression.
During manic episodes, people with the disorder may have excessive energy, activity, restlessness, racing thoughts and rapid talking. They may also have unrealistic beliefs about their own abilities and powers, and uncharacteristically poor judgment.
To see the adult advisory, go to:
http://www.fda.gov/cder/drug/advisory/SSRI200507.htm
The web site, “Antidepressant Use in Children, Adolescents and Adults,” provides links to various FDA documents.
www.fda.gov/cder/drug/antidepressants/default.htm
Cymbalta Linked to Suicidality
The Food and Drug Administration recently announced that there has been a higher-than-expected rate of suicide attempts or reports of suicidal thoughts in studies of the nation’s newest antidepressant drug, Cymbalta. The FDA reported the findings in studies of women trying Cymbalta as an incontinence treatment; the drug was never approved for that use.
The FDA said that suicidality occurred in a small number of patients, and insisted when it approved Cymbalta last year that studies of depressed patients showed no suicide link. Eli Lilly’s Cymbalta, also known as duloxetine hydrochloride, is in a class of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). It is prescribed for children, but the FDA has not approved it for use in children.
The agency said it will be evaluating additional data to determine whether there is a suicide risk in women treating stress urinary incontinence.
For more information, see FDA’s web site:
www.fda.gov/cder/drug/infopage/duloxetine/default.htm
www.fda.gov/cder/drug/InfoSheets/patient/duloxetinePIS.pdf
Advocates Address Congress About Public Health Crisis:
Current Practices Putting Mentally Ill Youth at Risk
Suicide is just one of the tragedies that will continue to occur if programs for the early identification, evaluation, and treatment of mental disorders in youth are not expanded.
Failure in school, falling into the criminal justice system, becoming unemployable and living in poverty, are among the other problems that will continue unless mental health initiatives are improved, said members of The Campaign for Mental Health Reform and other advocates as they addressed members of Congress at a recent Capitol Hill briefing.
The Campaign for Mental Health Reform is a coalition of 16 organizations, including the National Mental Health Association, whose mission is to improve access to, and the quality of mental health care.
The Campaign maintains that President Bush’s New Freedom Commission on Mental Health -- which called for a comprehensive study of the United States mental health service delivery system and ways to improve it -- offers great hope to the millions of children and adolescents with mental disorders and their families. But the majority of children with mental disorders fail to be identified, lack access to treatments or supports, and needlessly suffer throughout their lives.
“Children’s mental health is a complex topic,” said Cynthia Wainscott, spokeswoman for the Campaign for Mental Health Reform and chair of the National Mental Health Association’s board of directors. “Unfortunately, it’s also vulnerable to misinformation, misrepresentation and political rhetoric. The fact is that early identification, comprehensive evaluation, and if necessary, treatment of mental health problems can save lives.”
A statement by the Campaign said that no other illness harms children as seriously as mental illnesses do. Twenty-one percent of children in the United States, aged 9 to 17, have a diagnosable mental or addictive disorder that causes at least minimal impairment, but only 20 percent of children with mental disorders are identified and receive mental health services, a Campaign fact sheet said.
The statistics are startling: More than 90 percent of children and adolescents who commit suicide have a mental disorder, and suicide is the third leading cause of death in youth aged 15 to 24.
“The absence of a concerted effort to spot youth at risk for serious mental disorders is appalling and may contribute significantly to the 4,300 youth suicides that occur annually,” said Ken Duckworth in a statement before Congress. Duckworth, who is medical director of the National Alliance for the Mentally Ill, also worked as a child psychiatrist and school consultant for 15 years. “Thus as a child psychiatrist, I applaud the President’s New Freedom Commission for highlighting the need for early identification and intervention.”
Duckworth added that the medical response is often in the ninth hour. “But why do we wait until the teen is in the emergency room being treated for an overdose to intervene and why don’t we accept the fact that emotional distress is nothing to be ashamed of and that help in many forms can make a difference?”
A Campaign fact sheet also revealed that approximately 50 percent of students with a mental disorder aged 14 and older drop out of high school, the highest dropout rate of any disability group.
Youth with unidentified and untreated mental disorders also tragically end up in jails and prisons. A National Institute of Mental Health study -- the largest ever undertaken – found an alarming 65 percent of boys and 75 percent of girls in juvenile detention have at least one mental disorders.
“The data make it very clear that we have a public health crisis in mental health,” said Larke Nahme Huang, a clinical psychologist and managing research scientist at the American Institutes for Research and Commissioner of the 2002-2003 President’s New Freedom Commission on Mental Health.
Huang continued in a statement before Congress: “For any other conditions, such as juvenile diabetes, sickle cell anemia, lead poisoning, asthma and now obesity, data indicating a condition of such magnitude would warrant a national campaign and a mobilization of resources. Sadly, this is not the case for mental health disorders. Stigma and discrimination, fear and ignorance perpetuate the exclusion of these children and their families and deny them the chance to maximize their potential and lead productive lives in their communities.”
Huang also shared some findings from a report by the President’s Commission. It found striking disparities in mental health care, racially/ethnically and geographically. Some findings: Native American youth have a significantly higher rate of suicide than other youth. (See Institute of Medicine, Reducing Suicide: A National Imperative) http://www.iom.edu/file.asp?id=4158)
African-American and Latino youth are identified and referred at the same rates as the general population, but less likely to receive specialty mental health or medications. (See Report of the Surgeon General’s Conference on Children’s Mental Health: A National Action Agenda.) http://www.surgeongeneral.gov/topics/cmh/childreport.htm
One in five Latino girls aged 14 to 18 attempt suicide. (See National Governor’s Associaton’s Issue Brief: Suicide Prevention: Strengthening State Policies and School Based Strategies.)
http://notes.edc.org/hhd/csn/csnnews.nsf/0/3c1b355cecd2177f85256fee004218e6?OpenDocument
For more suicide statistics, see http://www.cdc.gov/ncipc/wisqars/default.htm.
FDA Stops Company’s Production of Drug Used to Treat Bipolar Patients
The Food and Drug Administration recently alerted consumers that Able Laboratories Inc. has ceased its production of all of its manufactured drugs, which includes the psychiatric drug lithium.
In a press release, FDA said that the move was born of its concern that the drugs may not have been produced according to its quality assurance standards. FDA officials said in the statement that the matter is still being investigated and that the public will be notified of its findings.
Able produced lithium carbonate, 300 milligram slow release tablets, the generic form of Lithobid. It is prescribed in the treatment of bipolar disorder, a psychiatric illness characterized by depression (lows) and mania (extreme highs).
Brand name Lithobid is in full supply and available in pharmacies. JDS Pharmaceuticals, LLC. has a considerable inventory of Lithobid and is increasing its production to meet the demands of patients.
Consumers who have been taking drugs produced by Able Laboratories Inc. should talk to their health care provider or pharmacist in order to obtain replacement medication. Consumers should not, however, immediately stop their medication since the risks of suddenly stopping medication before finding an alternative often outweighs the risks of continuing the medication.
To find out more about Lithobid, visit:
To read the FDA recall, visit:
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01182.html
Federal Budget Could Have Negative Impact on Suicide Prevention
The current guiding principle GOP Congressional leaders consider in developing the US budget is the Bush Administration’s pledge to cut the federal deficit in half by 2009. Constitutionally, the President must submit a budget for Congress to consider by February each year, and Bush’s proposed budget submission for Fiscal Year 2006 held to this principle. Excluding Defense and Homeland Security, Bush’s proposal could have had an adverse impact on suicide prevention as it called for huge and potentially devastating cuts to vital health, education, social service and other support programs for at risk individuals and families. Last month Congress adopted a Budget Resolution that mitigated the size of the cuts, by setting spending parameters to be considered by Congressional Committees for agencies and programs under their jurisdiction.
The most glaring items in the resolution was the commitment to cut Medicaid by $10 billion over the next five years, add $106 billion in tax cuts, and set aside only $843 billion for discretionary spending. This budget resolution should raise many concerns and while it did not deliver across the board cuts, no program is safe. The Budget Resolution narrowly passed 214 to 211 in the House and 52 to 47 in the Senate which suggests more contentious partisan and inter-party battles to come in order to achieve Bush’s deficit goal in later years.
Because this resolution leaves major decisions on where to allocate funds and how to achieve cuts, to congressional committees, it is crucial for crisis centers and concerned staff to contact their Congressional delegations, and make the link between crucial mental health, addictions treatment, education and social support programs and suicide. The next step or "round" of this budget bout is for the appropriations committees to begin developing their funding bills. The appropriators recently outlined a plan on how to divide the $843 billion set aside for total discretionary spending under the FY 2006 budget resolution.
Affected Programs
Medicaid
The budget resolution assumes $10 billion in Medicaid cuts over the next five years, beginning in October 2007. While this is a much lesser cut than the $60 billion the President wanted, or that the House budget resolution would have required, Medicaid is a primary payer of mental health and addictions treatment services. It should be noted that Medicaid was cut $13 billion by Congress in 1997, and for the past three years, many states have imposed additional cuts, limitations or restrictions on Medicaid services and beneficiaries to deal with their budget crises. Because untreated behavioral health disorders, or barriers to treatment, are one of the major contributing factors of suicide, the Hopeline Network is concerned over how the Senate Finance Committee and the House Energy and Commerce Committee will achieve these spending cuts, as well as additional cuts states could make threatened with loss of federal matching funds. The Hopeline Network opposes legislation that would eliminate coverage for beneficiaries, the position Administration officials have taken in calling for such cuts.
In addition, the budget agreement also provides for the establishment of a Medicaid commission, which is to recommend changes to the program by September 1st. Many questions remain to be answered about the composition and independence of this panel. The National Hopeline Network will work to see that suicide prevention be a factor in this process through recommendations, influencing potential appointees as well as testimony.
Domestic Discretionary Programs
The budget resolution sets aside $843 billion for overall discretionary funding for FY 2006 - roughly the same level proposed by the Administration. This would be a $23 billion cut over 2005, representing almost a 6% cut below current funding, adjusted for inflation. Since it is only a blueprint, the budget resolution provides no details about which specific programs might absorb these cuts. But given the likelihood that defense and homeland security accounts will be protected, appropriators will face tough decisions about winners and losers among federal programs and projects in achieving this $23 billion cut. Advocates clearly have a critical role to play in helping shape these decisions, among which are to urge restoration of funds that the Administration proposed cutting from key programs.
Taxes
The budget resolution calls for more than $100 billion in tax cuts over the next five years, including $70 billion in tax cuts that can be enacted through fast-track reconciliation legislation. Fast track legislation employs tactics like limited debate, prohibiting filibusters, restrictions on amendments, and requiring only a simple majority to be enacted. It is widely assumed that the tax reconciliation bill will include a two-year extension of the capital gains/dividend tax cut. The Urban Institute-Brookings Institution Tax Policy Center estimates that more than half of the benefits of this tax cut go to households with income in excess of $1 million per year and nearly 80% of the benefits to the 3% of households with annual income in excess of $200,000 per year. There is an inescapable link between tax cuts and federal and state revenues, which in turn could mean further cuts in entitlement and discretionary programs.
Action Requested
Congressional recesses offer opportunities to weigh in on these issues with your Members of Congress; these include Memorial Day Recess (5/30-6/3); Fourth of July Recess (7/4-8); and the August Recess (8/1-9/5). The National Hopeline Network will provide its members with specifics on the budget process and specific recommendations as the budget process continues. Now would be a good time to contact your Representative and Senators through the Capitol Switchboard at (202) 224-3121, or in their local district offices and make a connection. Let them know who you are, what services you provide to their constituents, and how continued cuts to vital programs like Medicaid, Section 8 Housing vouchers, programs for students with disabilities (IDEA) can adversely impact suicide prevention.
Stay tuned for legislative alerts that will arm you with advocacy tools for the next stages of the battle. Your contribution is invaluable. If you have any questions or need further information, please contact Pope Simmons through KBHC at 703-837-3370. pope@hopeline.com
FDA Black Box Warning Label on Antidepressants
In October of 2004, the U.S. Food and Drug Administration (FDA) issued a Public Health Advisory announcing a strategy that will warn the public about increased suicidality in children and adolescents being treated with antidepressant medication. The FDA has decided to require a “black box warning” label for all antidepressant medications used to treat depression and other disorders such as anxiety and obsessive-compulsive disorder (OCD) in children and adolescents. As described by the FDA’s labeling template for antidepressant drugs, according to short-term placebo controlled trials of nine antidepressant drugs in children and adolescents revealed a “greater risk of adverse events representing suicidal behavior or thinking (suicidality) during the first few months of treatment in those receiving antidepressants.”
Drugs with this “black box” warning will also be accompanied by a Patient Medication Guide or MedGuide. According to the ParentsMedGuide prepared by the American Psychiatric Association and American Academy of Child and Adolescent Psychiatry , “ children with a mood disorder such as depression are five times more likely to attempt suicide than children who are not affected by these illnesses.” Parents are no doubt attentive to this figure within the ParentsMedGuide.
The ParentMedGuide also says that “it is important to recognize that suicidal thoughts are a common part of depressive illnesses. In fact, research demonstrates that over 40 percent of children and adolescents with depression think about hurting themselves. Treatment that increases communication about these symptoms can lead to more appropriate monitoring which decreases the actual risk of suicide .” Suicidal thoughts do not always lead to suicide, nor do studies definitively show that antidepressants lead to suicide. They do however, lead to the communication of behaviors and ideations of suicide, which is critical for parents and doctors to monitor.
There have been concerns about the “black box warning” due to the language used and the alarm it may pose to families. It is important for parents and physicians to monitor children and adolescents for suicidal ideation and behaviors, and equally important to recognize the success that antidepressant drugs have with the comprehensive treatment of mental disorders. The American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry intend to monitor and participate in continuing research and discussions involving antidepressant medications and adolescent patients.
For more information on the Black Box Warning, visit:
http://www.fda.gov/cder/drug/antidepressants/default.htm
For more information on the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry, visit:
American Academy of Child and Adolescent Psychiatry
American Psychiatric Association
For new studies involved with antidepressants and adolescents from the National Institute of Mental Health:
http://www.nimh.nih.gov/studies/index.cfm
For more information about the ParentsMedGuide, visit:
http://www.parentsmedguide.org
Shredding Medical Records
Have a nanny? Or a tenant? Does anyone have access to your personal paperwork? Then you probably need a paper shredder. Or at least a wood-burning stove.
On Wednesday, a new federal law kicked in requiring those who handle other people's personal information to dispose of the data properly. Recycling the paperwork isn't good enough –the rule says it must be destroyed, rendered useless to anyone who might stumble upon it.
The disposal rule, developed by the Federal Trade Commission, covers, all employers, large and small -- even those with only one employee.
"You might be surprised," warned FTC attorney Catherine Armstrong. "If you hire a contractor or a nanny, you are covered by this law."
Even if you ordered a background check on your kid's coach, or nanny, or -- as is the latest trend in online dating -- on a prospective blind date, the law applies to you.
Tossing paperwork containing personal information into a recycling bin, or leaving it on a discarded computer's hard drive, might be costly. The FTC can sue and obtain fines of up to $2,500 for each instance of neglect. State attorneys general can also enforce the law. Victim consumers can, too. People who spot their old medical forms in a dumpster outside a doctor's office can obtain damages of up to $1,000, the rule says, if a judge agrees the dumpee was willfully negligent.
Carelessly discarded consumer reports have swelled in recent years, as the use of such data has become much more widespread. Background checks involving credit reporting data and other information have become increasingly common, even by home consumers such as companies like ChoicePoint who make accessing reporting data easier and cheaper. For its part, ChoicePoint says it is now training its operators to warn consumers doing "nanny checks" that they'd better be careful how they throw out that data.
'Need to plug the gaps'
The disposal rule is part of the 2003 Fair and Accurate Transaction Act, which contains dozens of provisions designed to slow the growth of identity theft, a crime that affects about 10 million Americans each year.
Some financial institutions and medical offices were already covered by other laws mandating safe records disposal, but the new regulations cover a wide swath of industries that deal in consumer data such as mortgage brokers, auto dealers, and private investigators, to name a few.
"We needed to plug all those gaps," said Michigan State's Judith Collins, author of Preventing Identity Theft in Your Business.
