Fentanyl: Situation Report

Clandestinely produced Fentanyl has been linked to hundreds of fatal and nonfatal overdoses across the Midwest, Northeast, and Mid-Atlantic Regions of the United States since late 2005. Fentanyl is a synthetic opiate approximately 50 times more potent than heroin.

Clandestinely produced Fentanyl powders, fentanyl mixed with heroin, and, to a lesser extent, fentanyl mixed with cocaine have been distributed in the Midwest, Northeast, and Mid-Atlantic Regions. The primary markets have been Chicago (IL), Detroit (MI), and Philadelphia (PA)/Camden (NJ). Overdoses linked to Fentanyl have been reported in areas of Delaware, Illinois, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, and Wisconsin

Fentanyl has been sold to drug abusers, primarily heroin abusers, in drug markets in each of the aforementioned areas, and abusers typically reflect the population demographics of those areas. Currently, there are an estimated 800,000 to 1,000,000 hard-core and casual heroin abusers in the United States who constitute the potential Fentanyl market. An intravenous dose of Fentanyl hydrochloride for pain relief is approximately 45 micrograms (a grain of salt is approximately 60 micrograms); however, depending on the weight of the abuser and his or her level of opiate tolerance, an abuser may tolerate a higher or lower dose. Accordingly, a small error in diluting, or cutting, Fentanyl can easily lead to an overdose.

U.S. Department of Justice
National Drug Intelligence Center
Date: June 5, 2006

Lilly Accused of Promoting Off-Label Zyprexa Use

December 18, 2006 · In: Healthcare Companies Healthcare Regulations

Has drugmaker Eli Lilly been promoting the off-label use of antipsychotic Zyprexa for elderly patients with dementia symptoms?

According to an investigation by The New York Times, Lilly has been doing just that since late 2000, despite FDA rules to the contrary. Materials given to the NYT outline a campaign called Viva Zyprexa, in which sales reps are told to suggest the drug for older dementia patients. However, such marketing would run afoul of FDA rules, as Zyprexa is approved to treat bipolar disorder and schizophrenia, not dementia or dementia-related psychosis. In fact, Zyprexa actually carries an FDA warning stating that the drug can increase the risk of death in older patients with dementia-related psychosis. A Lilly spokesperson contended that older patients who seem to have dementia may actually have untreated schizophrenia, but psychiatrists have strongly contested that claim. Lilly is currently facing federal and state investigations over its marketing of Zyprexa, which at $4.2 billion in 2005 sales is Lilly's best-selling product.

FDA Proposes Expanding Antidepressant Suicide Warning

Provided by: Associated PressWritten by: ANDREW BRIDGES Dec. 13, 2006

WASHINGTON (AP) - Antidepressants increase the risk of suicidal behaviour for people up to age 24, the government said Wednesday. It plans new warning labels, and says users of all ages should be closely monitored.The label change proposed Wednesday would expand a warning now on the antidepressants that applies only to children and adolescents.T

The Food and Drug Administration presented its plan to update the drug labels at a meeting of outside advisers on the issue. They endorsed the plan.The FDA also stressed that patients of all ages should continue to be carefully monitored for signs of suicidal tendencies when they are beginning treatment on the drugs.

Public reaction was split, with some saying the changes were overdue and others arguing they could keep drugs from those who need them.In emotional testimony illustrated at times by slides of family photos, relatives of suicide victims pleaded for the new warnings.Suzanne Gonzalez, shouting and in tears, goaded the panel to action, telling the experts that her 40-year-old husband who had been taking Paxil shot himself."I wake up every morning thinking, 'Oh my God, he's dead. He is freaking dead.' Do you wake up and think, 'How many people are going to die today because I am doing nothing?"' Gonzalez asked.

Still, mental health experts worry that additional warnings could curtail use of the drugs and ultimately do more harm than good.Dr. John Mann, a Columbia University psychiatrist, suggested simply replacing the proposed expanded warnings with the recommendation that doctors more closely monitor their patients.

"We can do more good by providing more treatment for depressed children and adults," Mann said.

The FDA proposed the changes after completing a review that found use of the drugs may increase the risk of suicidal thoughts and behaviour among young adults 18 to 24, as well as among younger patients.

Psychiatrists testified Wednesday that the 2004 addition of a warning for children led to a falloff in antidepressant prescriptions being written for patients under 18 - and an increase in suicides in that age group.Still, overall use of antidepressants continues to grow, with nearly 190 million prescriptions dispensed in the United States last year, according to IMS Health, a health care information company.That suggests doctors have placed more weight on the long-term benefits of the drugs than on any short-term risks, said Dr. Thomas Laughren, director of the FDA's division of psychiatry products.

Expanding the "black box" or other warnings on the drugs could dissuade patients from seeking or starting treatment, mental health experts said. They warned that people with untreated depression - about half of those who suffer from the disease - face an estimated 15 per cent greater likelihood of death by suicide.

Dr. Joseph Glenmullen, a Harvard Medical School clinical instructor in psychiatry and author of "Prozac Backlash," said expanding the warnings wouldn't scare off patients, but instead would allow them to make informed choices. The FDA recently completed a review of 372 studies involving about 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil. When the results were analyzed by age, it became clear there was an elevated though small and short-term risk for suicidal thoughts and behavior among adults 18 to 24, the FDA said in documents released ahead of Wednesday's meeting of its psychopharmacologic drugs advisory committee.The FDA's analysis of the multiple studies suggests an age-related shift in the risk of suicidal thoughts and behavior associated with treatment with the drugs. For instance, antidepressants seem to protect against suicidal thoughts and behavior in adults 30 and older, with the effect most pronounced in patients over 65.

The FDA said the increased risk could mean as many as 14 additional cases of suicidal thoughts or behavior in every 1,000 children treated with antidepressants. For adults 18 to 24, there could be four additional such cases per 1,000.

In May, GlaxoSmithKline and the FDA warned Paxil may raise the risk of suicidal behavior in young adults and added that to the drug's label."Anytime suicide is involved it is a tragic outcome. It is one of the things that keeps us motivated to search for better treatments because depression can be treated.

Self-Disclosure & Healing

As therapists, we generally are cast as the support-person, the listeners, the helpers, the objective re-framers and other client-focused “providers”. Clinicians, some more than others, tend not to self-disclose much with their clients; some prefer to keep their own feelings, life trials and even personal mental health experiences separate from the therapy relationship. Like most aspects of the client-therapist relationship there are no real hard and fast boundaries about how to act, what to say, what to reveal, when to set limits, etc; it is the art of therapy and the clinician experience that determines how the relationship develops.

Therapist self-disclosing can be an effective teaching opportunity that has real, human information and it can be a tremendously powerful client-therapist relationship building tool, remembering always that self-disclosure has its limits and the therapy session is for the client. I have personally known clinicians that quickly get caught up in self-disclosure to the degree the roles in therapy become reversed and therapist’s personal issues become the primary focus of the sessions; not good.

For example, recently my family learned my mother has been diagnosed with cancer; she is 76 years old. I am very fortunate to have a loving family with generally healthy siblings and parents; none of us really ever experiencing any tremendous life tragedies. Perhaps this is one reason the “news” has been emotionally devastating to me. My emotions have been flooding in since learning of her cancer diagnosis. I am scared for her, scared for me, scared for my Dad, wondering how I will balance being the ever-supportive “helper” and at the same time taking care of myself. I am preoccupied with all of this, at times finding myself in a daze when driving down the road or other times when I am generally attentive and focused. I have this ever-streaming thought process going on, saying to myself, “I want to know the outcome, I want to fix it, I know I can’t fix it, she’ll pull through this, am I ready to deal with this, how will I deal with this, why?, I will be there for her, she can count on me” and on and on. I know my Mom wants to fight for a cure, fight for more time. I want more time with my Mom yet I want to be unselfish as well. This is one of my life trials, perhaps the biggest yet for me. Deep down I know I can’t control this outcome, I am trying to settle for “maybe I can influence the outcome” through my support to her, my love for her, to my Dad, staying optimistic, praying for her/for us. My partner once told me, “Thoughts are things”. I will be trying to center on healing thoughts.

I hope you can see that struggling is part of our humanness, even healers need to heal and self-disclosure can open the path for others to become helpers too. When you may think that your life-challenges are overwhelming, unbearable or misunderstood, let someone know your pain, your struggle. By allowing ourselves to share our experiences we may influence the nature of our relationships and perhaps even the outcome of our struggle.

Alternative Treatments: Coach and Professional Organizer for Treatment of ADHD

NEW ORLEANS, Nov. 22 -- Although pharmacological treatments are the mainstay of therapy for attention-deficit hyperactivity disorder (ADHD) in adults, psychosocial treatments may be a useful adjunct and improve patients' quality of life.

Psychosocial treatments include not only psychotherapy and counseling but less-well known approaches such as an ADHD "coach" and a professional organizer, said Carol E. Watkins, M.D., of Northern Country Psychiatric Associates in Baltimore. Dr. Watkins outlined the array of psychosocial treatments available to adults with ADHD at the U.S. Psychiatric & Mental Health Congress here.

Individual psychotherapy: This approach can help patients identify "maladaptive patterns" related to the ADHD and find better ways of coping with them. Both the insight-oriented therapy and cognitive and behavioral therapy can be useful, Dr. Watkins said.
Couples and family therapy: ADHD can put a major strain on a marriage, Dr. Watkins said. Spouses may not understand that their partner's inattention and forgetfulness is not intentional. Extended couples therapy may help the non-ADHD spouse learn to give supportive structure without being controlling, Dr. Watkins said.
Group therapy may be useful for helping patients build a system of support, Dr. Watkins said. If, during group therapy, patients are able to make suggestions that help other group members, they may begin to feel a sense of competence. For patients who can not sit still in a chair for an entire therapy hour, psychodrama may be a better approach, Dr. Watkins added.
12 Step Groups are useful for adults with ADHD who are substance abusers. "These meetings help foster a sense of shared community and help the individual deal with issues of blame and responsibility," Dr. Watkins said.

ADHD Coaching is distinct from psychotherapy, Dr. Watkins said. An ADHD coach talks to patients at regular, daily intervals and helps them define, clarify, and prioritize their goals. Since ADHD coaching is relatively new phenomenon and there is no regulation or oversight of this profession, it is important to make sure that coaches are trained and have experience. However, in a pinch, even a mentor, a sympathetic teacher, or a friend can serve as a coach, Dr. Watkins said.

Electronic Organizers: "I am a big believer in the use of electronic organizers," Dr. Watkins said. "Unfortunately, many patients start out with them enthusiastically but then trail off within a month." A seminar that teaches patients how to set up and use the organizer is often useful. Some seminars will also follow up with encouragement and reminders to use the planner, Dr. Watkins noted.

A Professional Home Organizer can be hired for patients with cluttered, disorganized homes. Professional organizers come to the house and help determine what can be thrown away. Professional organizers are not the same as cleaning services, Dr. Watkins stressed, "although a cleaning service is probably also a good idea," she said.

Primary source: U.S. Psychiatric & Mental Health Congress
(C) 2006 MedPage Today LLC. All Rights Reserved.

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Pregnant Women recommended to Avoid Paxil

WASHINGTON (AP) - Pregnant women and those who plan to become pregnant should avoid taking the antidepressant Paxil if possible because of the risk of birth defects, a group of U.S. obstetricians said Thursday.

The opinion issued by the obstetric practice committee of the American College of Obstetricians and Gynecologists comes nearly a year after the U.S. Food and Drug Administration and manufacturer GlaxoSmithKline reclassified the drug to reflect studies in pregnant women that showed the drug poses a risk to the fetus.

Two studies of pregnant women who were taking Paxil during their first trimester have shown that their babies have heart defects at a rate that is as much as twice the norm, the FDA said at the time.

The American College of Obstetricians and Gynecologists also said the decision whether to treat pregnant women with SSRIs, a class of antidepressants that includes Prozac, Zoloft and Lexapro as well as Paxil, should be considered on an individual basis.

Exposure to SSRIs late in pregnancy has been associated with short-term complications in newborns, the doctors said.

However, reproductive-age women have the highest prevalence of major depressive disorders. The benefit to the mother of treatment with any of the drugs may outweigh the risk to the fetus.

The opinion appears in the December issue of the Journal Obstetrics & Gynecology.