Lead story: How one sentence has changed the psychiatrist-patient relationship.

Also in this issue:  A look back at 2002, Important renewal information, Prozac for kids, Serzone pulled off European markets, Seroquel for Mania, Testosterone gel to treat depression in men, Parkinson's drug for depression, Zyprexa vs Depakote, Pain and depression, Depression and ovarian function, Newborns of depressed mothers, Viagra, Psychiatric service dogs, Food and mood, Bipolar and math skills, the Mind-body connection, Mental health prevalence rates, Internet support, Dual diagnosis, Donation information.

The Big Event

If I had to name the most significant mental health event of last year, it would be a sleeper, one that passed virtually unnoticed at the time but has enormous implications for the future. That would be the inclusion of this sentence in the American Psychiatric Association's Revised Practice Guideline for the Treatment of Patients with Bipolar Disorder, issued in April 2002:

"Treatment is aimed at stabilization of the episode with the goal of achieving remission, defined as a complete return to baseline level of functioning and a virtual lack of symptoms." The Guideline goes on to list prevention of future episodes as a goal of long-term treatment.

The Guideline echoes the pioneering TIMA Bipolar Disorder Algorithms, issued by the state of Texas in Oct 2001, which lists as its treatment goal, "full symptom remission - not just response."

By contrast, the 1994 APA Guideline virtually wrote us off:

"The specific goals of treatment are to decrease the frequency, severity, and psychosocial consequences of episodes and to improve psychosocial functioning between episodes. Some patients with severe and chronic impairments will need specific rehabilitative services."

Ironically, raising the treatment bar comes at a time when psychiatry is waking up to just how sick we really are. At the Fourth International Conference on Bipolar Disorder in 2001, Robert Post MD of the Stanley Foundation Bipolar Network observed that bipolar is more recalcitrant to treatment than we thought, and according to Mark Bauer MD of Brown University, at the same conference, 30 to 50 percent of bipolar patients remain chronically ill.

So what good does a pie in the sky pronouncement do us, then? For one, it reflects the treatment choices that are now available to us, including the atypical antipsychotics for mania and Lamictal for bipolar depression. Two, unlike the old Guideline, this one works on the principle that if treatment A fails then let's try B and on to C until a favorable outcome is (hopefully) achieved. In no uncertain terms, the APA has put its members on notice that quitting on us is not an option, notwithstanding the severity of our symptoms or past treatment failures. In essence, our right to get well and stay well has been codified, and in this era of rising costs and deteriorating services that's no small feat.

Newer treatments and expanding knowledge will soon render this Guideline obsolete. But there is no turning back from its governing principle of "achieving remission ... return to baseline level of functioning and virtual lack of symptoms." For the first time, we have a standard by which we can hold those who treat us and possibly insure us accountable. How that plays out may turn out to be the big story of 2003 or 2004.

Other Major Events of 2002

From the point of view of the five lead stories it generated for this Newsletter, July’s Kirsch-Moore meta-analysis of 47 short-term placebo-controlled antidepressant trials from the FDA database was clearly the study of the year, raising serious questions about the effectiveness of antidepressants, the conduct of drug trials, and the FDA approval process. Yes, antidepressants probably do work. The catch is the drug companies have no reliable means of proving it.

A Dec 5, 2001 lead story reported on the budget crunch facing state and local governments, with anticipated cuts in mental health services. Unfortunately, it all came to pass in 2002, with no end in sight. In this context and in light of the federal budget deficit, the announcement of the President's Freedom Commission on Mental Health in April seemed like a cruel joke. Its interim report issued in October, however, with its emphasis on innovative cost-effective programs, demonstrated the art of the possible. Another government report, this time on co-occurring substance abuse and mental illness by SAMHSA, issued in December, paves the way for integrated treatment where fragmented treatment is the rule.

On the meds front, Abilify, referred to as "the first next-generation atypical antipsychotic," was approved by the FDA for treating schizophrenia in November, but is being used off-label for mania. Janssen has submitted Risperdal for a mania indication, and AstraZeneca has applied for Seroquel for the same use. Meanwhile, Clozaril got the conditional green light for anti-suicide, which, if approved, would make it the first drug to receive this indication (a reader reminded me that lithium, which is an orphan drug, has very strong studies supporting its anti-suicide qualities)..

For depression, Forest Laboratories has come up with a successor to Celexa - Lexapro, with fewer side effects. Eli Lilly, in the meantime, received conditional approval for Cymbalta, its new dual-action antidepressant. The company has also submitted a Zyprexa-Prozac combination to the FDA for the treatment of bipolar depression, which, if approved, would make it the first drug indicated for such a purpose.

In October, the mental health community lost a good friend in Senator Paul Wellstone of Minnesota, co-author of a mental health parity bill and supporter of a patients' bill of rights, in a plane crash with members of his family and staff.

Finally, there was the movie, "A Beautiful Mind," based on the life of Nobel Laureate John Nash, winning four Oscars, including Best Picture. In my first Newsletter of last year, I enthused: "After all these years, all this time, someone out there actually gets it." Now Hollywood has produced an encore. Currently in selected theaters is "The Hours," which has opened to critical acclaim, based on Virginia Woolf's final descent into madness, starring Nicole Kidman. In production is a movie based on the life of Sylvia Path, to star Gwyneth Paltrow. Bring in 2003.

Renewals

In light of the downturn in the US and world economy, and with regard to who bears the hardest economic burden, I have decided to indefinitely suspend renewals for this Newsletter. If you can no longer afford to renew, you will not be cut off. Please do not interpret this as an act of altruism. The prospect of a hemorrhaging reader base in this economic climate poses a serious mental health risk for me, so for the time being I would rather be broke than depressed. I am more than happy to accept donations from those with the ability to pay (please see instructions at the end). In the meantime, I'm open to any ideas for alternative funding, and would be especially interested in hearing from those of you with any experience in fund-raising. You can contact me at mcman@mcmanweb.com (Note the new email address. The old address also works.)

Format

In theory, this new format should be easier on the eyes, as well as being easier to print out.  Please let me know if you have any problems.

Website Makeover

Over the holidays, I gave McMan's Depression and Bipolar Web a complete makeover, featuring a cleaner look and easier navigation, with more than 240 articles in 16 categories, plus books, links, reader forum, and community. You can check out my latest article, on bipolar depression, at:

http://www.mcmanweb.com/article-221.htm

You can support this Newsletter by buying books and other items at Amazon.com through my website.

Prozac For Kids

The FDA has approved the use of Prozac for children seven to 17 for the treatment of depression and OCD. This is the first approval of an SSRI for treating depression in this population. The approval was based on two successful trials. In one trial, however, the kids on Prozac gained on average half an inch less in height and two pounds less in weight after 19 weeks than the placebo patients. Eli Lilly has agreed to conduct another study to evaluate the impact of the drug on long-term growth in children.

According to the NIMH, depression affects 2.5 percent of children and eight percent of adolescents in the US.

Serzone Out of Europe

Bristol-Myers Squibb will no longer sell Serzone in Europe. In the US, the drug carries a black box warning concerning the risk of liver failure. According to the Medicines Control Board in the UK: "As of December 2002, worldwide there have been 26 reports of liver failure ... Of these, there were 10 cases involving liver transplant and 13 deaths (five in patients following liver transplant)." The company said it based its decision to pull out of Europe due to low sales ($30 million in non-US markets vs $379 million in the US in 2001). The drug is due to lose its market exclusivity on Sept 16.

Seroquel For Mania

AstraZeneca is seeking FDA approval for Seroquel to treat acute mania. The application follows four successful trials, two with the drug as monotherapy and two with the drug as an add-on.

Testosterone Tested

A Harvard study of 56 depressed men not responsive to antidepressants found 24 had low testosterone levels. Of these, 12 were administered a transdermal testosterone gel and 10 a placebo, along with their antidepressants. At the end of eight weeks, a third of the men receiving testosterone showed significant improvement in their depression and anxiety scores. The remaining men showed some or no improvement. The authors caution that these findings are preliminary.

Mirapex

A University of Pisa study of 31 non-responders to anidepressants (both unipolar and bipolar depressed) has found that the Parkinson's drug pramipexole (Mirapex) added to their meds resulted in 21 responding after 16 weeks.

Dueling Studies

A recent Eli Lilly study found 47.2 percent of patients treated with Zyprexa achieved remission from mania compared to 34.1 percent for Depakote. In addition, the Zyprexa patients remitted in 14 days on average compared to 62 days with Depakote. Abbott has responded with its own study showing the two drugs were equally effective, but that Depakote was better tolerated, with fewer side effects. In the weight gain category, Zyprexa users put on 8.8 pounds after 12 weeks compared to 5.5 pounds for those on Depakote.

Pain and Depression

A Stanford University survey of 18,980 of the general population in Europe and the US found 17.1 percent reported at least one chronic painful condition (CPC), 16.5 percent had at least one depressive symptom, and four percent had major depression. Among those with at least one major depressive symptom, 27.6 percent had at least one CPC, and among those with major depression, 43.4 percent had at least one CPC.

Ovarian Function

From the Harvard Study of Moods and Cycles: A survey of of nearly a thousand women ages 36 to 45 over 36 months has found those with a history of depression had 1.2 times the rate of perimenopause of never-depressed women. Women with more pronounced depressive symptoms at study enrollment had twice the risk of an earlier perimenopausal transition (three times the risk if using antidepressants). The depressed women also had higher follicle-stimulating hormone and lutenizing hormoone levels and lower estradiol levels, leading the study’s authors to conclude: “A lifetime history of major depression may be associated with an early decline in ovarian function.”

Kids of Depressed Mothers

An Indian study comparing 37 babies of mothers with postpartum depression to 134 infants of women who were not depressed has found the newborns of depressed mothers were 2.3 times more likely to be underweight and 2.9 times likely to be short. According to the study's author, Dr Vikram Patel of the London School of Hygiene and Tropical Medicine, to Reuters Health: "Depressed mothers are less interested in their babies, and thus are less likely to exclusively breast feed their babies, which leads to use of milk substitutes and, consequently, poorer growth."

Upsidaisium

A University of New Mexico study of 90 men with sexual dysfunction related to an SSRI found 55 percent of the men in the Viagra group were "much or very much improved" taking the drug before sex compared to four percent in the placebo group.

Food and Mood

Two studies:

A Japanese study of 30 people with bulimia found that 40 percent experienced seasonal depression.

A University of Minnesota survey of adolescents found 29 percent of the girls and 28 percent of the boys who reported overeating and feeling distress also reported trying to kill themselves. Adolescent obesity has increased by 75 percent over the last three decades.

Manic Maths

So this is why I flunked algebra: A Dalhousie University (Halifax) study of 119 adolescents found those in remission from bipolar had significantly lower achievement in math compared to those in remission from major depression and healthy controls. Only nine percent of the bipolar group tested above average.

Busting Descartes

Two major pieces on the mind-body connection:

An editorial in the British Medical Journal calls for an end to the Cartesian distinction between res cognitans and res extensa, noting with regard to the mind: "We can map it, scan it, and explain its functions in biological or computational terms." But the mind has a context outside the brain: "Trying to grasp the meaningful reality of sadness, alienation, obsession, fear, and madness by looking at scans or analyzing biochemistry is like trying to understand a painting by looking at the canvas without reference to its wider world."

Meanwhile. Time magazine weighed in with a special issue, “Your Mind, Your Body,” noting: “Mind and body, psychologists and neurologists now agree, aren't that different. The brain is just another organ, albeit more intricate than the rest.” The issue notes that depression worsens heart disease, cancer, diabetes, epilepsy, and osteoporosis, and other illnesses.

How Many?

University of British Columbia researchers, at the Canadian Psychiatric Association, presented these estimated prevalence rates for major psychiatric disorders, worldwide:

Alcohol abuse: 6.6 per 100 over one year, 13.3 per 100 lifetime.

Major depression: 4.1 per 100 over one year; 6.7 percent over 100 lifetime.

Bipolar: .72 per 100 over one year; .82 percent lifetime.

Schizophrenia: .35 per 100 over one year; .55 per hundred lifetime.

These estimates are lower than other estimates.

Internet Support

In response to Newsletter4#42's lead story on internet support groups, Michelle writes about her experience with the Child and Adolescent Bipolar Foundation:

The internet saved us months, if not years of mistreatment, and  BP parents played the starring role. When our son was diagnosed in a good hospital with caring, effective (sort of) treatment, the only information we received from the staff was on adult bipolar. They had no information whatsoever on early onset BP. Within three weeks, I knew more than anyone there and within six months I'd learned everything that would later come out in The Bipolar Child. When
psychiatrists routinely misdiagnose kids and misprescribe antidepressants,
and routinely blame parents for their kids' behaviors, the only reliable
"reality check" was often other experienced parents. 

Dual DX

In response to Newsletter4#41's lead story on co-occurring substance abuse and mental illness, Astrid writes:

I have had a history of alcohol abuse and have bipolar affective disorder.  I quit drinking at 33.  Three years later when all the goodies AA promised were supposed to happen, I was worse.  I had my second abreactive memory experience, it triggered a mania, but my HMO shrink tried to prescribe Xanax, and wouldn't listen to my bipolar theory because I was adopted with no family health history.  I was concurrently being treated for incest. The doc did give me Prozac.  I went into another big mania within a short timespan and no one at that HMO figured that out.  My therapy group shamed me over taking meds, AA friends did the same.  So I continued with no pharmaceutical help for the next three years.  Then another (mild) manic episode, a better doctor, a lengthy list of my bipolar behaviors, and I was diagnosed in 5 minutes flat.  I'm grateful I managed to stay sober until I was treated with lithium.  My intelligence, stubbornness and persistence got me well.  Our system is shameful, not us. I am now 15 years sober and have been treated with lithium for 9 1/2 years. My first days on lithium I will never forget.  I was Dorothy landing in Oz - everything was suddenly in COLOR.  I am so very grateful to be alive today.  The best is yet to come.

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John McManamy
"Knowledge is necessity."