McMAN’S DEPRESSION AND BIPOLAR WEEKLY
Nov 1, 2002 Vol 4
No 36
Note: This
excellent newsletter is available weekly from:
http://mcmanweb.com/newsletter1.htm
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PAX-ILLS
The media is obviously far braver over in the UK than they are in the US.
Despite very stringent defamation laws there, the BBC aired on its flagship
current affairs program, Panorama, a no-holds barred documentary on Paxil
(marketed as Seroxat in the UK). Right off, with reporter Shelley Joffre's
allusion to the medication's "darker side," you knew this was no
industry-sponsored symposium:
In quick succession, we hear from two patients, one who cannot get off the drug
and the other who mutilated himself while on the drug, followed by David Healy
MD who testified in a successful wrongful death suit brought against the drug's
manufacturer, and attorney Andrew Vickery who brought that wrongful death suit.
Then Joffre cuts to the chase:
"The Maudsley Hospital in London runs a national information service for people
taking psychiatric medicines. Trouble coming off Seroxat is the number one
complaint from callers. Doctors too report far more withdrawal problems from
patients on Seroxat than on any other drug."
According to Davis Taylor, Chief Pharmacist at the Maudsley Hospital: "If a
patient is to stop taking Seroxat suddenly, then usually they would quite soon
become quite anxious. They may feel very dizzy and unsteady on their feet. Often
people experience electric shock sensations. They may also have a fever and feel
generally unwell and they also may experience mood changes or very vivid
nightmares for example."
Thanks to the wrongful death suit brought against manufacturer GlaxoSmithKline,
Dr Healy gained access to some quarter million documents in the company's
archives. He told Panorama that according to GSK's own studies, often on healthy
volunteers, that one in four experienced mental agitation while on the drug, and
in some instances up to 85 percent had withdrawal problems when they halted.
The wrongful death suit involved a retired man, Donald Schell, who tragically
shot his wife, daughter, nine-month-old granddaughter, and himself two days
after taking the drug. Due in part to Dr Healy's expert testimony, a Wyoming
jury last year concluded Paxil was to blame and awarded $6.4 million to
son-in-law Tim Tobin, the first successful suit brought against a drug company
involving an SSRI.
Two weeks later, GSK added this warning to patient leaflets in Britain:
"Occasionally the symptoms of depression may include thoughts of harming
yourself or committing suicide. Until the full antidepressant effect of your
medicine becomes apparent, these symptoms may increase in the first few weeks of
treatment."
Dr Alastair Benbow, head of GSK's European Clinical Psychiatry told Panorama
that:
"There is no reliable clinical evidence that Seroxat causes violence, aggression
or homicide. This tragic, tragic case is something that does occur from time to
time in patients who are depressed."
Meanwhile Panorama was saving its best for last: A "successful" US trial
involving 93 children found five experienced suicidal thoughts and gestures, and
five experienced severe psychiatric side effects.
One may ask, what happened to fairness? Nowhere in the program did Panorama talk
to a single patient who had been restored to good health thanks to Paxil, nor
did the documentary seek the opinion of any experts who might have testified to
the drug's benefits across large populations. Then again, GSK doesn't exactly
use its $90 million US advertising budget to present a balanced picture, either.
Quite the opposite, in fact. Recently, the company won a court case allowing it
to keep airing adds in the US claiming the drug is not habit-forming. The TV
viewing public here, needless to say, has no BBC to turn to for a competing
view.
http://news.bbc.co.uk/1/shared/spl/hi/programmes/panorama/transcripts/seroxat.txt
MORE
At about the same time the documentary aired, the Prescription Medicines Code of
Practice Authority in the UK ruled that GSK had breached the industry's of the
code of practice by playing down Paxil's side effects. Meanwhile, in the US,
Paxil's most recent TV ad leaves out its previous claim about the drug not being
habit-forming.
NUMBER ONE
According to the World Health Organization reported in The Guardian, Paxil tops
the list for drugs in terms of difficulty to quit followed by Effexor at number
two, Zoloft at number four, and Prozac at number seven. The benzodiazepines
Ativan and Valium come 11th and 13th.
http://www.guardian.co.uk/Archive/Article/0,4273,4201752,00.html
WALK, DON'T RUN
If you are on Paxil, please do not panic. Mental agitation or anxiety from SSRIs
usually occurs in the first few days, if at all, then recedes. If the agitation
or anxiety persists, it is advisable to notify your doctor or psychiatrist. If
the drug is working for you, it is sensible to stay on it. If the drug is being
prescribed to you for the first time, it is advisable, as with any medication,
to express any concerns to your doctor or psychiatrist. Should you no longer
need to stay on the drug, following is a "reprint" from a recent Newsletter:
Last December, GSK changed Paxil's label, encouraging physicians to recommend "a
gradual reduction in the dose rather than abrupt cessation." Paxil washes out of
the system more quickly than other SSRIs when stopped. In recent clinical
trials, GSK decreased the daily dose by 10 mgs a week (doses can range from 10
to 60 mg a day), then stopped treatment after reducing the dose to 20 mgs. The
Washington Post reports Frederick Goodwin MD, former head of the NIMH, as in
favor of an even more gradual taper, "dropping the dose every four or five days
by as little as possible, even if that means cutting pills in half."
ON THE LABEL
According to the manufacturer's product information, of patients who gradually
weaned off Paxil 2.3 percent experienced abnormal dreams, two percent
experienced a tingling sensation (paresthesia), and 7.1 percent experienced
dizziness. According to GSK, the majority of cases were mild and did not require
medical intervention.
MORE ON SSRI WITHDRAWAL
Abstracts from PubMed:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9219493&dopt=Abstract
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9219490&dopt=Abstract
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9476026&dopt=Abstract
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10855379&dopt=Abstract
PAXIL LAWSUITS
Not since the tobacco lawsuits have law firms been so eagerly licking their
litigious chops. A Google search turns up dozens of law firms in the US, Canada,
and the UK that have already been filed on behalf of individuals or classes of
individuals or are touting for business. The claims generally allege withdrawal
symptoms or suicidal gestures and the failure of GSK to issue appropriate
warnings.
DAVID HEALY
David Healy, the psychiatrist featured on Panorama, is the director of the North
Wales Department of Psychological Medicine at the University of Wales, and
author of "The Antidepressant Era" and numerous articles, several alleging a
Prozac-suicidality link. In small studies of SSRIs on healthy patients, he found
up to 20 percent lost their inhibitions. Dr Healy testified as an expert witness
in a wrongful death case concerning Prozac, which failed, and in the Tobin case,
which succeeded.
In 2000, Dr Healy was offered a post at the Centre for Addiction and Mental
Health and in the department of psychiatry at the University of Toronto. Prior
to taking up his position, he delivered a guest lecture at the university.
Highlights from that talk include:
"If our drugs really worked, we shouldn't have three times the number of
patients detained now compared with before, 15 times the number of admissions
and lengthier service bed stays for mood and other disorders that we have now.
This isn't what happened in the case of a treatment that works, such as
penicillin for GPI."
"A significant proportion of the scientific literature is now ghost written. A
large number of clinical trials done are not reported if the results don't suit
the companies' sponsoring study ... Within the studies that are reported, data
such as quality of life scale results on antidepressants have been almost
uniformly suppressed. To call this science is misleading."
But Dr Healy also said that antidepressants do work, notwithstanding the
shortcomings of drug trials, and he expressed concern that SSRIs might be
abandoned as the dependence factor became known, the fate of other classes of
drugs. The lecture had its origins in a talk he gave at an AstraZeneca seminar,
which led to further invitations to appear at AZ forums. The University of
Toronto, however, responded by rescinding its job offer with no explanation. Dr
Healy sued, and the two parties subsequently settled out of court.
http://www.nature.com/nm/voting/lecture.html
SEGUE
And now back to normal programming ...
DEPRESSION GENE?
University of Pittsburgh researchers have narrowed their search the for first
susceptibility gene for unipolar depression to an eight-gene region of
chromosome 2q33-35 in women, but not in men. According to lead researcher George
S. Zubenko MD, PhD, the finding may indicate why women suffer from depression in
twice the numbers as men. An excellent candidate gene is CREB1, which encodes a
protein CREB that affects other genes that play important roles in the brain.
Postmortem brain studies of depressed patients and animal studies have found
alterations in CREB1 expression.
http://www.eurekalert.org/
STAYING ON MEDS
A University of Texas Southwestern Medical Center at Dallas/Pfizer study of
Zoloft responders who remained on the drug through the last 18-month phase of a
three-phase trial found six percent relapsed compared to 23 percent on the
placebo. The Zoloft patients also recorded higher scores on functioning,
attitude, and quality of life.
http://www.eurekalert.org/
ALL THAT IT'S CRACKED UP TO BE?
One of my readers, Carter, saw the media release of the above study before I
did, and did the math, namely:
Out of an initial cohort of 635 patients completing a 12-week trial (we have to
assume a lot of patients dropped out during this stage, but we'll overlook
this), only 209 responded favorably to go into the four-month phase of the
trial, and ninety-five percent (199) qualified to go into the 18-month phase, of
which 94 percent remained well (had everyone remained on Zoloft, we can
extrapolate a number of 187). Carter notes, "in this projection only 29 percent
would have experienced long-term alleviation of symptoms - hardly 'most'
patients alluded to in the release." Moreover, assigning the placebo results in
the same fashion, 153 would have experienced relief. "So basically," concludes
Carter, "only 34 patients out of 635 experienced relief of symptoms at a higher
level than the placebo."
PAIN-BUSTERS
"Similarly, antidepressants have been used to help prevent migraines. 'If
antidepressants were discovered today and we didn't know they were
antidepressants, we'd call them analgesics,' says Dr. Seymour Diamond, director
of the Diamond Headache Clinic in Chicago. Intriguingly, the pain-fighting
effect of antidepressants takes just three to 10 days to kick in, less than half
the time needed to alleviate depression. This suggests that depression and
migraine are triggered by different, though related, neural pathways."
From a Time Magazine article on headaches.
http://www.time.com/time/health/article/0,8599,356029,00.html
THE PAIN CONNECTION
For more on the connection between pain and mood, please check out the article I
wrote for the Depression and Bipolar Support Alliance at:
http://www.ndmda.org/Research/ResearchUpdate22.html
INOSITOL
Safe Harbor's Alternative Mental Health News reports that Dr James Greenblatt of
McLean Hospital, affiliated with Harvard, is using inositol supplementation to
treat patients for depression and related ills. Inositol is made in the body and
"is shuttled around to various tissues as needed." The substance is reputed to
be efficacious without the usual meds side effects.
A Medline search turned up a small 2000 University of Pittsburgh study that
found six of the 11 patients on inositol plus their meds improved their Hamilton
depression scores by at least 50 percent. Eight patients achieved success using
the MADRS depression scale. A 2001 Israeli study, on the other hand, found that
inositol combined with SSRIs in treatment-resistant patients did not produce an
added benefit.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11254020&dopt=Abstract
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12404596&dopt=Abstract
PSYCH WARS
A Janssen survey of 4,308 patients on antipsychotics has found those taking
Clozaril, Zyprexa, Haldol, and Thorazine ran a higher risk of diabetes compared
to those not on antipsychotics while those on Risperdal (no surprise) did not
display a higher risk. The study represents the latest salvo in the high-stakes
war for the multi-billion antipsychotics market, featuring gloves-off negative
campaigning. Don't be surprised to find Eli Lilly retaliating with its own
study, this time involving prolactin levels affecting guess which drug.
http://www.psycport.com/
JAVA
This week coffee is good for you. A University of California, San Diego, study
has found that women at least 80 years-old who were lifetime coffee drinkers had
a slight edge over infrequent coffee drinkers on 11 of 12 mental acuity tests
such as counting backward from 100 by sevens. The same effect did not occur in
men.
http://www.reuters.com/news_article.jhtml;jsessionid=MRCZH3WI5PDXICRBAE0CFEY?type=healthnews&StoryID=1662532
RECESSION BLUES
USA Today reports that the economic downturn has many struggling with
depression, anxiety, substance abuse, and marriage woes. Calls to employee
assistance programs are up 10 percent, 25 states report an increase in requests
for drug and alcohol treatment, and the use of antidepressants grew 12.8 percent
in 2001 (180 million prescriptions last year). According to the University of
Western Ontario, 30 percent of husbands who experienced unemployment suffered
from significant mental health problems vs 16 percent in stable employment, with
unemployed and employed women at 36 percent and 23 percent, respectively.
Says Joanne McCall, who was laid off for eight months in 1993 to USA Today: "It
took a number of years to really get over it. It's such a blow to your
self-esteem and who you are, and it takes a long time to repair that. It's like
a grief process ... Your work is like family, and all of a sudden you feel cut
off and ostracized. It's huge. There's a period of loss."
http://www.usatoday.com/money/economy/employment/2002-10-28-stressx.htm
HIV
A Columbia University survey of 235 HIV-positive individuals has found 72
percent reported symptoms of depression and 65 percent reported anxiety.
According to HealthScout, although more than 80 percent of US doctors say mental
health is a top priority when they make decisions about treatment, 62 percent of
patients say physicians never ask about their mental state.
http://www.healthscout.com/template.asp?page=newsdetail&ap=1&id=509872
KIDS
A University of Michigan survey of 1,958 adolescents aged 15-19 has found 7.4
percent met the criteria for severe major depression, but only 11 to 15 percent
of them sought help for it.
http://www.docguide.com/
MEANWHILE ...
"More teenagers and young adults died from suicide than from cancer, heart
disease, AIDS, birth defects, stroke, pneumonia, influenza and chronic lung
disease combined."
David Fassler MD of the University of Vermont and author of "Help Me, I'm Sad:
Recognizing, Treating, and Preventing Childhood and Adolescent Depression," on
NPR's Talk of the Nation, hosted by Neal Conan.
MEN ARE FROM MARS
"Well, most of our diagnostic criteria talk about what you said earlier, that
you're weepy, although sadness can start to go away if the depression gets
worse, but you're hopeless and you express that kind of hopelessness or that
sadness, while a lot of men get angry, irritable, mean, impulsive, and we say
they're - well, what language shall I use on NPR? - they're SOBs and they're a
pain, and let's get rid of them, let's fire them, let's divorce them, when, in
fact, behind that mask of masculinity is actually the same
sadness, hurt and pain expressed in a male-based fashion."
William Pollack PhD of Harvard and author of "New Psychotherapy for Men" on why
men suffer from depression in equal numbers to women, though in unrecognized
ways, on NPR's Talk of the Nation, hosted by Neal Conan.
rTMS
A University of Washington review of 12 studies comparing rTMS (repetitive
transcranial magnetic stimulation) to sham treatment found the number of
responders (ie a 50 percent or greater reduction in depression scores) was only
13.7 percent vs 7.9 percent for sham treatment. No study showed at least a 50
percent reduction.
rTMS involves passing a magnetic coil over the scalp of a patient.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12397863&dopt=Abstract
UK PRISONS
According to the Financial Times, Prison Service figures in the UK reveal "as
many as 90 per cent of prisoners show evidence of mental distress, a psychiatric
disorder, or drug or alcohol addiction," with more than 5,000 suffering from
severe mental illness. Forty percent of women prisoners and 20 percent of men
have admitted to trying to kill themselves.
MAIL BAG
Carol writes:
"Related to the Rocky Mountain Low article, I was an insurance agent for many
years and you'll find this interesting: ALL life insurance policies state that
if the insured commits suicide within a specific time frame following policy
issue, the beneficiary will only receive the cash value - not the death benefit.
That time frame is two years in every state BUT Colorado. Colorado is only one
year. In theory, you can buy a policy and kill yourself 366 days later, leaving
your death benefit to loved ones. Personally, if you're in that frame of mind, I
think even one year is a long time."
IN MEMORIAM: PAUL WELLSTONE, 1944 - 2002
From NAMI's President, Jim McNulty:
"Our members have loved and admired Senator Wellstone for his tireless advocacy
on behalf of people with mental illnesses. Whether fighting for passage of
mental health insurance parity legislation or conducting an unannounced visit to
a juvenile justice facility, he brought a rare passion and energy to fighting
discrimination against people with mental illnesses as part of a broader
commitment to individual dignity, freedom, and bonds of justice that bring our
nation together as a community."
From the Depression and Bipolar Support Alliance:
"Senator Wellstone was a good friend and advocate for those working in mental
health and a leader of the mental health parity movement. DBSA is saddened by
this loss and expresses its condolences to family and friends."
From the Mental Health Association's President Michael Faenza:
"Not only was the Senator a committed, concerned and passionate individual, he
was also one of the finest elected officials I have ever met."
VOTE
For US readers, you can make it a habit starting Tuesday, Nov 5.
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