10/14/2000 – New Suicide Warning in Great Britain

Here’s an email that Circare, a health rights organization, has
sent to the White House recently. Note the new warning that is
eliciting controversy in Great Britain:

“people may feel suicidal in the first few weeks of taking Prozac
and similar antidepressants.”

Also attached are two relevant articles written by Sarah Boseley,
Health correspondent for the Guardian.

Mark

From: Vera Hassner Sharav, President
CIRCARE: Citizens for Responsible Care & Research,
A Human Rights Organization
Tel. 212-595-8974 FAX: 212-595-9086
veracare@…

In response to increasing public concern over suicides among
people taking Prozac and other SSRI anti-depressants, the
British Medicines Control Agency (MCA) (which is the equivalent
to the U.S. Food and Drug Administration) now requires the
manufacturers of Prozac and the other anti-depressants to add
the following warning to physicians and patients:

“people may feel suicidal in the first few weeks of taking Prozac
and similar antidepressants.”

Why has the FDA failed to issue similar warnings to protect the
American public?

In the U.S. these drugs, though associated with an array of
severe adverse reactions in some patients, are widely and
haphazardly prescribed, not only for adults, but for children–even
toddlers and infants. Contrary to industry claims that these
drugs are safe– based on short-term (usually 6 week) clinical
trials before they were approved by the FDA– their long-term
effects have not been studied, nor is it known whether they are
safe for children.

According to FDA compiled data, in 1994 Prozac was prescribed
349,000 times in pediatric patients under 16 years; Zoloft was
prescribed 248,000 times. Furthermore, PROZAC was
prescribed 3,000 times for infants under one year old ! [See,
Psychiatric Times, March 1998, p. 69]

Instead of protecting the public by warning physicians and
patients about the risks associated with the drugs, the FDA is
protecting the profit-margins of drug manufacturers.

http://www.guardianunlimited.co.uk/Archive/Article/0,4273,40677
31,00.html

THE GUARDIAN

Prozac warning comes under fire
Position on suicidal tendencies is ‘dangerously misleading’

Sarah Boseley, health correspondent Guardian
Monday September 25, 2000

A new warning issued by the Medicines Control Agency, stating
that people may feel suicidal in the first few weeks of taking
Prozac and similar antidepressants, is dangerously misleading
and could lead to more deaths, according to a leading authority
on the drugs.

David Healy, director of the North Wales Department of
Psychological Medicine in Bangor, has told the MCA that among
those who are not severely depressed – who are the majority of
those now being given antidepressants – it is the drugs, and not
the illness, that make people want to kill themselves. The
warning will lead to doctors keeping their patients on the drugs
in the assumption that the medication will eventually make them
better, when they need to be taken off.
The new warning is the MCA’s response to increasing public
concern over suicides among people on drugs in the Prozac
class. The agency has instructed manufacturers to include it in
the drug datasheets for doctors and information leaflets for
patients. It states that suicidal thoughts may occur or increase in
the early weeks of treatment, and may continue for some time
until the drug takes effect.

But Dr Healy, the UK’s leading historian of antidepressant
medication, believes it is the drugs themselves that are causing
some people to feel like killing themselves – not depression. And
if, as the patient leaflet warning states, there is an increase in
suicidal thoughts, he says, it can only be due to an effect of the
drug. But increasingly the SSRIs (selective serotonin reuptake
inhibitors) are being given to adults and children who are not
depressed, but merely anxious and who should therefore have
no suicidal feelings.

Dr Healy has written to Keith Jones, director of the MCA, pointing
to two studies – one of them carried out by his own team –
showing that healthy volunteers with no history of depression
have become dangerously suicidal after taking one of the SSRI
class of drugs for a couple of weeks. “This will lead to deaths,”
he told Dr Jones in a letter. “Your advice will lead to a situation
where patients who worsen on treatment will be kept on that
treatment by their GPs in the belief that it is only in this way that
the suicide risk can ultimately be lowered. This is mistaken
advice that is going to increase the rate at which patients move
from emergent suicidality[beginning to feel suicidal] to suicidal
acts.”

Earlier this year, Dr Healy published a study of the effects of one
of the SSRIs, sertraline, on 20 healthy volunteers. Two of them
became suicidal.

One told researchers that she had become obsessed with the
idea of throwing herself under a car or a train, while the other
fantasized about hanging herself from a beam in the bedroom
ceiling.

The MCA also has in its possession a much earlier study of the
effects of sertraline on healthy volunteers. Dr Jones
acknowledged in a letter to Dr Healy that this study similarly
shows a “pattern of severe adverse side-effects and drop outs.”

He goes on to remark that the pattern “seen in this small study
was not replicated in any other study involving sertraline”. Yet it
has been – in the Healy study published earlier this year in
Primary Care Psychiatry and revealed in the Guardian in May.

These two studies, says Dr Healy, would be conclusive enough
for the manufacturers to get a license from the MCA to market
sertraline as a drug to cause agitation – if anybody had a use for
such a medicine. Yet the MCA will not accept that this, and other
SSRIs, can cause people to feel suicidal as a side-effect. The
MCA’s decision to require a new warning with the SSRIs was
taken after a review of the data by the Committee on the Safety of
Medicines.

The MCA said in a statement that the CSM had considered both
the healthy volunteer studies as part of the overall risk
assessment. “The CSM concluded that reports of suicidal
thoughts in healthy volunteers were difficult to explain, however,
other data were reassuring. For this reason, the issue will be
kept under review and further advice will be sought as
necessary.”

Guardian Unlimited © Guardian Newspapers Limited 2000

http://www.guardianunlimited.co.uk/Archive/Article/0,4273,40208
31,00.html

The GUARDIAN

Happy drug Prozac can bring on impulse to suicide, study says
As best-selling pill is prescribed by GPs for ever more sufferers
from mild depression, research brings disturbing evidence to
light

Sarah Boseley, health correspondent
Guardian

Monday May 22, 2000

Alarming evidence from a new British study shows that the
Prozac class of antidepressants can make healthy men, women
and children with no history of depression feel suicidal.

The research undermines the claims of Eli Lilly, makers of
Prozac, that people who kill themselves while on the tablets do
so because of their depression, and that the disease, not the
drug, is to blame for their suicide. Its findings are particularly
worrying because of the increasing numbers of people,
including children, who are being given the drugs by their GP for
mild depression, and who are not seriously clinically ill.

Prozac, the wonder pill of the 1980s and 1990s, became the
biggest drug company blockbuster of all time, prescribed to
more than 38m people around the world. It became a metaphor
for late 20th century life and a cult in its own right, enshrined in
a
book called Prozac Nation.

What began as a medicine for the clinically depressed has been
transformed by use and demand into a pill for minor ills. But
while the happy drug works for many people, in a significant
number it can take them to the edge of despair. The study,
conducted by David Healy, director of the North Wales
Department of Psychological Medicine, reveals the real dangers
for some of the SSRIs (selective serotonin reuptake inhibitors),
as Prozac and its imitators are called.

Nightmare

It found that two out of 20 healthy volunteers on an
antidepressant in the Prozac class called Lustral (or Zoloft in the
USA) became dangerously suicidal, compared with none of
them when they were put on an antidepressant of a different
class called reboxetine.

One 30-year-old woman who took part had a nightmare about
having her throat slit after one week and by the end of a fortnight,
was suicidal. “She felt hopeless and alone. It seemed that all
she could do was to follow a thought that had been planted in
her brain from some alien force. She suddenly decided she
should go and throw herself in front of a car, that this was the
only answer. “It was as if there was nothing out there apart from
the car, which she was going to throw herself under. She didn’t
think of her partner or child,” says the study, published in the
journal Primary Care Psychiatry. Later she completed a diary
entry, describing herself as jumpy, anxious and suspicious. “Her
mind was racing and spiraling out of control. Then it went blank
except for the clear thought that she must kill herself violently by
throwing herself beneath a car or a train.”

Dr Healy says the results of the research should be a warning to
GPs prescribing any SSRIs. “They may not all be equally the
same,” he told the Guardian. “But the risk holds for the whole of
the group.

Generally the findings would indicate that women and children
and those who are least ill may be most at risk.” All the drugs
have been licensed as both safe and efficacious on the basis of
data from clinical trials. But Dr Healy believes that there are
serious problems with the reporting of side-effects in these
trials, and that this has allowed drugs to be handed out to
millions around the globe without their true risks being
understood.

Volunteers taking part in the early trials were never asked
whether they experienced any suicidal feelings or the restless
agitation which can be the precursor of a suicide attempt. If
patients in later trials said they felt suicidal, it was recorded as
part of their depression.

Dr Healey has written to the Medicines Control Agency, which
licenses medicines in the UK, expressing his concern and
pointing out that he believes patients who today become suicidal
on SSRIs are in a state of “legal jeopardy”.

Firms are using data from trials that were not designed to look at
suicidality to prove that their drugs could not have caused it. Until
the system for reporting side-effects is changed, he questions
whether anybody should take part in clinical trials.

The new study’s findings have emerged at a time of acute
embarrassment for Eli Lilly. Its patent on Prozac (fluoxetine), is
soon to expire, but it recently bought the license for a second
version of the drug, called R-fluoxetine. The patent for the new
drug, it has just been revealed in the US, states that R-fluoxetine
is improvement on Prozac specifically as it is less likely to cause
“suicidal thoughts and self-mutilation”.

Eli Lilly argues that the patent was filed by the American scientist
Martin Teicher and the company Sepracor which devised the
new drug. Mr. Teicher, in 1990, was the first to warn that patients
on Prozac were becoming suicidal, but Eli Lilly has always
dismissed his study on the basis that those patients were
suffering chronic depression.

Dr Healy, the UK’s leading historian of antidepressant
medication who has given evidence against Lilly in litigation in
the US, has frequently taken issue with the major study
commissioned by the company to persuade the US Food and
Drugs Administration that Prozac carried no suicide risk. Dr
Healy has argued there has never been a prospective study and
that the retrospective 1991 Beasley study, as it is known,
included only a small selection of the trials that had taken place
on Prozac.

An internal memo released by Eli Lilly during recent litigation
appears to support Healy’s argument. In one of a series of
memos, dated August 27, 1990, a UK-based clinician tells Eli
Lilly management in Indianapolis that critics will be suspicious
of the fact that not all the trials were included and concludes that
it gives “the impression that the question of whether fluoxetine
provokes suicidal thoughts or not has not been properly
considered.”

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