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Your
antidepressant your problem?
Date : 18
July 2004
Producer : Odette Quesnel, Nicola de
Chaud
Presenter : Derek Watts
Researcher :
Bernadette Cook
Genre : Medical
and Health
Derek Watts (Carte Blanche Presenter):
“It’s certainly not news [that] millions of people around the
world pop anti-depressants.”
Patient 1: “As long as it
keeps me out of that place where I was before because if I had
to go back there I don’t think I would make it
again.”
Patient 2: “Without it I just stayed in bed. I
couldn’t even get up.”
Dr Joseph Glenmullen
(Psychiatrist, Harvard Medical School): “It’s supposed to
raise your serotonin levels and that’s what makes you happy -
like when you exercise and stuff.”
Derek: “In the
United States alone almost two hundred million prescriptions
are handed out every year, but popularity doesn’t make a
medicine risk free.”
Dr Glenmullen: “The bottom line is
that we don’t know how these drugs work, we don’t know exactly
what their effects - both therapeutic and side effects, are in
the brain. And that’s one of the problems - to be giving
millions and millions of people drugs for years and years,
decades, when we don’t fully understand what they do and what
the long term risks are.”
Dr Joseph Glenmullen, a
Professor at Harvard Medical School and practicing
psychiatrist, believes that while anti-depressants work for
most people, they can drive some patients to suicide and
violence.
Dr Glenmullen: “I prescribe the drugs. I’ve
had many patients say that they work, they help them, that
they made them less suicidal. But I’ve seen a small percentage
of patients… and it’s significant because we’re talking about
a lethal side effect… who become worse. They become agitated,
they become restless, they develop a pre-occupation with
suicide that they did not have before they went on the drug.
It’s relentless. It’s very clear it’s the drug. When you stop
the drug it goes away.
Across the Atlantic, another
very vocal medical expert is calling for extreme caution when
prescribing anti-depressants.
Dr David Healy
(Psychopharmacologist, North Wales University): “If they are
not the right drug for you they can cause a range of problems.
They can make you suicidal. They can throw you into a state of
mental turmoil.”
There are few people in the world who
know as much about anti-depressants as Dr David Healy, a
prominent psychopharmacologist from North Wales University.
Dr Healy: “What you have got to realise is, by ‘mental
turmoil’ we mean a state where people are having thoughts and
impulses that they’ve never had before; thoughts of harming
themselves, or harming others.”
Of this there is
mounting anecdotal evidence from all over the
world.
Son of a suicidal patient: “Within eleven days
of being prescribed the Prozac, my father awoke in the early
hours of the morning, placed a pillow over my mother’s face
and suffocated her.”
Patient: “I started getting more
restless, agitated. That then became the problem… like a
nightmare.”
Mother of a suicidal daughter: “Her
symptoms of depression seemed to worsen after the Prozac, and
she committed suicide a few weeks after she
started.”
They are pointing fingers at a family of
anti-depressants known as SSRIs. Dr. Healy put this class of
drugs under the microscope when he conducted clinical trials
on healthy people.
Dr Healy: “These included GPs,
consultant psychiatrists, senior nurses, all of whom were
healthy, and senior, and what was seen when people were on the
wrong drug for them [was] that they went through a stage of
mental turmoil, on to becoming frankly suicidal.”
In
fact his study showed that one in five healthy volunteers
suddenly had thoughts of killing themselves. Alarming clinical
evidence, but Dr. Glenmullen says it’s no reason to give
anti-depressants the boot.
Dr. Glenmullen: “Medications
come with risks, medications come with side effects. We can
give them other drugs that counteract this side effect, but if
you don’t warn people… that’s the real danger.”
Cecily
Bostock never got that warning.
Sara Bostock: “I
noticed changes almost immediately, actually and I was frantic
because I thought it was the medication even then.”
Two
years ago, Sara Bostock’s daughter Cecily was prescribed the
American equivalent of Aropax for anxiety.
Derek:
“Twenty-five-year-old Cecily Bostock grew up in this quiet
home in San Francisco. She did well at school, excelled in the
Arts and graduated from Stanford University.”
A
musician, an artist, an all-round over achiever, Cecily
sometimes had trouble coping with the pressure.
Sara
Bostock (Mother of sufferer): “She was having a lot of trouble
sleeping and she had racing thoughts, and she was
over-analysing and she was overly sensitive… that is what
prompted the prescription.”
Within three weeks of
taking the SSRI, Sara says, her daughter became a totally
different person.
Sara: The last two days she was just
a complete zombie I have to say. She was just agitated,
jumping at every noise and not making sense. I was very
concerned. We were very close to Cecily. I just loved her
deeply.
As concerned as she was, Sara could never have
imagined the scene that confronted her one night in January
two years ago when she got up to let the cat out.
Sara:
“So I went into the kitchen and I turned the light on and she
was lying on the floor. And I knew she was dead. And there was
a knife on the floor by her and there was just a trickle of
blood from her chest.”
Cecily had stabbed herself twice
through the heart.
Sara: “I mean just unheard of for
someone like this.”
Her death came about 20 days after
she had started taking Aropax.
Sara: “Never made a
suicide attempt… never had written anything suicidal in her
journal. She loved us. It was just unreal! I’m sorry,
but.”
Sara Bostock buried her daughter believing the
anti-depressant medication had ultimately killed
her.
Professor Christopher Szabo (Clinical Head, WITS
[University of the Witwatersrand] Psychiatry Division): “I
mean there could be a host of different variables that haven’t
been factored in this scenario that we would need to look
at.”
Professor Chris Szabo heads up the Psychiatry
Departments at both Wits University and Tara Hospital in
Johannesburg.
Derek: “Chris, so you are saying to just
blame the drug in a case like that is
irresponsible?”
Chris: “I think it doesn’t serve
anybody’s purposes, and I think at the end of the day that
would be simplistic. And yes, that might be irresponsible.
When you’re treating a person who is depressed, forget the
drug that you’re treating them with. You know that suicidality
is always a possibility.”
Dr Glenmullen: “Yeah but
again, if you’re well educated it’s very easy to differentiate
in most cases underlying depression and suicidality from this
side effect.”
Dr Glenmullen says suicidal thoughts
could be the result of a well-documented condition called
akathisia.
Dr Glenmullen: “They become very agitated;
they want to jump out of their skin, and what they’ll say is
they want to kill themselves to escape this severe agitation.
That looks very different from someone who is depressed or
suicidal.”
Sara: “I think she had akathisia. She had
that agitation that is supposedly a drug-induced
effect.”
Another possible factor, says Dr Glenmullen,
is that some patients may not have the liver enzymes necessary
to metabolise the SSRI anti-depressants.
Dr Glenmullen:
“As a result, they might take a normal dose of the drug and
have a sky high level of it in their body. And we believe now
that some people are vulnerable to this side effect for that
reason.”
Sara Bostock insisted on an autopsy to test
for levels of Aropax - also called Paxil - in her daughter’s
body.
Sara: “And she had a sky-high blood level… way
above the therapeutic range. Clearly her system was not
adjusting to the Paxil.
Cecily is one of a tiny
minority. Dr Glenmullen estimates that one in a hundred people
could develop suicidal thoughts as a result of their
SSRI.
Dr Glenmullen: “It looks from the studies - and
these are not precise numbers because the large scale
systematic studies that you would need have not been done, but
it appears about one percent of people. And that’s the best
estimate that we have.”
Derek: “One percent?”
Dr
Glenmullen: “One percent. But given that millions and millions
of people are taking this drug, that’s an awful lot of
people.”
Voices from around the world confirm that for
the other 99 percent, SSRI anti-depressants are a
lifeline.
Patient: “I really don’t know what would have
happened if I hadn’t been helped in that way.”
Patient:
“I don’t know if that very next bag I had down[ed] would have
been the end.”
Patient: “I felt like a totally
different person.”
Professor Szabo believes without a
doubt that, if correctly prescribed and carefully monitored,
these drugs work.
Chris: “The truth of the matter is
these are powerful medications, and it would be sad if a class
of drugs is tarnished on the basis of a number of case
reports, and the good that is done from these agents is
lost.”
Derek: “Is it fair to say you’ve only
experienced positive effects?”
Patient: “Yes, yes, well
I am here.”
Chris: “There is no question that these
drugs do have a positive impact, but you’ve also got to be
aware that they’ve often got unwanted side effects.”
He
doesn’t buy the contention that suicidality is one of them.
Derek: “So the counter argument is, every medication
has side effects - even aspirin?”
Dr Glenmullen:
“Absolutely. I prescribe these medications. This side effect…
there’s a double negative here. This side effect is no reason
to not prescribe anti-depressants, but you need to warn
people.”
End of part one
Part
two
Derek: “In March this year the American Food
and Drug Administration - the FDA - issued an official warning
of the increased risks of suicidal tendencies when taking
anti-depressants.” They said that healthcare providers should
be aware that worsening symptoms could be due to the
underlying depression or might be the result of drug
therapy.”
Derek: “This came after more than ten years
of concerted efforts from a small group of doctors.”
Dr
Glenmullen: “It’s very unfortunate that the warning wasn’t put
in place in the early 1990s when there was strong evidence
that the drugs were causing this side effect.
Of the
ten American specialists who cleared the drugs of any links to
suicide and violence back in 1991, seven now say that new
information would prompt them to reconsider their decision -
that according to the New York Times.
One of the
loudest voices at the FDA hearings was that of Anne Blake
Tracey, director of the International Coalition for Drug
Awareness.
Anne Blake Tracey (Director, International
Coalition for Drug Awareness): “When I stood to testify to the
FDA on February 2nd, I said, ‘I am standing here before you at
a meeting that shouldn’t be taking place because this move
should’ve been made in 1991’.”
Derek: “Then would you
admit that you are on a crusade in a way?”
Anne: “Yes,
I’d admit to that.”
Anne is not a psychiatrist. She has
a doctorate In Health Sciences and has made the study of SSRI
anti-depressants a life’s work.
Derek: “Are you happy
with the FDA warning as it stands?”
Anne: “I am glad
that there is a warning. I believe that it should be a black
box warning. I believe that it should be really bold, instead
of included in the teeny tiny little print which they don’t
give you a magnifying glass to read.”
In South Africa a
magnifying glass won’t help you. The warning is not
there.
Derek [addressing the Director of Corporate
Affairs for Prozac manufacturer, Elli Lilly]: “Sipho, why
aren’t the FDA warnings being carried locally?”
Sipho
Moshoane (Director Corporate Affairs): “Derek there’s a
process, which is a legal and regulatory process, that is
followed.”
Sipho Moshoane is the Director of Corporate
Affairs for Prozac manufacturer, Elli Lilly.
Sipho:
“Typically, the Medicines Controls Council would approach a
company and would say, ‘We have seen this, could you submit
either extra data or change something?’”
Dr Frans Korb
(Clinical Expert): “No directive[s] have come from the MCC in
South Africa for all companies that produce anti-depressants
to put that warning in.”
Elli Lilly’s clinical expert,
Dr Frans Korb, may have to wait a while for that
directive.
Derek: “When we first contacted the MCC in
mid-June the Chair of the Council was in the dark about the
FDA warning.”
The Medicines Control Council is South
Africa’s FDA equivalent. It’s their job to protect the public
and make sure that all medicines sold here are
safe.
Derek: “For more than a month we’ve tried to
secure an interview with someone from the MCC. They never
flatly denied us, but also never managed to commit to a time.
They promised us a written statement… we’re still
waiting.
However, Glaxo Smith Kline, the makers of
Aropax, seem to have a hotline to MCC bosses
Dr Navin
Singh (Medical Director of GSK): “We have proactively
communicated to them our action on this and what we intend
doing.”
But, Medical Director Dr Navin Singh insists
their talks with the MCC are secret.
Derek: “But was
the essence of your letters the fact that the FDA has insisted
on a warning in America and we would like to put the same
warning on our [South African] package inserts?”
Dr
Singh: “I’ve said to you that those discussions are
confidential. I cannot divulge any more than
that.”
Derek: “But why is it confidential, when the
contention is people could be dying out there because they
take your drug?”
Dr Singh: “I disagree that people are
dying because they’re taking our drug. There’s no reliable
evidence that shows Aropax causes suicides, violence or
aggression in patients”.
That’s the argument the
company put forward in a legal battle on the other side of the
world four years ago.
Donald Shell had taken just two
Aropax tablets when he shot and killed his wife, daughter and
nine month old granddaughter. He then turned the gun on
himself.
The family believed Aropax turned Donald into
a killer, and the jurors unanimously agreed. The court ordered
that Glaxo Smith Kline pay out over six million dollars in
damages. The company appealed the decision and then settled
out of court.
Dr Singh: “This case is a tragic, tragic
case. These sort of events do occur in the normal day to day
events of the life of a depressed patient.”
Derek:
“We’ve been through that. That argument has been thrown out,
Navin. I mean it’s not a question of saying they were
depressed anyway. The court found that the tablets caused this
tragedy.”
Dr Singh: “I do not know enough about the
case to comment on this substantively. However, I can tell you
that there is no reasonable data that shows Aropax causes
suicides, aggression or leads to such events.”
Dr David
Healy was the expert witness for the family in that case. He
had to get an American court order to gain access to Glaxo
Smith Kline’s archives. In an extra-ordinary find, he
discovered that the company already knew that Aropax could
lead to mental turmoil.
Dr Healy: “It seemed clear that
some people who went on the drug had no major problems, but
equally clear that others that went on the drug became more
restless, in a state of mental turmoil, complaining about
dreams, nightmares and many things like this. These don’t seem
to have been studied further in any great detail.”
It’s
not the first time Glaxo Smith Kline has been accused of being
less then transparent. In June this year, the New York State
Attorney General filed a lawsuit against the company alleging
that it suppressed results which showed that Arapax may not be
effective for teenagers and that it could lead to an increased
risk of suicidal tendencies.
Dr Singh: “That is not
true. Those results were not hidden under the
carpet.”
He says they were presented at a scientific
meeting. However, an internal GSK document from the time
clearly states that the company intended to manage the
dissemination of the data in order to minimise any potential
negative commercial impact.
Dr Singh: “All I can tell
you is the company policy and the policy has it’s own
intention to make sure that data that is relevant to the
public is available to the public.”
While GSK talks
policy, the British aren’t playing games when it comes to
children and adolescents. In December last year, their Medical
Controls Agency banned the prescription of anti-depressants
for anyone under 18 [years].
But in America there is an
alarming turn towards anti-depressants for kids. The fastest
growing group of users are pre-schoolers aged from nought to
five years and prescriptions for adolescents have more than
doubled since the early 1990s.
Chris Allen
(anti-depressant user): “I did not have a normal life any
more. It was just doctors prescribing medicine like it was
candy.”
When Chris Allen was 16, his sights were set on
a career in professional basketball, but his emotional world
was falling apart. So, his GP prescribed an
anti-depressant.
Chris A: “I became a totally different
person. I started getting into altercations with people at
school and getting into fights. I never used to get into
fights, I’m not the kind to fight, but things got out of hand
real quick.”
He says that over a period of five years
doctors put him on just about every ant-idepressant on the
market.
Chris A: “It was common, especially in my high
school, for kids to be on anti-depressants but it’s just
weird, you know, because you think, ten to fifteen years ago
kids probably just dealt with stuff like that.”
Derek
[to Dr Glenmullen]: “Joe, it seems that anti-depressants are
almost a cultural phenomenon?”
Dr Glenmullen: “They
have become that. When you get ten percent of a population
taking a drug, they certainly have been.”
In America 70
percent of anti-depressant prescriptions are written by GPs.
In South Africa the picture is not that
different.
Chris: “I would say there is a lot of
prescribing of anti-depressant medication. It’s often been a
concern of mine that the extent to which these medications are
prescribed almost trivialises the condition of
depression.”
Dr Glenmullen: “They’ve been advocated for
people with no psychological symptoms at all to feel better
than well. So that’s how you get such large numbers of people
taking them
Professor Szabo is generally cautious when
prescribing anti-depressants, but particularly when it comes
to adolescents.
Chris: “My understanding of adolescent
depression is that one always looks at more psycho social
intervention as a first line.”
Chris A: “I could have
snapped out of it on my own over time. I think I was just so
confused all the time.
Confusion that he says nearly
ended in tragedy.
Chris A: “It actually got so bad and
I was so confused that at one point I was sitting in my room,
I had a shotgun in my mouth.”
In that moment a friend
walked in.
Derek: “You were seconds away from taking
your life?”
Chris A: “Milliseconds. Had she not opened
the door at that time, probably.”
Chris insists his
medication led him to this extreme act.
Chris A: “That
wasn’t me. Had I not have taken any of that medicine I’m fully
confident that that thought probably would have never… well, I
can’t say never crossed my mind, but it would have never been
that real to the point where I had a gun in my mouth. It would
have never escalated to that. Never.”
Again, most of
the medical world disagrees.
Chris: “The truth of the
matter is in medicine there are no absolutes, so I cannot sit
here and say it’s impossible, that that would never happen, I
think that that would never be the case. I think one has to be
wary though of making a simple cause and effect, because one
has to have an understanding of the nature of the condition
where suicidal thoughts can emerge. Suicidal thoughts can be
present, and not necessarily as a consequence of
medication.”
Of this, Elli Lilly’s clinical expert, Dr.
Frans Korb is convinced.
Dr. Frans Korb (Clinical
Expert, Elli Lilly): “Specifically with Prozac the clinical
trials have shown that the incidence of suicidal thoughts or
suicidal idealisation is the same as placebo. So it shows that
there isn’t an increase of suicidal thoughts.”
Derek:
“But front studies have been done, university studies have
been done, books have been written, saying just the opposite;
that it’s not just a result of depression, it’s a result of
the drug in a small minority.”
Dr. Korb: “Well that is
always very difficult and I think the current situation with
the FDA has actually made it very clear that suicidal
idealisation or worsening of suicidal symptoms is actually due
to the drug or due to the disease.”
Over at Glaxo
Smith Kline, Dr Navin has no doubts whatsoever.
Dr
Singh: “Firstly we disagree that Aropax causes suicide. There
is no reliable evidence.”
Derek: “Surely you can only
disagree if you’ve done the tests. My question is really, have
you done the tests?”
Dr Singh: “We have done in our
clinical trial program, and have looked at people from various
sectors and there is no clinical evidence that shows that
Aropax causes suicides, aggressive tendencies or induces
patients’ homicide.”
Derek: “Will you be able to show
me those studies?”
Dr Singh: “Our clinical research
data is available for everyone who wants to look at
them.”
Derek: “But surely you can’t show me the results
of the tests?”
Dr Singh: “Our clinical trial results
are available publicly. We have a policy where we declare all
our clinical policy results.”
That’s policy, but still
he couldn’t direct us to a single specific clinical
trial.
Dr Glenmullen: Well, particularly the industry
has tried to dismiss this side effect by blaming the victims,
by blaming their underlying psychiatric conditions -
particularly depression. However, many of [the] people who
have gotten this side effect weren’t depressed to begin with.
They’ve also tried to dismiss legitimate medical case reports
as anecdotes. And lastly, they’ve tried to frighten the media
and the public away from the side effects saying, ‘Oh these
patients need their medication if you tell them about this you
might scare them away from treatment’. Well let me tell you,
to all patients there is nothing more scary than getting side
effects, and not being told about it. And there is no room in
modern medicine for that authoritarian approach with a side
effect like this.”
SSRI anti-depressants continue to
help millions of people worldwide.
** Under no
circumstances should you discontinue medication without strict
medical supervision.
IMPORTANT DISCLAIMER: While every
attempt has been made to ensure this transcript or summary is
accurate, Carte Blanche or its agents cannot be held liable
for any claims arising out of inaccuracies caused by human
error or electronic fault. This transcript was typed from a
transcription recording unit and not from an original script,
so due to the possibility of mishearing and the difficulty, in
some cases, of identifying individual speakers, errors cannot
be ruled out.
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