JAGGED LITTLE PILLS

[Guest guest]

Many psychiatrists are now arguing that these antidepressants have been oversold

and overprescribed, while others claim the method of evaluating the drugs

through clinical trials is flawed. But there are plenty of psychiatrists

and patients who are dismayed by the attacks, saying the drugs are being

unfairly ? and dangerously ? vilified

I've been in an e-mail fest with Dr. Shelton from Vanderbilt who was quoted in the NYT article yesterday, saying that withdrawal from Paxil is mild and only lasts from 1 - 10 days. After several flurries of e-mails back and forth, he finally proposed to me that I should stop complaining about Paxil and get involved in some kind of gene study he's doing to find out why some people have such bad experiences with this drug. Needless to say, I wrote back that this concept was too Orwellian for me and it smacked of blaming the victim by the drug companies saying, "Hey, it's not our fault that you have brain damage from taking our neurotoxin, it's your faulty genes to blame." I was appalled that they are now going to try and prove that side effects are genetic. UGH!!!

Blind Reason

a novel of espionage and pharmaceutical intrigue

Think your antidepressant is safe? Think again.

An army of sheep led by a lion would

defeat an army of lions led by a sheep.

- Oriental proverb

[Guest guest]

Hi Glitter ,

I would love for Dr Shelton to say that to someone's face who is 10 days off Paxil.I want to watch it could be real interesting especialy if they went cold turkey.''Oh'' and about the gene thing, I guess that makes me and you related eh?.I wonder if us being Celts is anything to do with it.''LOL''.

Why do these Dr's talk like they have some experience about these drugs. Unless they have taken them then they have no right to open their big fat gobs and spout out a bunch of shit. 1 -10 days if only it had been I might have been able to forgive the Barstewards.

Hugs Ros

[Guest guest]

JAGGED LITTLE PILLS

The Bulletin with Newsweek, May 26, 2004

http://bulletin.ninemsn.com.au/bulletin/EdDesk.nsf/All/169F283BE2E8784DCA256E9D0\

0707567

The new generation of antidepressants was hailed as a godsend by many sufferers,

their families and doctors. A decade later, their safety and effectiveness

are under a cloud. -Anne Davies reports.

They were the superstar drugs of the 1990s, the magic bullets credited with

destigmatising mental illness and saving lives. But the reputation of the

Prozac generation of antidepressants is now under sustained attack and the

stakes couldn't be higher. Their efficacy is being re-evaluated by doctors,

regulatory authorities and we the guinea pigs who have been swallowing the

pills in their millions for more than a decade.

Amid mounting international concerns over whether selective serotonin reuptake

inhibitors (SSRIs) and other related antidepressants are dangerous in treating

depressed children, an investigation by The Bulletin has found that thousands

of Australians have suffered serious side effects, including a number of

deaths associated with their use.

British health authorities have already ruled Prozac the only SSRI safe enough

for children with depression. Australia and the US are still evaluating the

evidence but have placed strict caveats on their use by children and adolescents

in the interim. Australian doctors have written more than 50 million

prescriptions

for these drugs since the first SSRI, Prozac, was approved for sale here

in 1992.

Last year, 8.3 million prescriptions were issued, according to Health Insurance

Commission figures, at a cost to the Pharmaceutical Benefits Scheme of $270m.

But an investigation by The Bulletin into their use in Australia has found

the following:

A total of 61 deaths associated with these drugs has been reported to the

Therapeutic Goods Administration.

Patients have reported more than 7000 instances of adverse drug reactions.

More than half of all drug-withdrawal syndrome reports to the TGA concern

SSRIs.

An internal US Food and Drug Administration report casts significant doubt

on the efficacy of Zoloft ? the most commonly prescribed SSRI in Australia

? in treating depression.

According to the memo written by a former FDA official, Dr Leber, in

1991, there were concerns within the FDA that the approval of Zoloft might

" come under attack " because the FDA was not " as demanding as it ought to

be in regard to its standards for establishing the efficacy of antidepressant

drug products " .

Leber said: " I have considered the fact that the evidence marshalled to support

Zoloft's efficacy as an antidepressant is not as consistent or robust as

one might prefer it to be. "

Many psychiatrists are now arguing that these antidepressants have been oversold

and overprescribed, while others claim the method of evaluating the drugs

through clinical trials is flawed. But there are plenty of psychiatrists

and patients who are dismayed by the attacks, saying the drugs are being

unfairly ? and dangerously ? vilified.

Professor Henry, a former member of Australia's Pharmaceutical Benefits

Advisory Committee and an expert in clinical pharmacology at the University

of Newcastle, has told The Bulletin the scientific evidence on these drugs

is " breathtakingly inadequate " .

" The standards of evidence applied to other drugs by regulatory authorities

have simply been forsaken with these antidepressants, " Henry says. " We have

no clear idea how well these drugs work. "

British psychiatrist and SSRI critic Professor Healy, who has appeared

as an expert witness in a number of court cases involving the drugs, says

Australians should be concerned about the high numbers of negative side effects

reported to the TGA.

In particular, he claims Sertraline (better known as Zoloft) is prescribed

far more often in Australia than elsewhere in the world. " And this is the

drug the FDA said barely works, " Healy says. Sertraline is associated with

30 deaths in Australia since it was first marketed in 1994 and also accounts

for the most adverse reactions reported to the TGA.

Healy is especially critical of the Australian Health Insurance Commission,

whose data collection he claims is grossly inadequate. " Your regulators don't

have a feel for this issue at all, " Healy says. " We have tried to get data

out of Australia as part of our research on long-term usage of SSRIs

internationally

and I have to say that, when it comes to finding out who ends up on the drugs

and for how long, we enter a void. The drug companies know, of course, so

it's great for their business but Third World when it comes to the man in

the street. "

Australia's enthusiasm for these drugs mimics the overseas experience and

is understandable. SSRIs offered the first genuine breakthrough in the treatment

of depression since the advent of chemical cures for mental illness (tricyclic

antidepressant) more than 40 years ago. Patients and doctors gobbled up the

pharmaceutical company hype and with good reason. They were safer, cleaner

and their side effects seemed negligible compared with the old medications.

Suddenly it became OK to admit you were depressed because Prozac seemed a

benign kind of drug. It just made you happier, didn't it?

But there has been a cost. Since 1996, the TGA has issued 10 reports ? a

high number compared with many other drugs ? in its Adverse Drug Reactions

Bulletin warning of serious side effects associated with SSRIs. These have

included reports on withdrawal syndrome, neonatal disorders, bleeding and

bruising, urinary problems, sexual dysfunction, eye problems, convulsions

and serotonin syndrome, which can cause combinations of symptoms such as

agitation or confusion with sweating or shivering and muscle shakes and tremors.

And what about addiction? With so many of us swallowing these pills, many

people, notably patients, are worried that we are heading for a repeat of

the benzodiazepine disaster. Valium, another pharmaceutical cultural icon,

was the drug of choice for the worried well in the 1960s and 1970s amid

assurances

by the drug companies it wasn't addictive. They got it wrong and today, 40

years on, benzo addiction is still a major health problem.

SSRIs are not seen to be as toxic as the benzos and the argument is often

reduced to semantics by many doctors who say SSRIs and their cousins, such

as the newer antidepressant Venlafaxine (marketed as Efexor) ? which has

been implicated in 10 reported deaths to the TGA since 1996 ? are not addictive

because they don't produce the same drug-abuse behaviour of opiates such

as heroin.

But check out one of the many chat rooms on the internet devoted to the subject

of SSRIs and there are hundreds of messages posted by users complaining of

withdrawal symptoms that include nausea, agitation, " brain shake " ? a commonly

described condition among SSRI users in which they experience something akin

to an electrified dizziness ? insomnia, sweating, tremors. The list goes

on.

" I have been on Celexa [Citalopram] for almost a year now, " writes one SSRI

user. " It helps me tremendously with my depression; however, if I even miss

one day, I get extremely sick. I have also noticed fatigue after I take it

and a lack in my sex drive. Is this normal? My doctor doesn't seem to realise

how bad this is for me. "

But for millions of people, the trade-off is worth it. " The new antidepressants

[i take Zoloft] are absolutely wonderful, " says another. " I would rather

be dependent on them for the rest of my life than suffer one more day of

depression. "

The TGA's chief medical officer, Dr McEwen, cautions against drawing

overly negative conclusions based on the TGA's data, saying the reports are

" signals " of possible problems with the drugs.

" Yes, there are significant numbers of adverse effects reports for SSRIs

but these drugs are used by large numbers of people, " McEwen says. " When

they came on the market, they took over from a group of drugs that had serious

side effects and the hope was that these would be better. In the main, they

are but they do have significant adverse effects and we're still grappling

with that. "

Many argue ? and McEwen doesn't disagree ? that the numbers of reports received

by the TGA probably represents only a fraction of the real numbers of adverse

side effects caused by the drugs. It is a voluntary reporting system for

doctors, although drug companies are compelled to report serious side effects.

Jon Jureidini, in his job as head of the department of psychological medicine

at the Adelaide Women's and Children's Hospital, routinely sees children

diagnosed with depression and who have been prescribed SSRIs by GPs despite

the fact none of the drugs is licensed in Australia for such use. He estimates

the real number of side effects should be multiplied by a factor of 10.

" Doctors just don't report, it's as simple as that, " he says. " They are

especially

hesitant to report adverse effects associated with psychiatric illness and

drugs. " He is a trenchant critic of the drug companies and what he sees as

their " insidious " presence in psychiatry. " Just about everything we do

educationally

in psychiatry is funded by them; it is especially bad in this area of medicine. "

Jureidini says that, although there is plenty of very good research proving

that SSRIs perform only marginally better in drug trials than placebos, many

doctors refuse to accept this. " Their reasoning seems to be, 'We know in

our hearts they work', despite what the evidence now emerging is telling

us. "

This is one of the most contentious issues in the international debate over

whether these drugs work or cause harm. The genie was let out of the pill

bottle in 2002 when University of Connecticut psychologist Irving Kirsch,

using freedom-of-information laws, obtained details from the FDA of all clinical

trials sponsored by the drugs' makers. This included unpublished data on

safety and effectiveness.

Kirsch found that those patients taking placebos (sugar pills, in other words)

in drug trials experienced 80% of the benefits measured in people taking

the real thing: drugs such as Prozac, Zoloft and Efexor. " The pharmacological

effects of antidepressants are clinically negligible, " was the damning

conclusion.

Too easy, says Professor Gordon from the University of NSW who has

a different take on the efficacy argument. He agrees with concerns about

the drug trials that form the basis of decision-making by regulatory authorities

such as the TGA and FDA but he argues that the lack of clear proof that the

SSRIs perform much better than placebos in these trials is more a problem

with the methodology, not the drugs themselves.

" We need to weigh observation and common sense as much as theory and science, "

says. " The trials deserve to be criticised because of the way they

are set up, the patients selected, all kinds of things. But psychiatrists

know that, in practice, these drugs do work. "

He thinks it will be a tragedy if the TGA rules that the SSRIs can no longer

be prescribed in children. " These drugs can be of dramatic benefit in both

adults and children but the checks and balances must be there. I see a number

of adolescents and the benefits are huge. The phenomenon of severe agitation

that is the kernel of the current concerns in under-18s is a severe but rare

thing.

" I always warn pat-ients about it and that is something I don't have to do

with many other drugs. But I would hate to see them removed because of

mischief-making

by some of my colleagues. "

Jureidini is watching the TGA carefully, too. He says the drug regulator

is dragging its feet in not following the British lead in banning all SSRIs

with the exception of Prozac for anyone under the age of 18. " If they come

up with a softer line than the British, then you would have to question whether

they've been influenced by doctors who have cosy relationships with the drug

companies. "

It's a reasonable question but one that not too many doctors these days are

keen to answer, at least not without a flak jacket and an armful of scientific

reports.

In addition to depression, SSRIs are marketed for Obsessive-Compulsive Disorder,

Post-Traumatic Stress Disorder, Social Anxiety Disorder, Pre-Menstrual Dysphoric

Disorder and Panic Disorder. Various drug companies have also experimented

with their respective SSRIs for other indications including obesity, drug

abuse and smoking cessation, although these indications have not been marketed.

For the existing indications alone, however, the drug companies collectively

make more than $6bn per year from SSRIs.

[Guest guest]

Good for you! Sounds like the drug companies are peddling hard for excuses.

My guess is they'll use that one in court.

Debs

>-- Original Message --

>To: Withdrawal_and_Recovery

>From: glitterari@...

>Date: Thu, 27 May 2004 22:03:25 EDT

>Subject: Re: JAGGED LITTLE PILLS

>Reply-To: Withdrawal_and_Recovery

>

>

>In a message dated 5/27/04 7:42:21 PM Mountain Daylight Time,

>debs_n@... writes:

>

>

>> Many psychiatrists are now arguing that these antidepressants have been

>

>> oversold

>> and overprescribed, while others claim the method of evaluating the drugs

>> through clinical trials is flawed. But there are plenty of psychiatrists

>> and patients who are dismayed by the attacks, saying the drugs are being

>> unfairly ? and dangerously ? vilified

>

>I've been in an e-mail fest with Dr. Shelton from Vanderbilt who was quoted

>

>in the NYT article yesterday, saying that withdrawal from Paxil is mild

and

>

>only lasts from 1 - 10 days. After several flurries of e-mails back and

>forth,

>he finally proposed to me that I should stop complaining about Paxil and

>get

>involved in some kind of gene study he's doing to find out why some people

>have

>such bad experiences with this drug. Needless to say, I wrote back that

>this

>concept was too Orwellian for me and it smacked of blaming the victim by

>the

>drug companies saying, " Hey, it's not our fault that you have brain damage

>from

>taking our neurotoxin, it's your faulty genes to blame. " I was appalled

>that

>they are now going to try and prove that side effects are genetic. UGH!!!

>

>

>

>

>Blind Reason

>a novel of espionage and pharmaceutical intrigue

>Think your antidepressant is safe? Think again.

>

>

>An army of sheep led by a lion would

> defeat an army of lions led by a sheep.

>- Oriental proverb

>

>

>

[Guest guest]

http://groups.yahoo.com/group/socialWandR/ here you go it's normaly at the bottom of posts i am surprized you have not seen it.It's for when we talk off subject of withdrawal about other things.I will send you her off topic letter seeing as you missed it ok.

Hugs Ros