ANTIDEPRESSANTS: Murder-Suicide: 81 Year Old Man Kills Wife & Self: En…

Note From Ann Blake-Tracy: I do not know if I can tolerate reading another one of these stories!
This last week I went to the Iowa State Fair for the first time with my daughter and her family who were visiting. While riding the trolley through the fair the man sitting across from me asked an elderly couple as they got off how many years they had been together.
They answered that it was 53 years. And he wished them the best for their next 53 years together.
They smiled and said “Thank you.”
As we drove on I looked at the man across from me and said, “As long as neither of them take an antidepressant they should do okay.” And I went on to share with them how many of the absolutely horrifying reports we are getting of elderly couples, married for many years, killing one another.
I then returned home to open this report of yet another horrific tragedy for a couple who had been married a few years longer than the couple I had just met on the trolley  . . . there is just no excuse for this to continue! How sad! I is NORMAL for a man who has worked all of his life to become depressed if he has to sell his business. It is NOT a reason to medicate him!
What an absolutely horrific way to end a life of 60 years together. I hope their children know what really happened in the loss of their parents instead of one woman I met after one of my lectures who came forward crying. As she reached me she said, “I cannot thank you enough for helping me to finally have answers to why my father killed my mother and then himself 20 years ago while taking one of the older antidepressants!”
Dr. Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness

Website: &
Author: Prozac: Panacea or Pandora? – Our Serotonin Nightmare
& CD or audio tape on safe withdrawal: “Help! I Can’t Get
Off My Antidepressant!”
Order Number:

Paragraph seven reads:  “The court heard how Mr Mann became depressed after he sold his business in 2000 and from 2002 to 2005 was placed on anti-depressants, and again in 2008 after a reoccurrence of the mental illness.”

Depressed pensioner bludgeoned wife to death before drowning himself

Published Date:
12 August 2009
By Charles Heslett

A pensioner bludgeoned his wife of almost 60 years to death before drowning himself in the bath.

Police discovered the body of retired sales rep Doreen Mann, 80, sprawled in the living room of the house she shared with husband Kenneth.

The retired factory owner, 81, was found dead upstairs face down in a bath full water wearing only his vest and underpants.

Officers took away a hammer, a craft knife and another knife from the scene at Foxroyd Lane, Thornhill Edge, Dewsbury, after the alarm was raised by a visiting mental health nurse on December 23 last year (2008].

An investigation was launched at the time by West Yorkshire Police’s Homicide & Murder Inquiry Team.

But Detective Sergeant Ian Lawrie told Wednesday’s inquest at Huddersfield Coroner’s Court that no-one else was being sought in connection with the death of the couple, who were both born in Leeds and had been married for 57 years.

The court heard how Mr Mann became depressed after he sold his business in 2000 and from 2002 to 2005 was placed on anti-depressants, and again in 2008 after a reoccurance of the mental illness.

On December 18, 2008, he and his wife were visited by psychiatrist Dr Vinood Shukla and a psychiatric nurse, the court heard.

A psychiatric nurse came to the red-bricked home called Kendoreen, where the couple had lived for 21 years, at 2.30pm on December 23.

After getting no answer from the front door apart from the couple’s barking collie dog, the nurse saw a bathroom light on and called police.

Detectives found the two knives and the hammer close to Mrs Mann’s body.

Her cause of death was later found to be a blow to her head and cut wounds to her neck and forearms.

Mr Mann’s corpse was found in an upstairs bathroom, face down in a full bath – his cause of death was given as self-drowning.

Barbara Moore told the inquest three weeks before her sister’s death Doreen had said she feared her husband might harm her.

West Yorkshire Coroner Roger Whittaker described the deaths as a “double tragedy”.

He recorded a verdict that Mrs Mann was unlawfully killed and that her husband drowned.

Mr Whittaker said he was satisfied that the balance of Mr Mann’s mind was disturbed at the time of his death and “that imbalance…was present at the time of the death of his wife“.

Mr Whittaker added that Mr Mann had given no indication on December 18 that he intended to harm his wife and that Mrs Mann had raised no similar concerns.

But the coroner said lessons “had been learned” by the mental health trust involved.

A South West Yorkshire Partnership NHS Foundation Trust spokeswoman said: “The Trust re-iterates its sincere sympathies to the family and others affected by these tragic deaths.

“The circumstances have been thoroughly investigated, and we are grateful to the family for their input into this.

“Sadly, we cannot change the tragic events that happened but we can learn from them and a number of changes have been made as a result.”

These included: Improved systems for referrals between services and exchange of information; Improved training for staff on assessing risk; Improved record keeping following home visits.

The spokeswoman added: “The investigation findings have been shared with the family and we are continuing to offer support as appropriate.”

The full article contains 574 words and appears in n/a newspaper.
Page 1 of 1

  • Last Updated: 12 August 2009 4:14 PM
  • Source: n/a
  • Location: Leeds

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Zoloft SSRI Antidepressant Destroyed my Life

It’s now August of 2009, just past a year after being discharged from the psychiatric hospital.  I’ve been off Zoloft since March 2009 and am finally feeling like a human being again.  Fortunately, I don’t seem to have any neurological damage, memory impairment, concentration troubles or other lasting symptoms.

I’m 48 years old and my introduction to Zoloft began when I was 34. I’ve since learned that the symptoms of fatigue and difficulty sleeping and concentrating that I was having at that time were due to over-work and adrenal exhaustion. That doctor had me fill out a questionnaire and then spent maybe 10 minutes with me before giving me free samples of Zoloft.   Had I known then, what I know now?… And I must forgive the past and not dwell on it in order to heal.

In June of 2008, my nutritionist who was treating me with amino acid therapy took me off Zoloft abruptly.  This caused me to go into a manic state, which I had never experienced before.  It also brought up a lot of anger.  After about a ten days, my wife and I figured out it was the discontinuation of Zoloft that was causing all these problems, so I went back on it.

Because of all my weird behavior, I had left the house and was staying at a hotel.  My wife got my sister involved and she stayed with me for a couple of days but didn’t bring along her bi-polar medications.  I remember distinctly the night of July 13th:  I slept from about 9pm to 5am, went for a work out and did my meditation.  I was definitely stabilizing.

Then my sister took me into town, my wife and I had another fight and, in my anger and frustration, I broke the rear view mirror off my sister’s car.  This caused her to freak out.  We had picked up her meds and agreed to go back to the hotel and take a nap.  I later learned that she had already called the police.

When we arrived at the hotel, the cops came to my door (hands on their holstered guns) and ordered me out of the car.  They hand cuffed me, searched me and put me in the squad car.  Then, as I later learned, my sister and wife had a discussion about “wether or not to tell the police that I had threatened her.”  My sister told the police a lie, that I had threatened her with a gun and I was hauled off to the ER where I was doped up with an injection.

Later I was taken to the psychiatric hospital where I was asked to sign a bunch of forms and “releases.”  How absurd!  I was only semi-consicouss at the time.

At the hospital I was taken off the Zoloft and diagnosed as bi-polar.  Of course, this through me into another withdrawal episode and made me manic and aggressive again.

I want to point out that I have no history of violence, have never been in any sort of brawl, have never been arrested, have never before been put in handcuffs, no DUI tickets and even a clean driving record.

The hospital changed my drugs every few days.  Zyprexa, Lithium, Depakote, Abilify, etc.  After 20 days, I was discharged. The insurance and family money was expended, so I was well, right?

Far from it:  My wife filed for divorce.  I lost access to my home, which was also my office.  She cleaned out the company bank account, etc.

Eventually, I lost pretty much everything and got saddled with all our debt and received none of the assets due to a waiver of “appearance” I signed 3 days out of the hospital.  We had agreed on a negotiated, one lawyer divorce, but I ended up getting totally screwed.

Over the past 12 months, I’ve lived in 5 states.  I’ve had a couple of “room and board” jobs and stayed with friends.  Fortunately, my mother has been able to give me some financial support, so I haven’t been without the basic necessities of life.  Through a friend, I found Ann Blake-Tracy and she helped me understand what happened to me and gave me phone support while I finished the detox from the Zoloft these past few months.

Now, I’m well enough that I’m looking for  a job again so I can restart my life.

I’m certainly not bipolar.  What a bunch of total bullshit.  All I’m taking right now is 0.5 mg of Klonopin (Clonazepam) twice a day to help with anxiety and sleep.

I used to have a pretty normal life.  I made a six figure income.  My wife (18 years of marriage) didn’t have to work. We had a nice house and the swimming pool I had wanted since I was a child.  Now, all that’s gone.  All because of a stupid little pill and all the people that don’t know what the hell their doing with all these powerful drugs.

During the 13 years I was on SSRI Antidepressants, I saw several different psychiatrists and doctors.  They experimented on me with many different drugs: Effexor, Celexa, Abilify, Alprazolam, Clonazepam (Klonopin), Depakote, Lunesta, Trazodone, Xanax, Zyprexa and of course Zoloft (Sertraline).

Of all the drugs, Lamictal was the worst.  Once the doctor increased the dose from 50 mg a day to 200 mg a day (I’ve since found out that is NOT an increase in accordance with the manufacturers instructions) I had horrible, disgusting nightmares every single night and became highly suicidal.  This happened in October of 2008, and freaked me out so much that I went back on Zoloft and some other drugs so that I could get my sleep.

During all these crazy times, I have survived because of my spiritual faith, the generosity of my mother and some good friends and Divine Grace.  Also, because of the various nutritionists I’ve had over the years, I’ve learned how to eat well and take the right supplements.  Cenitol by metagenics is magnesium supplement that has been especially helpful with relaxing me and helping me sleep.  I order that online at:

Lastly, I would like to mention that none of these doctors I saw gave me any sort of what I would call informed consent.  I was never informed about all the adverse reactions and side-effects that I’ve now learned were well known back then.  None of the doctors explained that, according to their view of brain chemical imbalance, I would need to stay on these SSRI Antidepressants for the rest of my life.  None of the doctors EVER explained discontinuation syndrome etc, etc, etc.

These drugs manufactures and the doctors that push these drugs are all involved in a horrible scam, the tragic consequences of which yet to become fully manifest.

My intense gratitude to Ann Blake-Tracy and the good work she is doing!

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SSRI Antidepressant- Manie’s Story Paxil and birth defects

My son, Manie, was born with a rare heart defect because I took Paxil during my first three months of pregnancy. Manie had to have a hole ripped into his heart shortly after birth to save his life. At eight days old he had a 12hr. open heart surgery.

Manie is 5 yrs old now. He has a leaky valve which was caused by the open heart surgery. He has been on numerous medications. One of the medications he takes daily is for high blood pressure. He has been on this medication since he was one week old.

Manie has also suffered with severe acid reflux. This has cause extensive damage to his teeth and damage to his throat. Manie also experiences severe stomach cramps multiple times during the day and night. During the night he not only wakes from stomach cramps he often wakes screaming and crying because of arm and leg cramps.

When Manie was a year old it was discovered through a cardiac cath. he has collaterals (vessels) growing off of both sides of his heart. These collaterals attach to the arteries that go to his lungs. Manie has had to have several coils placed into the collaterals to plug them up. You can read more about Manie at

Thank You,
Julie Edgington

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List of SSRI Antidepressants and Common Psychiatric Drugs

Abilify, Adapin, Adderall, Alepam, Alertec, Aloperidin, Alplax, Alprax, Alprazolam, Alviz, Alzolam, Amantadine, Ambien, Amisulpride, Amitriptyline, Amoxapine, Anafranil, Anatensol, Ansial, Ansiced, Antabus, Antabuse, Antideprin, Anxiron, Apo-Alpraz, Apo-Primidone, Apo-Sertral, Aponal, Apozepam, Aripiprazole, Aropax, Artane, Asendin, Asendis, Asentra, Ativan, Atomoxetine, Aurorix, Aventyl, Axoren

Beneficat, Bimaran, Bioperidolo, Biston, Brotopon, Bespar, Bupropion, Buspar, Buspimen, Buspinol, Buspirone, Buspisal

Calepsin, Calcium carbonate, Calcium carbimide, Calmax, Carbamazepine, Carbatrol, Carbolith, Celexa, Chlordiazepoxide, Chlorpromazine, Cibalith-S, Cipralex, Citalopram, Clomipramine, Clonazepam, Clozapine, Clozaril, Concerta, Constan, Convulex, Cylert

Dalmane, Dapotum, Defanyl, Demolox, Depakene, Depakote, Deprax, Deprilept, Deroxat, Desipramine, Desirel, Desoxyn, Desyrel, Dexedrine, Dextroamphetamine, Dextrostat, Diapam, Diazepam, Dilantin, Disulfiram, Divalproex, Dogmatil, Doxepin, Dozic, Duralith

Edronax, Efectin, Effexor (Efexor), Eglonyl, Einalon S, Elavil, Endep, Epanutin, Epitol, Equetro, Escitalopram, Eskalith, Eskazinyl, Eskazine, Etrafon, Eukystol

Faverin, Fazaclo, Fevarin, Finlepsin, Fludecate, Flunanthate, Fluoxetine, Fluphenazine, Flurazepam, Fluvoxamine, Focalin

Geodon, Gladem

Halcion, Halomonth, Haldol, Haloperidol, Halosten

Imipramine, Imovane

Janimine, Jatroneural

Kalma, Keselan, Klonopin

Lamotrigine, Largactil, Levomepromazine, Levoprome, Leponex, Lexapro, Libritabs, Librium, Linton, Liskantin, Lithane, Lithium, Lithizine, Lithobid, Lithonate, Lithotabs, Lorazepam, Loxapac, Loxapine, Loxitane, Ludiomil, Lunesta, Lustral, Luvox, Lyogen, Lecital

Manegan, Manerix, Maprotiline, Mellaril, Melleretten, Melleril, Meresa, Mesoridazine, Metadate, Methamphetamine, Methotrimeprazine, Methylin, Methylphenidate, Minitran, Moclobemide, Modafinil, Modalina, Modecate, Moditen, Molipaxin, Moxadil, Murelax, Myidone, Mylepsinum, Mysoline

Nardil, Narol, Navane, Nefazodone, Neoperidol, Norebox, Normison, Norpramine, Nortriptyline, Novodorm

Olanzapine, Omca, Orap, Oxazepam

Pamelor, Parnate, Paroxetine, Paxil, Peluces, Pemoline, Permitil, Perphenazine, Pertofrane, Phenelzine, Phenytoin, Pimozide, Piportil, Pipotiazine, Pragmarel, Primidone, Prolift, Prolixin, Protriptyline, Provigil, Prozac, Prysoline, Psymion


Ralozam, Reboxetine, Resimatil, Restoril, Restyl, Rhotrimine, Risperdal, Risperidone, Rispolept, Ritalin, Rivotril, Rubifen, Rozerem

Sediten, Seduxen, Selecten, Serax, Serenace, Serepax, Serenase, Serentil, Seresta, Serlain, Serlift, Seroquel, Seroxat, Sertan, Sertraline, Serzone, Sevinol, Sideril, Sigaperidol, Sinequan, Sinqualone, Sinquan, Sirtal, Solanax, Solian, Solvex, Songar, Stazepin, Stelazine, Stilnox, Stimuloton, Strattera, Sulpiride, Sulpiride Ratiopharm, Sulpiride Neurazpharm, Surmontil, Symbyax, Symmetrel

Tafil, Tavor, Taxagon, Tegretol, Telesmin, Temazepam, Temesta, Temposil, Terfluzine, Thioridazine, Thiothixene, Thombran, Thorazine, Timonil, Tofranil, Trancin, Tranax, Trankimazin, Tranquinal, Tranylcypromine, Trazalon, Trazodone, Trazonil, Trialodine, Triazolam, Trifluoperazine, Trihexane, Trihexyphenidyl, Trilafon, Trimipramine, Triptil, Trittico, Tryptanol

Valium, Valproate, Valproic acid, Valrelease, Venlafaxine, Vestra, Vigicer, Vivactil


Xanax, Xanor, Xydep

Zamhexal, Zeldox, Zimovane, Zispin, Ziprasidone, Zolarem, Zoldac, Zoloft, Zolpidem, Zonalon, Zopiclone, Zydis, Zyprexa

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Paxil: Iraq War Vet Suicidal: Holds Police At Bay for 9 Hours: Michigan

Note from Ann Blake-Tracy: Yet another suicidal vet who first overdosed on his
antidepressant and Xanax and then became homicidal enough that he was going
to shoot police – often in an attempt to commit what is now called suicide
by cop. These drugs produce both suicide and violence as we see once again
in this case.

First three sentences read: "A suicidal veteran who held Howell Police at
bay for more than nine hours Thursday night into early this morning is
hospitalized and undergoing psychiatric evaluation. Howell Police Chief George
Basar says that just before 6 oâ

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Virginia Tech Gunman’s Mental Records Found

Note from Ann Blake-Tracy: The most important records in this case have never
been released. These may be interesting but we still need to know what he had
been prescribed over the period of time before the shooting. Roommates
spoke of him taking his antidepressant that morning, but then we never heard
another word about it.


By BOB LEWIS and SUE LINDSEY, Associated Press Writers Bob Lewis And Sue
Lindsey, Associated Press Writers â

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Experts: Women are drinking more, DUIs are up 28.8% from 1998-2007

Note from Ann Blake-Tracy: After researching and warning for two decades that this crisis with alcohol consumption would come, I can tell you the reason so many women are now drinking is because they are the main ones taking antidepressants which in turn cause overwhelming cravings for alcohol. And it has long been known that women suffer more adverse reactions to antidepressants than men do.

But why cravings for alcohol? These drugs drop the blood sugar causing cravings for sugar and/or alcohol and NutraSweet. Sugar and alcohol initially bring the blood sugar up quickly causing one to instinctively reach for them in a “self medicating” way because they quickly address the low blood sugar level. The problem with doing this is that both substances then drop the sugar levels even lower than before thus producing a vicious cycle of craving more and more sugar and/or alcohol. (To read the science behind this go to
Another aspect to this increased use in alcohol being tied to antidepressant use is the fact that antidepressants produce mania or Bipolar Disorder so frequently. (See the research article we posted earlier this week showing that 81% of those diagnosed with Bipolar Disorder have been found to have previously taken antidepressants or Ritalin.)
Initially doctors refused to prescribe the first SSRI, Prozac, because of its strong potential to chemically induce mania. There are several types of mania that are recognized. Many have never even heard of these types of mania. And most do not think of these various types of mania when they hear the term Bipolar. Let’s list just a few to shed some additional light on this drinking problem women, who have always taken more antidepressants than men, have developed since these drugs have become so widespread in use.

Pyromania: A compulsion to start fires
Kleptomania: A compulsion to embezzle, shoplift, commit robberies
Dipsomania: An uncontrollable urge to drink alcohol
Nymphomania and erotomania: Sexual compulsions – a pathologic preoccupation with sexual fantasies or activities

So there it is in black and white plain as day – one of the forms of mania, dipsomania, is described as an “uncontrollable urge to drink alcohol.” Could it be any clearer?

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And look at one of the comments from the article below:
“Younger women feel more empowered, more equal to men, and have been beginning to exhibit the same uninhibited behaviors as men,” said Chris Cochran of the California Office of Traffic Safety.
Does that not describe manic behavior – “empowered” or all powerful with grandiose thoughts of one’s self and “uninhibited”? Those have always been earmarks warning of mania.
Hopefully this news about women and drinking will FINALLY wake America up to what first caught my attention with the use of antidepressants – the OVERWHELMING out-of-character cravings for alcohol that is produced by these drugs. (Find much more additional information on this subject at
Ann Blake Tracy, Ph.D., Executive Director,
International Coalition For Drug Awareness
Website: &
Author: Prozac: Panacea or Pandora? – Our Serotonin Nightmare
& CD or audio tape on safe withdrawal: “Help! I Can’t Get
Off My Antidepressant!”
Order Number:

Experts: Women are drinking more, DUIs are up*

AP – Graphic shows driving under the influence arrests for men and women for 1998 and 2007; includes alcohol-impaired …
By LISA A. FLAM, Associated Press Writer Lisa A. Flam, Associated Press Writer 10 mins ago

NEW YORK – It seemed too horrendous even to imagine. But the case of the mother who caused a deadly wrong-way crash while drunk and stoned is part of a disturbing trend: Women in the U.S. are drinking more, and drunken-driving arrests among women are rising rapidly while falling among men.

And some of those women, as in the New York case, are getting behind the wheel with kids in the back.

Men still drink more than women and are responsible for more drunken-driving cases. But the gap is narrowing, and among the reasons cited are that women are feeling greater pressures at work and home, they are driving more, and they are behaving more recklessly.

“Younger women feel more empowered, more equal to men, and have been beginning to exhibit the same uninhibited behaviors as men,” said Chris Cochran of the California Office of Traffic Safety.

Another possible reason cited for the rising arrests: Police are less likely to let women off the hook these days.

Nationwide, the number of women arrested for driving under the influence of alcohol or drugs was 28.8 percent higher in 2007 than it was in 1998, while the number of men arrested was 7.5 percent lower, according to FBI figures that cover about 56 percent of the country. (Despite the incomplete sample, Alfred Blumstein, a Carnegie Mellon University criminologist, said the trend probably holds true for the country as a whole.)

“Women are picking up some of the dangerously bad habits of men,” said Chuck Hurley, CEO of Mothers Against Drunk Driving.

In New York’s Westchester County, where Diane Schuler’s crash killed her and seven other people last month, the number of women arrested for drunken driving is up 2 percent this year, and officers said they are noticing more women with children in the back seat.

“We realized for the last two to three years, the pattern of more female drivers, particularly mothers with kids in their cars, getting arrested for drunk driving,” said Tom Meier, director of Drug Prevention and Stop DWI for the county.

In one case there, a woman out clubbing with her teenage daughter was sent to prison for causing a wrong-way crash that killed her daughter’s friend.

Another woman was charged with driving drunk after witnesses said she had been drinking all day before going to pick up her children at school. Authorities said the children were scared during the ride, and once they got home, they jumped out of the car, ran to a neighbor’s house and told an adult, who called police. The mother lay passed out in the car, and police said her blood alcohol level was 0.27 percent — more than three times the legal limit.

In California, based on the same FBI figures, women accounted for 18.8 percent of all DUI arrests in 2007, up from 13.5 percent in 1998, according to the California Office of Traffic Safety.

Nearly 250 youngsters were killed in alcohol-related crashes in the U.S. in 2007, and most of them were passengers in the car with the impaired driver, according to the National Highway Safety Administration.

“Drunk drivers often carry their kids with them,” said MADD’s Hurley. “It’s the ultimate form of child abuse.”

Arrests of drunken mothers with children in the car remain rare, but police officers can generally list a few.

In the Chicago suburb of Wheaton, Supreme Court Justice Antonin Scalia‘s daughter was stopped by police after she pulled away from a McDonald’s with three of her kids in the car. She pleaded guilty to drunken driving and was sentenced to 18 months of court supervision.

Sgt. Glen Williams of the Creve Coeur, Mo., police department recalls stopping a suspected drunken driver on her way to pick up two preschoolers.

Sometime later, “she told me it actually changed her life, getting arrested,” he said. “She was forced to get help and realized she’d had a problem.”

The increase in arrests comes as women are drinking excessively more than in the past.

One federal study found that the number of women who reported abusing alcohol (having at least four drinks in a day) rose from 1.5 percent to 2.6 percent over the 10-year period that ended in 2002. For women ages 30 to 44, Schuler’s age group, the number more than doubled, from 1.5 percent to 3.3 percent.

The problem has caught the attention of the federal government. The Transportation Department’s annual crackdown on drunken driving, which begins later this month, will focus on women.

“There’s the impression out there that drunk driving is strictly a male issue, and it is certainly not the case,” said Rae Tyson, spokesman for the National Highway Traffic Safety Administration. “There are a number of parts of the country where, in fact, the majority of impaired drivers involved in fatal crashes are female.”

Schuler’s relatives have denied she was an alcoholic and said they were shocked to learn of her drug and alcohol use before the July 26 crash. The wreck, about 35 miles north of New York City, killed Schuler, her 2-year-old daughter, her three nieces and three men in an oncoming SUV she hit with her minivan. Schuler’s 5-year-old son survived his injuries.

Schuler, a cable company executive, could have had a drinking problem that her family didn’t know about, said Elaine Ducharme, a psychologist in Connecticut who has seen more excessive drinking, overeating, smoking and drug abuse during the recession.

Unlike men, women tend to drink at home and alone, which allows them to conceal a problem more easily.

Because of this, they seek treatment less often than men, and when they do, it is at a later stage, often when something catastrophic has already happened, said Dr. Petros Levounis, director of the Addiction Institute of New York at St. Luke’s-Roosevelt Hospital Center.

“Our society has taught us that women have an extra burden to be the perfect mothers and perfect wives and perfect daughters and perfect everything,” Levounis said. “They tend to go to great lengths to keep everything intact from an external viewpoint while internally, they are in ruins.”

In the current recession, women’s incomes have become more important because so many men have lost their jobs, experts say. Men are helping out more at home, but working mothers still have the bulk of the child rearing responsibilities.

“Because of that, they have a bigger burden then most men do,” said clinical psychologist Carol Goldman. “We have to look at the pressures on women these days. They have to be the supermom.”

And just becoming a parent doesn’t mean people will stop using drugs or alcohol, Ducharme said: “If you have a real addictive personality, just having a child isn’t going to make the difference.”


Associated Press writers Solvej Schou in Los Angeles, Mark Tarm in Chicago and Betsy Taylor in St. Louis contributed to this report.

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Matt Miller – Zoloft (1 week!) – induced suicide

By Anne McIlroy
As written in The Globe and Mail (

When Matt Miller’s family moved to a bigger house in a new neighbourhood in Kansas City, Mo., the athletic 13-year-old with thick blond hair found that he couldn’t penetrate the cliques at his new school. He was a nobody, an outsider.

“He was angry at us, he was angry at the school, his grades suffered. He wasn’t himself,” said his father, Mark Miller.

The boy’s teachers recommended that he see a psychiatrist, who prescribed Zoloft, an antidepressant in the same chemical family as Prozac. The doctor said it would help Matt’s mood, make him feel better about himself. The boy started taking the pills and seemed to be in good spirits for a few days.

But then he began showing signs of intense nervousness and agitation. He couldn’t sit still, his father remembers. He kept kicking people under the table. His eyes were sunken and he couldn’t sleep, yet he had a restless energy.

After six days on the drug, on July 28, 1997, Matt hanged himself in his bedroom closet.

“Suicide always takes you by surprise, but no one could have imagined that Matt would have done that,” Miller said in an interview. “There was no previous attempt, no serious threat of it, no note, no premeditation. “It was a very impulsive act I am convinced was brought about by the stimulant nature of the drug.”

Miller has launched a lawsuit against Pfizer Inc., which makes Zoloft. He is one of about 200 people who have sued — so far unsuccessfully — the makers of Prozac and similar products. The plaintiffs contend that the drugs, known as selective serotonin reuptake inhibitors, caused their loved ones to kill themselves and, in some cases, hurt or kill others as well. One of the few cases to go to trial so far was that of William Forsyth, a 63-year-old wealthy Hawaii businessman who stabbed to death his wife of 37 years and then killed himself in 1993. At the time, he had been taking Prozac for 11 days for panic attacks.

In 1999, a jury in the civil lawsuit cleared Prozac of liability in the deaths. Forsyth’s adult children began another suit last year accusing Eli Lilly and Co., the maker of the drug, of covering up damaging details about the antidepressant.

Chief among the scientific experts who have given people, including Miller and Forsyth’s children, reason to believe that a link may exist between antidepressants and suicide is Dr. David Healy, whom Miller has engaged as an expert witness in his suit.

Healy is a well-known British psychiatrist who argues that Prozac and similar drugs may trigger suicide in some patients, and that there should be warning labels on the products.

To Miller, Healy is a hero, a crusading scientist with the guts and credibility to challenge the powerful, multinational drug companies in an era in which many researchers and institutions depend on them for funding. But discussing the down side of Prozac does not appear to have been a good career move. Healy’s blunt expression of his views may have cost him a job at the Centre for Addiction and Mental Health, a teaching hospital associated with the University of Toronto. The centre had been recruiting him for months, but last year rescinded his written job offer after he gave a speech warning that Prozac may trigger suicide in some patients.

Eli Lilly Canada Inc. is a major corporate donor to the centre, but university and hospital officials say their decision had nothing to do with wanting to please the drug company or to avoid damaging future fundraising efforts. They say their reasons are confidential. Healy says the only explanation he was offered was that his lecture “solidified” the view that he was not a good fit.

For Eli Lilly’s part, it points out that a U.S. Food and Drug Administration panel of experts voted six to three against requiring Prozac to carry a suicide-risk warning label. In September of 1991, the FDA concluded that there was no credible evidence of a causal link between the use of antidepressant drugs, including Prozac, and suicides or violent behaviour. And a paper published in March of 1991 by Jerrold Rosenbaum of Massachusetts General Hospital found that patients on Prozac were not prone to suicide any more than patients on other medication.

Eli Lilly said, in a written response to questions from The Globe and Mail: “There is, to the contrary, published scientific evidence showing that Prozac and medicines like it actually protect against such behaviour — reducing aggressive and suicidal thoughts and behaviour.”

When Prozac was introduced in the late 1980s, it was billed as a wonder drug that could combat depression with far fewer risks than previous medications, including the danger of an overdose or problems when mixed with alcohol. Prozac and drugs like it — Zoloft, Paxil and Luvox — were said to help with emotional limitations such as low self-esteem and fear of rejection. Prozac was a commercial as well as a medical miracle, sold to an estimated 40 million people worldwide since it hit the market.

The drug boosts levels of the neurotransmitter serotonin, which seems to improve the mood of patients. But within a few years of Prozac’s launch came hints that it brought out a dark side in a small fraction of users. Martin Teicher, a researcher at Harvard University, published an article in the American Journal of Psychiatry in 1990 that discussed six cases in which patients became intensely preoccupied with suicide after taking the drug. Other scientists also found a potential link between Prozac and suicide.

Healy says in one of his published papers that Eli Lilly scientists collaborated with the FDA on designing an experiment that would measure how serious the problem was, but they then decided against conducting it. Instead, in 1991, Eli Lilly published an analysis of data taken from existing trials. Its conclusion? There was no increase of suicidal thoughts or suicide among depressed patients taking Prozac.

But Healy says in the paper that data from only about one-eighth of the patients in the clinical trials were included. No mention was made that some had been prescribed a sedative that may have alleviated an intense nervous state that can lead to suicide, which is called akathisia, he says. The analysis also did not point out that 5 per cent of patients dropped out of the studies because they were anxious and agitated and may have been suffering from akathisia, Healy says.

Another document, dated Nov. 13, 1990, shows that company scientists were pressured by executives to soften physicians’ reports of suicidal thoughts or suicide attempts, according to Harvard psychiatrist Joseph Glenmullen, who obtained the document and is author of the book Prozac Backlash. Additional evidence about the potential risks can be found in the patent for a second-generation Prozac pill, which Eli Lilly has licensed. The patent says the new and improved Prozac would decrease side effects including: “nervousness, anxiety, and insomnia,” as well as “inner restlessness (akathisia), suicidal thoughts and self-mutilation.”

But at the same time, Eli Lilly says these symptoms are not associated in any significant way with taking the current version of Prozac. The new Prozac — which incidentally was co-developed by Teicher, one of the drug’s early critics — isn’t yet on the market, Last year, Healy published a study in the journal Primary Care Psychiatry that said two of 20 healthy volunteers taking an antidepressant in the same family as Prozac reported feeling suicidal.

But by his calculations, probably 40,000 people have committed suicide while on Prozac since its launch, above and beyond the number who would have taken their own lives if their condition had been left untreated.

The German government now requires warning labels, and Britain is considering them. Canada and the United States do not. Healy says he is not opposed to Prozac and thinks that it can do a lot of good. But he says it is unethical and irresponsible not to warn doctors about the potential dangers, and believes Eli Lilly chose not to do so to maximize profits.

He says family doctors seem to be increasingly prescribing Prozac and other antidepressants to children and now to women complaining of severe premenstrual symptoms, yet patients in North America do not have to be told about the potential risks.

Eli Lilly and the other drug companies argue that depression, not antidepressants, are to blame for suicides. Pfizer is trying to have Healy barred from testifying in the Miller case, questioning his credibility as an expert witness.

So what are Canadian consumers to think? Jacques Bradwejn, chairman of the psychiatry department at the University of Ottawa, says he has reviewed the literature and agrees with the FDA and Eli Lilly that there is no evidence that Prozac and similar drugs cause more suicides than would have occurred if patients had not been treated.

But a small number of patients — even as many as 1 per cent — may fall into a nervous state that could trigger suicide, he said, adding that more research is needed to better understand the problem.

While Prozac may be overprescribed for patients who are not truly ill, Bradwejn worries that the message that the Prozac is dangerous will do more harm than good for those who are moderately to severely depressed. “If the message is too alarmist, it could have a very negative effect on Canadians.”


A study by Dr. David Healy found that two of 20 healthy volunteers taking a selective serotonin reuptake inhibitor in the same family as Prozac reported suicidal feelings. This is the story of one of those people, a 30-year-old woman who didn’t know what drug she was taking, as recorded in the study. “On the Friday she telephoned early in the morning, distressed and tearful from the previous night. Her conversation was garbled. She described almost going out and killing herself. . .

“The night previously she had felt complete blackness all around her. . . . She felt hopeless and alone. It seemed that all she could do was to follow a thought that had been planted in her brain by 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. . . . She didn’t think of her partner or child. She was walking out the door when the phone went. This stopped the tunnel of suicidal ideation.

“She later became distraught at what she had nearly done and guilty that she had not thought of her family.”

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SSRI Medications

Below is a the drug manufactures BEST GUESS as to how SSRI antidepressants work in your brain. They fully admit that they really don’t know how they work. However, we maintain that the positive effects that patients report come from the stimulant, amphetamine-like, nature of these mind-altering drugs.

Learn the truth about these drugs in “Prozac: Panacea or Pandora?”

What you need to know about serotonin-enhancing medications

Selective Serotonin Reuptake Inhibitors do exactly that: Inhibit the reuptake of serotonin, thus leaving excess serotonin which allows this stimulation to continue. It has long been known that inhibiting the reuptake of serotonin will produce depression, suicide, violence, psychosis, mania, cravings for alcohol and other drugs, reckless driving, etc. [See full list of reactions below]

The most popular drugs that produce this reuptake of serotonin are:

SSRI Antidepressants: Prozac, Serafem, Zoloft, Paxil, Luvox, Celexa, Lexapro

SNRI Antidepressants: Effexor, Remeron, Serzone, Cymbalta

Atypical Antipsychotics: Zyprexa, Geodon, Abilify, Seroquel, Risperdal

Weight Loss Medications: Fen-Phen, Redux, Meridia

Pain Killers: (Any opium or heroin derivative) Morphine, OxyContin, Ultram, Tramadol, Percocet, Percodan, Lortab, Demerol, Darvon or Darvocet, Codeine, Buprenex, Dilaudid, Talwin, Stadol, Vicodin, Duragesic Patches, Fentanyl Transdermal, Methadone, Dextromethorphan (commonly used in cough syrups), etc.

WARNING: Anesthetics can also fall into this group as well as drugs used for other purposes. Always check to see what the mechanism of action is in a drug before combining it with another serotonergic agent or using it soon after the use of a serotonergic agent because the combination of two can cause the potentially fatal reaction known as Serotonin Syndrome. As the main function of serotonin is constriction of smooth muscle tissue, Serotonin Syndrome produces death via multiple organ failure.

“Psychedelic agents mimic the effects of serotonin.”

The brain chemical these drugs increase, serotonin, is the same brain chemical that LSD, PCP and other psychedelic drugs mimic in order to produce their hallucinogenic effects. And remember that psychedelic agents are “a class of compounds with no demonstrated therapeutic use, a history of extensive abuse, and the ability to provoke psychosis. Yet many brain researchers value the psychedelic agents above any of the other psychoactive drugs” because “the research into psychedelic drugs has already enriched our understanding of how the brain regulates behavior.” (Dr. Solomon Snyder, DRUGS AND THE BRAIN). Just how much will these brain researchers learn from our experience with these drugs designed to specifically increase serotonin, the same brain chemical the psychedelic agents mimic to produce their effects?

We know that these drugs interfere with serotonin metabolism (demonstrated by levels of the serotonin metabolite 5HIAA). It is not serotonin that is low in these disorders, it is this by-product 5HIAA, which indicates the level of serotonin metabolism, that is low in depression, suicide, etc. Yet as serotonin (5HT) goes up serotonin metabolism (5HIAA) generally comes down. We already have studies demonstrating at what percentage each of these drugs increase 5HT and decrease 5HIAA. Here are the results of elevated levels of serotonin (5HT) and decreased levels of serotonin metabolism (5HIAA):

Elevated 5HT (serotonin) levels:

  1. schizophrenia, psychosis, mania, etc.
  2. mood disorders (depression, anxiety, etc.)
  3. organic brain disease – especially mental retardation at a greater incident rate in children
  4. autism (a self-centered or self-focused mental state with no basis in reality)
  5. Alzheimer’s disease
  6. old age
  7. anorexia
  8. constriction of the blood vessels
  9. blood clotting
  10. constriction of bronchials and other physical effects

Lower 5HIAA (serotonin metabolism) levels:

  1. suicide (especially violent suicide)
  2. arson
  3. violent crime
  4. insomnia
  5. depression
  6. alcohol abuse
  7. impulsive acts with no concern for punishment
  8. reckless driving
  9. dependence upon various substances
  10. bulimia
  11. multiple suicide attempts
  12. hostility and more contact with police
  13. exhibitionism
  14. arguments with spouses, friends and relatives
  15. obsessive compulsive behavior
  16. impaired employment due to hostility, etc.

All are exactly what patients and their families have continued to report to be their experience on these drugs since Prozac was introduced! These individuals are frantically searching for answers while this research sits right under our noses. Although this is a totally different picture than pharmaceutical marketing departments would have us believe, marketing claims and reality rarely have much in common.

Researchers tell us that five, ten or twenty years later it is not uncommon to find we have another thalidomide on our hands. Raising 5HT (serotonin) and lowering 5HIAA (serotonin metabolism) in such a high number of people can produce very serious, extensive and long term problems for all of society. Even more frightening for the future of our society is the rapidly rising and widely accepted practice of prescribing these drugs to small children and adolescents. This crucial medical research must be addressed openly, without delay, rather than remain buried in seldom read medical research documents as has been the case in the past with other mind-altering medications, once thought to be safe, which were subsequently prohibited by law.


  • Adverse SSRI Reactions
  • Prozac Package Insert
  • Hyperserotonemia
  • Serotonin Syndrome

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How a New Policy Led to Seven Deadly Drugs

How a New Policy Led to Seven Deadly Drugs


WASHINGTON–For most of its history, the United States Food and Drug Administration approved new prescription medicines at a grudging pace, paying daily homage to the physician’s creed, “First, do no harm.”

Then in the early 1990s, the demand for AIDS drugs changed the political climate. Congress told the FDA to work closely with pharmaceutical firms in getting new medicines to market more swiftly. President Clinton urged FDA leaders to trust industry as “partners, not adversaries.”

The FDA achieved its new goals, but now the human cost is becoming clear.

Seven drugs approved since 1993 have been withdrawn after reports of deaths and severe side effects. A two-year Los Angeles Times investigation has found that the FDA approved each of those drugs while disregarding danger signs or blunt warnings from its own specialists. Then, after receiving reports of significant harm to patients, the agency was slow to seek withdrawals.

According to “adverse-event” reports filed with the FDA, the seven drugs were cited as suspects in 1,002 deaths. Because the deaths are reported by doctors, hospitals and others on a voluntary basis, the true number of fatalities could be far higher, according to epidemiologists.

An adverse-event report does not prove that a drug caused a death; other factors, such as preexisting disease, could play a role. But the reports are regarded by public health officials as the most reliable early warnings of danger.

The FDA’s performance was tracked through an examination of thousands of pages of government documents, other data obtained under the Freedom of Information Act and interviews with more than 60 present and former agency officials.

The seven drugs were not needed to save lives. One was for heartburn. Another was a diet pill. A third was a painkiller. All told, six of the medicines were never proved to offer lifesaving benefits, and the seventh, an antibiotic, was ultimately judged unnecessary because other, safer antibiotics were available.

The seven are among hundreds of new drugs approved since 1993, a period during which the FDA has become known more for its speed than its caution. In 1988, only 4% of new drugs introduced into the world market were approved first by the FDA. In 1998, the FDA’s first-in-the-world approvals spiked to 66%.

The drug companies’ batting average in getting new drugs approved also climbed. By the end of the 1990s, the FDA was approving more than 80% of the industry’s applications for new products, compared with about 60% at the beginning of the decade.

And the companies have prospered: The seven unsuccessful drugs alone generated U.S. sales exceeding $5 billion before they were withdrawn.

Once the world’s unrivaled safety leader, the FDA was the last to withdraw several new drugs in the late 1990s that were banned by health authorities in Europe.

“This track record is totally unacceptable,” said Dr. Curt D. Furberg, a professor of public health sciences at Wake Forest University. “The patients are the ones paying the price. They’re the ones developing all the side effects, fatal and non-fatal. Someone has to speak up for them.”

The FDA’s faster and more lenient approach helped supply pharmacy shelves with scores of new remedies. But it has also yielded these fatal missteps, according to the documents and interviews:

1. Only 10 months ago, FDA administrators dismissed one of its medical officer’s emphatic warnings and approved Lotronex, a drug for treating irritable bowel syndrome. Lotronex has been linked to five deaths, the removal of a patient’s colon and other bowel surgeries. It was pulled off the market on Nov. 28.

2. The diet pill Redux, approved in April 1996 despite an advisory committee’s vote against it, was withdrawn in September 1997 after heart-valve damage was detected in patients put on the drug. The FDA later received reports identifying Redux as a suspect in 123 deaths.

3. The antibiotic Raxar was approved in November 1997 in the face of evidence that it may have caused several fatal heart-rhythm disruptions in clinical studies. FDA officials chose to exclude any mention of the deaths from the drug’s label. The maker of the pill withdrew it in October 1999. Raxar was cited as a suspect in the deaths of 13 patients.

4. The blood pressure medication Posicor was approved in June 1997 despite findings by FDA specialists that it might fatally disrupt heart rhythm and interact with certain other drugs, posing potentially severe risk. Posicor was withdrawn one year later; reports cited it as a suspect in 100 deaths.

5. The painkiller Duract was approved in July 1997 after FDA medical officers warned repeatedly of the drug’s liver toxicity. Senior officials sided with the manufacturer in softening the label’s warning of the liver threat. The drug was withdrawn 11 months later. By late 1998, the FDA had received voluntary reports citing Duract as a suspect in 68 deaths, including 17 that involved liver failure.

6. The diabetes drug Rezulin was approved in January 1997 over a medical officer’s detailed opposition and was withdrawn this March after the agency had linked 91 liver failures to the pill. Reports cite Rezulin as a suspect in 391 deaths.

7. The nighttime heartburn drug Propulsid was approved in 1993 despite evidence that it caused heart-rhythm disorders. The officials who approved the drug failed to consult the agency’s own cardiac specialists about the signs of danger. The drug was taken out of pharmacies in July after scores of confirmed heart-rhythm deaths. Overall, Propulsid has been cited as a suspect in 302 deaths.

The FDA’s handling of Propulsid put children at risk.

The agency never warned doctors not to administer the drug to infants or other children even though eight youngsters given Propulsid in clinical studies had died. Pediatricians prescribed it widely for infants afflicted with gastric reflux, a common digestive disorder.

Parents and their doctors had no way of knowing that the FDA, in August 1996, had found Propulsid to be “not approvable” for children.

“We never knew that,” said Jeffrey A. Englebrick, a heavy-equipment welder in Shawnee, Kan., whose 3-month-old son, Scott, died on Oct. 28, 1997, after taking Propulsid. “To me, that means they took my kid as a guinea pig to see if it would work.”

By the time the drug was pulled, the FDA had received reports of 24 deaths of children under age 6 who were given Propulsid. By then the drug had generated U.S. sales of $2.5 billion for Johnson & Johnson Co.

Questions also surround the recent approvals of other compounds that remain on the market, including a new flu drug called Relenza. In February of 1999, an FDA advisory committee concluded that Relenza had not been proved safe and effective. The agency nevertheless approved it. Following the deaths of seven patients, the FDA in January issued a “public health advisory” to doctors.

A ‘Lost Compass’
A total of 10 drugs have been pulled from the market in just the past three years for safety reasons, including three pills that were approved before the shift that took hold in 1993. Never before has the FDA overseen the withdrawals of so many drugs in such a short time. More than 22 million Americans–about 10% of the nation’s adult population–took those drugs.

With many of the drugs, the FDA used tiny-print warnings or recommendations in package labeling as a way to justify approvals or stave off withdrawals. In other instances, the agency has withheld safety information from labels that physicians say would call into question the use of the product.

Present and former FDA specialists said the regulatory decisions of senior officials have clashed with the agency’s central obligation, under law, to “protect the public health by ensuring . . . that drugs are safe and effective.”

“They’ve lost their compass and they forget who it is that they are ultimately serving,” said Dr. Lemuel A. Moye, a University of Texas School of Public Health physician who served from 1995 to 1999 on an FDA advisory committee. “Unfortunately the public pays for this, because the public believes that the FDA is watching the door, that they are the sentry.”

The FDA’s shift is felt directly in the private practice of medicine, said Dr. William L. Isley, a Kansas City, Mo., diabetes specialist. He implored the agency to reassess Rezulin three years ago after a patient he treated suffered liver failure taking the pill.

“FDA used to serve a purpose,” Isley said. “A doctor could feel sure that a drug he was prescribing was as safe as possible. Now you wonder what kind of evaluation has been done, and what’s been swept under the rug.”

FDA officials said that they have tried conscientiously to weigh benefits versus risks in deciding whether to approve new drugs. They noted that many doctors and patients complain when a drug is withdrawn. “All drugs have risks; most of them have serious risks,” said Dr. Janet Woodcock, director of the FDA’s drug review center. She added that some of the withdrawn drugs were “very valuable, even if not lifesaving, and their removal from the market represents a loss, even if a necessary one.” Once a drug is proved effective and safe, Woodcock said, the FDA depends on doctors “to take into account the risks, to read the label. . . . We have to rely on the practitioner community to be the learned intermediary. That’s why drugs are prescription drugs.”

In a May 12, 1999, article co-authored with FDA colleagues and published by the Journal of the American Medical Assn., Woodcock said, “The FDA and the community are willing to take greater safety risks due to the serious nature of the [illnesses] being treated.”

Compared to the volume of new drugs approved, they wrote, the number of recent withdrawals “is particularly reassuring.”

However, agency specialists point out that both approvals and withdrawals are controlled by Woodcock and her administrators. When they consider a withdrawal, they face the unpleasant prospect of repudiating their original decision to approve.

Woodcock, 52, received her medical degree at Northwestern University and is a board-certified internist. She alluded in a recent interview to the difficulty she feels in rejecting a proposed drug that might cost a company $150 million or more to develop. She also acknowledged the commercial pressures in a March 1997 article.

“Consumer protection advocates want to have drugs worked up well and thoroughly evaluated for safety and efficacy before getting on the market,” Woodcock wrote in the Food and Drug Law Journal. “On the other hand, there are economic pressures to get drugs on the market as soon as possible, and these are highly valid.”

But this summer–following the eighth and ninth drug withdrawals–Woodcock said the FDA cannot rely on labeling precautions, alone, to resolve safety concerns.

“As medical practice has changed . . . it’s just much more difficult for [doctors] to manage” the expanded drug supply, Woodcock said in an interview. “They rely upon us much more to make sure the drugs are safe.”

Another FDA administrator, Dr. Florence Houn, voiced similar concern in remarks six months ago to industry officials: “I think the lessons learned from the drug withdrawals make us leery.”

Yet the imperative to move swiftly, cooperatively, remains.

“We are now making decisions more quickly and more predictably while maintaining the same high standards for product safety and efficacy,” FDA Commissioner Jane E. Henney said in a National Press Club speech on Dec. 12.

Motivated by AIDS
The impetus for change at the FDA emerged in 1988, when AIDS activists paralyzed operations for a day at the agency’s 18-story headquarters in Rockville, Md. They demanded immediate approval of experimental drugs that offered at least a ray of hope to those otherwise facing death.

The FDA often was taking more than two years to review new drug applications. The pharmaceutical industry saw a chance to loosen the regulatory brakes and expedite an array of new products to market. The companies and their Capitol Hill lobbyists pressed for advantage: If unshackled, they said, the companies could invent and develop more remedies faster.

The political pressure mounted, and the FDA began to bow. By 1991, agency officials told Congress they were making significant progress in speeding the approval process.

The emboldened companies pushed for more. They proposed that drugs intended for either life-threatening or “serious” disorders receive a quicker review.

“The pharmaceutical companies came back and lobbied the agency and the Hill for that word, ‘serious,’ ” recalled Jeffrey A. Nesbit, who in 1991 was chief of staff to FDA Commissioner David A. Kessler. “Their argument was, ‘Well, OK, there’s AIDS and cancer. But there are drugs [being developed] for Alzheimer’s. And that’s a serious illness.’ They started naming other diseases. They began to push that envelope.”

The wielding of this single, flexible adjective–“serious”–swung wide the regulatory door knocked ajar by the AIDS crisis.

New Order Takes Hold
In 1992, Kessler issued regulations giving the FDA discretion to “accelerate approval of certain new drugs” for serious or life-threatening conditions. That same year a Democrat-controlled Congress approved and President Bush signed the Prescription Drug User Fee Act. It established goals that call for the FDA to review drugs within six months or a year; the pharmaceutical companies pay a user fee to the FDA, now $309,647, with the filing of each new drug application.

The newly elected Clinton administration climbed aboard with its “reinventing government” project. Headed by Vice President Al Gore, the project called for the FDA, by January 2000, to reduce “by an average of one year the time required to bring important new drugs to the American public.” As Clinton put it in a speech on March 16, 1995, the objective was to “get rid of yesterday’s government.”

For the FDA’s medical reviewers–the physicians, pharmacologists, chemists and biostatisticians who scrutinize the safety and effectiveness of emerging drugs–a new order had taken hold.

The reviewers work out of public view in secure office buildings clustered along Maryland’s Route 355. At the jet-black headquarters building, the decor is institutional, the corridors and third-floor cafeteria without windows. The reviewers examine truckloads of scientific documents. They are well-educated; some are highly motivated to do their best for a nation of patients who unknowingly count on their expertise.

One of these reviewers was Michael Elashoff, a biostatistician who arrived at the FDA in 1995 after earning degrees from UC Berkeley and the Harvard School of Public Health.
“From the first drug I reviewed, I really got the sense that I was doing something worthwhile. I saw what a difference a single reviewer can make,” said Elashoff, the son and grandson of statisticians.

Last year he was assigned to review Relenza, the new flu drug developed by Glaxo Wellcome. He recommended against approval.

“The drug has no proven efficacy for the treatment of influenza in the U.S. population, no proven effect on reducing person-to-person transmissibility, and no proven impact on preventing influenza,” Elashoff wrote, adding that many patients would be exposed to risks “while deriving no benefit.”

An agency advisory committee agreed and on Feb. 24 voted 13 to 4 against approving Relenza. After the vote, senior FDA officials upbraided Elashoff. They stripped him of his review of another flu drug. They told him he would no longer make presentations to the advisory committee. And they approved Relenza as a safe and effective flu drug.

Lost Faith in the System
Elashoff and other FDA reviewers discern a powerful message.
“People are aware that turning something down is going to cause problems with [officials] higher up in FDA, maybe more problems than it’s worth,” he said. “Before I came to the FDA I guess I always assumed things were done properly. I’ve lost a lot of faith in taking a prescription medicine.”

Elashoff left the FDA four months ago.

“Either you play games or you’re going to be put off limits . . . a pariah,” said Dr. John L. Gueriguian, a 19-year FDA medical officer who opposed the approval of Rezulin, the ill-fated diabetes drug. “The people in charge don’t say, ‘Should we approve this drug?’ They say, ‘Hey, how can we get this drug approved?’ ”

Said Dr. Rudolph M. Widmark, who retired in 1997 after 11 years as a medical officer: “If you raise concern about a drug, it triggers a whole internal process that is difficult and painful. You have to defend why you are holding up the drug to your bosses. . . . You cannot imagine how much pressure is put on the reviewers.”

The pressure is such that when a union representative negotiated a new employment contract for the reviewers last year, one of his top priorities was to defend what he called the “scientific integrity” of their work.

“People feel swamped. People are pressured to go along with what the agency wants,” said Dr. Robert S.K. Young, an FDA medical officer who in 1998 formed a union chapter to represent the reviewers. “You’re paying for these highly educated, trained people, and they’re not being allowed to do their job.”

Each new drug application is accompanied by voluminous medical data, enough at times to fill 1,000 or more phone books. The reviewers must master this material in less than six months or a year, while juggling other tasks.

“The devil is in the details, and detail is something we no longer have the time to go into,” said Gurston D. Turner, a veteran pharmacologist with the FDA’s scientific investigations division who retired this year. “If you know you must have your report done by a certain date, you get something done. That’s what they [top FDA officials] count, that’s all they count. And that is really, to me, a worrisome thing.”
The FDA did spur reviewers to move at record speed.

In 1994, the FDA’s goal was to finish 55% of its new drug reviews on time; the agency achieved 95%. In 1995, the goal was 70%; the FDA achieved 98%. In 1996, the goal was 80%; the FDA achieved 100%. In both 1997 and 1998, the goal was 90% and the FDA achieved 100%.

From 1993 to 1999 the agency approved 232 drugs regarded as “new molecular entities,” compared with 163 during the previous seven years, a 42% increase.

The time-limit goals quickly were treated as deadlines within the FDA–imposing relentless pressure on reviewers and their bosses to quickly conclude their work and approve the drugs.

“The goals were to be taken seriously. I don’t think anybody expected the agency to make them all,” said William B. Schultz, a deputy FDA commissioner from 1995 to 1999.

Schultz, who helped craft the 1992 user-fee act as a congressional staff lawyer, added: “You can meet the goal by either approving the drug or denying the approval. But there are some who argue that what Congress really wanted was not just decisions, but approvals. That is what really gets dangerous.”

Indeed, the FDA drug center’s 1999 annual report referred to the review goals as “the law’s deadlines.” And, Dr. Woodcock, the center director, elaborated in a subsequent agency newsletter:

“In exchange [for the user fees], FDA makes a commitment to meet certain goals for review times. [The agency] has exceeded almost all of the goals, and it expects to continue to exceed them. Basically, the number of new approved drugs has doubled, and the review times have been cut in half.”

The user fees have enabled the FDA to hire more medical reviewers. Last year, 236 medical officers examined new drugs compared with 162 officers on duty in 1992, the year before the user fees took effect.

Even so, Woodcock acknowledged in an FDA publication this fall that the workloads and tight performance goals “create a sweatshop environment that’s causing high staffing turnover.”

An FDA progress report in 1998, describing the work of agency chemists, said that “too many reviews are coming ‘down to the wire’ against the goal date. . . . This suggests a system in stress.”

Said Nesbit, the former aide to Commissioner Kessler: “The clock is always running, whereas before the clock was never running. And that changes people’s behavior.”

Dozens of officials interviewed by The Times made similar observations.

“The pressure to meet deadlines is enormous,” said Dr. Solomon Sobel, 65, director of the FDA’s metabolic and endocrine drugs division throughout the 1990s. And the pressure is not merely to complete the reviews, he said. “The basic message is to approve.”

Over the last seven years, “there has been a huge shift,” said Kathleen Holcombe, a former FDA legislative affairs staffer and congressional aide who now is a drug industry consultant. “FDA, historically, had an approach of, ‘Regulate, be tough, enforce the law [and] don’t let one thing go wrong,’ ” Holcombe said, adding that now, “the FDA sees itself much more in a cooperative role.”

How Deaths Were Calculated
Reports of adverse drug reactions to the Food and Drug Administration are considered by public health officials to be the most reliable early warnings of a product’s danger. The reports are filed to the FDA by health professionals, consumers and drug manufacturers. The Los Angeles Times inspected all reports filed in connection with seven drugs that were approved and withdrawn since 1993. By hand and by computer, The Times counted 1,002 deaths in which the filer identified the drug as the leading suspect. Since fall 1997, this top category has been termed “primary suspect.” The Times did not count any death in which the drug was identified as the “secondary suspect” or less. The methodology and results were reviewed by Sheila R. Weiss, a former FDA epidemiologist who is an assistant professor at the University of Maryland’s department of pharmacy practice and sciences.

The perception of coziness with drug makers is perpetuated by potential conflicts of interest within the FDA’s 18 advisory committees, the influential panels that recommend which drugs deserve approval or should remain on the market. The FDA allows some appointees to double as consultants or researchers for the same companies whose products they are evaluating on the public’s behalf. Such was the case during committee appraisals of several of the recently withdrawn drugs, including Lotronex and Posicor, The Times found.

Few doubt the $100-billion pharmaceutical industry’s clout. Over the last decade, the drug companies have steered $44 million in contributions to the major political parties and to candidates for the White House and both houses of Congress.

The FDA reviewers said they and their bosses fear that unless the new drugs are approved, companies will erupt and Congress will retaliate by refusing to renew the user fees. This would cripple FDA operations–and jeopardize jobs.

The companies’ money now covers about 50% of the FDA’s costs for reviewing proposed drugs–and agency officials say that persuading Congress to renew the user fees into 2007 is now a top priority.

Yet even if the user fees remain, the FDA is prohibited from spending the revenue for anything other than reviewing new drugs. So while the budget for pre-approval reviews has soared, the agency has gotten no similar increase of resources to evaluate the safety of the drugs after they are prescribed.

“It’s shocking,” said Dr. Brian L. Strom, chairman of epidemiology at the University of Pennsylvania. “How can you say, ‘Release drugs to the market sooner,’ and not know if they’re killing people? . . . It really is a dramatic statement of public priorities.”

More than 250,000 side effects linked to prescription drugs, including injuries and deaths, are reported each year. And those “adverse-event” reports by doctors and others are only filed voluntarily. Experts, including Strom, believe the reports represent as few as 1% to 10% of all such events. “There’s no incentive at all for a physician to report [an adverse drug reaction],” said Strom, who has documented the phenomenon. “The underreporting is vast.”

Even when deaths are reported, records and interviews show that companies consistently dispute that their product has caused a given death by pointing to other factors, including preexisting disease or use of another medicine.

To be sure, a chain of events affects the safe use of a prescription drug: The companies’ conduct of clinical studies; the FDA’s regulatory actions; the doctor’s decision to prescribe; the pharmacist’s filling of a handwritten prescription; the patient’s ability to take the drug as directed. A lapse at any link could prove fatal.

And once a pill is approved by the FDA, the manufacturer often spends heavily on promotion to seize the largest possible market share. This can exacerbate the risk to public health, according to experts.

“Aggressive promotion increases exposure–and doesn’t give you the time to find the problem before patients get hurt,” said Dr. Raymond L. Woosley, pharmacology department chairman at Georgetown University and a former FDA advisory committee member.

When serious side effects emerge, the FDA officials have championed using package labeling as a way to, in their words, “manage” risks. Yet the agency typically has no way to know if the labeling precautions–dense, lengthy and in tiny print–are read or followed by doctors and their patients.

The FDA often addresses unresolved safety questions by asking companies to conduct studies after the product is approved. But the research frequently is not performed–prompting the inspector general of the Department of Health and Human Services to say in 1996 that “FDA can move to withdraw drugs from the market if the post-marketing studies are not completed with due diligence.”

Since that report was issued, the FDA has not withdrawn any drug due to a company’s failure to complete a post-approval safety study. Officials conceded this week that they still do not know how often the studies are performed.

One consequence is that greater risk is shifted to doctors and patients.

For example, Woodcock and her senior aides allowed Rezulin to remain on the U.S. market nearly 2 years after it was withdrawn in Britain in December 1997. The FDA recommended frequent laboratory testing of patients using the drug but had no scientific assurance that the tests would prevent Rezulin-induced liver failure.

“They kept increasing the number of liver-function tests you should have,” noted Dr. Alastair J.J. Wood, a former FDA advisory committee member who is a professor of medicine at Vanderbilt University. “That was clearly designed to protect the FDA, to protect the manufacturer, and to dump the responsibility on the patient and the physician. If the patient developed liver disease and he hadn’t had his [tests] done, somebody was to blame and it wasn’t the manufacturer and it wasn’t the FDA.”

Industry Assurances
Leading industry officials say Americans have nothing to fear from the wave of drug approvals.

“Do unsafe drugs enter and remain in the marketplace? Absolutely not,” said Dr. Bert A. Spilker, senior vice president for scientific and regulatory affairs for the Pharmaceutical Research and Manufacturers of America, in remarks last year to industry and FDA scientists.

But during interviews over the last two years, current and former FDA specialists cited repeated instances when drugs were approved with less than compelling evidence of safety or effectiveness. They also said that important information has been excluded from the labels on some medications.

Elashoff, for instance, was surprised at the labeling for a drug called Prograf, approved in 1997 to prevent rejection of transplanted kidneys. The drug first had been approved in 1994 for use among liver-transplant patients.

The new label notes that Prograf was proved effective in a study of 412 U.S. kidney transplant patients. But no mention is made of the company’s 448-patient European study, in which 7% of the patients who took Prograf died–double the 3.5% death rate among those who received a different anti-rejection drug, documents show.

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An auditor from the FDA’s scientific investigations unit, Antoine El-Hage, examined the European study results and concluded the “data are reliable.” Elashoff agreed in his review.
Yet the only way for doctors or patients to find that data is to search the medical literature or seek the FDA’s review documents.

Excluding the European study from the Prograf label, Elashoff said, “was just a total whitewash. . . . I think any rational person would reconsider taking this drug if they knew what happened in Europe.”

A spokesman for the manufacturer of Prograf said the company had no objection to including the European study results in the labeling. William E. Fitzsimmons, a vice president of drug development for Fujisawa Healthcare Inc., said the decision to exclude the results was entirely the FDA’s.

“We submitted that data,” he said. “It came down to what the FDA was comfortable putting in the label. We certainly have no interest in trying to hide that information. We presented it at major meetings on transplantation. . . . We’re comfortable with that information being out in the public domain.”

But if the FDA had included the European results in the label, it would have impugned the agency’s basis for approving the new, expanded use for Prograf, according to Elashoff and others.

Asked why the agency excluded the information, Woodcock said the European results were “unreliable and could be potentially misleading to doctors and patients in the U.S. if these were included in the label.”

Copyright 2000 Los Angeles Times

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