LEXAPRO: Journalist Has Side-Effects: Not Sure Lexapro is Working: U.S…

NOTE BY Ann Blake-Tracy (www.drugawareness.org):

From the last paragraph in the article below I quote the author: “I will say only this: I no longer count on Lexapro to make me well. Which is to say I no longer fret if I miss a day or two, I no longer rush to the drug store to get my refills, and I place far more importance on getting my life in order: regulating my alcohol consumption, getting a decent night’s sleep, exercising (I’m not the only depressive who’s become an amateur triathlete) and, corny as it sounds, pausing at intervals to ponder my blessings.”

Although there are some good ideas mentioned here that I have been recommending forever for depressives such as the great importance of sleep and exercise and counting one’s blessings, there are other things that could produce life-threatening consequences for both the author who is using an SSRI or those around him. Those areas of grave concern are the consumption of alcohol with an antidepressant and the lack of concern about skipping a pill or picking up a refill for his Lexapro – both all too common with antidepressant users.

Why are they common although dangerous? They are common because of two side effects produced by these drugs:

1, Antidepressants can produce overwhelming cravings for alcohol as well as a tolerance for alcohol and then when mixed can produce toxic effects leading to psychotic breaks.

2. Antidepressants produce what the patients call the “I don’t give a damn” attitude leading one to not care about missing a pill or refilling a prescription. The grave concern with this is the warning put in place by the FDA along with the Black Box warning of suicide. That FDA warning is that ANY ABRUPT CHANGE IN DOSE of an antidepressant can produce suicide, hostility or psychosis – generally a manic psychosis. Skipping a pill is an abrupt change in dose as is starting or stopping the use of one of these drugs or switching the brand of antidepressant you are taking. If you survive a manic psychosis instead of being told what caused that psychotic break, you will likely be diagnosed as Bipolar and/or spend the rest of your life in prison for what you did while psychotic. The possibilities can be more than just frightening!

Paragraphs 18 through 22 read:

” ‘How’s the Lexapro working’?”

” ‘I don’t know’.”

‘Agnosticism, I’ve found, is a common refrain among my medicated friends. We’re feeling OK, thanks. Is it the pill? Natural cycles? A good week at work? The fact that the sun is shining? Not always apparent. The only thing we’re really clear on, honestly, is our side effects. Nausea, nightmares, hypomania, agitation, headaches, decreased sex drive, decreased sex performance … the list is exquisite in its variation. My first two nights on Lexapro, I lay for hours on the precipice of unconsciousness, unable to take the last plunge. To fall asleep, I had to get a prescription for Ambien, which I then spent another week weaning myself off. To this day, the prospect of sleep holds a mild terror for me that it never did before.’

‘Oddly enough, the side effects are often the pills’ best advocates. If we’re feeling that crappy, we figure something of great moment is happening inside us. What’s harder to accept is the alternative explanation — that, when it comes to depression, we’re still wandering in the dark. As Charles Barber, author of “Comfortably Numb,” argues, scientists don’t really know how antidepressants work. ‘They change the brain chemistry, but the infinite spiral of what they do from there is very unclear’.”

“So if you don’t know how something works, and you can no longer credibly claim it does work (even some industry spokesmen are beginning to qualify their claims), you’re not left with much of a fallback position. The placebo effect is real — the body actually does heal itself when it believes it is being healed — but it is founded on faith, and in the wake of the JAMA study, it’s becoming harder and harder to maintain that faith except through a rather larger act of denial.”

http://www.salon.com/life/feature/2010/04/05/is_my_lexapro_working/

Monday, Apr 5, 2010 04:01 EDT

My antidepressant gets harder to swallow

As studies shed doubt on certain psychiatric drugs, I wonder: Do I really need my little white pill?

By Louis Bayard

Salon

I take it every morning, right after I brush my teeth. A single white pill, with the letters F and L stamped on one side, the number 10 on the other. It’s so small it nearly disappears into the folds of my palm. You could drop it in my orange juice or my breakfast cereal, and I’d swallow it without a hitch.

And, for the last three years, I have been swallowing my Lexapro — and everything that comes along with it. And, apparently, I’m not alone.

Between 1996 and 2005, the number of Americans taking antidepressants doubled. According to the Centers for Disease Control, antidepressants are now the most commonly prescribed class of drugs in the U.S. — ahead of drugs for cholesterol, blood pressure and asthma. Of the 2.4 billion drugs prescribed in 2005, 118 million were for depression. Whether the pills go by the name of Lexapro or Effexor or Prozac or Wellbutrin, we’re downing them, to the tune of $9.6 billion a year, and we’re doing it for a very good and simple reason. They’re supposed to be making us better.

Which leaves a quite massive shoe waiting to drop. What if these costly, widely marketed, bewitchingly commonplace drugs really aren’t fixing our brains?

The implications are troubling, and not just for the pharmaceutical industry. In a study published last January by the Journal of the American Medical Association, scientists conducting a meta-analysis of existing research found that antidepressants were unquestionably “useful in cases of severe depression” but frankly not much help for the rest of us. “The magnitude of benefit of antidepressant medication compared with placebo,” the study’s authors concluded, “may be minimal or nonexistent, on average, in patients with mild or moderate symptoms.”

In other words, antidepressants work, but only because we believe they’re working. If we’re not seriously depressed and we’re taking a tricyclic or a serotonin reuptake inhibitor or a norepinephrine booster, we’d fare about as well with a sugar pill. Which means that antidepressants are, to borrow the phraseology of Newsweek writer Martha Begley, “basically expensive Tic Tacs.”

And so, like millions of Americans, I’m left with the problem of it: that little white pill that travels down my gullet every morning. What is it really doing down there — up there? What if it’s not doing anything? Is there any good empirical unassailable reason that I should be swallowing it day after day after day? If I stop believing in it, will it stop working?

More than half a century has passed since the first antidepressants were prescribed, but it’s fair to say that the opposition to them coalesced in the 1990s, with the explosive sales growth of Prozac. As critics like David Healy and Ronald W. Dworkin warned that Big Pharma was medicalizing sadness for profit, the widespread usage of ironic terms like “happy pills” conjured up visions of smiling zombies wandering through sinister dreamscapes. Eric G. Wilson, in his overwrought “Against Happiness,” actually envisioned a day when antidepressants would “destroy dejection completely” and “eradicate depression forever.”

Looking back, we can see that both critics and advocates were working from the same premise: that these drugs change us in some fairly profound way. (Even pro-drug Peter Fisher [Kramer], in his bestselling “Listening to Prozac,” worried about the cost of making people “better than well.”) But as researchers like Irving Kirsch and Guy Sapirstein are increasingly finding, the truth may shade more toward the comic end of the spectrum. Far from transforming us, antidepressants are leaving us pretty much as they found us. Emperors in gleaming new clothes.

The more I ponder my experience, the less surprised I am. I turned to medication because I couldn’t stop crying in public places — Starbucks was a popular spot — or imagining my death. (Crucially, I never got around to planning it.) And because I realized that although I was meeting life’s core requirements, I was not always exceeding them. And because, after a couple of years of sessions with an empathetic therapist, I came to believe that my wiring really had shorted out, that some form of grayer matter had fastened itself to my brain and was hard at work, siphoning away my joy.

I remember watching the camcorder footage of my son’s first birthday party and being shocked by the sight of myself, staring back at the camera with sad eyes. Depression had always been a sporadic companion, but in my 43rd year, it began to take up permanent residence. I felt like I was walking around on rotting floorboards. I cried. I lost my temper on the flimsiest of pretexts. I saw myself dead.

At which point medication seemed like a reasonable alternative. Before another week had passed, I had secured a low-dosage prescription for Lexapro, prescribed not by my therapist but by my primary-care physician. (Even that’s not quite true. It was the doctor who was taking my doctor’s patients while she was on vacation.)

“Who’s going to monitor this drug?” my partner asked.

“Um … you? Me?”

When it came to Lexapro, all my responses had the same interrogative lilt. If someone asked me how I was feeling, I’d say, “Better, I guess?” When asked if I would recommend Lexapro to others, I’d say: “Maybe kind of?”

This was the most surprising part of the whole experience: that the transformation or malformation I had expected to feel never quite arrived, that in the course of ramping up my serotonin levels, I should remain so freakishly myself.

It is, in fact, one of the amusing side effects of living in the age of pharmaceuticals that you can always compare your lack of progress with those nearest and dearest to you in this case, my mother. Not a lunch goes by that one of us doesn’t say to the other:

“How’s the Lexapro working?”

“I don’t know.”

Agnosticism, I’ve found, is a common refrain among my medicated friends. We’re feeling OK, thanks. Is it the pill? Natural cycles? A good week at work? The fact that the sun is shining? Not always apparent. The only thing we’re really clear on, honestly, is our side effects. Nausea, nightmares, hypomania, agitation, headaches, decreased sex drive, decreased sex performance … the list is exquisite in its variation. My first two nights on Lexapro, I lay for hours on the precipice of unconsciousness, unable to take the last plunge. To fall asleep, I had to get a prescription for Ambien, which I then spent another week weaning myself off. To this day, the prospect of sleep holds a mild terror for me that it never did before.

Oddly enough, the side effects are often the pills’ best advocates. If we’re feeling that crappy, we figure something of great moment is happening inside us. What’s harder to accept is the alternative explanation — that, when it comes to depression, we’re still wandering in the dark. As Charles Barber, author of “Comfortably Numb,” argues, scientists don’t really know how antidepressants work. “They change the brain chemistry, but the infinite spiral of what they do from there is very unclear.”

So if you don’t know how something works, and you can no longer credibly claim it does work (even some industry spokesmen are beginning to qualify their claims), you’re not left with much of a fallback position. The placebo effect is real — the body actually does heal itself when it believes it is being healed — but it is founded on faith, and in the wake of the JAMA study, it’s becoming harder and harder to maintain that faith except through a rather larger act of denial.

Of course, even the most ardent critics of antidepressants caution strongly against sudden withdrawal. (Those side effects suck, too.) And few scientists will deny that drugs help people with severe unipolar depression. But what of the rest of us? Should we find some way to make ourselves believe in our little white pills again? Or should we find other things to believe in? Should we, in fact, begin to rethink our relationships with our brains?

I don’t bring much in the way of ideology to these questions. I’ve always felt that the rise of Prozac and its ilk at least had the salutary effect of removing the stigma attached to depression. Reconfigured as a chemical condition, it could now be owned and acknowledged and treated. But by translating it from the personal to the pharmacological, we may have left people even less empowered to combat it.

It’s bracing to see how depression is treated in other countries, where the relationship between drug manufacturers and physicians isn’t quite so hand-in-glove. Great Britain’s National Institute for Health and Clinical Excellence, for example, recommends that, before taking antidepressants, people with mild or moderate depression should undergo nine to 12 weeks of guided self-help, nine to 12 weeks of cognitive behavioral therapy, and 10 to 14 weeks of exercise classes. They should, in short, work on themselves before they can be worked upon.

Unfortunately, as Barber notes, that’s work, and not always pleasant. If we are to be honest with ourselves, we should admit that the drug companies aren’t the only ones who want that pill. We want it, too. If every last antidepressant were to vanish from the market today and a new one were to appear tomorrow, promising greater benefits than before, which of us would not line up? There is, after all, a strength in numbers, whereas grappling with yourself — your self — is a lonely business.

But it is, finally, a necessary one. The little white pill sits in my palm. In the glare of the bathroom light, I give it a good hard searching look. And then once more I clap it in my mouth and swallow it down.

Maybe, as one team of researchers has suggested, it’s the triumph of marketing over science. Maybe, as Samuel Johnson once said of second marriages, it’s the triumph of hope over experience. Maybe I’m just weak.

I will say only this: I no longer count on Lexapro to make me well. Which is to say I no longer fret if I miss a day or two, I no longer rush to the drug store to get my refills, and I place far more importance on getting my life in order: regulating my alcohol consumption, getting a decent night’s sleep, exercising (I’m not the only depressive who’s become an amateur triathlete) and, corny as it sounds, pausing at intervals to ponder my blessings. And also appreciating the ways in which my brain and body regulate their own climate through such time-honored techniques as the crying jag. Which is no less effective for happening in the middle of a busy Starbucks.

Three years and however many dollars later, can I honestly say Lexapro has made me a happier person? No. Has it usefully complicated my thinking? Maybe. In my pre-pill days, I regarded happiness as a form of grace, descending upon me whether or not I was worthy of it. Now I think of it as something that, however elusive, is there to be sought. Swallowing a pill every morning is not, in my mind, an act of obedience but a tiny spark of volition, a sign that I’m willing to find the light wherever it’s hiding. My Lexapro may be no better than a Tic Tac, but it’s a daily reminder that I won’t take depression’s shit lying down.

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Luvox (SSRI)

Luvox (SSRI)
amy Bond
Was prescribed Luvox to treat my OCD prior to during and after birth of my 2nd child Having OCD i I was obsessed that this drug may harm the baby. I was reassured that it is a safe drug Our son was born with double outlet right ventricle, craniosynostosis and otosclerosis. Genetic testing was performed,but came back with no missing chromosomes or abnormalities,FISH etc we found out recently that this class C drug may have caused these defects in our child. A class C drug is a drug that no testing was performed on a pregnant woman but has been known to cause defects and morbidity in animals Why would a doctor prescribe a drug to a pregnant woman why would the FDA approve such a drug why would a company Solvay pharm make such a harmful product.. Our son has had 4 open heart surgeries, he’s deaf in 1 ear and he has a mis shaped skull and ear. My OCD was not severe enough to out weigh these possible defects. Any pregnant women DO NOT TAKE ANY SSRI good luck finding an attorney to rep you it’s been 3 years and no one will takr this case to court!!!!!!

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ANTIDEPRESSANT: Mother of Columbine killer tells of horror 10 yrs after massacre

Michael Moore obtained a copy of Ann Blake-Tracy’s book at the premiere of his movie Bowling for Columbine. Now listen to his bold statement about what really did cause Columbine.


SEE FULL VIDEO Click here

INFO ON OTHER SCHOOL SHOOTINGS

Mark Taylors Site.
NOTE FROM Ann Blake-Tracy: Michael Moore, after reviewing all
the data on Columbine in making his movie, Bowling for Columbine, made his
message clear in the new movie The Drugging of Our Children about what he NOW
believes caused Columbine. Click on his picture to view his video
statement at www.drugawareness.org

In all of these articles out yesterday in the news covering the story by
Dylan’s mother there is STILL no mention of any medication use on Dylan’s part.
Yet we have a friend of Dylan’s who came forward claiming to have been helping
him withdraw from both Zoloft and Paxil.
But the coroner claims they found nothing in his system (I could go into
why that report is suspect but will save that for another time).
IF there really was nothing in his system, was Dylan in withdrawal from his
SSRIs at that point? We know that withdrawal can produce that same extreme out
of character violence since the REM Sleep Behavior Disorder (RBD) is more
prevalent in the withdrawal from these drugs than while on them. And yet of
those being diagnosed with RBD a staggering 86% were taking an antidepressant!
(To learn more about RBD read my FDA testimony on comedian Phil Hartman and is
wife’s Zoloft-induced murder/suicide – a classic case of RBD also found posted
at www.drugawareness.org.)
And if Dylan had been taking antidepressants were they prescribed to
Dylan? If not, where was he getting them? (Let us point out that anyone can
obtain these drugs easily. They have been sold in the streets since the early
90’s to be used recreationally and samples can be found ANYWHERE. Someone just
let me know that they found a bottle of Effexor in a shoe at a second
hand store!) Was a friend sharing their prescription? It happens regularly
from reports I get from kids. Were either of his parents taking one that he was
using for himself?
Years ago I was called in on a case of a 19 year old who was staying with a
married couple where the wife had been prescribed Zoloft and did not like how it
made her feel. She stopped taking it and placed in on top of the fridge. So when
the young man started feeling a little down he remembered the pills were for
depression and were suppose to help you feel better. So he took a couple, waited
a couple of hours and took more because he still was not feeling any better.
Then again took more a little later expecting to feel better right away. After

about five pills he recalls nothing about stabbing a man over 100 times with a
screwdriver.

Mother
of Columbine killer tells of horror 10 years after massacre

•Susan Klebold says she is haunted by school killings
•’I cannot look at a child without thinking about it’

Columbine High School student Dylan Klebold

Dylan
Klebold pictured in the 1999 Columbine High School yearbook. Photograph:
Reuters/© Ho New

The
mother of one of the two teenagers who murdered a dozen fellow students and a
teacher in the massacre at Columbine high school has broken a decade of

silence to say that she is unable to look at another child without thinking
about the horror and suffering her son caused.

Susan
Klebold, whose son Dylan and another youth, Eric Harris, hunted down pupils at
the Colorado school with shotguns, a semi-automatic pistol and a rifle before
killing themselves, has described her trauma over her son’s actions.

“For
the rest of my life, I will be haunted by the horror and anguish Dylan caused,”
she wrote in O, The Oprah Magazine. “I cannot look at a child in a grocery
store or on the street without thinking about how my son’s schoolmates spent the
last moments of their lives. Dylan changed everything I believed about myself,
about God, about family and about love.”

Neither
the Klebold nor Harris families has spoken about the massacre, in which 21
students were also wounded.

Klebold
recounts how the last word she heard from her son was a gruff goodbye as he
rushed out of the door early on the morning of the killings in April 1999.

“I
was getting dressed for work when I heard Dylan bound down the stairs and open
the front door … I poked my head out of the bedroom. ‘Dyl?’ All he said was
‘Bye.’ … His voice had sounded sharp. I figured he was mad because he’d had
to get up early to give someone a lift to class. I had no idea that I had just
heard his voice for the last time,” she said.

Dylan
Klebold was headed to make a final video with Harris to say goodbye and
apologise to their families before they drove to the school to plant bombs,
which failed to detonate, and to carry through their plan to kill their fellow
students.

After
the killings, the authorities said there were indications that the two youths
were disturbed and hints of the looming catastrophe. Harris’s blog included
instructions on how to make explosives and, later, angry denunciations of
society that attracted the attention of the police after Harris posted a death
threat against another student. Closer to the massacre, Harris listed his
stockpile of weapons and posted a hit list. Klebold was less overt but with
Harris made secret videos of their weapons and wrote in his diary of a desire to
plan an attack that would match the bombing in Oklahoma City by rightwing
militiamen that killed 168 people.

Klebold
writes that she had no idea that Dylan was contemplating killing himself or
anyone else. “From the writings Dylan left behind, criminal psychologists have
concluded that he was depressed and suicidal. I’d had no inkling of the battle
Dylan was waging in his mind,” she wrote.

“Dylan’s
participation in the massacre was impossible for me to accept until I began to
connect it to his own death. Once I saw his journals, it was clear to me that
Dylan entered the school with the intention of dying there. In order to
understand what he might have been thinking, I started to learn all I could
about suicide.”

Five
years after the killings, the FBI said they believe that Harris was a clinical
psychopath who masterminded the plan and Klebold depressive.

The
massacre continues to generate debate about the motives of the two youths and
whether anything could have been done to stop them. The magazine said that Susan
Klebold was not paid for the article and will not be making an appearance on
Oprah Winfrey’s television
show.


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How a New Policy Led to Seven Deadly Drugs

How a New Policy Led to Seven Deadly Drugs

http://www.latimes.com/news/nation/reports/fda/lat_fda001220.htm

By DAVID WILLMAN

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.

Contributors to this Report
Design director: Joe Hutchinson
Photographer: Brian Walski
Photo editor: Steve Stroud
Graphics: Rebecca Perry
Graphics editor: Chris Erskine
Researchers: Janet Lundblad, Sunny Kaplan
Editors: Roger Smith, Nan Williams, Steve Devol, Bobbi Olson, Kathie Bozanich
Web site Editors: Sarah D. Wright, Clare Sup

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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Sen. Grassley: Drug Companies “Bamboozled the FDA” on SSRI Antidepressants

Mon Nov 10, 2008

The following information should go out to every reporter and every other
human on the planet. Please. Please. Please help us get this information out to
as many as possible as a warning. [BUT in doing so always remember to warn
of the extreme potential danger of abrupt withdrawal with the FDA warning that
such can cause suicide, hostility or psychosis.

Please give them our 800 order line or website to download or order my CD, “Help! I Can’t Get Off My
Antidepressant!” so that they will have the formula for safe and almost
painless withdrawal and methods of recovery from the damage they have suffered.]
Now if you have read my book most of this will sound all too familiar and
old. But now the cold hard facts are coming out to the public with Iowa’s own
Senator Grassley leading the way because these drugs grabbed his attention
after overseeing many of the hearings on children and antidepressants. THANK
YOU

SENATOR GRASSLEY FOR YOUR EFFORTS!!!
Some of the most important points in the article to file in your memory
banks and repeat as often as possible to as many as possible are as follows:

#1 US HIGHEST USER OF ANTIDEPRESSANTS & ANTIDEPRESSANTS ARE AMERICA’S
MOST WIDELY PRESCRIBED DRUGS:

“Antidepressant prescribing is more rampant in this country than any other.
The US accounted for 66% of the global market in 2005, compared to 23% in
Europe and 11% for the rest of world, according to a December 2006 report by
Research and Markets.
“A June 2007 survey by the Centers for Disease Control of doctor and
hospital visits in 2005 showed that the most commonly prescribed drugs were
antidepressants, with 48% of the prescriptions issued by primary care
physicians. They have remained in the number one position ever since. Last year, 232
million prescriptions were filled for antidepressants worth nearly $12 billion,
according to a March 2008 report by IMS Health. . . .


#2 YET THE MANUFACTURERS KNEW AND HID THE FACT THAT THESE DRUGS INCREASE
THE RISK OF SUICIDE:

“For fifteen years, the SSRI makers fought against adding a warning about an
increased risk of suicidality, knowing all the long that the risk existed.
[We had the data in court cases for years but could not get the press to cover
it.] Now, the companies are making the irresponsible argument (in defense of
lawsuits claiming they failed to warn doctors and the public of the risk)
that the FDA did not require them to add a warning, so they are immune from
liability. . . .

#3 SINCE 1989 THE MANUFACTURER OF PAXIL KNEW THAT THIS DRUG INCREASES SUICIDE ATTEMPTS BY EIGHT TIMES MORE THAN PLACEBO!

“The report shows that Glaxo [makers of Paxil] knew in 1989, long before
Paxil was FDA approved, that people taking the drug were 8 times more likely to
engage in suicidal behavior than people given a placebo, or sugar pill. Now,
it stands to reason that even the most depressed person would decline to take
Paxil if given these facts. Also, parents certainly would decline if they
were told about the risks. . . .

“The FDA approved Paxil on December 29, 1992, with no warning to doctors or
patients of the significant increased risk of suicidal behavior,” he writes.
. . .

#4 SENATOR GRASSLEY FINDS THAT PAXIL MAKER “BAMBOOZLED” THE FDA PUTTING
PATIENT SAFETY AT RISK

“Senator Grassley has also asked the FDA to go back and review the clinical
trial data submitted on Paxil. In a statement on the Senate floor on June 11,
2008, he said: “Essentially, it looks like GlaxoSmithKline bamboozled the
FDA.”
“We cannot live in a nation where drug companies are less than candid, hide
information and attempt to mislead the FDA and the public,” he stated. “These
companies are selling drugs that we put in our bodies, not sneakers.”
“When they manipulate or withhold data to hide or minimize findings about
safety and/or efficacy they put patient safety at risk,” Senator Grassley said.
“And with drugs like Paxil, the risks are too great.”
Now I need to note here that the only reason Paxil is taking so much heat
and the only reason we have all of this inside information on Paxil is because
of the information obtained during the Wyoming murder/suicide case of Donald
Schell. Before that these companies were settling cases so that they did not
have to go to court and disclose all of this information to the attorneys
working in our behalf.
After waiting three long years for one attorney to decide if he would take
the case, it went to Andy Vickery’s office. Andy took the case and Glaxo
allowed it to go all the way into court instead of settling the case. The jury
heard and saw enough to rule that the two pills of Paxil that Donald Schell
took before getting up one morning and shooting his wife, his daughter and his
baby grand daughter before shooting himself was the main cause.
Glaxo did all they could to seal that information back up again, but it was
too late. The cat was out of the bag. And it is long past time to let the cat
out of the bag on all these other antidepressants as well!
#5 THE RESULTS OF SENATOR GRASSLEY’S INVESTIGATION OF THE LARGE PAYMENTS
AND KICKBACKS TO DOCTORS BY DRUG MAKERS

“According to Senator Grassley’s June 4, 2008 statement in the Congressional
record, although conflict-of-interest disclosure forms make it appear that
the Harvard psychiatrists only received a couple hundred thousand from drug
companies over the past 7 years, the true figures show Dr Biederman received
over “$1.6 million,” Dr Spencer “over $1 million” and Dr Wilens “over $1.6
million” in payments from the drug companies.

“Based on reports from just a handful of drug companies,” he states, “we
know that even these millions do not account for all of the money.”
“Senator Grassley also notes that Dr Schatzberg owns stock worth more than
$6 million in one drug company. Ed Silverman reports on Pharmalot that there
are “30 or so physicians at two dozen universities which the Senate Finance
Committee is probing concerning disclosure of grants from drugmakers.” The
names of those 30 doctors, along with the research mills they operate out of,
need to be made public. . . . .


#6 RESEARCH INSTITUTIONS AND ACADEMIA ON THE TAKE FROM DRUG MAKERS AS WELL
ACTING AS “APOLOGISTS FOR COMMERCIAL SCIENTIFIC FRAUD” – SENIOR ACADEMICS
PROSTITUING MEDICINE.

“It is no longer a case where Americans need only be concerned about the
amount of money the academics are pulling in. The pharmaceutical industry also
has a stronghold on most major research institutions in this country. Many
could not exist if the drug companies withdrew all their research funding, a
state of affairs that did not occur by accident.

“In fact, according to Dr Aubrey Blumsohn, who publishes the Scientific
Misconduct Blog, when all is said and done:

“The chief villains remain our academic institutions and medical leadership.
They have colluded with and have acted as apologists for commercial
scientific fraud. They have tolerated the telling of lies by senior academics.
They have encouraged the prostitution of medicine. They have allowed abuse of the
most fundamental safeguards of science. Most importantly, they have set
terrible examples for our students.”

#7 WHO TOOK THE MONEY TO PUSH ANTIDEPRESSANTS TO CHILDREN?

“. . . . While Dr Keller took the lead on pushing Paxil for children and
adolescents, Dr Emslie was the main man on the Prozac trials, and Dr Wagner was
the queen bee on Zoloft studies. The co-authors of papers that appear in the
medical literature encouraging the use of SSRI’s for kids include Drs
Biederman, Schatzberg, Wilens and, of course, Charles Nemeroff.
“Dr Nemeroff was recently forced to resign as chairman of Emory’s psychiatry
department after Senator Grassley’s investigation revealed that he failed to
disclose to his university more than a million dollars in drug industry
income. All total, Nemeroff had earnings of $2.8 million from drug companies
between 2000 and 2007, but failed to report at least $1.2 million. . . . .


#8 YET AMAZINGLY ENOUGH . . . .

“Shrinks on the take are so addicted to industry money that it’s impossible
to embarrass them. Last year, the press ran major stories when this report
came out, highly critical of how much money they were making. This year, the
average amount rose by 25%.

Now for some hard questions. . . .

*** When Glaxo knew in 1989 that Paxil was inducing suicide at a rate EIGHT
TIMES HIGHER than with a placebo and did not warn, is that not at least
negligent homicide?

Or is it not in some way contributing to a premeditated loss of life?

How often do we read in criminal cases where someone has died and someone
else did not assist that person in need but instead allowed the death to happen
and that person has then been prosecuted and given a prison term?

What is the difference here? The only difference I see is that these people
at Glaxo made a lot of money by keeping quiet and allowing these deaths to
continue!!

*** I have been asking this question for a very long time. Why is it okay
for our academic institutions to peddle drugs and use our students as guinea
pigs in studies?

Why is it okay for them to make so much money from drug companies? Much of
their operating expenses come from this drug company blood money.

Why would anyone be surprised, when seeing this close financial situation
with the drug companies and the academic institutions, that so many students
are placed on these same drugs by campus health centers often addicting them to
the drugs for many years to come?

*** How can shrinks be so stupid, or just plain “in your face” with it, as
to take even more money from these companies while they are already in the
process of being investigated for doing so???

Oh, that’s right we already know the answer to that one – they take more of
these mind altering drugs than just about anyone else! The psychiatric nurse
attending my lecture last year estimated that at least 75% of her colleagues
are on these drugs.

And why are they on these drugs? Because the drug reps are telling them all
that they are in a stressful profession and that sooner or later they are
going to be hit by the anxiety or depression that comes with the stress . . .
so they need to start on the drugs now so as to ward off “the pending
inevitable” anxiety or depression.

Of course then we need to ask the question, “How could they have fallen for
that old sales pitch?” That alone makes you wonder about their sanity!

But then you must ask if it is okay for a drug user to then be a drug pusher
even when we are discussing “legal” drugs? Because that is exactly what we
are seeing happen with this situation with antidepressants – doctors on the
drugs pushing them to others – no different than what you see in street drug
use where those hooked on the drugs are the ones pushing them to others. When
you see how similar in action these antidepressants are to LSD or PCP that
whole scenario becomes totally transparent.

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
_www.drugawareness.org_ (http://www.drugawareness.org/) &
_www.ssristories.org_ (http://www.ssristories.org/)
Author of Prozac: Panacea or Pandora? – Our
Serotonin Nightmare & the audio, Help! I Can’t
Get Off My Antidepressant!!! ()

_atracyphd1@…_ (mailto:atracyphd1@…)

_http://www.scoop.co.nz/stories/HL0811/S00080.htm_
(http://www.scoop.co.nz/stories/HL0811/S00080.htm)

Pharmaceutical Industry Hustlers – Part I
Thursday, 6 November 2008, 1:25 pm
Column: Evelyn Pringle
Pharmaceutical Industry Hustlers – Part I
SSRI Antidepressants Pushers

By _Evelyn Pringle_
(http://www.scoop.co.nz/stories/print.html?path=HL0811/S00080.htm#a)
After twenty long years, it appears that the epidemic in mental disorders in
America might be coming to an end. It won’t happen because of any great
medical breakthrough but rather because the perpetrators of the greatest
healthcare fraud in history are finally being exposed. The demolition of the
giant “psycho-pharmaceutical complex” appears to be on the horizon.
For far too long, the focus has been on the drugmakers only. In recent
months, the spotlight has shown where it belongs – on the highly-paid
opportunists responsible for fueling the epidemic in prescribing of psychiatric drugs by
doctors in every field of medicine and the research institutions that enabled
the process.
The antidepressants known as selective serotonin reuptake inhibitors, or
SSRI’s, such as Prozac, Paxil, Zoloft, Celexa and Lexapro are at the center of
the storm. These drugs have been prescribed to more Americans than any other
class of medications over the past two decades. Cymbalta, Effexor and
Wellbutrin are often referred to as SSRI’s, but they are slightly different
chemically. However, the drugs all carry similar side effects and warnings.
The top sales pitch for SSRI’s has been the “chemical-imbalance-in-the-brain”
myth.

“There is no evidence whatsoever that depression is caused by a
biochemical imbalance,” says Dr Peter Breggin, one of the world’s leading
experts on psychiatric drugs and author of the new book, “Medication Madness.”
People take for granted pronouncements such as, “You have a biochemical
imbalance,” and “mental disorders are like diabetes,” he explains in the book.

“In reality,” Dr Breggin writes, “these are not scientific observations –
they are promotional slogans, so adamantly repeated in the media and by
individual psychiatrists that people assume them to be true.”
“The psycho-pharmaceutical complex fosters these falsehoods in order to
promote the widespread use of their products,” he says. “Reluctant patients by
the millions are pushed into taking drugs by doctors who tell them with no
uncertainty that they need medication.”

“If you have got a biochemical imbalance in your brain,” Dr Breggin advises
in the book, “the odds are overwhelming that your doctor put it there with a
psychiatric drug.”

All Eyes on Glaxo
At the moment, all eyes are on Paxil maker, GlaxoSmithKline (formerly
SmithKline Beecham), due to reports that the company is under investigation by
the US Department of Justice, as well as the Senate Finance Committee, with
Iowa’s Senator Charles Grassley, the ranking Republican on the Committee,
leading the charge.

The report that led to the investigation by Senator Grassley was generated in
litigation and was only recently made public after it was unsealed by the
court. It was submitted by Dr Joseph Glenmullen, a Clinical Instructor in
Psychiatry at Harvard Medical School and author of “The Antidepressant
Solution”

and Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil, and
Other Antidepressants with Safe, Effective Alternatives.” He was retained as
an expert by the Los Angeles-based law firm of Baum, Hedlund, Aristei & Goldman.
The litigation involves several Paxil-induced suicide cases, including a 13-year-old child.

The report shows that Glaxo knew in 1989, long before Paxil was FDA approved,
that people taking the drug were 8 times more likely to engage in suicidal
behavior than people given a placebo, or sugar pill. Now, it stands to reason
that even the most depressed person would decline to take Paxil if given
these facts.

Also, parents certainly would decline if they were told about the
risks. Dr Glenmullen explains that, by submitting what he refers to as “bad” Paxil
numbers to the FDA, Glaxo was able to avoid adding a warning about suicide to
the label when the drug was approved. “GlaxoSmithKline’s ‘bad’ Paxil numbers
carried the day: The FDA approved Paxil on December 29, 1992, with no warning
to doctors or patients of the significant increased risk of suicidal behavior,” he writes.

Instead, Glaxo listed suicide and suicide attempts that took place during the
“run-in” period of the studies as if they happened in the placebo group. The
run-in period, also called the “wash-out” phase, occurs when all patients
are taken off their existing drugs to let the old drugs wash out of their
systems, and all patients are given placebos. The rationale for washing out old
drugs is to prevent them from confusing the results of the study, so that
patients start out in a similar condition, according to the report.
The official trial only begins after the wash-out phase, once the patients
are assigned to receive either the antidepressant or a placebo. The patients
who continue to receive the placebo are referred to as the placebo group.

“Confusing the pre-study placebo wash-out phase with the placebo group in the
actual study is improper,” Dr Glenmullen writes, “especially when the
concern is a potentially lethal side effect.”

The “correct data shows that suicide attempts in patients on Paxil occurred
at a rate eight times higher than the rate in patients on placebo,” he notes.
Senator Grassley has also asked the FDA to go back and review the clinical
trial data submitted on Paxil. In a statement on the Senate floor on June 11,
2008, he said: “Essentially, it looks like GlaxoSmithKline bamboozled the
FDA.”

“We cannot live in a nation where drug companies are less than candid, hide
information and attempt to mislead the FDA and the public,” he stated. “These
companies are selling drugs that we put in our bodies, not sneakers.”
“When they manipulate or withhold data to hide or minimize findings about
safety and/or efficacy they put patient safety at risk,” Senator Grassley said.
“And with drugs like Paxil, the risks are too great.”

A good start as the Glaxo scandal unravels, the public will learn that other
antidepressant makers such as Eli Lilly, Pfizer, Wyeth and Forest Laboratories
are equally guilty. Likewise, there are many more supposedly independent academic
doctors who have been receiving substantial financial benefits from drug
companies than are currently identified in the media as being under investigation.

Exposing Harvard University’s Joseph Biederman, Thomas Spencer, Timothy
Wilens, Stanford’s Alan Schatzberg, Brown University’s Martin Keller, Melissa
DelBello at the University of Cincinnati, and Drs Karen Wagner and John Rush,
who operated out of the University of Texas, might be a good place to start, but
the trail of Big Pharma’s funding academic research for marketing
purposes certainly does not end with a handful of psychiatrists.

According to Senator Grassley’s June 4, 2008 statement in the Congressional
record, although conflict-of-interest disclosure forms make it appear that the
Harvard psychiatrists only received a couple hundred thousand from drug
companies over the past 7 years, the true figures show Dr Biederman received
over “$1.6 million,” Dr Spencer “over $1 million” and Dr Wilens “over $1.6
million” in payments from the drug companies.

“Based on reports from just a handful of drug companies,” he states, “we know
that even these millions do not account for all of the money.”
Senator Grassley also notes that Dr Schatzberg owns stock worth more than $6
million in one drug company. Ed Silverman reports on Pharmalot that there are
“30 or so physicians at two dozen universities which the Senate Finance
Committee is probing concerning disclosure of grants from drugmakers.” The names
of those 30 doctors, along with the research mills they operate out of, need
to be made public.

The new book, “Side Effects: A Prosecutor, a Whistleblower, and a
Best-selling Antidepressant on Trial,” by investigative journalist Alison Bass,
provides the inside scoop on the fraudulent SSRI research conducted at Brown
University by Dr Keller.

The book also supplies background information on the financial ties between
the so-called “opinion leaders” in psychiatry and the other antidepressant
makers. For instance, Ms Bass explains that Drs Schatzberg and Keller worked as
a team a decade ago to promote Bristol-Myers Squibb’s antidepressant Serzone.

In 1998, Dr Schatzberg was paid to moderate an industry-sponsored symposium
that touted the benefits of Serzone, and Dr Keller was one of the paid
speakers at the event. The same year, Dr Keller received $77,400 in consulting
fees from Bristol-Myers, Ms Bass points out.

Dr Keller later published a study in the New England Journal of Medicine also
touting the benefits of Serzone. The drug was removed from the market in
2004 after it was found to cause liver damage but not before a number of
patients died.

Ms Bass reports that Keller did not report any income from Glaxo on his 1998
tax return. But during her research for “Side Effects,” she discovered he had
earned personal income from Glaxo in 1998, as well as subsequent years.
Keller admitted as much during a September 2006 deposition for a lawsuit filed
against Glaxo, she says.

It is no longer a case where Americans need only be concerned about the
amount of money the academics are pulling in. The pharmaceutical industry also
has a stronghold on most major research institutions in this country. Many could
not exist if the drug companies withdrew all their research funding, a state
of affairs that did not occur by accident.

In fact, according to Dr Aubrey Blumsohn, who publishes the Scientific
Misconduct Blog, when all is said and done:

“The chief villains remain our academic institutions and medical leadership.
They have colluded with and have acted as apologists for commercial
scientific fraud. They have tolerated the telling of lies by senior academics.
They have encouraged the prostitution of medicine. They have allowed abuse of the
most fundamental safeguards of science. Most importantly, they have set
terrible examples for our students.”


U
niversities keep corrupt academics on board for good reason. “Side Effects”
reports that, between 1990 and 1998, “Martin Keller brought in nearly $8.7
million in research funding from pharmaceutical companies.”
The clinical trial industry itself provides a perfect slush fund. Spending in
the U.S. was an estimated $25 billion in 2006 and is expected to reach about
$32 billion by 2011.

Most of the money for trials comes from private
industry, and federal funding assumes a second place position, with the
National Institute of Health budgeting $3 billion for clinical trials in 2006, according
to the paper, “State Medical Board Responses To An Inquiry On Physician
Researcher Misconduct,” by Dr Stefan Kruszewski, Dr Richard Paczynski and
Marzana Bialy, in the Journal of Medical Licensure and Discipline 2008: Vol 94 No 1.
Paxil Study 329 “Side Effects” also covers the whole sordid affair on Paxil Study 329, the
most infamous fraudulent pediatric trial of all time. The study “offers a
landmark for the point at which science turned into marketing,” according to Dr
David Healy.

Dr Healy is a Professor of psychiatry and Director of the North Wales School
of Psychological Medicine at the University of Wales, and an outspoken critic
of the psycho-pharmaceutical complex, with 21 books to his name, including
“The Creation of Psychopharmacology.”

He explains that, in 1998, Glaxo’s original assessment of Study 329 had
concluded that it and another study had shown Paxil did not work for children,
but that it would not be “commercially acceptable” to publicize this finding.
“Instead the positive findings from the study would be published; they were in
an article whose authorship line contains some of the best known names in
psychopharmacology (Keller et al., 2001),” Dr Healy writes in the 2007 paper,
“The Engineers of Human Souls & Academia.”

Dr Keller gets most of the credit for the study, which was completed in
the mid-90’s. Keller et al had some difficulty getting it published at first,
but finally found a journal willing to take the bate in 2001, the Journal of
the American Academy of Child and Adolescent Psychiatry. In all, 20 academics
allowed their names to be attached to this ghostwritten infomercial, and not
one has stepped forward to acknowledge wrongdoing or to admit that a mistake
was made.

Long before the paper was published, the authors of study 329 were fanned out
all the way to Canada giving lectures and presentations to prescribing
doctors at medical conferences and seminars to promote the off-label use of
Paxil for kids. More than any other paper, Study 329 led to an epidemic in
pediatric prescribing. “After its publication, the use of antidepressants for
children skyrocketed,” Dr Glenmullen notes.

These handsomely paid key opinion leaders all deserve to have their names
in lights, especially Drs Graham Emslie and Karen Wagner from the University
of Texas.

Between 2000 through 2005, Glaxo paid Dr Wagner $160,404, but the only
payment she reported to the university was $600 in 2005, according to Senator
Grassley. Dr Wagner also failed to disclose earnings of more than $11,000 from
Prozac-maker Eli Lilly in 2002.

On August 18, 2008, the Dallas Morning News reported that a state mental
health plan naming the preferred psychiatric drugs for children has been quietly
put on hold over fears drug companies may have given researchers consulting
contracts, speakers fees or other perks to help get their products on the
list.

The Children’s Medication Algorithm Project, or CMAP, was supposed to
determine which psychiatric drugs were most effective for children and in what
order they should be tried at state-funded mental health centers, the Morning
News explains.

The academics who developed the CMAP include Drs Wagner and Emslie. Records
show Dr Emslie may have made up to $125,000 from drug companies since
2004, according to the report in the Morning News. While Dr Keller took the lead on
pushing Paxil for children and adolescents,Dr Emslie was the main man on the Prozac
trials, and Dr Wagner was the queen bee on Zoloft studies.

The co-authors of papers that appear in the medical
literature encouraging the use of SSRI’s for kids include Drs Biederman,
Schatzberg, Wilens and, of course, Charles Nemeroff.
Dr Nemeroff was recently forced to resign as chairman of Emory’s psychiatry
department after Senator Grassley’s investigation revealed that he failed to
disclose to his university more than a million dollars in drug industry
income. All total, Nemeroff had earnings of $2.8 million from drug companies
between 2000 and 2007, but failed to report at least $1.2 million.

A complete list of academics who should to be investigated can be found among
the authors of the SSRI papers and studies highlighted in the 2006 Third
Edition of, “Essentials of Clinical Psychopharmacology,” described as “a
synopsis and update of the most clinically relevant material from ‘The American
Psychiatric Publishing Textbook of Psychopharmacology,'” by none other than Drs
Schatzberg and Nemeroff.

Keep Following the Money
On July 10, 2008, Senator Grassley extended his investigation to include
psychiatry’s top industry-funded front group with a letter to Dr James Scully,
Medical Director and Chief Executive Officer of the American Psychiatric
Association, asking for “an accounting of industry funding that pharmaceutical
companies and/or the foundations established by these companies have provided to
the American Psychiatric Association.”

The Senator wants records from January 2003 to the present. According to the
July 12, 2008, New York Times, in 2006, the “industry accounted for about 30
percent of the association’s $62.5 million in financing.”
A factor rarely discussed in this debate is the amount of money doctors who
prescribe SSRI’s make during brief office calls charged at regular rates. This
practice has taken a tremendous toll on public healthcare programs and has
resulted in higher insurance premiums and overall healthcare costs for all
Americans.

In fact, the bilking of public healthcare programs is what led to the current
investigations by the Finance Committee, which has the responsibility of
overseeing spending in Federal programs. When doctors prescribe drugs for
unnecessary uses, public programs not only have to pay for the drugs, they must
also pay the fees of the prescribing doctors and for the medical care for
injuries caused by the drugs. Government spending tied to the prescribing of
psychiatric drugs has gone through the roof in the past decade.

While testifying before the House Committee on Oversight and Government
Reform on February 9, 2007, Lewis Morris, Chief Counsel at the Department of
Health and Human Services’ Office of Inspector General, discussed kickbacks to
doctors and told the panel:

“Kickbacks potentially increase the costs to Federal programs because they
encourage overutilization and may encourage the prescribing of more expensive
drugs when clinically appropriate and cheaper options (such as generic drugs)
may be equally effective.”

Mr Morris explained that, “kickbacks offered to prescribing physicians by
pharmaceutical manufacturers take a variety of forms, ranging from free samples
for which the physician bills the programs to all-expense-paid trips and sham
consulting agreements.”

Vermont is a rare state in requiring the pharmaceutical industry to disclose
the money paid to doctors. On July 8, 2008, Vermont’s Attorney General
William Sorrell released the state’s annual report on “Pharmaceutical Marketing
Disclosures,” which lists the payments made by drug companies in 2007. Of the
top 100 recipients, once again, psychiatrists received the highest payments.
Eleven psychiatrists received a total of $626,379, or about 20% of the total
value of payments made, according to the report.

Shrinks on the take are so addicted to industry money that it’s impossible to
embarrass them. Last year, the press ran major stories when this report came
out, highly critical of how much money they were making. This year, the
average amount rose by 25%.

The report also analyzes the payments based upon the drugs being marketed. Of
the top 10 drugs for which disclosures were reported, five are used to treat
mental illness and include Lilly’s Cymbalta and Forest Lab’s Lexapro.
Ironically, Cymbalta sales are also up 25%, according to Lilly’s latest SEC
filing.

Overall, estimates indicate that the drug industry spends $19 billion
annually on marketing to physicians in the form of gifts, travel, meals and
other consulting fees, according to a May 22, 2008, press release by Senator
Grassley’s office. In the November 1, 2007, New England Journal of Medicine
paper, “Doctors and Drug Companies Scrutinizing Influential Relationships,” Dr
Eric Campell, associate professor at the Institute of Health Policy at
Massachusetts General Hospital and Harvard Medical School, writes:

“Individual physicians can take some steps to maximize the benefits for
patients and minimize the risks associated with their own industry
relationships. They can start by recognizing that such relationships are designed to
influence prescribing behavior and by carefully considering the potential
effects that their own associations may have on their patients.”

“And they can bear in mind,” he says, “that the costs of industry dinners,
trips, and other incentives are passed along to their patients in the form of
higher drug prices.” Antidepressant prescribing is more rampant in this country than any other.
The US accounted for 66% of the global market in 2005, compared to 23% in
Europe and 11% for the rest of world, according to a December 2006 report by
Research and Markets.

A June 2007 survey by the Centers for Disease Control of doctor and hospital
visits in 2005 showed that the most commonly prescribed drugs were
antidepressants, with 48% of the prescriptions issued by primary care
physicians. They have remained in the number one position ever since. Last year, 232 million
prescriptions were filled for antidepressants worth nearly $12 billion,
according to a March 2008 report by IMS Health.

The top dogs in the pharmaceutical industry are literally laughing all the
way to the bank. For example, in 2007, Pfizer CEO Jeff Kindler’s pay package
was worth $9.5 million, according to the March 14, 2008, Wall Street Journal. A
previous CEO, David Shedlarz, left last year with an “exit package” worth
over $34 million. In 2007, the total value of Wyeth’s then-CEO Robert Essner’s
pay package was $24.1 million, the Journal reports.

In the meantime, state Medicaid programs are going bankrupt as a result of
the mental illness epidemic occurring only in the US. Attorneys General all
over the country are using consumer fraud statutes to sue the drug giants to
recoup the money lost due to the illegal off-label promotion of psychiatric
drugs and the concealment of their side effects.

For instance, Baum Hedlund has been litigating Private Attorney General
consumer fraud class-action lawsuits against Glaxo since 2004, on behalf of
individuals and entities such as insurance companies in California, Florida,
Illinois, Massachusetts, Minnesota, Missouri, New Jersey, North Dakota, Ohio and
Washington.

The cases are based on documents showing Glaxo promoted Paxil for kids, fully
aware that Paxil failed to out-perform a placebo in the clinical trials and
had higher suicidality rates. A national class settlement of individual
claims was reached in April 2007 in which Glaxo agreed to reimburse parents for
all of the money paid for Paxil prescriptions for their children. A national
class settlement on behalf of third party payors (insurance companies) was just
approved in September 2008.

If not for the few law firms willing to stay the course, the truth would
never have been revealed. Baum Hedlund has been pursuing the SSRI makers for
nearly two decades. Most recently, it has taken up the fight for babies born
with birth defects caused by SSRI’s.

Because the industry was so successful at keeping the original SSRI trial
data hidden, the drugs most serious side effects largely became public only
as a result of the bravery and integrity of such medical experts as Dr Healy, Dr
Glenmullen and Dr Breggin, who could not be bought and could not be bullied.

For fifteen years, the SSRI makers fought against adding a warning about an
increased risk of suicidality, knowing all the long that the risk existed.
Now, the companies are making the irresponsible argument (in defense of
lawsuits claiming they failed to warn doctors and the public of the risk) that the
FDA did not require them to add a warning, so they are immune from liability.
Worse yet, the industry-controlled FDA under the Bush Administration is
supporting this audacious preemption defense and siding with the SSRI makers
against private citizens in courts all over the country, telling judges to rule
in favor of the drug companies and throw out the SSRI cases before they even
make it to a jury.

Although not an SSRI case, the Supreme Court heard oral argument in a case
involving federal preemption, in Wyeth v Levine, on November 3, 2008.
*************
Evelyn Pringle
epringle05@…
(Written as part of the Paxil Litigation Round-Up, Sponsored by Baum,
Hedlund, Aristei & Goldman’s Pharmaceutical Litigation Department
_www.baumhedlundlaw.com_ (http://www.baumhedlundlaw.com/) )


Search Engine Submission – AddMe

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5/01/2001 – World Health Organization – SSRI Addiction

“A league table of withdrawal and dependency side-effects, published by the
WHO, shows that drugs including Prozac and Seroxat [Paxil] have produced far
more complaints from patients than old-fashioned tranquillisers . . . SSRIs
(selective serotonin reuptake inhibitors), including Prozac, are more
addictive than tranquillisers such as Valium.”

Yesterday, in several major newspapers Lilly placed full page ads offering a
coupon for a month of free Prozac. Do you think they warned the consumer in
those ads that these free pills were addictive? Because so few doctors are
aware of this withdrawal and do not know how to withdraw patients from SSRIs,
after the month on the “free” pills the patient would have to continue to
purchase the drug until they could find my tape on how to get off Prozac
safely.

If you had told me ten years ago, shortly after I began researching the SSRIs
and dealing with patients going through horrific withdrawal from Prozac, that
it would take TEN years for the World Health Organization to finally see what
I was seeing, I would not have believed it. It was so obvious! But I have
waited and waited and waited as I have warned and warned and warned of this
addiction and withdrawal and finally today we see the WHO admit it.

At least the WHO have warned the public now, but where is the FDA? Will they
finally at least admit this much about SSRIs? All of these organizations that
society thinks are there to protect them – where were they as millions
suffered needlessly? How many times do we need to see this repeated with one
drug after another before we realize that there is no protection to the
consumer via these agencies? Obviously “buyer beware” most definitely applies
in this arena of prescription drug use. This is why I feel it is so important
to educate the public about these drugs.

You can mark my words when I say that this is only one of MANY more
admissions that will continue to come confirming all the warnings that I gave
in my book about the SSRI antidepressants, Prozac: Panacea or Pandora?

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org and author of
Prozac: Panacea or Pandora? ()

http://news.independent.co.uk/uk/health/story.jsp?story=69366

01 May 2001
Home > News > UK > Health

World health watchdog warns of addiction risk for Prozac users

By Robert Mendick

29 April 2001

Prozac, billed for years as a harmless wonder drug, often creates more
problems than the depression it is supposed to be treating, warns the head of
the World Health Organisation’s unit monitoring drug side-effects.

Professor Ralph Edwards says Prozac and drugs similar to it are
overprescribed. A league table of withdrawal and dependency side-effects,
published by the WHO, shows that drugs including Prozac and Seroxat [Paxil]
have produced far more complaints from patients than old-fashioned
tranquillisers prescribed by doctors in the 1970s. Campaigners say this
proves that the drugs called SSRIs (selective serotonin reuptake inhibitors),
including Prozac, are more addictive than tranquillisers such as Valium.

“SSRIs are probably over-used,” says Professor Edwards. “They are used for
relatively minor psychiatric problems, and the issue of dependence and
withdrawal has become much more serious. You risk creating a greater problem.
For serious psychiatric problems, it is worth the risk. But if you are just
tired or going through a bad patch, well, people get over that without
medication.”

A spokeswoman for Eli Lilly, makers of Prozac, accepted there are potential
side-effects including head-aches, dizziness, sleeplessness and nausea but
added: “The benefits of Prozac far outweigh the downsides. Extensive
scientific and medical experience has demonstrated that Prozac is a safe,
effective antidepressant that is well-tolerated by most patients.”

Prozac has been taken by an estimated 35 million people worldwide since its
launch a decade ago. But the reputation of SSRIs as wonder drugs is being
questioned. Research by Dr David Healy, at the University of Wales, appeared
to show that two people in a trial group of 20 became violent after taking an
SSRI.

Dr Healy’s research may be presented as evidence in a High Court case being
brought by the family of Reginald Payne, a retired teacher who was taking
Prozac when he killed his wife then jumped off a cliff. The family is suing
Eli Lilly, claiming negligence and saying the pharmaceutical firm failed to
warn Mr Payne of side-effects, which they say include suicidal and violent
behaviour.

The experiences of Ramo Kabbani on Prozac prompted her to set up the Prozac
Survivors Support Group. In two years, it has taken 2,000 calls. Ms Kabbani
claims SSRI withdrawal causes side-effects ranging from flu-like symptoms
such as dizziness and aching muscles to suicidal tendencies. She began taking
Prozac to combat depression after the death of her 27-year-old fiance from a
heart attack.

“The medication stopped me working through the feelings of grief which had
caused the depression.” she says. “When I came off Prozac I became
super-sensitive and very emotional. I found it worse going through withdrawal
than going through the depression.”

Council for Involuntary Tranquilliser Addiction 0151 949 0102; Prozac
Survivors Support Group 0161 682 3296.

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4/9/2001 – FDA Doc Claims Fen-Phen Cover Up

Once again the CBS Health Watch has given us another great article – this
time on the subject of corruption in the FDA.

With this revelation about the cover up with Fen-Phen let us hope that the
truth will begin to come out about the rest of these dangerous serotonergic
drugs. The real shame about Fen-Phen and Redux is that the drug company is
still getting away with all the psychiatric side effects their drugs
produced. The serotonergic effect with these drugs produced as many psychotic
breaks as the SSRIs have and in the end we will see that the SSRIs are
producing similar heart and lung problems as Fen-Phen and Redux did.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

http://cbshealthwatch.medscape.com/SRS/c/ShowDoc.asp?ContentID=214123&ContentType=5

FDA Doc Claims Fen-Phen Cover Up

April 7 (CBS) The drug company that manufactured “fen-phen,” a diet
medication linked to heart ailments, covered up problems with the drug that
emerged during Food and Drug Administration testing, a former FDA scientist
tells CBS News.

Fen-phen was removed from the market in 1997. Thousands of people who took
the drug have sued American Home Products of Madison, N.J., for health
problems they claim the drug caused.

In an Eye on America investigation, CBS News Correspondent Sharyl Attkisson
reports the FDA’s key reviewer of fen-phen, Dr. Leo Lutwak, claims the
company knew about the problems long before the drug was pulled.

“I felt from the very beginning the drug companies were covering up. I felt
from the very beginning that these drugs were dangerous,” said Lutwak.

He claims American Home Products twisted the meaning of his research to make
it seem as if there was no way to predict fen-phen’s hazards.

“What I had actually written was, that in view of the covering up of
information by the drug company, the FDA had no way of predicting some of
these side effects,” he said.

One of those who sued American Home Products was Patricia Buol, who developed
severe heart problems after taking fen-phen. She’s now in line for a life
saving heart-lung transplant.

The company settled with Buol this week.

“Being part of my kids’ lives and doing their everyday activities is a
struggle,” said Buol. “But I just take one day at a time and do the best I
can.”

Dr. Lutwak’s testimony is crucial to fen-phen cases like Buol’s. But the FDA
won’t let him testify. Now Lutwak says he’s planning to retire, making him
free to testify at will.

“I followed the rules and regulations, I didn’t go public. I tried to work
within the system, it didn’t work. People died as a result of a dangerous
deadly drug being released,”he said.

Defendant American Home Products would not be interviewed, but has said in
the past it “acted responsibly and lawfully.”

FDA Commissioner Jane Henney refused a CBS News request to answer the
allegations.

The agency’s last commissioner, Dr. David Kessler, criticized the agency’s
current approach to drug regulation.

“I have some concerns that we may be losing sight of what the FDA is all
about,” said Kessler. “The question is, who’s the agency’s customers? Who’s
the agency partner?”

Consumer advocates say the FDA is constantly keeping damaging information
from the public.

“They view the drug industry in many ways as their customers, at least the
bosses do, as opposed to viewing the public as the customers they need to
protect from some of the excesses of the drug industry,” said Sidney Wolfe of
Public Citizen.

Concerns about the FDA also emerged during the controversy over the diabetes
drug Rezulin.

Kessler said the agency needs to realize the American consumer is its
customer.

American Home Products also makes such drugs as Caordarone, Sectral,
Protonix, Synvisc and Pnu-Imune.

Fen-phen is actually a combination of two drugs, fenfluramine and
phentermine, which work by suppressing the appetite of a person who is trying
to lose weight.

It was estimated that in 1996, 18 million Americans took the drugs.

But a report in the August 1997 New England Journal of Medicine found that
fenfluramine can in some cases lead to pulmonary hypertension, a rare, almost
always fatal, disease. It was also linked to heart valve malfunction.

In September, 1997, the FDA, saying it was “acting on new evidence about
significant side-effects,” asked the manufacturers to voluntarily withdraw
both medications, marketed under the names Pondimin (fen-phen), and Redux, a
similar medication.

Wyeth-Ayerst Laboratories, a subsidiary of American Home Products, complied.

However, the company continued to deny the drugs caused the alleged problems.
In November, 1998, Wyeth-Ayerst published a study that compared heart
function in people who had taken fen-phen and a group who hadn’t, and
concluded there was “no significant differences in cardiovascular clinical
outcomes.”

But that didn’t stop the fen-phen fallout.

A February, 1999 60 Minutes II investigation with U.S. News & World Report
revealed that Wyeth-Ayerst knew more than it told about the pulmonary
hypertension risks, a charge the company denied.

In September 1999, the Wall Street Journal reported that the FBI was
investigating the FDA’s approval of Redux.

A month later, American Home Products agreed to pay up to $4.83 billion to
settle the more than 11,000 fen-phen lawsuits, one of the biggest product
liability settlements ever.

As part of the settlement agreement, the company admitted no wrongdoing.

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7/23/2000 – FDA officer advised diet-drug clinic about Fen-Phen

In case any of you missed this last fall when it broke in the Philadelphia
Inquirer and the Wall Street Journal, here it is again so you have it for
reference.

Notice that this FDA official is also the doctor who is credited with
starting the Fen-Phen craze with a medical study he published suggesting the
use of this deadly combination of drugs.

Ann Blake-Tracy

http://www.FreeRepublic.com/forum/a37f02e3073c5.htm

FreeRepublic.com “A Conservative News Forum”

Crime/Corruption

News Source: AP
Published: 9/27/99 Author: AP
Posted on 09/27/1999 19:55:44 PDT by Joe Montana

CROOKED FDA WORKS HAND IN HAND WITH DRUG COMPANIES THEY ARE SUPPOSED TO
“REGULATE”–

Ex-FDA officer advised diet-drug clinic about fen-phen

9/27/99

PHILADELPHIA (AP) – A high-ranking U.S. Food and Drug Administration official
helped a small businessman in Florida promote the popular diet drug fen-phen
in 1995, during the height of the pill combination’s popularity, newspapers
reported.

Though the FDA never approved or endorsed fen-phen, which has since been
linked with heart-valve problems, Dr. Michael Weintraub provided advice and
patient referrals to a fledgling chain of weight-loss clinics dispensing
fen-phen, The Philadelphia Inquirer reported Sunday and The Wall Street
Journal reported Monday.

Weintraub suggested a list of doctors who might endorse the diet drug
combination, talked to at least three potential clients and allowed his name
to be used in advertising, said Tampa, Fla., attorney John Trevena, who
founded Advantage Weight Control in 1994. Weintraub denies allowing his name
used in advertising.

Weintraub, who left the FDA in 1998 after five years and is now a
pharmaceutical consultant, has not been investigated by the FDA for
wrongdoing. Weintraub said his activities were similar to assistance he
offered to other people who sought advice about fen-phen.

“I couldn’t reject talking to people who called me up,” Weintraub told the
Inquirer. “I believed that the drugs could help people.”

Weintraub is largely credited for launching the fen-phen fad with a 1992
medical study that suggested combining fenfluramine, sold under the brand
names Pondimin and Redux, and phentermine in an “off-label” combination
use. Each drug was FDA approved, but the cocktail was not.

American Home Products Corp. marketed Pondimin and Redux until September
1997, when the FDA pushed for their withdrawal after a study linked the drugs
to potentially fatal heart valve damage. [And after an August 1997 National
Institute of Health study linked the drugs to brain damage.] American Home
Products now faces thousands of lawsuits from patients who claim to be hurt
by them and is negotiating a settlement estimated at $4 billion.

Weintraub joined the FDA in 1993, and eventually became director of
over-the-counter-drug evaluation. Weintraub agreed to advise Trevena
beginning in 1995, though he refused to be paid, citing government ethics
policies.

In the months that followed, Trevena recommended names of prominent obesity
experts who might serve as the center’s medical director. He testified before
the state medical board urging it not to ban fen-phen – though he explained
his remarks were not on behalf of the FDA – and praised Trevena’s centers to
the Florida news media.

Weintraub also personally advised at least three prospective Trevena clients
who were considering joining the program, Trevena said. After speaking with
Weintraub, all three signed up.

In one case, a client asked Weintraub for a referral to a weight-loss
physician in her area. Weintraub’s reply, written on FDA letterhead dated
February 1995, gave her the name of Trevena’s marketing consultant – not a
physician.

“He enthusiastically assisted us,” Trevena told the Journal.

He said his business, which has since filed for bankruptcy, relied heavily
on Weintraub’s advice on such matters as how to monitor patients. Its
publicity materials said the center used the “Weintraub Protocol.”

Weintraub said he did suggest a name or two as possible medical directors and
referred at least one patient to Trevena. He said that to anyone who asked
about fen-phen he explained the possible side effects, “potential and
real,” and stressed the need for a full physical exam and medical
monitoring.

In one of their three conversations, Trevena said he asked Weintraub whether
his advice and help with the weight-loss clinic were ethical.

“Dr. Weintraub indicated that because of his high-level position and
contacts within the FDA, he wasn’t concerned about it,” Trevena said. “He
said it wasn’t a problem.”

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7/15/2000 – FDA Warning Comes 40 Years Too Late on Mellaril

We are grateful to our e-group member, Martin Hirschfeld,
and also to Vera Hassner Sharav, President, CIRCARE:
Citizens for Responsible Care & Research, for forwarding
this information to us.
AFTER 40 YEARS OF USE – the FDA has put new
restrictions on the use of the antipsychotic, Mellaril.
Obviously for many patients this strong warning about
life threatening side effects has come 40 years too late!
How many patients would still be alive had the warning
come when it should have – 40 years ago? This should
cause us to ask just how many more drugs are as
damaging or even more dangerous, that we have yet
to be warned by the FDA of their dangers?

For those using SSRIs, note that an additional warning
of contraintication is issued to those using Luvox or another
drug often given in conjunction with SSRIs, propranolol.
Considering the accumulation rate of SSRIs, including
Luvox, the contraindication for Mellaril should include
anyone who has been on Luvox in the recent past
as well. And because psychosis is listed as a “frequent”
side effect of Luvox, the prescribing of an antipsychotic
such as Mellaril could be a fairly common practice
threatening the lives of many.

Dr. Ann BlakeTracy
________________________

New Labeling For Novartis’ Mellaril Reflects Restricted Use

http://www.medscape.com/reuters/prof/2000/07/07.13/20000713rglt002.html
NEW YORK, Jul 13 (Reuters Health) – The US Food and
Drug Administration (FDA) has asked Novartis to update
the labeling for its antipsychotic drug Mellaril (thioridazine)
to warn of potentially life-threatening side effects, the
company said on Wednesday.

Thioridazine has been shown to prolong patients’ QTc
interval, an electrocardiogram measurement reflecting
the refractory period of the heart, which can lead to the
potentially fatal ventricular tachycardia known as torsades
de pointes and sudden death, according to the FDA.

As a result, Mellaril is now indicated only for patients
with schizophrenia who either cannot tolerate other
antipsychotic drugs or who fail to respond to them,
the company said.

In addition to changing Mellaril’s label, Novartis will
send letters to about 360,000 US doctors and 60,000
pharmacies apprising them of the FDA’s new position
on the drug, and asking them to share the information
with their patients.

The letters advise that “switching to a different antipsychotic
agent should be considered.”

Mellaril, which was approved in 1959, has already been
eclipsed by newer therapies for many patients, a Novartis
spokesperson told Reuters Health. While the new warnings
threaten to slash sales of the drug even further, “in the short
term, we won’t be discontinuing it,” he said.

The product is also sold by a handful of generic manufacturers,
including Geneva and Mylan.

Novartis’ letter to physicians stresses that, in light of the new
information about Mellaril, the drug is “now contraindicated
with certain other drugs,” including the antidepressant
fluvoxamine [Luvox] and the beta-blocker propranolol, and
is considered inappropriate for patients with a history of
cardiac arrhythmias and certain other conditions.

Before being treated with Mellaril, patients should be
evaluated with a baseline ECG and should have their
serum potassium levels measured, the letter adds,
noting that monitoring should be continued throughout
the treatment.

The letter points out that Boehringer Ingelheim’s Serentil
(mesoridazine), which is chemically related to thioridazine,
“also appears to have the capacity to prolong the QTc interval.”

Boehringer Ingelheim and the FDA did not respond to telephone
calls seeking comment.

Copyright © 2000 Reuters Ltd. All rights reserved.
=================================================================
New Labeling For Novartis’ Mellaril Reflects Restricted Use

www.medscape.com/reuters/prof/2000/07/07.13/20000713rglt002.html
NEW YORK, Jul 13 (Reuters Health) – The US Food and Drug Administration
(FDA) has asked Novartis to update the labeling for its antipsychotic drug
Mellaril (thioridazine) to warn of potentially life-threatening side

effects, the company said on Wednesday.
Thioridazine has been shown to prolong patients’ QTc interval, an
electrocardiogram measurement reflecting the refractory period of the heart,
which can lead to the potentially fatal ventricular tachycardia known as
torsades de pointes and sudden death, according to the FDA.
As a result, Mellaril is now indicated only for patients with schizophrenia
who either cannot tolerate other antipsychotic drugs or who fail to respond
to them, the company said.
In addition to changing Mellaril’s label, Novartis will send letters to
about 360,000 US doctors and 60,000 pharmacies apprising them of the FDA’s
new position on the drug, and asking them to share the information with
their patients.
The letters advise that “switching to a different antipsychotic agent should
be considered.”
Mellaril, which was approved in 1959, has already been eclipsed by newer
therapies for many patients, a Novartis spokesperson told Reuters Health.
While the new warnings threaten to slash sales of the drug even further, “in
the short term, we won’t be discontinuing it,” he said.
The product is also sold by a handful of generic manufacturers, including
Geneva and Mylan.
Novartis’ letter to physicians stresses that, in light of the new
information about Mellaril, the drug is “now contraindicated with certain
other drugs,” including the antidepressant fluvoxamine and the beta-blocker
propranolol, and is considered inappropriate for patients with a history of
cardiac arrhythmias and certain other conditions.
Before being treated with Mellaril, patients should be evaluated with a
baseline ECG and should have their serum potassium levels measured, the
letter adds, noting that monitoring should be continued throughout the
treatment.
The letter points out that Boehringer Ingelheim’s Serentil (mesoridazine),
which is chemically related to thioridazine, “also appears to have the
capacity to prolong the QTc interval.”
Boehringer Ingelheim and the FDA did not respond to telephone calls seeking
comment.

Copyright © 2000 Reuters Ltd. All rights reserved.

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5/24/2000 – Effexor – FDA Discontinuation Warnings

Thanks to Steve Whiting for alerting us to the following warnings from the
FDA. It is about time the gave us some warning about the terrible withdrawal
associated with the SSRI and SNRI antidepressants. I have highlighted a few
spots in this warning that I want you to take note of in particular.

Knowing HOW TO safely withdraw from serotonergic medications is one of the
most critical pieces of information patients need about these drugs –
information they are unfortunately not getting from their doctors. How one
withdraws can make the difference between life and death and can prevent the
long term debilitating effects that come from an abrupt or a much too rapid
withdrawal. Let me remind you once again that I have made an hour and a half
long audio tape to give patients and doctors withdrawal tips on safe and
successful withdrawal from these drugs as well as information on rebuilding
the body after their use. I could not longer find time to eat or sleep
because I was spending all of my time answering questions from doctors and
patients about safe withdrawal. A tape answering those questions seemed the
logical solution. The tape is inexpensive and very helpful. You can find
order information at

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org
________________________________

The FDA has forced safety related drug labeling changes regarding Effexor.

The changes acknowledge the existence of severe
discontinuation problems which are both dose and time
related and that the evidence of the problems has been
obtained from a retrospective survey of the clinical trials
database.

Steve Whiting
http://www.effexorfx.freeuk.com
__________________________

Please refer to
http://www.fda.gov/medwatch/safety/2000/mar00.htm#effexo

EFFEXOR & EFFEXOR XR (venlafaxine HCl) Tablets
[March 3, 2000: Wyeth-Ayerst]

DRUG ABUSE AND DEPENDENCE:

Physical and Psychological Dependence: New third paragraph –
“Discontinuation effects have been reported in patients receiving venlafaxine
(see DOSAGE AND ADMINISTRATION).”

DOSAGE AND ADMINISTRATION:
Discontinuing Effexor (venlafaxine HCl): First sentence revised –

“When discontinuing Effexor after more than 1 week of therapy, it is
generally recommended that the dose be tapered to minimize the risk of
discontinuation symptoms. Patients who have received Effexor for more than 6
weeks or more should have their dose tapered gradually over at least a 2-week
period.”

New second paragraph –

“Discontinuation symptoms have been systematically evaluated in patients
taking venlafaxine, to include prospective analyses of clinical trials in
Generalized Anxiety Disorder and retrospective surveys of trials in
depression. Abrupt discontinuation or dose reduction of venlafaxine at
various doses has been found to be associated with the appearance of new
symptoms, the frequency of which increased with increased dose level and with
longer duration of treatment. Reported symptoms include agitation, anorexia,
anxiety, confusion, coordination impaired, diarrhea, dizziness, dry mouth,
dysphoric mood, fasciculation, fatigue, headaches, hypomania, insomnia,
nausea, nervousness, nightmares, sensory disturbances (including shock-like
electrical sensations), somnolence, sweating, tremor, vertigo, and vomiting. I
t is therefore recommended that the dosage of Effexor be tapered gradually
and the patient monitored. The period required for tapering may depend on the
dose, duration of therapy and the individual patient. Discontinuation effects
are well known to occur with antidepressants.”

Discontinuing Effexor XR:

“When discontinuing Effexor XR after more than 1 week of therapy, it is
generally recommended that the dose be tapered to minimize the risk of
discontinuation symptoms. In clinical trials with Effexor XR, tapering was
achieved by reducing the daily dose by 75 mg at one week intervals.
Individualization of tapering may be necessary. [The remainder of the
paragraph beginning with “While the discontinuation effects of Effexor XR
have not been systematically evaluated in controlled clinical trials,
retrospective…” has been deleted] and replaced with –

“Discontinuation symptoms have been systematically evaluated in patients
taking venlafaxine, to include prospective analyses of clinical trials in
Generalized Anxiety Disorder and retrospective surveys of trials in
depression. Abrupt discontinuation or dose reduction of venlafaxine at
various doses has been found to be associated with the appearance of new
symptoms, the frequency of which increased with increased dose level and with
longer duration of treatment. Reported symptoms include agitation, anorexia,
anxiety, confusion, coordination impaired, diarrhea, dizziness, dry mouth,
dysphoric mood, fasciculation, fatigue, headaches, hypomania, insomnia,
nausea, nervousness, nightmares, sensory disturbances (including shock-like
electrical sensations), somnolence, sweating, tremor, vertigo, and vomiting.
It is therefore recommended that the dosage of Effexor XR be tapered
gradually and the patient monitored. The period required for tapering may
depend on the dose, duration of therapy and the individual patient. Discontinu
ation effects are well known to occur with antidepressants.”

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