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.

And who did they pay to “cook the books” on this research?!! Was the same
researcher who just plead guilty to falsifying research for GlaxcoThe initial
studies done by Lilly on dogs and cats demonstrated that the animals given

Prozac began to growl and hiss within days on the drug and the behavior
continued until several days AFTER withdrawal of the medication. Those results
would indicate a contraindication for Prozac being given to dogs as they
have for close to two decades now.

The only thing new with Reconcile, the name of the drug in the US, is
that it is a time release Prozac. All the time released change does is make
it FAR MORE difficult to withdraw from. If your dog happens to be a
rapid metabolizer then he/she will metabolize the drug faster than expected and
go into withdrawal before the next dose is given. And according to FDA warnings
you could have a dog that could be going into a withdrawal reactions
of suicide, hostility, or psychosis. . . . We need to do a survey to see
how many dogs are running in front of mack trucks and trains instead of just
chasing cars once they begin taking this medication.  :-)
 . . . . Back to the seriousness of this issue, this is an
extremely dangerous way for dogs and humans or any other living creature to take
a drug!

____________________________________

At the time, Steve Connell, Eli Lilly’s manager of consumer services for
companion animal health, said that more than 10million US dogs exhibit strange
symptoms from being left alone too long. [Hmmmmm and how many humans and other
living creatures exhibit strange symptoms from being left alone too
long?!!!]

‘Lilly research shows that 10.7million, or up to 17 per cent, of US dogs
suffer from separation anxiety,’ he said. ‘We’re thrilled that our first product
for dogs can help restore the human-pet bond.’

He said research showed that 73 per cent of dogs taking Reconcile and
undergoing therapy showed better behaviour within eight weeks, compared to dogs

receiving therapy alone.

Rebound symptoms may keep many on drugs

News

Owosso man judged incompetent to stand trial

Comment on this Story

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, PhD, 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!!! (800-280-0730)

E-mail: _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.”

Universities 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/) )

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