5/24/2000 – Questions Persist Concerning Prozac’s Role in Suicide Risk

The former US Surgeon General, Dr. C. Everett Koop has joined
in the current concern over SSRI medications and suicide, and
posts this on his site, drkoop.com.
————-

Questions Persist Concerning Prozac’s Role in Suicide Risk

May 11, 2000

Lee Hickling
drkoop.com Health News

The question of whether Prozac, the most-prescribed
antidepressant, can make some patients more likely to commit
suicide just won’t go away, despite repeated and categorical
rebuttals by the drug’s manufacturer, Eli Lilly and Co.

Based on his experience as a suicide counselor and
investigator, Dr. Ronald W. Maris, director of the Center for the
Study of Suicide at the University of South Carolina, is firmly
convinced that a risk exists.

Research done in Wales by Dr. David Healy, director of the
University of Wales’ North Wales Department of Psychological
Medicine, appears to show a cause-and-effect relationship
between Zoloft (sertraline) and the emergence of suicidal
thinking in a group of physically and mentally healthy adult
volunteers. Zoloft, like Prozac (fluoxetine), is a selective
serotonin
uptake inhibitor (SSRI). Healy has completed a similar study with
Prozac, but its results have not yet been published.

A spokesman for Lilly said today, “There is no scientific evidence
to establish a link between Prozac and suicide.” He cited a l991
study by a Food and Drug Administration advisory panel, which
unanimously agreed that there was “no credible evidence of a
causal link between the use of antidepressants, including
Prozac, and violent behavior.”

Even the drug’s critics agree that the effect, which the company
says does not exist, occurs in only a small number of cases —
fewer than 1 percent. Maris said that although the incidence is
very low, when it happens it is such a serious matter that doctors
should be very careful in prescribing Prozac, and extremely
watchful when they do.

Maris said the danger is greatest during the first week or two of
Prozac use, when some patients who were already at risk for
suicide have a rare reaction that makes them feel energized and
more ready to act on their self-destructive impulses. There is
another dangerous time later, when a patient, who had been
virtually immobilized by deep depression, still entertains suicidal
thoughts. At this time, the drug has moderated their depression
enough to make them able to carry out these thoughts.

Healy’s study showed a similar pattern, and left him convinced
that a direct link exists between SSRIs and the emergence of
suicidal thinking in people who had never had such thoughts. He
is not the first medical researcher to suspect such a reaction. Dr.
Martin Teicher of Harvard Medical School reported in 1990 that
he and his colleagues had observed suicidal thoughts emerging
in six patients who were taking Prozac. Other researchers and
clinicians began reporting that they saw it too.

Serotonin is a relatively simple chemical that is vital to the
brain’s
regulation of a great many body functions — sleep, appetite, and
even more basic activities such as muscular activity, breathing
and blood circulation. Abnormal serotonin levels have been
blamed for a large number of mental and physical problems,
including depression, obsessive-compulsive disorder and panic
disorder.

Prozac and the other SSRIs have been prescribed for all those
problems and more, and have produced dramatic improvement
in a majority of cases. “Prozac is a valuable drug,” Maris said.
“For every horror story, there are thousands of persons who say
their lives were saved by it.”

But he said, doctors need to be much more careful about
prescribing it. They should investigate the patient’s history,
particularly the psychological history, to see if there have been
any indications of suicidal thought or other instability, and then
should monitor each patient very carefully. He said that is not
always done.

Because any physician can prescribe Prozac, and general
practitioners, primary care doctors and specialists in other areas
might not be as alert for danger signs as a psychiatrist might be,
Maris said Lilly should have warned doctors about Prozac’s
dangers.

The company did not do that. According to a Boston Globe story
earlier this week, internal Lilly documents show that in 1990,
corporate executives pressured Lilly scientists to alter records
on physicians’ experiences with Prozac. They changed mentions
of suicide attempts to “overdose” and of suicidal thoughts to
“depression.”

Some of Lilly’s own studies were cited by the German equivalent
of the Food and Drug Administration, delaying Prozac’s approval
there. They showed that previously nonsuicidal patients who
took the drug had five times the rate of suicide or suicide
attempts as patients on older antidepressants. When the drug
was approved for sale in Germany, a warning was required on
the label. The label warned that the drug’s use carried a risk of
suicide, and recommended that sedatives be given along with it.

The Globe said figures in Lilly internal documents showed that
in early clinical trials, 1 in 100 previously nonsuicidal patients
who took Prozac became anxious and agitated, and either
attempted or committed suicide during the studies.

Some of the previously unknown information that Eli Lilly
possessed about the drug has come to light during civil trials in
which the company was sued for wrongful deaths following
suicides, or during criminal trials in which defense lawyers
argued that Prozac caused a defendant’s violent and homicidal
behavior.

Maris has been an expert witness in a number of trials, including
one in Hawaii last year in which Healy also testified. William D.
Forsyth Sr., a retired businessman, stabbed his wife 17 times
and then stabbed himself to death. He had been taking Prozac
for 10 days. His family brought a wrongful death suit against Lilly,
claiming that the company knew Prozac could make some
people violent or suicidal, and failed to notify physicians about it.

The plaintiffs wanted $1 million in damages and the addition of a
warning statement to the Prozac label. A jury found for the
defendant, Lilly. So far, Lilly has won every Prozac-related civil
suit against it, more than 100 and possibly 200. The number is
difficult to verify because most did not go to trial. Some — Lilly
says only a few — were settled out of court to avoid the expense
of defending them.

In criminal cases up to now, prosecutors, frequently with the help
of expert witnesses suggested by the company, have been able
to obtain convictions despite defense claims that the drug had
turned a previously stable and nonviolent person into a
murderer.

The most often-prescribed antidepression drug in the world,
Prozac has been Lilly’s major moneymaker ever since it was
introduced in 1988. Its sales, however, have been falling, for
which the company’s annual report blames “changes in
wholesaler purchasing patterns and intense competition.” Four
years ago, it accounted for more than one-third of Lilly’s total
sales. Last year it represented just over one-quarter.

The company’s patents on Prozac will start to expire next year. A
patent has been granted for its successor, R-fluoxetine, which
Lilly will make and market. In the patent application, which the
Boston Globe obtained, the company said the new drug will
decrease such side effects such as headaches, anxiety and
insomnia, and also “inner restlessness (akathisia), suicidal
thoughts and self-mutilation.”

Akathisia, an overwhelming physical and mental restlessness,
has been cited by physicians and researchers as a frequent
side effect in the cases in which they believe Prozac is causing
violent, impulsive and sometimes suicidal behavior. Teicher,
who pioneered research on the question, observed it in a
number of Prozac patients who attempted or committed suicide.

Teicher is one of the developers of the “new Prozac,”
R-fluoxetine, and a co-owner of the patent.

THIS POSTING CAN BE FOUND AT
http://www.drkoop.com/news/stories/may/prozac.html

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5/23/2000 Accutane May Be Linked To Depression, Suicide

In case you missed this I wanted to send this out again. I feel it is very
important to know. There are too many children on this type of medication and
little knowledge of these serious side effects to this drug. How many
children are ending up on antidepressants as a result of their acne meds?

Ann Blake-Tracy
_______________________________

http://www.pslgroup.com/dg/5d8e2.htm

FDA Reports Accutane May Be Linked To Depression, Suicide

WASHINGTON, MD — February 26, 1998 — The United States Food and Drug
Administration is advising consumers and health care providers of new
safety information regarding the prescription anti-acne drug Accutane
(isotretinoin) and isolated reports of depression, psychosis and rarely
suicidal thoughts and actions.

Accutane was approved in 1982 to treat only a very special type of acne —
severe nodular acne that has not responded to other therapies.

Although the Accutane label already included information regarding
depression as a possible adverse reaction, the agency felt health care
providers and others needed additional information as a result of adverse
event reports the agency has received.

FDA and the drug manufacturer are strengthening this label warning, even
though it is difficult to identify the exact cause of these problems. Such
problems could already be more common among the patient populations likely
to be on the drug.

However, because some patients who reported depression also reported that
the depression subsided when they stopped taking the drug and came back
when they resumed taking it, the agency and the manufacturer felt the
strengthened labelling was warranted as a precautionary measure.

Given the complex nature of depression and suicidal conditions, the new
label information will advise health care providers that merely
discontinuing the drug may be insufficient to remedy these adverse events
and that further evaluation may be needed.

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5/15/2000 – PROZAC, ZOLOFT, MAYHEM & SUICIDE

The revelations contained in this press release from Vickery and
Waldner are remarkable. It is being sent to major news media
today, Monday, May 15th. Mark
===============================

FOR IMMEDIATE RELEASE:
PROZAC, ZOLOFT, MAYHEM & SUICIDE
Teicher & Cole – Together Again and Still Sounding the Alarm

The February 1990 article by Harvard psychiatrists Martin
Teicher and Jonathan Cole (along with their colleague nurse
Carol Glod) brought the issue of Prozac/SSRI induced suicidality
to the public consciousness. The article spawned immediate
regulatory interest and a whirlwind of publicity in the popular
media.

Primed by company spin doctors, Lilly top scientist Leigh
Thompson blamed the publicity on the Scientologists and the
suicides on the underlying disease of depression. It was a
good public relations tactic, and it has been an effective
products liability stratagem for over a decade.

However, after ten years more experience, on May 7, 2000, in a
rare interview with the Boston Globe, Dr. Teicher said that he
stood by his work, and that the ability of Prozac to induce suicide
in a minority of patients “is a real phenomenon.” Meanwhile, on
April 28, 2000, Dr. Cole, who has been described by Pfizer
experts as a “pioneer” in the field of psychopharmacology,
signed a sworn declaration in a federal wrongful death case
concerning the tragic suicide of a 13 year old boy, only seven
days after he began taking Zoloft promotional samples. Dr. Cole
wrote:

In 1990 I co-authored an article with my colleague Martin Teicher
. . . Our purpose in writing this article was to alert the
profession
to an alarming, probable drug side effect which we had
observed. . . . The SSRI drugs, as a class, clearly have the
potential to cause, and in reasonable medical probability or
certainty do cause, akathisia in some patients. . . . they may also
cause emotional blunting or disregulation. Either of these
conditions could, and probably do, trigger or contribute to violent
or suicidal behavior. . . .

A side effect that occurs in a relatively small percentage of
patients, such as the treatment emergent suicidality which Dr.
Teicher, Nurse Glod and I reported on in 1990, is not likely to be
detectable in a standard RCT [clinical trial] or measured by a
relative risk calculation. That does not mean, however, that the
side effect is not real, not dangerous, and not caused by the
drug.

Although the drug companies continue to deny the existence of
this phenomenon in public and in court, in a 1986 report to the
FDA, Pfizer quietly admitted that “drug-induced activation is a
plausible explanation for the emergence of suicidal behavior in
our patient #4 . . .”, an 8 year old boy who mutilated his feet with
a
razor blade and tried to strangle himself with a necktie. And
Lilly? Well, it paid $90 million for a patent, the ostensible
usefulness of which is that it reduces a few really troublesome
side effects of the original Prozac: “nervousness, anxiety,
insomnia, inner restlessness (akathisia), suicidal thoughts, self
mutilation [and] manic behavior” .

A peer-reviewed journal article this month recounts the
experiences of two healthy, non-depressed volunteers who
became actively suicidal within two weeks of taking Zoloft.
Harvard psychiatrist Joe Glenmullen’s powerfully endorsed but
provocative book, PROZAC BACKLASH, continues to receive
wide public interest and to engender industry obloquy. And the
FDA? Hopefully, they are working right now on a proper warning
for Prozac II, and the entire class of SSRI drugs.

Vickery & Waldner May 11, 2000
www.justiceseekers.com Houston, Texas

——–
ENDNOTES

Teicher, Glod, Cole, Emergence of intense suicidal
preoccupation during fluoxetine treatment. Am.J.Psychiatry
1990: 147: 207-210.
——
Dr. Thompson’s coaching came via a memo dated April 15,
1991 from the now current executive VP of Lilly, Mitch Daniels. It
was introduced into evidence as Px 123 in the case of Forsyth v.
Eli Lilly. Lilly’s hardball litigation tactics through the years
are
well covered in the Lilly’s legal tactics disarmed legions of
Prozac lawyers article by Indianapolis reporter Jeff Swiatek,
available online at the paper’s website, www.starnews.com. and
ours, www.justiceseekers.com.
——–
Leah Garnett, Prozac revisited: As drug gets remade, concerns
about suicide surface, available online at the paper’s website,
www.boston.com and ours, www.justiceseekers.com.
——–
“Q. Is Dr. [Jonathan] Cole a man of considerable stature and
reputation in the field of neuropsychopharmacology in this
country?

A. He’s one of the pioneers of the field.”

March 29, 2000 deposition of retained Pfizer expert
witness,pre-eminent suicidologist and psychopharmacologist, J.
John Mann, M.D. in case of Miller v. Pfizer, No. 99-2326 KHV
(United States District Court, Kansas). Another Pfizer expert, Dr.
Daniel Casey, not coincidentally the chairman of the 1991 FDA
advisory committee that considered this issue, agreed with Dr.
Mann’s description of Dr. Cole’s professional standing.
——-
The term “RCT” refers to randomized, clinical trial. The industry,
which has never conducted such a study to test the hypothesis
that SSRI drugs induce suicidality, nevertheless argues in Court
that only such tests are truly “scientific.” All other opinions, no
matter who renders them or what they base them upon, are
merely “junk”. The Declaration is being filed in federal court in
Kansas City in the case of Miller v. Pfizer, docket number
99-2326 KHV. The case is set for trial before Judge Kathryn
Vratil and jury on July 18, 2000. A copy of Dr. Cole’s
Declaration
is posted on our website, www.justiceseekers.com. Matt Miller’s
story, “He Never Said Goodbye” is available at
www.drugawareness.org and on our site,
www.justiceseekers.com.
——-
Report, Suicide-Related Behavior in Children and Adolescents
in the Sertraline OCD Clinical Development Program, Pfizer, Inc.
(May 23, 1996), Pfizer Exhibit #40 in Miller v. Pfizer pretrial
motions. It based its determination of causality on the clinical
judgment of its own investigator and its scientists’ review of
published “anecdotal case reports” in a 1991 article.
——–
U.S. Patent 5,708,035
——–
Healy, Emergence of antidepressant induced suicidality, Primary
Care Psychiatry 2000, Vol.6 No. 1.

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The Aftermath of Antidepressants

The Aftermath Of Prozac, Zoloft, Luvox, Fen-Phen, & Many Other Serotonergic Drugs

By Ann Blake-Tracy – Executive Director,
International Coalition For Drug Awareness

Ann Blake-Tracy has specialized for 10 years in adverse reactions to serotonergic medications. She is the executive director of the International Coalition for Drug Awareness (www.drugawareness.org) and author of the book PROZAC:PANACEA OR PANDORA?

WARNING: IT SHOULD BE NOTED THAT A GRADUAL TAPERING OFF OF MEDICATIONS IS SAFEST WITHDRAWAL METHOD TO AVOID SERIOUS WITHDRAWAL EFFECTS

Often there is the terrible withdrawal associated with the SSRIs. Unless patients are warned to come very slowly off these drugs by shaving minuscule amounts off their pills each day, as opposed to cutting them in half or taking a pill every other day, they can go into terrible withdrawal which is generally delayed several months. This withdrawal includes bouts of overwhelming depression, terrible insomnia and fatigue, and can include life-threatening physical effects, psychosis, or violent outbursts.

Note: Keep in mind that these drugs are all serotonergic agents and clones or “copy cat” drugs of Prozac – the first SSRI antidepressant introduced to the market in America. Basically what applies to one, applies to the others. For instance we have more data out on Prozac because it has been around longer, but as the mode of action is the same for all of these meds the effects will be the same for the other drugs on this list as it is for Prozac. If we are discussing one drug, similar effects would be expected from any other company’s version of the drug. In fact it would be more honest to give them the titles of Prozac #1, Prozac #2,Prozac #3, etc. rather than the brand names they have been given, from the second clone, Zoloft, to the latest Prozac clone, Celexa.

My concern is that each new SSRI introduced seems to be a little stronger on serotonin reuptake and therefore potentially more dangerous. And the all too common practice of going from one SSRI to another blocks additional receptors and magnifies the harmful effects of these medications. It is crucial to learn that according to medical research the theory behind this group of drugs is invalid. Known as serotonin reuptake inhibitors. They are designed to block serotonin in the brain, thereby increasing brain levels of this neurotransmitter. Yet for three decades researchers have been intensely interested in serotonin because LSD and PCP produce their psychedelic effects by mimicking serotonin. Elevated serotonin is found in: psychosis or schizophrenia, mood disorders, organic brain disease, mental retardation, autism and Alzheimer’s. While low levels of the metabolism of serotonin (which also produces high serotonin), are found in those with: depression, anxiety, suicide, violence, arson, substance abuse, insomnia, violent nightmares, impulsive behavior, reckless driving, exhibitionism, hostility, argumentative behavior, etc. The drugs increase serotonin and decrease the metabolism of serotonin leading to any and all of the above results. This information is extremely crucial for patients and physicians to learn as soon as possible. We have a high rate of use of these drugs nationwide. Raising serotonin and lowering the metabolism of serotonin in such a large number of people can produce very serious, widespread and long term problems for all of society.

So why are we now in the 90’s being told that increased serotonin is good for us? Is it because it is good for the pocketbooks of the manufacturers? One manufacturer is running full page newspaper and magazine ads and half hour TV infomercials to bring in over $7 million daily, while on the other hand they are settling Prozac suicide cases for huge amounts of money in exchange for silence from victim’s families on the details of those settlements. The silence in the court cases insures that the drug will be allowed to finish out its patent time, thus bringing in the highest possible profits for the company. They know that with $7 million coming in daily, they can afford to settle a large number of lawsuits and still come out “smelling like a rose” financially.

Eli Lilly has been sued for Prozac related deaths in numerous state and federal courts with most of these cases being settled or dismissed – many were dismissed due to the unethical manipulation of the Wesbecker verdict
(see time line for details).

We have witnessed no decrease in suicide, but increases in murder/suicide, suicide, unwed pregnancies, domestic violence, manic-depression, MS, hypoglycemia, diabetes, bankruptcies, divorce, mothers (parents) killing children, road rage, school shootings, cancer, Chronic Fatigue Syndrome, and Fibromyalgia since these serotonergic drugs have become so popular and I relate it directly to the effects of these drugs.

The death toll has continued to climb drastically since I wrote PROZAC: PANACEA OR PANDORA? Some of the cases you may be familiar with are:

1. Mr. and Mrs. Phil Hartman (Zoloft), Prozac was found in the van of Mark Barton, the Atlanta day trader, who recently killed his family and others in a shooting spree before taking his own life;
2. Neal Furrow, in LA Jewish school shooting was reported to have been court ordered to be on Prozac along with several other medications;
3. The Salt Lake Family History Library shooting;
4. School shootings in Littleton, Colorado (Luvox), Atlanta, Georgia, Springfield, Oregon (Prozac), and Caldwell, Idaho;
5. Another boy in Pocatello, ID in 1998 who in seizure activity from Zoloft had a stand off at the school;
6. 15 year old Chris Shanahan (Paxil) in Rigby, ID who out of the blue killed a woman;
7. The shooting at the lottery in Connecticut last spring by Matthew Beck (Luvox) that left five dead in a murder/suicide;
8. The New York City Subway bombing by Edward Leary (Prozac);
9. Nick Mansies (Paxil) in New Jersey who was convicted of killing a little boy who was selling cookies door to door;
10. In Orange County, CA Dana Sue Gray (Paxil) who co-workers described as a very caring nurse killed several elderly people;
11. Officer Stephen Christian (Prozac) one of the finest officers on the Dallas Police force, who ran into a police substation shooting at fellow officers and was killed;
12. 13 year old Chris Fetters (Prozac) in Iowa who killed her favorite aunt;
13. David Rothman (Prozac) killed two co-workers and himself at the Dept. of Agriculture in Ingelwood, CA;
14. Williams Evans (Zoloft) shot one co-worker at the Ohio Bureau of Employment Services before shooting himself in Columbus, OH;
15. Winatchee, WA where 43 people were wrongfully imprisoned in a false accusation of sexual abuse “witch hunt” fury started by a child under the influence of Prozac and Paxil;
16. Christopher Vasquez (Zoloft) killed Michael Morrow in Central Park;
17. Megan Hogg (Prozac) duct taped the mouths and noses of her three little girls and took a handful of pills; Vera Espinoza (Prozac) in Randolph, VT shot her small son and daughter before shooting herself;
18. An elderly man (Prozac) in Layton, UT axed his wife and daughter to death;
19. Margaret Kastanis (Prozac) used a knife and hammer to kill her three children before stabbing herself to death;
20. An elderly man (Paxil) in Dallas, TX strangled his wife before shooting himself twice in the chest;
21. Larramie Huntzinger (Zoloft) blacked out and ran his car into three young girls killing two in Salt Lake City, UT;
22. Mary Hinkelman (Prozac), a nurse in Baroda, MI shot her two small daughters and her sister before shooting herself;
23. Lisa Fox (Prozac) shot her small son and her dog before shooting herself in Brighton, MI;
24. Debi Louselle (Zoloft) shot daughter and then herself in Salt Lake City, UT;
25. A father in Wyoming shot his wife, daughter and baby grand-daughter then himself after only days on Paxil;
26. A mother (Prozac) in Pleasant Grove, UT killed her 17 year old son with a sledge hammer while he slept before she attempted suicide by drinking Drano;
27. Larry Butz, a superintendent of schools in Ames, IA shot his wife, son and daughter before shooting himself – many cases pending in court are not mentioned.

This is only a handful of MANY, MANY more cases – there would not be room for anything else if I continued listing the cases.

A few additional famous victims: Princess Di (Prozac) and Dodi Fayed -via their driver Henri Paul (Prozac), Monica Lewinsky (Prozac, Zoloft, Effexor, Serzone and Phen-Fen), Chris Farley (Prozac), Pres. Clinton’s ex-partner Jim Mc Dougal (Prozac), Abby Hoffman (Prozac), Del Shannon (Prozac), Danielle Steele’s son (Prozac), INXS singer Michael Hutchence (Prozac), Sarah – Dutchess of York (Phen-Fen)

The latest figures show Prozac has about 44,000 adverse reports filed with the FDA. Out of those reports there are about 2,500 deaths with the large majority of them linked to suicide or violence.

The suicide statistics relating to women are shocking. According to the CDC there are about 30,000 suicides yearly in the United States. Out of those about 6,000 are women – a ratio of about 4.3 to 1, male to female. About twice as many women as men are treated for depression demonstrating that generally men are more than 8 times as lethal in their suicidal gestures as women. Women were known to use less lethal means until the SSRI antidepressants hit the market. But on Prozac and Paxil, women committed 40% of the suicides – many were strikingly violent and clearly leaving no
means for rescue. (Remember that because Prozac was the first of this group of drugs its track record gives us a vision of what is to come with other serotonergic antidepressants, especially when they are so powerful in the reuptake of serotonin.)

TIME LINE OF CRITICAL INFORMATION DISCOVERED SINCE THE BOOK:

*NOTE: Any documents beginning with PZ are Lilly documents on Prozac which have been ferreted out by attorneys and are now being used in lawsuits against the drug company. (Christian vs. Eli Lilly, by Vickery & Waldner, Houston, TX)

* Mid 1950’s: Dr. Felix Sulman began his research on those who suffer from high serotonin levels because of an inability to metabolize serotonin. He found that serotonin is a stress neuro-hormone leading even rabbits, the most docile of creatures, to be aggressive. He coined the term “serotonin irritation syndrome.” He found that those who were unable to break down serotonin would have the levels increase. They were in effect being poisoned by the serotonin produced by their own bodies, the irritation victims suffered from migraines, hot flashes, irritability, sleeplessness, pains around the heart, difficulty in breathing, a worsening of bronchial complaints, irrational tension and anxiety. . . horrifying nightmares. It also caused his volunteers to sleep badly – that is, always on the edge of consciousness so that they were not properly rested – and to wake after only a few hours of sleep.” (sleep apnea) He also found it caused pregnant women to abort.
* October, 1977: Slater, et.al., Inhibition of REM Sleep by Fluoxetine, a Specific Inhibitor of Serotonin Uptake, October 1977, at p. 385 – Prozac was found to affect sleep habits, specifically to suppress deep sleep, which the scientists call REM (rapid eye movement) sleep in cats. By the fourth day of drug treatment the cats receiving the larger doses, which had been friendly for years, began to growl and hiss. After cessation of the drug treatment, the cats returned to their usual friendly behavior in a week or two; those on the higher doses recovering more slowly. – – 1977: [PZ 1298 1999] “A total of six dogs from the high dose group were removed from treatment … due to severe occurrences of either aggressive behavior, ataxia, or anorexia.”]
* July 31, 1978: [PZ1061 1025-28, July 31, 1978] Human subjects began to be used by Lilly in controlled clinical trials. The first group of patients showed no improvement in their depression, but there were a “large number of reports of adverse reactions.” The first human to receive Prozac experienced “dystonia resembling an extrapyramidal reaction” – an uncontrollable, Parkinson-like shaking or trembling.
* July 23, 1979 [PZ 1297 969] The clinical studies in depression showed that “some patients have converted from severe depression to agitation within a few days; in one case the agitation was marked and the patient had to be taken off drug. In future studies the use of benzodiazepines to control the agitation will be permitted.”
* August 3, 1979: The clinical trials excluded patients who had serious suicidal risk. [E.g. control #001519, IND Protocol No. 14, August 3, 1979; PZ1135 695, July 2, 1986 memorandum of Dr. Wernicke].
* December 17, 1984: [PZ 65 449, report of Lilly to FDA] Lilly reported to the FDA that benzodiazepines and other sedatives were given with Prozac throughout the clinical trials. This was to help offset the stimulant effect of the drug. In a memorandum of Lilly scientist Charles Beasley [PZ 541 2007-08] issues of “agitation vs. sedation” and concomitant sedative medications like benzodiazepines (to control the agitation) are discussed. Concerns are that agitation in a suicidal patient can induce suicide.
* March 3, 1986 Lilly controlled the flow of information to the FDA and decided that suicide data on Prozac should not be evaluated, “in the safety-update for the FDA the number of suicides and suicide attempts will not be especially evaluated.” [PZ 879 1966, March 3, 1986 telex]
* September 12, 1986: German BGA very concerned with the risk of suicide and ultimately approved Prozac on the condition that physicians be warned of the risk of suicide and told to consider using sedatives and closely monitor patients. [PZ 878 1383, report of Lilly consultant Pohlmeier; PZ 2467 299, September 12, 1986] Lilly actually warned physicians in Germany and other countries that this measure “can be necessary” to minimize the risk of suicide, [PZ 1341 402, December 6, 1989 German warning; PZ 2469 490]
* February 7, 1990: In response to the Harvard study, Teicher, et al., Lilly’s top scientist, Leigh Thompson, told his fellow executives that “Lilly can go down the tubes if we lose Prozac”. [PZ 1941 827, February 7, 1990]. In the ensuing months Dr. Thompson spoke frequently with his principal FDA regulator about the issue, once at 6:15 in the morning. [PZ 391 1959, July 18, 1990]. Lilly later described the man as “our defender”. [PZ1941 2256, September 12, 1990]
* May 29, 1990, Lilly added “suicidal ideation” in the section dealing with post-marketing reports. [PZ883 562, July 26, 1990 memorandum]
* September 14, 1990: Contrary to the advice of his staff, Dr. Thompson told the Eli Lilly Board of Directors that suicide and hostile acts were probably, caused by the patients’ underlying disorders rather than Prozac. [PZ542 2101, September 14, 1990; PZ4002 889, Board Minutes]. The staff was concerned because they knew that this issue was never studied during the clinical trials.
* September 11, 1990: Note from Dr. Bruce Stadel, Chief of the Epidemiology Branch, attaching an analysis done by Dr. David Graham, Section Chief within the Epidemiology Branch, of Lilly’s July 17, 1990 submission to the FDA on the Prozac/suicidality/violence issue. The following factors were (a) brought to the attention of those in the higher echelons of the FDA, but (b) ignored, discounted or “trashed” by them: #1 Lilly’s analysis improperly excluded 76 out of 97 suicides; as Dr. Stadel expressed it, “[i]t is inappropriate in a safety analysis to exclude such a large proportion of case”; #2 Lilly admitted that its clinical trials “were not designed for the prospective evaluation of suicidality” and that “[i]n these trials, patients with current suicidal ideation were excluded”; #3 Lilly admitted that the HAMD-3 rating scale it used to assess suicidality in clinical trials was inadequate; and that Lilly’s statements about violence only demonstrated “how great under-reporting is” and that “[t]he actual data showed a higher percentage of treatment-emergent suicidality among fluoxetine (2.9% than tricyclic (0.8%) patients . . . [which percentage] was similar to that reported by Teicher.”
* July 1, 1992: A study lead by Dr. Lorne Brandes of the Manatoba Institute of Cell Biology in Winnipeg, Canada was published in CANCER RESEARCH linking the two most popular anti-depressants, Elavil and Prozac to cancer.
* 1994: A study headed by Howard Markell published in The Journal of Pediatrics showed LSD flashbacks and LSD reactions induced by Prozac.
* June 9, 1994: The New York Review of Books article by Dr. Sherwin Nuland slams Peter Kramer for pushing Prozac in his book Listening to Prozac. He pointed out that all docs are taught in med school this little poem about serotonin: “This man was addicted to moanin’, confusion, edema, and groanin’, intestinal rushes, great tricolored blushes, and died from too much serotonin.” He listed constriction of lungs and intestines, diarrhea, wheezing, flushing, mental confusion, tightening of bronchioles, and lessening conscious control over behavior from increases in serotonin. “Moreover, . . . it is still too early to arrive at a reliable estimate of possible dangers that may appear in the long term,” and 15% dropped out of the clinical trials on Prozac because of adverse reactions. He also discussed the similarity of serotonin to the psychedelics like LSD and PCP.
* November, 1994: Krystal JH, Webb E, Cooney N, et al., “Specificity of Ethanol-like Effects Elicited in Serotonergic and Noradrenergic Mechanisms,” ARCHIVES OF GENERAL PSYCHIATRY, Vol. 51, Issue 11, pgs 898-911, 1994 demonstrated that an increase in brain levels of either of two neurotransmitters, serotonin or noradrenalin, produces:
#1 a craving for alcohol,
#2 anger,
#3 anxiety.
They found this to be especially true for those who have a history of alcoholism. An increase serotonin in turn increases noradrenalin. Numerous reports have been made by reformed alcoholics who are being “driven” to alcohol again after being prescribed a serotonergic drug. And many other patients who had no previous history of alcoholism have continued to report an “overwhelming compulsion” to drink while using these drugs.

A few personal accounts:

#1 A young woman, a recovering alcoholic, reported that during the eight month period she had been using Prozac she found it necessary to attend AA meetings every day in order to fight off the strong compulsions to begin drinking again.
#2 In the Southeastern United States a middle aged psychologist, also a recovering alcoholic, after being prescribed Prozac, found herself needing to attend AA meetings morning, noon, and night to keep from destroying the sobriety she had achieved.
#3 A young father, who was Mormon and had never before in his life used alcohol, found himself drinking Ever Clear and exhibiting bizarre as well as violent behavior, after being prescribed Prozac and Ritalin.
#4 A young mother who had never used alcohol before began drinking large amounts within weeks of being prescribed Prozac and quickly found herself committed to a mental institution due to the psychotic behavior that resulted. Added to her Prozac prescription were anti-psychotic meds and electric shock treatments. She then began to experience seizures and was started on anti-seizure meds.
#5 A concerned neighbor reported her friend was drinking straight Vodka on a regular basis after being prescribed Zoloft. #6 A daughter reported her father, sober for 15 years, began drinking again on Prozac.

* December, 1994: Not guilty verdict on Wesbecker wrongful death suit against Lilly’s Prozac.
* Treatment emergent suicidality with Prozac has been demonstrated to be two to three times higher than any other anti-depressant. (Jick, et al., Antidepressants and Suicide)
* May, 1995: Judge John Potter who presided over the Wesbecker case filed documents to demand that Lilly be forced to disclose the secret deal they made with the plaintiffs to withhold very damaging evidence in exchange for settlement. In his pleading to the court Potter stated, “Lilly sought to buy not just the verdict, but the court’s judgment as well.” Potter accused Lilly of “giving the verdict the widest possible publicity” accompanied by the claim that Lilly had “proven in a court of law that Prozac was safe.” Furious with Lilly’s attempt to turn his courtroom into an advertising agency for Prozac, he claims his motion reflects “the court’s duty to protect the integrity of the judicial system.” He believes, as do prominent legal ethicists, that a full and open disclosure of the terms of the settlement is a necessary public safety issue.
* July, 1997: Mayo Clinic found that the increased serotonin, which produces blood clotting, was causing a gummy glossy substance to build up on heart valves. Dr. Heidi Connolly with the Divisions of Cardiovascular Diseases and Internal Medicine, who headed the study stated, “We do know that fenfluramine and phentermine [Fen-Phen] alter the way the brain chemical serotonin is metabolized, and serotonin that circulates in the blood can cause valve injury.” Fenfluramine produces a rapid release of serotonin, inhibits serotonin reuptake, and may also have receptor agonist activity. The study’s revelations should send a loud and very clear warning throughout the medical community concerning all serotonergic medications.
* August 25, 1997: Letter to Ann Blake-Tracy, “I caught the last part of your presentation on Radio Station KEX, Portland, while flipping through the dial last night. I was flabbergasted to hear you speak of the horrible potential side effects from Prozac, which I have been taking for approximately four years, particularly since I have been diagnosed recently with cardiomyalgia, severe artery disease, congestive heart failure and also Fibromyalgia. (I was a very “well” person prior to taking the Prozac and am now exhausted all the time, with horrible aching joints and considerable pain and a massive heart problem.) The adverse cardiovascular effects from Prozac, the one drug in this class of drugs out long enough to have somewhat of track record, are listed in the drug information sheet put out by the manufacturer. The “frequent” effects listed are hemorrhage and hypertension. The “infrequent” effects include very serious adverse effects: congestive heart failure, myocardial infarct, tachycardia, angina pectoris, arrhythmia, hypotension, migraine syncope and vascular headache.
* September, 1997: Redux and Phen-Fen were pulled from the market.
* October 20, 1997: Dr. Candace Pert, Research Professor at Georgetown University Medical Center, past head of the brain chemistry department at the National Institute of Health, and author of the new book, MOLECULES OF EMOTION, sounded an alarm in TIME, October 20. She stated, “I am alarmed at the monster that Johns Hopkins neuroscientist Solomon Snyder and I created when we discovered the simple binding assay for drug receptors 25 years ago. Prozac and other antidepressant serotonin-receptor-active compounds may also cause cardiovascular problems in some susceptible people after long-term use, which has become common practice despite the lack of safety studies.”
As we are being led to believe these drugs produce effects only in the brain, Dr. Pert accuses the medical profession of oversimplifying the action of these drugs and adds that “the public is being misinformed about the precision of these selective serotonin-uptake inhibitors.” It is critical that both physicians and patients be made aware of these adverse physical reactions. She points out that the medical profession not only oversimplifies the action of these drugs in the brain, but “ignores the body as if it exists merely to carry the head around!” And that, “these molecules of emotion regulate every aspect of our physiology.” The body plays a very significant role in how we feel and act the way we do. This fact can no longer be ignored. Serotonin and serotonin receptors exist throughout the body, as well as the brain, and every aspect of the body’s physiology is affected by these serotonergic medications. In fact approximately 90% of the body’s serotonin is produced in the intestinal tract. According to Dr. Michael Gershon of New York’s Columbia Presbyterian, this is the reason why Prozac produces so many gastrointestinal side effects.
* March, 1998: Two new studies published. One that shows Prozac so strongly inhibits one particular serotonin receptor that this produces both obesity and seizures and the other discusses the blockage of muscle and neuronal nicotinic acetylcholine receptors indicating interactions between the serotonergic and cholinergic systems in the central nervous system.
* April, 1998: Our next generation of guinea pigs – one month before a 15 year old on Prozac, Kip Kinkel, in Springfield OR killed his parents and two classmates the American Psychiatric Association and the American Academy of Pediatric Psychiatrists asked the FDA to consider the serotonergic antidepressants for use in children as young as two and drugs for anxiety, aggression and manic depression in babies only one month old! The use of Prozac among young children ages 6 – 12 has increased an alarming 400% from 1995 (51.000 new prescriptions) to 1996 (203,000 new prescriptions).
* June, 1999: CLINICAL PSYCHIATRY NEWS reported that Dr. Malcolm Bowers a psychiatrist at Yale has found that physicians are not paying enough attention to patient factors that could make initiation of SSRIs dangerous. He found that “SSRI-induced psychosis has accounted for 8% of all general hospital psychiatric admissions over a recent 14-month period.” And “What is surprising is that this particular group of side effects is really underplayed.” (The 8% figure represents over 150,000 SSRI induced psychotic breaks per year!!!!!!!)

WARNING: Children so often get coughs and colds, yet using a cough or cold medication with dextromethorphan could cause the serotonin syndrome, a very serious and potentially fatal adverse reaction and/or produce PCP reactions.

Serotonin syndrome remains an often misdiagnosed or unrecognized fatal reaction due to the medical profession being so uninformed about this drug-induced disorder.

Developing brains are far more vulnerable than adult brains and brain damage generally becomes more apparent after the brain is fully developed, rather than immediately. Increases in cortisol produce brain damage while medical research shows that one single 30mg dose of Prozac DOUBLES the level of cortisol. This drastic increase in cortisol causes a multitude of serious physical reactions including impairment of linear growth, as well as impairing the development and regeneration of the liver, kidneys, muscles, etc. In light of so many unspeakable tragedies, I have grown weary of all the silly philosophical discussions we have heard since Kramer’s LISTENING TO PROZAC came out. Patients are dying or having their health destroyed mentally as well as physically (when do we begin to discuss the very serious physical side effects associated with high levels of serotonin?). These patients and their families are frantically searching for answers while this research sits right under our noses and could easily be made available to them. The widespread use of Prozac and its clones is not a statement of either their safety or their effectiveness. It is a statement about the effectiveness of an infinite marketing budget and incredible advertising campaign! These drugs have very serious physical side effects, as well as dangerous psychiatric side effects.

To prevent further tragedy this medical research must be acknowledged and addressed in headline news without delay rather than remain buried in seldom read medical research documents as has been the case in the past with other mind- altering medications, once thought to be safe, which were subsequently prohibited by law, i.e. LSD, PCP, cocaine, etc.

PRAISE FOR PROZAC: PANACEA OR PANDORA?

“I started having bad reactions . . . Oct ’96 I found Prozac to be causing joint and muscle pain itself . . . signs of Cushing’s Syndrome. . . I was very pro-Prozac until last October and wouldn’t have listened to anything said against it until I got problems (thought it was saving my life, while all the time it was insidiously and interested but quite skeptical. However, since reading it and having suffered so many problems with Prozac, I have come to the conclusion that the book is brilliant, and a life-line as far as I am concerned. I tried to fault the research and reasoning, but could not and still can’t. I would like to extend my thanks to you for your heroic stance on this enormously important issue. I have tremendous respect and admiration for your hard work, determination and courage in pursuing this subject so vigorously, against so much powerful opposition for the benefit of people like me. Your integrity puts many, if not most doctors and psychiatrists to shame. It is reassuring to find that there are a few people who are prepared to fight for the truth for the benefit of mankind.” Oct. 1998 note from a British nurse

“PROZAC: PANACEA OR PANDORA? is an incredible compilation of medical data that will lay the groundwork to educate other professionals and the general public about the new SSRI antidepressants – Prozac, Zoloft, Paxil, Luvox, Effexor and Serzone.” (Jeff Wise, psychologist, Salt Lake County Drug and Alcohol Abuse )

“In 15 years of reading books on drugs I have never read a book with more information or so well documented as PROZAC: PANACEA OR PANDORA?” (Dr. Kevin Millet, Bountiful, UT)

“As I lecture to physicians nationwide on the medical use of psychoactive drugs PROZAC: PANACEA OR PANDORA? always accompanies me in my brief case.” (Dr. Bruce Woolley, neuropsychopharmacologist, Brigham Young University)

“I found PROZAC: PANACEA OR PANDORA? fascinating reading and the most complete analysis of the various factors pertaining to the Prozac controversy.” (Attorney Donald Sokol, Susanville, CA)

“PROZAC: PANACEA OR PANDORA? literally saved my life, and if I’d known about it a year earlier, could have saved me untold grief and agony as well. It is the only collated, comprehensive source I know of for this information , . . .. this book described everything that had happened to me in great detail, gave scientific reasons why it happened, backed it all up with solid research, included testimonials from hundreds of others in the same situation, it immaculately details, explains, and refers one to the latest research on a whole hornet’s nest of ‘atypical’ side-and/or after-effects from the use of these antidepressants. It also contains information on how to reduce the severity of problems encountered while starting on or going off these meds.” (Nick Jameson, Prozac patient)

“Magnificent! This text is a monument to Ann Tracy’s tenacity and love for her fellow human beings.” (Dr. Paul Kennedy, N.J.)

“PROZAC: PANACEA OR PANDORA? has not left one question about these drugs unanswered! Ann Tracy has covered them all.” (Margaret McCaffery, N.Y. who lost her daughter, a neurosurgeon, in a Prozac suicide)

“The work Ann Blake-Tracy is doing is very important and she is truly a heroine.” (Dr. Candace Pert, Washington, DC, one of the two developers of the serotonin binding process which made possible the development of the serotonergic drugs. Dr. Pert has boldly stated, speaking of these serotonergic medications, “I am alarmed at the monsters I created!”)

WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

The FDA also now warns that any abrupt change in dose of an antidepressant can produce suicide, hostility or psychosis. And these reactions can either come on very rapidly or even be delayed for months depending upon the adverse effects upon sleep patterns when the withdrawal is rapid! You can find the CD on safe and effective withdrawal helps here: http://store.drugawareness.org/

Learn More
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Withdrawing from Paxil has been a Nightmare

“Feelings of suicide and hopelessness are worse now than ever.”

 

I liked your comments on Prozac, Paxil, and Zoloft. I have been on Paxil since 1995, and it has been a nightmare. I am slowly getting off the drug on my own, without telling my doctor. Believe me, I am cutting back VERY slowly because of how long I have been on it. I have gotten worse over the years, and not better, and have told my doctor so, but to no avail. Feelings of suicide and hopelessness are worse now than ever.

I know that many people wish there was a drug that really would help without the incredible side effects, such as weight gain, etc. By the way, I have gone from 180 (my ideal weight) to 240 pounds during the time I have been on Paxil. That in itself is depressing.

Tom Gadowski
27627 El Capitan Dr.
Warren, MI 48092-3078
(810) 751-6791

5/2/2000

This is Survivor Story number 23.
Total number of stories in current database is 96

 

 

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5/1/2000 – PA Suit blames Prozac for suicide try

Suit blames Prozac for suicide try

By Jeff Swiatek

The Indianapolis Star

Last updated 11:58 PM, EST, Monday, May 01, 2000

A Pennsylvania woman and her husband have sued Eli Lilly and Co., charging
that Prozac caused the woman to attempt suicide in 1997.

The lawsuit, filed Friday in federal court in Pittsburgh, says Diane V.
Cassidy was prescribed Prozac by her family doctor in July of 1997 for weight
loss.

Three weeks later, Cassidy checked into a motel, slit her wrists and took an
overdose of a drug that damaged her brain, the lawsuit says.

Cassidy, 47, survived, but is brain-damaged and requires constant care, the
lawsuit says.

A co-plaintiff is Cassidy’s husband of 29 years, Melvin J. Cassidy. They live
in Monroeville, Pa.

Lilly spokesman Edward A. West said, “Prozac had nothing do with this woman’s
situation.” He added, “There is a real serious question about whether there
was a suicide attempt or not.”

The 23-page initial complaint asks for $4.84 million to cover medical
expenses, lost wages and life-care needs. Intangible damages also are sought.

The lawsuit accuses the Indianapolis drugmaker of negligence for not warning
doctors that Prozac can cause suicidal behavior in some patients.

Prozac, the nation’s top-selling antidepressant, is not federally approved as
a weight-loss drug, but the lawsuit says Lilly “has either actively or
tacitly encouraged doctors to prescribe Prozac for weight loss.”

The lawsuit joins a dwindling number of fewer than 10 product-liability
claims over Prozac. Five years ago, there were more than 150 claims. Most
have been dismissed, dropped or settled.

Handling the Pittsburgh lawsuit are Greensburg, Pa., attorney Lawrence D.
Kerr and Houston attorney Andy Vickery, who has three other Prozac lawsuits
pending against Lilly.

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Study Links Older Bipolar Drug to Fewer Suicides

http://www.nytimes.com/2003/09/17/health/17SUIC.html

Dr. Frederick K. Goodwin, senior author of the study and director of the psychopharmacology research center at George Washington University Medical Center

Journal of the American Medical Association

The new study, published today in The Journal of the American Medical Association, found that patients taking Depakote were 2.7 times as likely to kill themselves as those taking lithium. Earlier studies by others had also found that lithium could prevent suicide, but today’s report is the first to compare suicide and attempted suicide rates in lithium and Depakote users. The study was based on medical records of 20,638 patients aged 14 and older in Washington State and California who were treated from 1994 to 2001.

Lithium, an old and inexpensive drug that has fallen out of favor with many psychiatrists, is better than the most commonly prescribed drug, Depakote, at preventing suicide in people who have manic-depressive illness, researchers are reporting.

People with the illness, also called bipolar disorder, swing back and forth between bleak spells of depression and periods of high excitability that may run the gamut from euphoria to rage. From 1.3 percent to 1.5 percent of people in the United States suffer from bipolar disorder, and their risk of committing suicide is estimated to be 10 to 20 times that of the rest of the population.

Perhaps because patients are more likely to seek medical help when they are depressed than when they are manic, the disorder is often misdiagnosed at first as depression alone, but antidepressants are not the correct treatment for bipolar disorder and may in fact make it worse.

The new study, published today in The Journal of the American Medical Association, found that patients taking Depakote were 2.7 times as likely to kill themselves as those taking lithium. Earlier studies by others had also found that lithium could prevent suicide, but today’s report is the first to compare suicide and attempted suicide rates in lithium and Depakote users. The study was based on medical records of 20,638 patients aged 14 and older in Washington State and California who were treated from 1994 to 2001.

Solvay Pharmaceuticals, a maker of lithium, paid for the study, but did not influence the findings or the way they were reported, the authors said.

The study included 53 actual suicides and 383 attempted suicides that led to hospitalization. But the researchers, as well as Depakote’s manufacturer, cautioned that because this study was based only on patients’ records, it was not conclusive.

Precisely how lithium might prevent suicide is not known, although it is believed to help regulate levels of serotonin, a brain chemical that influences mood.

“Lithium is clearly being underutilized,” said Dr. Frederick K. Goodwin, the senior author of the study and director of the psychopharmacology research center at George Washington University Medical Center. The drug can save lives, he said, adding, “The real tragedy is that a lot of young psychiatrists have never learned to use lithium.”

Lithium, which can smooth out the highs and the lows of bipolar disorder, was first used in the 1950’s, and in the 1970’s was the first drug to be designated a “mood stabilizer” by the Food and Drug Administration. But the drug has been around for so long that its patent has expired and generic versions exist, meaning that lithium cannot generate substantial earnings for industry, Dr. Goodwin said. Drug companies promote newer, more profitable drugs like Depakote.

Some difficult cases referred to Dr. Goodwin turn out to be people who have never taken lithium because their psychiatrists, often under 40, never thought of prescribing it. But Dr. Goodwin also emphasized that lithium did not work for everyone and that other drugs like Depakote were also needed.

Dr. John Leonard, a spokesman for Abbott Laboratories, the maker of Depakote, questioned the findings. Dr. Leonard said that studies looking back at patients’ records were inherently flawed and not as reliable as studies in which patients were randomly assigned by researchers to take one drug or the other. He said conclusions could not be drawn from the data, and doctors should not base treatment decisions on it.


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