Fwd: [drugawareness] Americans Warned to Say NO to Effexor for Under Age 18

[Guest guest]

Why isn't this front page news and all over the TV channels? This probably

affects a large part of the population.

 

Any dirt real or false on vitamins or herbs and we hear of it for days on end.

 

F.

 

 

 

atracyphd2

Wed, 3 Sep 2003 16:35:36 EDT

[drugawareness] Americans Warned to Say NO to Effexor for Under Age 18

 

 

 

Four news services including the Wall Street Journal, New York Newsday, iWon

Money & Investment as well as the Hartford Courant, whose article is listed

below, have now carried the report that Wyeth (who we will recall gave us the

Fen-Phen and Redux fiasco leaving many victims in its wake) have just sent out a

warning of increased suicide and suicidal thoughts along with self harm and

hostility with their drug Effexor in children and teens. They also state that

the drug is not effective in treating depression or anxiety.

 

Aug. 22, Dr. Victoria Kusiak, Wyeth's vice president for global medical

affairs, warned in a two page letter that in recent clinical trials

Effexor was not only " not effective in treating depression or anxiety " but

that there were increased " reports of hostility and especially in Major

Depressive Disorder, suicide-related adverse events such as suicidal ideation

and

self-harm. "

 

How much of an increase? Well, when it comes to having suicidal thoughts, 2

percent of those on Effexor had them, compared with none on the placebo. And

with hostility or aggressive behavior, the numbers were 2 percent on Effexor and

1 percent on a placebo. The figures are similar to what was found with

Effexor's cousin Paxil.

 

This only goes to support the statements made by experts in the front page

article of the New York Times on August 7, 2003. In that article seven out of

the ten FDA panel members who originally assured us these SSRIs were safe now

say they would vote differently given the information they now have on these

drugs. They also warn that what we see with Paxil should be expected with all

the

other SSRIs pr SNRIs because they work the same. They also stress that if we

are seeing this with those under 18 we can expect it in all age groups.

 

Dr. Irving Kirsch, a professor of psychology at the University of Connecticut

was quoted in this article as stating, " There's no reason why Paxil should be

any different than other drugs in this class. If they analyzed them all the

same way, they would likely get similar results. "

 

The FDA originally approved Effexor for use in adults in December of 1993 and

doctors began quickly to use it in children as well even though it was never

approved for use in youth. It is the company's best-selling drug. So it is no

wonder that this is of great interest to the Wall Street Journal and iWon

Money and Investment.

 

What is of great interest is the quotes by Dr. Leigh Thompson, a former top

scientist with Eli Lilly who played a large part in getting Prozac approved by

the FDA. Thompson now runs his own consulting business assisting drug

companies in winning FDA approval. What I am wondering is if he tells companies

to

stretch the truth as well as he did about Prozac and suicide to get FDA

approval?

 

Find below the information that comes from the case of Officer Stephen

Christian, a Dallas, TX officer with 19 commendations in his 23 years of service

who

ran into a police station shooting in the middle of the night while under the

influence of Prozac. (This wrongful death case has been settled by Lilly -

Oops! What I meant to say was the case has been " resolved " by Lilly. They prefer

that word over settled even though it all means the same thing.) This case

was handled by Andy Vickery and he and his staff should be credited for finding

the following information in Lilly's records. additional information may be

found on our web site at www.drugawareness.org or Andy Vickery's web site at

www.justiceseekers.com. And the warning on Effexor is found below this

information on Dr. Thompson.

 

Please get this Effexor warning to your local media and ask them to print it

to get this safety information to parents and children on these drugs. And

have parents report their children's reactions to our website with the title

" For

Senate Hearing " so that those can be turned over to the proper authorities

for the upcoming hearing.

 

Dr. Ann Blake Tracy,

Executive Director, International Coalition For Drug Awareness

& author of Prozac: Panacea or Pandora? - Our Serotonin Nightmare

& tape on safe withdrawal " Help! I Can't Get Off My Antidepressant! "

 

Order Number: 800-280-0730

Website: www.drugawareness.org

_

 

Legacy of Dr. Leigh Thompson:

 

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 pa

tients. [PZ 878 1383, report of Lilly consultant Pohlmeier; PZ 2467 299,

September 1

2, 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.

_______________________________

 

http://www.ctnow.com/news/custom/newsat3/hc-wyeth0830.artaug30,0,5502972.sto

ry?coll=hc-headlines-newsat3

 

2nd Firm Warns Against Having Kids Take Its Drug

 

August 30, 2003

By DAVE ALTIMARI And JACK DOLAN, Courant Staff Writers

 

For the second time in the past two months, a pharmaceutical company is

warning that an anti-depressant drug should not be prescribed to children

because

it may cause suicidal thoughts or self-harm.

 

Wyeth Pharmaceuticals Inc., based in New Jersey, has sent a letter to

health care professionals across the country warning of possible problems

with giving Effexor to children.

 

In a two-page letter dated Aug. 22, Dr. Victoria Kusiak, Wyeth's vice

president for global medical affairs, warned that in recent clinical trials

Effexor was not effective in treating depression or anxiety and that there

were increased " reports of hostility and especially in Major Depressive

Disorder, suicide-related adverse events such as suicidal ideation and

self-harm. "

 

In June, British drug manufacturer GlaxoSmithKline sent letters to doctors in

Britain and Ireland warning of a similar concern with its well-known

anti-depressant, Paxil. Officials at the U.S. Food and Drug Administration then

advised American doctors not to prescribe Paxil for children, citing unpublished

studies done by Glaxo indicating that the drug increases suicidal thinking among

adolescents.

 

Effexor is used to treat depression and bipolar disorder and is similar to

Paxil, Prozac and Zoloft.

 

Wyeth spokesman Douglas Petkus said the company decided to notify health care

professionals as a precaution.

 

" Companies typically don't release data that is sent to the FDA, but in

this case we felt it was important for physicians to be aware of the

studies because we know it is being prescribed to children, " Petkus said.

 

Petkus said the company is still doing clinical trials on adolescents. He

would not say if Wyeth is trying to obtain FDA approval to give Effexor to

children. Even though the drugs aren't approved for children, many doctors

prescribe the anti-depressants to them because they have used them successfully

with adult patients.

 

In the late 1990s, the FDA offered drug makers a six-month extension on the

patents for certain drugs, including anti-depressants, if the companies were

willing to do clinical trials of their effects on children, said FDA spokesman

Brad Stone.

 

So far, the makers of Effexor and Paxil are the only two manufacturers of

anti-depressants who have submitted data pointing to a potential link

between their drugs and increased thought of suicide in teens, Stone said.

 

The FDA originally approved Effexor for use in adults in December of 1993. It

is one of the company's bestselling drugs.

 

In its letter, Wyeth points out that there were no suicides in the clinical

trials. The studies were done on children and teenagers 6 to 17. Wyeth did

not say how large the study group was.

 

But the studies did show that when it comes to having suicidal thoughts, 2

percent of those on Effexor had them, compared with none on the placebo. With

hostility or aggressive behavior, the numbers were 2 percent on Effexor and 1

percent on a placebo.

 

Those numbers are similar to GlaxoSmithKline's studies on Paxil, which

doesn't surprise some experts.

 

" There's no reason why Paxil should be any different than other drugs in

this class. If they analyzed them all the same way, they would likely get

similar results, " said Dr. Irving Kirsch, a professor of psychology at the

University of Connecticut. Kirsch has done several studies on the effects of

anti-depressant drugs on adults.

 

Others said the company may be sending out a notice now because the FDA is

taking a closer look at anti-depressants and their effects on children after the

Paxil studies.

 

" I doubt the company would have sent this out without some pressure from the

FDA, " said Dr. Leigh Thompson, a former top scientist who was involved at Eli

Lilly with getting Prozac approved by the FDA.

 

Thompson runs his own consulting business assisting drug companies in winning

FDA approval.

 

" This is now two drugs in this class that seem to have problems when it

comes to children, " Thompson said. " I think you'll see the FDA look closely

at this whole field. "

 

Just as Glaxo did with Paxil, Wyeth officials cautioned that Effexor is not

FDA-approved for children.

 

" You may need to reassess the benefit-risk balance when treating individual

patients, " the letter states. " If a decision is made to discontinue a patient

from Effexor, treatment should not be discontinued abruptly due to risk of

discontinuation symptoms. "

 

Dr. Ann Blake Tracy, Executive Director,

International Coalition For Drug Awareness

<A HREF= " www.drugawareness.org " >www.drugawareness.org</A> and author of Prozac:

Panacea or Pandora? - Our Serotonin Nightmare

 

______________________________