British Medical Journal Retracts Part of Its Prozac Story

BOOM...there goes another anti-psychiatry yarn....


British Medical Journal Retracts Part of Its Prozac Story

Thu Jan 27,11:47 PM ET


THURSDAY, Jan. 27 (HealthDayNews) -- The British Medical Journal has
apologized to Eli Lilly & Co. for claiming in a Jan. 1 report that Lilly
documents outlining a heightened risk of suicide use among Prozac users were
missing for a decade.

The Associated Press quotes the journal's statement: "The BMJ accepts that
Eli Lilly acted properly in relation to the disclosure of these documents in
these claims. The BMJ is happy to set the record straight and to apologize
to Eli Lilly for this statement, which we now retract, but which we
published in good faith."

The original BMJ report said editors had given U.S. regulators internal
company documents it had received from an anonymous source, indicating Lilly
officials were aware in the 1980s that the antidepressant could have
potentially troubling side effects, and that those documents vanished during
a 1994 lawsuit against Lilly. But AP reported that, on Jan. 4, 2005, Eli
Lilly officials maintained the company had given those records to the U.S.
Food and Drug Administration (news - web sites) (FDA (news - web sites))
more than a decade ago, and the documents had not gone missing during the
court case.

After further investigation, the journal said it had determined that Lilly
had indeed disclosed the documents during the lawsuit, according to the AP.
However, the journal added that whether the FDA had been given the documents
is still being investigated.

In a statement, Lilly Chairman and CEO Sidney Taurel, said the retraction
was an "important step in gaining closure on this unfortunate event. It is
Lilly's policy to be honest in our dealings with the public, the media,
regulatory bodies and our customers."

The journal said the documents had formed part of a 1994 lawsuit against Eli
Lilly on behalf of victims of a workplace shooting in Louisville, Ky. Joseph
Wesbecker, the gunman who killed eight people and himself in 1989, had been
prescribed Prozac a month before the shootings. Lilly won the case, but
later disclosed it had settled with the plaintiffs during the trial.

The editor of the BMJ stressed that the apology was limited to the issue of
whether the documents were missing from the court case, according to the AP.

"Whether or not Eli Lilly made all of the information available to the FDA
at the appropriate times is a question for the FDA to answer. That is why we
sent the documents to the FDA, and we await their response," said acting
editor Kamran Abbasi.

HealthDay News reported on Dec. 30, 2004, that confidential company
documents obtained by the BMJ suggested that drug giant Lilly was aware that
Prozac was linked to troubling side effects as far back as 1988, the same
year the drug was introduced to the U.S. market.

The discovery, reported in the Jan. 1 2005 issue of the BMJ, adds to the
growing body of bad news for pharmaceutical companies. The papers have been
turned over to the U.S. Food and Drug Administration.

Amid the pile of internal reviews and memos, according to the journal, is a
document dated November 1988 that reports Prozac (fluoxetine) had caused
behavioral problems, including agitation and panic attacks, in clinical
trials.

The issue of disclosure is a loaded one. The FDA announced in October 2004
that antidepressants such as Prozac would now have to carry a "black box"
warning that health-care providers should be on the lookout for, among other
things, increased agitation, panic attacks, and aggression among users of
the drugs.

This latest report also fuels the ongoing debate over which clinical studies
should come to the attention of federal regulators and which ones should
never the see the light of day.

Morry Smulevitz, manager of global product communications at Eli Lilly, said
his company was committed making certain the public understood both the
benefits and risks of its products.

"Certainly Lilly is committed to public disclosure of all clinical trial
data so health-care providers and patients can make informed treatment
decisions," he said. "Prozac has been prescribed for over 50 million people
worldwide. It is one of the most studied drugs in the history of medicine,
and its safety and efficacy is well-studied and well-documented and
well-established."

Smulevitz said he had requested the documents from Jeanne Lenzer, a
Kingston, N.Y.-based medical investigative journalist who received them and
then sent them on to the BMJ and the FDA. But, he said, the request was not
met.

Dr. Richard Kapit, the FDA reviewer who originally approved fluoxetine in
1987, told the BMJ that he had never been given the Lilly data.

"If we have good evidence that we were misled and that data was withheld,
then I would change my mind [about the safety of fluoxetine]," he said in a
statement. "I do agree now that these stimulatory side effects, especially
in regard to suicidal ideation and homicidal ideation, are worse than I
thought at the time that I reviewed the drug."

The internal company document that stood out to Lenzer, she said, was one
that discussed the finding that 38 percent of people have a stimulation
effect, such as panic attacks and agitation, and that 19 percent of those
could be attributed to the drug.

According to Lenzer, the document stated "one in five [patients] could be
expected to experience this activation. And, later in the document, they
talk about how to do damage control, how to get the doctors not to worry
about this. Maybe the information actually got out and got buried. It's like
a little flicker of a flame. Obviously they didn't get this out to a wide
circulation. They didn't get it out to the people who needed to know. They
didn't get it to the FDA safety officer who reviewed it."

Dr. Peter Breggin, a medical expert in the Wesbecker case, has said the
activation effects could be higher than 38 percent.

Mark Probert wrote:
BOOM...there goes another anti-psychiatry yarn....

"...whether the FDA had been given the documents
is still being investigated."

Zee






British Medical Journal Retracts Part of Its Prozac Story

Thu Jan 27,11:47 PM ET


THURSDAY, Jan. 27 (HealthDayNews) -- The British Medical Journal has
apologized to Eli Lilly & Co. for claiming in a Jan. 1 report that
Lilly
documents outlining a heightened risk of suicide use among Prozac
users were
missing for a decade.

The Associated Press quotes the journal's statement: "The BMJ accepts
that
Eli Lilly acted properly in relation to the disclosure of these
documents in
these claims. The BMJ is happy to set the record straight and to
apologize
to Eli Lilly for this statement, which we now retract, but which we
published in good faith."

The original BMJ report said editors had given U.S. regulators
internal
company documents it had received from an anonymous source,
indicating Lilly
officials were aware in the 1980s that the antidepressant could have
potentially troubling side effects, and that those documents vanished
during
a 1994 lawsuit against Lilly. But AP reported that, on Jan. 4, 2005,
Eli
Lilly officials maintained the company had given those records to the
U.S.
Food and Drug Administration (news - web sites) (FDA (news - web
sites))
more than a decade ago, and the documents had not gone missing during
the
court case.

After further investigation, the journal said it had determined that
Lilly
had indeed disclosed the documents during the lawsuit, according to
the AP.
However, the journal added that whether the FDA had been given the
documents
is still being investigated.

In a statement, Lilly Chairman and CEO Sidney Taurel, said the
retraction
was an "important step in gaining closure on this unfortunate event.
It is
Lilly's policy to be honest in our dealings with the public, the
media,
regulatory bodies and our customers."

The journal said the documents had formed part of a 1994 lawsuit
against Eli
Lilly on behalf of victims of a workplace shooting in Louisville, Ky.
Joseph
Wesbecker, the gunman who killed eight people and himself in 1989,
had been
prescribed Prozac a month before the shootings. Lilly won the case,
but
later disclosed it had settled with the plaintiffs during the trial.

The editor of the BMJ stressed that the apology was limited to the
issue of
whether the documents were missing from the court case, according to
the AP.

"Whether or not Eli Lilly made all of the information available to
the FDA
at the appropriate times is a question for the FDA to answer. That is
why we
sent the documents to the FDA, and we await their response," said
acting
editor Kamran Abbasi.

HealthDay News reported on Dec. 30, 2004, that confidential company
documents obtained by the BMJ suggested that drug giant Lilly was
aware that
Prozac was linked to troubling side effects as far back as 1988, the
same
year the drug was introduced to the U.S. market.

The discovery, reported in the Jan. 1 2005 issue of the BMJ, adds to
the
growing body of bad news for pharmaceutical companies. The papers
have been
turned over to the U.S. Food and Drug Administration.

Amid the pile of internal reviews and memos, according to the
journal, is a
document dated November 1988 that reports Prozac (fluoxetine) had
caused
behavioral problems, including agitation and panic attacks, in
clinical
trials.

The issue of disclosure is a loaded one. The FDA announced in October
2004
that antidepressants such as Prozac would now have to carry a "black
box"
warning that health-care providers should be on the lookout for,
among other
things, increased agitation, panic attacks, and aggression among
users of
the drugs.

This latest report also fuels the ongoing debate over which clinical
studies
should come to the attention of federal regulators and which ones
should
never the see the light of day.

Morry Smulevitz, manager of global product communications at Eli
Lilly, said
his company was committed making certain the public understood both
the
benefits and risks of its products.

"Certainly Lilly is committed to public disclosure of all clinical
trial
data so health-care providers and patients can make informed
treatment
decisions," he said. "Prozac has been prescribed for over 50 million
people
worldwide. It is one of the most studied drugs in the history of
medicine,
and its safety and efficacy is well-studied and well-documented and
well-established."

Smulevitz said he had requested the documents from Jeanne Lenzer, a
Kingston, N.Y.-based medical investigative journalist who received
them and
then sent them on to the BMJ and the FDA. But, he said, the request
was not
met.

Dr. Richard Kapit, the FDA reviewer who originally approved
fluoxetine in
1987, told the BMJ that he had never been given the Lilly data.

"If we have good evidence that we were misled and that data was
withheld,
then I would change my mind [about the safety of fluoxetine]," he
said in a
statement. "I do agree now that these stimulatory side effects,
especially
in regard to suicidal ideation and homicidal ideation, are worse than
I
thought at the time that I reviewed the drug."

The internal company document that stood out to Lenzer, she said, was
one
that discussed the finding that 38 percent of people have a
stimulation
effect, such as panic attacks and agitation, and that 19 percent of
those
could be attributed to the drug.

According to Lenzer, the document stated "one in five [patients]
could be
expected to experience this activation. And, later in the document,
they
talk about how to do damage control, how to get the doctors not to
worry
about this. Maybe the information actually got out and got buried.
It's like
a little flicker of a flame. Obviously they didn't get this out to a
wide
circulation. They didn't get it out to the people who needed to know.
They
didn't get it to the FDA safety officer who reviewed it."

Dr. Peter Breggin, a medical expert in the Wesbecker case, has said
the
activation effects could be higher than 38 percent.

wrote in message
oups.com...

Mark Probert wrote:
BOOM...there goes another anti-psychiatry yarn....

"...whether the FDA had been given the documents
is still being investigated."

Snipped out of context. Lily claimed they were given to both the suit and
the FDA and someone comes along and says they did not. Now we see that Lily
was truthful when they claimed the docs were given to the suit, and, this
puts the onus on the FDA to show that they were not *given the documents*
not merely that they cannot find them.


Zee






British Medical Journal Retracts Part of Its Prozac Story

Thu Jan 27,11:47 PM ET


THURSDAY, Jan. 27 (HealthDayNews) -- The British Medical Journal has
apologized to Eli Lilly & Co. for claiming in a Jan. 1 report that
Lilly
documents outlining a heightened risk of suicide use among Prozac
users were
missing for a decade.

The Associated Press quotes the journal's statement: "The BMJ accepts
that
Eli Lilly acted properly in relation to the disclosure of these
documents in
these claims. The BMJ is happy to set the record straight and to
apologize
to Eli Lilly for this statement, which we now retract, but which we
published in good faith."

The original BMJ report said editors had given U.S. regulators
internal
company documents it had received from an anonymous source,
indicating Lilly
officials were aware in the 1980s that the antidepressant could have
potentially troubling side effects, and that those documents vanished
during
a 1994 lawsuit against Lilly. But AP reported that, on Jan. 4, 2005,
Eli
Lilly officials maintained the company had given those records to the
U.S.
Food and Drug Administration (news - web sites) (FDA (news - web
sites))
more than a decade ago, and the documents had not gone missing during
the
court case.

After further investigation, the journal said it had determined that
Lilly
had indeed disclosed the documents during the lawsuit, according to
the AP.
However, the journal added that whether the FDA had been given the
documents
is still being investigated.

In a statement, Lilly Chairman and CEO Sidney Taurel, said the
retraction
was an "important step in gaining closure on this unfortunate event.
It is
Lilly's policy to be honest in our dealings with the public, the
media,
regulatory bodies and our customers."

The journal said the documents had formed part of a 1994 lawsuit
against Eli
Lilly on behalf of victims of a workplace shooting in Louisville, Ky.
Joseph
Wesbecker, the gunman who killed eight people and himself in 1989,
had been
prescribed Prozac a month before the shootings. Lilly won the case,
but
later disclosed it had settled with the plaintiffs during the trial.

The editor of the BMJ stressed that the apology was limited to the
issue of
whether the documents were missing from the court case, according to
the AP.

"Whether or not Eli Lilly made all of the information available to
the FDA
at the appropriate times is a question for the FDA to answer. That is
why we
sent the documents to the FDA, and we await their response," said
acting
editor Kamran Abbasi.

HealthDay News reported on Dec. 30, 2004, that confidential company
documents obtained by the BMJ suggested that drug giant Lilly was
aware that
Prozac was linked to troubling side effects as far back as 1988, the
same
year the drug was introduced to the U.S. market.

The discovery, reported in the Jan. 1 2005 issue of the BMJ, adds to
the
growing body of bad news for pharmaceutical companies. The papers
have been
turned over to the U.S. Food and Drug Administration.

Amid the pile of internal reviews and memos, according to the
journal, is a
document dated November 1988 that reports Prozac (fluoxetine) had
caused
behavioral problems, including agitation and panic attacks, in
clinical
trials.

The issue of disclosure is a loaded one. The FDA announced in October
2004
that antidepressants such as Prozac would now have to carry a "black
box"
warning that health-care providers should be on the lookout for,
among other
things, increased agitation, panic attacks, and aggression among
users of
the drugs.

This latest report also fuels the ongoing debate over which clinical
studies
should come to the attention of federal regulators and which ones
should
never the see the light of day.

Morry Smulevitz, manager of global product communications at Eli
Lilly, said
his company was committed making certain the public understood both
the
benefits and risks of its products.

"Certainly Lilly is committed to public disclosure of all clinical
trial
data so health-care providers and patients can make informed
treatment
decisions," he said. "Prozac has been prescribed for over 50 million
people
worldwide. It is one of the most studied drugs in the history of
medicine,
and its safety and efficacy is well-studied and well-documented and
well-established."

Smulevitz said he had requested the documents from Jeanne Lenzer, a
Kingston, N.Y.-based medical investigative journalist who received
them and
then sent them on to the BMJ and the FDA. But, he said, the request
was not
met.

Dr. Richard Kapit, the FDA reviewer who originally approved
fluoxetine in
1987, told the BMJ that he had never been given the Lilly data.

"If we have good evidence that we were misled and that data was
withheld,
then I would change my mind [about the safety of fluoxetine]," he
said in a
statement. "I do agree now that these stimulatory side effects,
especially
in regard to suicidal ideation and homicidal ideation, are worse than
I
thought at the time that I reviewed the drug."

The internal company document that stood out to Lenzer, she said, was
one
that discussed the finding that 38 percent of people have a
stimulation
effect, such as panic attacks and agitation, and that 19 percent of
those
could be attributed to the drug.

According to Lenzer, the document stated "one in five [patients]
could be
expected to experience this activation. And, later in the document,
they
talk about how to do damage control, how to get the doctors not to
worry
about this. Maybe the information actually got out and got buried.
It's like
a little flicker of a flame. Obviously they didn't get this out to a
wide
circulation. They didn't get it out to the people who needed to know.
They
didn't get it to the FDA safety officer who reviewed it."

Dr. Peter Breggin, a medical expert in the Wesbecker case, has said
the
activation effects could be higher than 38 percent.