Prozac Maker Knew of Problems in 1988 .....Forbes.com

[Guest guest]

Confidential company documents obtained by a leading medical journal

suggest that drug giant Eli Lilly & Co. was aware that its

antidepressant Prozac was linked to troubling side effects as far

back as 1988, the same year the drug was introduced to the U.S.

market.

http://www.network54.com/Forum/message?

forumid=281849 & messageid=1104487614

The discovery is reported in the Jan. 1 issue of the British Medical

Journal, and 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 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

should never the see the light of day.

" The discovery of research, reportedly 'missing' for the past 10

years, that connects Prozac to increased suicidal tendencies and

violence is one more tragic example of a greater problem: Unless we

mandate that all research be disclosed to the FDA during the drug

approval process, regulators have no choice but to make their

decisions based on the best-case scenarios that drug companies

report to them, " U.S. Rep. Maurice Hinchey (D-N.Y.), whose office is

reviewing the documents, said in a statement. " These decisions

affect the health and lives of millions of Americans. If Eli Lilly's

research indicated dangerous side effects of their product and they

withheld that information, they knowingly jeopardized the public's

health. Their failure to disclose what they knew may have cost

lives. "

Morry Smulevitz, manager of global product communications at Eli

Lilly, said he could not comment on the documents because he hasn't

seen them.

" 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. Beyond that,

unfortunately, it's really difficult without having the ability to

review the supposed missing documents that we're not aware of to

know what we're trying to make comments upon. "

Smulevitz said he had requested the documents from Jeanne Lenzer, a

New York-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. 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 documents in question reportedly disappeared during a product

liability suit brought in 1994 by families of the victims of ph

Wesbecker, who, in 1989, killed eight people and wounded another 12

with an AK-47 before turning the gun on himself at his workplace in

Louisville, Ky. Wesbecker, who had suffered a long history of

depression, had started using fluoxetine just one month before the

shootings.

The relatives' civil suit alleged that the company had known about

possible side effects of the drugs, including a tendency towards

violence.

The jury ruled 9-3 in favor of Lilly, but, in a shocking turnaround,

the company later admitted it had made a secret deal with the

plaintiffs. In 1997, the judge on the case, Potter, amended the

verdict to " dismissed as settled with prejudice, " meaning it could

be reopened. Potter was presiding over another case Thursday, and

could not be reached for comment on the latest developments.

" It's been a big puzzle for many years, " Lenzer said. " The documents

went missing during a critical period in the [wrongful death]

trial. " Lenzer would not reveal who had sent her the documents.

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. Breggin, the medical expert in the Wesbecker case, has

said the activation effects could be higher than 38 percent.

Lenzer, however, said she is concerned that what she called a

pattern of secrecy among drug companies continues.

She referred to the Treatment for Adolescents with Depression Study

(TADS), the results of which appeared in the Aug. 18 issue of the

Journal of the American Medical Association. Although the findings

were hailed as a victory for antidepressants, Lenzer stated in a

September letter to the BMJ that the research had a flawed

methodology and failed to report certain negative results.

" This is still going on. It's not just 16 years ago. It's going on

today, right now, " she said.

An FDA spokeswoman said the agency had no comment at this point.

More information

The U.S. Food and Drug Administration has more on antidepressant use

in children.

http://www.forbes.com/lifestyle/health/feeds/hscout/2004/12/30/hscout

523176.html

[Guest guest]

Confidential company documents obtained by a leading medical journal

suggest that drug giant Eli Lilly & Co. was aware that its

antidepressant Prozac was linked to troubling side effects as far

back as 1988, the same year the drug was introduced to the U.S.

market.

http://www.network54.com/Forum/message?

forumid=281849 & messageid=1104487614

The discovery is reported in the Jan. 1 issue of the British Medical

Journal, and 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 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

should never the see the light of day.

" The discovery of research, reportedly 'missing' for the past 10

years, that connects Prozac to increased suicidal tendencies and

violence is one more tragic example of a greater problem: Unless we

mandate that all research be disclosed to the FDA during the drug

approval process, regulators have no choice but to make their

decisions based on the best-case scenarios that drug companies

report to them, " U.S. Rep. Maurice Hinchey (D-N.Y.), whose office is

reviewing the documents, said in a statement. " These decisions

affect the health and lives of millions of Americans. If Eli Lilly's

research indicated dangerous side effects of their product and they

withheld that information, they knowingly jeopardized the public's

health. Their failure to disclose what they knew may have cost

lives. "

Morry Smulevitz, manager of global product communications at Eli

Lilly, said he could not comment on the documents because he hasn't

seen them.

" 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. Beyond that,

unfortunately, it's really difficult without having the ability to

review the supposed missing documents that we're not aware of to

know what we're trying to make comments upon. "

Smulevitz said he had requested the documents from Jeanne Lenzer, a

New York-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. 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 documents in question reportedly disappeared during a product

liability suit brought in 1994 by families of the victims of ph

Wesbecker, who, in 1989, killed eight people and wounded another 12

with an AK-47 before turning the gun on himself at his workplace in

Louisville, Ky. Wesbecker, who had suffered a long history of

depression, had started using fluoxetine just one month before the

shootings.

The relatives' civil suit alleged that the company had known about

possible side effects of the drugs, including a tendency towards

violence.

The jury ruled 9-3 in favor of Lilly, but, in a shocking turnaround,

the company later admitted it had made a secret deal with the

plaintiffs. In 1997, the judge on the case, Potter, amended the

verdict to " dismissed as settled with prejudice, " meaning it could

be reopened. Potter was presiding over another case Thursday, and

could not be reached for comment on the latest developments.

" It's been a big puzzle for many years, " Lenzer said. " The documents

went missing during a critical period in the [wrongful death]

trial. " Lenzer would not reveal who had sent her the documents.

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. Breggin, the medical expert in the Wesbecker case, has

said the activation effects could be higher than 38 percent.

Lenzer, however, said she is concerned that what she called a

pattern of secrecy among drug companies continues.

She referred to the Treatment for Adolescents with Depression Study

(TADS), the results of which appeared in the Aug. 18 issue of the

Journal of the American Medical Association. Although the findings

were hailed as a victory for antidepressants, Lenzer stated in a

September letter to the BMJ that the research had a flawed

methodology and failed to report certain negative results.

" This is still going on. It's not just 16 years ago. It's going on

today, right now, " she said.

An FDA spokeswoman said the agency had no comment at this point.

More information

The U.S. Food and Drug Administration has more on antidepressant use

in children.

http://www.forbes.com/lifestyle/health/feeds/hscout/2004/12/30/hscout

523176.html