Documents suggest Lilly concealed drug's risks .........Zyprexa!!!

[Guest guest]

Documents suggest Lilly concealed drug's risks

By Berenson

http://seattletimes.nwsource.com/html/health/2003481751_drug17.html

The New York Times

The drug maker Eli Lilly has engaged in a 10-year effort to downplay

the health risks of Zyprexa, its best-selling medication for

schizophrenia, according to hundreds of internal Lilly documents and

e-mails among top company managers.

The documents, given to The New York Times by a lawyer representing

mentally ill patients, suggest Lilly executives kept important

information from doctors about Zyprexa's links to obesity and its

tendency to raise blood sugar, both known risk factors for diabetes.

Lilly's published data, which it told its sales representatives to

play down in conversations with doctors, have shown that 30 percent

of patients taking Zyprexa gain 22 pounds or more after a year on the

drug, and some patients have reported gaining 100 pounds or more.

But Lilly was concerned Zyprexa's sales would be hurt if the company

was more forthright about the fact the drug might cause unmanageable

weight gain or diabetes, according to the documents, which cover 1995

to 2004.

Link denied

Critics, including the American Diabetes Association, have argued

that Zyprexa, introduced in 1996, is more likely to cause diabetes

than other widely used schizophrenia drugs.

Lilly has consistently denied such a link and did so again Friday in

a written response to questions about the documents. The company

defended Zyprexa's safety and said the documents had been taken out

of context.

The drug

Zyprexa has become Lilly's best-selling product by far, with sales of

$4.2 billion last year, when about 2 million people worldwide took

the drug.

Its chemical name is olanzapine, and it is used to treat such

illnesses as schizophrenia, other psychotic conditions and bipolar

disorder.

It is one of a class of drugs called atypical anti-psychotics that

includes & 's Risperdal and AstraZeneca's Seroquel.

The drug's maker, Eli Lilly, based in Indianapolis, is the sixth-

largest U.S. drug-maker, with $14 billion in revenue last year.

The New York Times

But as early as 1999, the documents show that Lilly worried that side

effects from Zyprexa, whose chemical name is olanzapine, would hurt

sales.

" Olanzapine-associated weight gain and possible hyperglycemia is a

major threat to the long-term success of this critically important

molecule, " Dr. Alan Breier wrote in a November 1999 e-mail to 24

Lilly employees that announced the formation of an " executive

steering committee for olanzapine-associated weight changes and

hyperglycemia. "

Hyperglycemia is high blood sugar.

At the time, Breier, now Lilly's chief medical officer, was the chief

scientist on the Zyprexa program.

In 2000, a group of diabetes doctors that Lilly had retained to

consider potential links between Zyprexa and diabetes warned the

company that " unless we come clean on this, it could get much more

serious than we might anticipate, " according to an e-mail from one

Lilly manager to another.

And in that year and 2001, the documents show, Lilly's marketing

research found that psychiatrists were consistently saying that many

more of their patients developed high blood sugar or diabetes while

taking Zyprexa than other anti-psychotic drugs.

The documents, which until last week remained under court seal, were

collected for lawsuits on behalf of mentally ill patients against the

company.

Last year, Lilly agreed to pay $750 million to settle suits by 8,000

people who claimed they developed diabetes or other medical problems

after taking Zyprexa. Thousands more suits against the company are

pending.

On Friday, in its written response, Lilly said it believed Zyprexa

remained an important treatment for patients with schizophrenia and

bipolar disorder.

The company said it had given the Food and Drug Administration (FDA)

all its data from clinical trials and reports of adverse events, as

it is legally required to do. Lilly also said it shared data from

literature reviews and large studies of Zyprexa's real-world use.

" In summary, there is no scientific evidence establishing that

Zyprexa causes diabetes, " the company said.

Lilly also said the documents should not have been made public

because they might " cause unwarranted fear among patients that will

cause them to stop taking their medication. "

How effective?

Some psychiatrists said Zyprexa will continue to be widely used

despite its side effects, because it works better than most other

anti-psychotic medicines in severely ill patients.

But others said Zyprexa appears no more effective overall than other

medicines.

Some doctors who specialize in diabetes care disputed Lilly's

assertion that Zyprexa does not cause more cases of diabetes than

other psychiatric drugs.

" When somebody gains weight, they need more insulin; they become more

insulin resistant, " Dr. Zonszein, the director of the clinical

diabetes center at Montefiore Medical Center, said when asked about

the drug.

In 2003, after reviewing data provided by Lilly and other drug

makers, the FDA said the current class of anti-psychotic drugs may

cause high blood sugar. It did not single out Zyprexa, nor did it say

the drugs had been proved to cause diabetes.

The Zyprexa documents were provided to The New York Times by

Gottstein, a lawyer who represents mentally ill patients and has sued

Alaska over its efforts to force patients to take psychiatric

medicines against their will. Gottstein said the information in the

documents raised public-health issues.

" Patients should be told the truth about drugs like Zyprexa, "

Gottstein said.

Lilly called the release of the documents " illegal. "

The company said it could not comment on specific documents because

of the continuing product-liability suits.

Lilly has never conducted a clinical trial to determine how much

Zyprexa raises patients' diabetes risks.

But scientists say conducting such a study would be exceedingly

difficult, because diabetes takes years to develop, and it can be

hard to keep mentally ill patients enrolled in a clinical trial.

Copyright © 2006 The Seattle Times Company

[Guest guest]

Documents suggest Lilly concealed drug's risks

By Berenson

http://seattletimes.nwsource.com/html/health/2003481751_drug17.html

The New York Times

The drug maker Eli Lilly has engaged in a 10-year effort to downplay

the health risks of Zyprexa, its best-selling medication for

schizophrenia, according to hundreds of internal Lilly documents and

e-mails among top company managers.

The documents, given to The New York Times by a lawyer representing

mentally ill patients, suggest Lilly executives kept important

information from doctors about Zyprexa's links to obesity and its

tendency to raise blood sugar, both known risk factors for diabetes.

Lilly's published data, which it told its sales representatives to

play down in conversations with doctors, have shown that 30 percent

of patients taking Zyprexa gain 22 pounds or more after a year on the

drug, and some patients have reported gaining 100 pounds or more.

But Lilly was concerned Zyprexa's sales would be hurt if the company

was more forthright about the fact the drug might cause unmanageable

weight gain or diabetes, according to the documents, which cover 1995

to 2004.

Link denied

Critics, including the American Diabetes Association, have argued

that Zyprexa, introduced in 1996, is more likely to cause diabetes

than other widely used schizophrenia drugs.

Lilly has consistently denied such a link and did so again Friday in

a written response to questions about the documents. The company

defended Zyprexa's safety and said the documents had been taken out

of context.

The drug

Zyprexa has become Lilly's best-selling product by far, with sales of

$4.2 billion last year, when about 2 million people worldwide took

the drug.

Its chemical name is olanzapine, and it is used to treat such

illnesses as schizophrenia, other psychotic conditions and bipolar

disorder.

It is one of a class of drugs called atypical anti-psychotics that

includes & 's Risperdal and AstraZeneca's Seroquel.

The drug's maker, Eli Lilly, based in Indianapolis, is the sixth-

largest U.S. drug-maker, with $14 billion in revenue last year.

The New York Times

But as early as 1999, the documents show that Lilly worried that side

effects from Zyprexa, whose chemical name is olanzapine, would hurt

sales.

" Olanzapine-associated weight gain and possible hyperglycemia is a

major threat to the long-term success of this critically important

molecule, " Dr. Alan Breier wrote in a November 1999 e-mail to 24

Lilly employees that announced the formation of an " executive

steering committee for olanzapine-associated weight changes and

hyperglycemia. "

Hyperglycemia is high blood sugar.

At the time, Breier, now Lilly's chief medical officer, was the chief

scientist on the Zyprexa program.

In 2000, a group of diabetes doctors that Lilly had retained to

consider potential links between Zyprexa and diabetes warned the

company that " unless we come clean on this, it could get much more

serious than we might anticipate, " according to an e-mail from one

Lilly manager to another.

And in that year and 2001, the documents show, Lilly's marketing

research found that psychiatrists were consistently saying that many

more of their patients developed high blood sugar or diabetes while

taking Zyprexa than other anti-psychotic drugs.

The documents, which until last week remained under court seal, were

collected for lawsuits on behalf of mentally ill patients against the

company.

Last year, Lilly agreed to pay $750 million to settle suits by 8,000

people who claimed they developed diabetes or other medical problems

after taking Zyprexa. Thousands more suits against the company are

pending.

On Friday, in its written response, Lilly said it believed Zyprexa

remained an important treatment for patients with schizophrenia and

bipolar disorder.

The company said it had given the Food and Drug Administration (FDA)

all its data from clinical trials and reports of adverse events, as

it is legally required to do. Lilly also said it shared data from

literature reviews and large studies of Zyprexa's real-world use.

" In summary, there is no scientific evidence establishing that

Zyprexa causes diabetes, " the company said.

Lilly also said the documents should not have been made public

because they might " cause unwarranted fear among patients that will

cause them to stop taking their medication. "

How effective?

Some psychiatrists said Zyprexa will continue to be widely used

despite its side effects, because it works better than most other

anti-psychotic medicines in severely ill patients.

But others said Zyprexa appears no more effective overall than other

medicines.

Some doctors who specialize in diabetes care disputed Lilly's

assertion that Zyprexa does not cause more cases of diabetes than

other psychiatric drugs.

" When somebody gains weight, they need more insulin; they become more

insulin resistant, " Dr. Zonszein, the director of the clinical

diabetes center at Montefiore Medical Center, said when asked about

the drug.

In 2003, after reviewing data provided by Lilly and other drug

makers, the FDA said the current class of anti-psychotic drugs may

cause high blood sugar. It did not single out Zyprexa, nor did it say

the drugs had been proved to cause diabetes.

The Zyprexa documents were provided to The New York Times by

Gottstein, a lawyer who represents mentally ill patients and has sued

Alaska over its efforts to force patients to take psychiatric

medicines against their will. Gottstein said the information in the

documents raised public-health issues.

" Patients should be told the truth about drugs like Zyprexa, "

Gottstein said.

Lilly called the release of the documents " illegal. "

The company said it could not comment on specific documents because

of the continuing product-liability suits.

Lilly has never conducted a clinical trial to determine how much

Zyprexa raises patients' diabetes risks.

But scientists say conducting such a study would be exceedingly

difficult, because diabetes takes years to develop, and it can be

hard to keep mentally ill patients enrolled in a clinical trial.

Copyright © 2006 The Seattle Times Company

[Guest guest]

Documents suggest Lilly concealed drug's risks

By Berenson

http://seattletimes.nwsource.com/html/health/2003481751_drug17.html

The New York Times

The drug maker Eli Lilly has engaged in a 10-year effort to downplay

the health risks of Zyprexa, its best-selling medication for

schizophrenia, according to hundreds of internal Lilly documents and

e-mails among top company managers.

The documents, given to The New York Times by a lawyer representing

mentally ill patients, suggest Lilly executives kept important

information from doctors about Zyprexa's links to obesity and its

tendency to raise blood sugar, both known risk factors for diabetes.

Lilly's published data, which it told its sales representatives to

play down in conversations with doctors, have shown that 30 percent

of patients taking Zyprexa gain 22 pounds or more after a year on the

drug, and some patients have reported gaining 100 pounds or more.

But Lilly was concerned Zyprexa's sales would be hurt if the company

was more forthright about the fact the drug might cause unmanageable

weight gain or diabetes, according to the documents, which cover 1995

to 2004.

Link denied

Critics, including the American Diabetes Association, have argued

that Zyprexa, introduced in 1996, is more likely to cause diabetes

than other widely used schizophrenia drugs.

Lilly has consistently denied such a link and did so again Friday in

a written response to questions about the documents. The company

defended Zyprexa's safety and said the documents had been taken out

of context.

The drug

Zyprexa has become Lilly's best-selling product by far, with sales of

$4.2 billion last year, when about 2 million people worldwide took

the drug.

Its chemical name is olanzapine, and it is used to treat such

illnesses as schizophrenia, other psychotic conditions and bipolar

disorder.

It is one of a class of drugs called atypical anti-psychotics that

includes & 's Risperdal and AstraZeneca's Seroquel.

The drug's maker, Eli Lilly, based in Indianapolis, is the sixth-

largest U.S. drug-maker, with $14 billion in revenue last year.

The New York Times

But as early as 1999, the documents show that Lilly worried that side

effects from Zyprexa, whose chemical name is olanzapine, would hurt

sales.

" Olanzapine-associated weight gain and possible hyperglycemia is a

major threat to the long-term success of this critically important

molecule, " Dr. Alan Breier wrote in a November 1999 e-mail to 24

Lilly employees that announced the formation of an " executive

steering committee for olanzapine-associated weight changes and

hyperglycemia. "

Hyperglycemia is high blood sugar.

At the time, Breier, now Lilly's chief medical officer, was the chief

scientist on the Zyprexa program.

In 2000, a group of diabetes doctors that Lilly had retained to

consider potential links between Zyprexa and diabetes warned the

company that " unless we come clean on this, it could get much more

serious than we might anticipate, " according to an e-mail from one

Lilly manager to another.

And in that year and 2001, the documents show, Lilly's marketing

research found that psychiatrists were consistently saying that many

more of their patients developed high blood sugar or diabetes while

taking Zyprexa than other anti-psychotic drugs.

The documents, which until last week remained under court seal, were

collected for lawsuits on behalf of mentally ill patients against the

company.

Last year, Lilly agreed to pay $750 million to settle suits by 8,000

people who claimed they developed diabetes or other medical problems

after taking Zyprexa. Thousands more suits against the company are

pending.

On Friday, in its written response, Lilly said it believed Zyprexa

remained an important treatment for patients with schizophrenia and

bipolar disorder.

The company said it had given the Food and Drug Administration (FDA)

all its data from clinical trials and reports of adverse events, as

it is legally required to do. Lilly also said it shared data from

literature reviews and large studies of Zyprexa's real-world use.

" In summary, there is no scientific evidence establishing that

Zyprexa causes diabetes, " the company said.

Lilly also said the documents should not have been made public

because they might " cause unwarranted fear among patients that will

cause them to stop taking their medication. "

How effective?

Some psychiatrists said Zyprexa will continue to be widely used

despite its side effects, because it works better than most other

anti-psychotic medicines in severely ill patients.

But others said Zyprexa appears no more effective overall than other

medicines.

Some doctors who specialize in diabetes care disputed Lilly's

assertion that Zyprexa does not cause more cases of diabetes than

other psychiatric drugs.

" When somebody gains weight, they need more insulin; they become more

insulin resistant, " Dr. Zonszein, the director of the clinical

diabetes center at Montefiore Medical Center, said when asked about

the drug.

In 2003, after reviewing data provided by Lilly and other drug

makers, the FDA said the current class of anti-psychotic drugs may

cause high blood sugar. It did not single out Zyprexa, nor did it say

the drugs had been proved to cause diabetes.

The Zyprexa documents were provided to The New York Times by

Gottstein, a lawyer who represents mentally ill patients and has sued

Alaska over its efforts to force patients to take psychiatric

medicines against their will. Gottstein said the information in the

documents raised public-health issues.

" Patients should be told the truth about drugs like Zyprexa, "

Gottstein said.

Lilly called the release of the documents " illegal. "

The company said it could not comment on specific documents because

of the continuing product-liability suits.

Lilly has never conducted a clinical trial to determine how much

Zyprexa raises patients' diabetes risks.

But scientists say conducting such a study would be exceedingly

difficult, because diabetes takes years to develop, and it can be

hard to keep mentally ill patients enrolled in a clinical trial.

Copyright © 2006 The Seattle Times Company

[Guest guest]

Documents suggest Lilly concealed drug's risks

By Berenson

http://seattletimes.nwsource.com/html/health/2003481751_drug17.html

The New York Times

The drug maker Eli Lilly has engaged in a 10-year effort to downplay

the health risks of Zyprexa, its best-selling medication for

schizophrenia, according to hundreds of internal Lilly documents and

e-mails among top company managers.

The documents, given to The New York Times by a lawyer representing

mentally ill patients, suggest Lilly executives kept important

information from doctors about Zyprexa's links to obesity and its

tendency to raise blood sugar, both known risk factors for diabetes.

Lilly's published data, which it told its sales representatives to

play down in conversations with doctors, have shown that 30 percent

of patients taking Zyprexa gain 22 pounds or more after a year on the

drug, and some patients have reported gaining 100 pounds or more.

But Lilly was concerned Zyprexa's sales would be hurt if the company

was more forthright about the fact the drug might cause unmanageable

weight gain or diabetes, according to the documents, which cover 1995

to 2004.

Link denied

Critics, including the American Diabetes Association, have argued

that Zyprexa, introduced in 1996, is more likely to cause diabetes

than other widely used schizophrenia drugs.

Lilly has consistently denied such a link and did so again Friday in

a written response to questions about the documents. The company

defended Zyprexa's safety and said the documents had been taken out

of context.

The drug

Zyprexa has become Lilly's best-selling product by far, with sales of

$4.2 billion last year, when about 2 million people worldwide took

the drug.

Its chemical name is olanzapine, and it is used to treat such

illnesses as schizophrenia, other psychotic conditions and bipolar

disorder.

It is one of a class of drugs called atypical anti-psychotics that

includes & 's Risperdal and AstraZeneca's Seroquel.

The drug's maker, Eli Lilly, based in Indianapolis, is the sixth-

largest U.S. drug-maker, with $14 billion in revenue last year.

The New York Times

But as early as 1999, the documents show that Lilly worried that side

effects from Zyprexa, whose chemical name is olanzapine, would hurt

sales.

" Olanzapine-associated weight gain and possible hyperglycemia is a

major threat to the long-term success of this critically important

molecule, " Dr. Alan Breier wrote in a November 1999 e-mail to 24

Lilly employees that announced the formation of an " executive

steering committee for olanzapine-associated weight changes and

hyperglycemia. "

Hyperglycemia is high blood sugar.

At the time, Breier, now Lilly's chief medical officer, was the chief

scientist on the Zyprexa program.

In 2000, a group of diabetes doctors that Lilly had retained to

consider potential links between Zyprexa and diabetes warned the

company that " unless we come clean on this, it could get much more

serious than we might anticipate, " according to an e-mail from one

Lilly manager to another.

And in that year and 2001, the documents show, Lilly's marketing

research found that psychiatrists were consistently saying that many

more of their patients developed high blood sugar or diabetes while

taking Zyprexa than other anti-psychotic drugs.

The documents, which until last week remained under court seal, were

collected for lawsuits on behalf of mentally ill patients against the

company.

Last year, Lilly agreed to pay $750 million to settle suits by 8,000

people who claimed they developed diabetes or other medical problems

after taking Zyprexa. Thousands more suits against the company are

pending.

On Friday, in its written response, Lilly said it believed Zyprexa

remained an important treatment for patients with schizophrenia and

bipolar disorder.

The company said it had given the Food and Drug Administration (FDA)

all its data from clinical trials and reports of adverse events, as

it is legally required to do. Lilly also said it shared data from

literature reviews and large studies of Zyprexa's real-world use.

" In summary, there is no scientific evidence establishing that

Zyprexa causes diabetes, " the company said.

Lilly also said the documents should not have been made public

because they might " cause unwarranted fear among patients that will

cause them to stop taking their medication. "

How effective?

Some psychiatrists said Zyprexa will continue to be widely used

despite its side effects, because it works better than most other

anti-psychotic medicines in severely ill patients.

But others said Zyprexa appears no more effective overall than other

medicines.

Some doctors who specialize in diabetes care disputed Lilly's

assertion that Zyprexa does not cause more cases of diabetes than

other psychiatric drugs.

" When somebody gains weight, they need more insulin; they become more

insulin resistant, " Dr. Zonszein, the director of the clinical

diabetes center at Montefiore Medical Center, said when asked about

the drug.

In 2003, after reviewing data provided by Lilly and other drug

makers, the FDA said the current class of anti-psychotic drugs may

cause high blood sugar. It did not single out Zyprexa, nor did it say

the drugs had been proved to cause diabetes.

The Zyprexa documents were provided to The New York Times by

Gottstein, a lawyer who represents mentally ill patients and has sued

Alaska over its efforts to force patients to take psychiatric

medicines against their will. Gottstein said the information in the

documents raised public-health issues.

" Patients should be told the truth about drugs like Zyprexa, "

Gottstein said.

Lilly called the release of the documents " illegal. "

The company said it could not comment on specific documents because

of the continuing product-liability suits.

Lilly has never conducted a clinical trial to determine how much

Zyprexa raises patients' diabetes risks.

But scientists say conducting such a study would be exceedingly

difficult, because diabetes takes years to develop, and it can be

hard to keep mentally ill patients enrolled in a clinical trial.

Copyright © 2006 The Seattle Times Company