Study Finds Death Risk From Anemia Drugs: raise the risk of death among cancer patients ... NY Times February 27, 2008

[Guest guest]

from a silent sister . . . BTW, I met a drug sales representative today . . . She got a total of TWO MONTHS training in THREE drugs, before being put on the road! . . . NO MEDICAL OR SCIENCE BACKGROUND!-----------------------------------------------------------------

NY Times February 27, 2008 Study Finds Death Risk From Anemia

Drugs By

ANDREW POLLACK Widely

used anemia drugs sold by Amgen and & raise the risk of

death among cancer patients by about 10 percent,

according to a new analysis of previous clinical trials that is to be published

Wednesday.

The study is the first compilation of clinical trial data — called a

meta-analysis — to show a statistically significant increase in the risk

of death from the drugs, said Dr. L. , a professor at Northwestern University and its lead

author.

The Food and Drug Administration

is planning to convene an advisory committee on March 13 to discuss whether to

impose further restrictions on the use of the drugs, Aranesp from Amgen and

Procrit from & , with cancer patients.

The Amgen drug Epogen, which is the same as Procrit but is aimed at kidney dialysis patients, will not be directly

affected by the discussions.

Amgen said the study, being published in The Journal of the American Medical Association, provided

little new information. “What he observes is the risks that we’ve

already talked about that are in the label,” said Perlmutter,

Amgen’s executive vice president for research and development.

The F.D.A. ordered stronger warnings on the drugs’ labels last year,

after a flurry of studies suggested that the products, if used too

aggressively, could worsen cancer conditions or hasten death. And Medicare sharply restricted reimbursement

for the drugs when used to treat anemia caused by cancer chemotherapy.

Sales of Aranesp, Amgen’s best-selling product, declined to $3.6 billion

last year from $4.1 billion in 2006.

One option that analysts expect to be discussed at the meeting in March would

be to bar the use of the drugs for specific types of cancer, like breast cancer and head and neck cancer.

Another would be to delay treatment with the drugs until patients became more

anemic than the current threshold, a change that would more closely match the

Medicare reimbursement policy.

A third option, which many analysts say is unlikely, would be for the F.D.A. to

no longer authorize the drugs’ use in treating anemia caused by

chemotherapy. The drugs would still be allowed to treat anemia caused by kidney

disease.

Jim Birchenough, an analyst with Lehman Brothers, estimated in a report on

Monday that rescinding approval for chemotherapy-induced anemia would reduce

Amgen’s sales of Aranesp by $1 billion a year. A change in the label to

match the Medicare policy would cut them by $300 million.

The new analysis on death risk, which could play into the discussions on March

13, combines data from 51 clinical trials involving 13,611 patients. The study

also found a 57 percent increase in the risk of blood clots in veins, a known

side effect of the drugs.

Dr. , an oncologist and hematologist, said he did not think that the higher

risk of death came from those blood clots. Rather, he said, there is evidence

that the drugs, which are synthetic forms of a natural hormone called

erythropoietin, directly stimulate the growth and spread of tumors. Amgen scientists dispute that

explanation.

Procrit, which & sells under license from Amgen, was

approved for treatment of cancer patients in 1993, and Aranesp in 2002, based

on their ability to reduce the need for blood transfusions. But the studies on

which the approvals were based were not large and long enough to measure the

effect on patients’ longevity.

As a result, efforts have been made to pool the results of many smaller trials

to look for safety problems.

A meta-analysis published in 2004 by the Cochrane Collaboration, an

international research group, found that patients who were given the drugs

tended to live longer.

But in recent years, some new clinical trials, aimed at showing that using the

drugs at higher doses than indicated on the label would improve survival, found

the opposite. As those studies were added to the compilations, the safety

balance appeared to shift.

A meta-analysis published in 2006 by the Cochrane Collaboration found an 8

percent higher risk of death among users of the drugs, but the result just

missed being statistically significant. The analysis being published Wednesday

adds some more recent studies and reaches statistical significance.

That still leaves unclear whether the drugs are dangerous if used at the levels

indicated on the label, a question that bedeviled an F.D.A. advisory committee

last year and is likely to do so again in March.

“We didn’t ask the right questions for 15 years,” Dr.

said.

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[Guest guest]

from a silent sister . . . BTW, I met a drug sales representative today . . . She got a total of TWO MONTHS training in THREE drugs, before being put on the road! . . . NO MEDICAL OR SCIENCE BACKGROUND!-----------------------------------------------------------------

NY Times February 27, 2008 Study Finds Death Risk From Anemia

Drugs By

ANDREW POLLACK Widely

used anemia drugs sold by Amgen and & raise the risk of

death among cancer patients by about 10 percent,

according to a new analysis of previous clinical trials that is to be published

Wednesday.

The study is the first compilation of clinical trial data — called a

meta-analysis — to show a statistically significant increase in the risk

of death from the drugs, said Dr. L. , a professor at Northwestern University and its lead

author.

The Food and Drug Administration

is planning to convene an advisory committee on March 13 to discuss whether to

impose further restrictions on the use of the drugs, Aranesp from Amgen and

Procrit from & , with cancer patients.

The Amgen drug Epogen, which is the same as Procrit but is aimed at kidney dialysis patients, will not be directly

affected by the discussions.

Amgen said the study, being published in The Journal of the American Medical Association, provided

little new information. “What he observes is the risks that we’ve

already talked about that are in the label,” said Perlmutter,

Amgen’s executive vice president for research and development.

The F.D.A. ordered stronger warnings on the drugs’ labels last year,

after a flurry of studies suggested that the products, if used too

aggressively, could worsen cancer conditions or hasten death. And Medicare sharply restricted reimbursement

for the drugs when used to treat anemia caused by cancer chemotherapy.

Sales of Aranesp, Amgen’s best-selling product, declined to $3.6 billion

last year from $4.1 billion in 2006.

One option that analysts expect to be discussed at the meeting in March would

be to bar the use of the drugs for specific types of cancer, like breast cancer and head and neck cancer.

Another would be to delay treatment with the drugs until patients became more

anemic than the current threshold, a change that would more closely match the

Medicare reimbursement policy.

A third option, which many analysts say is unlikely, would be for the F.D.A. to

no longer authorize the drugs’ use in treating anemia caused by

chemotherapy. The drugs would still be allowed to treat anemia caused by kidney

disease.

Jim Birchenough, an analyst with Lehman Brothers, estimated in a report on

Monday that rescinding approval for chemotherapy-induced anemia would reduce

Amgen’s sales of Aranesp by $1 billion a year. A change in the label to

match the Medicare policy would cut them by $300 million.

The new analysis on death risk, which could play into the discussions on March

13, combines data from 51 clinical trials involving 13,611 patients. The study

also found a 57 percent increase in the risk of blood clots in veins, a known

side effect of the drugs.

Dr. , an oncologist and hematologist, said he did not think that the higher

risk of death came from those blood clots. Rather, he said, there is evidence

that the drugs, which are synthetic forms of a natural hormone called

erythropoietin, directly stimulate the growth and spread of tumors. Amgen scientists dispute that

explanation.

Procrit, which & sells under license from Amgen, was

approved for treatment of cancer patients in 1993, and Aranesp in 2002, based

on their ability to reduce the need for blood transfusions. But the studies on

which the approvals were based were not large and long enough to measure the

effect on patients’ longevity.

As a result, efforts have been made to pool the results of many smaller trials

to look for safety problems.

A meta-analysis published in 2004 by the Cochrane Collaboration, an

international research group, found that patients who were given the drugs

tended to live longer.

But in recent years, some new clinical trials, aimed at showing that using the

drugs at higher doses than indicated on the label would improve survival, found

the opposite. As those studies were added to the compilations, the safety

balance appeared to shift.

A meta-analysis published in 2006 by the Cochrane Collaboration found an 8

percent higher risk of death among users of the drugs, but the result just

missed being statistically significant. The analysis being published Wednesday

adds some more recent studies and reaches statistical significance.

That still leaves unclear whether the drugs are dangerous if used at the levels

indicated on the label, a question that bedeviled an F.D.A. advisory committee

last year and is likely to do so again in March.

“We didn’t ask the right questions for 15 years,” Dr.

said.

No virus found in this outgoing message.

Checked by AVG Free Edition.

Version: 7.5.516 / Virus Database: 269.21.1/1302 - Release Date: 2/27/2008 4:34 PM