The rise and fall of a billion-dollar drug

Amgen and Johnson & Johnson earned billions on the trio of anemia drugs Epogen, Procrit and Aranesp since their introduction in 1989. But over time, an understanding of their risks has grown, as have doubts about their effectiveness. Amgen says it acted quickly and responsibly as its understanding of the drugs evolved. (Read related story.)

KIDNEY
■ June 1989:
The FDA approves use of a new anemia drug, erythropoietin alfa, in patients with kidney disease. It will be marketed as Epogen and Procrit.

■ 2003: The average weekly dose of the drugs in dialysis patients has tripled since the ‘90s.

March 2007: After studies showing dangers, the FDA places a “black box warning” on the drug, warning that higher dosing levels increase the risk of death and heart attacks.

CANCER
■ April 1993:
The FDA approves the use of Epogen and Procrit in patients under-
going cancer chemotherapy. Concurrent with approval, Amgen promises a study to see whether the drugs aid patients or make tumors grow. Eleven years later, it halts the uncompleted study, with FDA approval, and promises another. That study has yet to be finished.

■ September 2001: Amgen wins approval for a longer lasting version of the drug. It will be marketed as Aranesp.

2003: A breast cancer trial shows that women taking the drugs have lower rates of survival. A second trial in people with head and neck cancers shows a similar drop in survival.

QUALITY OF
LIFE CLAIMS
■ June 1994:
The FDA-approved label includes the drugmaker’s broad claim that the drugs improve quality of life, including “life satisfaction” and “happiness.”

■ May 2007: The FDA finds that the drugmaker’s claims that the drugs improve “quality of life” were “not established” in properly conducted trials, according to its revised standards. Most of its claims are withdrawn from the label.

■ November 2008: The FDA-approved label says the drugs are not to be used on cancer chemotherapy patients considered curable. Doses for other cancer patients are significantly reduced.

Amgen’s sales of Epogen and Aranesp

$95.8
million

Total:$5.3 billion

Total: $3 billion

ARANESP

EPOGEN

Note: Complete sales data
for Procrit are unavailable.

1990

1995

2000

2005

2010

$5

billion

4

3

2

1

0

LOBBYING BY AMGEN
Amgen begins spending
more on lobbying efforts,
topping out at $16.3 million
in 2007.

DOSES RISE
The size of the average dose
more than tripled.

EPO drug doses
Average weekly units
in thousands

After pressure from
Congress, Medicare
increases the
amount of drug for
which it will pay.

Black box warning issued.

In millions of dollars

$16

14

12

10

8

6

4

2

0

’98

’00

’02

’04

’06

’08

’10

20,000

15,000

10,000

5,000

0

’91

’93

’95

’97

’99

’01

’03

’05

’07

’09

COMPARING COUNTRIES
The United States administered the highest EPO doses of 12 countries studied.

Average EPO doses
for 2002, in units
per week

Note: Excludes Aranesp.

Japan

Germany

France

Spain

Britain

Italy

Australia/New Zealand

Canada

Sweden

Belgium

United States

5,297

6,846

7,401

7,607

8,010

8,118

8,725

10,808

12,202

12,312

17,360

Sources: Amgen, Food and Drug Administration, opensecrets.org, IMS Health, staff reports, American Journal of Kidney Diseases. Graphic: Peter Whoriskey and Tobey/The Washington Post. Published July 19, 2012.