Amgen Spends Big Protesting Curbs On Anemia Drugs

[Guest guest]

Amgen Spends Big Protesting Curbs On Anemia Drugs

By NICK TIMIRAOS

November 13, 2007; Page B1

Nearly a million cancer and dialysis patients turn to Amgen Inc. for essential

medicines every year. Now, Amgen is turning to its patients for some medicine of

its own.

Amgen is pouring millions of dollars into a lobbying campaign to get Congress to

change a Medicare rule that dealt a big blow to the company's lucrative anemia

drugs. Amgen's argument: Federal guidelines limiting payments for

anemia-fighting drugs could hurt cancer patients.

It's rare for a company to focus an entire lobbying campaign on a single

regulatory rule, and this one would appear to be a long shot: Congress has

repealed only one of 41,000 such rules in the past decade, according to a

Congressional Research Service report. The push underscores Amgen's dependence

on Epogen and Aranesp, which together accounted for 48% of its revenue last year

-- and the fact that the federal government pays for the biggest share of

Epogen.

Since the summer, the company has run an Internet-centered campaign, Protect

Cancer Patients, that tries to capture the feel of a grass-roots effort by

encouraging cancer patients, survivors and family members to send in their

stories and to upload video and audio testimonials. The Web site also encourages

individuals to phone members of Congress.

" We were very interested in making sure that the Medicare beneficiaries had a

vehicle to make their voices heard, " says Josh Ofman, Amgen's vice president of

global reimbursement and payment policy. The company says it has already

generated hundreds of emails and phone calls to lawmakers.

But on Friday Amgen said it had suspended the site as part of a re-evaluation of

its online campaign. The company said the decision was unrelated to a report in

the Cancer Letter, an influential newsletter, suggesting that testimonials on

the site advocating off-label uses of the drug could violate Food and Drug

Administration marketing rules.

Last week, & launched a similar effort for its anemia-fighting

drug, Procrit, with a Web site, www.voiceforcancerpatients.com, that allows

individuals to send emails to the Center for Medicare and Medicaid Services and

contact their representatives in Washington. The site doesn't include patient

testimonials.

The lobbying is showing some results. Majorities in both the House and Senate

signed letters to the Medicare center warning against the new rule earlier this

year, and legislation to reverse the decision has been introduced in both

chambers. But prospects for passage are unclear because of new budget rules that

would require Congress to offset the increased cost of paying for more of the

drug. Even if the resolution fails, lobbyists could push for language in the

annual appropriations bill that would delay the new rules for one year.

Anemia-fighting drugs treat nearly a million cancer and dialysis patients

annually, and sales totaled $7.3 billion last year, making them the biotech

industry's most lucrative medications. Cancer patients often become anemic

during treatment, and the drugs are designed to prevent the need for blood

transfusions, which can be uncomfortable at best and risky at worst.

Last week, the FDA ordered that the drugs carry a new " black-box " label -- the

agency's strictest -- warning against the increased risk of death and

accelerated tumor growth that could result from higher doses of the drug. The

FDA approved a less-serious warning in March, urging doctors to use the lowest

dose possible and warning against raising levels of hemoglobin -- a measure of

red blood cells -- above 12 grams per deciliter of blood. Several

medical-journal studies had previously warned that overuse of the drug increased

risk of hypertension, blood clots and accelerated tumor growth.

Medicare officials issued rules this past summer that would reduce the dosages

of the drugs that the government covers for Medicare patients. It won't pay to

start cancer patients on the drugs unless their hemoglobin has fallen below 10

grams per deciliter, though dialysis, and other noncancer patients aren't

affected. Sales of Epogen and Aranesp declined last quarter by 5% and 23%,

respectively, helping to drive down Amgen's earnings by 82%.

Amgen and & appealed the Medicare payment rules last week,

seizing on the FDA's new ruling, which they say gives doctors greater latitude

in determining the proper drug dose. Amgen has also argued that the payment

regimen would create a " two-tiered " health-care system, one for privately

insured individuals and one for Medicare beneficiaries. But the FDA defended the

decision as consistent with Medicare's payment decision.

Amgen's fight on this front is only the latest evidence of its increasing

presence in Washington. The company doubled its lobbyist spending to $10.2

million last year and has already spent $9 million in the first half of 2007,

pushing Amgen ahead of Pfizer Inc. among pharmaceutical companies this year,

according to the Center for Responsive Politics.

The Thousand Oaks, Calif., biologic drug maker has a dozen in-house lobbyists

and retains more than 100 external lobbyists, including former aides to

Democratic House Speaker Pelosi of California and former Republican Senate

Majority Leader Bill Frist. In addition to reimbursement policies, Amgen has

boosted lobbying on patent legislation and attempts to introduce generic

biologic drugs. " Lobbying is becoming a better investment than researching new

drugs, " says Vaughan, a senior analyst at Consumers Union, which has

encouraged Congress to support the federal rule change.

Amgen says its lobbying spending is no different from other drug makers'. " We

operate in a very highly regulated industry ... and with that recognition we

have established a presence in Washington, D.C., " says Amgen's Dr. Ofman.

Indirect grass-roots campaigns have become a popular tactic among lobbyists

because they focus the issue away from a powerful entity and toward ordinary

people who would ostensibly suffer if the government fails to respond. In this

case, the front group is especially sympathetic.

" How many people don't have a relative who's a cancer patient? " says

Sloan, executive director of Citizens for Responsibility and Ethics in

Washington, a lobbyist-watchdog group. " The public is much more likely to

support legislation that benefits cancer patients than a company like Amgen. "

Cancer doctors, who benefit from Medicare's unusually high reimbursement rate

for anemia drugs, are also in Amgen's corner.

The influential American Society of Clinical Oncology and the American Society

of Hematology have called on the government to review its decision, and last

month released their own guidelines for members that reflect the FDA's new

warning. Silver, a physician who heads the subcommittee on reimbursement

for the American Society of Hematology, says the government's revised payment

policy sets a threshold for treatment that would force doctors " to draw blood on

cancer patients up to 12 times a month just to see if we're eligible ... for

reimbursement. "

Because the drugs are Medicare's greatest medication expense, the government

estimates that limiting their use would save $2 billion over the next five

years. That has led a handful of independent patient-advocacy organizations to

characterize the guidelines, in a letter sent last month to members of Congress,

as " high-risk, cost-cutting tourniquets " that ask patients " to pay for Medicare

budget cuts with their life-blood. "

Government officials reject those charges. " We have been exceedingly careful to

not even get into the discussion of cost. We made this decision specifically

because of the FDA black-box warning, " says Barry M. Straube, chief medical

officer for the Center for Medicare and Medicaid Services.

And not all patient groups are on Amgen's side. " I am astounded that this has

been reduced to, 'We want to protect patients,' " says Frances M. Visco,

president of the National Breast Cancer Coalition and a 20-year cancer survivor.

Ms. Visco says the campaign has confused cancer patients who " feel used by

this, " and she has urged Congress to reject what she calls Amgen's " abusive "

efforts. " Amgen is primarily interested in protecting Amgen, " she says.

Rep. Pete Stark, a California Democrat who is a leading Amgen critic, warns that

the integrity of Medicare rules decisions are at stake. If Congress overturns

the new guidelines, the effect would be to tell " industry they can spend

millions of dollars and hire lobbyists all over town to push Congress to

overrule sound science. "

Write to Nick Timiraos at nick.timiraos@...

http://online.wsj.com/public/article/SB119491787202490761.html