Healthy Skepticism Library item: 12019

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Timiraos N.
Amgen Spends Big Protesting Curbs On Anemia Drugs
The Wall Street Journal 2007 Nov 13B1
http://online.wsj.com/article/SB119491787202490761.html

Full text:

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an entire lobbying campaign on a single regulatory rule, and this one would appear to be a long shot: Congress has repealed only one of 41,000 such rules in the past decade, according to a Congressional Research Service report.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, Johnson & Johnson 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 Johnson & Johnson 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 Nancy 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 William 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 Melanie 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. Samuel 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.”