Washington Editor

Cancer patients who rely on high-dose interleukin-2 therapy nearly slipped through the cracks when hospitals began eliminating such treatment services due to dwindling Medicare reimbursements.

Chiron Corp., the Emeryville, Calif.-based company that makes Proleukin (aldesleukin), the only FDA-approved high-dose IL-2 treatment for metastatic renal cell carcinoma and the first therapy approved for the treatment of metastatic melanoma in 20 years, joined a group of physicians and cancer advocacy organizations to lobby Congress to restore funding for the therapy.

It took five years, but eventually the cancer advocates were able to convince lawmakers of the necessity of the therapy, and on Oct. 1 a reimbursement change in favor of patients was implemented.

In an interview with BioWorld Today, Bryan Walser, Chiron's vice president of corporate strategy, explained that high-dose IL-2 patients receive therapy on an inpatient basis, either in an intensive care unit or in a room immediately adjacent to one.

"It is a fairly rigorous therapy, although doctors have learned how to give it with minimum side effects," he said. "But for patient safety, it requires a fairly high degree of resources."

And it's expensive. Walser estimates that one round of therapy costs about $53,000, and the government, via the Centers for Medicare and Medicaid Services (CMS) was reimbursing to the tune of $7,000 to $12,000.

Not only did Medicare patients begin suffering from cut services, but non-Medicare patients began feeling the effects as well.

"Several hospitals that shut down services for Medicare patients shut it down for everyone, because if you receive federal funding, you can't discriminate," Walser said. "When it was impossible to take care of Medicare patients, they had to refuse everyone."

In a worst-case scenario, Walser said it was possible that all IL-2 centers would be forced to close because of money. Without IL-2 therapy, patients would die, he said. (Low-dose IL-2 is given on an outpatient basis.)

"This is no-joke stuff about how broken our health care system is," Walser said. "You can't understate the job of CMS. They have to save as much money as possible while at the same time delivering the therapies that make a difference to people.

"But, if you can reflect back to people that this is what is really happening to patient care as a result of what you are doing, then you can make some progress," he said.

Chiron assisted physicians and cancer advocates in getting meetings with decisions makers in Washington to state the case for IL-2.

Proleukin is a recombinant form of human IL-2 that has many of the same properties as naturally occurring IL-2, including activation of specialized defense cells that can attack and destroy cancer cells. Between 15 percent and 19 percent of patients with metastatic renal cell carcinoma and metastatic melanoma respond to high-dose IL-2. Long-term follow-up data on high-dose IL-2 has shown that it can evoke an immune response that completely eradicates cancer in a subset of patients, with some responses lasting more than 15 years, Chiron said.

Spot Checks Turn Up Hundreds Of Imported Drugs

While Congress continues debating whether it should legalize the practice of reimporting FDA-approved prescription drugs from other countries, government officials have conducted a survey of their own to obtain a representative picture of the types of drugs illegally entering the U.S.

The FDA and U.S. Customs and Border Protection examined 100 parcels a day for three days at mail facilities in Miami, New York, San Francisco and Carson, Calif. The survey turned up 1,153 imported drug products, including 1,019 (88 percent) un-approved drugs.

The drugs were imported from various countries, according to a press statement released by the FDA. For example, 15.8 percent entered from Canada, 14.3 percent from India, 13.8 percent from Thailand and 8 percent from the Philippines.

Many products arriving are not approved in the U.S., the agency said. For example, un-approved versions of Viagra, made by Pfizer Inc., of New York; Lipitor, also made by Pfizer; Zocor, made by Merck & Co. Inc., of Whitehouse Station, N.J.; and Accutane, made by F. Hoffmann-La Roche Ltd., of Basel, Switzerland, have been found.

The agency said many of the products were not properly packaged or labeled.

The so-called "blitz" exam was conducted to help government officials understand trends in the illegal importation of unsafe drugs. The agency conducted a similar analysis in 2001, which did not net as many un-approved and counterfeit products.

As a result of the most recent blitz, the FDA said it is re-evaluating enforcement strategies used at international mail facilities.