Washington Editor

WASHINGTON - Senators Bill Frist (R-Tenn.) and Ron Wyden (D-Ore.) outlined their parties' full-year health care agendas during last week's meeting of America's Health Insurance Plans.

Frist, the Senate majority leader, discussed pushing for a "five-point prescription" and focused on increasing choices to empower individuals. Chief among his matters of discussion was a call to end lawsuit abuse that drives up health care cost.

"Abusive personal injury lawyers must be stopped," Frist said.

He also advocated an expansion of tax-free health savings accounts, an easier system for small businesses to provide employee insurance, the ownership of secure medical records by all Americans and a stronger safety net for those who can't afford coverage.

"We need to fundamentally reduce the cost of health care," Frist said, noting that the continuing growth of health care cost will be an increasingly larger portion of the total U.S. economy. "This trend is not sustainable."

Wyden said Democrats are focusing on protecting the poor, relative to debates over federal Medicaid cuts, as well as senior advocacy in light of the Medicare prescription drug benefit. In fact, he noted that few seniors have signed up thus far, pointing to future problems.

"I think this program is heading into very troubled waters," said Wyden, who voted in favor of the prescription drug benefit but now projects a danger in a large government expenditure on a small amount of seniors. Looking further down the road, he warned that the looming retirement of the baby boomer generation would further tax an already-stressed system.

"The problems we're seeing today," Wyden said, "are going to look like small potatoes compared to what we're going to see in 2010 and 2011."

To that end, he noted that a bipartisan effort is getting under way, in partnership with Orrin Hatch (R-Utah), aimed at a government disclosure of its public health care spending.

Both Frist and Wyden agreed that expanding health care information technology was necessary. They each said such a system would reduce overall costs and also improve communication for patients, providers and payers.

Sarbanes Announces Retirement Plans

Senator Paul Sarbanes (D-Md.), whose name is familiar to industry executives through the Sarbanes-Oxley Act, on Friday said he would retire at the end of next year.

The 72-year-old son of Greek immigrants, who is in his fifth term, jointly authored the eponymous bipartisan bill with Rep. Michael Oxley (R-Ohio) to reform the accounting industry and restore investor confidence following a series of financial scandals at a number of high-profile public companies, including New York-based ImClone Systems Inc. The legislation was signed into law in 2002, and among its requirements is a mandate that companies report earnings on the basis of generally accepted accounting principles (GAAP) and non-GAAP.

Sarbanes was first elected to the Senate in 1976. Prior to that, he served three terms in the House of Representatives and in the Maryland state legislature.

FDA Warns Of Eczema Drug Risks

Following the recommendation of an advisory committee, the FDA is placing black box warnings on Elidel (pimecrolimus, from Novartis AG) and Protopic (tacrolimus, from Fujisawa Pharmaceutical Co. Ltd.) and advising health care professionals to prescribe the topical drugs "only as directed and only after other eczema treatments have failed to work because of a potential cancer risk associated with their use."

In addition, the agency is developing a medication guide for patients. The products' manufacturers have agreed to study whether there is an actual risk of cancer in humans, and, if so, its extent.

The FDA's actions follow the recommendations made last month by its Pediatric Advisory Committee, which drew its conclusion on cancer findings in three different animal species. The data showed that the risk increased in proportion to increased drug doses. The data also included a small number of reports of cancers in children and adults treated with Elidel or Protopic.

In other FDA news, the agency released a guidance document that describes a means by which drug metabolizing enzyme genotyping systems may comply with the requirements of special controls for Class II devices.

New NCI Database For Genetic Studies

Researchers at the National Cancer Institute, part of the National Institutes of Health in Bethesda, Md., constructed an open-source database for normal tissue from human organs. A total of 158 tissue samples were harvested an average of 11 hours after death, from males and females of different ethnic groups, ranging from ages 3 months to 39 years old.

The 18,927-gene database is designed as a point of reference by pinpointing genes that are expressed in many of the body's major organs under normal conditions, without known disease. Each organ revealed a very distinct profile of active genes, different from all others, but the gene profiles from different organs that share similar biological functions also showed patterns of expression. Scientists can compare the genes from their own biological samples to the dictionary of normal expression. A study validating the database appears in the March 2005 issue of Genome Research.