By Lisa Seachrist

Washington Editor

WASHINGTON - With Congress readying for its Memorial Day recess, President Clinton took aim at the Republican plan to provide a prescription drug benefit to Medicare beneficiaries.

Clinton said the Republican plan, which relies on subsidies for private insurance products, fell short of the promise of providing affordable prescription drugs to seniors because the insurance industry was unlikely to respond with suitable insurance plans.

"Suggesting a private insurance benefit that insurers, themselves, say they will not offer and no one will buy if they did offer it because it would be too expensive is an empty promise," Clinton said in a Rose Garden address on Thursday. "So, we're here to say we have a full-time obligation to deal with the big opportunities and the big challenges of this country, and Congress should feel that obligation, even when they go on recess. There is no heavier evidence of that today than the need to provide voluntary, affordable prescription drug coverage."

Clinton argued the unified Democratic plan based on pharmacy benefits managers delivering bulk purchasing advantages in a universal benefit was a more realistic and equitable plan. The Democratic plan would provide a voluntary prescription drug benefit that would provide at least 50 percent of the premium to all Medicare beneficiaries. For people with incomes under 150 percent of poverty level, the government would absorb a greater level of the premium costs on a sliding scale, with those who make less than 135 percent of the poverty level receiving the full cost of their premiums.

"If we were creating Medicare today, there is no way in the wide world we wouldn't provide prescription drugs," Clinton said. "It is a big issue, and it's a big hole in American's social safety net. [Our plan] is totally voluntary; it is driven by the market, and we ought to do it."

Clinton urged Congress to act when it returns from the recess because the country is experiencing "a moment of unprecedented prosperity" that should be used to lengthen life and modernize Medicare as well as shore up Social Security.

Jeff Trewhitt, media spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA), said the group agrees with the president that Medicare needs to be modernized, but PhRMA takes issue with the Democratic plan.

"We favor a plan that calls for a reform of Medicare to create a better, more efficient Medicare," Trewhitt said. "We want a system that produces maximum choice and we favor private sector solutions."

Even though the Democrats and the president have widely repeated statements by private insurers at a congressional hearing indicating there would be no interest in providing a prescription drug policy for senior citizens, Trewhitt's group doubts that would be reality.

"There are all kinds of insurance for all kinds of things," Trewhitt said. "We can't believe companies aren't going to take advantage of a new competitive marketplace."

Because the issue is gaining such intense scrutiny among both legislators and the general public, PhRMA placed ads in 28 major newspapers to explain its position about drug price controls and prescription drug coverage for senior citizens.

"We wanted to make sure our complete message goes out unfettered to make sure the American people completely understood we want to see prescription drugs available to our senior citizens, preferably in the context of Medicare reform," Trewhitt said.

Penn's Institute For Human Gene Therapy Won't Run Trials, Consult On Gene Transfer

In response to the recommendations of an independent panel, the University of Pennsylvania's Institute for Human Gene Therapy (IHGT) will focus on molecular and animal studies and cease conducting clinical studies.

That doesn't mean there won't be any human clinical trials testing gene therapy products at Penn. Any such trials will be conducted under the auspices of the Medical Center with the oversight of an institutional review board (IRB) with special expertise in gene therapy.

"The panel's report found IHGT was really trying to do too much," said Kenneth Wildes, director of university communications. "The plan scales down the responsibility of the institute. It will no longer conduct clinical trials, no longer make vectors and no longer consult on gene therapy trials."

IHGT, led by James Wilson, entered the hot seat in September when an 18-year-old gene therapy patient, Jesse Gelsinger, died as a result of participating in a gene therapy experiment. In the wake of Gelsinger's death, the institute has had all of its gene therapy trials placed on hold, received a warning letter from FDA and undergone both internal and external scrutiny.

The decision to lessen the institute's responsibilities came as a result of recommendations from a panel of independent scientists led by William Danforth, chancellor emeritus of St. Louis-based Washington University.

In addition to changing activities at IHGT, the panel recommended the university examine methods for monitoring investigator-initiated clinical trials, evaluate the function of IRBs and evaluate the process of ethical decision making. The panel also recommended the university re-examine its policies on conflict of interest and ensure patients are given informed consent.

In addition to the recommendations outlined by the panel, Wildes noted Penn has an internal panel assessing the role of IRBs in monitoring all clinical trials conducted there.

"As a result of that investigation, we have already begun to adopt some changes," Wildes said. "I expect we will see even more changes. I doubt we are the only institution that needs to take a look at its IRB system."

Public Citizen Joins Biotech, Pharma In Opposing Columbia Patent Extension

Consumer watchdog organization Public Citizen and a coalition of 16 other groups have joined the pharmaceutical, biotech and generic drug industries in denouncing appropriations language that would extend a Columbia University patent.

The provision would grant a patent extension for the cotransformation process that enables animal cells to produce therapeutic proteins. It was slipped into the Agriculture Department's fiscal year 2001 appropriations bill by Columbia alumnus Sen. Judd Gregg (R-N.H.).

The coalition sent letters to Sens. John McCain (R-Ariz.) and Richard Durbin (D-Ill.) urging them to strike the patent extension from the legislation.

In the letter, the groups oppose the measure on the grounds that it rewrites the 1984 Hatch-Waxman Act that lays out guidelines for patent extensions on drugs, that it would ultimately cost consumers, and that it would open the floodgates for drug companies whose patents are about to expire to ask Congress for special extensions.