By Kim Coghill

Washington Editor

WASHINGTON ¿ To help justify giving more money to the National Institutes of Health, Richard Klausner pulled out an extensive display of charts and graphs and took on the job of educating congressmen about the development and approval of a new drug named Gleevec.

Klausner, director of the NIH¿s Cancer Institute, was among the speakers Wednesday who addressed the House Appropriations subcommittee on Labor, Health and Human Services, and Education regarding proposed increases to the NIH¿s budget.

President Bush is considering doubling the $20 billion-plus budget of Bethesda, Md.-based NIH by 2003. His first proposed budget represents a 13.8 percent, or $2.8 billion, increase over this year¿s $20.3 billion budget. Beginning in fiscal year 1999, Congress and the Clinton administration agreed to double NIH funding by 2003. (See BioWorld Today, March 1, 2001.)

But on Wednesday, Klausner had the floor when Reps. Ralph Regula (D-Ohio) and Roger Wicker (R-Miss.) wanted to know whose idea it was to double the budget and whether it was really necessary.

Using the breakthrough cancer drug Gleevec as an example, Klausner said it is possible that the product could work beyond leukemia, ¿but we won¿t know that without more research.¿

And of course, research costs money.

Gleevec, a leukemia drug developed by Switzerland-based Novartis AG, is a molecularly targeted drug. Approved under orphan designation, Gleevec is specifically targeted to disrupt cancer cells, unlike most cancer therapies that also harm healthy cells.

¿Because of additional funding [since FY1999], progress in the medical sciences is advancing at a speed we only dreamed of a few years ago,¿ Ruth Kirschstein, acting director of the NIH, told the House members. ¿This is a time of extraordinary scientific opportunity.¿

The FY2002 budget request enables the NIH to sustain the momentum of research already in progress, to open the way to new research opportunities and to augment both the NIH¿s research infrastructure and its human capital, Kirschstein said. The upcoming budget calls for funding of 36,143 research grant awards, the highest annual total ever awarded.

Several NIH institutes will begin or expand their clinical trials networks that evaluate new prevention strategies, drugs and vaccines in large numbers of patients.

Other initiatives in clinical research include regional centers of excellence for research on rare diseases, research on care at the end of life and the self-management of chronic illnesses.

FDA Seeks To Increase Clinical Trial Inspections

A week before the NIH hearing, Bernard Schwetz, acting principal deputy commissioner of the Food and Drug Administration, told a Senate subcommittee that the FDA intends to increase the number of annual inspections of clinical trials by more than 23 percent.

Schwetz testified before the Senate Committee on Appropriations, Subcommittee on Agriculture, Rural Development and Related Agencies, about FDA¿s proposed $1.4 billion budget, up $123 million over fiscal year 2001.

Included in the budget is an extra $10 million for human subject protection to increase the number of clinical inspections of high-risk trials from 1,200 to 1,475 per year. Trials considered for inspection would include those enrolling vulnerable populations (mentally retarded, pediatric) and sponsor investigators who have a proprietary interest in the product being studied.

Oversight of human subject protection has become more essential than ever because of the proliferation of multisite clinical trials and the emergence of gene therapy and other technologies, according to FDA.

Without an effective independent oversight body, participation in clinical trials may be adversely affected by fewer volunteers, thus stunting new product development and depriving consumers of medical advances, Schwetz said.

FDA¿s efforts to protect human subjects usually emphasize education, outreach and training programs for investigators and members of the institutional review boards.

BIO Urges Congress To Avoid Price Controls

The ongoing battle over Medicare reform continues to draw the attention of drug companies that are holding their breath hoping history doesn¿t repeat itself.

For one thing, too many biotechnology and pharmaceutical veterans remember all too well what happened several years ago when former president Bill Clinton and his wife, Hillary, took a stab at health care reform.

¿When the Clinton health bill was being considered in the mid-1990s, the growth rate of research and development investment dropped markedly, potentially delaying new products on their way to American consumers,¿ said Robert Chess, chairman of Inhale Therapeutic Systems, of San Carlos, Calif.

Chess testified Wednesday before the House Energy and Commerce Committee¿s health subcommittee on behalf of the Washington-based Biotechnology Industry Organization.

Chess reminded House members that early in the Clinton era venture capitalists became less willing to invest in biotech companies, forcing 13 out of 16 companies to withdraw their initial public offerings of stock and their efforts to go public.

¿Clearly, many biotech companies are fragile and would be devastated by a drop in investor confidence,¿ he said. ¿BIO urges Congress to ensure that any Medicare drug coverage proposal considered or enacted does not upset the delicate balance of the biotechnology industry.¿

Many of the products in biotech pipelines target diseases that predominantly affect seniors. Accordingly, BIO said Medicare programs should include drug coverage for all Medicare beneficiaries.

Furthermore, Chess said BIO opposes any type of price control that would harm innovation and said any proposal should rely on the private marketplace and competition.

BIO recommends that the government promote strong incentives for the discovery and development of innovative new prescription drugs and biologics.

¿BIO believes that such innovation and discovery will generate real savings by reducing the need for hospital, long-term care and other expensive services and procedures,¿ Chess said.

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