The Washington Times, DC

Analysis: NIH funding could help new drugs

By Steve Mitchell
UPI Medical Correspondent

WASHINGTON, June 3 (UPI) -- The Bush administration is trying to ease the regulatory burden on the pharmaceutical
industry to spur development of new, innovative drugs, but it seems to be overlooking an obvious and proven action --
increasing funding for the National Institutes of Health.

Although pharmaceutical companies ultimately bring drugs to market, many medications have their roots in fundamental
research that is sponsored by the NIH. Such research has led to many breakthroughs over the past decade for treating
conditions ranging from AIDS to cancer.

Yet the administration seems to be headed in the opposite direction. The White House has proposed only a 2.7-percent
increase in the NIH's budget for fiscal year 2004, a far cry from the 13-percent to 15-percent increases the agency has
seen in each of the past five years.

The NIH, which funds about 50,000 scientists and researchers in the United States and foreign countries, still would
receive nearly $28 billion under Bush's proposal. But experts warn that a leveling of the agency's budget allocation
could stifle medical research and delay development of new therapies for treating disease. That is exactly what Mary
Woolley, president of Research!America, a group comprised of medical researchers and patient advocacy groups, told
United Press International.

"Not very many people realize ... just what a terribly screeching blow it's going to have," Woolley said. It will
stymie advances in treatments for "everything you can name, including disabilities and diseases we are really very
close" to treating effectively, she said. Diabetes, Alzheimer's and Parkinson's would be prime candidates, she added.

Several analyses have shown NIH-funded research plays a critical role in the development of many new drugs. For
example, a report by the Congressional Joint Economic Committee concluded federally funded research paved the way for
seven of the 21 most-important drugs developed between 1965 and 1992 -- including the cancer drugs Taxol and Tamoxifen,
the AIDS drug AZT and the depression treatment Prozac.

An internal NIH document obtained by the consumer advocacy group Public Citizen shows scientists funded by the agency
accounted for 55 percent of the research that resulted in the five top-selling drugs in 1995.

In addition, the NIH spent more than $1 billion on drug research in 1996 and 45 of the 50 top-selling drugs during 1992-
1997 stemmed from NIH-funded research, the Boston Globe reported in 1998.

Woolley termed a 2.7-percent increase in the NIH budget "absolutely criminal" at a time when there is a desperate need
for new drugs, treatments and preventive measures.

"It won't cover inflation and it's not going to get us where we want to go," she said. However, this is not to ignore
the critical role of pharmaceutical companies in developing new medications, she added.

"I don't think its an 'either/or' thing," Woolley said. "We need both (the NIH and the pharmaceutical industry) and we
need them badly."

Although the administration is taking steps to address the industry side, it is not making the same effort on the NIH
side, she said.

Part of the effort to spur drug development by easing the regulatory burden on the pharmaceutical industry has included
a recent action by the Food and Drug Administration in January to streamline the drug approval process.

The measure seeks to clarify requirements for applying for new product approvals. The idea is to reduce delays and
repeated procedures, and to cut costs associated with bringing a novel drug to market, which can amount to several
hundred million dollars.

The FDA took the step, officials said, because it was concerned the high costs of developing new medical products is
forcing companies to make fewer of them, noting there was a drop last year in applications for approval of new
products, compared with the previous year.

The pharmaceutical industry, however, by its own admission, has indicated the FDA move was not necessary to stimulate
drug innovation on its end because companies already have many new drugs in development.

The Pharmaceutical Research and Manufacturers of America, a trade group representing major drug companies, released a
statement the day prior to the FDA's move saying the number of new drugs in clinical trials in 2002 was up by 15
percent compared to 2001 and there was a rising number of new medicines in the research pipeline.

In addition, the industry as a whole increased its research and development expenditures by almost 8 percent last year,
spending a record $32 billion -? $4 billion more than the entire NIH budget proposed by Bush.

The industry contended the drop-off in NIH funding would not affect their role in developing new medications.

Alan Goldhammer, PhRMA's associate vice president for regulatory affairs, told UPI: "I'm not at all certain that having
a smaller increase (in the NIH budget) will have much of an impact in the near term (on drug development). As we see
it, the current pipeline seems to be pretty full and a lot of these new developments (in biomedical research) are still
being digested."

This sounds promising on its face, but pharmaceutical companies are profit-making institutions. This makes them tend to
concentrate their research on drugs to treat diseases or conditions where the marketability already has been proven,
rather than developing new drugs based on the need for treatment, Larry Sasich, a pharmacist and research analyst with
Public Citizen's Health Research Group, told UPI.

"We're looking at the second or third generation of (the impotence treatment) Viagra that's in the pipeline and that's
not exactly a major public health issue," Sasich said.

Of the billions of dollars the drug industry spends on research, only a small fraction goes toward basic science that
could identify potential new medications, Sasich explained. Most of the money is spent on product development and
turning promising candidates into drugs only after they have been found to be marketable products.

A recent study by the National Science Foundation backs up Sasich's claim. It found that only 14 percent of the drug
industry's total spending on research goes for basic research studies. The other 86 percent is for applied research and
product development.

Sasich agreed not enough attention has been focused on the NIH's role in the development of innovative new drugs.

"That's largely because the pharmaceutical industry has been able to weave this myth that the industry has a public
health mandate and that's their main concern," he said. "NIH has a totally different and much more important role from
a public health standpoint" because it can fund research that might not turn out to be profitable but still could yield
important scientific discoveries, he added.

The pharmaceutical industry contends though NIH research is important, companies still play a key role in drug
development. Basic science research conducted by the NIH "can be very valuable and very helpful in the development of
new products but it is a dramatic jump from basic science theory to research and development of a new pharmaceutical
product, and that's where the companies come in," Jeff Trewhitt, spokesman for PhRMA, told UPI.

"(Also), a growing number of companies are now doing more basic research than they have done in many years," Trewhitt
said, though he could not provide numbers on how many companies are doing this.

Another concern raised by Sasich is drug companies receive the results of NIH-funded research free of charge and are
able to profit from it.

"The people of the United States give that away because all of that stuff gets licensed to (companies) who have
marketing exclusivity and in some cases charge atrocious prices for products that were being developed using taxpayer
money," he said. "So consumers pay twice for these products."

Several members of Congress have attempted to address this issue. But so far they have achieved little success. In the
House, Rep. Bernie Sanders, I-Vt., led a bipartisan effort to require drug companies to offer medications developed
from taxpayer-funded research at a reasonable price. The House passed the bill in 2000 but no counterpart legislation
was introduced in the Senate.

Woolley's organization and other advocacy groups think a 10-percent increase in the FY 2004 NIH budget would be
necessary to fund the most promising biomedical research. The House and Senate have yet to set the agency's budget for
next year.

"It's time to just push aggressively," Woolley said. "We spend more on cut flowers every year than we do on all of
cancer research at NIH," she said.

"We can afford it in this country," she said. "Right now, everybody is worried about the big deficit (but) frankly
another few billion dollars wouldn't even be noticed. It's chalk dust in the deficit and it has the potential to save
hundreds of thousands of lives a year, literally."
 
SOURCE: The Washington Times, DC
http://washingtontimes.com/upi-breaking/20030603-045039-6517r.htm

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