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REMARKS BY:  DONNA E. SHALALA, SECRETARY OF HEALTH AND
                 HUMAN SERVICES
PLACE:       Baylor College of Medicine
             Houston, Texas
DATE:        February 17, 1995

And, thanks to all of you.

Academic health centers like Baylor are the very foundation of the best health care system in the world.

It is you who provide a lifelong system of learning ...

... You, who continuously improve the skills of our health professionals ...

... You who disseminate new treatments and new technologies...

... And, it is you who act as a driving force in preserving and improving the quality of our health care system.

I believe that scientists are not like the rest of us. They aren't content simply to sit back and experience life as it unfolds before them.

Instead, they dare to dream of life as it should be -- and then go to work making it happen.

They dare to imagine a vaccine for polio, and then achieve it.

They dare to imagine a new treatment for Alzheimer's, and then achieve it.

And, they dare to imagine a world without AIDS -- and then do everything they can to make that dream a reality.

When President Roosevelt dedicated the NIH campus, he summed up our national commitment to research in this way. He said, and I quote:

"I dedicate it to the underlying philosophy of public health. To the conservation of life. To the wise use of the vital resources of the nation. I voice for America and for the stricken world our hopes, our prayers, our faith in the power of man's humanity to man."

That was over fifty years ago.

Fifty years from now, the American people will judge us by one simple yardstick: Are Americans healthier?

For all of us, that is our mandate -- and our obligation.

Your job as scientists and clinicians is to push the envelop on research and practice that will improve the quality of people's lives.

Our job as policymakers is to help you when you need it - - and get out of your way when you don't.

At the University of Wisconsin-Madison, I had the opportunity to witness many proud achievements borne of brilliant minds, hard work, and partnerships with the private sector.

One lesson I learned at Wisconsin is that the research agenda of this country is not advanced with heavy government bureaucracy, regulations, and micromanagement.

Our health care system is and probably always will be a private/public partnership -- and our R&D is undoubtedly the best in the world.

Still, within our private/public system, this Administration believes there is a strong, limited role for the federal government to promote, protect, and guide biomedical research -- and we have taken actions to put muscle behind these convictions.

You know, my claim to fame in Wisconsin is that I recruited Barry Alvarez to come to Madison and build a Rose Bowl caliber program.

And I take a lot of pride in that catch -- in part because I didn't know a thing about football when I got there.

But I take even more pride in having recruited the best scientific minds in the country to come to Washington -- where they play a rougher brand of ball than in the Big Ten -- to lead and fight for resources in our research agenda.

One writer compared our extraordinary team to the 1927 Yankees:

Phil Lee as the Assistant Secretary for Health.

Nobel Prize winner Harold Varmus at the NIH.

Dr. Francis Collins at the Human Genome Project.

Claude Lenfant at the Heart, Blood, and Lung Institute.

Sam Broder at the National Cancer Institute

And, Bill Paul in the Office of AIDS Research.

These are leaders who have built laboratories; leaders who understand the care and feeding of scientists; and leaders who know the kind of independence you need.

And, their vision has resulted in big victories during the past two years.

We reinvigorated the President's National Science and Technology Council -- so that the President get the very best advice about basic science and technology.

And, in an era of zero growth across government, we have fought for major investments in biomedical research at NIH -- not once, not twice, but in three straight federal budgets.

That's because, when it comes right down to it, we believe that an investment in basic research is an investment in prevention -- saving precious resources and precious lives for this generation and every generation to follow.

Over the past few years, this commitment to basic science has paid off in some dramatic ways:

American researchers uncovered BRCA1, a gene linked to about half of hereditary breast cancers.

We have developed the most promising treatment in history for Sickle Cell Anemia.

We discovered that AZT can help prevent the perinatal transmission of the HIV virus from mother to child.

And, we conducted clinical trials that showed that hormonal therapy can help post-menopausal women prevent heart disease.

For us to continue to solve these great scientific mysteries, we need a sustained commitment to basic science -- and that's just what the President's 1996 budget has given us.

During a time when other programs are being frozen, cut, or eliminated, we have proposed a $468 million increase (4 percent) in the research budget at NIH.

It's a budget that deepens our commitment to basic research -- so that you can continue to make the incremental breakthroughs in scientific understanding that culminate in blockbuster discoveries over time.

It deepens our commitment to research in high-priority areas like AIDS, breast cancer, minority health, high performance computing and tuberculosis.

It deepens our commitment to biomedical research in high- return areas like prevention, gene therapy, brain disorders, environmental cancers, and drug design.

And, it deepens our commitment to you as researchers ...

A commitment to simplify our grant procedures and make our Federal investment in research more understandable to the public and to Congress.

All across the Department, we are working to ensure that our efforts to make America healthier are not undermined by excessive bureaucracy, red tape, and regulation. Let me give you a few examples.

This year, in the Public Health Service, we have consolidated 108 services into 16 Performance Partnerships that will wipe out a ton of bureaucracy and give local communities greater flexibility to solve their own problems.

But I think the accomplishments that are most relevant to you are the historic changes that have taken place at the FDA, under David Kessler's leadership.

There is too much reckless talk in Washington about the FDA.

The truth is, drug companies and medical device manufacturers are right to expect faster turn around times.

Researchers are right to expect less paperwork and better service.

And, people afflicted with life-threatening diseases are right to expect expedited approval and increased access to potentially helpful therapies.

And, that's what we're trying to do.

Thanks, in part, to the new user fee program, we cut the median time for drug approvals last year by more than 20 percent.

And, for biological products, we cut the approval time by almost one-half.

We are continuing to accelerate approval for drugs that treat serious and life-threatening conditions.

We are working with drug companies to help provide pediatricians the information they need to use drugs safely and effectively in children.

And, we are hoping to employ user fees to speed up our approval times in the expanding medical device field.

But, even as we make these vital improvements, we can never lose sight of -- or compromise -- the fundamental mission of the FDA.

Those of us in leadership positions have the responsibility to remind all Americans of the safety net provided -- time after time -- by vigorous FDA watchdogs.

We can never forget the 10,000 children who were born deformed in Europe and elsewhere during the 1960s.

These children had one thing in common: all of their mothers had taken a tranquilizer called Thalidomide -- a drug that was kept out of the United States by an FDA doctor named Francis Kelsey.

In 1961, a prominent newspaper called her a "bureaucratic nitpicker."

But, the next year, President Kennedy had something else to say about Dr. Kelsey when he commended her "high ability and steadfast confidence" in saving Americans from Thalidomide.

So, yes, we should decrease bureaucracy.

And, yes, we should improve the process -- and make it more efficient.

But, there is one thing we should never do: we must never take this country back to the days of scientific darkness.

We must not go back to the days when abortion was a criminal act.

We must not restrict research on reproductive health or gag caring professionals.

And, we must not allow our choices for Surgeon General to be narrowed by a litmus test.

Because, regardless of whether we are doctors, patients or parents, we need the medicine in this country to be safe, effective, reliable, and accessible.

We need to be confident that the food we put on our dinner tables will not make our families sick.

And, we need to be assured that the medical devices we use -- will make us feel better, not cause greater harm.

That's the role of the FDA. You provide the sound data - - and we back you up 100 percent.

Over the past two years, we have made smart choices on behalf of the research community -- and we will continue to do so.

We will continue to protect your resources;

we will continue to establish smart R&D priorities;

we will continue to work with you to confront the major ethical issues of the day;

we will continue to work effectively across agency lines and across scientific disciplines;

and, we will continue to work to open up new markets for your products in the U.S. and overseas.

But, for us to improve the health care status of Americans, there's something else we have to do in this session of Congress.

We have to join together to reform our ailing health care system.

As you know, there are 3.8 million non-elderly Texans who wake up every morning without the security of health insurance.

Each and every day, teaching hospitals like yours make heroic efforts to patch the holes in our health care safety net -- from your outreach efforts to reach people in rural areas to the uncompensated care you provide to many of those who come to you in need.

I don't have to tell any of you that current health trends are putting vital institutions like yours in peril.

You've seen it all yourself: Rising costs. Rising numbers of uninsured. Health insurance companies gradually squeezing academic health centers out of the private market.

And you know, as do we, that this trend not only creates an economic crisis at your institutions, but it also adds to the health care crisis faced by every American.

We must continue to support first-rate academic health centers: Your teaching, your training, your research, and your healing roles in many different communities are simple irreplaceable.

And, we must continue to work together to solve the health care challenges that have defined our era:

... to inject simple fairness and accountability into our insurance system, ...

... to contain the skyrocketing costs of our health care system so that we still have resources to invest in research and teaching, ...

... and, finally, to take steps to provide insurance coverage for all working families and their children.

This Administration has also made a strong commitment to the seniors of America. We've said, "when you get older, we'll provide for your security -- we won't leave you out in the cold."

Let me be clear: We believe that Medicare must remain strong!

And, we are fundamentally opposed to any cuts in Medicare simply to pay for tax cuts.

Investing in basic research and clinical practice. Reinvigorating the FDA. Reforming our health care system. To be sure, these are all great challenges.

And, as we move into the 21st century, academic health centers must be the driving force that helps us meet these challenges -- and turn them into opportunities.

So, today, as I conclude my remarks, I want to challenge all of us to keep educating the American people about the importance of investing in basic science and its infrastructure.

We have to write the poetry of science in prose that the American people can understand.

Because, as this country debates the size, scope and role of government, we no longer have guarantees that funding levels for biomedical research will continue to grow.

In this climate, it is not enough for the American people to be simply literate in science.

They must become passionately aware that biomedical research is central to their health, their lives, and their future. Because, it is.

I like the way that the great Texan, Lyndon Johnson, put it, when he said:

"Nothing so challenges the American spirit as tackling the biggest job on earth."

That job is protecting the health of our people -- and, together, we can ignite the spirit to get it done.

Thank you.