SPEECH BY: TOMMY G. THOMPSON, SECRETARY OF HEALTH AND HUMAN SERVICES
PLACE: Emerging Issues Forum on "Biotechnology and Humanity at the Crossroads
of a New Era,
North Carolina State University, Durham, North Carolina
DATE: February 11, 2002
Bob, you were here in North Carolina last summer, when you gave the commencement address at the Duke University graduate school of business. You said something then that I think is so on-point that I want to quote it again today. "Business leaders are highly visible and must set the pace for giving back to the community," you said. And, you noted, "The real success is in doing what's right."
What a tremendous statement to make to a group of young people beginning their business careers. It's just as true for public servants as for business leaders, and I appreciate your helping some of America's future leaders get their priorities straight. Jim (Hunt, former Governor of North Carolina), it's wonderful seeing you. We served together in the National Governors Association and we were co-founders of the Governors Biotechnology Partnership, so I know firsthand what a tremendous leader you are.
As Governor of the great state of Wisconsin, I put a major emphasis on building the biotech infrastructure and industry of my state, just as what Jim did here in North Carolina. In fact our states are a lot alike, only in Wisconsin we have brats and cheese instead of barbeque.
Chancellor Marye Ann Fox, it's good to see you here, as well. Your work with President Bush on the Council of Advisors on Science and Technology has been tremendous, and we appreciate it so very much. And, as a Texan, you must be very proud of the job your state's favorite son, our great President, George W. Bush, is doing for America. And all of us share that pride.
The Research Triangle is a national treasure. From biotechnology to microelectronics, the Triangle is home to some of America's most leading-edge research. In fact, according to the Triangle Web site, there are 106 research and development-related organizations in the Research Triangle Park.
I should note that the National Institute of Environmental Health Services is located here in the Triangle. The NIEHS is part of the National Institutes of Health, which is, of course, part of HHS, and I know you'll enjoy hearing from NIEHS Director Kenneth Olden later in the conference. I'm so proud of the work the scientists of the NIEHS do, and of the work the Institute helps others do through its nationwide grants program. The Institute, private sector firms and academic institutions like many of yours are making the economy stronger and our lives healthier by making advances that only a generation ago would have seemed almost impossible. And that's true of the biotech industry as a whole.
As the title of this conference indicates, biotechnology is leading us into a new era. Biotechnology is fundamentally transforming the practice of medicine. For example, just last week, scientists from the FDA and the National Cancer Institute reported a new way to determine the presence of ovarian cancer through a simple blood screening. The test can be completed in as little as 30 minutes from blood obtained from a finger-stick.
The research behind this advance depends on two disciplines - proteomics and computer intelligence. The diagnostic test relied on software that is able to detect patterns of key proteins in the blood. Using a sophisticated artificial intelligence computer program, scientists were able to "train" the computer to tell the difference between patterns of small proteins found in the blood of cancer patients versus control samples.
We made a similar breakthrough last year, when artificial intelligence combined with gene-expression micro-rays to develop a method of genetic fingerprinting that can tell the difference between several closely related types of childhood cancer. This method combined, for the first time, the cutting-edge technology of gene chips with a form of artificial intelligence called an artificial neural network. The network automatically analyzes the large amounts of data produced by the gene chip to make a highly accurate diagnosis.
Just few days ago, two more breakthroughs were reported. Researchers at the National Genome Research Institute -- another branch of the NIH -- said they've found a gene associated with an inherited form of prostate cancer. They worked with scientists at Johns Hopkins and the Cleveland Clinic in this study, which shows the continued value of the kinds of public, private and academic partnerships many of you are involved in.
And now scientists at Johns Hopkins and the M.D. Anderson Cancer Center at the University of Texas have announced that screening stool samples for abnormal DNA can help identify colorectal cancer.
Just imagine -- being able to detect life-threatening cancers early on. Think of how many, many lives these kinds of breakthroughs will save! And they are just a couple of the thousands of biotech research projects being conducted in labs, hospitals and clinics across the country.
These kinds of breakthroughs make the President and me passionate about research. That's why in his budget this year, the President is significantly increasing funding for the National Human Genome Research Institute and the National Center for Research Resources.
In the next few moments, I'd like to discuss three specific aspects of our biotechnology agenda I believe have relevance to you: bioterrorism preparedness, food and drug safety and stem cell research. And afterward, I'll be glad to take a few questions.
First, let me comment on something on many of our minds these days -- bioterrorism. As President Bush said two weeks ago in his State of the Union message, preventing a bioterrorist attack is of paramount importance to the security of our country. At the same time, should an attack occur, the President and all of us in the Administration are committed to making sure we are prepared to handle it successfully.
To that end, the Department of Health and Human Services is providing the medical and public health resources America needs to respond effectively to any act of bioterrorism. Our budget for the next fiscal year includes $4.3 billion for bioterrorism preparedness, an increase of $1.3 billion, or 45 percent, above FY 2002. This budget supports a variety of activities to prevent, identify and respond to incidents of bioterrorism.
The NIH will get substantial new funding for research into new vaccines and diagnostics as well as strengthening the security of its facilities. The CDC will see increases for the security of its facilities as well as upgrading its lab capacity. And the FDA will see an increase for its review of vaccines and diagnostics.
The FDA will also see an important increase to enhance the safety of our nation's food supply. Food safety is a matter of national security, plain and simple, and I'll talk about that more in a moment.
The President's budget also provides $1.7 billion in grants for promising science research. These grants will focus on both short- and long-term health care needs and also encourage the support of industry and academia in developing biomedical tools to combat, detect and diagnose diseases caused by bioterrorism agents.
The budget also calls for resources to enhance preparedness at the nation's hospitals so they can better respond to incidents of biological or chemical terrorism and funding to train health care professionals at poison control centers and emergency medical services for children on how to watch for signs of bioterrorist-generated illnesses.
We're getting stronger each and every day in our ability to respond to a bioterrorism attack. This new investment shows the President is determined to make sure our response capabilities get to where they need to be at the federal, state and local levels.
As all of us know, it is often at the state level that real change takes place. That's one reason why Jim Hunt and I were among the original members of the Governor's Biotechnology Partnership. Our purpose was to engage our fellow governors and other state officials in an ongoing effort to better understand the role of biotechnology, particularly with respect to agriculture and food safety.
Biotech enables farmers to create hybrid plants more quickly. And the scientific data show that biotechnology can result in healthier foods and be better for the environment. Biotech foods could improve food yields by up to 25 percent in the developing world and feed the more than three billion people to be born in the next three decades. This will save forestland, reduce the use of chemical pesticides and provide a higher standard of living for everyone, whether in the U.S. and Europe or in places like Sub-Saharan Africa and other developing regions.
The President is committing nearly $100 million to further ensure the safety of America's food supply. While our food supply is remarkably safe, we're concerned about attempts at deliberate contamination. So, we're hiring and training close to 700 new food inspectors, investigators, support scientists and compliance officers to make sure no terrorist can strike America through our food supply.
The FDA also plays a critical role in the approval of life-saving drugs. Last year, the FDA approved a drug called Gleevec in under three months. Gleevec treats chronic myeloid leukemia, a form of cancer that has historically been devastating to its victims.
Gleevec is the first cancer drug produced by molecular targeting: the groundbreaking ability to deliver a drug directly to the diseased cells, leaving the healthy cells alone. Gleevec targets a single cancer-causing protein and, like a light switch, turns off its signal to produce leukemia cells. So, a three-month approval time frame was very welcome.
We're going to continue move forward with rapid authorization of useful drugs, in part through the reauthorization of the Prescription Drug User Fee Act, of PDUFA. PDUFA authorizes the collection of user fees for reviewing drug applications. And in his new budget, the President has committed $272 million for PDFUA, an increase of nearly 40 percent over last year.
PDUFA does so much to reduce the time needed to review applications for new drugs and biologics, while maintaining the safety standards essential to public health. So let ask for your help. Many of you will play a vital role in moving PDUFA forward. We need the counsel and the commitment of the health care industry and of physicians and scientists, to make sure PDFUA is passed through Congress and enacted into law.
Preparing for bioterrorism, improving the safety of our food and providing new, life-saving drugs are critical. But so is medical research that touches directly on the way we seek to heal those who are ill and diseased. That introduces the final aspect of biotechnology I want to discuss, an issue you will be talking about at some length later in the conference - stem cell research.
When I was Governor of Wisconsin, Jaime Thompson of the University of Wisconsin conducted groundbreaking research into embryonic stem cells. I worked hard to provide funding for his research, and was gratified when, last year, the President authorized research on existing embryonic stem cell lines.
Now, our National Institutes of Health has named 14 laboratories throughout the world that can distribute 78 embryonic stem cell lines that meet President Bush's criteria for federally funded research.
Basic research will be done on these cell lines, and will be done, in part, with the use of federal funds. Also, the NIH is welcoming grant applications for federal funds, including use of existing funds, for stem cell research.
I also want to tell you about some amazing developments in the area of adult stem cell research. Last month, researchers at the University of Minnesota announced that they made a discovery about an adult stem cell that has the potential to develop into many different cell types in the human body. Previously, researchers had believed that only embryonic stem cells could be developed into multiple cell types. But it now seems entirely possible that cells from one's own body can be coaxed into replacement organs and tissue that match one's body precisely.
This is remarkable, and offers tremendous promise. So, we're continuing to move forward with stem cell research as a means of improving the health and well-being of people of all ages and many, many different conditions.
Well, we've covered a lot of territory and I know we'll cover more during our question and answer time. But let me leave you with a quote from one of my favorite philosophers, Will Rogers. As he put it, "You've got to out on a limb, because that's where the fruit is."
Each of you here goes out on a limb every day, looking for new treatments, new drugs and new cures - all to give life and hope and healing to the suffering.
Let me ask you to keep venturing out on that limb. Our country needs your wonderful work to help ensure that every generation of Americans is healthier than the one before it. I can think of few more noble goals, or more exciting challenges, than that.
Thank you again for letting me come speak with you today. I look forward to your questions.