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U.S. Department of Health and Human Services | ||||
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| REMARKS BY: | TOMMY G. THOMPSON, SECRETARY OF HEALTH AND HUMAN SERVICES |
| PLACE: | The 15th Annual Bear, Stearns Healthcare Conference, New York, New York |
| DATE: | September 17, 2002 |
Thank you so very much, Alan (Schwartz), for those very kind words and for your wonderful leadership. And I'm so very grateful to Bear Stearns, one of America's and the world's leading financial houses, for holding this conference - truly one of the most important events of its kind anywhere.
I also want to greet Bear's distinguished health care policy analyst, John Rex, surely one of the most knowledgeable medical policy people in the nation. John, just face it - sooner or later, you're going to come to work for me.
Alan, when you last introduced me to a Bear Stearns conference, you did so by phone because I was unable to join you due to the attacks of September 11th. On September 11, 2001, every American became a New Yorker. Every American became a soldier, sailor or airman at the Pentagon. Every American stood with the heroes of Flight 93.
Our enemies mistook our desire to live in peace with weakness. What a profound misjudgment. I was so intensely proud of our President's remarks last week at Ellis Island and then, just a short distance from here, at the United Nations.
We are resolved, as a nation, to defend our security and our freedoms. Let no one - no one - doubt it. And if anyone does doubt our resolve, I urge them to consider two places on the globe: Kabul, Afghanistan and New York City.
There's a new, free and democratic government in Kabul because America ended the tyranny of the Taliban. And there's a new, vibrant, united spirit right here in New York, a spirit renewed and made stronger over the past 12 months.
So, it's with great pride that I come to this amazing city and stand with all of you as we conduct the business of America together.
As important as economic growth is, the business of America is not just about profit and loss. It's about extending care to an ailing senior, a sick child, a disabled veteran. It's about developing new devices that bring hope and healing … new drugs that get at the very molecular basis of disease … new technologies that transform the way hospitals and health providers care for their patients.
Today, I want to talk with you about these issues and then have a dialogue with you about them. I welcome your questions, because you are the men and women who are on the leading edge of American, and global, health care.
First, the FDA: We're bringing some systemic, long-term change to the way the FDA does business. We're changing the FDA's culture and bring long-needed change to the way we address medical device issues. I have with me someone who has been at the forefront of these changes, a man for whom I have great respect, Dr. Les Crawford of the FDA. Les, please stand to be recognized.
Dr. Crawford and I share a bold new vision for the FDA. We are creating an FDA where risk management is the rule, not the exception. We're putting together extensive risk assessment programs - the most far-reaching in the history of the FDA - to assure that the United States has the purest food supply possible.
We're going to achieve this goal through some exciting new initiatives. The risk assessment programs are going to be integrated into all of FDA's centers and operating units … with a special emphasis on the field force, where about half of all FDA employees work.
We're converting the focus of inspections to possible contamination by bioterrorists and to defective product detection. And the FDA has hired all of the 832 new employees authorized this year. By the end of this year, FDA will be able to conduct 24,000 on-site import inspections, nearly double the total in the past. That capacity will continue to increase.
We are also advancing breakthrough devices that use artificial intelligence, nanotechnology and robotics. Our Center for Devices and Radiological Health, or CDRH, an agency within the FDA, is working hard to move product approval along at an accelerated pace but to maintain the safety of consumers, as well.
We're investing nearly $215 million in the fiscal year 2003 budget in medical device research and approval efforts. And in the area of medical devices, FDA has streamlined its efforts and realized significant improvements in review time. So, we're moving forward in this area.
I know you're also concerned with drug reimportation. Let me be clear that we in the Bush Administration are committed to providing seniors with affordable drugs, as I will discuss in a few moments. But affordability must not come at the risk of the public health.
The World Health Organization and the Pharmaceutical Research and Manufacturers' Association have estimated that between eight to ten percent of prescription drugs on the world market are counterfeit. That's scary, and we simply cannot - and will not - allow counterfeit drugs in this country.
Opening our borders to reimported drugs potentially could increase the flow of counterfeit drugs, cheap foreign copies of FDA-approved drugs, expired and contaminated drugs, and drugs stored under inappropriate and unsafe conditions. In light of the anthrax attacks of last fall, that's a risk we simply cannot take.
All of that said, my friends, pharmaceutical firms need to do more to bring down the price of drugs. We appreciate the good work a number of major firms have done in providing drug discount cards for seniors, but let me ask you to do more.
Pharmaceuticals in the United States have got to become more affordable. If they do not, I fear that those who wish to mandate price controls might eventually win the day, and that would do serious harm to America's entire health care system.
So, the FDA is being reinvigorated and transformed from top to bottom. But, of course, transformation isn't limited to government. It's happening in so many areas, including that of biotechnology.
Many of your firms deal directly with the integration of biology and technology, so let me touch on some developments that bear on your work.
When I was Governor of Wisconsin, Jaime Thomson 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. We have begun issuing grants to companies and academic institutions to study the stem cell lines we have approved.
We're already beginning to realize the promise of stem cell research. At the Waisman Center at the University of Wisconsin, neural stem cells are being genetically modified to release glial derived neurotrophic factor, or GDNF. GDNF is known to prevent the death of dopamine neurons - the very thing that underlies Parkinson's Disease.
These stem cells have been transplanted into rat and money models of Parkinson's Disease at the Waisman Center and Primate Center. The result: significantly improved motor skills in rats and monkeys with Parkinson's symptoms.
There are other amazing developments in the area of adult stem cell research. In January, 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. 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.
And recently a man named Dean Grimm of Charlotte, Iowa regained his sight after having been blind due to a chemical accident in 1983. His physician implanted adult stem cells and, over time, three new corneas.
Now, after being blind for so many years, he can see. And his son says that since his Dad regained his sight, he and his siblings "can't get away with a lot of stuff," as he put it. What a nice problem for that young man to have.
There are so many other areas where the confluence of biology and technology are transforming lives. Just last week, the National Institute of Neurological Disorders and Stroke - a division of the National Institutes of Health within my department - announced that researchers using a unique scanning device have shown that they can detect fetal brain activity in response to flashes of light transmitted through the mother's abdomen.
With refinement, this technique may help physicians detect and prevent fetal brain damage resulting from maternal hypertension, diabetes, and other conditions. The potential benefits for women and their unborn children are dramatic.
This device was developed in tandem with a private sector firm, CTF Systems, and a physician at the University of Arkansas, Dr. Curtis Lowery. Its development is a classic example of government, industry and academic research all working in partnership.
So, for the many of you who are involved in biotech research and development, let me urge you to redouble your efforts. We are seeing tremendous dividends in countless saved lives and immeasurable health benefits.
Yet advances in biotechnology will fail to help many of those who need them unless we change the very way we provide health care to the American people.
First, it must be said that America has the finest health care professionals and the finest caliber of medical treatment of any nation … at any time … in history.
The problem is the means by which care is delivered or paid for. The system by which care is delivered has simply not matured at the same pace as the technologies and treatments now available.
I've traveled all over the country and throughout Europe. I've discussed health care with some of the leading policymakers and caregivers in the world, with physicians in rural clinics and administrators in major medical centers. And sadly, I have to report that in Western society broadly, the various systems of care are eroding.
My friends, we have to work together to fundamentally change the current health care delivery system in our country. Rules, regulations and restrictions that make obtaining good health care difficult, if not impossible, have to be reviewed carefully and, when necessary, discarded.
We're already taking some significant steps. We've launched a 27-member commission - my Advisory Committee on Regulatory Reform, headed by Dr. Doug Wood of the Mayo Clinic - whose job is to develop a plan for comprehensive regulatory reform.
When we flood doctors and hospitals with excessive paperwork, patients suffer the consequences. The commission is especially focused on CMS and the FDA, which have the heaviest regulatory burdens. This panel, which has already held hearings all over the country, is helping us restore common sense to the regulatory process.
Regulatory reform is one step. Patient care and health administration are among the other key issues. My friends, medicine has to become less focused on the bureaucracy and more focused on the relationship between physician and patient.
This goal is being furthered as we move toward a system of home-based care where the patient will routinely contact their physician through the use of telemedicine, the Internet and other electronic technologies. Prevention will be key to medical therapies and will begin in prenatal care and infancy.
We will have computer chips that inform us of our genetic predisposition to illness, medication sensitivities and the environmental risk factors that may trigger these problems. A coordinated team of physicians, nurses and allied health professionals will work together through a paperless system to provide care to the patient, independent of where they are cared for.
We will carry wallet-sized cards that have our latest EKG, chest x-ray, lab tests, operative reports and other critical data encoded in them. And to protect privacy we will use iris scanners -- scanners that evaluate the unique features of the iris in a person's eye -- to activate these cards.
Billing will be processed at the time of care. Patients will know the costs and will be satisfied with the quality of care you provide, but will not be encumbered by mountains of confusing paperwork.
That, at least, is the ideal, one that we can envision as real. But the challenge is a large one -- how to make it happen.
But there's one component of the larger health care picture I've not yet mentioned - prevention.
Preventive health is a passion for me. I'm aggressively trying to educate Americans about the importance of good nutrition and eating the right balance of foods. One of the sad realities of our time is that too few of us are enjoying the wonderful fruits and vegetables so readily available in our great country.
Consider a few very sobering facts: We know that one-third of all cancers, at a minimum, are caused by poor nutrition, overweight and simply being inactive.
Today, no less than 17 million Americans have diabetes and another 16 million more have a condition called pre-diabetes. And each year, there are one million new cases … and nearly 200,000 people die annually from this largely preventable ailment.
The cost to the economy: $100 billion annually in direct and indirect medical costs. All for a disease that, to a great extent, can be controlled or prevented by better management of our weight.
That's just one example. Exercise moderately but consistently. Lose 10 to 15 pounds. If you don't smoke, don't start. If you do, quit. And don't abuse alcohol or drugs.
You will live longer and healthier. Your family will appreciate your commitment to them and to yourself. And the money we, as a society, save in treatment costs can be devoted to things our country needs.
That's where my favorite word comes into play yet again. That word is partnership - joining together to work toward the policies and practices and technologies and treatments that are necessary for the new era of medicine really to take off.
I know you are eager to do this, and it's been good, since being Secretary, to work with so many of you on these and other critical issues. I look forward to continuing to do so.
Let me leave you with a quote by someone I admire so very much - a great hero of mine and of all lovers of freedom, Winston Churchill.
In his words, "Some regard private enterprise as if it were a predatory tiger to be shot. Others look upon it as a cow that they can then milk. Only a handful see it for what it really is - the strong horse that pulls the whole cart."
My friends, as champions of our great free enterprise system, let me thank you for the strength and courage and determination you display every day in pulling the cart of the America's dynamic economy.
I'm so very proud to join you "in harness" as we pull forward together. Thank you again so very much, and I look forward to your questions.