Keynote Address by

David Satcher, M.D., Ph.D.
Assistant Secretary for Health and Surgeon General
Office of Public Health and Science

to the

American Pharmaceutical Association
Washington, DC

March 13, 2000
9:30 a.m.

[This text is the basis for the Assistant Secretary for Health and Surgeon General's oral remarks. It should be used with the understanding that some material may be added or omitted during presentation.]

Thank you, Lisa, for that gracious introduction. I am delighted to be here with you this morning. I bring you greetings from the Department of Health and Human Services and the Office of Public Health and Science.

The Secretary wanted me to be sure to offer her regrets for not being able to be here and also to let you know how appreciative she is that you have made her an honorary member of the American Pharmaceutical Association. She is proud of this honor—and even more proud that she was the first Secretary of HHS to elevate a pharmacist to the level of Deputy Assistant Secretary.

Dr. Art Lawrence—a long time member of the American Pharmaceutical Association—is a distinguished member of the Public Health Service, and a trusted advisor to both the Secretary and me.

Surgeon General's Prescription

Well, as you know, I have a Surgeon General's prescription. I take it with me and throughout the country as a way of talking about healthy lifestyles. And since I knew I was going to be in the midst of a group of pharmacists, I did not dare leave it behind. Let me read one to you.

It says: 

1. Engage in moderate physical activity at least five days a week, 30 minutes a day;
2. Eat at least five servings of fruits and vegetables a day;
3. Avoid toxins, such as tobacco; and
4. Practice responsible sexual behavior, including abstinence as appropriate.

Princeton Train Station

I was at Princeton, New Jersey, a few months ago, speaking to the Board of the Robert Wood Johnson Foundation. And since I am away from home so much I was determined that I wanted to get back to Washington to get back home that night. We rushed to the train station after I spoke to catch the last train from the Trenton station. Even though we rushed down into the station, the train was a little late.

As we were standing there, this young man looked over and he noticed me. He said: "You know, you look just like the Surgeon General." I was dressed in full uniform, just like I am now. I said: "There's a reason for that."

Well, he discovered that I was the Surgeon General so he started shouting, "The Surgeon General is here, the Surgeon General is here." So other people started coming around who were supposed to be working. The first guy got there and said to his friend: "You mean you are smoking in front of the Surgeon General?" So he threw his cigarette away and stomped it. And I wrote him a prescription that said "stop smoking."

The other guys started laughing and he said: "Well you can't laugh, you're overweight." So I wrote him a prescription. Then there was another guy laughing, and one of them said to him, "You can't laugh, the way you mess around, you're going to get AIDS or something." So I wrote him one. By the time I left there, I had written about 10 prescriptions.

As they were leaving, one guy said: "I'm going to put this in a frame." Another one said: "I'm going to put mine on the refrigerator to remind me to eat nutritious meals." But the third guy, who is my favorite, said: "I'm going to quit smoking."

We're serious about promoting healthy lifestyles. As important, if not more, than our most sophisticated medical technology and our most medically advanced drugs, is promoting healthy lifestyles among American people. If we can do that, we can make a difference.

Healthy People 2010

To help move us closer to that goal, we launched our new Healthy People initiative in January. It's the third in a series of prevention-based initiatives and it sets the nation's health goals for the next decade.

The Healthy People 2010 plan has two goals. One is to increase the years and quality of healthy life—emphasis on quality. For the first time ever, we will be focusing on such areas as alleviating chronic pain and disability and slowing down the progression of Alzheimer's, an area where you play a particularly important role.

The second goal is to eliminate disparities in health based on race and ethnicity. Many people have informed us of how much of a challenge this one is—as if we did not know—but we believe that through a community-based approach, we can achieve it.

In fact, we've formed partnerships with foundations, such as Grantmakers in Health, with States that have developed their own plans, and with organizations and associations like this one. With our REACH grants, we've funded 32 communities throughout the country to address the disparities problem. So as you can see we're well on our way.

We've also asked the Nation to get on board by adopting the new 10 Leading Health Indicators and helping to implement them. Five of them are health systems initiatives and include access to quality care, immunizations, violence and injury prevention, mental health, and environmental quality. The other five lifestyle-related indicators, just like what you find on my prescription: tobacco use, overweight and obesity, physical activity, responsible sexual behavior, and substance abuse.

The Secretary's Prescription

Rather than focus today on the Surgeon General's Prescription, I want tell you about the Secretary's prescription for a new course of therapy for America's health care system.

The fact is this: an all-star team of pharmacists, drug manufacturers, the FDA, physicians, nurses, the public health community, and supportive families have extended the lives of countless Americans. Today, we are truly in a golden age of biomedicine and pharmacology, with new drugs to fight breast cancer. New drugs to fight Parkinson's disease. New drugs to fight AIDS. New drugs to limit damage from strokes. And you know better than I that this list is a tiny fraction of the miracles that are here—and the wonders yet to come.

So this is a new day with a whole lot more lives saved. Together, we've made great progress over the last seven years. What should be going up is going up. And what should be coming down is coming down...

• Childhood immunization rates are at record highs.
• HIV mortality is down more than 70 percent since 1995.
• AIDS has fallen from 8th leading cause of death to the 15th leading cause of death, although we are being particularly challenged in communities of color.
• Overall cancer deaths—while still too high—are starting to decline.
• Teen pregnancy rates—while still too high—have gone down every year for the past seven years.
• Use of illicit drugs and tobacco by teens is also down but still far too high.
• We've enrolled 2 million children in our State Children's Health Insurance Program.

So we have a lot to be proud of. But like any long-term course of treatment, we still have a long way to go to meet the demands of the new millennium. Just as pharmacy cannot live in the past, our health care system cannot live in the past either.

Robert Frost used to say: "The woods are lovely dark and deep, but I have promises to keep, and miles to go before I sleep, and miles to go before I sleep." And we, too, have miles to go before we sleep. That's why this morning I brought along with me the Department's prescriptions—endorsed by the Secretary herself—for a new course of therapy for America's health care system. And written on each prescription is a remedy for creating healthy interactions and a healthier nation. There are three: the first one deals with modernizing Medicare; the second one deals with privacy; and the third one deals with improving the quality of health care for all Americans.

Prescription One: Modernizing Medicare

When we talk about modernizing Medicare, we cannot equate that with strengthening the Trust Fund. Yes, we want to set aside a portion of the surplus to keep the Trust Fund solvent all the way to 2025. But that is just the beginning.

Modernizing Medicare means bringing in private sector expertise to improve management.

Modernizing Medicare means allowing displaced workers between 55 to 65 years of age, and their spouses, to buy into Medicare.

Modernizing Medicare means using PPOs, Centers of Excellence, and state-of-the-art disease management.

Modernizing Medicare means contracting reform to increase competition and to make sure Medicare uses its market strength to negotiate fair prices.

And, of course, modernizing Medicare means facing up to the demographic changes facing our Nation, both age and diversity in race and ethnicity.

The Baby Boom has become a Senior Boom. In 30 years, the number of Americans over 65 will double. And Americans over 85 will be the fast growing segment of our population. This increase in life expectancy is a national dream come-true. But it's also a dream with serious implications for health care in the 21st century, which is why it's a part of Healthy People 2010.

The Secretary wants me to emphasize that as part of modernizing Medicare, we must—I repeat, must—bring its benefits package into the 21st century. Nobody designing a car today would even consider leaving out seat belts. And nobody designing a Medicare system today would—or should—consider leaving out a prescription drug benefit.

Keep in mind that Medicare was originally created because the cost of health care was forcing millions of older Americans to choose between being poor and being sick. In 1963, over 40 percent of seniors had no hospital coverage. Today, about one-third have no prescription drug coverage—and another third have coverage that is, at best, unreliable.

In rural areas the problem is even worse. If you live in a small town or farming community and you're on Medicare, your chances of having drug coverage is a flip of the coin...it's not even 50-50. 

This year more than half of all Medicare beneficiaries will use prescription drugs costing $500 or more. And 38 percent will spend over $1,000. Also this year, nearly three-quarters of Medicare managed care plans will cap their drug benefit at or below $1,000.

Medicare beneficiaries who do not have prescription drug coverage fill fewer prescriptions and have higher out-of-pocket drug costs than beneficiaries with coverage. The number of private employers offering health benefits to their retirees is going down—and Medigap premiums are going up. Frankly, beneficiaries who get coverage through individually purchased Medigap policies or through Medicare+Choice cannot count on keeping that coverage. Finally, contrary to what many people believe, most of the Nation's 44 million uninsured are not low income.

In fact, over half of the 13 million Medicare beneficiaries who lack drug coverage have incomes greater than 150 percent of poverty. That means a benefit targeted only to low income beneficiaries will not help most seniors.

So as the President said in his State of the Union Address, "In good conscience we cannot let another year pass without extending to all seniors the lifeline of affordable prescription drugs." That's why we have been battling to make affordable, accessible prescription drugs part of Medicare's basic benefits package.

We have many important allies in this battle—especially among health professionals. We hope they are checking out your Web site, because you are absolutely right when you say, "Inadequate prescription drug coverage, increasing use of prescription drugs for medical treatment, and increasing chronic diseases in the elderly all support the need for a Medicare drug benefit." You are right and we thank you.

You go on to say that patients need to be better educated in the use of prescription drugs, that patients need to have their medications carefully monitored, and that pharmacists have the training and personal relationships with patients necessary to meet those two goals. We agree. Just last week, the President reiterated those principles and said:

• the prescription drug plan must be voluntary and accessible to all beneficiaries;
• the plan must provide meaningful protection and bargaining power for seniors;
• the plan must be affordable—for both the beneficiary and for Medicare;
• the plan must offer competitive prices and be easy to administer through the private sector; and
• the plan must be part of an overall strategy to strengthen and modernize Medicare.

The President's plan meets all of these principles. Beneficiaries will have access to an optional drug benefit through either traditional Medicare or Medicare+Choice. Any retiree who has coverage can keep it. Premiums will be affordable, and low-income beneficiaries will receive extra help. The benefit will cover up to $2,000 of prescription drugs starting in the year 2003, and increase to $5,000 by the year 2009. Beneficiaries will be required to make a 50 percent co-pay.

As for competitive and efficient administration: The President's plan will have no price controls and, I want to make this point very clear, no new government bureaucracy. Instead, the new benefit will be offered through pharmacy benefit managers, or other entities, such as groups of pharmacies.

I want to emphasize too that we see the individual pharmacists as indispensable in making the prescription drug benefit a cost-effective tool for high quality care.

Prescription Two: Privacy

Knowledge of a family's medical history ought to carry with it an obligation of discretion. But this technology age has brought with it both conveniences and complications. We live in the world of Internet drugstores and filing claims on-line; databanks that can be moved at the touch of a keyboard; and companies looking to sell to selected—and sometimes vulnerable—audiences.

These dramatic changes have brought fear that our medical records will be sold to the highest bidder—or used to discriminate against us in employment and insurance. The challenge, I believe, is to figure out how to use the speed and accuracy of computer technology—without sacrificing our precious right to privacy.

The Secretary likes to tell audiences that their Blockbuster card guarantees more Federal privacy protection than their health insurance card.

Computers have shown great potential for spotting harmful drug interactions, managing patient care, and lowering costs. Nevertheless—if you have a family history of breast cancer, if you've been prescribed anti-depressant drugs, if you're on AZT, if your child takes Ritalin—there is no Federal law telling pharmacists or any other health care worker what they can and cannot do with that information. There is, however, a new Federal regulation that will finally provide some measure of protection for the sanctity of our medical records. The comment period for this regulation ended on February 17th, and we are now reviewing all of the comments, including those from APhA, and have a final regulation later this year.

But let's not lose the forest for the trees. The overriding principle guiding our approach to privacy is that health care records should be used for health care purposes. Unfortunately, our regulation, while a very important step forward, will not be enough to fully protect the American public.

The HIPAA (Health Insurance Portability and Accountability Act) legislative authority for this rule does not extend to employers, life insurers, and many others who hold health information. The rule can only reach providers who engage in electronic transactions, not those who maintain solely paper information systems. It doesn't impose confidentiality requirements on many people who obtain health information from plans and providers, such as researchers. And it cannot allow an individual to enforce his or her own own privacy rights.

That's why we're calling on Congress to pass a national law to provide fundamental privacy rights for patients, and to define the responsibilities of everyone who has access to medical records.

I want to be clear: as much as we need national legislation, no law can take the place of ethical conduct and high morals.

You recognize that in your own code of ethics, which says, "A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner." That's the point.

I urge you to continue your long tradition of protecting patient's health and privacy—and to make the careful use of medical records an ongoing part of your professional development.

Which brings me to...

Prescription Three: Improving the Quality of Health Care for All Americans

In 1997, the President created the Advisory Commission on Consumer Protection and Quality, co-chaired by Labor Secretary Alexis Herman and our Secretary Donna Shalala. The Commission issued a landmark report that included the first Patient's Bill of Rights. Just two weeks ago, House and Senate conferees finally sat down to finish work on the Patient's Bill of Rights.

But, here again, I should emphasize: The President will not sign a bill that is nothing more than an empty promise. And the Secretary insists that there must be strong protections for all Americans—and a meaningful way to enforce those protections. That's why we support the Norwood-Dingell legislation, which has already been endorsed by over 200 health care providers and consumer advocacy groups

But quality is more than just a Patient's Bill of Rights. Quality is doing the right thing for the right person at the right time in the right way. That means government, the private sector and all health care professionals—including pharmacists—have a critical role to play in improving health care quality.

As part of the Commission's work, we issued a second report about health care quality and the need to reduce medical errors. We also called for the establishment of a Federal Quality Interagency Coordination Taskforce, now known as QuIC. At the President's request, Vice President Gore launched the Quality Forum—a group of mostly private sector advisors—to come up with uniform quality standards.

Our Agency for Healthcare Research and Quality is the lead agency in improving quality health care, and has funded critical research into the frequency and causes of medical errors. This research was used by the Institute of Medicine in its recently released report, which revealed that at least 44,000 deaths occur every year because of preventable medical errors. That number could be as high as 98,000, making medical errors the leading cause of death in this country. In one study of hospitals in New York, 30 percent of individuals with drug-related injuries died.

Last month, the President announced a comprehensive plan that will help meet our goal of cutting medical errors by 50 percent in five years.

• First, we're going to put our own house in order. That means requiring the over 6,000 hospitals participating in Medicare to put in place error reduction programs. We support a nationwide system of error reporting—one that will have complimentary voluntary and mandatory components, and that will be State-based and phased in over time.
  
  I know mandatory reporting has raised some concerns, but under our plan, disclosure of information will be limited to the relatively small number of serious, preventable, and adverse events that cause lifelong disability or death. Information will be aggregated from a large number of health systems and made public without identifying patients and individual health care providers.
  
  
• We also want to develop new standards to make sure that pharmaceuticals are packaged and marketed in a way that promotes safety. Within one year, the FDA will come up with new standards to help prevent medical errors caused by easily confused names or packages. Similarly, the FDA will develop new label standards that highlight drug interaction and dosage problems.
  
  
• I should add that we're putting our money where our commitment is on medical errors. As part of our FY 2001 budget, we're requesting an additional $16 million for FDA to reduce these errors, and the Agency for Health Care Research and Quality will invest $20 million for more research into medical errors and what can be done to reduce them.

Well, I hope you will join us in filling this prescription for improving Medicare, ensuring privacy, and improving the quality of health care for all Americans.

The Master Carpenter

There's a story about a master carpenter who worked for many years and was well known throughout his community for his craft. As time grew on, he became old and tired and readied himself for retirement. His boss was very disappointed after hearing the master carpenter's plans for retirement. But deep down he understood.

He asked the man to postpone his retirement to build just one more home and encouraged him to make it his finest work yet. The old man reluctantly agreed and set out to build the house, but his heart was not in it. He hurried through the process and cut corners all along the way. When he finally finished, he rushed to his boss and reported the news. The boss immediately handed the man a set of keys and said, "The house you have just built is my gift to you."

Together, as a Nation, we are putting together the materials to build a healthier Nation. We cannot afford to be slipshod or to cut corners in the process. And we must work in partnership with one another to build the best possible system we can. I look forward to working with you.