Remarks as Delivered to Personalized Health Care: Delivering Value to Patients

Thank you all very much. I am pleased to be here with such a distinguished group, and I'm pleased to be listed among a list of distinguished people who have occupied this podium in the past.

I'd like to begin today by relating to you the moment that personalized medicine became personalized to me. It was in the late �90s. I was the Governor of Utah.

There is in Utah a database called the Utah Population Database. It is essentially the merger of a lot of genealogic records from the Mormon Church and health records that have been developed. They have merged these into quite a significant database.

It was the origin of the family list that the human genome project used. I'm told that�at least the lore is�that the human genome project actually got its start on a weekend when a bunch of scientists got snowed in�and Francis [Collins, National Human Genome Research Institute] validates that.

There is a long history there, but I became fascinated by this while I was Governor. I began to ask what we could do to enhance this into a tool that could begin to unlock the promise.

We concluded one of the things we could do is to begin to identify the core families that were part of that database, and to begin to enhance it with robust clinical records.

So we made a list of families. I would, one at a time, invite the oldest, most senior members of that clan I could find to the Governor's mansion. We would have dinner, and then I would have a scientist I respect�a man named Steve Prescott�who many of you will know. He and some of his colleagues would come and we would talk about genetics and some of their problems.

At the end of one of these meetings, an older man stood up and he said, "I think there's something to this genetics thing." He said, "I'm 71 years old, and when I turned 70, I was diagnosed as having macular degeneration." He said, "When my father was 70 years old, he got macular degeneration. In fact when his father turned 70 years old, he got macular degeneration."

He said, "Doctor, if there's something I can do and my family can do to keep my grandson or my great grandson from having that moment, when he turns 70 years old, I want to do it, and I'm in."

Well today, I think I just want to make clear to you that I'm in, and that this is in fact a priority.

Now a nice thing happened shortly after I became Secretary of Health and Human Services.

I ironically went back to Salt Lake City where a large group was meeting and I was able to attend, along with Francis Collins, the announcement of the Hap Map. At that time we talked about the fact that this macular degeneration was one of the first areas of significant promise.

Well since that time, a great deal has happened that most of you are aware of�the gene has been identified; we now actually have drugs in clinical trials that�dependent upon the genetic makeup of a particular person�may have a positive impact. And we are well on our way to seeing the virtue that that man foresaw, along with us, become a reality.

I'm told that Sharon Terry is here today who leads the Coalition on Genetic Fairness, an organization that's had an enormous amount to do with the progress in that area. Sharon, where are you, I'd like to acknowledge you.

All of this has become possible of course because of phenomenal leaps forward in two areas:

• The new discoveries in bioscience, especially human genomics about which we've spoken, and
• New tools in the computer age�meaning health information technology.

These great leaps enable us to give better care to all patients � by targeting the unique biology of every patient. What lies ahead is this frontier we refer to today as Personalized Health.

Every one of us is biologically unique. We've always known that. But what we haven't had is the knowledge or the tools to deliver health care on a truly individualized basis. That's what we all aspire for today. That's what we are all "in" today to produce.

Right now, no matter how advanced we are or how advanced we feel, I think the reality is we're still very much in the information twilight:

• A patient's most basic data, the medical records, is scattered in pieces of paper in paper files in a way that surely makes them incomplete.
• A doctor's idea of the "best practices" are still based on haphazard factors. The "best practices" for a given condition can be one thing in one region of the country, and another thing in a different region of the country.
• So we have "variability" in the way we care for patients�the problem is that variability is on the basis of zip code, not medical practice.
• Meanwhile, we don't have variability where we need it, and that is in being able to take the personal genetic differences that we all have and design care for that purpose.

That's the real breakthrough that we're here to talk about today.

Today, our medical knowledge is tied to our anatomy. We talk about lung cancer and heart disease. But in the future, we'll be talking about diseases at a much different level. We'll be talking about molecular-based diseases.

That will give us all kinds of new treatments that are effective for very specific conditions in individual patients.

Take an example of a 50-year-old woman with an advanced form of breast cancer.

In the past, her doctor would have put her on chemotherapy, without having really any specific idea of what her chances were of responding well. Well today, her doctor knows about Herceptin, a drug that we can use in conjunction with chemotherapy.

A simple test shows that this woman could indeed get help from this medication. Within weeks, her tumor could be responding.

That genetic information, as simple as it is to get, has made treatment far more effective for a patient who is trying to avoid the unpleasant side effects of chemotherapy.

That's just one example of what we're here again today to talk about.

Another example is Warfarin, the drug that is used for preventing stroke.

It's widely prescribed�I understand almost 2 million prescriptions a year. But it's a difficult drug to use. Physicians tell me that patients respond in very different ways and the results can be extremely dangerous.

The FDA has recently added a Black Box warning for that very reason. In the past, doctors have had to rely on trial and error to reach the best dose for every patient. But today we know that two genes are closely associated and they provide entirely different reactions to the drug.

It appears very likely that doctors will be able to determine the right dose with such accuracy that they'll have far greater degrees of predictability based on genetic testing. The result would obviously be an end of suffering or prevention of suffering for many people, and it would also have a profound impact financially. Almost a billion dollars in savings simply by using that one therapy.

Personalized Health Care will help us know our individual vulnerabilities�every one of us. It can make health care more preventive. It can help us spot the onset of disease at a much earlier stage. It can help us give new therapies that are much more targeted and far more effective. And it should even give us the tools that we need to move faster and more economically toward developing targeted therapies.

But we have a long way to go.

The Human Genome Project, as I've heard Francis say, is really "a race to the starting line."

The work that remains is sweeping, from the most fundamental science to the details of health care practice. This is the health-care project of our generation.

Think of the work that needs to get done at this point:

• The basic science of genomics is still in its adolescence. We need to understand the interactions between our genes, and the environment, and our lifestyle.
• Health information technology also needs to be more mature�and much more widely adopted.
• We need common terminologies and standards so our health information systems can talk to each other.
• We'll need more sophisticated knowledge management tools that haven't even been conceived of yet.
• And we'll need new regulatory tools that will turn the new science into safe products.
• Most of all, we'll need useful tools that doctors will employ�and that patients will trust.

We have our work cut out for us�but we're all in.

It's underway in the private sector. It's underway in academia, and I can assure you, it is underway in government.

As you may know, we've identified Personalized Health Care as one of the top priorities at HHS. We're making a growing investment in our Department. This is important to me, I know it's important to you, and it's important to the President, and we're going to lay a strong foundation to bring the future closer, faster.

One of the most important elements of this effort is a collaboration between all of you. When we talk about the state of Personalized Medicine, it's the collective work of what is happening by people in this room and obviously many who are not.

One of those areas of collaboration I've mentioned as being especially important is health information technology, and the work of developing standards. The American Health Information Community, or AHIC, as we refer to it, has assembled "know how" from across the spectrum to develop consensus on health information technology.

This year, AHIC has created a special work-group that will focus on Personalized Health Care. We will begin to develop standards for genetic test information as well as family history that can go into an electronic health record. Their aim is to have recommendations done by the end of this year.

Another important area is health-care safety and effectiveness:

The President's budget for 2008 proposes a new Personalized Health Care Partnership�and a new electronic network to support the kind of learning system that's necessary to improve health-care quality.

This is a very important part of it and a cutting-edge proposal.

• This network of networks, if you will, will draw on data repositories that are already being created across the country. With it, we'll be able to look, in real-time, for the benefits and harm of different treatments. We'll be able to learn quickly about what treatments work best, and for whom they work best.

• This would be a distributed network�not a centralized database. It will enable researchers to learn about the outcomes of very specific approaches to particular conditions.

• For example, you could query this distributed network with a question like: "What are the most effective treatments for people who have several chronic diseases at the same time�a person who has hypertension, diabetes and emphysema?"

These are people who are not well-reflected in large clinical trials. The interaction between those chronic diseases is broadly unknown. And yet it's especially important for them to have the kind of effective care that could come in a personalized way.

The goal is to make this network useful for everyone: for researchers, for doctors, for patients.

Now, clearly, this is a long-term vision. But we're building on work already being done at the Agency for Healthcare Research and Quality. And we expect that this investment will begin to show a return in the near-term in as soon as 18 months.

Dr. Zerhouni [Director of the National Institutes of Health] is here. At NIH, many institutes are taking data from years of clinical trials, and beginning to use that information to add to our genetic knowledge. That looks very promising. We're looking for associations between genetic elements and health outcomes.

NIH (The National Institutes of Health) has already begun to post results of some of these Genome-Wide Association projects that are on a new website referred to as dbGaP.

This fall, we'll see a milestone event, when NIH releases a wealth of genetic data from the well-known Framingham study. Most of you will be aware that this is a community-wide study that has followed over 10,000 volunteers for almost 60 years. By going back to these volunteers, and matching genetic profiles with other health information, this study will yield huge amounts of information and be of major importance.

In addition, the National Human Genome Research Institute is leading our efforts to measure the interactions of genes, and the environment and lifestyle. I was the head of EPA for a time. I became persuaded that at the root of many of the environmental harms is a genetic base. Until we fully understand the genetic impact of various pollutants, we won't truly know how to regulate. This goes well beyond personalized to public health and has benefits for all.

The first grants from the Genes and Environment Initiative will be made this summer.

At FDA (The Food and Drug Administration), the Critical Path initiative is organizing work across 76 science and regulatory areas to build a better base for new products.

One area of special importance is the Co-Development of Drug and Diagnostic Products. FDA will be releasing its guidance on its Co-Development this fall.

In addition, FDA will publish its semiannual concept paper on Qualification of Biomarkers before the end of this year. And it will publish draft guidance on best practices for micro-array data in pharmacogenomic data submissions by this summer.

The CDC (Centers for Disease Control and Prevention) will be doing important work in genetics and the population health, as well as to bring about genetic medicine into common practice. That includes leadership on assessing genetic tests.

The first public recommendation on genetic tests will be issued by an independent work group sponsored by CDC.

CDC has also worked with the National Cancer Institute to define the leading 100 genetic variants of public health significance. CDC is using national health surveys to determine how common these variants are in the United States. These results will also be released this summer.

They'll be especially valuable for researchers who are seeking to understand how genetic variation contributes to human disease.

Most of the work being done by HHS agencies is being developed about this information so that we can contribute to this Personal Health Care future.

But it's only half of our challenge. The other half is using this information correctly.

We need to work now in three crucial areas:

• First, we need to question who has access to basic data for researchers. We need to strike the right balance between open information to support progress, and rewarding those who achieve real discovery and innovation.

In particular, we need to develop clear and consistent policies for access to federally-sponsored genetic databases. These data resources mustn't be locked away. Access to basic knowledge is a door that we must keep open.

• The second is that we need clear policies for appropriate oversight of genetic tests. Important medical decisions are being made based on these tests. We need a better understanding of the validity of individual tests.

We also need to help patients and providers understand the potential and the limitations of gene-based information.

• Most importantly, we need to continue to address privacy and security issues in health information technology as it is increasingly adopted. These issues will surround genetic information.

This is a new frontier in human behavior. It is something we all must wrestle with individually, and as a culture. Unlike most medical data, our genetic information is permanent. We also share genetic traits with family members. We know how sensitive this information is to patients. We need to handle and protect it carefully.

HHS will be addressing each of these concerns with a careful look at our current policies.

In yet another area, we need to take action immediately. We need to establish a federal law that genetic information may not be used in an unfair way to deny insurance or employment.

Personalized Health Care�and the use of genetic information�depends on public trust. We know that the majority of Americans are concerned about how genetic information might be misused.

President Bush recently called for the genetic non-discrimination law to be passed by Congress. He repeated that call at the NIH.

I'm happy to tell you that, just today, at about 10 o'clock, that bill passed the Energy and Commerce Committee. It is on its way to the House for a vote. That's very good news.

Someone expressed amazement that Francis Collins was here and not up there. I think the fact that it passed at 10 o'clock and not right now was the reason. He and many others deserve a great deal of admiration and thanks for using their credibility to make this known and possible.

The Senate and the House are going to be finishing that bill and I can assure you it will be going to The President, and he's made it clear that he hopes to sign it very soon.

These are policy steps we can take right now to build a strong foundation for Personalized Health Care. As I told you before, I intend to lay this groundwork during my tenure at HHS.

Personalized Health Care is about opportunities that we've never had before. Our job is to seize these opportunities, and to turn them squarely to the benefit of individual patients.

When we do that, we're improving care for every patient, and we'll improve the value in health care generally.

Value in health care is realized in just one place, and that's with the patient. So in a way, personalizing health care and achieving value in health care are the same thing.

What's truly frustrating for a patient today isn't just the long trek from one specialist to another. It isn't even the way patients carry around their own records and X-rays, just to make sure they don't get lost.

The real frustration, for patients and providers alike, is that at the end of all this work, if we're not able to do the right thing for the patient.

So much of medicine is trial and error. So much of diagnosis is guesswork.

Our opportunity, in Personalized Health Care, is to deliver the right treatment, to the right patient, at the right time�every time.

That's our customer. That's where value is found. That's the reason I'm in, and the reason I know you are too.

Thank you.

Last revised: March 30, 2007

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