Remarks as Prepared for the Clinical Trials Conference

Thank you, Samir [Khleif, Director General and CEO of the King Hussein Institute for Biotechnology and Cancer]. Your Excellency Salah Mawajdeh [Minister of Health], representative of His Majesty King Abdullah II; Your Excellency Faisal El-Fayez [Chairman of the King Abdullah II Fund for Development]; Distinguished Guests:

I would like to start by thanking His Majesty King Abdullah II for his patronage of this important conference. I’ve traveled all over the world in my time as Secretary of Health and Human Services. But there are few places I have visited where the leadership — at the very highest level — is as forward-thinking as the Hashemite Kingdom of Jordan.

On his own initiative, and through both his governmental policy and his personal largesse, His Majesty has worked to make Jordan a hub for health care and medical research in the Middle East. I admire both his vision and his commitment.

Health care is a universal language. It unites people in the recognition of our common humanity. It reminds us that our survival depends on our service to one another. And it inspires us through the selfless examples of society’s care-givers.

We live in a smaller world today. Threats to health spread more easily from one continent to the next. But medical knowledge spreads more easily also — when countries collaborate on health issues.

The Hashemite Kingdom of Jordan and the United States have enjoyed a partnership on health matters for many years now. In 1998, the United States Centers for Disease Control and Prevention began working with the Jordanian Ministry of Health on a program to track the spread of diseases and other health risks.

The United States has provided CDC with nearly $6 million for this surveillance program, which includes support for an on-site resident advisor. The program provides

early warning for outbreaks of infectious diseases. It can also alert health officials to many behavioral risk factors adversely affecting public health.

My Department is also pleased to have worked with Ministry of Health on the King Abdullah II Award for Physical Fitness. With the support of the Royal Health-Awareness Society, chaired by Her Majesty Queen Rania, the King’s Award for Physical Fitness encourages a culture of fitness among Jordan’s young people. 

Physical fitness and disease prevention are also one of my priorities. Chronic diseases afflict 100 million Americans, cause seven out of 10 deaths, and consume two out of every three dollars spent on health care in the United States. A major contributing factor is the lack of physical activity.

The King Abdullah II Award for Physical Fitness speaks to that problem. I have seen the results of this program myself. Earlier this year, I had the pleasure of meeting with a group of teen athletes from Jordan on a 10-day visit to the United States. I was impressed not only by their physical fitness, but also by their positive mental attitude, which goes hand in hand with a physically active lifestyle.

Two years ago, we were pleased to begin assisting His Majesty in another major contribution to the health of his people — the founding of the King Hussein Institute for Biotechnology and Cancer.

The King Hussein Institute will do much to realize His Majesty’s vision of Jordan as a regional hub for health care and biotech research. When completed in 2011, the institute’s hospital will provide state-of-the-art medical care for hundreds of cancer patients in Jordan and the region. The institute will also provide facilities for basic and translational research by 20 to 30 principal investigators — as well as an infrastructure for clinical trials.

Dr. Khleif from our own National Cancer Institute serves as the King Hussein Institute’s Director General and CEO. Samir went to medical school here in Amman, and one of the benefits of the institute is that it will provide opportunities for bright, talented Jordanians like Samir to pursue careers in medicine and biotech research without leaving home.

Instead of “brain drain,” the institute will provide a “brain gain,” drawing medical experts back to the region. They will be able to work right here in Jordan, using their expertise to serve the people of the Middle East. This is the stated vision of His Majesty.

In 2006, my Department and the King Abdullah II Fund for Development signed an agreement to collaborate on bringing the King Hussein Institute into being. I am pleased now to renew and expand that agreement.

Dr. Khleif has earned the respect of his colleagues both here and in the United States. He has my full support in his efforts on behalf of the Institute. Under his leadership, my Department and the Institute will continue to work together toward enhancing medical sciences, improving patient care in the oncology field, and advancing biotechnology research. 

The timing of this effort is providential. Only in the last few years have scientists begun to unlock the secrets of the human genome. The pace of discovery has been accelerating.

In 2005, scientists identified just one new gene associated with a one common disease. In 2006, they discovered genetic elements in six common diseases. Last year, they identified some 60 genetic contributions to more than 20 common diseases.

These discoveries have raised the prospect of “customizing” health care based on a person’s genetic profile. People have begun to talk about “personalized health care” — personalized to a degree not imaginable before.

As Secretary of Health and Human Services, I decided early-on to make personalized health care a Departmental priority. This is a long-standing interest for me. I believe in its potential.

But it soon became clear to me that personalized health care is not just about genomic science. It’s also about our health-care systems. To make the most of the science, we need systems that incorporate the science into both our research and our treatment.

The science is our starting point. But at least two other new elements are also needed to make Personalized Health Care work:

• One is health information technology.
• The other is a transformed role for medical evidence.

These are not new areas. There is already great interest and considerable activity in both of these. But to truly personalize Health Care, we need all three of these tools working together — science, health I-T, and evidence-based medicine.

The collaboration between my Department and the King Hussein Institute will focus on the use of these tools by health professionals in the Middle East. 

We will be working to develop the necessary standards that allow health information to be share interoperably by health professionals. We will also be working to accelerate widespread application and adoption electronic health records and other health-information technology in Jordan and the Middle East.

Together, my Department and the King Hussein Institute will be developing the necessary infrastructure. They will also collaborate on recruiting and training the staff needed to establish a solid foundation for biomedical research and clinical trials.

My Department will help establish a biomedical informatics infrastructure and a telecommunications link through the caBIG™ program of the National Cancer Institute. caBIG™ stands for the Cancer Biomedical Informatics Grid. It’s an information network that enables all stakeholders in the cancer community — researchers, physicians, and patients — to share data and knowledge. 

By sharing information more often and easily, we can accelerate the discovery of new approaches for the detection, diagnosis, treatment, and prevention of cancer, ultimately improving patient outcomes. caBIG™ software and resources are widely distributed and available to everyone in the cancer research community. But institutions maintain local control over their own resources and data.

Through caBIG™, researchers, physicians, and patients at the King Hussein Institute will be able to participate in the global conversation about cancer and biotech research. And the whole cancer and research community will benefit.

We will also collaborate to test a new technology developed by my Department called “My Family Health Portrait.” My Family Health Portrait is an Internet tool that enables individuals to document and organize their family health history.

Family history helps predict risk for health conditions such as heart disease, cancer, osteoporosis, diabetes, and suicide. It can also serve as a guide to the most effective health care for each individual.

Unfortunately, many people don’t know much about their family health history. So a few years ago, my Department created a web-based tool called “My Family Health Portrait.” This tool lets you download a format for recording family health information. Since its creation, it has been downloaded almost 250,000 times.

Our collaboration with the King Hussein Institute will test and evaluate an Arab-language “My Family Health Portrait,” which could serve as a starting point for a broader discussion on behavior change and preventative health. 

My Department may also be able to assist the King Hussein Institute in developing a national biorepository — as well as the epidemiology infrastructure needed to run a research program to study genetic causes of cancer and other diseases.

In recognition of the critical role that biospecimens play in cancer research, our National Cancer Institute established the Office of Biorepositories and Biospecimen Research (OBBR) in 2005. The OBBR is responsible for developing a common biorepository infrastructure promoting resource sharing and team science.

The OBBR has identified the Best Practices employed by existing biorepositories, which could serve as models for a national repository created by the King Hussein Institute.

My Department also has a lot to offer on the conduct of clinical trials. The importance of clinical trials cannot be overstated. Medical science depends on them. They tell us not only what works and what doesn’t, but what side-effects we are likely to see.

But the more we learn about genetic differences, the more we see the necessity for clinical trials among diverse populations. What works well among people from Copenhagen might not work well among people from Congo.

Today, most clinical trials are conducted among people of European ancestry — for the simple reason that most trials are conducted in the United States and Europe. In the future, to take full advantage of the new science of genomics, researchers will need to conduct more trials elsewhere.

This raises the issue of international standards. The science must be the same wherever you go. Researchers in one hemisphere need to know that research conducted in another hemisphere can be trusted.

Some countries already have extensive experience conducting clinical trials. Their researchers and regulators have already settled upon what constitutes good clinical practice. National and international agencies have issued guidelines and regulations based on these standards, which cover, among other issues, the ethical conduct of trials on human subjects.

Researchers in other parts of the world must familiarize themselves with international standards if they wish to contribute to medical science through clinical trials. This conference will help you do that.   

There are, of course, other issues that only researchers in each region can resolve. There may be cultural considerations that are not a part of our experience in the United States. Here, again, this conference should help — by bringing you together with colleagues from the region to begin or continue that discussion.

Collaboration between the King Hussein Institute and my Department, including our National Cancer Institute, should speed the process of establishing the infrastructure needed to support clinical trials in the Middle East. This conference is an example of that collaboration. We might also be able to provide additional training or perhaps collaborate on joint clinical trials.

The United States should be able to help in another way as well. In the past few months, we have begun establishing — for the first time ever — a global presence for our Food and Drug Administration. The FDA is part of my Department, and for the past year I’ve been working to open offices of the FDA in countries that import goods to the United States.

We will open the first FDA offices this year in China and India. We will also open regional FDA offices this year in Europe and Latin America. We hope to open a regional office here in Amman sometime next year.

The FDA experts in these offices will be able to work with governments and producers to assure that products exported to the U.S. meet U.S. standards. They will also be able to advise researchers here on the conduct of clinical trials, so that the trials you conduct here won’t have to be repeated in the United States.

There’s still work to be done to get these offices operational. But I’m confident things will move ahead as planned.

You have an impressive line-up of speakers to tell you more about the issues I have just touched upon. I’m sure your time here will be well spent. Congratulations on making this first Clinical Trials Conference a success.

Last revised: January 12, 2009