John J. Castellani on The Global Health Challenge

John J. Castellani
PhRMA President and CEO
delivered these remarks at the
Department of State Symposium
LoyHenderson Conference Center
Thursday, March 17, 2011

The Global Health Challenge: Innovative Approaches

I am honored to be here representing America’s biopharmaceutical research companies.

From the outset I want to emphasize a simple fact: PhRMA member companies are global citizens with an increasingly global perspective.

Because our member companies exist to help find solutions to disease and to help improve health, they are directly concerned about and contribute to improving global health.

This means that America’s biopharmaceutical research companies are keenly aware of growing global health care challenges - especially those facing the developing world. As a result, many have expanded their commitment to researching and developing medicines targeting all to common, deadly conditions of the developing world - including malaria, tuberculosis, and dengue fever.

One advantage in following Andrew Witty today is that Andrew and GlaxoSmithKline are a great example of this proposition: a world leading biopharmaceutical company with global interests and vision. As Andrew amply demonstrated, GSK is committed to helping find real solutions to some of the most pressing global health problems.

And, GSK – while certainly a singular company – is not alone in this commitment.

So, as we think about ways to spur more research into the diseases plaguing the developing world, I think we must also remember that medicines pioneered here in America and elsewhere in the developed world are valuable tools in the fight against diseases in the developing world.

This means, for example, that innovative medicines to fight cancer, heart disease, diabetes, rare diseases, HIV/AIDS and other conditions all have universal application and can help treat these conditions whether the patient is in New York, Sub-Saharan Africa, Latin American or Asia.

This point is important because global economic development and economic progress can mean that many of the health challenges we today confront in developed world are now, increasingly, also health problems in rapidly developing economies.

For instance, a recent study from India highlights the exploding levels of non-communicable chronic diseases like heart disease, stroke and diabetes now occurring in that country.

The growth of these conditions is attributed to the increasing wealth of populations as a result of economic and social development. With increasing wealth and opportunity came changes in diet and life-style.

Our challenge in fighting these diseases whether in the United States or India, of course, is the perennial one: creating an infrastructure and healthcare delivery system able to meet patients’ needs, help them prevent the onset of these conditions, and make treatments more broadly available.

I raise this example to emphasize that innovative medical research and development conducted to help meet health care needs in the developed world also can help treat patients around the world.

But, while treatments for heart disease or diabetes may be essentially the same in New York and Bangalore, how we identify and meet the individual needs of potential patients in these disparate parts of the globe is clearly very different.

The key is to construct solutions geared to the specific needs of individual countries and regions.

But, as you just heard from Andrew, biopharmaceutical research sectors companies are also focused on fighting diseases and conditions that most affect patients in the developing world.

They have a profound, long-standing commitment to applying the best science and best talent available to help solve the particular health challenges confronting the people of the developing world.

The scope and vision is truly and demonstrably global.

In fact, the G-Finder Report 2010 showed that the biopharmaceutical research sector is the third largest investor in efforts to find solutions for global health challenges behind the U.S. Government and the Gates Foundation.

And this sector’s ability to innovate is one of the principal strengths it brings to the health care challenges we face.

To quote Bill Gates’ 2010 Gates Foundation Annual Letter:

“If we project what the world will be like 10 years from now without innovation in health, education, energy, or food, the picture is quite bleak. Health costs for the rich will escalate, forcing tough trade-offs and keeping the poor stuck in the bad situation they are in today. However, I am optimistic that innovations will allow us to avoid these bleak outcomes. . . . With vaccines, drugs, and other improvements, health in poor countries will continue to get better . . .”

Over the last decade, the biopharmaceutical research industry has committed over $9.2 billion in direct assistance to healthcare in the developing world.  This includes donations of medicines, vaccines, diagnostics and equipment as well as other materials and labor.

In fact, in 2009 alone, biopharmaceutical research companies invested more than $411 million researching new cures and treatment to fight neglected tropical diseases.

And our member companies have made specific, on-going strategic commitments to focus on both research and developing infrastructure in the developing world.

Andrew spoke about GlaxoSmithKline’s laudable commitments.  GSK’s work on Malaria, tuberculosis at its Tres Cantos facility should inspire us all.

And, GSK’s Tres Cantos commitment is mirrored by that of other global biopharmaceutical companies.

The Tres Cantos effort, for instance, is one of five state-of-the-art research and development centers targeting neglected tropical disease established by individual biopharmaceutical research companies since 2000.

• Merck has opened a research center in India in partnership with the Wellcome Trust to focus on developing affordable vaccines to prevent diseases that commonly affect low-income countries.
• Lilly recently started the Infectious Disease Research Institute in cooperation with the Gates Foundation and the University of Washington to further it’s work on tuberculosis;
• Novartis has two research institutes, one in Singapore and one in Siena, Italy that focus on dengue fever, malaria, diarrheal diseases and salmonella; and
• AstraZeneca started the Bangalore Research Institute to continue its search for new treatments for tuberculosis.

Further, SanofiAventis, has dedicated 35 scientists in its research laboratories to find cures and treatments for many of the diseases that we are discussing today.

Additionally, many companies are working with third party groups or Private Development Partners to further the development of these medicines.

These efforts, like the global research centers, are part of a growing list of academic and NGO partnerships with the biopharmaceutical research industry that focus on critical issues like access, capacity building as well as research and development. These partnerships include

• 54 HIV/AIDS prevention programs
• 16 tuberculosis programs
• 17 anti-malaria programs
• 9 tropical disease programs
• 10 preventable disease programs29 child and maternal health programs and
• 24 chronic disease programs

And these are just some of the industry’s efforts to find healthcare solutions for the developing world.

Today, there are over 90 projects designed to research medicines specifically to meet the needs of the developing world, up from 32 in 2005.

And, there are now 11 projects specifically focused on vaccines, up from six and including the exciting testing of the first vaccines to treat malaria.

There are also projects that support innovative efforts to develop medicines and treatments that can be safely and easily administered where there are limited health care resources.

These include, for example, projects to develop treatments that can be sustained in hot climates where refrigeration is unavailable. This critically important work recognizes the need for medicines that can be administered under conditions all too prevalent in the developing world and where there is often limited local healthcare infrastructure and few health care providers.

Research-based biopharmaceutical companies are also playing an important role in building the healthcare work force of developing countries. For example, working with governmental, intergovernmental and NGO partners to provide training for more than 220,000 health workers. This is the equivalent of more than one-third of the total health work force in Africa.

Other examples include Abbott’s capacity building partnerships. Working with the government of Tanzania, Abbott has helped to rebuild major hospitals throughout the country. Last week, in fact, Abbott announced that its partnership with the Tanzanian Ministry of Health  has helped rebuild more than 23 hospitals.

In addition, since 2002, the Abbott Fund has provided technical assistance and funding to more than 80 hospitals and health clinics in Tanzania.

The result is that more than 10,500 healthcare workers have been trained.

Yet another example is Pfizer’s partnership with Makere University in Uganda. That collaboration has helped train thousands of doctors and health care professionals to better diagnose and treat patients in sub Saharan Africa.

And Tibotec, a Johnson and Johnson subsidiary, has granted multiple, non-exclusive licenses to make, market and distribute generic versions of a possible new HIV medicine.

As you can see, our companies’ efforts are almost too many to list.

I want to leave you with a few observations about the costs and challenges of researching and developing new drugs.

As we think about the future, the enormous global health care needs still to be met and the research and development needed to bring the benefits of medical innovation to the health problems of the developing world, I hope we will all keep some important factors in mind.

First, whether the research is done on diseases of particular concern in the developed world or on conditions in the developing world such as neglected tropical diseases, the need for the highest research standards and our concern for patients remains the same.

Second, the cost of researching and developing new medicines continues to increase. Today, in the United States, it takes anywhere from 10 to 15 years and, on average, around $1.3 billion dollars to research and develop a new medicine, taking it from the laboratory through FDA approval for use by patients.

My point is not to emphasize how daunting these costs are – though they are daunting – but rather how hard and increasingly complex the science has become.

We must remember that the complexity and difficulty of the science doesn’t change as we seek to inspire and motivate new research into medicines needed to treat neglected tropical diseases and other conditions that adversely impact the developing world.

Finally, we can and are doing more. The biopharmaceutical research industry is strongly committed to being an active, positive partner in the search for innovative and appropriate health care solutions that can help meet global health needs. And our companies are working in great partnerships and collaborative efforts to move the research and development agenda forward.