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Copyright 2000 Federal News Service, Inc.  
Federal News Service

April 11, 2000, Tuesday

SECTION: PREPARED TESTIMONY

LENGTH: 1395 words

HEADLINE: PREPARED TESTIMONY OF ADEL MAHMOUD, MD, PHD PRESIDENT, MERCK VACCINE DIVISION
 
BEFORE THE SENATE APPROPRIATIONS COMMITTEE FOREIGN OPERATIONS SUBCOMMITTEE
 
SUBJECT - GLOBAL HEALTH FUNDING

BODY:
 Mr. Chairman and members of the Committee. Good morning. Today's hearing reinforces a renewed global vision of a world free of preventable diseases through international immunization programs; of economic and social development spurred by investing in health; and an energized partnership committed to secure the policies and resources needed to bring this vision alive.

MERCK WELCOMES THE RENEWED FOCUS ON VACCINES

Merck applauds the efforts of the Administration, the World Health Organization, the World Bank, the Gates Foundation and others to assure children of every nation in our global community access to safe and effective vaccines. Merck pledges to do our part to shape and implement a comprehensive package of policies and programs that will support this truly exciting momentum. As one of only two major remaining U.S.-based pharmaceutical companies with an ongoing program of innovative vaccine discovery, manufacturing and delivery, Merck is pleased to have the opportunity to comment on the specific proposals before this Committee today. When Merck testified before this Committee in 1997, we stressed that solutions to controlling infectious diseases include more than just direct spending by various government agencies. Providing access to comprehensive health services in developing nations presents a unique set of challenges, including poor nutrition and sanitation, lack of trained medical staff, minimal medical facilities--particularly in rural areas--lack of disease awareness, poor or non-existent medical recordkeeping capability or capacity.

AVAILABILITY DOES NOT GUARANTEE DELIVERY

Perhaps the hardest lesson of all for those of us with a commitment to improved global health through immunization is that simply having vaccines available is not enough. For example, while it has been shown that in the industrialized countries immunization can dramatically reduce hepatitis and hepato-cellular carcinoma caused by hepatitis B, and childhood meningitis caused by Haemophilus influenza type B (or Hib), relatively few developing countries have introduced these vaccines into their national prevention programs.

What's missing is deliverability. Why this disparity among countries exists is not a simple matter. It's a function of: 1) political will; 2) adequate health care infrastructure; and, 3) sufficient financial resources. The need for adequate, dedicated funding for the purchase of safe and effective vaccines will become even greater with the introduction of new vaccines--like rotavirus--and combination vaccines, which could be considerably more expensive than the older products.

GAVI AND THE MILLENNIUM INITIATIVE

Mr. Chairman, you've asked for Merck's comments in three areas: the United States' contribution to the Global Alliance for Vaccines and Immunization---or GAVI; President Clinton's proposal for a $1-billion tax credit for vaccine purchase; and the need for increased resources to combat infectious diseases and strengthen the public health infrastructure in developing countries.

As a package, we believe these initiatives go a long way in supporting the three conditions defining true deliverability just mentioned.

Specifically, GAVI, with its focus on expanding worldwide access to the new safe and effective vaccines--beginning with vaccines to prevent hepatitis B, Haemophilus influenza type B (or Hib ) and yellow fever--clearly is on target.

What is significant about the President's initiative is that it is multifaceted: it takes into consideration the barriers just mentioned.

Specifically, the President's request for a $50-million contribution to the GAVI vaccine purchase fund will help save lives today and could create confidence that a market for new vaccines will be available in countries where there is a great need in the future.

His recommendation for additional funding to support the National Institutes of Health basic research in HIV/AIDS, tuberculosis and malaria is in keeping with Merck's long-standing position on NIH's role in the discovery process. Vaccines are complex products with a multi-stepped process for research, development and manufacturing. Industry traditionally provides the expertise and experience in product development and manufacturing, with government focusing more on reducing the barriers to new discovery through the creation and expansion of the scientific base in the disciplines that underlie product development.

The biggest obstacle in the search for vaccines against these three diseases remains lack of basic science, not money or markets. Fueling the research engines at NIH and other research institutions and biotechnology companies can help fill this void.This additional support would prove particularly timely, given recent advances in the genetic sequencing of both tuberculosis and malaria.

President Clinton's proposal for a $1-billion tax credit for future vaccine sales is an interesting approach to promoting vaccines for diseases that would have primary health value to developing countries. The tax credit represents a funding source for future vaccine purchases and sends the fight message to those who are currently engaged in research as well as to those who may be considering initiating research in these disease areas. It's the message that the Administration wants to do everything possible to ensure a future market for these critically needed vaccines.

DEVELOPING A MEDICAL INFRASTRUCTURE

The Millennium Initiative truly hits the nail on the head in its emphasis in shifting international resources toward building health infrastructure in poor countries. Merck learned first hand how the lack of medical infrastructure can stymie even the best intentions. Our experience with the donation of our drug MECTIZAN, to prevent onchocorciasis, or river blindness is an example. MECTIZAN involves only minimal medical care one pill, once a year--and is relatively easy to handle, store and transport.

Yet the significant challenges to delivering it and getting it administered cannot be overstated. Government commitment to a distribution program, establishing a system of identifying infected individuals, persuading them that the drug was safe to take, getting the patients to the drug or the drug to the patients and maintaining records--all were critically necessary components to the program's success.These are the more classic challenges. Others include: black market sales that can divert products from those who need them most; epidemiology gaps--inadequate data to assess the incidence of an infectious disease in a country; and the lack of quality assurance-- storage, handling, administration--which is of particular concern with vaccines.

Merck supports policies that would constructively redirect resources to overcome any or all-of these gaps in the health care infrastructure, not only in the interest of the delivery of vaccines and medicines, but also to provide access.to essential basic health services.

IN CONCLUSION

As the world awakens to the power of immunization as the central policy for health in stimulating economic and social development, the need for partnerships becomes even more vital. Governments, industry, the private sector, international organizations and agencies all need to step up to the challenge. Achieving global access to safe and effective vaccines will require both collaboration and individual contribution.

Last month, Merck was pleased to demonstrate our own commitment to the cause with the donation of $100-million of RECOMBIVAX HB, our vaccine to prevent hepatitis B. In terms of its volume--1 million doses for each of 5 yes--and value, this donation is second only to our Mectizan program. We also reaffirmed our dedication to the global targets of our 14-year-and-still-counting research program in HIV/AIDS. And we hope to do more.

I want to thank you, Mr. Chairman, and the Committee, for inviting Merck to share in the discussion here today. Certainly the broad issues surrounding global infectious disease deserve this Committee's full attention. And the opportunities for improving global health through disease prevention, as outlined in the mission of GAVI and the President's proposal, deserve the careful consideration this hearing offers. We look forward to working with you on these and other issues in the future.

END

LOAD-DATE: April 12, 2000




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