Page 2.

ANTONIO M. GOTTO, JR., M.D.

Thus, the Helsinski Heart Study will further our knowledge of the benefits of controlling blood lipids and raising HDL in the prevention of coronary heart disease.

I believe that such pioneering research efforts should be recognized and will greatly appreciate your consideration of this matter.

The Honorable Robert W. Kastenmeier

Chairman, Subcommittee on Courts, Civil

Liberties and the Administration of Justice Committee on the Judiciary

U.S. House of Representatives

2137 Rayburn House Office Building

Washington, D.C. 20515

Dear Mr. Kastenmeier:

It has come to my attention that your subcommittee will hold hearings on September 23 to review H.R. 3074, involving a patent extension for Lopid. I would sincerely appreciate

this letter being entered into the hearing record.

I am Professor of Pediatrics and Medicine at the Johns Hopkins University School of Medicine and have dedicated a considerable amount of my time researching the area of lipids, lipoproteins and coronary artery disease.

Clearly, I cannot comment on the legislative issue before
your committee. However, with coronary heart disease
continuing to be a major health problem in this country,
public health policy demands that we emphasize medical
education and further research targeted at this disease.
The recently completed Helsinki Heart Study represents an
important step in furthering our understanding of the
atherosclerotic process and appropriate cardiovascular
therapy. While it is a privately funded study, the Helsinki
Heart Study will take its place with such major publicly
funded efforts such as the Framingham Heart Study and the
National Heart, Lung and Blood Institutes' Coronary Primary
Prevention Trial. Warner-Lambert should be commended for
sponsoring the Helsinki Heart Study, which should provide
basic scientific information as well as information about
Lopid. It is unusual for a clinical study on a
pharmaceutical product to have such far reaching and
important implications.

-2

I appreciate the opportunity to provide my views on this

The Honorable Robert W. Kastenmeier

Chairman Sub-Committee on Courts, Civil Liberties
and the Administration of Justice

Committee on the Judiciary
U.S. House of Representatives
2137 Rayburn Office Building
Washington, DC 20515

Dear Mr. Kastenmeier:

It is my understanding that your committee will hold hearings on October 1, regarding H.R. 3074, involving a patent term extension. I am requesting that this letter be entered into the hearing record.

Although I am not in a position to address the legislative issue, I am very much aware of the medical need for more effective treatment to prevent coronary heart disease. The Helsinki Heart Study represents a valuable step in furthering our understanding of the mechanism and prevention of a major health problem--cardiovascular disease.

This was a privately funded study, whose results will contribute to such pioneering landmark research as the National Institutes of Health, Framingham Heart Study and Lipid Research Clinics Coronary Primary Prevention Trial. It is my belief that this type of pioneering research should be recognized and supported.

Sincerely,

leluce & Eckel, md

Robert H. Eckel, M.D.

Associate Professor of Medicine

RHE: cn

I understand your committee will hold hearings on September 23 regarding_H.R. 3074, a patent term extension.

I am not in a position to speak on the legislative implications of the matter. Because of my role in the Framingham Heart Study, I can address the medical significance of the issue.

As the medical director of the Framingham Heart Study, the longest running publicly funded cardiovascular study in history, I recognize the need for epidemiological based research studies. The Helsinki Heart Study is a valuable example of a private initiative which should contribute to our growing understanding of the mechanism and progression of coronary heart disease.

I think that any company that provides a large sum of time and money to a truly scientific endeavor should have those resources and those efforts calculated in the formula we use to decide whether patent extensions should be granted.

From the standpoint of public policy, I believe that such private initiatives deserve support.

Sincerely,

William Castity

William P. Castelli, M.D.
Medical Director
Framingham Heart Study

WPC:gr

cc: Mr.F.C. Boucher, US House of Representatives

Mr.B. Derrick, US House of Representatives