about research, we did not think it was necessary, at that time, for Congress to give any incentive. When the compromise was struck between the-and the generic part was added to it-and that all happened very quickly, we, at the end, I think were helpful in getting the bill through the Senate, and we went along with the judgment in the end. Mr. LUNGREN. See, I understand the need to balance, and I also understand the point that you make about the apparent financial of fiscal health of the pharmaceutical industry, but it seems to me we ought not to make the decision that we should not entertain legislation such as this, unless they can prove that they are in an economically disastrous situation. I mean, then it is too late. Yes, they are healthy, but in part because they are healthy, they are allowed to commit the large resources to further research and development, and it seems to me that is something we want to maintain. You say they made $3 billion in sales, or whatever it was, but you have got a commitment of 1.5 billion towards research and development. I daresay they would not be able to put 1.5 billion into research and development unless they were doing well now. And when we talk about costs, it seems to me one of the things that has been forgotten in this whole process is, that as expensive as prescription drugs are and they indeed are expensive-the alternative to not having a viable approach towards lowering your cholesterol-and therefore we believe the Helsinki study shows us-reducing the risk of heart disease is far more expensive, both in terms of economics and in terms of the impact in human terms. Telling somebody now, that they are going to have to pay a dollar a day, or $1.40 a day for the rest of their life to put them in a position where they will not have the heart attack or they will not have the clogged arteries, and they will not have to have the hospitalization and the incapacitation-in terms of overall economics, in my view, it is probably a hell of lot cheaper than the other side. And at least I think we ought to throw that into the mix when we are discussing the costs involved here. Mr. HARD. I agree with you, entirely. I would just like to point out, that more or less expensive, at some point it does not matter, because if you have not got enough money to buy the pills, you are not going to take the pills, and therefore you cannot benefit from the technology. And I think that, really, there is a fiduciary obligation on the part of an industry that is involved in promoting the saving of lives in this country, to not interfere with natural parts of the market, or the whole regulatory scheme and market combined, that would permit people who do not have adequate health coverage to be able to get access to those pills. And I really think that we are talking about a relatively small part of their market. Secondly, I think that it is relevant, their health is relevant in this case, because historically, Congress, when passing private legislation, has looked into the question of whether the patent owner, or the innovator, has not received a return on their investment. In this case, the evidence is ample, that they are receiving a considerable return, and that that return is going to continue to multiply in the coming years. They are doing fine on this investment. Mr. LUNGREN. I understand that, but I also understand the point made by your colleague there, that 80 or 90 percent—and I think it is even higher than that Mr. HARD. Yes. It may be. Mr. LUNGREN. --of all of the drugs that they try out do not work, at least do not work in an economic sense. They are not marketable, or they do not reach the perceived objective. And therefore, you have to have healthy investments on your successes in order to cover your failures. Mr. HARD. Right. And they are doing that. They are doing fine. That is my point. They are doing fine. Yes, if you look at all those large figures they look big, but it is within the context of immense profits, and it just has to all be-you have to compare benefits versus losses here. They are doing fine. Mr. LUNGREN. Thank you very much, Mr. Chairman. Mr. Hard, I do not want to insert words into your mouth, but I am a little concerned in that as I view, or as I perceive this, you appear to be pointing an accusatory finger at a group because they are financially healthy. And my gosh, as Mr. Lungren said, if they were not financially healthy this ship would never have left the dock. So I am glad they are financially healthy, and I hope they can continue with their research and development, and hopefully, older Americans will be direct beneficiaries. That is where you and I may be at odds, but we will talk about that some time before the dinner bell rings. Thank you, Mr. Chair man. Mr. MORRISON. I want to thank you for your testimony, and this being the last panel, that concludes the hearing. The hearing is adjourned. [Whereupon, at 12:35 p.m., the subcommittee was adjourned, subject to the call of the Chair.] It is requested that this letter be included in the record of the October 8 hearing by the Subcommittee concerning H.R. 3074, the "Lopid Patent Term Extension and Fairness Act of 1987." H.R. 3074 merits support for a number of reasons. First, fairness dictates that Warner-Lambert be provided the legislative relief which it is seeking. Second, in light of the terrible toll that coronary heart disease currently takes on the American public and the rest of the world, it is important that national health policy adequately reward those who take major steps toward alleviating this devastating and costly disease. The Helsinki Heart Study will soon take its place with the Framingham Heart Study, the WHO Study and the LRC STudy as one of the primary coronary research studies ever undertaken. of these principal coronary research studies, the Helsinki Study is the only privately funded study. Additionally, it is highly unusual for a privately funded study to contain so much basic research. Clearly, this kind of undertaking by a private company should be encouraged. Additionally, patent protection is extremely important in fostering innovation in the pharmaceutical arena, since, without it, the high cost of research and the cost and time delays associated with the regulatory process would make the funding of vitally needed new drugs prohibitive. Given this strong support for patent protection for pharmaceutical products, where unusual circumstances exist that have deprived an innovator from receiving the benefits of its costly research, as in the - 2 case with Lopid, legislative relief to provide additional patent protection would seem to be wholly appropriate. ANTONIO M. GOTTO, JR., M.D. August 26, 1987 The Honorable Robert W. Kastenmeier Chairman, Subcommittee on Courts, Civil U.S. House of Representatives 2137 Rayburn House Office Building Washington, D.C. 20515 Dear Mr. Kastenmeier: I understand your subcommittee will hold hearings on September 23 to review H.R. 3074, involving a patent extension matter. I would appreciate this letter being entered into the hearing record. I am Chairman of the Department of Medicine at the Baylor College of Medicine and The Methodist Hospital and have been involved in cholesterol and heart disease research for twenty years. I am also past president of the American Heart Association. I am not in a position to address the legislative issue, but I am very much aware of developments affecting the treatment and prevention of heart disease. With three-quarters of a million cardiovascular deaths a year in this country, public health policy demands that we emphasize education and research initiatives. The recently completed Helsinski Heart Study represents an important step in furthering our understanding of prevention of cardiovascular disease. While this was a privately funded study, its results will be analyzed in context with such major publicly funded efforts as the NIH Framingham Heart Study and the NIH Lipid Research Clinic Coronary Primary Prevention Trial. |