[Congressional Record Volume 140, Number 48 (Thursday, April 28, 1994)]
[Extensions of Remarks]
[Page E]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: April 28, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
                              HEALTH CARE

                                 ______


                        HON. GERALD B.H. SOLOMON

                              of new york

                    in the house of representatives

                        Thursday, April 28, 1994

  Mr. SOLOMON. Mr. Speaker, as we finalize the health care debate in 
the House of Representatives and come closer to agreement, there is an 
issue that has not received the attention that it clearly merits. The 
matter of quality medical care and cost effectiveness with respect to 
new medical technologies and procedures deserves close scrutiny as we 
move forward on healthcare reform. At the heart of this issue is the 
need for a reliable national emphasis on medical technology research 
and development as well as the necessity for quickly bringing 
lifesaving innovations into the medical mainstream.
  Pursuant to these matters, I would like to draw the attention of the 
Congress to the statement of Dr. Ken Fox presented to the House Science 
Committee on March 17. Dr. Fox is one of the inventors of laser 
angioplasty medical technology. Given that heart and circulatory 
disease is America's greatest killer, it is interesting to read about 
the debate between balloon angioplasty, laser angioplasty, and open 
heart surgery. This is an important debate, and I am pleased to be able 
to bring Dr. Fox' remarks to the attention of the House of 
Representatives today.

    Statement of Dr. Ken Fox Presented to the House Subcommittee on 
Technology, Environment and Aviation on Matters Related to Health Care 
 Reform, the Role of Medical Technologies, and the President's Health 
                        Security Act, H.R. 3600

       Thank you Chairman Valentine for allowing me to present 
     some remarks to the Subcommittee on matters related to the 
     President's health care initiative and how it may affect 
     leading edge medical technologies such as laser angioplasty. 
     I commend the Subcommittee on Technology, Environment, and 
     Aviation for holding these hearings and providing a forum for 
     these important technological concerns.
       PILLCO, of which I am CEO, holds the key patents in the 
     United States and in some foreign countries related to the 
     current treatment method which utilizes a pulsed ultraviolent 
     excimer laser. The procedure is FDA-approved and uses these 
     lasers to vaporize atherosclerotic plaque and restore normal 
     blood flow to arteries of the heart. The fact that ours is a 
     pulsed laser--which utilizes carefully selected energy 
     parameters--permits the physician to vaporize plaque without 
     thermal harm to surrounding arterial tissue. Needless to say, 
     this innovative method is a revolutionary approach to cardiac 
     disease mitigation.
       The FDA approved these technologies for commercial use in 
     1992 after many years of evaluation. Presently, two companies 
     are licensed to manufacture these lasers in the United 
     States: Advanced Interventional Systems and Spectranetics. 
     Dr. A. Arthur Coster and I began working on these advances in 
     the late seventies, and I can tell you without bias today 
     that the list of difficulties in bringing this technology to 
     fruition in American hospitals for human benefit would 
     easily, as a popular song once noted, fill the entire Royal 
     Albert Hall. Any changes to our health care system should 
     address the dual matter of bringing life saving and quality-
     enhancing technologies safely and efficiently to the 
     marketplace in its opening legislative clauses.
       Technology drives our health care system as well as our 
     entire economy. The advent in the later 1970's of ``balloon 
     angioplasty'' gave interventional cardiologists a tremendous 
     advantage. However, balloon angioplasty is primarily 
     effective in a smaller number of cardiac patients. The 
     balloon can be effectively used when the lesions (plaque 
     blockages) are simple, and changes in personal diet may 
     provide additional success. When the disease gets more 
     complex and includes long lesions, diffused lesions, heavily 
     calcified lesions, and other difficult blockages the pulsed 
     laser is undeniably the best angioplasty method. Obviously 
     the best method of eradication of the most difficult 
     plaque lesions will also be the best method for attacking 
     the smaller and simpler lesions. The net benefit of this 
     thesis statement becomes more apparent when surgery rates 
     for failed balloon angioplasty are taken into 
     consideration. The resultant expense of open heart and 
     bypass surgery is well documented. Announcements in the 
     news recently that the national cost figure for coronary 
     artery bypass grafting (CABG) is approximately $9 billion 
     a year was astounding! Both the Bureau of National Affairs 
     and the Health Care Data Information Center have jointly 
     claimed in a study that CABG has inflated our national 
     health costs without a correlating enhancement in our 
     national health status. Their study also suggested that we 
     should quantify our projected financial savings in 
     relation to real changes in our medical practice patterns. 
     I believe this would be helpful, too.
       Another interesting facet in this debate is that the pulsed 
     laser advance in angioplasty technology can be less expensive 
     than other angioplasty remediations including balloon. For 
     ease of reference, attached to my statement is a comparative 
     hospital reimbursement and length of stay survey we developed 
     via interviews with hospital administrators for the three 
     major cardiovascular procedures. While the initial hospital 
     investment in the excimer laser technology may appear 
     substantial, the vaporization of the plaque via these lasers 
     provides dramatic cost efficiencies and time savings when the 
     survey results are compared. Although many reasons exist for 
     this, the major ones are:
       1. People are out of the hospital sooner than after surgery 
     or balloon,
       2. Patients are back to work faster,
       3. Laser angioplasty offers lower mortality rates than 
     bypass,
       4. Plaque is vaporized via laser versus being compressed 
     against the arterial wall by balloon angioplasty, and
       5. Surgery is risky, expensive, and the recurrence of 
     plaque is a familiar result.
       The ``Wall Street Journal'' on February 4, 1994, reported 
     on a U.S. Centers for Disease Control and Prevention study in 
     an article entitled ``Coronary Disease Poses Risk to 82% of 
     Americans, Despite Lifestyle Changes.'' The study points out 
     that we should not ignore the risk factors: obesity, lack of 
     exercise, high blood pressure and cholesterol, diabetes, and 
     cigarette smoking (which was defined as having smoked at 
     least 100 cigarettes in one's lifetime!). The CDC's 
     Cardiovascular Health Studies Branch notes that physical 
     activity and diet changes do help reduce one's risk but do 
     not erase the disease altogether. Contrary to popular 
     understanding, coronary heart disease is America's greatest 
     health threat today. In response, ``Medical Laser Marketplace 
     '93'' quotes 1992 Arthur D. Little Co. statistics which 
     project a 25% penetration of lasers in cardiovascular surgery 
     by 1995. The trend is established, and it is based on medical 
     success and the positive cost-benefit ratio of lasers in 
     cardiovascular treatment.
       President Clinton's concern for access to good medical care 
     for all Americans is an honorable goal for our nation. I want 
     to amend that goal with the thought that access to medical 
     care must include access to effective medical care for all 
     Americans. Biotechnology has been an engine of growth for our 
     economy and must remain a locomotive of growth for the 
     continued enhancement of our national health. Everyone should 
     have access to the best medical procedures when warranted. We 
     cannot ignore costs in this equation, and, at the same time, 
     we cannot ignore medical success either. Coronary artery 
     disease cuts across both socioeconomic and geographic 
     boundaries in our country. Our hospitals must be adequately 
     reimbursed for advanced, efficient, and effective procedures 
     like laser angioplasty. If they are not, the companies that 
     develop and supply these and related technologies cannot 
     survive. In a directly related manner our national health 
     status will falter. The resultant macro-economics and macro-
     politics of this potential turn of events should be evident.
       In addition, we are very much in favor of a continued 
     increase in support for research and development in 
     biotechnology. The debate over how much R&D should remain 
     public versus private creates a problem. Lip service has been 
     given to increasing support for R&D by various Federal 
     agencies including NIH. Unless private enterprise is 
     supportive of this increase, the results will not be 
     totally successful. The fact remains that the majority of 
     current R&D is through private innovation, and I believe 
     this is the way it should be in a free market economy.
       This view of total cost is really the key with regards to 
     cost outcomes analysis. In other words, if something like 
     laser angioplasty ultimately gets people out of the hospital 
     sooner, back to work quicker, and permits them to remain in 
     an improved health status for a longer period of time, then 
     many of the more myopic traditional views of health care 
     costs are antiquated. Traditional economics notes that unit 
     costs decrease when efficient production patterns are 
     successfully established. If economic benefits of a healthier 
     society are included in this economic equation as it relates 
     to medical innovation and macroeconomic health care costs, a 
     $200,000 laser angioplasty unit with $1,000 per use catheter 
     costs may be less expensive in total cost to society than a 
     $100 balloon procedure. Is not this a major them of the 
     present health care debate? Are we not in a debate regarding 
     what is best for the American people, both in regard to 
     health care results and as they relate to total expenditure 
     of GNP?
       It is penny wise and pound foolish to reject new 
     biotechnology merely because there is a higher initial price 
     tag on the equipment. It follows then that if we are going to 
     pursue `cheaper' treatments (including diagnostics) without 
     regards to total cost, we will have a much less healthy 
     society with fewer medical options. We also may well end up 
     exporting our biotechnology leadership if we take this 
     approach. With regards to cost outcomes analysis, total cost 
     is the key. High technology will win out in the end. Higher 
     technology will improve health and eventually reduce the 
     total costs of disease for the nation. This is not only true 
     with instrumentation and drugs but also with delivery of 
     medical services and tasks. For instance, the development of 
     an efficient outpatient surgery center will initially have a 
     high price tag. However, over time an efficient outpatient 
     center will incrementally begin to save society money in 
     variable costs as well as promote earlier rehabilitation.
       The concept of price caps disguised as premium limitations 
     is an absolute anathema to biotech's success as well as 
     health care's continuing ability to prosper. When we cut 
     costs for health care without a just review of the resultant 
     total cost to society, we can effectively reduce the health 
     of the entire nation. In addition, the thought of extra 
     bureaucracy created under the new terminology of 
     ``alliances'' and ``regional boards'' ordinarily runs 
     contrary to the needs of technological innovation. History 
     has shown that government bureaucracies cannot adequately 
     evaluate new technology.
       The freedom to choose specialty health care--including 
     those that involve new and high technologies in the biotech 
     field--is essential to preserve. Our concerns are that if 
     someone is locked into a ``network'' or ``alliance'' which 
     limits choice, the availability of innovation in severely 
     restricted and the free market is negated. This is 
     counterproductive for the nation. On the companion matter of 
     liability reform, PILLCO favors an immediate review of this 
     matter by the Congress. It cannot be separated out of the 
     cost outcomes analysis for patient care. In addition, cost 
     outcomes analysis must include an analysis of the total cost 
     to society as well as the total effects of procedures and 
     technologies rather than limiting these evaluations to 
     technology's initial costs and the like.
       Chairman Valentine, thank you for allowing me to provide 
     the Science Committee some details related to a very complex 
     medical arena--that of laster angioplasty. In closing, I wish 
     to point out that we at PILLCO are not opposed to managed 
     care in the health industry. What kind of managed care is the 
     important issue. We must provide for the American people a 
     health care system which takes advantage of advances in 
     technology and requires the advances to pay back solid 
     dividends in terms of a longer and better quality of life for 
     all Americans.

                          ____________________