DRUG RESEARCH:
Edict Hampers Testing
Goodyear's old and new hearts Now small enough to go inside
MEDICINE:
The All-rubber Heart Goodyear Tire & Rubber Co. in cooperation with medical research scientists from the Cleveland Clinic in Ohio and the University of Utah are currently experimenting with an all-rubber life-size heart that will fit inside the human body. Previous rubber artificial hearts were too large to be enclosed in the chest cavity. With the number of heart transplants being done, the gravest problem now is the limited number of hearts available for transplants, Goodyear's manager of synthetic rubber research Robert M. Pierson tells C&EN. Most medical research scientists working with artificial hearts and doing transplants look on the artificial heart as the ultimate solution. The life-size artificial heart is possible because natural rubber is used for the inner sac of the heart, Mr. Pierson says. Natural rubber is stronger and has a longer flexing life than other materials that have been used, he adds. Goodyear is also developing synthetic rubbers for artificial blood vessels and heart surface linings. Present efforts center on a dispersion of conductive carbon black in matrices of polyurethane or natural rubber. These rubbers closely simulate the bioelectric and anticlotting functions of the human vascular system, Mr. Pierson says. Small artificial arteries, like the carotid, made of these rubbers, have remained open for more than 4 1 / 2 months without complication, he says. 20 C&EN AUG. 26, 1968
The life-size artificial heart, which looks and works much like a natural one, operates similarly to previous artificial hearts. The outer layer or shell is made of semirigid polyurethane, and the inner sac is natural rubber. Compressed aii* is used to collapse the inner sac of the heart's ventricles and pump the blood. At least 2 gallons of blood per minute can be pumped with the heart, enough to permit a fairly active human life, Goodyear says. Adequate pumping capacity in so compact a unit is an important advance, the University of Utah's Dr. W. J. Kolff explains. Dr. Kolff pioneered the development of the artificial kidney, the artificial heart, and the heart-lung machine while at the Cleveland Clinic. Dr. Yukihike Nose, head of the Cleveland Clinic's research team, has used the heart to sustain life in animals for up to 50 hours, slightly longer than with previous hearts. At the present stage of development, the heart is powered by an external compressed-air source and monitoring system. Thus, patients using it would be confined to a hospital. A second generation of artificial hearts is needed for permanent implants, Dr. Nose explains. These might have a portable power supply to give the patient mobility, he adds with a note of optimism. Studies on power supply and monitoring systems for second-generation hearts are being conducted by the National Aeronautics and Space Administration at the Lewis Research Center in Cleveland.
Procedures for assigning patent rights under medicinal chemistry research grants of the National Institutes of Health may be hampering the development of potential new drugs. This, essentially, is what the General Accounting Office concludes in a report submitted to the Congress a fortnight ago. While the finding comes as no surprise, the fact that GAO is bringing the matter to the attention of Congress likely will spur action on various measures the Department of Health, Education, and Welfare now has in the works to correct some of the problems. GAO says its investigation was prompted by the difficulties NIH grantee investigators were encountering in getting their compounds screened and tested. The root cause of these difficulties, many investigators told GAO, was HEW's 1962 patent procedures revisions. Since that time, investigators say they have been "no longer able to obtain the cooperation of the pharmaceutical industry and that no adequate substitute services were available," GAO reports. It notes that, as a result of these difficulties, some investigators were redirecting their research efforts away from drug development. Before 1962, drug companies had screened and tested compounds prepared under NIH grants routinely and at no charge, the report points out. In return the companies generally acquired certain rights to the development and marketing of promising compounds. This cooperative arrangement ended in 1962 when the Public Health Service required the use of a formal patent agreement which was a part of the terms and conditions of the grant whenever a commercial organization became involved in the research. The agreement provided that any invention which arose or which was developed during the course of the work aided by the grant would be referred to the Surgeon General for determination of patent rights. One condition of the agreement specified that the company shall be permitted to obtain patent rights to new uses of compounds developed at its own expense, "except where the grantee contributed or participated in the conception or reduction to practice of such new use . . ., or where such new use is within the field of research work supported by the grant." The Pharmaceutical Manufacturers Association advised GAO that its members had declined to sign the agreement and had discontinued such screening and testing services because of "uncertainties concerning the interpretation of new uses rights." H E W
