892 Am. J. Hum. Genet. 51:892-893, 1992
Survival of Academic-based Genetic Laboratory Services To the Editor: As an owner-operator of a private genetic service laboratory since 1974, I wish to respond to Dr. Milunsky
(1992). He states that the "complex nature of genetic testing . . . make[s] commercial laboratories a poor choice for such studies" (p. 644). This generalization is misguided and can be challenged. Selecting a reference laboratory, either private or academic, is an awesome responsibility. The choice should be a function of quality of service and confidence of results. Numerous academic laboratories fall short of the mark. Some are hampered by outdated equipment and techniques and by disinterested directors. They frequently do less than an adequate job and, according to Milunsky, should "improve . . . services to match those of industry" (p. 644). Such commercial activities are in direct conflict with their chosen career of teaching and research. The very fact that the faculty operates a clinical (fee-for-service) laboratory is contrary to the fundamental concept of academia. This conflict at the faculty level could result in poor performance due to lack of interest and frustration. A well-run, focused commercial lab could be a better choice. There are responsible commercial genetic service laboratories. Some have active and well-run research sections making a contribution to and bringing new technology to the community. Some provide salary and research or contract support to academia. Some are deeply involved in publishing, teaching, and lecturing, to educate the general and medical/scientific public. Their focus and dedication is to medical genetics at the highest level. They are manned by staff and consultants who are board certified in the various categories of the American Board of Medical Genetics. To be commercial or private does not equate with sloppy or inadequate. Also, I am very concerned about Milunsky's implication that physicians trained in clinical genetics should handle the intricacies of patient communications. Genetic counselors are specifically trained in the intricacies of this communication. To openly contend that commercial laboratories invite "direct liability by sending genetic counselors with a masters degree into doctors' offices to provide genetic counseling" (p. 644) is uncalled-for.
Letters to the Editor Dr. Milunsky indicates there may be a threat to academic establishments. Contrary to this, data presented at the 1992 SERGG (Southeastern Regional Genetics Group) meeting indicated that 86% of the cytogenetics samples processed in the southeastern region was done by academic labs. In 1991, only 7,601 of 54,718 samples were processed by private laboratories. There are in this region 33 academic cytogenetic laboratories and 3 private genetic laboratories that reported in 1991. Since 1983, the overall efficiency has doubled for university cytogenetic labs and has increased sevenfold in private labs. It is clear that both efficiency and proficiency have been positively influenced by interaction between laboratories. To advocate partitioning of private labs and academia is foolish. Milunsky's steps to protect academia might be modified to be steps toward better genetic services. To this end I submit the following: 1. Educate referring physicians so they are capable of selecting competent genetic laboratories, both private and academic. 2. Update equipment, technical expertise, and protocols. 3. Promote collaboration between academic and commercial entities. Public corporations have funds for research, faculty salaries, and operation oftraining programs - a valuable resource in these times of unavailable government grants. 4. Support the laboratory proficiency and inspection program with the College of American Pathologists or another responsible agency. Consolidation of genetic services is ongoing. Cytogenetics, biochemical genetics, and specific areas of molecular genetics are highly specialized, esoteric laboratory tests requiring a team, including qualified counselors and physicians. Those involved in the consolidation of genetic services need to be sensitive to this. There will be leaders of the consolidated genetic services. Those who become leaders will be those dedicated to providing the best possible service, constantly developing and refining techniques and protocols, monitoring new developments, and implementing new techniques in the most timely manner. This entire matter is akin to Darwinism. The fittest will survive. I thank Dr. Milunsky for bringing this topic into the open. It needs to be aired. I hope that no one's job is truly threatened. Learn, adjust, improve, and con-
Letters to the Editor
tinue onward and upward with the rest of us, rather than lose a job. RICHARD J. WARREN Medical Genetics of American Board Diplomate, Miami Reference Milunsky A (1992) Threatened survival of academic-based genetic laboratory services. Am J Hum Genet 50:643645 i 1992 by The American Society of Human Genetics. All rights reserved. 0002-9297/92/5104-0025$02.00
Am. J. Hum. Genet. 51:893-894, 1992
Descent into Demonology and Protectionism To the Editor:
We personally admire Aubrey Milunsky but feel he has taken the wrong tack in his letter about the threatened survival of academic genetic-testing laboratories (Milunsky 1992b). We fear, in fact, that he has descended into demonology and retreated into protectionism. The demons in his mind are the commercial laboratories that have mounted an "invasion" (Milunsky 1992a). His solution is to take protective steps by forming a closed academic shop. It is easy to depict our colleagues in commercial genetics as demonic, to call their companies unscrupulous and unethical, and to point out their mistakes. It also implies that everyone in academic genetics is scrupulous, ethical, and error free, when we know that such is not always the case. Genetic-testing companies are not the creation of the devil hell-bent on destroying academic genetics. These companies arose because they saw a market for their services and perceived a growth industry with the
potential for considerable profits. Milunsky notes the "not unexpected excesses" of genetic-testing companies. The success of these companies, in fact, was made possible because of the excesses and deficiencies of academic genetics. The excesses have included intellectual arrogance and high fees. The deficiencies have been in not providing consistently prompt, convenient, and low-cost services. It is no secret that these days most referring doctors, clinics, and hospitals respond first to the fee structure,
893
second to turnaround times, third to the delivery of services, and not much to the total cells analyzed or the number of chromosome bands. Analysis of chromosomes from amniotic-fluid cells used to take academic centers 3-4 wk for the results to be reported back to the referring physicians. Commercial laboratories began offering the same test, usually at a lower price, with results in 5-7 d. For many years, academic and clinical programs in medical genetics, as Dr. Milunsky knows but does not discuss, have been nicely subsidized by the profits from fee-for-service genetic laboratory tests. The laboratory fees have usually included academic or administrative surcharges. Consumers are no longer willing to pay this tax. The solution proposed by Dr. Milunsky is his "academic laboratory network" (Milunsky 1992a). (Translation: Let's form a private club and exclude the other guys.) This is, unfortunately, predicated on the delusion that academic geneticists still control the routing of most genetic laboratory specimens. We have all had the experience in which, although a doctor or patient voices a preference for the academic laboratory, the specimen ends up elsewhere because an exclusive contract has been negotiated between a third-party payor and a specific commercial laboratory. To "educate referring physicians to the wisdom of formal and comprehensive services" (p. 644) in academic genetics is to do nothing new. Most referring physicians already know about the formal and comprehensive services available at academic institutions. Many physicians do not want to refer their patients to formal and comprehensive services. That is why many of them use commercial laboratories that, in turn, return the genetic laboratory results directly to the referring physician. Medical schools and academic hospitals have two main purposes-to provide teaching and to do research. They are in no way designed to render efficient, cost-effective, large-volume laboratory services for doctors and patients all over the United States and even in other countries. What is the current status of genetic-testing laboratories within academic institutions? Some of them are already separately incorporated, often as a for-profit laboratory within a nonprofit academic institution. A number of academic laboratories have already been purchased by commercial companies that operate quietly behind the scenes. Many academic genetic-laboratory directors serve as consultants or on boards of directors and/or own stock in one or several commer-
Survival of Academic-based Genetic Laboratory Services To the Editor: As an owner-operator of a private genetic service laboratory since 1974, I wish to respond to Dr. Milunsky
(1992). He states that the "complex nature of genetic testing . . . make[s] commercial laboratories a poor choice for such studies" (p. 644). This generalization is misguided and can be challenged. Selecting a reference laboratory, either private or academic, is an awesome responsibility. The choice should be a function of quality of service and confidence of results. Numerous academic laboratories fall short of the mark. Some are hampered by outdated equipment and techniques and by disinterested directors. They frequently do less than an adequate job and, according to Milunsky, should "improve . . . services to match those of industry" (p. 644). Such commercial activities are in direct conflict with their chosen career of teaching and research. The very fact that the faculty operates a clinical (fee-for-service) laboratory is contrary to the fundamental concept of academia. This conflict at the faculty level could result in poor performance due to lack of interest and frustration. A well-run, focused commercial lab could be a better choice. There are responsible commercial genetic service laboratories. Some have active and well-run research sections making a contribution to and bringing new technology to the community. Some provide salary and research or contract support to academia. Some are deeply involved in publishing, teaching, and lecturing, to educate the general and medical/scientific public. Their focus and dedication is to medical genetics at the highest level. They are manned by staff and consultants who are board certified in the various categories of the American Board of Medical Genetics. To be commercial or private does not equate with sloppy or inadequate. Also, I am very concerned about Milunsky's implication that physicians trained in clinical genetics should handle the intricacies of patient communications. Genetic counselors are specifically trained in the intricacies of this communication. To openly contend that commercial laboratories invite "direct liability by sending genetic counselors with a masters degree into doctors' offices to provide genetic counseling" (p. 644) is uncalled-for.
Letters to the Editor Dr. Milunsky indicates there may be a threat to academic establishments. Contrary to this, data presented at the 1992 SERGG (Southeastern Regional Genetics Group) meeting indicated that 86% of the cytogenetics samples processed in the southeastern region was done by academic labs. In 1991, only 7,601 of 54,718 samples were processed by private laboratories. There are in this region 33 academic cytogenetic laboratories and 3 private genetic laboratories that reported in 1991. Since 1983, the overall efficiency has doubled for university cytogenetic labs and has increased sevenfold in private labs. It is clear that both efficiency and proficiency have been positively influenced by interaction between laboratories. To advocate partitioning of private labs and academia is foolish. Milunsky's steps to protect academia might be modified to be steps toward better genetic services. To this end I submit the following: 1. Educate referring physicians so they are capable of selecting competent genetic laboratories, both private and academic. 2. Update equipment, technical expertise, and protocols. 3. Promote collaboration between academic and commercial entities. Public corporations have funds for research, faculty salaries, and operation oftraining programs - a valuable resource in these times of unavailable government grants. 4. Support the laboratory proficiency and inspection program with the College of American Pathologists or another responsible agency. Consolidation of genetic services is ongoing. Cytogenetics, biochemical genetics, and specific areas of molecular genetics are highly specialized, esoteric laboratory tests requiring a team, including qualified counselors and physicians. Those involved in the consolidation of genetic services need to be sensitive to this. There will be leaders of the consolidated genetic services. Those who become leaders will be those dedicated to providing the best possible service, constantly developing and refining techniques and protocols, monitoring new developments, and implementing new techniques in the most timely manner. This entire matter is akin to Darwinism. The fittest will survive. I thank Dr. Milunsky for bringing this topic into the open. It needs to be aired. I hope that no one's job is truly threatened. Learn, adjust, improve, and con-
Letters to the Editor
tinue onward and upward with the rest of us, rather than lose a job. RICHARD J. WARREN Medical Genetics of American Board Diplomate, Miami Reference Milunsky A (1992) Threatened survival of academic-based genetic laboratory services. Am J Hum Genet 50:643645 i 1992 by The American Society of Human Genetics. All rights reserved. 0002-9297/92/5104-0025$02.00
Am. J. Hum. Genet. 51:893-894, 1992
Descent into Demonology and Protectionism To the Editor:
We personally admire Aubrey Milunsky but feel he has taken the wrong tack in his letter about the threatened survival of academic genetic-testing laboratories (Milunsky 1992b). We fear, in fact, that he has descended into demonology and retreated into protectionism. The demons in his mind are the commercial laboratories that have mounted an "invasion" (Milunsky 1992a). His solution is to take protective steps by forming a closed academic shop. It is easy to depict our colleagues in commercial genetics as demonic, to call their companies unscrupulous and unethical, and to point out their mistakes. It also implies that everyone in academic genetics is scrupulous, ethical, and error free, when we know that such is not always the case. Genetic-testing companies are not the creation of the devil hell-bent on destroying academic genetics. These companies arose because they saw a market for their services and perceived a growth industry with the
potential for considerable profits. Milunsky notes the "not unexpected excesses" of genetic-testing companies. The success of these companies, in fact, was made possible because of the excesses and deficiencies of academic genetics. The excesses have included intellectual arrogance and high fees. The deficiencies have been in not providing consistently prompt, convenient, and low-cost services. It is no secret that these days most referring doctors, clinics, and hospitals respond first to the fee structure,
893
second to turnaround times, third to the delivery of services, and not much to the total cells analyzed or the number of chromosome bands. Analysis of chromosomes from amniotic-fluid cells used to take academic centers 3-4 wk for the results to be reported back to the referring physicians. Commercial laboratories began offering the same test, usually at a lower price, with results in 5-7 d. For many years, academic and clinical programs in medical genetics, as Dr. Milunsky knows but does not discuss, have been nicely subsidized by the profits from fee-for-service genetic laboratory tests. The laboratory fees have usually included academic or administrative surcharges. Consumers are no longer willing to pay this tax. The solution proposed by Dr. Milunsky is his "academic laboratory network" (Milunsky 1992a). (Translation: Let's form a private club and exclude the other guys.) This is, unfortunately, predicated on the delusion that academic geneticists still control the routing of most genetic laboratory specimens. We have all had the experience in which, although a doctor or patient voices a preference for the academic laboratory, the specimen ends up elsewhere because an exclusive contract has been negotiated between a third-party payor and a specific commercial laboratory. To "educate referring physicians to the wisdom of formal and comprehensive services" (p. 644) in academic genetics is to do nothing new. Most referring physicians already know about the formal and comprehensive services available at academic institutions. Many physicians do not want to refer their patients to formal and comprehensive services. That is why many of them use commercial laboratories that, in turn, return the genetic laboratory results directly to the referring physician. Medical schools and academic hospitals have two main purposes-to provide teaching and to do research. They are in no way designed to render efficient, cost-effective, large-volume laboratory services for doctors and patients all over the United States and even in other countries. What is the current status of genetic-testing laboratories within academic institutions? Some of them are already separately incorporated, often as a for-profit laboratory within a nonprofit academic institution. A number of academic laboratories have already been purchased by commercial companies that operate quietly behind the scenes. Many academic genetic-laboratory directors serve as consultants or on boards of directors and/or own stock in one or several commer-
