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STATE OF LABORATORY ANIMAL MEDICINE AROUND THE WORLD Europe Hans Hedrich The most credible training for veterinarians in the area of laboratory ani- mal medicine is through the European College of Laboratory Animal Medicine (ECLAM). Diplomate status in ECLAM goes beyond FELASA Category D, and I personally refer to it as FELASA Category E. It would be desirable to have European governments accept that requiring laboratory animal veterinarians to become diplomates is the best way to control and govern animal experimenta- tion. In Europe, we have a long-standing history of laboratory animal science associations, whose membership is about 50% veterinarians and the other 50% those trained in biomedicine or biology or other sciences. The laboratory animal science perspective, therefore, is encompassed by FELASA. To address the laboratory animal medicine side of things, in the UK there is the Royal College of Veterinary Surgeons as well as the British Laboratory Animals Veterinary Association. Both are long-standing and laboratory animal medicine has always been an important issue with them. The primary body in Europe is the European Society of Laboratory Animal Veterinarians (ESLAV), which initiated the European College of Laboratory Animal Medicine (ECLAM). However, this is a relatively new approach. Of the 27 member states in the European Union, 26 have veterinary schools. Europe in total has 31 countries and 80 veterinary schools, but this number does not reflect the size of the population or the culture of the countries. For example, there are 16 veterinary schools in Italy and 16 in Spain, but only one in the Nether- lands. Programs in laboratory animal medicine are relatively rare. Veterinary training in accordance with FELASA Category D occurs in Italy, Germany, the Netherlands, Spain, and Sweden. The program in laboratory animal science in Milan, Italy, includes two years of training. In Germany, specialists in laboratory animal science have to train for four years. In the Netherlands, labo- ratory animal specialists undergo government-recognized training in Utrecht and several other places for 18 months. In Spain there is a master’s degree program 102

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Europe 103 in laboratory animal science and welfare in Barcelona and Madrid that lasts two years. Sweden also has a two-year master’s degree at Uppsala. Thus there is quite a variety in the training of laboratory animal science specialists. In Europe, veterinarians have a special legal responsibility and profes- sional obligation, especially in treating animals with medications, using anesthe- sia, or administering analgesics, all of which are not permitted to any other pro- fession. However, from a regulatory perspective, there are differences among countries as to how much veterinary involvement is permitted in animal experi- mentation aside from the requirements for medications or prescriptions and an- esthesia. These differences are apparent going from west to east in Europe, with some of the new countries in the EU being rather undeveloped in the field of laboratory animal medicine. Programs for FELASA Category D based on veterinary training or in vet- erinary medicine are in Italy, Belgium, Germany, the Netherlands, Norway, Spain, Sweden, Switzerland, and the United Kingdom. Again, there is inconsis- tency in the requirements of the various programs. In Italy, a diploma in labora- tory animal science takes three years, while in Belgium it takes only two years. In Germany, the program is provided through the veterinary boards and training in approved institutions and takes three to four years; the four-year program is for laboratory animal science or laboratory animal medicine, while the three- year program is for animal welfare, which is also accepted under Category D. In the Netherlands the program is one and a half years, in Norway three years, Spain two years, Sweden two years, Switzerland four years. The United King- dom has a two-tiered approach, with a certificate in two years and the diploma provided by the Royal College of Veterinary Surgeons in five years. ECLAM was established in 2000 and in 2008 received permanent recogni- tion by the European Board of Veterinary Specialization, which is our governing and controlling group, to which we must report directly. The founding of the College was an initiative of ESLAV and covers everything important in labora- tory animal medicine. The leadership of ECLAM identified the issues important to the organiza- tion and proposed initiating discussion on including ethics in addition to improv- ing animal welfare in order to make these issues permanently a part of the or- ganization’s goals. ECLAM has established guidelines for examination and qualification of veterinarians for diplomate status. Although the examination is difficult, those who pass are highly qualified to direct a program in laboratory animal medicine. ECLAM encourages research and promotes the communication and dis- semination of knowledge in the field of laboratory animal medicine. The Euro- pean Board of Veterinary Specialization has required training programs to be four years long, at least two and a half years of which should be under the su- pervision of a diplomate. There are 23 different veterinary specialty colleges and all are expected to have minimum standards. The alternate training program takes two more years, but again two and a half years under the supervision of a diplomate. There are currently eight pro-

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104 Animal Research in a Global Environment: Meeting the Challenges grams in various European countries. Once again, there is diversity among the programs. However, regardless of the training program, all who pass the exam are able to [attain] diplomate status. Reevaluation occurs every five years based on a 100-point credit system. ECLAM and ESLAV have been involved with FELASA on defining appro- priate veterinary care of laboratory animals. A paper describing the guidelines for veterinary care of laboratory animals was published by the FELASA/ECLAM/ ESLAV working group in 2008. The working group agreed that care of laboratory animals may be pursued by various professionals with different backgrounds, but the veterinarian is unquestionably the most appropriate person to provide veteri- nary care. The concepts presented in the paper have not been accepted as yet throughout the European Community. The guidelines indicate that the professional judgment of a veterinarian trained in laboratory animal science is essential in the application of the recom- mendations on animal care and use to the specific institution. Veterinarians have specific legal responsibilities and professional obligations with respect to regula- tory bodies. A key part of the guideline paper is that education provides the basic knowledge and enables a person to work as a veterinarian, although legal and professional obligations vary among the countries. Undergraduate education emphasizes mostly the treatment and care of companion and farm animal spe- cies without much [attention] to laboratory animals. Because of this, it is critical that the laboratory animal veterinarian obtain specific education, training, and competence in dealing with these species. Education in laboratory animal medicine needs to be improved throughout Europe and especially in the Eastern European countries. Generally, it is not the veterinary schools that train specialists in laboratory animal medicine; such training is done at medical schools where the actual research on the animals is conducted. The European legislation currently does not specify further educational requirements for a veterinarian with legal responsibilities for longitudinal care, even in the most recent draft. The multilateral consultation of parties to the con- vention has adopted the resolution on education and training of persons working with laboratory animals. This resolution is based on the FELASA recommenda- tions for the education and training of persons involved in animal experiments. These recommendations were suggested to be included in EU Directive 86/609, which currently reads “a veterinarian or other competent person.” It should be changed to read “a veterinarian trained and experienced in laboratory animal medicine or, exceptionally, another competent person” should be charged with advisory duties in relation to the well-being of the animals, but that person should also have the appropriate authority. Based on the FELASA recommenda- tions, these would be persons trained under Category D and in rare exceptions Category C. It is now possible to say that consistent veterinary postgraduate specialty training and certification has been fully established in Europe through the efforts

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Europe 105 of the veterinary profession, arising from the advice of the Commission’s Advi- sory Committee on Veterinary Training and overseen by the European Board of Veterinary Specialization. There is a recognized European veterinary specializa- tion in laboratory animal medicine, as well as training, certification, and con- tinuing education organized by ECLAM and ESLAV in addition to other or- ganizations such as Royal College of Veterinary Surgeons and other veterinary boards. The Royal College of Veterinary Surgeons announced that, once ECLAM had achieved permanent recognition, they would drop their own di- ploma in favor of the ECLAM diploma. Finally, I want to comment on the information received by FELASA and other organizations about the revision of the EU directive. It seems that the vari- ous commission directorates, in particular the directorate of research, have not been able to agree on the draft text of the EU directive. The Commission has therefore decided that it will submit the text as it stands to the “oral procedure.” This means that the College of Commissioners will decide whether to release the text as it stands into the codecision process or with only minor amendments, or they may decide it requires more extensive amendment and postpone its adop- tion. Another possibility is that the College of Commissioners might decide that the directive requires more extensive amendment and may postpone the adop- tion of the draft. Apparently also in the Members of Cabinet meeting many ob- jections were raised, especially in relation to the current draft, and thus no con- sensus could be reached. The discussion that seemed to be most important concerned the excessive limitations on the use of nonhuman primates in Europe and there was potential bureaucracy originating from unclear definitions in the draft. This may all change with the upcoming elections to the European Parlia- ment in the spring. Also, quite a number of new commissioners will be ap- pointed next year, so there will be different groups of people in Brussels as well as in Strasbourg.

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Latin America Rafael Hernandez Latin America is the region south of the border of the United States to Chile near the Antarctic. It includes 21 countries, 21 million square kilometers, and purchasing power of $5 trillion. Although most Latin American people are Western oriented, it really is not considered for some cultures part of the West but rather a unique and different region. Latin American countries share many things, such as language, Spanish- Portuguese background, culture (to a greater or lesser extent) with Indian roots. Some of those countries also have scientific traditions, such as Mexico, where José de la Luz Gómez, using the Pasteur method, produced rabies vaccine in 1888 and became the first laboratory animal veterinarian in Mexico. Carlos Juan Finlay y Barres from Cuba identified the mosquito as the yellow fever agent and was the first scientist to identify an insect as a biotransmitting agent. Oswaldo Cruz, from Brazil, was probably the most well known veterinarian, and Bernardo A. Houssay from Argentina was the first Latin American to win the Nobel Prize in medicine, in 1947. However, in spite of this glorious past, the present panorama for research and development is not equal and sustained for all Latin American countries. Latin American countries are divided into blocs of nations with respect to the potential economic impact of the region. Countries like Brazil, Argentina, Chile, Colombia, Mexico, and Costa Rica have enough resources and capacity to sup- port the training of researchers [whereas] other countries do not. The importance of the number of PhDs earned in a country has already been discussed. There is a very large gap between North America and Latin American countries as well as among the Latin American countries. Brazil has the highest number of students enrolled in tertiary institutions. This is also evi- dent in the investment of the various countries in scientific research; on average Latin American countries allocate less than half a point of their GNP, [only] Brazil allocates more than 1%. Latin American countries are trying to encourage their populations to pur- sue university educations. Mexico, Cuba, Colombia, Brazil, and Argentina have a large number of universities, but even so they are still distantly behind the 106

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Latin America 107 United States and Western Europe. Similarly, Latin American countries lag the four top countries—the US, England, Germany, and Japan—in the number of highly cited researchers. The scientific productivity of Latin America represents only 4% of that of the world. However, Mexico, Cuba, Brazil, Argentina, Uruguay, and Chile are striving to do high-quality science, in part by producing and using transgenic animals. Most of the countries have institutional standards, ethics committees, or institutional animal care and use committees, but only Costa Rica (1994), Mex- ico (2002), and Brazil (2008) have national laws for the care and use of labora- tory animals. In Latin America there are several associations for laboratory animal sci- ence; these exist in Argentina, Brazil, Colombia, Cuba, Mexico, Peru, Uruguay, and Venezuela. There are also associations that bridge more than one country, like the Central American, Caribbean, and Mexican Association for Laboratory Animal Science (ACCMAL), and federations, like the South American Federa- tion for Laboratory Animal Science (FeSSACAL), which includes countries in the southern part of Latin America. It is important to note that these associations include not only veterinarians but also technicians and scientists working in the field; there is no specific association or college for veterinary practitioners. Appropriate courses in a formal educational program for laboratory animal medicine are found only in Cuba, which awards a master’s degree in laboratory animal science. Brazil, Argentina, Chile, and Mexico don’t have specific pro- grams for laboratory animal science, but it is possible to get master’s or PhD degrees in the field by selecting credits on related subjects at veterinary, pharmacy, or medical schools. This is possible in at least two universities in Mexico, several in Brazil, and at the Universities of La Plata and Buenos Aires in Argentina. In undergraduate veterinary medicine education in Mexico, it is possible to get a four-hour introduction to laboratory animal science, and students who are interested in pursuing laboratory animal science may take a 48-hour labora- tory animal course. Similar programs exist in Argentina at La Plata University and Buenos Aires University. In other Latin American countries it is the phar- macy schools that teach care and pharmacologic use of animals, but not breed- ing, health, genetics, or environmental control. The majority of animal facilities in Latin America do not have a full- or part-time appointed veterinarian except in Argentina, Mexico, Cuba, Venezuela, and some parts of Brazil. Distance education is viewed as a very important endeavor in the future. The veterinary school in Mexico is working to sign an agreement with the Uni- versity of Guelph in Canada to be able to use a Spanish version of their animal medical certification program to provide education not only in Mexico but in all countries interested in the field. Other programs are available in both Spanish and English—e.g., a bilingual institutional training program for scientists of- fered by the University of Miami.

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108 Animal Research in a Global Environment: Meeting the Challenges A certification program run by ConeVet (National Council for Veterinary Medical Education, the academic branch of the Mexican Veterinary Medical Association) for laboratory animal veterinarians aims at improving the quality of education. There are actually two programs, one for accreditation of veterinary schools and one for certification of practitioners. The certification program is board-specific for each species, and each candidate must pass one of two boards: one based on credentials for those who have a lot of training or experience, and the other on an exam for those newly coming into the field. The credential certi- fication process occurred only in 2006, for the initial certification period. The assessment was based on professional experience (500 possible points), continu- ing education (500), professional education (400), teaching or academic activi- ties (200), publications (400), and related association/college membership (150). The minimal certification score for this evaluation was 1100 points. For the laboratory animal medical certification process by exam, there is an agreement between CENEVAL (National Center for Higher Education Evaluation) and ConeVet. CENEVAL is an independent organization for test- ing, very similar to the Educational Testing System in the United States, and runs the license and certification examinations. The certification is actually given by ConeVet. The exam is long—two days for four hours each day—and is divided into different sections covering diverse areas of knowledge and professional abilities. It is given twice a year, in April and December during the AMCAL (Mexican Association for Laboratory Animal Science) meeting. The future holds some interesting opportunities. While Latin America cov- ers a large area, there is a real advantage because the countries share the same language (with the exception of Brazil, but Portuguese may actually be closer to Spanish than British English is to American English). Therefore, if we work together to establish high-quality courses for this kind of education, we may be able to consolidate the examination process, particularly if we share experience with similar certification bodies, not only from Latin America but also from Europe or Asia. We can also benefit by working together to establish an umbrella organi- zation, a Latin American Association for Laboratory Animal Science. This may also serve to help establish a Latin American College for Laboratory Animal Medicine or a Laboratory Veterinary Association. In these ways, we will have an opportunity to encourage and improve the quality of veterinary education in laboratory animal science in these areas.

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North America James G. Fox I would like to address a very serious issue in terms of the state of com- parative medicine and laboratory animal medicine worldwide, particularly the state of the veterinary medicine profession in North America. I urge all who have not seen the Foresight Report (J Vet Med Ed 34:1-41; 2007), commissioned by the American Association of Veterinary Medical Col- leges (AAVMC), to read and digest it since I believe it is critical for the progress and the future of veterinary medicine in general, and certainly for comparative medicine. The summary of the report states that veterinary medicine is the only profession in the health and medical field whose members are trained in com- parative medicine. Veterinarians are critical components of public health and essential health care providers to society locally, nationally, and internationally in light of their concern for animals, their health and well-being, and their inter- face with people. However, the summary also states that veterinarians must first demonstrate relevance to new societal needs and trends in order to be recognized and remunerated for their knowledge, compassion, integrity, and judgment. Since 1989, the veterinary profession in the United States has been fairly static in terms of the number of veterinarians graduated, which is a little over 2,000 per year. Based on public demand, veterinary schools are primarily train- ing veterinarians to fulfill roles in small animal practice. So about 44,000 veteri- narians practice small animal medicine, while a much smaller number are in- volved in large animal and equine medicine, with the remainder in public and corporate veterinary medicine. Thus with respect to the veterinary curriculum, the disciplines of labora- tory animal medicine and biomedical research are competing against tremen- dous odds for young veterinary professionals. Several publications of the Na- tional Research Council—National Needs and Priorities for Veterinarians in Biomedical Research (2004), Critical Needs for Research in Veterinary Science (2005), and an earlier document, New Horizons in Veterinary Medicine (1972)—stress the need for the veterinarian to become involved in corporate veterinary medicine, academia, and industry to fulfill societal needs. 109

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110 Animal Research in a Global Environment: Meeting the Challenges In recognition of these reports and the Foresight Report, the National Re- search Council has appointed a committee to assess the current and future work- force needs in veterinary medicine. The report, which is still in preparation, will be an important report exploring both historical changes in veterinary medicine and the adequacy of the current supply of veterinarians in different occupational categories and employment sectors. The report will also explore factors that will likely affect the future demographics of veterinarians. It has been well documented that there is a tremendous need for ade- quately trained laboratory animal medicine veterinarians and veterinarians in- volved in biomedical research. From 1999 to 2002, the average numbers of job postings per year for these positions were 68.5 in academic institutions, 28.3 in industry, and 7.5 in government. Those numbers are not likely to be different now. What are we doing as a profession in the United States to fulfill the needs in these three sectors? In looking at the number of diplomates of the American College of Laboratory Animal Medicine (ACLAM), from 1996 to 2002 there was a 3% annual increase in membership; from 2002 to 2008, the total number has increased to 718 diplomates, but over those six years there was only a 7% overall increase, a little over 1% a year. The numbers clearly indicate that the profession has not met the needs of the academic, industrial, and government sectors. Compounding the problem is the significant number of retirements that will occur over the next 20 years. Al- though we practice the 3Rs and are looking for in vitro models and other alterna- tive methods with which to conduct biomedical research, there is no doubt that animal use is going to remain a considerable part of the biomedical research engine. In reviewing the NIH grants portfolio over the last 20 years, the data show that an average of 50% of grants involve the use of laboratory animals. It is very likely that the use of laboratory animals in research institutions continues to grow but at a more modest rate in the last several years because of the con- straints of the NIH budget. Given the continued need for animal research, we must meet the challenge of eliciting interest and enthusiasm for comparative medicine in our young veterinary colleagues. While veterinary medicine is thought of as a clinical-based profession we need to provide persuasive argu- ments and opportunities in public health, regulatory agencies, academic, indus- try, and biomedical research. In addition, we need to promote and transmit this breadth of opportunity to our young colleagues and to the public in general. The veterinary profession must exert coordinated efforts to communicate to students beginning in middle and high school, provide research opportunities to undergraduates, and, importantly, provide opportunities to veterinary students to work in research laboratories. Another approach to meeting the needs is to diversify the career interests of the veterinary student body. This means that we must include in the applicant pool individuals who are interested in diverse careers, including biomedical re-

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North America 111 search and comparative medicine. The admission process for veterinary schools must reflect this need. One of the recommendations that came out of the 2004 NRC report was that all veterinary schools should offer at least an elective course in laboratory animal medicine and more veterinary schools should require course work in this specialty. Also, the National Examination Board should include questions ger- mane to the subject matter on the national veterinary boards. Comparative medi- cine specialists should actively seek out and mentor students with an aptitude for and interest in comparative medicine. ACLAM did a survey in 2006; this project, led by Lesley Colby, is in re- view and will soon be published. The committee asked the question that we posed in our Academy report: Is a laboratory animal medicine course offered as part of the current curriculum to your students? In a somewhat reassuring re- sponse, 65% said yes, but 35% said no. Asked whether the students received lectures in laboratory animal medicine as part of other courses, a higher percent- age (87%) said yes because having a few lectures scattered through the course is easier in terms of curriculum development. However, when asked if laboratory animal medicine–related problems were used in case studies, only 29% re- sponded yes. So it is clear that we are not doing a very good job of exposing veterinar- ian students to career potential in comparative medicine or biomedical research. Dr. Steve Barthold illustrates this outcome very effectively by comparing career choices with pipes: the largest-volume pipe is the one for clinical practice; the pipes for science and laboratory animal medicine are much smaller. One obstacle in attracting veterinary students into biomedical research is financial debt. A survey of veterinary students revealed that they averaged over $100,000 of debt at graduation. They must weigh this loan repayment obligation with salary expectations over their career. In addition, choosing a career in bio- medical research presents the daunting task of having to successfully secure funding over the duration of their career from NIH and other external sources. These impediments must be considered when trying to help the students understand that the profession of laboratory animal medicine is a viable alterna- tive to clinical practice in terms of remuneration and biomedical research. This requires mentoring and an environment in the laboratory to set the proper tone for a research experience. I would like to share a quote with you from one of the students at the con- ference last year: “A brilliant mentor with a great sense of humor will undoubt- edly be more inspiring than a brilliant mentor who won’t crack a smile or works 18 hours a day.” This quote makes me think of my friend Steve Barthold. One must balance the successes and the satisfaction gained from a career in labora- tory animal medicine and must transmit that enthusiasm to younger colleagues and high school students to let them know that research and involvement in cor- porate practice is a satisfying career. There has been a very aggressive effort by ACLAM as well as the Ameri- can Society of Laboratory Animal Practitioners and others to establish, critique,

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112 Animal Research in a Global Environment: Meeting the Challenges and approve training programs in the United States. There are currently 41 of these training programs that cover a wide spectrum of opportunities for students, including positions in medical schools, veterinary schools, research institutions, pharmaceutical companies, primate centers, and the military. An important component to consider is funding. The NIH National Center for Research Resources (NCRR) has historically been the catalyst and the major provider of training in laboratory animal medicine and biomedical research, and it continues to do so. Although its efforts and the successes of these programs over the years are truly appreciated, the amount of dollars put into these pro- grams for biomedical training programs has been flat over the last 20 years, with the exception of the relatively new T-35 program, which continues to grow and provides a summer research fellowships for veterinary students. The number of trainees has grown to 146 per year. These are the students who can be cultivated into postgraduate careers in laboratory animal medicine. We must continue to help our colleagues at the NIH convince the legislators of the importance of this occupation as part of the biomedical research enterprise. NCRR recently announced its intention to build the research workforce as part of its strategic plan. One of its central recommendations is to increase the number of qualified research veterinarians and ensure that veterinarians are rec- ognized partners on translational research teams. This presents a real opportu- nity for all of us to embrace this plan and to champion the concept of one medi- cine, one health. We must capitalize on the opportunity and move forward. In conclusion, there clearly are challenges that lie ahead for us. We have to convince the deans and professors in the veterinary schools that there is a vital place for a veterinarian in a research setting. Clinician scientists may also be involved, but the goal is to create a higher profile for veterinarians in their pro- fessional training so they may reach out beyond the clinical track. We want to encourage new career paths and role models. We must try to effect substantive curriculum change in the veterinary profession and encourage students to apply for these T-35 training programs. In addition, we need to expand our opportuni- ties in the comparative medicine programs, not only in veterinary schools but also in other research institutions, including medical schools. I leave you with the epilogue of the Foresight Report: “This is…a pivotal point in time for the veterinary profession and for veterinary medical education. A decision to broaden the scope and potential of veterinary medical education is fundamental for the profession to navigate this transition.” And finally, as Paulo Coelho said, “The truth is that all problems seem very simple once they have been resolved. The great victory, which appears so simple today, was the result of a series of small victories that went unnoticed” (from Warrior of the Light, 2003).