Part II: DNA Ownership, Health Requirements, Multiple Sired Litters
In the first article you were asked to attend a hypotical board meeting for a presentation on the DNA requirements for Frequently Used Sires. Today's special meeting includes three DNA topics. It begins at 7:30AM, so you briefly visit Juan Valdez en route then you settle in and listen as the chairman announces the subjects: Who owns your dog's DNA, the AKC registration of DNA-tested carriers and multiple-sired litters.
The speaker - who is called "Linda", begins by handing out an article about the human genome that appeared in the March 10th, 2000, issue of the Washington Post (page A24) entitled "Who should own Your Genes?" There is a strong public interest in keeping the genome as freely accessible as possible, not only because it is an unparalleled scientific resource but because, as the underpinning of human life, it belongs, in a certain sense, to humanity. More pragmatically, it belongs to the public because public funds have been the foundation of the genome mapping effort.
The article, in part, says, "Last year, after much outcry, the patent office issued revised guidelines-- open for public comment until March 22 -- that require a somewhat more specific showing of utility. The patent office should tighten its rules on the genome to the point where the vast majority of the basic sequence will end up in the public, not private, hands. If that proves impossible under current law, Congress should carve an exception in the patent law to recognize the public's unique claim on the genome. And companies that already have gene patents should be obliged -- by Congress if necessary -- to make them available on reasonable licensing terms to researchers and doctors".
Linda tells the group that ownership and use of DNA are different topics. You learn that 4,000 human genes out of an estimated 140,000 have already been patented. She tells the group that when historians look back at the twentieth century, they will probably view it as having been dominated by macro events that affected large numbers of people such as World War I, the Great Depression of the 1930's, World War II and decades of the Cold War ending with the 1991 collapse of the Soviet Union. She goes on to say that unfortunately little attention was given too perhaps the greatest event, the biotechnology revolution. It has already affected the largest group possible, the entire public and most of their pets. It is interesting to note how little the public/breeders know about it or how this new research is being used to affect their futures. You learn, for example, that DNA material is routinely taken from individuals and animals during surgery without their knowledge or consent for some later use. You learn about the remarkable advances made in using mouth saliva, which originally was limited to testing only parentage verification. Dr. Houge at VetGen and Dr. Brewer at the University of Michigan have found a way to use DNA mouth swabs in testing for genetic hip dysplasia in German Shepherds. With the thousands of DNA mouth swabs already in storage this research may get a boost.
The famous trial lawyer called "Barry" reminds the group that the courts, by a slim margin of five to four have already set the stage for the privatization of genes. You learn that the court ruled in favor of Chakrabarty granting him a patent on the first genetically engineered life form. Andrew Chakrabarty was an employee of the GE Corporation who had applied for a patent on a genetically engineered microorganism to consume oil spills on the ocean. Chief Justice William Burger argued that "the reverent consideration was not between living and inanimate things", but whether Chakrabarty's microbe was "human-made invention". On October 14, 1980, a few months after the Supreme Court cleared the way for the commercial use of life, Genentech offered one million shares of stock for sale and by the end of the trading day had raised $36 million. That led the way for the pharmaceutical, agribusiness and biotech companies to understand the profound implications afforded them by the law. Today the US patent office has granted patents on several species of mammals. A genetically engineered mouse containing human genes which predisposed it to developing cancer was the first. This so-called "onco-mouse" was the "invention" of a Harvard biologist, Philip Leder. It was sold to the DuPont Corporation as a "research model" for studying cancer. By the end of 1999, hundreds of animals had been patented including pigs, cows and sheep, along with the DNA markers used for parentage testing in canines.
Barry tells the board that in 1999, the AKC board announced its ownership of the DNA samples collected for the purpose of parentage testing. In May, one delegate thought the board may have gone too far and questioned its ownership policy. He suggested that permission of the owner " would be required should there be any other request for any other use of the archival samples''. The AKC studied the question and agreed that the DNA samples collected for their programs should remain the property of the owner.
Closely related to this topic is the question of DNA samples used by research organizations for disease testing. According to the researchers, DNA collections are treated as gifts meaning that researchers are free to develop genetic markers, patent and sell them without the owner's involvement. The breeders who provided the DNA from their dogs along with some of the money which was used to fund the research are considered donors, which means their "gifts" are the property of the organization that received them. Hence, the scientist who discovers a marker for a disease has the right to sell it to a private-for-profit laboratory. Neither the breeder nor his club has rights to the discovery nor are they entitled to share in the royalties. Someone in the meeting asks about fairness mentioning that most DNA health tests cost upwards of $120 each, which makes testing litters and breeding stock a costly venture.
You notice some notes on the black board. It's an example of the costs related to breeding and testing a litter of four pups for one disease.
Stud fee $ 500
Required AKC DNA certification (FUS) $ 40
DNA litter for one disease (4 puppies) $ 480
Litter Registration $ 10
TOTAL COST $1030
The group listens to another method that is suggested to control a dreaded eye disease. It is the suggested that each studbook (AKC, UKC, CKC etc) begin by encouraging member clubs to add language to their Codes of Ethics that require DNA testing and that non-signers be excluded from holding office or serving on committees. Someone mentions that when Codes of Ethics have used discipline for non-compliance they tended to polarize memberships and their attempts to achieve compliance usually failed. The group is not convinced that this kind of mandatory participation would work in breeding dogs because no one has offered any data to show that the honest breeders should be forced to pay the high cost of DNA fees to prove their honesty.
The speaker - who is called "Linda", begins by handing out an article about the human genome that appeared in the March 10th, 2000, issue of the Washington Post (page A24) entitled "Who should own Your Genes?" There is a strong public interest in keeping the genome as freely accessible as possible, not only because it is an unparalleled scientific resource but because, as the underpinning of human life, it belongs, in a certain sense, to humanity. More pragmatically, it belongs to the public because public funds have been the foundation of the genome mapping effort.
The article, in part, says, "Last year, after much outcry, the patent office issued revised guidelines-- open for public comment until March 22 -- that require a somewhat more specific showing of utility. The patent office should tighten its rules on the genome to the point where the vast majority of the basic sequence will end up in the public, not private, hands. If that proves impossible under current law, Congress should carve an exception in the patent law to recognize the public's unique claim on the genome. And companies that already have gene patents should be obliged -- by Congress if necessary -- to make them available on reasonable licensing terms to researchers and doctors".
Linda tells the group that ownership and use of DNA are different topics. You learn that 4,000 human genes out of an estimated 140,000 have already been patented. She tells the group that when historians look back at the twentieth century, they will probably view it as having been dominated by macro events that affected large numbers of people such as World War I, the Great Depression of the 1930's, World War II and decades of the Cold War ending with the 1991 collapse of the Soviet Union. She goes on to say that unfortunately little attention was given too perhaps the greatest event, the biotechnology revolution. It has already affected the largest group possible, the entire public and most of their pets. It is interesting to note how little the public/breeders know about it or how this new research is being used to affect their futures. You learn, for example, that DNA material is routinely taken from individuals and animals during surgery without their knowledge or consent for some later use. You learn about the remarkable advances made in using mouth saliva, which originally was limited to testing only parentage verification. Dr. Houge at VetGen and Dr. Brewer at the University of Michigan have found a way to use DNA mouth swabs in testing for genetic hip dysplasia in German Shepherds. With the thousands of DNA mouth swabs already in storage this research may get a boost.
The famous trial lawyer called "Barry" reminds the group that the courts, by a slim margin of five to four have already set the stage for the privatization of genes. You learn that the court ruled in favor of Chakrabarty granting him a patent on the first genetically engineered life form. Andrew Chakrabarty was an employee of the GE Corporation who had applied for a patent on a genetically engineered microorganism to consume oil spills on the ocean. Chief Justice William Burger argued that "the reverent consideration was not between living and inanimate things", but whether Chakrabarty's microbe was "human-made invention". On October 14, 1980, a few months after the Supreme Court cleared the way for the commercial use of life, Genentech offered one million shares of stock for sale and by the end of the trading day had raised $36 million. That led the way for the pharmaceutical, agribusiness and biotech companies to understand the profound implications afforded them by the law. Today the US patent office has granted patents on several species of mammals. A genetically engineered mouse containing human genes which predisposed it to developing cancer was the first. This so-called "onco-mouse" was the "invention" of a Harvard biologist, Philip Leder. It was sold to the DuPont Corporation as a "research model" for studying cancer. By the end of 1999, hundreds of animals had been patented including pigs, cows and sheep, along with the DNA markers used for parentage testing in canines.
Barry tells the board that in 1999, the AKC board announced its ownership of the DNA samples collected for the purpose of parentage testing. In May, one delegate thought the board may have gone too far and questioned its ownership policy. He suggested that permission of the owner " would be required should there be any other request for any other use of the archival samples''. The AKC studied the question and agreed that the DNA samples collected for their programs should remain the property of the owner.
Closely related to this topic is the question of DNA samples used by research organizations for disease testing. According to the researchers, DNA collections are treated as gifts meaning that researchers are free to develop genetic markers, patent and sell them without the owner's involvement. The breeders who provided the DNA from their dogs along with some of the money which was used to fund the research are considered donors, which means their "gifts" are the property of the organization that received them. Hence, the scientist who discovers a marker for a disease has the right to sell it to a private-for-profit laboratory. Neither the breeder nor his club has rights to the discovery nor are they entitled to share in the royalties. Someone in the meeting asks about fairness mentioning that most DNA health tests cost upwards of $120 each, which makes testing litters and breeding stock a costly venture.
You notice some notes on the black board. It's an example of the costs related to breeding and testing a litter of four pups for one disease.
Stud fee $ 500
Required AKC DNA certification (FUS) $ 40
DNA litter for one disease (4 puppies) $ 480
Litter Registration $ 10
TOTAL COST $1030
The group listens to another method that is suggested to control a dreaded eye disease. It is the suggested that each studbook (AKC, UKC, CKC etc) begin by encouraging member clubs to add language to their Codes of Ethics that require DNA testing and that non-signers be excluded from holding office or serving on committees. Someone mentions that when Codes of Ethics have used discipline for non-compliance they tended to polarize memberships and their attempts to achieve compliance usually failed. The group is not convinced that this kind of mandatory participation would work in breeding dogs because no one has offered any data to show that the honest breeders should be forced to pay the high cost of DNA fees to prove their honesty.
After the morning break Linda suggests another way to mandate DNA participation. She offers two ideas taken from page 10 of the recent Purina publication, "Today's Breeder", where Dr. George Padgett suggests that the first step be to require the " registration of dogs and bitches affected with genetic defects and those known to carry genes for these traits". Padgett's second recommendation is to "register those dogs and bitches known to be free of genes for undesirable traits". Some of this data is already being collected and stored in a health database so it would be possible to implement his suggestions. Whether the AKC would accept either of these two recommendations and make health testing another mandatory program of registration has not yet been determined.
Health testing as a condition of registration has some tough built in problems. If a laboratory report shows that in a litter of four, there were three carriers and one normal, only one pup would be registerable. The two carriers would be denied registration even though they are purebred and perhaps good candidates for the show ring. If the normal pup were mediocre or of poor quality the breeder would have a pet and would probably start over. More breedings might occur in order to find a DNA-normal pup with sufficient quality to be saved. What would be done with the surplus of unhealthy pups and those who were carriers? Would they be sold as pets? Someone suggests that AKC registrations could be based on the percentage of normals in each litter. At first the percentage could be low, then increased later as the breed shows improvement. This would require lots of record keeping and each breeder would be forced to disclose the test results for each litter. The group learns that the delegate body would probably want input from all of the parent clubs since this would change the rules of AKC registration. The other side of the question is asked which focuses on the data that is available to support the use of mandatory DNA testing. She asks if the purebred dogs are so unhealthy that mandatory health testing is needed to save breeds? Or, are so many breeders cheating that no one can trust their pedigrees? Linda points out that no one has offered any data to support why DNA testing should be mandatory even though new programs have already begun.
You learn that mandatory health testing, as a condition of AKC registration, is not without its problems. The breeders who produce over 65% of all the pups born only breed one litter a year and most of them are not active in the sport. Finding them to provide the necessary information about mandatory testing would probably be difficult now that Americans are becoming more mobile. We know that most do not leave forwarding addresses with the AKC.
You sit there in bewilderment and wonder why DNA should be a mandatory requirement at all given the cost of each test. You also wonder why it seems to be so appealing when no studies and no data have been presented to justify-wide spread mandatory requirements at the expense of AKC registrations. It is remarkable that all of the suggestions for these mandatory requirements come with no facts and no data to support them. Someone asks if we have become a slave to this new technology?
Linda changes the subject by writing "Multiple Sired Litters"on the black board. She reads from a report by the AKC Delegate Health Committee that recommends the registration of a litter even if more than one sire was involved as long as DNA was used to test and prove parentage. She mentions that there are three reasons to allow multiple sired litters. The first is to help breeders with their breeding program, which will result in fewer breedings. Second, it will benefit those with aging bitches whose breeding life is limited and third, DNA can be used to identify the correct sire in an accidental breeding. Many times bitches are campaigned until they are 5-6 years of age leaving time for only one or two litters. A litter from two sires would reduce the number of breedings. Those who own small breeds that average 1-2 puppy litters would especially benefit from it. They would not miss the opportunity to get a pup from two outstanding sires. The speaker mentions that there are several built-in barriers and limitations. For example, the window of time to breed a bitch is very short and most of the better sires usually live in distant cities from where the bitches are. Two airfares, two or more stud fees and a lot of coordination would discourage most. Frozen and chilled semen would add even more costs to the process. In the spring of 2000, the AKC approved the use of multiple sired litters but the cost was not cheap. The dam, each sire and all of the pups must have DNA ($40 each) on file and the breeder must also pay a $200.00 processing fee. Some quick math brings even a small litter to about $400.00 and then it goes up from there. When abuse is suspected the AKC inspections program could be used to investigate.
You learn from this briefing that most breeders were unaware of the DNA changes already in place. Hardly any one could explain how these changes would affect them in the future. A raise of hands confirms that most were unaware of any future plans being made for DNA, confidentiality, safe guards for its storage, test costs, royalties, or the mandatory test requirements already in place.
Health testing as a condition of registration has some tough built in problems. If a laboratory report shows that in a litter of four, there were three carriers and one normal, only one pup would be registerable. The two carriers would be denied registration even though they are purebred and perhaps good candidates for the show ring. If the normal pup were mediocre or of poor quality the breeder would have a pet and would probably start over. More breedings might occur in order to find a DNA-normal pup with sufficient quality to be saved. What would be done with the surplus of unhealthy pups and those who were carriers? Would they be sold as pets? Someone suggests that AKC registrations could be based on the percentage of normals in each litter. At first the percentage could be low, then increased later as the breed shows improvement. This would require lots of record keeping and each breeder would be forced to disclose the test results for each litter. The group learns that the delegate body would probably want input from all of the parent clubs since this would change the rules of AKC registration. The other side of the question is asked which focuses on the data that is available to support the use of mandatory DNA testing. She asks if the purebred dogs are so unhealthy that mandatory health testing is needed to save breeds? Or, are so many breeders cheating that no one can trust their pedigrees? Linda points out that no one has offered any data to support why DNA testing should be mandatory even though new programs have already begun.
You learn that mandatory health testing, as a condition of AKC registration, is not without its problems. The breeders who produce over 65% of all the pups born only breed one litter a year and most of them are not active in the sport. Finding them to provide the necessary information about mandatory testing would probably be difficult now that Americans are becoming more mobile. We know that most do not leave forwarding addresses with the AKC.
You sit there in bewilderment and wonder why DNA should be a mandatory requirement at all given the cost of each test. You also wonder why it seems to be so appealing when no studies and no data have been presented to justify-wide spread mandatory requirements at the expense of AKC registrations. It is remarkable that all of the suggestions for these mandatory requirements come with no facts and no data to support them. Someone asks if we have become a slave to this new technology?
Linda changes the subject by writing "Multiple Sired Litters"on the black board. She reads from a report by the AKC Delegate Health Committee that recommends the registration of a litter even if more than one sire was involved as long as DNA was used to test and prove parentage. She mentions that there are three reasons to allow multiple sired litters. The first is to help breeders with their breeding program, which will result in fewer breedings. Second, it will benefit those with aging bitches whose breeding life is limited and third, DNA can be used to identify the correct sire in an accidental breeding. Many times bitches are campaigned until they are 5-6 years of age leaving time for only one or two litters. A litter from two sires would reduce the number of breedings. Those who own small breeds that average 1-2 puppy litters would especially benefit from it. They would not miss the opportunity to get a pup from two outstanding sires. The speaker mentions that there are several built-in barriers and limitations. For example, the window of time to breed a bitch is very short and most of the better sires usually live in distant cities from where the bitches are. Two airfares, two or more stud fees and a lot of coordination would discourage most. Frozen and chilled semen would add even more costs to the process. In the spring of 2000, the AKC approved the use of multiple sired litters but the cost was not cheap. The dam, each sire and all of the pups must have DNA ($40 each) on file and the breeder must also pay a $200.00 processing fee. Some quick math brings even a small litter to about $400.00 and then it goes up from there. When abuse is suspected the AKC inspections program could be used to investigate.
You learn from this briefing that most breeders were unaware of the DNA changes already in place. Hardly any one could explain how these changes would affect them in the future. A raise of hands confirms that most were unaware of any future plans being made for DNA, confidentiality, safe guards for its storage, test costs, royalties, or the mandatory test requirements already in place.
The meeting ends as quickly as it started. You are asked to think about how would you vote on these issues? Yes, No, or would you ask for a delay until you have more facts, more answers and time to think? Someone asks that the vote be delayed. The speaker says, "have we considered any of the alternatives to mandatory DNA"? Someone else says "why not simply work to make it popular by making it cheap enough for breeders to DNNA their whole litter. Then they could be sold as DNA-certified pups with certified pedigrees." Everyone agrees with the idea. Another asks for a copy of the reports and the data used to support the new programs and the new proposals. None are provided. You wonder why?
The next article, called Part III will focus on the biotech future, what the scientists are planning, embryo transplants and clones.
The next article, called Part III will focus on the biotech future, what the scientists are planning, embryo transplants and clones.
ABOUT THE AUTHOR
Carmen L Battaglia holds a Ph.D. and Masters Degree from Florida State University. As an AKC judge, researcher and writer, he has been a leader in promotion of breeding better dogs and has written many articles and several books.Dr. Battaglia is also a popular TV and radio talk show speaker. His seminars on breeding dogs, selecting sires and choosing puppies have been well received by the breed clubs all over the country.
Carmen L Battaglia holds a Ph.D. and Masters Degree from Florida State University. As an AKC judge, researcher and writer, he has been a leader in promotion of breeding better dogs and has written many articles and several books.Dr. Battaglia is also a popular TV and radio talk show speaker. His seminars on breeding dogs, selecting sires and choosing puppies have been well received by the breed clubs all over the country.
