Gene Doping

Ethics @ Work: Let the ‘Mutant Games’ begin

Aug. 14, 2008
Asher Meir , THE JERUSALEM POST
We are fortunate that the sporting news from Beijing has come mainly from the playing field, and not from the laboratory. Cycling coverage is always a close race between the results from the course and the results of the drug policing, but following the disqualification of a number of Russian women athletes, doping has been pretty much out of the news at the Olympics. However, the reality of doping is always looming in the background, and the spectators are left wondering, does s/he or doesn’t s/he?

The assumption that doping is more or less pervasive, and that the vagaries of defining and detecting it will always make enforcement arbitrary, has led a number of observers to draw a fascinating parallel between today’s prohibition on doping and the previous prohibition on professionalism.

Nowadays the Olympics are all about money. The papers are filled with estimates of how much a gold medal costs in terms of the infrastructure needed to create champions (it’s about $30 million) and much how one is worth in terms of endorsements (often seven figures for tennis players or track athletes, more like five or six for fencers or synchronized swimmers).

It’s hard to believe that as recently as the 1980s strict rules against professionalism were in place. Anyone who earned money from sport (this once applied even to teachers of sport), or anyone who competed against others who earned money from sport, was disqualified. The legendary American athlete Jim Thorpe, who won two Olympic gold medals in the 1912 Stockholm Olympics, had his medals stripped after it was revealed that he had played minor league baseball years before.

Strict enforcement of the amateurism rules would have meant that only independently wealthy individuals would be able to compete. What happened instead was a cynical and arbitrary application of the rules.

The Soviet bloc had athletes who were professionals in every sense, though their profession was usually listed as soldier or student, while the West had an elaborate system of under-the-table payments, “expense” payments, trust funds and so on. The system was a nightmare, since all athletes received money but only some were disqualified. Finally in the 1990s the system fell apart. The de facto professionalism of Soviet bloc athletes, which gave them an immense advantage in international competition, was a critical factor.

The parallel to doping is expressed as follows: Just as it was practically impossible to compete on an international level in the 20th century without accepting money, so it is practically impossible to compete on an international level in the 21st century without using performance-enhancing substances. (This of course has not been proven.)

The exact definition of doping is subject to dispute, just as the exact definition of professionalism is. Both can take place in secret, making enforcement necessarily arbitrary. The conclusion: Rules against doping should fall by the wayside just as rules against professionalism did.

The counterargument is as follows: In the case of professionalism, almost all the athletes wanted to get money, and most of the spectators didn’t mind if they did. In the case of doping, almost all of the athletes prefer not to take performance-enhancing substances, and almost all of the spectators also prefer that they don’t.

The athletes prefer no doping because doping regimens require a huge amount of effort and expense, and because many of the drugs are dangerous. For example, the endurance-enhancing drug EPO thickens the blood, and is the prime suspect in the sudden early deaths of a number of cyclists. Insiders tell of cyclists getting up in the middle of the night to exercise in order to get the blood moving to prevent their doped blood from killing them; obviously they would prefer getting a good night’s sleep.

The spectators prefer no doping because they don’t care about outcomes, they only care about the competition – a level playing field. Women’s tennis is nearly as popular as men’s, even though the top women are no match for mediocre male players, because it is a fair and exciting game. The playing field is most level without doping.

But what if it’s not true? The same “arms race” hypothesis was advanced for professionalism in sport, and was proven false. Maybe the athletes want to push the envelope of the ultimate capabilities of the technology-aided human body, while the spectators want to see the tallest, fastest and strongest athletes science can provide!

John Tierney of The New York Times has an interesting suggestion to test this idea: Set up an alternative “no-holds-barred” competition with no doping tests allowed. (He even gives some suggestions for names, including the “Mutant Games.”) One must assume that the regular leagues will ban anyone who takes part in these competitions, even if they submit to the testing regimen, just as the amateur rules forbade not only professionals but also amateurs who competed against them.

If the athletes are chafing at the testing regimen and the spectators want to see drug-aided competitors, then the new league will draw competitors and spectators; if not, then the “arms-race” hypothesis of doping will have been proven true.

There is a slight problem with this test, due to the great prestige of the official events. Attempts to establish professional athletic competitions in the 20th century were unsuccessful, because athletes discovered they could make much more money in the more prestigious amateur leagues. Yet when the prestige events themselves allowed professionals, everyone was happy.

I personally am strongly inclined to believe the received wisdom; that doping is a destructive arms race, and that everyone besides the undertakers would be happy to get rid of it. But Tierney’s suggestion is an interesting way to see if the received wisdom is correct.

ethics-at-work@besr.org

Asher Meir is research director at the Business Ethics Center of Jerusalem (www.besr.org), an independent institute in the Jerusalem College of Technology.

Gene Doping

Gene doping in sport: fact or fiction?

Experts believe it is only a matter of time before athletes manipulate their genetic material to gain an unfair advantage despite the current lack of proven cases.
A science journalist, who has published a novel on the theme, and a scientist working in the field of genetics talked to swissinfo about the likelihood and dangers of gene doping in sport.

Since the times of ancient Greece, a minority of athletes have employed a variety of potions to artificially boost their performance. More recently, amphetamines, anabolic steroids and hormones have been the drugs of choice.

The World Anti-Doping Agency (WADA) has recently turned its attention to the threat of gene doping and officially banned the practice in 2003. There have already been suspicions of some athletes using the gene therapy Repoxygen to increase their red blood cell count and thereby allow the body to absorb more oxygen.

Professor Max Gassmann of Zurich University’s Institute of Veterinary Physiology has manipulated the erythropoietin (EPO) gene of mice to produce more oxygen carrying red blood cells – a process that could eventually be transferred to humans.

Gassmann does not think gene doping has infiltrated sport at the moment but believes some people may already be testing its potential, just as beneficial gene therapy is currently undergoing clinical trials.

“I can hardly imagine that we had a gene doping cheat winning at the Beijing Olympics,” he told swissinfo. “But there has been doping throughout history and if gene doping becomes viable then you cannot stop it, because people want to win.”
Fictional leap
Author Beat Glogger has taken the theory a stage further by writing a thriller – “Run For My Life” – about genetically modified athletes. Glogger, also a science journalist, and Gassmann contributed to a Swiss sports ministry document warning about the risks of gene doping.

Scientists have already identified more than 150 genes that potentially influence performance in sports. These include genes that control muscle growth, muscle speed and the production of red blood cells.

“I take the next step into fiction by saying it is possible to manipulate the genes that control speed, power, endurance and even mental strength. These are the four key factors for athletic performance,” Glogger told swissinfo.

There are many cases of people with naturally malfunctioning genes. Most of the time this results in health problems, such as muscular dystrophy, but the rare occurrence of a mutation can also bring benefits.

Finnish cross-country skiing legend Eero Mäntyranta won race after race in the 1960s because of a natural genetic mutation that helped his blood absorb large amounts of oxygen. It would be very hard in future to determine if such a case was caused by nature or gene manipulation, according to Glogger.

“If, after the introduction of the relevant genes, the body produces more EPO or testosterone by itself then you cannot detect it – it looks like you are a natural,” he said.
To die for
However, athletes run a high risk of developing serious diseases such as cancer or even dying if they submit to gene manipulation that is still in the early days of scientific development.

Gassmann’s genetically modified mice live only half as long as other mice. Scientists know how to modify genes and introduce them into the body, but not how to control the behaviour of such genes once they have been implanted.

“Whatever you put into the body is hard to control. If you realise it is no good then it is almost impossible to stop, and that is what could happen with gene cheating athletes,” Gassmann said. “It is easy to switch on a light but much more complicated to dim it.”

One method of controlling modified genes is to develop drugs that act like on and off switches, but this process is still in its infancy.

“Gene doping could be undetectable and it could improve performance but you could also die,” Glogger warned. Just like the characters in his book.

swissinfo, Matthew Allen in Zurich

Gene Doping

Couch-Potato Drugs Are WADA’s First Banned for Gene-Doping Ties

By Mason Levinson
Jan. 14 (Bloomberg) — Two drugs that activate genetic switches, fooling the body into believing it has exercised, are the first to be added to the Olympic sports prohibited list for their ties to gene doping.
The drugs, whose effects were first disclosed in a report published online by the journal Cell on July 31, were added to the nine-page list issued by the World Anti-Doping Agency under the “Gene Doping” classification as of Jan. 1.
It’s a category that is likely to grow over the next five to 10 years, said Dr.Gary Wadler , who heads WADA’s Prohibited List Committee, as gene therapy becomes “part of the matrix of what physicians have to treat patients.”
“There’s gene-therapy stuff going on in research labs everywhere in the world,” Wadler said in an interview at his Manhasset, New York, office. “I think they’re going to cause breakthroughs, and those breakthroughs, if they have any application to enhance athletic performance, then you’ll ultimately see it banned.”
One of the drugs is a synthetic protein called Aicar that, when given to mice, improved endurance by 44 percent after four weeks, even without exercise. The other is an experimental medicine made by GlaxoSmithKline Plc , GW1516, which remodeled the mice’s skeletal muscle and raised their endurance levels by 75 percent when the animals also ran on a treadmill.
WADA ’s 2009 prohibited list includes nearly 70 anabolic steroids; about 60 stimulants; hormones; diuretics and other masking agents; blood-doping methods; and several narcotics. The Montreal-based agency oversees anti-drug programs for Olympic- level sports.
2002 Prediction
Wadler said he “predicted the future” when in 2002 he wrote a chapter on emerging science and technologies for the textbook “Performance Enhancing Substances in Sport and Exercise.” In it, he discussed the implications of the U.S. Human Genome Project, which was launched in 1990, and examined gene transfer therapy.
“The dissection of the human genetic code not only opened a Pandora’s box of diagnostic tools and methods; it has significantly paved the way for an array of therapeutic interventions never conceived before and has spawned the field of pharmacogenetics,” he wrote at the time.
WADA held a gene-doping workshop for scientists, ethicists, athletes and representatives from the Olympic movement in March 2002 and again in December 2005 and June 2008. It formed its expert panel on gene doping in 2004.
‘Couch Potato’
Last July, a news release , titled “Exercise in a Pill,” announced the results of the study by the Salk Institute for Biological Studies in San Diego that detailed the effects of Aicar, which it called the “ultimate couch-potato experiment,” as well as the effects of GW1516.
The findings may lead to the development of obesity and muscle-wasting-disease treatments, and has implications for the treatment of diabetes and lipid disorders.
By activating different genetic switches with the two drugs, the scientists were able to increase fat burning and the mice showed major transformation of skeletal muscle fibers. In giving the mice GW1516 and a regular exercise regimen, for example, they saw a 38 percent increase in “slow twitch” muscle fibers, which relate to a muscle’s endurance.
“They have the capacity of changing the patterns of gene expression in cells and tissues, so our view is that that’s a form of gene manipulation,” Theodore Friedmann , chairman of WADA’s Gene Doping Panel, said in a telephone interview. “I don’t think that list is going to shrink. It’s probably going to increase markedly over the years.”
Test Procedures
Ronald Evans , who is a professor in the Salk Institute’s Gene Expression Laboratory and led the research into the use of Aicar and GW1516 to manipulate signaling pathways, also developed a test to readily detect the drugs in blood and urine, and is working with WADA to enact its implementation.
While these drugs can be easily detected, other gene- therapy methods are much more problematic for WADA, and in turn sports associations and leagues. These involve the use of genetic techniques to bring doping substances to muscle tissue and other targets without passing through blood and urine, thereby confounding testing efforts.
“It’s better for patients, but it also makes it more challenging because of doping,” Wadler said.
Friedmann, who runs a gene-therapy laboratory at the University of California, San Diego, said WADA has mounted a major research program to develop ways to find evidence of gene manipulation.
Drug’s Effect
“WADA is very forward-looking into designing new forms of doping detection based on the new principle that you don’t look for the drug itself, you look for the effect of the drug,” said Friedmann.
In February, the committee will begin reviewing the 2009 list, assessing research and what they’ve learned about doping through everything from medical journals to police investigations. They’ll then tweak the list and turn it over to WADA’s Executive Committee for final approval Oct. 1, giving sports organizations three months to adopt new regulations and understand the changes.
To contact the reporter on this story: Mason Levinson in New York atmlevinson@bloomberg.net .

Gene Doping

The World’s First GM Human Embryo Could Dramatically Alter the Future
“The advance of genetic engineering makes it quite conceivable that we will begin to design our own evolutionary progress.”
~Isaac Asimov, famous thinker and sci-fi writer
Cornell University researchers in New York revealed that they had produced what is believed to be the world’s first genetically altered human embryo—an ironic twist considering all the criticism the US has heaped on South Korea over the past several years for going “too far” with its genetic research programs. The Cornell team, led by Nikica Zaninovic, used a virus to add a green fluorescent protein gene, to a human embryo left over from an in vitro fertilization procedure. The research was presented at a meeting of the American Society of Reproductive Medicine last year, but details have emerged only after new controversy has emerged over the ethics and science of genetically modifying humans.
Zaninovic has pointed out that in order to be sure that the new gene had been inserted and the embryo had been genetically modified, scientists would ideally want to keep growing the embryo and carry out further tests. However, the Cornell team did not get permission to keep the embryo alive. The GM embryos created could theoretically have become the world’s first genetically altered man or woman, but it was destroyed after five days.
British regulators form the Human Fertilization and Embryology Authority (HFEA), have warned that such controversial experiments cause “large ethical and public interest issues”.
Much of the debate stems from the fact that the effects of genetically altering an embryo would be generational and permanent. In other words, if we create a mutant baby and it grows up to have children of it’s own—they’ll all be mutant gene carriers too. Genes injected into embryos and reproductive cells, such as sperm, affect every cells in the body and would be passed on to future generations. Critics say current humans don’t have the right to tamper with the gene pool of future generations.
On the other hand, proponents of such technology say that this science could potentially erase diseases such as cystic fibrosis, hemophilia and even cancer. In theory, any “good” gene could be added to embryos to offset any “bad” genes they are currently carrying. That could potentially mean the difference between life and death for many children.
John Harris, the Sir David Alliance Professor of Bioethics at Manchester University, takes it a step further. He believes that as parents, citizens, and scientists, we are morally obliged to do whatever we can genetically to make life better and longer for our children and ourselves. Society currently devotes so much energy and resources towards saving lives, which, in reality, is simply postponing death, he notes. If it is right to save life, Harris reasons, then it should also be right to postpone death by stemming the flow of diseases that carry us to the grave.
For Harris, having the ability to improve our species lot in life but refusing to do so, makes little sense. He has a difficult time understanding why some people are so insistent that we shouldn’t try to improve upon human evolution.
“Can you imagine our ape ancestors getting together and saying, ‘this is pretty good, guys. Let’s stop it right here!’. That’s the equivalent of what people say today.”
Ethicists, however, warn that genetically modifying embryos will lead to designer babies preloaded with socially desirable traits involving height, intelligence and coloring.
Dr David King, director of Human Genetics Alert, warns, “This is the first step on the road that will lead to the nightmare of designer babies and a new eugenics.”
Harris, however, doesn’t support that argument. He says it’s not about “beauty” it’s about health, and what parent wouldn’t want a healthy child, he asks.
“Certainly, sometimes we want competitive advantage [for our children], but for the enhancements I talk about, the competitive advantage is not the prime motive. I didn’t give my son a good diet in the hope that others eat a bad diet and die prematurely. I’m happy if everyone has a good diet. The moral imperative should be that enhancements are generally available because they are good for everyone.”
The only other route to equality, he says, is to level down so that everyone is as uneducated, unhealthy and unenhanced as the lowest in society – which would be much more unethical in his opinion. Even though we can’t offer a liver transplant to all who need them, he says, we still carry them out for the lucky few. “Much better to try to raise the baseline, even if some are left behind.”
The Human Fertilization and Embryology Bill in currently under consideration in Britain will likely make it legal to create GM embryos in that country, but only for research—implantation in the womb will still be banned—at least for now. However, ethicists believe that the legislation could easily be relaxed even further in the future.
People who believe that genetically modified humans is something way into the future might want to consider that many experts are worried that some forms of it are already happening in the sports world.
Faster, bigger, better, stronger—in theory, the single most effective way to radically alter your physical capacities is to manipulate your genes. Athletes are beginning to take notice. Now that we’ve mapped out the human genome and identified exactly which genes make you buff, tough and rough—experts are concerned about the future of genetic doping.
Gene doping could spawn athletes capable of out-running, out-jumping and out-cycling even the world’s greatest champions. However, researchers at the University of Florida are attempting to prevent that from happening by detecting the first cases of gene doping in professional athletes before the practice becomes mainstream.
Montreal-based World Anti-Doping Agency (WADA), responsible for monitoring the conduct of athletes, is working with investigators around the globe to develop testing to identify competitors who have injected themselves with genetic material that is capable of enhancing muscle mass or heightening endurance.
“If an athlete injects himself in the muscle with DNA, would we be able to detect that?” asked one of France’s leading gene therapy researchers, Philippe Moullier, M.D., Ph.D., director of the Gene Therapy Laboratory at the Universite de Nantes in France.
Right now, he says the answer is clearly “no”. But that may soon change. The UF scientists are among several groups collaborating with national and global anti-doping organizations to develop a test that can detect evidence of “doped” DNA.
“WADA has had a research program in place for some years now, to try to develop tests for gene-based doping,” said Theodore Friedmann, M.D., head of the agency’s panel on genetic doping and director of the gene therapy program at the University of California, San Diego.
Nearly every day now we are inundated with new genetic discoveries. Scientists can now pinpoint many specific genes including being lean, living a long life, improved self-healing, thrill seeking behavior, and having an improved memory among many other incredible traits. Many believe that these genes can be manipulated in ordinary humans, in effect creating Super-Mutants.
Theoretically, options are nearly limitless. Even a gene that exists in another species could be brought over to a human cell. Imagine some of the incredible traits of the animal kingdom that some humans don’t possess such as night vision, amazing agility, or the ability to breath underwater. The precedence for these types of radical changes is already in place. Experimental mice, for example, were successfully given the human ability to see in color. If animals can be engineered to have human traits, then humans can certainly be mutated to have desirable animal traits.
It is even thought possible to so drastically alter human genomes that a type of superhuman species could emerge. The fear with germline engineering is that since it is inheritable, offspring and all succeeding generations would carry the modified traits. This is one reason why this type of engineering is currently banned- it could lead to irreversible alteration of the entire human species.
Ethics, not scientific limitations, is the real brick wall. Most scientists believe manipulating genes in order to make an individual healthy is a noble and worthwhile pursuit. Some are against even that notion, arguing that historically amazing individuals have sometimes been plagued by genetic mental and physical disorders, which inadvertently shaped the greatness of their lives. Should we rob the human race of character shaping frailty? Very few scientists would dare to publicly endorse the idea of using genetic engineering to make a normal, healthy individuals somehow superior to the rest of the human race.
“The push to redesign human beings, animals and plants to meet the commercial goals of a limited number of individuals is fundamentally at odds with the principle of respect for nature,”
said Brent Blackwelder, President of Friends of the Earth in his testimony before the Senate Appropriations Committee.
However, would it be so bad if the human race were slightly improved? What if a relatively simple procedure could make an individual and his or her offspring resistant to cancer? After all, Nature isn’t always right. Nature has naturally selected many people to carry the burden of uncomfortable and often lethal genetic disorders. If nature knows best, then shouldn’t we quit trying to “improve” upon nature by “curing” people of genetic conditions we consider inferior? Many say we shouldn’t change human genetics, UNLESS it’s the RIGHT thing to do. Who gets to decide where the line is between righteous endeavor and the corruption of nature? These are the questions facing our generation.
Posted by Rebecca Sato
Related Galaxy posts:
Can Humans Live to 1,000? Some Experts Claim We Can — Others Want to Prevent That
The “Mickey Mouse” Experiment -Mice with Human Eyes
Enhancing Evolution: Do Humans have a Moral and Ethical Duty to Improve the Human Race?
Are We Close to Creating Super-Mutant Humans?
The Story of a Biologist & the Extension of the Human Life Span
Scientists Bio-engineer a Virus that Destroys Cancer Cells
“Mind Children”: Transhumanism & the Search For Genetic Perfection
Sources & Related Stories:

http://www.sciam.com/article.cfm?id=000E7ACE-5686-10CF-94EB83414B7F0000

http://www.timesonline.co.uk/tol/news/uk/science/article3908516.ece

http://www.andhranews.net/Health/2008/May/11-Scientists-create-first-44379.asp

http://press.princeton.edu/titles/8480.html

Gene Doping

Genetic Engineering Limits—A Planet Responds
Richard Hayes
December 22nd 2008
Cutting Edge Genetics Analyst
Over the past half century, the world has been transformed through rapid developments in communications, transportation, weaponry, and trade. A vast infrastructure of intergovernmental institutions has been established to help ensure that these and related developments generate more benefit than they do harm. These include global institutions such as the United Nations and the World Bank, regional groups such as the European Union and the African Union, and those with issue-specific agendas such as the Intergovernmental Panel on Climate Change and the World Health Organization. Although the record of these institutions is far from perfect, a world without them would be fraught with even more risk than it is today.
The rapid development of powerful new human biotechnologies raises precisely the sort of questions that such intergovernmental institutions are positioned to address. If developed wisely, these technologies could help prevent and cure diseases that have afflicted humanity for millennia; if misapplied, they could pose new and profoundly consequential risks. Detailed knowledge of the human genome might lead to improved medical diagnostics, but could also lead to a Gattaca-like world in which affluent couples genetically modify their embryos in an attempt to create “designer babies.” The creation of clonal human embryos gives researchers tools to help investigate the developmental origin of congenital diseases, but brings us closer to the day when rogue scientists might attempt to create live-born human clones. Genetic interventions intended to help those suffering from degenerative muscular diseases could be used by athletes to illicitly enhance their strength and endurance.
Many countries are adopting comprehensive national policies that establish guidelines, regulations, and laws stipulating which applications of the new human biotechnologies are permitted and which are not. But the greater majority of the world’s countries have not adopted policies regarding these technologies.
Intergovernmental institutions are in a position to play major leadership roles in ensuring the proper use of the new human biotechnologies. They can promote greater understanding of both the benefits and the risks that these technologies pose; develop statements of principles to guide national policies; prepare model national legislation; and take the lead in negotiating binding multilateral treaties and conventions.

It will not be an easy task to come to formal agreement on even a minimal set of international principles and policies. These technologies are new and the issues involved are complex. But the encouraging news is that many key intergovernmental institutions have already begun taking steps to address the new human biotechnologies, and broad areas of at least implicit agreement are evident.
The United Nations
In 2001 France and Germany proposed a binding UN treaty calling for a prohibition on human reproductive cloning. An early procedural vote suggested unanimous support for this measure. A significant number of countries subsequently expressed opposition to banning reproductive cloning without simultaneously banning the use of cloning for research purposes. This led to extended controversy, and the debate became, essentially, a debate over the acceptability of research cloning.
By 2003 it became clear that a consensus concerning research cloning could not be achieved. In 2005 a non-binding declaration opposing both research cloning and reproductive cloning was introduced and received a plurality of votes (46 percent), which under UN rules makes it the official UN position. However, the lack of a clear consensus rendered moot any proposals to promote this position further.
In the absence of a formal global treaty, individual countries have proceeded to adopt their own policies addressing human cloning. By 2007 human reproductive cloning had been banned by 59 countries—including the great majority of those with robust biomedical research sectors—and approved by none. In 2007 scholars associated with the United Nations University noted that the prohibition of reproductive cloning might be considered to have attained the status of customary international law. This was not the case for cloning for research purposes, however, as policies adopted by individual countries varied widely.
UNESCO
The United Nations Educational, Social and Cultural Organization (UNESCO) is a specialized agency of the United Nations working to promote international collaboration through education, science, and culture. In 1993 UNESCO established a Bioethics Programme within its Division of the Ethics of Science and Technology. The Programme is led by the International Bioethics Committee (IBC), consisting of 36 outside experts, and the Intergovernmental Bioethics Committee (IGBC), consisting of representatives from 36 member states.
The Bioethics Programme has sponsored three major nonbinding international agreements. The Universal Declaration on the Human Genome and Human Rights was adopted unanimously by the UNESCO General Conference in 1997 and ratified by the UN General Assembly in 1998. The declaration calls for member states to undertake specific actions, including the prohibition of “practices which are contrary to human dignity, such as reproductive cloning of human beings.” It also calls on the IBC to study “practices that could be contrary to human dignity, such as germline interventions.”
The International Declaration on Human Genetic Data was adopted in 2003. The declaration is intended “to ensure the respect of human dignity and protection of human rights and fundamental freedoms in the collection, processing, use and storage of human genetic and proteomic data, and of the biological samples from which they are derived, in keeping with the requirements of equality, justice and solidarity, while giving due consideration to freedom of thought and expression, including freedom of research.”
The Universal Declaration on Bioethics and Human Rights was adopted in 2005. The declaration used a human rights framework to establish normative principles in fifteen areas, including human dignity and human rights; equality, justice, and equity; and protecting future generations. These principles cover a wider range of issues than did the previous two bioethics declarations.
UNESCO took the lead in negotiating the International Convention Against Doping in Sports in collaboration with the World Anti-Doping Agency (WADA), which had been established earlier by the International Olympic Committee. The Convention includes language banning the use of genetic technology to enhance athletic performance in official athletic events, referred to as “gene-doping.” It entered into force on February 1, 2007, and has been ratified by 86 countries. The earlier Copenhagen Declaration on Anti-Doping in Sport has been signed by 192 countries.
Council of Europe
The Council of Europe is an international organization of 47 member countries working to foster democracy and human rights. It maintains a Bioethics Division, guided by a Steering Committee on Bioethics. The Council’s Convention on Biomedicine and Human Rights was opened for signatures in 1997 and went into force in 1998. As of March 2008 it had been signed or ratified by 34 countries. It explicitly prohibits inheritable genetic modification, somatic genetic modification for enhancement purposes, social sex selection, and the creation of human embryos solely for research purposes. The Convention is perhaps the single most well-developed intergovernmental agreement extant addressing the new human biotechnologies, banning human reproductive cloning through an Additional Protocol on the Prohibition of Cloning Human Beings, which went into force in 1998.
European Union
With 27 member states, the European Union and its constituent bodies play a major and growing role in European policy integration. Article 3 of the EU’s Charter of Fundamental Rights, entitled “Rights to the Integrity of the Person,” prohibits human reproductive cloning, “eugenic practices, in particular those aiming at the selection of persons,” and “making the human body and its parts as such a source of financial gain.” Importantly, the EU disburses some $5 to 6 billion U.S. every seven years for biomedical and health-related research, and sets policies on the use of these funds. Under the current programme, which runs from 2007 to 2013, these funds cannot be used for research that involves human reproductive cloning, inheritable genetic modification, the creation of human embryos solely for research purposes, or the destruction of human embryos.

African Union
The African Union (AU) is an intergovernmental organization consisting of most African nations. At its 1996 Assembly of Heads of State, the AU (then called the Organization of African Unity) approved a Resolution on Bioethics that affirmed “the inviolability of the human body and the genetic heritage of the human species” and called for “supervision of research facilities to obviate selective eugenic by-products, particularly those relating to sex considerations.”
World Health Organization
The World Health Organization (WHO) and its governing body, the World Health Assembly, are specialized agencies of the United Nations that address issues of international public health. In 1997 the WHO called for a global ban on human reproductive cloning. In 1999 a Consultation on Ethical Issues in Genetics, Cloning and Biotechnology was held to help assess future directions for the WHO. The draft guidelines prepared as part of this consultation, Medical Genetics and Biotechnology: Implications for Public Health, called for a global ban on inheritable genetic modification. In 2000 WHO Director-General Dr, Gro Harlem Brundtland reiterated opposition to human reproductive cloning.
In September 2001 the WHO convened a meeting to review and assess “recent technical developments in medically assisted procreation and their ethical and social implications.” The review covered, among other items, preimplantation genetic diagnosis, intracytoplasmic sperm injection, and cryopreservation of gametes and embryos. In February 2002 the WHO repeated its opposition to human reproductive cloning and cautioned against banning cloning techniques for medical research. In October 2002 the WHO established a Department of Ethics, Equity, Trade, and Human Rights to coordinate activities addressing bioethical issues.
Group of Eight
The Group of Eight (G-8) is an international forum for the governments of Canada, France, Germany, Italy, Japan, Russia, the United Kingdom and the United States. It convenes annual summits to consider issues of common concern, typically of an economic or military nature. At its June 1997 summit in Denver, Colorado, the G-8 called for a worldwide ban on human reproductive cloning. According to the Final Communique of the Denver Summit of the Eight, the leaders of the G-8 nations agreed “on the need for appropriate domestic measures and close international cooperation to prohibit the use of somatic cell nuclear transfer to create a child.”
The Consensus
There appears to be broad support for applications intended to prevent or cure disease, but strong opposition to applications that involve selecting or modifying the genes of future generations for non-medical purposes. There is wide opposition as well as to human reproductive cloning and to non-medical genetic modification, including athletic “gene doping.” The one practice for which a consensus does not appear to be in the cards is medical research involving human embryos. Some intergovernmental institutions explicitly support this and others oppose it.
Real opportunities exist for one or more respected intergovernmental institutions to mount a global initiative to clarify, codify and promote—indeed, to universalize—those human biotech policies about which broad agreement exists, while agreeing to disagree on the fewer number about which disagreements persist. Such an initiative would go a long way towards ensuring that these powerful new technologies are used in the best interests of all humanity.
Cutting Edge Genetic Analyst Richard Hayes is executive director of the Center for Genetics and Society and can be found at www.geneticsandsociety.org. This article draws on an
appendix of an article published by Science Progress, and on data compiled on CGS’s BioPolicyWiki.

For a full account of the state of policies among individual countries see The Quest for Global Consensus on Human Biotechnology in The Cutting Edge News Nov 24, 2008.

Gene Doping

Gene doping in sport: fact or fiction?
Experts believe it is only a matter of time before athletes manipulate their genetic material to gain an unfair advantage despite the current lack of proven cases.
A science journalist, who has published a novel on the theme, and a scientist working in the field of genetics talked to swissinfo about the likelihood and dangers of gene doping in sport.

Since the times of ancient Greece, a minority of athletes have employed a variety of potions to artificially boost their performance. More recently, amphetamines, anabolic steroids and hormones have been the drugs of choice.

The World Anti-Doping Agency (WADA) has recently turned its attention to the threat of gene doping and officially banned the practice in 2003. There have already been suspicions of some athletes using the gene therapy Repoxygen to increase their red blood cell count and thereby allow the body to absorb more oxygen.

Professor Max Gassmann of Zurich University’s Institute of Veterinary Physiology has manipulated the erythropoietin (EPO) gene of mice to produce more oxygen carrying red blood cells – a process that could eventually be transferred to humans.

Gassmann does not think gene doping has infiltrated sport at the moment but believes some people may already be testing its potential, just as beneficial gene therapy is currently undergoing clinical trials.

“I can hardly imagine that we had a gene doping cheat winning at the Beijing Olympics,” he told swissinfo. “But there has been doping throughout history and if gene doping becomes viable then you cannot stop it, because people want to win.”
Fictional leap
Author Beat Glogger has taken the theory a stage further by writing a thriller – “Run For My Life” – about genetically modified athletes. Glogger, also a science journalist, and Gassmann contributed to a Swiss sports ministry document warning about the risks of gene doping.

Scientists have already identified more than 150 genes that potentially influence performance in sports. These include genes that control muscle growth, muscle speed and the production of red blood cells.

“I take the next step into fiction by saying it is possible to manipulate the genes that control speed, power, endurance and even mental strength. These are the four key factors for athletic performance,” Glogger told swissinfo.

There are many cases of people with naturally malfunctioning genes. Most of the time this results in health problems, such as muscular dystrophy, but the rare occurrence of a mutation can also bring benefits.

Finnish cross-country skiing legend Eero Mäntyranta won race after race in the 1960s because of a natural genetic mutation that helped his blood absorb large amounts of oxygen. It would be very hard in future to determine if such a case was caused by nature or gene manipulation, according to Glogger.

“If, after the introduction of the relevant genes, the body produces more EPO or testosterone by itself then you cannot detect it – it looks like you are a natural,” he said.
To die for
However, athletes run a high risk of developing serious diseases such as cancer or even dying if they submit to gene manipulation that is still in the early days of scientific development.

Gassmann’s genetically modified mice live only half as long as other mice. Scientists know how to modify genes and introduce them into the body, but not how to control the behaviour of such genes once they have been implanted.

“Whatever you put into the body is hard to control. If you realise it is no good then it is almost impossible to stop, and that is what could happen with gene cheating athletes,” Gassmann said. “It is easy to switch on a light but much more complicated to dim it.”

One method of controlling modified genes is to develop drugs that act like on and off switches, but this process is still in its infancy.

“Gene doping could be undetectable and it could improve performance but you could also die,” Glogger warned. Just like the characters in his book.

swissinfo, Matthew Allen in Zurich

Gene Doping

I interviewed for Simon, got him to Florence for the gene doping meet, gave him a copy of my book and he didnt even bother to quote me. Bad form Simon!

Gene doping – the battleground
Telegraph Sport take a look at the front-line of drug-enhanced sport.

By Simon Hart
Last Updated: 5:47PM GMT 15 Nov 2008
Myostatin
What is it?
A protein that inhibits muscle growth in animals and humans.
How can it benefit athletes?
If the gene responsible for myostatin is switched off, muscles will increase in size.
Does gene modification work?
Successful in trials on mice and dogs and set to go into commercial use as a veterinary treatment next year. Untested on humans but known to produce an immune reaction, so risky.
Can it be detected?
No, but researchers hope to find ways of testing for the virus used to deliver the gene.
IGF-1
What is it?
Insulin-like growth factor 1, a natural protein that promotes muscle- growth and repair but declines with age.
How can it benefit athletes?
Over-production of IGF-1 will cause an increase in muscle mass and strength.
Does gene modification work?
Successful in animal trials but human application still being tested. Has to be injected locally into muscle because high levels in the bloodstream cause problems with other tissues.
Can it be detected?
Not without a muscle biopsy.
EPO
What is it?
A naturally occurring protein that produces red blood cells.
How can it benefit athletes?
A richer supply of oxygen-carrying blood cells reduces fatigue in muscles, which makes EPO so beloved of endurance athletes such as road cyclists and cross-country skiers.
Does gene modification work?
Offers prospect of permanent source of extra EPO rather than short-term burst. Trials on monkeys have had mixed results, with some producing dangerously high amounts of EPO and others developing immune responses. Very risky for humans at present.
Can it be detected?
Preliminary research suggests it will be detectable to drug-testers.
What if…
…genetically modified animals were allowed into sport?
By Andrew Baker
· Lewis Hamilton dedicates second world motor racing title to the artificially enhanced hamsters who turn the wheels of his McLaren. “I’d have been nowhere without Nibbles, Whiflet, Coco and Mr Muscles,” the driver acknowledges.
· Ranks of matadors decimated by giant, four-horned bulls.
· Scientifically improved chimpanzee wins Tour de France. “The team pay me peanuts,” the muscular ape tells reporters on the Champs Elysees.’’What could be better?”
· Air-breathing octopus with eight rackets wins Wimbledon singles title.Defeated finalist Andy Murray vows to clone himself and enter next year’s men’s doubles.
· Greyhound Derby won by Tiny, a powerful Chihuahua who runs between his opponents’ legs.
· Dee Caffari towed to victory in Vendee Globe round-the-world yacht race by killer whale fitted with genetic SatNav. “To be honest, I read my book most of the way”, the skipper confesses.

Drug cheats may benefit from animal test
Lee Sweeney, professor of physiology at the University of Pennsylvania, is a popular man in the world of sport.

By Simon Hart
Last Updated: 5:48PM GMT 15 Nov 2008
He gets between five and 10 emails a week from athletes, some from Britain, and so many phone calls that his secretary has stopped putting them through. And that is in a quiet week.
If he publishes an academic paper or does a media interview, a flurry of 50 or more calls and emails usually follows, as it did 10 years ago when he first revealed his ‘mighty mice’ to the world at a meeting of the American Society for Cell Biology – laboratory mice with enormous muscles that retained their strength and regenerative ability even when the animals reached old age.
Sweeney’s super-strong rodents were the product of his pioneering research into gene transfer technology and the implications were clearly not lost on the athletes and coaches who got in touch, one of whom offered $100,000 for what the mice were getting.
Shockingly, Sweeney also received a request from a high school American football coach for his entire team to be genetically modified.
Sweeney told him what he is still telling everyone a decade later, that bulking up on gene therapy is not yet safe enough for humans and would require heavy-duty immune suppression. He always gets the same response.
“Even if I explain to them that to make it work might require all sorts of heroic measures, they basically say, ‘Fine. I’ll do it’. And if it’s a matter of money, they’ll get the money.”
Sweeney has never been contacted by a name he recognises – “I don’t get Barry Bonds calling me up” – and says most of the would-be guinea pigs appear to be young athletes trying to make the big time.
“Some of them are from Europe,” he says. “I get quite a few from the UK and Germany.”
He says he would feel uneasy about passing on their names to the anti-doping authorities but is sufficiently concerned to have accepted a seat on the gene-doping panel of the World Anti-Doping Agency (Wada), who are funding eight research projects on gene-doping detection in a desperate attempt to stay ahead of the cheats.
Sweeney is bracing himself for another surge of calls and emails next year when his work moves from the laboratory to the commercial world with a muscle-building gene therapy for dogs.
It will be available not only for dogs with muscular diseases but dogs that are just old and immobile who, after an injection in their liver, could soon be running around like puppies again.
“We are now in the final stages of getting all the approvals to offer this through the veterinary hospital as a treatment to try to improve strength in pet dogs,” he says.
“As the dogs get weak their owners get upset that they can’t walk around any more. So we’re hoping that within the next year we will begin the era of genetic enhancement in dogs.”
Sweeney hopes his new canine anti-aging treatment will be just the start. Humans have the same gene that Sweeney is manipulating in dogs and the next step will be to treat people with serious genetic diseases such as muscular dystrophy. Ultimately, he hopes to give the elderly, like the pampered pooches of Pennsylvania, greater muscle strength and mobility in their final years.
But any breakthrough will inevitably be seized upon by dope cheats in the same way that clinical drugs such as steroids, human growth hormone and the red blood cell-boosting EPO soon found their way into kit bags. With the prospect of as yet undetectable, lifelong enhancement, how could any drug cheat resist?
As gene transfer technology enters the medical mainstream as a treatment for numerous diseases from blindness to cancer, scientists are agreed it is only a matter of time before it crosses over into sport.
Some predict that London 2012 could be the first genetically modified Olympic Games. Others say the Beijing Games may already have that dubious honour.
“We do not have any proof that gene doping has been practised yet but we have had signs that people are interested and they are looking at it,” says Arne Ljungqvist, chairman of the International Olympic Committee’s medical commission.
Evidence that sport is closing in on the science came two years ago when German police discovered an email sent by Thomas Springstein, the disgraced former coach of sprinter Katrin Krabbe, complaining about how difficult it was to get hold of Repoxygen, a sophisticated agent for delivering EPO by means of gene transfer. Springstein was later convicted of giving doping substances to children.
Cyclists are also beating at the door. A French gene expert, Professor Philippe Moullier, had his eyes opened when a couple of former Tour de France cyclists paid a visit to his laboratory in Nantes, where he is experimenting on EPO genes in monkeys as a treatment for anaemia.
The pair were working for an anti-doping organisation – or at least that is what they told Moullier – and said they wanted to learn about his research.
“The thing that really surprised me was that when I told them it was just the start of the technology, they told me that the riders would not care,” says Moullier. “They would go for it if they had a chance to be undetectable.
“They said there were kids in the Tour de France who would do anything just to have the most advanced technology. It’s a concern because there are still severe adverse side-effects. We are taking such care before it comes to patients so we are scared to see guys who are ready to use it. It’s terrible.”
If the risks are no deterrent, cheats still have to overcome the complexity of gene modification, though if the BALCO conspirators were able to find a biochemist capable of altering a molecule and synthesising a new designer steroid, engaging the services of gene expert should not be beyond the wit and wealth of an athlete determined enough to cheat.
“I think the real threat is from scientists and clinicians who decide they want to make money off the athletes to make this available,” says Sweeney.
“There are people in India and China who will do stem cell transplantation in anyone who’ll pay them. There is no evidence anything they are doing has any effect on the patients but they’ll do it for money. At some point someone will say, ‘I’ll do immune suppression if you want me to and I’ll put in any gene you want’.”
Sweeney admits that day could not be far away. “The bottom line is that we’re going to be able to do genetic enhancement for serious diseases,” he says. “It’s not beyond the realm of possibility that over the next few years, if someone has sufficient help and sufficient motivation, it could be done outside that arena.”

Elderly dogs to be offered genetic enhancement to make them young again
Frail elderly dogs could be injected with genes which allow them to run around like puppies, with technology which could be approved by next year.

Simon Hart and Laura Donnelly
Last Updated: 12:09AM GMT 16 Nov 2008
An American professor is preparing to market a form of canine gene therapy, which would see dogs injected with substances which switch off the genes that regulate their muscle growth.
Prof Lee Sweeney, from the University of Pennsylvania, has pioneered research into gene transfer technology, a field in which poorly functioning and abnormal genes are manipulated, switched off or replaced.
Ten years ago he created “mighty mice” in the lab with enormous muscles and strength in old age. Now he says experiments on dogs have been so successful that he is preparing to market the treatments to owners of ageing pets across the United States.
He said: “We are now in the final stages of getting all the approvals to offer this through the veterinary hospital as a treatment to try to improve strength in pet dogs.
“As the dogs get weak their owners get upset that they can’t walk around any more. So we’re hoping that within the next year we will begin the era of genetic enhancement in dogs.”
Under the therapy, dogs would be given an injection into the liver of an inhibitor which switches off the gene which produces myostatin, a protein which inhibits muscle growth in animals and humans.
The treatment has passed laboratory trials, but regulatory authorities are now discussing whether the dogs would have to be held in quarantine after treatment, because of possible risks if humans came into contact with their waste after the procedure, Prof Sweeney said.
Scientists hope the same technology could be used in humans, to treat serious genetic diseases such as muscular dystrophy.
Human trials of gene therapy have faced difficulties due to the risks of introducing new genes into cells or unintentionally interfering with genes other than those being targeted, which can include inducing cancers.
In some cases the immune system may also have to be suppressed, which can also have increase the risk of infection and other diseases.
Despite the dangers attached to the use of genetic transfer in humans, the professor of physiology is regularly contacted by athletes desperate to use the technology to enhance their performance.
Gene doping is one of the greatest fears of sports regulators, because injections of genes directly into muscle would be almost impossible to detect.
Prof Sweeney says every week he refuses approaches from athletes who will do anything to get their hands on genetic material, including one from a high-school football coach who wanted his entire team to be genetically modified. He tells them that bulking up on gene therapy is not yet safe enough for humans, and would require heavy-duty immune suppression, even if it were legal. Prof Sweeney said he always gets the same response: “Even if I explain to them that to make it work might require all sorts of heroic measures, they basically say ‘Fine, I’ll do it’.