DEBATE!!!

Pick a side and defend your position.  You must formulate a legitimate argument, as well as discount someone else's argument.  Use facts and/or possible issues arising from the SCOTUS decision.  Do not make or take it personal.

Supreme Court weighs whether human genes can be patented

Published April 15, 2013

Associated Press

DNA may be the building block of life, but can something taken from it also be the building block of a multimillion-dollar medical monopoly? 

The Supreme Court grapples Monday with the question of whether human genes can be patented. Its ultimate answer could reshape U.S. medical research, the fight against diseases like breast and ovarian cancer and the multi-billion dollar medical and biotechnology business. 

"The intellectual framework that comes out of the decision could have a significant impact on other patents -- for antibiotics, vaccines, hormones, stem cells and diagnostics on infectious microbes that are found in nature," Robert Cook-Deegan, director for genome ethics, law & policy at Duke University, said in a statement. 

"This could affect agricultural biotechnology, environmental biotechnology, green-tech, the use of organisms to produce alternative fuels and other applications," he said. 

The nine justices' decision will also have a profound effect on American business, with billions of dollars of investment and years of research on the line. The U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years. 

And Myriad Genetics alone has $500 million invested in the patents being argued over in this case. Without the ability to recoup that investment, breakthrough scientific discoveries needed to combat all kind of medical maladies wouldn't happen, the company says. 

"Countless companies and investors have risked billions of dollars to research and develop scientific advances under the promise of strong patent protection," said Peter D. Meldrum, the president and CEO of Myriad Genetics, in a statement. 

But their opponents argue that allowing companies like Myriad to patent human genes or parts of human genes will slow down or cripple lifesaving medical research like in the battle against breast cancer. 

"What that means is that no other researcher or doctor can develop an additional test, therapy or conduct research on these genes," said Karuna Jagger, executive director of Breast Cancer Action. 

The Supreme Court has already said that abstract ideas, natural phenomena and laws of nature cannot be given a patent, which gives an inventor the right to prevent others from making, using or selling a novel device, process or application. 

Myriad's case involves patents on two genes linked to increased risk of breast and ovarian cancer. Myriad's BRACAnalysis test looks for mutations on the breast cancer predisposition gene, or BRCA. Those mutations are associated with much greater risks of breast and ovarian cancer. 

Women with a faulty gene have a three to seven times greater risk of developing breast cancer and a higher risk of ovarian cancer. Men can also carry a BRCA mutation, raising their risk of prostate, pancreatic and other types of cancer. 

The mutations are most common in people of eastern European Jewish descent. 

Myriad sells the only BRCA gene test. 

The American Civil Liberties Union challenged Myriad's patents, arguing that genes couldn't be patented, and in March 2010 a New York district court agreed. But the U.S. Court of Appeals for the Federal Circuit has now twice ruled that genes can be patented. In Myriad's case, it's because the isolated DNA has a "markedly different chemical structure" from DNA within the body. 

Mark C. Capone, president of Myriad Genetics Laboratories, Inc., a subsidiary of Myriad, said some of the concerns over what they have patented are overblown and some simply incorrect. 

"Myriad cannot, should not and has not patented genes as they exist in the human body on DNA," Capone said in an interview. "This case is truly about isolated DNA molecules which are synthetic chemicals created by the human ingenuity of man that have very important clinical utilities, which is why this was eligible for a patent." 

But the ACLU is arguing that isolating the DNA molecules doesn't stop them from being DNA molecules, which they say aren't patentable. 

"Under this theory, Hans Dehmelt, who won the Nobel Prize for being the first to isolate a single electron from an atom, could have patented the electron itself," said Christopher A. Hansen, the ACLU's lawyer in court papers. "A kidney removed from the body (or gold extracted from a stream) would be patentable subject matter." 

The Obama administration seems to agree. Artificially created DNA can be patented, but "isolated but otherwise unmodified genomic DNA is not patent-eligible," Solicitor General Donald Verrilli said in court papers. 

That was the ruling of the original judge who looked at Myriad's patents after they were challenged by the ACLU in 2009.  U.S. District Judge Robert Sweet said he invalidated the patents because DNA's existence in an isolated form does not alter the fundamental quality of DNA as it exists in the body or the information it encodes. But the federal appeals court reversed him in 2011, saying Myriad's genes can be patented because the isolated DNA has a "markedly different chemical structure" from DNA within the body. 

The Supreme Court threw out that decision and sent the case back to the lower courts for rehearing. This came after the 

high court unanimously threw out patents on a Prometheus Laboratories, Inc., test that could help doctors set drug doses for autoimmune diseases like Crohn's disease, saying the laws of nature are unpatentable. 

But the federal circuit upheld Myriad's patents again in August, leading to the current review. The court will rule before the end of the summer. 

"The key issue now for the court will therefore be whether the scientist working in the lab to isolate a particular gene innovated in a way that allows for that isolated gene to be patented," said Bruce Wexler, a lawyer with the law firm Paul Hastings, who advises pharmaceutical and biotech companies on patent issues. 

The case is 12-398, Association for Molecular Pathology v. Myriad Genetics, Inc.

Read more: http://www.foxnews.com/politics/2013/04/15/supreme-court-weighs-whether-human-genes-can-be-patented/print#ixzz2QYFoNXVz

BioEthics Article 2

Is it Ethical to genetically engineer humans to have certain desirable traits?  What traits would be okay and what traits wouldn't be?  You probably have already eaten genetically engineered vegetables and fruit, but would you eat genetically engineered meat (like from Big Blue up above)?

Think performance enhancers are a problem now?

Welcome to the era of the genetically engineered superathlete

Posted: Tuesday March 11, 2008 12:27PM; Updated: Wednesday March 12, 2008 10:52AM

By David Epstein

I am one of the most avid sports fans you'll find," Se-Jin Lee says. It's true. He'll watch anything. Basketball. Football. Fútbol. Billiards on channel seven-hundred-whatever. As a graduate student in the '80s Lee used to sit in his car in the driveway with the radio on to listen to the games of faraway baseball teams. Even now, in his lab at Johns Hopkins Medical School in Baltimore, he easily rattles off the NCAA basketball tournament winners in order from 1964 to 2007. And, like anyone who values fair competition these days, he's disturbed by the issue of performance-enhancing drugs in sports.

Why, then, is Lee working to usher in technology that will make even today's most inventive doping methods look primitive? A professor of molecular biology and genetics, the 49-year-old Lee studies genes that tell muscles what to do -- genes that he knows how to change. As clever as chemists are in altering steroid molecules to avoid detection (recall BALCO's THG, a.k.a. "the Clear"), those designer drugs can be spotted once antidoping agencies know what to look for. Even human growth hormone will be detectable soon, after a valid blood test becomes commercially available. But if athletes develop ways to alter their genes, the very blueprints for their own muscles, there may be no test of blood or urine that can pick that up.

Lee is pushing the frontier of genetic research into muscle building because the same breakthroughs that could boost performance in sports might also bring about a medical revolution. Advances could not only reduce or eliminate the effects of diseases like muscular dystrophy but also give senior citizens back their strength -- which, often, would amount to giving them back their lives.

In 1995 in his lab on North Wolfe Street, Lee and two colleagues identified the function of myostatin, a protein that tells muscles when to stop growing. It does so, scientists believe, by signaling "satellite cells," or stem cells that lie dormant around the muscle until they're needed to build or repair it. Experimenting on mice, Lee inactivated both copies of the gene in the animal that code for myostatin. The result: Over four to six weeks the rodents developed twice their normal muscle mass without a formal exercise regimen. After Lee's results were published in 1997, he was awash in e-mails from people with muscle-wasting disease (no surprise) offering themselves as subjects for human experiment. He got similar offers (surprise!) from bodybuilders and athletes. Imagine: double the muscle mass. Could he do to them what he had done on the mice?

Some of the athletes barely knew what they were inquiring about. They'd ask Lee where they could purchase some myostatin. "Of course, they didn't want myostatin," he says. "They wanted to block it." But if they could block it with a synthetic gene, the alteration would be a part of their DNA, and it would last for years at the center of their cells. The most straightforward way of detecting the new gene would be to remove a piece of the muscle and probe for it, a procedure most likely too invasive for widescale use. It would be enough to make one long for the simplicity of the steroid era.

The year after Lee's mice results went public, H. Lee Sweeney, a physiology professor at the University of Pennsylvania, published a paper detailing his own mighty mice, which he had injected with a gene engineered to produce a muscle builder called insulin-like growth factor (IGF-1). Sweeney, too, was inundated with inquiries from athletes. He says a high school football coach and a high school wrestling coach volunteered their entire teams as guinea pigs.

Since the gene genie escaped from the bottle a decade ago, researchers have discovered dozens more genes that appear to affect athletic performance. This is old news in the rodent community. Scientists have created mice whose bodies are flooded with oxygen-carrying red blood cells, creating greater endurance. Other mice have been engineered to produce extraordinary amounts of growth hormone, while still others metabolize fat and carbs in such a way that they can live like couch potatoes yet run like marathoners.

Significant safety hurdles remain before gene therapy is widespread for humans. The most efficient means of delivering a synthetic gene is by attaching it to a virus that shuttles it into human cells. Viruses are great at that. They can also trigger the immune system in a way that can lead to fatal results. In 1999 Jesse Gelsinger, an 18-year-old with a rare liver disease who had volunteered for a gene-therapy trial, died from a massive immune response to the virus used in the treatment. And the dangers extend beyond the immune system. In a gene-therapy trial in France, 12 boys were successfully treated for X-linked severe combined immunodeficiency, commonly known as Bubble Boy syndrome, but at least three of them developed leukemia.

One delivery method -- flushing the bloodstream with the desired gene -- is simple enough, says Sweeney, that it could be achieved by a clever undergrad in a molecular biology lab. The method is not very efficient and hasn't been thoroughly tested, but it hints at the possibilities for the spread of gene tampering in sports. Despite the unknowns and the dangers, chances are good that someone at the Beijing Olympics in August, someone willing to weigh his or her mortality in gold, will have undergone gene transfer in an attempt to enhance performance. "Even when I tell them it's not safe," Sweeney says, "some athletes are willing to try anything."

The signs are ominous. In January 2006, during German track coach Thomas Springstein's trial on charges of providing performance-enhancing drugs to minors, evidence emerged indicating that Springstein had attempted to procure Repoxygen, a gene-therapy drug developed to treat anemia by prompting cells to produce EPO and, in turn, red blood cells. (He was found guilty of giving illegal substance to minors and received a 16-month suspended sentence.) In addition, Mauro Di Pasquale, the 1976 world powerlifting champion and an Ontario physician who has written several books on sports doping, says he knows that athletes are experimenting with gene doping, with the help of Chinese doctors and researchers.

Human data relating to myostatin has been hard to come by. Soon after his discovery, Lee attempted to identify potential test subjects with natural mutations in their myostatin genes. He placed an ad in Muscle and Fitness, and close to 1,000 muscle-bound men and women responded. But after collecting samples from 150 of them, he has yet to find a single one with the myostatin mutation he had engineered in his mice.

From his study of Belgian Blue cattle, Lee knew the mutation could occur naturally. A cross between the Shorthorn and the Holstein, which have been bred for some 150 years, these massive animals look as if their skin has been stuffed with watermelons. Lee got in touch with Dee Garrels, owner of the Lakeview Belgian Blue Ranch in Stockton, Mo., who sent him samples for testing. Garrels knew Belgian Blues were strong -- her 2,500-pound bull once ripped a metal restraining gate off its hinges with its horns to get at a cow in heat -- and Lee found out why. He discovered that they had mutations in their myostatin genes.

Lee didn't see the power of a human myostatin mutation until Markus Schuelke contacted him in 2003. A pediatric neurologist in Berlin, Schuelke had been summoned three years earlier to examine a jittery baby in the nursery at Charité hospital in Berlin, where he was taken aback by the newborn's chiseled calves and sculpted quads. By the age of four the boy could hold up a pair of 6.6-pound dumbbells at arm's length. Schuelke had been monitoring the boy's development, and he got in touch with Lee, who confirmed the boy had mutations on both myostatin-coding genes, leaving no detectable amount of the protein in his body.

Apparently it ran in the family. The boy's mother, who was 24 when she gave birth to the "superbaby," had a mutation on one of her two myostatin genes, presumably leaving her less of the protein than normal but not so little that she was as muscle-bound as her son. Nevertheless, she is a testament to the tantalizing temptation of gene-doping. Superbaby's mother, the only adult in the world with a documented myostatin mutation, was a professional sprinter.

The world anti-doping agency has banned gene tampering in athletes and spent millions attempting to develop tests to identify it. Such a procedure will require technology unlike any employed by antidoping scientists. The theory, according to Ted Friedmann, the scientist leading WADA's search for gene-doping countermeasures, is to fight genes with genes. If one medical breakthrough is revolutionizing doping, perhaps another can beat it back.

Thanks to the Human Genome Project, someday all of us could carry our entire genetic blueprint on a microchip, which we'd present to doctors during medical treatment. As that technology matures, Friedmann hopes athletes' genomes can be screened, and that gene-doping markers or signatures will emerge.

As pharmaceutical companies race to turn genetic research into medicine, new gene-therapy drugs could come to market en masse over the coming years. In practical terms it will be impossible to develop specific tests for each of them. "We can keep buying instruments and keep building labs," says pharmacologist Don Catlin, founder of the UCLA Olympic Laboratory, "but [the antidoping] industry isn't like Exxon. There are certain limits."

Perhaps a time will come when there is no longer a need to define those limits -- not because of new artillery in the war on doping but because gene therapy will have become so widespread that it will be as controversial as Flintstone chewables. So far Sweeney has aided antidoping officials. "But I've often told WADA my position would change if [gene therapy] is proven to be safe," he says. "Then we're withholding something that would make the athletes healthier."

That would, in turn, raise a new series of questions: What is it we seek to gain from sport? Do we want to see larger-than-life behemoths swatting 600-foot home runs? Or do we prefer to see people more like us pressing the limits of their strength and skill? After all, with their doctors and coaches and cutting-edge equipment, professional athletes, doped or not, are hardly us.

The gravest danger in the debate over gene transfer is not that athletes might taint sport by tampering with their genes. It's that by abusing such treatment, they'll create the same stigma for gene therapy that they have for steroids.

Pat Furlong has felt the effects of that stigma. She is the head of Parent Project Muscular Dystrophy. Her two sons began life happy and healthy, "and then over 10 to 15 years, you watch them go away, helpless," she says. Part of her job is to persuade parents of kids with muscular dystrophy and their doctors that anabolic steroids are beneficial. "I get calls from parents nervous about steroids because of what they've heard," she says. "But the flip side is that steroids have benefits in people who are losing function. In Duchenne muscular dystrophy, it's all we have.

"We know there's no drug that will come without side effects, but steroids are an option to preserve and protect muscle for a few minutes longer, or a few months longer, or a few more years." The local newscasts, and Congress, rarely mention the part about how they can help kids with MD walk longer, which keeps their spines straighter and helps them breathe better.

As he stands at the edge, looking over the gene-doping precipice, Se-Jin Lee has similar concerns. The hysteria that will ensue when an athlete is caught gene-doping, Lee frets, will result in restrictions on gene-therapy drugs, making them hard to obtain by those who truly need them.

"If [an athlete] did cheat, it was his choice," Lee says. "If [the league] turned its back and allowed that to happen, it was their choice. Patients with debilitating diseases did not get there by choice."

Read and Respond!!

A huge part of science is the issue of ethics in science.  Read the following article and comment about the bioethics of the topic.  Is it morally acceptable to have this technology.  Feel free to begin a debate on this topic.  With that in mind keep comments appropriate, intellectual, and do not take return comments personal.

3D printer spits out human embryonic stem cells

By

Published February 06, 2013

| LiveScience

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Imagine if you could take living cells, load them into a printer, and squirt out a 3D tissue that could develop into a kidney or a heart. Scientists are one step closer to that reality, now that they have developed the first printer for embryonic human stem cells.

In a new study, researchers from the University of Edinburgh have created a cell printer that spits out living embryonic stem cells. The printer was capable of printing uniform-size droplets of cells gently enough to keep the cells alive and maintain their ability to develop into different cell types. The new printing method could be used to make 3D human tissues for testing new drugs, grow organs, or ultimately print cells directly inside the body.

Human embryonic stem cells (hESCs) are obtained from human embryos and can develop into any cell type in an adult person, from brain tissue to muscle to bone. This attribute makes them ideal for use in regenerative medicine — repairing, replacing and regenerating damaged cells, tissues or organs. [Stem Cells: 5 Fascinating Findings]

In a lab dish, hESCs can be placed in a solution that contains the biological cues that tell the cells to develop into specific tissue types, a process called differentiation. The process starts with the cells forming what are called "embryoid bodies." 

Cell printers offer a means of producing embryoid bodies of a defined size and shape.

In the new study, the cell printer was made from a modified CNC machine (a computer-controlled machining tool) outfitted with two "bio-ink" dispensers: one containing stem cells in a nutrient-rich soup called cell medium and another containing just the medium. These embryonic stem cells were dispensed through computer-operated valves, while a microscope mounted to the printer provided a close-up view of what was being printed.

The two inks were dispensed in layers, one on top of the other to create cell droplets of varying concentration. The smallest droplets were only two nanoliters, containing roughly five cells.

The cells were printed onto a dish containing many small wells. The dish was then flipped over so the droplets now hung from them, allowing the stem cells to form clumps inside each well. (The printer lays down the cells in precisely sized droplets and in a certain pattern that is optimal for differentiation.)

Tests revealed that more than 95 percent of the cells were still alive 24 hours after being printed, suggesting they had not been killed by the printing process. More than 89 percent of the cells were still alive three days later, and also tested positive for a marker of their pluripotency — their potential to develop into different cell types.

Biomedical engineer Utkan Demirci, of Harvard University Medical School and Brigham and Women's Hospital, has done pioneering work in printing cells, and thinks the new study is taking it in an exciting direction. "This technology could be really good for high-throughput drug testing," Demirci told LiveScience. One can build mini-tissues from the bottom up, using a repeatable, reliable method, he said. Building whole organs is the long-term goal, Demirci said, though he cautioned that it "may be quite far from where we are today."

Others have created printers for other types of cells. Demirci and colleagues made one that printed embryonic stem cells from mice. Others have printed a kind of human stem cells from connective tissues, which aren't able to develop into as many cell types as embryonic stem cells. The current study is the first to print embryonic stem cells from humans, researchers report in the Feb. 5 issue of the journal Biofabrication.

Copyright 2013 LiveScience, a TechMediaNetwork company. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Scientific Reading

Read the article, and try to find evidence of this article being true, one-sided, slanted, or false.  Cite Evidence, and give an example of how it could be written differently.

Dirtying Up Our Diets

By JEFF D. LEACH

Published: June 20, 2012

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OVER 7,000 strong and growing, community farmers’ markets are being heralded as a panacea for what ails our sick nation. The smell of fresh, earthy goodness is the reason environmentalists approve of them, locavores can’t live without them, and the first lady has hitched her vegetable cart crusade to them. As health-giving as those bundles of mouthwatering leafy greens and crates of plump tomatoes are, the greatest social contribution of the farmers’ market may be its role as a delivery vehicle for putting dirt back into the American diet and in the process, reacquainting the human immune system with some “old friends.”

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Lauren Nassef

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Increasing evidence suggests that the alarming rise in allergic and autoimmune disorders during the past few decades is at least partly attributable to our lack of exposure to microorganisms that once covered our food and us. As nature’s blanket, the potentially pathogenic and benign microorganisms associated with the dirt that once covered every aspect of our preindustrial day guaranteed a time-honored co-evolutionary process that established “normal” background levels and kept our bodies from overreacting to foreign bodies. This research suggests that reintroducing some of the organisms from the mud and water of our natural world would help avoid an overreaction of an otherwise healthy immune response that results in such chronic diseases as Type 1 diabetes, inflammatory bowel disease, multiple sclerosis and a host of allergic disorders.

In a world of hand sanitizer and wet wipes (not to mention double tall skinny soy vanilla lattes), we can scarcely imagine the preindustrial lifestyle that resulted in the daily intake of trillions of helpful organisms. For nearly all of human history, this began with maternal transmission of beneficial microbes during passage through the birth canal — mother to child. However, the alarming increase in the rate of Caesarean section births means a potential loss of microbiota from one generation to the next. And for most of us in the industrialized world, the microbial cleansing continues throughout life. Nature’s dirt floor has been replaced by tile; our once soiled and sooted bodies and clothes are cleaned almost daily; our muddy water is filtered and treated; our rotting and fermenting food has been chilled; and the cowshed has been neatly tucked out of sight. While these improvements in hygiene and sanitation deserve applause, they have inadvertently given rise to a set of truly human-made diseases.

While comforting to the germ-phobic public, the too-shiny produce and triple-washed and bagged leafy greens in our local grocery aisle are hardly recognized by our immune system as food. The immune system is essentially a sensory mechanism for recognizing microbial challenges from the environment. Just as your tongue and nose are used to sense suitability for consumption, your immune system has receptors for sampling the environment, rigorous mechanisms for dealing with friend or foe, and a memory. Your immune system even has the capacity to learn.

For all of human history, this learning was driven by our near-continuous exposure from birth and throughout life to organisms as diverse as mycobacteria from soil and food; helminth, or worm parasites, from just about everywhere you turned; and daily recognition and challenges from our very own bacteria. Our ability to regulate our allergic and inflammatory responses to these co-evolved companions is further compromised by imbalances in the gut microbiota from overzealous use of antibiotics (especially in early childhood) and modern dietary choices.

The suggestion that we embrace some “old friends” does not immediately imply that we are inviting more food-borne illness — quite the contrary. Setting aside for the moment the fact that we have the safest food supply in human history, the Food and Drug Administration, the Centers for Disease Control and Prevention, and food processing plants and farmers continue to take the blame for the tainted food that makes us ill, while our own all-American sick gut may deserve some blame as well.

While the news media and litigators have our attention focused on farm-to-table food safety and disease surveillance, the biological question of why we got sick is all but ignored. And by asking why an individual’s natural defenses failed, we insert personal responsibility into our national food safety strategy and draw attention to the much larger public health crisis, of which illness from food-borne pathogens is but a symptom of our minimally challenged and thus overreactive immune system.

As humans have evolved, so, too, have our diseases. Autoimmune disease affects an estimated 50 million people at an annual cost of more than $100 billion. And the suffering and monetary costs are sure to grow. Maybe it’s time we talk more about human ecology when we speak of the broader environmental and ecological concerns of the day. The destruction of our inner ecosystem surely deserves more attention as global populations run gut-first into the buzz saw of globalization and its microbial scrubbing diet. But more important, we should seriously consider making evolutionary biology a basic science for medicine, or making its core principles compulsory in secondary education. Currently they are not.

As we move deeper into a “postmodern” era of squeaky-clean food and hand sanitizers at every turn, we should probably hug our local farmers’ markets a little tighter. They may represent our only connection with some “old friends” we cannot afford to ignore.

Jeff D. Leach is a science and archaeology writer and founder of the Human Food Project.