• High court signals skepticism on patenting genes

    Pete Williams, Justice Correspondent, NBC News writes

    In a Supreme Court test of whether a company can be granted a patent on the genes in the human body, a majority of the justices indicated during Monday's oral arguments that the court is likely to rule that a human gene can’t be patented. 

    It would be one thing, several of the justices said during Monday’s oral arguments, for a company to seek a patent on a test for breast cancer that was developed by analyzing a human gene, but it would be going too far to be awarded a patent on the gene itself.

    "What's the difference between snipping off a piece of the liver or kidney, and seeking a patent on that, and seeking a patent on a piece of a gene?" asked Justice Sonia Sotomayor.

    Justice Samuel Alito made a different analogy, to someone seeking a patent on a plant found in the Amazon rain forest that bore leaves containing a cancer cure. "You could patent the process used to get the chemical out and the use of the result, but you cannot patent the plant," he said. 

    Stelios Varias / Reuters file photo

    The U.S. Supreme Court in Washington

    The case, Association for Molecular Pathology v. Myriad Genetics, involves a test that has helped guide more than a million women in their medical decisions. The test can determine whether the composition of their genes makes them more likely to get breast or ovarian cancer.

    Myriad Genetics, a Utah company, owns patents on two parts of human genes known as BRCA 1 and BRCA 2, named for the first two letters of the words breast and cancer.

    Women with mutations in those genes face up to an 85 percent risk of getting breast cancer and up to a 50 percent risk of ovarian cancer. Because of the patents, Myriad has a monopoly on performing all diagnostic tests related to BRCA 1 and BRCA 2.

    In the past three decades, the federal government has granted nearly 3,000 similar patents on genetic material. Without such protection, Myriad argues, companies would be less willing to spend the money required for making genetic discoveries.

    "Countless companies and investors have risked billions of dollars to research and develop advances under this promise of stable patent protection," according to Gregory Castanias, a Washington, D.C, lawyer who argued the case for Myriad.

    The idea of patenting DNA material has provoked a strong debate among scientists, and many have lined up on opposite sides of the case.

    "Human genes should not be patented," says James Watson, the Nobel Prize winner and co-discoverer of the double helix structure of DNA.

    "Life's instructions ought not be controlled by legal monopolies created at the whim of Congress or the courts," he says.

    But a group of researchers at the University of Maryland is among those arguing just the opposite. "The costs are outweighed by the benefits stemming from the fruits of increased inventive activity," they say in their friend-of-court brief.

    In the 220 years since Thomas Jefferson wrote the cornerstone of U.S. patent law, the courts have agreed on a general principle: patents protect inventions, not products of nature. A central issue in this case is whether Myriad has obtained a patent on something already in the body or has created something new.

    The ACLU, representing a group of scientists, doctors, and cancer patients, claims that Myriad has merely removed from the body something that was already there -- the DNA sequence making up the BRAC 1 and BRAC 2 genes. Because it is a creation of nature, the ACLU says, it cannot be protected by a patent, even though Myriad claims that removing it is what makes it useful.

    "Gold does not become patentable once taken out of a stream because it can be used in jewelry. Kidneys do not become patentable once taken out of a body because they can be transplanted," says the ACLU's Christopher Hansen.

    Myriad's exclusive patent, says the ACLU, creates a monopoly that denies women the ability to seek a second opinion, based on another test of the genetic material, and dissuades other laboratories from pursuing research on the patented genes.

    The ACLU also contends that because the test costs roughly $3,000, many women cannot afford it or lack the necessary insurance coverage. If the gene was not under patent protection, the ACLU says, competition would make the test cheaper.

    But Myriad argues that removing the gene sequence from the body requires breaking chemical bonds that lock it into place, thereby creating a new chemical entity.

    The resulting genetic materials, the company says, "were never available to the world until Myriad's scientists applied their inventive faculties to a previously undistinguished mass of genetic matter."

    Myriad cites a line of cases finding patent eligibility for naturally occurring substances that were isolated and purified, including aspirin, vitamin B12, and adrenaline derived from cows.

    As for availability, the company says the cost of the test is covered by private insurance, Medicare, and Medicaid. It also says many other labs provide second opinions regarding the company's test results and that thousands of researchers have done studies on the gene sequence involved, unimpeded by the patent.

    The Obama administration has urged the court to be deeply skeptical of Myriad's broad claim of what can be patented. The Justice Department's brief in the case says the public interest has consistently been given precedence by the Supreme Court "in avoiding undue restrictions imposed by patents that effectively preempt natural laws and substances."   

    NBC's Tom Curry contributed to this report.

    This story was originally published on Mon Apr 15, 2013 4:17 AM EDT

  • 'Brimming with energy' after $20K stem cell treatment

    Jennifer Vasilakos got the shocking surprise of her life after helping a man who stopped to ask her for directions. That man happened to be the billionaire founder of the Beanie Baby company and what he did may have saved her life. NBC's Kristen Dahlgren reports.

    By Kristen Dahlgren and Erica Ayisi, NBC News

    What started out as a modest fundraising event held in a Santa Barbara, Calif., parking lot has turned into a life-changing moment for Jennifer Vasilakos, thanks to a chance meeting with Beanie Baby billionaire Ty Warner. 

    It all began in a parking lot in July of last year. Vasilakos, 42, set up a table near her hometown's annual Santa Barbara French Festival to raise money for stem cell treatment, displaying signs and flyers that explained her cause. She also brought a small moneybox to stash cash made from parking cars for festival-goers.

    Equipped with sunglasses, a water bottle and coffee, Vasilakos was prepared to spend the day raising awareness and telling people her personal story – that she was diagnosed with acute renal failure in 2011 and had received dialysis three times a day, three times a week. It was a grueling regimen that she would endure the rest of her life. A kidney transplant wasn’t an option; she had been rejected as a candidate because of a previous bout with cancer.

    Vasilakos, a Reiki teacher and herbalist, decided her only option was to save up for stem cell treatment – a costly procedure that is not performed in the United States.

    But as the day wore on, her moneybox largely remained empty. The festival, she said, “was completely dead.”

    That's when a lost driver in a “small little car” drove up, looking for directions. Jennifer chatted him up.

    Louis Lanzano / ASSOCIATED PRESS

    Ty Warner, Beanie Baby creator and chief executive of Ty Inc., arrives at the Toy Fair to sign

    “The man rolls down the window, has a piece of paper in his hand and he’s looking for a local business,” she recalled. “I provide him instructions and because I am fundraising that day to get my stem cell treatment, I hand him my flyer.”

    The man gave her $50.

    About an hour later, the driver returned, looked her in the eye and asked if she was the woman in the flyer raising money for stem cell treatment. She confirmed that she was.

    Courtesy of Jennifer Vasilakos

    Jennifer Vasilakos received this note from Ty Warner, accompanied by a check for $20,000. It reads: "Dear Jennifer, Someone up there loves you because I was guided to meet you on Saturday. I never lose my way, but fate had me lost and ask you for direction. The rest of the story I hope will be a wonderful new life for you. God bless you Jennifer. Ty."

    The man replied, “I’m Ty Warner, and I’d like to help you with this and take care of it for you.”

    Yes, that Ty Warner – of Ty Inc., the billionaire brain behind the Beanie Babies collectibles craze. Vasilakos said she recognized his name but had no idea he would ultimately make a huge donation.

    “I was hoping to raise a few hundred dollars that day by the generosity of my community for the stem cell treatment that I needed to get,” she said. “I had no idea I would meet Ty Warner that day.”

    On her blog, Vasilakos wrote: “I listened as he repeated over and over that he was going to help me. That my fundraising was done.  That I didn’t need to worry any longer. He said he would send a check after he returned to his offices during the week.”

    Several days after they met, Vasilakos received a $20,000 check from Warner along with a handwritten note. She said she hopes it “was a little birdy in his ear that said, ‘You should help this woman.’”

    Vasilakos had the stem cell treatment last year in Trinidad. 

    Warner, according to a prepared statement, was enlightened by their chance encounter.

    "After I serendipitously met Jennifer, I further educated myself on her stem cell needs. I was shocked that this particular type of treatment wasn't available to her in the U.S.," Warner said. "My hope is that we can bring this lifesaving treatment to the forefront so that it can become more readily available and provide alternatives for people like Jennifer."

    Vasilakos underwent the treatment in September 2012 and now, after months of recovery, she says she feels great. 

    "The day the length of my dialysis treatment was reduced to two and half hours per treatment was an exciting day. I regained three hours of freedom per month! My blood pressure has dropped down to normal with lower and lower levels of medication," she wrote recently on her blog. "The biggest change is how amazing I feel, and I am brimming with energy. My immune system has become resilient, and I can feel the difference in my body." 

     

     

     

     

  • Putin signs law banning American adoptions

    Those already undergoing the costly process of adopting a child from Russia found out Russian President Vladimir Putin signed a law barring any future adoptions, canceling the ones in progress. NBC's Kerry Sanders reports.

    NBC News staff and wire reports writes

    President Vladimir Putin signed a law on Friday that bans Americans from adopting Russian children and imposes other measures in retaliation for new U.S. legislation meant to punish Russian human rights abusers.

    The law, which has ignited outrage among Russian liberals and children's rights advocates, enters into force on Jan. 1 and is likely to strain U.S.-Russia relations.

    As well as banning U.S. adoptions, it will also outlaw some non-governmental organizations that receive U.S. funding and impose a visa ban and asset freeze on Americans accused of violating the rights of Russians abroad.

    The law could block dozens of Russian children expected to be adopted by American families from leaving the country and cut off one of the main international routes for Russian children to leave orphanages that are often dismal. Russia is the single biggest source of adopted children in the United States, with more than 60,000 Russian children being taken in by Americans over the past two decades.

    The bill is retaliation for an American law that calls for sanctions against Russians deemed to be human rights violators and part of an increasingly confrontational stance by the Kremlin against the West.

    Related: Americans may lose right to adopt Russian children


    Putin said U.S. authorities routinely let Americans suspected of violence toward Russian adoptees go unpunished — a clear reference to Dima Yakovlev, a Russian toddler for whom the bill is named. The child was adopted by Americans and then died in 2008 after his father left him in a car in broiling heat for hours. The father was found not guilty of involuntary manslaughter.

    Children's rights ombudsman Pavel Astakhov on Wednesday said that 46 children who were about to be adopted in the United States would remain in Russia if the bill came into effect. On Thursday, he petitioned the president to extend the ban to other countries.

    Courtesy Thomas family

    John and Renee Thomas with their son, Jack, 7, who was adopted from Russia at the age of 3. Jack is hoping for his brother, Nikoly, now in a Russian orphanage, to join him in the United States.

    Would-be adoptive parents in the United States are left hanging by Putin's signing of the bill, which was passed by Russian lawmakers last week.

    Among them are John and Renee Thomas of Minnetonka, Minn., Kari Huus of NBC News reported. The Thomases have already adopted Jack, 7, from Russia. When they found out he had a little brother, they began the process to try to adopt him, too. The wait has stretched to four years, and now the adoption may be in danger. 

    "When Jack is asked about his family, he talks about his brother," John Thomas said. "He always asks, 'When is he coming home?' We just tell him we’re waiting for the call."

    More: Adoption of little brother caught in US-Russia spat

    UNICEF estimates that there are about 740,000 children without parental custody in Russia, while only 18,000 Russians are now waiting to adopt a child.

    Russian President Vladamir Putin has said he'll sign a proposed law that would halt adoptions of Russian children to Americans. NBC's Duncan Golestani reports.

    The U.S. State Department on Thursday repeated its opposition to the Russian measure.

    "The welfare of children is simply too important to tie to the political aspects of our relationship," State Department spokesman Patrick Ventrell said. "Additionally, we are deeply troubled by the provisions in the bill that would restrict the ability of Russian civil society organizations to work with American partners."  

    Critics of the bill left dozens of stuffed toys and candles outside the parliament's lower and upper houses to express solidarity with Russian orphans. 

    An online petition urging the Kremlin to scrap the bill garnered more than 100,000 Russian signatures. 

    The Associated Press contributed to this report.

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  • Mystery kidney disease decimates Central America sugarcane workers

    An inexplicable epidemic in Central America, where more than 16,000 people — mostly sugarcane workers — have died from incurable chronic kidney disease. NBC's Kerry Sanders reports from Nicaragua.

    Kerry Sanders and Lisa Riordan Seville writes

    CHICHIGALPA, Nicaragua – You won’t see a road sign pointing to “La Isla de Viudas,” or “The Island of Widows,” as it’s not the community’s official name. It’s a nickname born from a horrific body count. 

    In the past 10 years, it’s believed that hundreds, if not thousands, of residents of Chichigalpa — mostly male sugarcane workers — have died from chronic kidney disease, or CKD. That in a city of nearly 60,000, roughly the size of Ames, Iowa. 

    The mysterious and hidden epidemic, first highlighted by the Center for Public Integrity, has claimed thousands more lives across Central America. In El Salvador and Nicaragua alone, the number of men dying from the excruciatingly painful disease has risen five-fold in the last two decades. High rates of CKD also have been found in rural villages in India and among the rice paddies of Sri Lanka.

    Sacorro Mendez Flores, who lives in the “La Isla” district of Chichigalpa, remembers when her son first fell ill. Jorge Luis Silva didn’t look sick at first, but inside he was dying. His kidneys struggled to filter waste from his body, to no avail. Five months ago, Flores buried him. 

    “The same thing happened to my husband,” she said. “They both died the same.”

    Sacorro Mendez-Flores, surrounded by her grandchildren, holds a family photo. The resident of Chichigalpa, Nicaragua, lost both her son and husband to chronic kidney disease.

    Researchers are searching for answers about why this disease is ravaging not only the bodies of its victims, but the communities they leave behind. 

    The illness spreads
    More than 20 million Americans aged 20 and older have chronic kidney disease, according to the Centers for Disease Control and Prevention. In developed countries like the U.S., CKD often goes hand in hand with obesity, diabetes and hypertension. With treatment, including dialysis and kidney transplants, many with the disease survive. 

    The CKD plaguing parts of Central America, however, is something scientists have never seen before.

    “It affects people who don't have diabetes or hypertension, which are the usual risk factors for chronic kidney disease,” said Sasha Chavkin, a CPI reporter who has covered the mysterious epidemic for several years. “No one can figure out what it is that's making all these people sick.”

    Slideshow: Mysterious malady fells sugarcane workers

    Estbean Felix / AP

    Workers in Central American sugarcane fields are dying of chronic kidney disease at an astonishing rate and experts are unable to say why.

    Launch slideshow

    “It comes at great social, economic and humanitarian cost,” said Dr. Daniel R. Brooks, an associate professor of epidemiology at the Boston University School of Health who is leading a research team looking for the cause of the epidemic. “These are working-age people who are being struck down, and whole communities are really hurt and devastated by this disease.” 

    And with little or no access to the life-saving treatments available in the developed world, a CKD diagnosis is often tantamount to a death sentence. 

    Related stories

    In Nicaraguan sugarcane community, workers stare death in the face

    Chronic kidney disease: 'Silent killer' may have multiple triggers

    “Where we stand right now is that ultimately this disease is not treatable in this community,” said Nate Raines, a researcher with the Mt. Sinai School of Medicine Global Health program, which is collaborating with two organizations in Nicaragua on research independent from the Boston University group. “What we need to do is find the cause. That's the only way to really help the health situation.” 

    Many in Chichigalpa believe that the root of the disease lies in chemicals sprayed in the sugarcane fields while men are working, or seeping into the water supply. A spokesperson from the sugar industry says the chemicals used are standard fertilizer and are not used to excess.  

    Science, so far, points to a more complicated answer. 

    'Markers' of kidney damage found
    The research team from the Boston University has linked the disease in Central America to strenuous labor, dehydration and environmental conditions in which chemicals may play a role. That theory was supported by the group’s most recent study, which found “markers” of kidney damage in adolescents as young as 12 in affected communities. 

    Thousands of miles away, research in Sri Lanka’s affected communities also indicates chemicals may play a key role in the illness devastating communities there.

    As reported last month by the Center for Public Integrity, the country’s health ministry and World Health Organization announced in June that a years-long study had identified chemicals thought to be an essential cause of the disease: cadmium and arsenic. Both are heavy metals found in fertilizers and pesticides that can cause an array of health effects, including the type of kidney damage ravaging communities in Sri Lanka and Nicaragua.

    While most of those tested had lower levels of the toxic elements than officially designated as dangerous by the United Nations, researchers believe that long-term exposure, likely through the food chain, may explain the high incidence of CDK. 

    Why are thousands of sugarcane workers dying from chronic kidney disease each year? Sasha Chavkin, of The Center for Public Integrity, discusses the search for the cause of this mysterious epidemic.

    The findings, due to be officially released in October, represent a potential breakthrough in the research about CDK worldwide, including the epidemic in Nicaragua. 

    Researchers in Central America have not pinpointed a chemical cause. But the new research on adolescents indicates the kidneys of those going into the fields may already be damaged, making the long days and repeated dehydration in the fields potentially deadly. 

    Some experts also suggest that sugarcane workers may also unwittingly be harming themselves as they struggle to stay hydrated while cutting up to 11 tons of cane a day by hand.

    For a refreshing pick-me-up, they occasionally slice a stalk of cane, peeling back its “bark” and sticking it in their mouths, where it produces a sweet sugary liquid. 

    But investigators now wonder: Could that constant flow of sucrose, combined with 90-plus degree temperatures and severe daily dehydration, be a deadly cocktail that slowly brings on CKD? 

    “We believe high amounts of sugar solutions may not cause much kidney damage,” said Dr. Richard Johnson, head of the division of renal disease and hypertension at the University of Colorado, Denver. “But under certain circumstances, such as dehydration, we’re concerned the sugar may actually be toxic in causing damage to the kidneys.”

    The sugar link
    Whether or not sugar consumption plays a direct role in causing the Central American form of CKD, activists say it is a thread that connects the disease to its northern cousin.

    In the U.S., rampant sugar consumption – Americans eat an average of 22.2 teaspoons of sugar per day according to the American Heart Association—drives many of the diseases linked to CKD, including diabetes and hypertension. 

    And with recent steep increases in the price and demand for sugar, more people are working longer hours in the sugarcane fields of Central America. In 2011, the U.S. imported 330,000 metric tons of raw sugar from Central America, or nearly one-quarter of total raw sugar imports that year, according to the United States Department of Agriculture.

    “Not only is the production of sugar killing people, but the consumption of it is killing people,” said Jason Glaser of La Isla Foundation, a nonprofit group he founded to focus attention on the epidemic and fund research that he hopes will solve the mystery. “It's bad for you and it's bad for workers.” 

    The sugar industry, however, rejects suggestions that it is causing the epidemic of CKD among workers at its mills and plantations.

    “We are not responsible for it,” said Mario Amador, a spokesman for the sugarcane industry. “We’re working to find a solution.”

    He also blames the workers themselves, saying they drink too much alcohol. “It’s part of our culture,” Amador said. “It’s part of the things we do in our country. Poor people do it a lot.” 

    Amador also speculated that active volcanoes in the region could have contaminated the water supply. But he admits he does not know why so many have died from CKD.

    No matter what the research finds, Central America is unlikely to curb its cane production anytime soon. The world market for sugar is strong, and the industry receives direct help from abroad. 

    The International Finance Corp., the private-sector arm of the World Bank, has provided loans of more than $100 million to promote production and biofuel in Nicaragua in recent years. Though the loans went to two plantations whose workers have been heavily affected by kidney disease, they were approved without formal consideration of the disease because the IFC did not find a link between the cane fields and CKD, according to the Associated Press. 

    After workers complained about the loans, the IFC helped to negotiate an $800,000 donation to sponsor the ongoing Boston University study, the Center for Public Integrity reported. The money was provided by Nicaragua Sugar Estates Limited, a major sugar producer in the west of the country, part of more than $4 million it has committed toward research and community development in recent years.

    Waiting to die
    But for many in Chichigalpa, the results of the research – whatever they may be – will come too late. 

    Like most of the men in this community, Maximiliano Lopez, spent years in the fields cutting sugarcane. He began at 5 a.m., when the air was cool, and continued to work as the sun beat down, sometimes logging 14 hours a day. Then he was informed he had CKD.

    In his own words, Maximiliano Lopez describes an average day in the life of a sugarcane cutter and how he's coping with the chronic kidney disease that he expects will soon kill him.

    Even after his diagnosis, which bans him from working in the fields or at the mill, the muscular 32-year-old said he used a friend’s identification to return to cutting cane. Nicaragua is the second-poorest country in the Western Hemisphere, he explained, and many workers continue to work the harvest after being diagnosed with kidney disease because it is the only work they can find. 

    “A lot of people do it out of necessity,” Lopez said. “They have a big family and they're the head of the household, so even if they're sick, you have to find work to support your family.” 

    But, as Lopez and other cane workers eventually discovered, short-term survival may mean leaving behind the families that they labored so mightily to support.

    “I began working there to earn a living and instead I earned death,” he said. “I’m just waiting for the day to come.” 

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  • New report shows nationwide stress levels are down

    According to a new report by the American Psychological Association, nationwide stress levels are down for the first time in five years. The organization began commissioning an annual nationwide survey in 2006 to examine the state of stress across the country and understand its impact.

    The results suggest the overall stress average is down, and the percentage of those reporting episodes of extreme stress has dropped from 32 percent in 2007 to 22 percent in 2011.

    The annual "Stress in America" survey was conducted online among 1,200 adults across the United States.

    Read the full report here.