New paradigm for genetic counseling

In the old days (like a year or two ago) only a small portion of the patient population were thought to be candidates for genetic testing.

Now, though, this model of genetic testing only for the select few may be replaced in the near future by the idea that everyone – healthy, sick, high risk, low risk – should have genetic testing. Population scale genetic testing, with its promises of personally tailored medical care and better health outcomes, assumes that everyone – except for a handful of Luddites, people who do not own mobile phones or have Twitter accounts, Flower Children, and conspiracy theorists – will incorporate DNA into their routine medical care. Genetic testing becomes a foregone conclusion, not an ethically and emotionally weighty matter to be carefully explored and considered. If everyone has a genetic test and everyone carries gene mutations, doesn’t that make everyone a patient?

View the original article here: Resistance Is Futile: A New Paradigm for Genetic Counseling?

Is gene therapy finally emerging from the shadows?

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The prospect of using gene therapy to treat diseases—particularly inherited diseases, such as sickle cell anemia and cystic fibrosis that involve one errant gene—has tantalized scientists for decades. It has a simple premise. If there is a problem with part of a patient’s genetic code then alter the code. However, the field has been plagued with problems. Patients have developed leukemia and in one trial in the United States a teenager died. In Europe and the US, the therapies are currently used only in research labs. Now that’s about to change, which raises a host of intriguing medical, financial and ethical issues.

The European Commission has given Netherlands-based uniQure marketing authorization for Glybera, its treatment of lipoprotein lipase deficiency (LPLD), which is a very rare inherited condition that is associated with increased levels of chylomicrons (particles carrying certain fat in the blood). The authorization means the gene therapy can be sold throughout the European Union.

The aim of gene therapy is to correct genetic errors that lead to malfunctioning or even absent proteins, which are at the root of many diseases. One in a million people have damaged copies of a gene, which is essential for breaking down fats. Fat builds up in the blood of those with the default leading to abdominal pain and life-threatening inflammation of the pancreas (pancreatitis). Until now, the only way to manage the condition was through a very low-fat diet. Glybera, administered via a one-time series of small intramuscular injections in the legs, introduces a normal, healthy LPL gene into the body so that it can make functional LPL protein.

Gene therapy has been around since the 1970s, but with only spotty success. Theodore Friedmann and Richard Roblin promoted the concept in 1972, although they concluded that it was premature to begin gene therapy studies in humans because of lack of basic knowledge of genetic regulation and of genetic diseases, and for ethical reasons.

Gene therapy research suffered an almost crippling blow in 1999 after 18-year-old Jesse Gelsinger, who suffered from an inherited liver disease, died of multiple organ failure while participating in an experiment at the University of Pennsylvania. As Smithsonian Magazine has reported, “News of the death prompted an uproar in the scientific community and hearings in Congress, with the teenager’s father, Paul Gelsinger, and others accusing the Penn researchers of being too hasty to test the treatment in people. According to the Food and Drug Administration, the researchers had not sufficiently warned Gelsinger and his family of the experiment’s risks. The lead researcher had also failed to disclose that he had a financial stake in a company that stood to gain if the treatment succeeded.”

“Those were the terrible days. The field bottomed out,” Smithsonian quoted Leon Rosenberg, a Princeton University human geneticist, who performed early lab studies on the liver disease that Gelsinger had, as saying. “The integrity of science was damaged tremendously.”

After that incident, gene therapy moved back into the shadows. However, between 2003 and 2012, researchers quietly developed more advanced gene therapy technologies and conducted clinical studies while entrepreneurs, like Glybera, built specialty companies to commercialize this research. The question now being asked: Does this approval signal a new and more high profile role for gene therapy?

Biopharmconsortium Blog discusses that possibility in an informative post. It appears the jury is still out. Jörn Aldag, the CEO of uniQure, is quoted as saying that “just like antibodies, gene therapy will one day be a mainstay in clinical practice” and will stretch “far beyond rare diseases.”

However, others are not so sure that the approval of Glybera will usher in a new era of gene therapy, at least not in the near future. Writing in Nature, Fulvio Mavilio, scientific director of Genethon (Evry, France), which is a non-profit center for development of gene therapies, does not believe that a large number of patients will be treated with gene therapies in the near future mainly because of restrictive regulations that grew out of prior disappointments. That creates financial uncertainty, he says, which presents a major challenge to gene therapy developers.

One of the more promising developments is the innovative technique developed by Cambridge, MA based bluebird bio to treat a rare, inherited neurological disorder known as childhood cerebral adrenoleukodystrophy (ALD). It affects one in every 21,000 boys worldwide and was featured in the 1992 movie Lorenzo’s Oil. That’s a much larger market than the therapy now approved for Glybera meaning that it is closer to the sweet spot targeted by biotechs and BigPharma and thus is far more likely to attract risk capital. It also uses a cellular approach that may enable it to circumvent many of the pitfalls of gene therapy.

Jon Entine, Senior Fellow for the Center for Health & Risk Communication and STATS at George Mason University, is Executive Director of the Genetic Literacy Project.

 

 

European Society of Human Genetics reprimands Myriad on patent secrets

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The European Society of Human Genetics policy committee has chastised Myriad Genetics for refusing to share its patented genetic database on the grounds that the information is commercially sensitive.

 While Myriad primarily uses its patented BRCA genetic test to look for cancer-causing mutations, it has also used the test to compile a database of “variants of unknown significance” which some scientists, activists and lawyers argue argue should be released because they could facilitate other research.

View the original article here: European Society of Human Genetics reprimands Myriad Genetics on patent secrets

 

Goldfish Crackers targeted in ‘natural’ lawsuit in wake of Prop 37

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While Prop 37 did not pass, the failure to disclose the presence of GMOs in foods that are marketed as ‘natural’ is still generating a steady stream of civil litigation, with Goldfish Crackers the latest brand to be targeted in a class action lawsuit over genetically engineered ingredients.

View the original article here: Goldfish Crackers targeted in ‘natural’ lawsuit over genetically engineered soy as Prop 37 supporters launch ‘GMO inside’ initiative

Ten lessons from Monsanto’s swift-boating of Prop 37

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The populist campaign to label genetically modified food has been successfully Swift-Boating by Monsanto and the largest pesticide and junk food companies on earth. Our consumer movement made the costly mistake of arming itself with peace signs and love beads for what turned out to be a gunfight with a ruthless, assault rifle-equipped enemy.

What can we do about it? We can learn from our mistakes for the next necessary round in our struggle for food safety and environmentally responsible agriculture.

View the original article here: Ten Grassroots Lessons From Monsanto’s Swift-Boating of the Prop37/Label GMO Campaign

GMO labeling efforts change course after California defeat

The failure on Tuesday of a California ballot initiative that would have mandated labeling of genetically modified foods is not a death knell for those seeking nationwide labeling, U.S. labeling proponents said. President Barack Obama’s re-election could be a boost, as he is seen, in general terms, as being supportive of labeling. Still, efforts to force change at a federal level could face an uphill climb.

View the original article here: GMO labeling efforts change course after California defeat

Cloning versus habitat protection in wildlife conservation

Biotechnicians want to use cloning to save endangered species, but they are having only limited success. Critics say that the push toward a new era of wildlife conservation trivializes extinction and funding would be better spent on preserving animal habitats.

View the original article here: Scientists Hope Cloning Will Save Endangered Animals

The Monsanto fallacy

It’s my favorite new logical fallacy, the “Appeal to Monsanto”, the world’s largest producer of biotech agriculture seeds. This is the logic that compels many anti-GMO activists to reply to any argument in support of biotech crops with “So you love Monsanto?” It’s so wonderful because it combines many other logical fallacies into one, and is thus a great time saver.

View the original article here: ARGUMENTUM AD MONSANTIUM

Identical twins may not be quite so identical

Identical twins may not be so identical after all. Even though identical twins supposedly share all of their DNA, they acquire hundreds of genetic changes early in development that could set them on different paths, according to new research.  Other studies have shown that chemical modifications, or epigenetic effects, can change which genes are expressed over the years, one factor that renders twins not completely identical. Still, other work has shown that identical twins can have different gene mutations, but didn’t determine how often they occur.

View the original article here: Identical Twins Are Genetically Different, Research Suggests

Link between child prodigies and autism

While child prodigies have been recognized throughout history, a new study has found a possible link between those we would deem prodigies and a relatively new mental health condition, autism. The study, out of the Ohio State University in Columbus, Ohio, did a comparative study of eight child prodigies.

Three of the eight subjects, it was found, had a diagnosis of autism spectrum disorders. Add to that the fact that the group, on the whole, tended to have slightly elevated scores on a test of autistic traits, when held in comparison to a control group. But what was also very interesting to note was that half of the prodigies, it was found, had a family member or a first- or second-degree relative who had received an autism diagnosis.

View the original article here: Some Child Prodigies May Have A Form Of Autism Spectrum Disorder

Extra chromosome 21 removed from Down syndrome cell line

University of Washington scientists have succeeded in removing the extra copy of chromosome 21 in cell cultures derived from a person with Down syndrome, a condition in which the body’s cells contain three copies of chromosome 21 rather than the usual pair.

Someday Down syndrome leukemia patients might have stem cells derived their own cells, and have the trisomy corrected in these lab-cultured cells.  They could then receive a transplant of their own stem cells – minus the extra chromosome – or healthy blood cells created from their fixed stem cells and that therefore don’t promote leukemia, as part of their cancer care.

View the original article here: Extra chromosome 21 removed from Down syndrome cell line

What’s next for the anti-GM food movement?

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The reflections and recriminations over the rejection of California’s Proposition 37 is in full swing. The measure was soundly defeated, 57 percent to 43 percent. Support for the labeling initiative was strong at first, with popularity reaching 60 percent according to opinion polls, but collapsed over the course of the last month of the campaign.

To many on the left, the loss was directly attributable to the spending blitz and a campaign of “deception” by Monsanto and other “Big Food” companies opposed to the labeling of GM foods. Andrew Pollack, at The New York Times, offers an excellent breakdown of the raw facts, including the imbalance of campaign spending, around Prop 37′s defeat, but it’s hardly the whole story.

Mainstream scientists were by and large opposed to the measure, and are relieved at the outcome.  They point to the deceptive framing of the proposition as a referendum on a “right to know.” It sounds so justifiable and transparent: why shouldn’t people have a right to know if their food is genetically modified? What do Monsanto and Syngenta have to hide? But couching the issue in terms of knowledge assumes that labeling, at least as would have been mandated by Prop 37, would have been informative.

University of California biologist Michael Eisen framed the issue well on his blog: “This language reflects the belief of its backers that GMOs are intrinsically bad and deserve to be labeled – and avoided – en masse, no matter what modification they contain or towards what end they were produced. This is not a quest for knowledge—it is an attempt to reify ignorance.

Intriguingly, many left leaning journalists, who had long stayed out of the fray—taking an anti-GM stance had long been a litmus test of liberal fidelity—are celebrating the initiative’s defeat.  Andrew Revkin, in The New York Times’ Dot Earth blog, wrote he is “glad that the sloppy, unscientific and protectionist initiative failed, but glad an important discussion of transparency in food sourcing has begun.”

Will the anti-GM movement take the opportunity to genuinely reconsider both their science and their tactics? Early signs are mixed. Keith Kloor, at Slate, who has been a voice of sanity throughout the process, pulled no punches, attacking the proposition for its shaky scientific grounding (a common complaint) but calling it “politically stupid” as well.

Two of the most prominent foodies, writer Michael Pollan and the Times’ food writer Mark Bittman may not yet be ready to reconsider their positions. In an article last month for the New York Times Magazine, the writer Michael Pollan argued that passage of Prop 37 would “change the politics of food not just in California but nationally too,” proving that the foodies could exert real political as well as economic power.  He’s gone silent since.

Bittman’s coverage on the issue has been bizarre and clearly out of touch with both the science and public opinion. “It’s not an exaggeration to say that almost everyone wants to see the labeling of genetically engineered materials contained in their food products,” he wrote in a mid-September piece. After the vote, he abandoned one of the major anti-GM narratives, saying, “I think there is very little evidence that eating foods that contain GMOs is dangerous.” However, he continues to embrace the remaining myth—that GM crops are environmentally dangerous. “I think that they have done more damage to the environmental landscape than they have helped it,” he told California Public Radio in an interview.

Not all “progressives” remain so steadfast in their resistance to the science, however. Alexandra Le Tellier at the Los Angeles Times offered an excellent walk-through of how she, as a self-described “health-conscious foodie,” eventually sided against the initiative.

What’s next? Much like the über-conservative Tea Party Right, the hard core is not likely to soften its position. Grist issued a rallying cry to take the issue ‘to the people’ whatever that means. Isn’t that what just happened, and failed? Jason Mark at the Earth Island Journal offers a more considered road to redemption, calling the movement “half-baked” but also offering suggestions for how foodies might build the infrastructure they need to make a more persuasive case.

Jon Entine, Senior Fellow for the Center for Health & Risk Communication and STATS at George Mason University, is Executive Director of the Genetic Literacy Project. Kenrick Vezina is a writer and editor for the Genetic Literacy Project.

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