Panama City Beach shark feeding frenzy 11/22/2015

Personalized Drug Screening on Horizon for Multiple Myeloma Patients

A personalized method for testing the effectiveness of drugs that treat multiple myeloma may predict quickly and more accurately the best treatments for individual patients with the bone marrow cancer. The process, developed by scientists at Washington University School of Medicine in St. Louis, also may aid patients with leukemia or lymphoma.

The screening method suggests which commonly prescribed multiple myeloma drug, or combination of drugs, a physician should consider first for a particular patient. The test also suggests optimum dosage.

A study validating the new method will be published in the December issue of the journal Biomaterials and now is available online.

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If the GMO salmon is as good as its maker says, why not label it?

This undated 2010 handout photo provided by AquaBounty Technologies shows two same-age salmon: a genetically modified salmon, rear, and a non-genetically modified salmon, foreground. (AquaBounty Technologies/Associated Press)

By now, you’ve probably heard that the Food and Drug Administration has approved the first-ever genetically engineered animal for human consumption. It’s an Atlantic salmon modified for fast growth with genes from two other edible fish, and it has been — and will undoubtedly continue to be — a lightning rod for all the issues associated with genetically modified foods. There’s safety, there’s escape into the environment and there’s labeling: a trifecta of discord. The fish’s lengthy approval process — the salmon’s developer, AquaBounty Technologies, first approached the FDA 20 years ago — indicates just how intense that discord has been.

So, safety first. Groups such as Consumers Union and Food and Water Watch have expressed concern about both safety and allergenicity, with Consumers Union citing small sample sizes and “inadequate analysis.” It’s unlikely that the FDA assessment will put their minds at ease, since the final decision is largely consistent with preliminary findings from 2010, when the agency determined that food from the GE salmon is as safe as, and no more allergenic than, food from any other Atlantic salmon, and concluded there is “reasonable certainty of no harm.” (Although “genetically engineered” is the term the FDA uses, this salmon is commonly referred to as a genetically modified organism, or GMO.)

The larger issue is the possibility of escape, important because escapees could outcompete or interbreed with native fish. AquaBounty says it has several layers of safeguards to prevent that: The fish are raised on land, in tanks, and the fish grown for food (as opposed to breeding) are all females, and sterile. The FDA calls the possibility of the salmon’s escape “highly unlikely,” and the possibility of their breeding in the wild commensurately unlikely. Environmental conditions around the company’s Canadian and Panamanian facilities, the agency found, make it unlikely that any escapees could thrive and establish a viable population. (The FDA approval is for only those two facilities. Any new installations will require a new environmental assessment and separate approval.)

Consumers Union, again responding to preliminary FDA findings that today’s announcement confirmed, says the agency’s determination that escape is a remote possibility was built on “inadequate science and unfounded assumptions” and expresses concern that the sterilization process isn’t 100 percent successful. (That’s true; the FDA requires that the rate be at least 95 percent, and AquaBounty chief executive Ron Stotish says that rates, in practice, are generally over 99 percent.)

A Canadian governmental risk assessment issued in 2013 also looked at both safety and escapes and described the risk to human health as “low” and the risk to the Canadian environment as “negligible.”

On both of those issues, there will always be some doubt. Safety can’t be proved (we can only infer it from absence of harm so far), and any containment system can fail. So the questions aren’t “Is it safe?” and “Could they escape?” The question is whether the risk in those two areas is outweighed by the benefits.

So let’s talk about the benefits. According to AquaBounty, the advantages are that the fish reaches market weight in about half the time taken by conventional salmon and requires 25 percent less feed to get there. If that’s true (and there’s no reason to suppose it isn’t), what we have here, finally, is a GMO that can benefit people and planet — unlike the other genetically engineered foods approved for use in the United States, which chiefly benefit farmers. Growing healthful fish in less time, with less feed, is a win for humans (in the form of more affordable salmon) and environment (in the form of reduced feed requirements and less pressure on forage fish stocks).

I do have one concern about whether those benefits will play out, but it’s related to neither safety nor the potential for escape. It’s about raising fish in tanks. Although tanks eliminate the potential for ocean pollution and the spread of disease to wild fish, and virtually eliminate the problem of escapees, they require both water and energy. Does that increase in resources counterbalance the decrease that comes from faster growth and better feed conversion? AquaBounty’s Stotish says that energy requirements vary widely by location and that the Panamanian location is very resource-efficient, as the water is gravity-fed and doesn’t need cooling. Although he hasn’t done the calculation in greenhouse gases, he has done it in money, a reasonable proxy. “We have a lower cost per kilo than net pen production,” he says.

That leaves the third issue: labeling. The United States, unlike many other countries, has no requirement that genetically modified food be labeled as such, and the salmon is no exception. When the fish is introduced, Stotish says, it probably will not be identified as genetically engineered — a decision I think is unfortunate. “When you’re the first and only, labeling is a dangerous decision,” he says. “We’d like to label it as a premium product, but we’ll probably introduce it as ‘Atlantic salmon.’ ”

Because there is so much fear and so many misconceptions about genetically engineered food, I feel his pain. But I’d ask him to suck it up and put the label on it. One of the reasons GMOs became such a brouhaha is that consumers feel the technology was foisted, in secret, on an unsuspecting public.

The company has a limited capacity to grow fish, so consumers won’t be seeing the salmon on store shelves right away. Stotish estimates that it’ll be two years before production levels are high enough to get a regular supply to market, and I think that gives AquaBounty plenty of time to change its mind about labeling. If the fish has all the advantages the company claims it does, say it loud. And let everyone — pro and con — vote with their wallets.

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FDA approves J&J drug for advanced multiple myeloma

U.S. regulators have approved an experimental treatment from Johnson & Johnson that may offer hope to multiple myeloma patients who have run out of other options against the blood cancer.

The U.S. Food and Drug Administration on Monday said it had approved Darzalex (daratumumab) for patients who had already undergone at least three prior standard treatments for the cancer, which affects infection-fighting plasma cells that reside in the bone marrow.

Darzalex, given as an infusion, is a monoclonal antibody that works by helping the immune system attack cancer cells. J&J licensed worldwide rights to the medicine from Danish biotech company Genmab A/S.

In one 106-patient study, tumors shrank or were no longer detectable in 29 percent of patients taking Darzalex, and the benefit lasted for an average of 7.4 months. In a second trial, involving 42 patients, 36 percent of patients taking the J&J/Genmab drug saw a partial or complete reduction in tumors.

Researchers said it is the first antibody drug to demonstrate effectiveness against myeloma without having to be combined with other medicines.

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Pesticide Peddler Monsanto Wins 2015 Rubber Dodo Award

TUCSON, Ariz.— Monsanto, producer and seller of Roundup and its toxic active ingredient glyphosate, is the recipient of the Center for Biological Diversity’s 2015 Rubber Dodo Award, given annually to those who have done the most to destroy wild places, species and biological diversity. Glyphosate is now used in more than 160 countries, and more than 1.4 billion pounds are applied each year. It has been classified as a “probable human carcinogen” by the World Health Organization and its heavy use, particularly on herbicide-resistant GMO crops, also developed by Monsanto, is considered a leading cause of the recent, drastic 80 percent decline in monarch butterflies.

Previous Rubber Dodo winners include U.S. Department of Agriculture’s Wildlife Services (2014), the Koch brothers (2013), climate denier James Inhofe (2012), the U.S. Chamber of Commerce (2011), former BP CEO Tony Hayward (2010), massive land speculator Michael Winer (2009), Alaska Gov. Sarah Palin (2008) and Interior Secretary Dirk Kempthorne (2007).

“The science is increasingly clear that glyphosate is damaging wildlife and putting people at serious risk, yet Monsanto continues to aggressively peddle the stuff to farmers and really any customer it can find,” said Kierán Suckling, the Center’s executive director. “It’s hard to fathom the depth of the damage that glyphosate is doing, but its toxic legacy will live on for generations, whether it’s through threatening monarchs with extinction or a heightened risk of cancer for people where it’s spread.”

Earlier this week the Center released an analysis that found more than half of the glyphosate sprayed in California is applied in the state’s eight most impoverished counties, where the populations are predominantly Hispanic or Latino.

“Those sitting in Monsanto’s boardrooms and corporate offices won’t pay the price for this dangerous pesticide. It’s going to be people on the ground where it’s sprayed,” Suckling said. “This kind of callous pursuit of profits is at the core of what’s driving the loss of wildlife and diversity on a massive scale around the globe.”

More than 15,000 people cast their votes in this year’s Rubber Dodo contest. Other official nominees were Volkswagen, Sen. John McCain (R-Ariz.), Exxon and notorious Nevada rancher Cliven Bundy.

Background on the Dodo

In 1598 Dutch sailors landing on the Indian Ocean island of Mauritius discovered a flightless, 3-foot-tall, extraordinarily friendly bird. Its original scientific name was Didus ineptus. (Contemporary scientists use the less defamatory Raphus cucullatus.) To the rest of the world, it’s the dodo — possibly the most famous extinct species on Earth after the dinosaurs. It evolved over millions of years with no natural predators and eventually lost the ability to fly, becoming a land-based consumer of fruits, nuts and berries. Having never known predators, it showed no fear of humans or the menagerie of animals accompanying them to Mauritius.

Its trusting nature led to its rapid extinction. By 1681 the dodo had vanished, hunted and outcompeted by humans, dogs, cats, rats, macaques and pigs. Humans logged its forest cover while pigs uprooted and ate much of the understory vegetation.

The origin of the name dodo is unclear. It likely came from the Dutch word dodoor, meaning “sluggard,” the Portuguese word doudo, meaning “fool” or “crazy,” or the Dutch word dodaars meaning “plump-arse” (that nation’s name for the little grebe).

The dodo’s reputation as a foolish, ungainly bird derives in part from its friendly naiveté and the very plump captives that were taken on tour across Europe. The animal’s reputation was cemented with the 1865 publication of Lewis Carroll’s Alice's Adventures in Wonderland.

Based on skeleton reconstructions and the discovery of early drawings, scientists now believe that the dodo was a much sleeker animal than commonly portrayed. The rotund European exhibitions were likely produced by overfeeding captive birds.

The Center for Biological Diversity is a national, nonprofit conservation organization with more than 900,000 members and online activists dedicated to the protection of endangered species and wild places.