Posted but not written by Louis Sheehan


Last March, when President Obama travelled to Argentina to meet with the country’s new President, Mauricio Macri, his public appearances were dogged by protesters who noisily demanded explanations, and apologies, for U.S. policies, past and present. There are few countries in the West where anti-Americanism is as vociferously expressed as in Argentina, where a highly politicized culture of grievance has evolved in which many of the country’s problems are blamed on the United States. On the left, especially, there is lingering resentment over the support extended by the U.S. government to Argentina’s right-wing military, which seized power in March of 1976 and launched a “Dirty War” against leftists that took thousands of lives over the following seven years.

Obama’s visit coincided with the fortieth anniversary of the coup. He pointedly paid homage to the Dirty War’s victims by visiting a shrine built in their honor on the outskirts of Buenos Aires. In an address he gave at the shrine, Obama acknowledged what he characterized as American sins of omission, but he stopped short of issuing an outright apology. “Democracies have to have the courage to acknowledge when we don’t live up to the ideals that we stand for,” he said. “And we’ve been slow to speak out for human rights, and that was the case here.”

In the run-up to Obama’s trip, Susan Rice, the President’s national-security adviser, had announced the Administration’s intention to declassify thousands of U.S. military and intelligence documents pertaining to that tumultuous period in Argentina. It was a good-will gesture aimed at signalling Obama’s ongoing effort to change the dynamic of U.S. relations with Latin America—“to bury the last remnant of the Cold War,” as he said in Havana, during that same trip.

Last week, the first tranche of those declassified documents was released. The documents revealed that White House and U.S. State Department officials were intimately aware of the Argentine military’s bloody nature, and that some were horrified by what they knew. Others, most notably Henry Kissinger, were not. In a 1978 cable, the U.S. Ambassador, Raúl Castro, wrote about a visit by Kissinger to Buenos Aires, where he was a guest of the dictator, Jorge Rafael Videla, while the country hosted the World Cup. “My only concern is that Kissinger’s repeated high praise for Argentina’s action in wiping out terrorism may have gone to some considerable extent to his hosts’ heads,” Castro wrote. The Ambassador went on to write, fretfully, “There is some danger that Argentines may use Kissinger’s laudatory statements as justification for hardening their human rights stance.”

The latest revelations compound a portrait of Kissinger as the ruthless cheerleader, if not the active co-conspirator, of Latin American military regimes engaged in war crimes. In evidence that emerged from previous declassifications of documents during the Clinton Administration, Kissinger was shown not only to have been aware of what the military was doing but to have actively encouraged it. Two days after the Argentine coup, Kissinger was briefed by his Assistant Secretary of State for Inter-American Affairs, William Rogers, who warned him, “I think also we’ve got to expect a fair amount of repression, probably a good deal of blood, in Argentina before too long. I think they’re going to have to come down very hard not only on the terrorists but on the dissidents of trade unions and their parties.” Kissinger replied, “Whatever chance they have, they will need a little encouragement . . . because I do want to encourage them. I don’t want to give the sense that they’re harassed by the United States.”

Under Kissinger’s direction, they certainly were not harassed. Right after the coup, Kissinger sent his encouragement to the generals and reinforced that message by expediting a package of U.S. security assistance. In a meeting with the Argentine foreign minister two months later, Kissinger advised him winkingly, according to a memo written about the conversation, “We are aware you are in a difficult period. It is a curious time, when political, criminal, and terrorist activities tend to merge without any clear separation. We understand you must establish authority. . . . If there are things that have to be done, you should do them quickly.”

Argentina’s military forces had launched their coup in order to expand and institutionalize a war that was already under way against leftist guerrillas and their sympathizers. They called their campaign the Process of National Reorganization, or, simply, “el proceso.” During the Dirty War, as it became known, as many as thirty thousand people were secretly abducted, tortured, and executed by the security forces. Hundreds of suspects were buried in anonymous mass graves, while thousands more were stripped naked, drugged, loaded onto military aircraft, and hurled into the sea from the air while they were still alive. The term “los desaparecidos”—“the disappeared”—became one of Argentina’s contributions to the global lexicon.

At the time of the coup, Gerald Ford was the caretaker U.S. President, and Henry Kissinger was serving as both Secretary of State and national-security adviser, as he had done under Nixon. Immediately after the Argentine coup, on Kissinger’s recommendations, the U.S. Congress approved a request for fifty million dollars in security assistance to the junta; this was topped off by another thirty million before the end of the year. Military-training programs and aircraft sales worth hundreds of millions of dollars were also approved. In 1978, a year into Jimmy Carter’s Presidency, mounting concerns about human-rights violations brought an end to U.S. aid. Thereafter, the new Administration sought to cut the junta off from international financial assistance. In early 1981, with Reagan coming into the White House, however, the restrictions were lifted.

There have, in fact, been no legal consequences whatsoever to Kissinger for his actions in Chile, where three thousand people were murdered by Pinochet’s thugs, or for those in Vietnam and Cambodia, where he ordered large-scale aerial bombardments that cost the lives of countless civilians. One of his foremost critics was the late Christopher Hitchens, who in 2001 wrote a book-length indictment entitled “The Trial of Henry Kissinger.” Hitchens called for Kissinger’s prosecution “for war crimes, for crimes against humanity, and for offenses against common or customary or international law, including conspiracy to commit murder, kidnap, and torture.”

While Argentina’s Dirty War was taking place, of course, its generals habitually denied that anything untoward was occurring. Questioned about los desaparecidos, the coup leader, General Videla, explained with chilling vagueness, “The disappeared are just that: disappeared. They are neither alive nor dead. They are disappeared.” Other officers suggested that missing people were probably in hiding, carrying out terrorist actions against the fatherland. In fact, the vast majority were being brutalized in secret prisons by government-salaried employees, and then, more often than not, executed. As happened in Germany during the Holocaust, most Argentines understood what was really going on, but kept silent out of a spirit of complicity, or fear. A see-no-evil national refrain was adopted by those Argentines who witnessed neighbors being dragged from their homes by plainclothes men, never to return: “Algo habrán hecho”—“they must have done something.”

We have repeatedly reviewed evidence of Kissinger’s callousness. Some of it is as inexplicable as it is shocking. There is a macho swagger in some of Kissinger’s remarks. It could, perhaps, be explained away if he had never wielded power, like—thus far—the gratuitously offensive Presidential candidate Donald Trump. And one has an awareness that Kissinger, the longest-lasting and most iconic pariah figure in modern American history, is but one of a line of men held in fear and contempt for the immorality of their services rendered and yet protected by the political establishment in recognition of those same services. William Tecumseh Sherman, Curtis LeMay, Robert McNamara, and, more recently, Donald Rumsfeld all come to mind.

In Errol Morris’s remarkable 2003 documentary “The Fog of War,” we saw that McNamara, who was an octogenarian at the time, was a tormented man who was attempting to come to terms, unsuccessfully, with the immense moral burden of his actions as the U.S. defense secretary during Vietnam. McNamara had recently written a memoir in which he attempted to grapple with his legacy. Around that time, a journalist named Stephen Talbot interviewed McNamara, and then also secured an interview with Kissinger. As he later wrote about his initial meeting with Kissinger, “I told him I had just interviewed Robert McNamara in Washington. That got his attention. He stopped badgering me, and then he did an extraordinary thing. He began to cry. But no, not real tears. Before my eyes, Henry Kissinger was acting. ‘Boohoo, boohoo,’ Kissinger said, pretending to cry and rub his eyes. ‘He’s still beating his breast, right? Still feeling guilty.’ He spoke in a mocking, singsong voice and patted his heart for emphasis.”

McNamara died in 2009, at the same age Kissinger is today—ninety-three—but his belated public struggle with his conscience helped leaven his clouded reputation. Now that he is nearing the end of his life, Kissinger must wonder what his own legacy is to be. He can rest assured that, at the very least, his steadfast support for the American superpower project, no matter what the cost in lives, will be a major part of that legacy. Unlike McNamara, however, whose attempt to find a moral reckoning Kissinger held in such scorn, Kissinger has shown little in the way of a conscience. And because of that, it seems highly likely, history will not easily absolve him.

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test 6/6/16


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Endologix, Inc. and TriVascular Technologies, Inc. Announce Merger to Create a Leading Cardiovascular Growth Company Focused on the Treatment of Aortic Disorders

Posted but not written by Lou Sheehan
October 26, 2015

Combined Product Portfolio to Provide Clinicians With a Broad Range of Endovascular AAA Devices

Will Expand U.S. and European Sales Organizations to Enhance Growth and Provide Excellent Clinical Support

Endologix to Host Conference Call Today at 5:00 p.m. ET

IRVINE, Calif., and SANTA ROSA, Calif., Oct. 26, 2015 (GLOBE NEWSWIRE) — Endologix, Inc. (Nasdaq:ELGX) and TriVascular Technologies, Inc.(Nasdaq:TRIV) announced today that they have entered into a definitive merger agreement under which Endologix and TriVascular will combine in a stock and cash transaction. The transaction is valued at $9.10 per TriVascular share, or a total of approximately $211 million, based on Endologix’s closing stock price of $13.81 per share on October 23, 2015.

John McDermott, Chairman and Chief Executive Officer of Endologix, said, “This merger enhances the near and long-term growth potential of our business by bringing together two of the most innovative companies in the field of endovascular abdominal aortic aneurysm (“AAA”) treatment. We believe the combined company will be uniquely positioned to provide physicians with three complementary products to treat a wide range of patient anatomies. These devices, the AFX®, Ovation® and Nellix® systems, each offer unique clinical advantages and together will offer physicians the ability to choose the best solution for each patient – all provided by one company. In addition to the existing products, the combined company will have a deep pipeline of new devices including AFX2 and the Ovation iX™ system that are both planned for market introduction by the first quarter of 2016. These new products are expected to be followed by additional new technologies including the launch of Nellix in the U.S., which is expected to receive PMA approval by the end of 2016.”

Mr. McDermott added, “In addition to the strong product portfolio, the merger brings together two experienced endovascular AAA sales and clinical teams in the U.S. and Europe. The combined organizations will provide broader coverage, increased clinical support and convenience for physicians and hospitals who want to access multiple technologies through a single company and representative.”

Christopher G. Chavez, President and Chief Executive Officer of TriVascular, said, “Endologix and TriVascular are two entrepreneurial companies that share a strong strategic focus on providing physicians with innovative and less invasive technologies to make endovascular aortic repair safer and available to more patients, including the significant number of patients with challenging aortoiliac anatomy. We believe physician and patient access to the Ovation platform will be significantly enhanced from a combined larger, stronger and more experienced field sales and service organization. We look forward to combining our significant and complementary expertise and capabilities for the benefit of our customers, patients, employees and stockholders.”

Terms of the Transaction

Under the terms of the agreement, which has been unanimously approved by the boards of directors of both Endologix and TriVascular, Endologix will acquire TriVascular through the merger of a wholly-owned subsidiary of Endologix with and into TriVascular. TriVascular will survive the merger as a wholly-owned subsidiary of Endologix. As consideration for the merger, each outstanding TriVascular share will be entitled to receive a number of shares of Endologix common stock and an amount of cash, each to be determined at the closing of the merger. The stock portion of the consideration will equal in the aggregate 19.999% of Endologix’s outstanding shares of common stock as of the effective time of the merger, and is expected to be tax-free toTriVascular stockholders. The cash portion of the consideration will be determined at closing based on the intrinsic value of TriVascular options, restricted stock units, and warrants and, if applicable, the conversion of TriVascular convertible debt prior to such time. Upon completion of the merger, Endologixstockholders will own approximately 84% of the shares of the combined company on a fully diluted basis and TriVascular stockholders will own approximately 16%. The transaction is expected to close in January of 2016, subject to customary closing conditions, including the approval ofTriVascular’s stockholders and completion of all necessary regulatory reviews.

Following the closing of the transaction, the combined company will conduct business as Endologix, Inc. with its U.S. headquarters in Irvine, California, where Endologix’s current headquarters are located. Endologix will be led by John McDermott, who will become Chairman and Chief Executive Officer of the combined company. Endologix’s board of directors will be comprised of Endologix’s existing board along with one representative from TriVascular’sexisting board who is anticipated to be Mr. Chavez.

In connection with the merger, certain executive officers and the directors of TriVascular, including investment entities affiliated with the directors ofTriVascular, have entered into voting agreements with Endologix covering approximately 32.5% of TriVascular’s outstanding shares.

Piper Jaffray is acting as the financial advisor to Endologix, and Stradling Yocca Carlson & Rauth is serving as legal counsel. J.P. Morgan Securities is acting as the financial advisor to TriVascular, and Arnold & Porter LLP is serving as legal counsel.

Presentation Slides, Conference Call and Webcast

Endologix management, joined by Mr. Chavez, will host a conference call today, October 26, 2015, beginning at 5:00 p.m. ET (2:00 p.m. PT) to discuss the transaction, followed by a question and answer session. The conference call will be available to interested parties through a live audio webcast, where it will be archived and accessible for approximately 12 months. The webcast will include presentation slides to accompany management’s prepared remarks. The live dial-in number for the call is 877-407-0789 (U.S.) or 201-689-8562 (International), which should be used by those interested in participating in the question and answer session. A telephonic replay of the call will be available from October 26, 2015 to November 2, 2015. The replay dial in numbers are 877-870-5176 (U.S.) or 858-384-5517 (International). The replay pin number is 13622012.

About Endologix, Inc.

Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. Endologix’s focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 80%, making it a leading cause of death in the U.S. Additional information can be found on Endologix’s website

The Nellix EndoVascular Aneurysm Sealing System has obtained CE Mark in the EU and is only approved as an investigational device in the United States.

About TriVascular Technologies, Inc.

TriVascular is a medical device company developing and commercializing innovative technologies to significantly advance minimally invasive treatment of abdominal aortic aneurysms. TriVascular manufactures the Ovation Abdominal Stent Graft platform, the lowest profile FDA-approved endovascular aortic repair (EVAR) system, which utilizes a novel, polymer-based sealing mechanism. TriVascular is based in Santa Rosa, California.

Forward-Looking Statements

This communication includes statements that may be forward-looking statements. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. Endologix and TriVascular caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, the likelihood that the transaction is consummated on a timely basis or at all, including whether the conditions required to complete the transaction will be met, realization of the expected benefits of the transaction, competition from other products, changes to laws and regulations applicable to our industry, status of our ongoing clinical trials, clinical trial results, decisions and the timing of decisions of regulatory authorities regarding our products and potential future products, risks relating to foreign currency fluctuations, and a variety of other risks. Additional information about the factors that may affect the companies’ operations is set forth in Endologix’s and TriVascular’s annual and periodic reports filed with the Securities and Exchange Commission (the “SEC”). Neither Endologix nor TriVascular undertakes any obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

Additional Information and Where to Find It

The transaction referenced in this communication has not yet commenced, and no proxies are yet being solicited. Endologix plans to file a registration statement on Form S-4 (“S-4”) that will serve as a prospectus for Endologix shares to be issued as consideration in the merger and as a proxy statement of TriVascular for the solicitation of votes of TriVascular stockholders to approve the proposed transaction (the “Proxy Statement/Prospectus”). This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares. It is also not a substitute for the S-4, the Proxy Statement/Prospectus or any other documents that Endologix or TriVascular may file with the SEC or send to stockholders in connection with the proposed transaction. THE DEFINITIVE PROXY STATEMENT/PROSPECTUS WILL CONTAIN IMPORTANT INFORMATION ABOUT ENDOLOGIX, TRIVASCULAR AND THE TRANSACTIONS. TRIVASCULAR STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS CAREFULLY AND IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE BEFORE MAKING ANY DECISION REGARDING VOTING ON THE PROPOSED TRANSACTION.

In addition to the SEC filings made in connection with the transaction, each of Endologix and TriVascular files annual, quarterly and current reports and other information with the SEC. Endologix’s and TriVascular’s filings with the SEC, including the Proxy Statement/Prospectus once it is filed, are available to the public free of charge at the website maintained by the SEC at Copies of documents filed with the SEC by TriVascular will be made available free of charge on TriVascular’s website at Copies of documents filed with the SEC by Endologix will be made available free of charge on Endologix’s website at

Participants in the Solicitation

Endologix, TriVascular and their respective directors and executive officers may be deemed to be participants in any solicitation of proxies fromTriVascular’s stockholders in connection with the proposed transaction. Information regarding Endologix’s directors and executive officers is available in its proxy statement for its 2015 annual meeting of stockholders, which was filed with the SEC on April 17, 2015; information regarding TriVascular’s directors and executive officers is available in its proxy statement for its 2015 annual meeting of stockholders, which was filed with the SEC on April 14, 2015. Other information regarding the interests of such potential participants will be contained in the Proxy Statement/Prospectus when it becomes available. You may obtain free copies of these documents as described in the preceding paragraph.

CONTACT: Endologix, Inc. Company Contact:

         John McDermott, CEO

         (949) 595-7200

         Endologix, Inc. Investor Contacts:

         The Ruth Group

         Nick Laudico (646) 536-7030

         Zack Kubow (646) 536-7020

         TriVascular Technologies, Inc. Company Contact:

         Michael Kramer

         Chief Financial Officer


         TriVascular Technologies, Inc. Media Contact:

         Vivek K. Jayaraman

         VP, Sales & Marketing


         TriVascular Technologies, Inc. Investor Relations Contact:

         Westwicke Partners

         Jamar Ismail


Source: Endologix; TriVascular Technologies, Inc.

News Provided by Acquire Media

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Abbott said on Monday that it had agreed to acquire Alere for an expected $5.8 billion to enhance its diagnostics business.

Posted but not written by Lou Sheehan

Alere, which had a market value of $3.2 billion as of Friday, makes “point of care” medical tests that can provide results in a matter of minutes. The company, based in Waltham, Mass., will become a subsidiary of Abbott, which is expecting to have annual diagnostic sales of $7 billion after the transaction closes, according to a statement released by the companies on Monday.

“We want to offer our customers the best and broadest diagnostics solutions,” Miles D. White, chairman and chief executive of Abbott, said in the statement. “Alere helps us do that.”

Alere, which was founded in 2001, said it delivered more than 1.4 billion tests last year, producing annual sales of $2.5 billion — half of that from the United States. The company provides tests for H.I.V., tuberculosis, malaria and dengue, as well as the flu and strep.

Some analysts were concerned that the acquisition of Alere could weigh on Abbott’s growth. In the 12 months through December, Alere’s revenue declined 3.6 percent, according to estimates compiled by Standard & Poor’s Capital IQ, while Abbott’s increased 0.8 percent over that period.

Abbott will pay $56 a common share of Alere, and it will assume, or refinance, $2.6 billion of Alere’s net debt. Abbott also plans to finance the deal with debt, Brian J. Blaser, the executive vice president of diagnostics products at Abbott, said in the company’s conference call on Monday.

The offer represents a premium of more than 50 percent over Alere’s closing stock price on Friday, and its shares were up 45 percent in morning trading on Monday.

Thomas C. Freyman, Abbott’s executive vice president of finance and administration, said in the call that the process for acquiring Alere was “competitive.” It was the “fair premium” and the “strategic fit” that allowed Abbott to prevail, he said.

Other potential bidders before Monday’s deal announcement may have been private equity firms or the Danaher Corporation, Mark Massaro, an analyst with Canaccord Genuity, said in a note on Monday. It’s unlikely that other bidders will enter the fray at such a high premium, he said.

Point-of-care tests represented about 10 percent of Abbott’s total diagnostic sales of $4.6 billion last year. In addition to diagnostics, Abbott also makes medical devices, nutritionals and generic pharmaceuticals.

The transaction will be accretive to Abbott’s earnings per share when the deal closes, and is expected to add about 12 to 13 cents a share in 2017 and more than 20 cents a share in 2018. The combined company is expecting to extract $500 million in savings by 2019 through sales and operational benefits.

Medical testing was not the only health care sector announcing a deal on Monday. The Stryker Corporation agreed to acquire Sage Products, which makes products for the intensive care unit, from the private equity firm Madison Dearborn Partners for $2.8 billion in cash.

As a result of the deal, which the company said was accretive, Stryker raised its full-year 2016 adjusted earnings guidance by $0.05 a share to a range of $5.55 to $5.75 a share.

Evercore is providing financial advice to Abbott, while JPMorgan Chase is working with Alere. Kirkland & Ellis is providing legal counsel to Abbott, and Cravath, Swaine & Moore is serving Alere.

JPMorgan also served as Stryker’s financial adviser, while Barclays worked with Sage. Sullivan & Cromwell provided legal advice to Stryker, and Kirkland & Ellis and Madden, Jiganti, Moore & Sinars advised Sage.

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Posted, but not written by, Louis Sheehan.



NASA/Crew of STS-132

International Space Station

250 miles up into outer space, the International Space Station (ISS) hurtles silently around Earth at about 5 miles per second. Inside, scientific experiments are constantly underway, from harvesting lettuce to studying what living a year in space does to the human body. One particular study, conducted by the European Space Agency (ESA) and concluded last month, has found that two species of tiny fungi originally from Antarctica have survived living in Mars-like conditions for a period of 18 months. These results could prove critical in the efforts to find an answer to the question immortalized by David Bowie: Is there life on Mars? The findings werepublished in the journal Astrobiology.

The barren, windswept McMurdo Dry Valleys in Antarctica are widely considered the most inhospitable environments on Earth. Powerful winds scrape clean the snow and ice and leave bare rock in a landscape cold, dry, and desolate. Yet even there life persists. Tucked in the rocky crags live particularly hardy creatures known as cryptoendolithic microorganisms. Among them are the two species of black fungi that rode on the ISS.

S. Onofri et al.

Extreme fungi

Section of rock colonized by cryptoendolithic microorganisms and the Cryomyces fungi in quartz crystals under an electron microscope.

The species, known as Cryomyces antarcticus and Cryomyces minteri, were collected from the windy valleys by particularly enterprising individuals for the ESA and, once blasted into space, were carefully inserted into the EXPOSE-E platform. The EXPOSE-E is an experimental platform designed by the European Space Agency (ESA) to simulate extreme conditions. And extreme it was for the little fungi.

The cells in which the cultures lived contained Martian atmospheric conditions, with approximately 95 percent carbon and a mere 3 percent nitrogen and 0.15 percent oxygen. Earth’s atmospheric makeup is mostly nitrogen and oxygen (78 percent, 21 percent, respectively) by comparison. And yet, even after existing in this extremely low pressure environment, with constant blasts of ultraviolet radiation for 18 months, 60 percent of the fungi managed to survive with their DNA perfectly intact. “The results help to assess the survival ability and long-term stability of microorganisms and bioindicators on the surface of Mars” Rosa de la Torre Noetzel, of Spain’s National Institute of Aerospace Technology (INTA), and co-researcher on the project, explained in a statement.



An astronaut fixes the EXPOSE-E platform onto the International Space Station.

The fungi were a part of a larger ongoing experiment involving lichens titled, creatively, Lichens and Fungi Experiment (LIFE) where the two types of organisms are exposed to the harsh environments of space in order to aid in the search for life outside of Earth. And as we continue to find various life forms on Earth that can survive the seemingly inhospitable environments of space, perhaps we can glean information relevant to our own future on the red planet.

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FDA bans imports of genetically engineered salmon — for now

Posted, but not written, by Louis Sheehan.



FDA bans imports of genetically engineered salmon — for now

By Brady Dennis January 29 at 5:21 PM

A genetically engineered salmon approved last year by the FDA grows twice as fast as a normal Atlantic salmon. (AquaBounty Technologies/AP)
Genetically engineered salmon won’t be hitting U.S. dinner tables anytime soon. Two months after federal regulators approved the nation’s first genetically engineered salmon for human consumption, the Food and Drug Administration on Friday issued a ban on the import and sale of the fish until the agency can publish guidelines for how it should be labeled.

The FDA’s action was prompted by language in a sprawling federal spending bill passed by Congress recently, which instructed regulators to forbid the sale of genetically engineered salmon until the agency finalizes rules about how it should be labeled — a process that potentially could take years.

In November, after a prolonged regulatory battle, the FDA approved the AquAdvantage salmon, produced by Massachusetts-based AquaBounty. The Atlantic salmon contains a growth hormone from a Chinook salmon and a gene from the ocean pout — a combination to help it grow large enough for consumption in 18 months instead of the typical three years. The agency initially said it could require additional labeling of genetically engineered foods only if “there is a material difference — such as a different nutritional profile” between the altered food and its natural counterpart. In the case of the AquaAdvantage salmon, FDA found no such differences.

[The FDA just approved the nation’s first genetically engineered animal: A salmon that grows twice as fast]

But Sen. Lisa Murkowski (R-Alaska) pushed for language in an omnibus spending bill on Capitol Hill, directing the FDA to prevent the AquaBounty salmon from reaching the U.S. market until regulators finalized labeling guidelines. Friday’s import alert was a response to that directive, an FDA spokeswoman said, adding that the agency “intends to fully comply with the language” in the bill.

“This is a huge step in our fight against ‘Frankenfish,’ ” Murkowski said in a statement Friday, using the derisive nickname critics use to refer to the genetically altered fish. “I firmly believe that mandatory labeling guidelines must be put in place as soon as possible so consumers know what it is they are purchasing. It seems that the FDA has begun to listen, and I hope this is a sign that the agency plans to develop these necessary guidelines.”
The effort marks a victory — though perhaps a temporary one — for activists and commercial fishermen who have raised concerns about whether the AqauaBounty fish is safe to eat and whether potential environmental harms could result if any of the modified salmon made their way into ocean waters and mated with wild salmon. The Massachusetts-based company repeatedly has argued that its fish, which are all female, sterile and currently raised only in land-locked facilities in Canada and Panama, actually could reduce pressure on wild stocks and prevent the over-fishing of Atlantic salmon. The FDA has said its approval was “based on sound science and a comprehensive review” and that regulators are confident the genetically altered fish is safe to eat.

AquaBounty’s chief executive, Ronald Stotish, said in a statement Friday that the FDA’s import alert “has no impact on AquaBounty’s operations as we are not currently importing our salmon into the United States.”


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Theranos notes

Not written, just posted buy, Lou Sheehan



January 25, 2016, 1:15pm EST

Problems reported after regulators inspect Theranos lab in Newark

Enlarge Image »Theranos CEO Elizabeth Holmes

Theranos, led by founder and CEO Elizabeth Holmes, has been the target of a series of articles by the Wall Street Journal which question claims made about its blood testing technology. David Paul Morris/Bloomberg

Cromwell Schubarth
TechFlash Editor
Silicon Valley Business Journal
SILICON VALLEY—U.S. health inspectors have reportedly found serious deficiencies atTheranos Inc.’s laboratory in Newark.

The Wall Street Journal cited unnamed people it said are familiar with the matter who said the problems were discovered in an inspection by the Centers for Medicare and Medicaid Services. The company reportedly must correct the problems or risk suspension from the Medicare program.

The Palo Alto startup led by CEO Elizabeth Holmes has been on the defensive since The Journal in October wrote the first of a series of articles that question its blood test technology.

The Journal didn’t say exactly what the problems found in the inspection are but said they are more serious than when the agency previously inspected the facility in 2013. It said the results are expected to be made public soon.

A Theranos representative told The Journal the company had yet to see the CMS report cited by the newspaper.

Theranos stopped using its proprietary finger-prick technology this year for all but a blood test for herpes, something it said was done voluntarily as it sought Food and Drug Administration approval for more tests. The Journal stories, however, claim that the company was pressured to make the move by regulators.

The company was valued as high as $10 billion by its investors last year before the controversy around its technology erupted. Its backers include Draper Fisher Jurvetson, ATA Ventures and billionaire Larry Ellison’s Tako Ventures.

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