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dimanche 8 septembre 2013

Margaret Anderson: Science, Cures and All the Stuff In Between

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The outlook for science has never been brighter -- we know more today than ever before about the molecular basis for thousands of diseases that impact millions of patients -- but the outlook for funding has also never been bleaker. With the National Institutes of Health losing a billion and a half dollars to the sequester, traditional investors retreating from early-stage life sciences, industry pipelines shrinking, and philanthropy unable to fill the gap, we are poised to leave a huge scientific opportunity on the table, namely our ability to get important new medicines out of the lab and to patients more quickly. And with millions of lives hanging in the balance, it's just not something Americans can afford to do.

FasterCures hosted over 100 congressional staffers, patient advocates, academics and drug developers at a Capitol Hill briefing about the importance of federal support for translational research, the phase of medical R&D between the birth of a basic scientific discovery made in the lab and when a pharmaceutical company tests out a potential new therapy with patients -- or, more plainly put, "the stuff in between" microscope and marketplace.

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"If there is anything I believe can bring this nation together for a cause, it is finding cures for disease," said House Majority Leader Eric Cantor in his opening remarks. "We ought to be about research regardless of political leaning, because it is an investment that yields tangible returns for our country." In an environment where Congress is laser-focused on coming up with ways to spend dollars more wisely, his advice to advocates was to emphasize the following message to policymakers:

It is good to be about cures. Disease touches us all, and as compassionate humans we should all care about improving and saving lives.It is good for the economy to invest in research. This leads to job creation and global competitiveness.It is a good way to bend the cost curve of health care. We have mounting deficits and debts, and we should prioritize the allocation of funds to areas like this that have the greatest impact.

"This is really an engineering problem," said NIH Director Francis Collins. "It's about taking a pipeline that is too long and too leaky and fixing it." With each new therapy that comes to market taking up to 15 years to develop and costing over $1 billion, it's more challenging than one might think to successfully navigate the translational stage. There is great momentum in science, and we are poised to start solving several of these problems, particularly with the existence of the new National Center for Advancing Translational Science (NCATS) at NIH, but if we don't continue to invest, we risk losing not only time and lives but a significant driver of economic health.

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"NCATS is a unique new entity, purpose-built to solve this central paradox: that we know more than ever before about how the body works and what goes wrong in disease but lack the equivalent ability to fix it," said NCATS director Chris Austin. "We're designed to be perpendicular to how the rest of NIH works, and to focus not on what's different about disease but what is common." He went on to describe the institute as a biomedical equivalent to the Internet, focusing not on creating companies or products but on allowing people with ideas to share them in a more productive way, and de-risking investment by other sectors in this translational space.

Both Collins and Austin said that there is no better time to pursue translational research. Today, we know the molecular causes behind 4,500 diseases, yet there are drugs available to treat just 250 of them.

"We are operating on hope, not hype," said Sharon Terry of the Genetic Alliance. "The network solutions that have overtaken other industries and streamlined them are finally starting to hit the biomedical research space, and we can't afford to lose momentum." She specifically referenced networked programs such as the Clinical and Translational Science Awards at NIH that are significantly advancing systems improvement in the translational phase and are primed, with the proper support, to foster more integrated research across communities. A new report released this week by the Institute of Medicine goes into more detail.

"Industry can't do it alone. ... Companies depend on basic science coming from the NIH," Simeon Taylor of Bristol-Myers Squibb said. He described how Big Pharma relies on the basic science discoveries made early on in the lab to develop drugs for patients who need them so desperately. Just last week, BMS, along with eight other companies, provided 58 compounds for an NCATS pilot program called Discovering New Therapeutic Uses for Existing Molecules, designed to develop partnerships between pharmaceutical companies and the biomedical research community to advance the development of therapeutics.

I had the privilege of moderating this discussion. The message that rose the top was clear: Getting a therapy from discovery to patients requires partnership and collaboration across all sectors in the medical research ecosystem: scientists, regulators, industry, investors, and, most importantly, the patients themselves. An effective R&D system is an efficient one, but reengineering the system in the way we know is possible requires support, and with funding at critically low levels, the ripple effects could be devastating. If we are to improve our odds for success for our patients and for our economy, there is no time to waste.

Follow Margaret Anderson on Twitter: www.twitter.com/fastercures

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Nikolas Kozloff: Snowden Affair Highlights Epic David and Goliath Struggle Between Quito and Washington

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If there was any doubt that Ecuador's pugnacious President Rafael Correa would back down in the rapidly escalating diplomatic spat over NSA leaker Edward Snowden, recent events will certainly put such notions to rest. Thumbing his nose once again at the Obama administration, Correa has just announced that his government will unilaterally give up special U.S. trade preferences under the so-called Andean Trade Promotion and Drug Eradication Act or ATPA. Originally, the measure was designed to counteract drug-trafficking by providing export opportunities to poor Andean nations. Under the act, Ecuador exports billions in tax free goods every year to the U.S. including tropical fruits, flowers and petroleum.

After Correa audaciously offered to provide diplomatic asylum to Snowden, the mainstream media, legislators from both sides of the aisle as well as conservative think tanks called for Ecuador to be punished for its impudence and cut off from the ATPA. Correa, however, says Ecuador will not submit to such "blackmail" and threats. Hardly intimidated by the Beltway establishment, defiant Correa has announced for good measure that he will send the U.S. millions of dollars for use in human rights training. Taunting Washington, Ecuador's Minister of Communications declared that the money could be used to avoid "espionage, torture, extrajudicial killings and other acts that denigrate humanity."

For Ecuador, the Snowden affair has all the elements of an epic David and Goliath story pitting the Colossus of the North against a small and impoverished South American nation. While it's unclear how the Snowden imbroglio will play out in Ecuador itself, many will surely rally to Correa's defense. For decades, Ecuador has smarted under Washington's influence and ongoing CIA intervention [for a further accounting of such history, see my earlier article here]. As a result, fiery populism plays well here.

Nationalist Backlash Against the U.S.?

Furthermore, Ecuadorans have little regard for "neo-liberal" style economic austerity which exacted a heavy social toll on the country and contributed to chronic political instability. Indeed, it was precisely such political instability which propelled leftist Correa to power in 2006. Since that time, the maverick politician has challenged Washington in the military, diplomatic and economic spheres, and now seems poised to inherit the South American populist mantle from recently deceased Hugo Chávez.

To be sure, Correa hardly ingratiated himself with Washington when he harbored WikiLeaks founder Julian Assange, a man who has spent more than a year holed up at the Ecuadoran Embassy in London. However, unlike Snowden, Assange is not a U.S. national and has never been formally charged by the Department of Justice. By offering to shelter Snowden, Correa has signaled that he is willing to take an economic hit over ATPA and the President also risks further opposition from his country's powerful export elite. Just how did we get to this point?

U.S. Business Lobby vs. Correa

Correa's recent moves cap an action-packed year of diplomatic friction. Indeed, as early as last August I wrote that U.S. business groups had lobbied the Obama administration to cut off trade benefits to Ecuador. The indignant companies had been spurred to action after Correa tried to hold Chevron responsible for its oil damage in the Ecuadoran Amazon. However, Quito's harboring of Assange probably added ammunition to ongoing lobbying efforts. Eric Farnsworth, Vice President of the Council of Americas, a group representing U.S. companies doing business throughout the hemisphere, told Reuters that Correa's harboring of Assange was not "a move destined to win many new friends in Washington." Moreover, the President of the National Foreign Trade Council brazenly remarked that the Assange imbroglio "would provide the excuse (to suspend benefits) if the administration is looking for one to do it."

In Washington, the Ecuadoran Ambassador grew puzzled by the business lobbying. "Ecuador is the only country in the Andean region with zero coca cultivation," he said. While the U.S. Chamber of Commerce, the National Association of Manufacturers, the National Foreign Trade Council and the Business Roundtable alleged that Ecuador had violated investor rights, there was no specific explanation for cutting off trade preferences. Ecuador, the Ambassador argued, had observed proper protocol in regard to all its pending investor disputes.

Back in Quito meanwhile, the Ecuadoran business sector was also growing jittery. A full 350,000 jobs depended on ATPA, including the flower industry, broccoli, tuna and other sectors. Fearful lest Ecuador lose its special trading privileges, businessmen alerted Correa to the risks of harboring Assange. Correa, however, was hardly impressed and remarked that if he were reelected in the upcoming presidential election he would never knuckle under to economic blackmail. "Let them have their ATPA," the feisty President declared, "and we'll give them a few million dollars for a course on ethics and human rights."

Emboldened Correa

In February of this year, Correa got his wish and cruised to electoral victory. Feeling emboldened by his new mandate, the President said that ATPA had turned into a "vulgar foreign policy instrument: if you behave well, we continue the agreement; if you behave badly, we take away the privileges. We can't continue to live like this." Preparing his countrymen for a possible cutoff, Correa remarked that regardless of ATPA Ecuador would continue to export its goods to the U.S.

The economic impact of an ATPA cutoff, Correa has argued, would be minimal and amount to less than $24 million in losses. What is more, Correa adds, the government is prepared to provide economic support to vulnerable industries such as fresh roses, canned tuna and broccoli. Not everyone, however, is reassured by the President's words. Indeed, the President of Ecuador's Agricultural Chamber told the Associated Press that loss of preferential trading provisions would exert a heavy toll. The flower industry, he said, "constitutes an escape valve from social pressure, unemployment and under-employment."

Beltway Backlash

Fast forward to the Snowden scandal, and it was not long before the Beltway establishment began to threaten Ecuador with retaliation. Take for example hawkish Florida Republican Senator Ileana Ros-Lehtinen who declared that Correa's conduct would not stand. Democrats, however, have proven equally bullish. Sandy Levin, the top Democrat on the House Ways and Means Committee, said that if Correa offered asylum to Snowden there "would be no basis" for renewing trade preferences. Another Democrat, Senator Bob Menéndez of New Jersey, chimed in for good measure, declaring that Washington was ready to punish Ecuador if Correa chose to snub the colossus of the north. Joining in the fray, conservative Heritage foundation has also been leading the charge against Quito.

The Snowden affair has also generated a heated debate in the media, and predictably enough Fox News has weighed in against Correa. The Washington Post, too, has gone on the war path, remarking "when it comes to anti-American chutzpah, there's no beating Rafael Correa, the autocratic leader of tiny, impoverished Ecuador." Mincing no words, the Post adds, "as it happens, the preferences will expire next month unless renewed by Congress. If Mr. Correa welcomes Mr. Snowden, there will be an easy way to demonstrate that Yanqui-baiting has its price." It turns out the Post has long been on Correa's case: a year ago, the paper issued an almost identical threat when Correa was considering its asylum request for Julian Assange. Commenting on the Post's relentless Ecuador bashing, Fairness and Accuracy in Reporting muses, "it's good that someone at the Post's editorial page knows how to copy and paste."

Hardly amused by the Post's ongoing campaign, Correa has taken to Twitter no less in an effort to counteract the mainstream media. Tweeting to his million followers, Correa said the media had put up a smokescreen and was doing its utmost to distract the public from Snowden's main disclosures. In Quito, members of Correa's own Aliaza País party have backed up the President while echoing his nationalist rhetoric. The political opposition, meanwhile, argues that Correa is hypocritical for offering asylum to Snowden while simultaneously cracking down on free expression at home.

Correa's Gamble

Having opened a veritable Pandora's box of trouble, can Correa thrive and ride a nationalist wave of indignation, or will he be brought down by domestic and international forces? Perhaps, Correa reasons that Ecuador had little chance of having its ATPA status renewed, and so Ecuador risked little by beating Washington to the punch. Nevertheless, Correa has galvanized the American establishment against him yet further, not to mention Ecuador's export elite.

The Guardian of London suggests that Correa is also putting great strains on his own political coalition, with some leftists embracing Snowden and other centrists fearing economic and diplomatic fallout. "Some in the government," the paper writes, "are believed to be annoyed that Julian Assange, the WikiLeaks founder who has sheltered at Ecuador's London embassy to avoid extradition, has seized the limelight in the Snowden saga." According to the paper, Assange caught Quito by surprise when he recently announced that Ecuador had provided Snowden with a safe-conduct pass to travel from Hong Kong to Moscow.

By offering shelter to first Assange and now Snowden, Correa has embarked on a high stakes game. The pugnacious president is constantly upping the ante, casting Ecuador's plight as a David and Goliath struggle against the odds. So far, playing the nationalist card has suited Correa well, though Ecuador's President may find that playing with fire carries significant risk.

Nikolas Kozloff is the author of Revolution! South America and the Rise of the New Left. Follow him on Twitter here.

Follow Nikolas Kozloff on Twitter: www.twitter.com/NikolasKozloff

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