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2016

The Missing Man in the Big GOP Debate By Roger L Simon

It was a fun Republican debate Thursday night, definitely the most spirited, with some of the best interchanges since Who’s Afraid of Virginia Woolf?, but, sadly, the candidates must have missed the new memo about who their adversary is supposed to be, giving the whole event a decidedly retro feel.

Listen guys (and gals — this would definitely include Carly, who was, no surprise, the star of the undercard), you were running against the wrong Democratic candidate tonight.

You’re not going to be running against Hillary. Our Lady of Chappaqua has 150, count ’em, 150 FBI agents looking into her doings. What single person in our history has had anything close to that? Maybe Al Capone, but he wasn’t a politician. You think they’re not going to come up with something? For all we know, she’s already plea-bargaining her pardon. If you don’t believe me, check out DC Whispers’ “Bill & Hillary Clinton Fear the End – Go Into Survival Mode.”

No, no Hillary. You’re going to be running against Bernie (or Joe Biden or Jerry Brown or Fauxcahontas, but most probably Bernie, because he’s done all the spade work and his supporters are going to be mighty angry if the Democratic Party fat cats cut him out).

And here’s the bad news — Bernie is a much more dangerous opponent. Most of the GOP candidates have been thinking — oh, well, he’ll be much easier to beat than Hillary. He’s a socialist, for crissakes. Didn’t Margaret Thatcher put an end to that silliness decades ago?

Hillary’s long goodbye By Thomas Lifson

I must be an awful human being, because I am reveling in the déjà vu Hillary Clinton must be experiencing, as her presidential campaign appears to be heading toward collapse. And this time, the humiliation – and peril – is far greater than anything 2008 dealt her. To state the obvious, her longstanding preference for pantsuits is one thing, but the orange jumpsuits of a federal penitentiary are quite something else.

I realize I am getting way ahead of myself here, that predictions are always risky – especially about the future, as Yogi Berra reminded us. We don’t yet know if there will be a criminal referral from the FBI, though the D.C. rumor mill is operating at full steam, averring that 50 more FBI special agents have been added to the case, making the total team well into triple digits. That the FBI would devote that level of resources to the case suggests that they are tying up any possible loose ends, to have an airtight cases presented to Loretta Lynch. (More on this later.)

Potential legal peril aside for the moment, the humiliations she faces are daunting for a woman of her arrogance. Her husband’s penchant for illicit sex with women far younger and more attractive is once again being thrown in her face, and this time the trusty old injured wife gambit not only doesn’t work, but is being used against her, painting her as an enabler of a sexual abuser.

Guilty for Obeying the Feds J&J is punished in state court for following federal labeling rules.

Can a drug company be held liable for following the directions of federal regulators on warning labels? Johnson & Johnson did exactly that, only to be slapped with a $63 million jury verdict in Massachusetts for inadequate warnings. The Supreme Court is being asked to hear J&J’s appeal in a case with major implications for uniform national business regulation.

In 2003 Richard Reckis treated his seven-year-old daughter Samantha with over-the-counter Children’s Motrin for a fever. Samantha developed a rare and advanced case of Stevens-Johnson syndrome called toxic epidermal necrolysis which caused skin blistering, as well as lung, liver and vision damage. Her parents sued Johnson & Johnson in state court for failing to alert buyers to the potential side effects, and the Massachusetts Supreme Judicial Court affirmed the jury verdict.

The legal problem is that the federal Food and Drug Administration had rejected the specific labelling enhancement that lawyers for the Reckis family say should have been applied. In 2005 what’s known as a Citizen Petition to the FDA suggested that Motrin should include language on “serious skin reactions” and “potentially life-threatening diseases” and specify the names of some of the conditions.

The FDA agreed on the need for improved warnings about skin reactions, but it said it would not be helpful to include a mention of “life-threatening” conditions or the names of the conditions, which most people were unfamiliar with. Instead, the agency said, “a description of symptoms” was more appropriate for the over-the-counter medication. J&J would have been defying federal regulatory guidelines if it had included the warning that the Reckis lawsuit claims should have been on the bottle.

The legal doctrine at issue is federal pre-emption, and in 2009 the U.S. Supreme Court ruled (Wyeth v. Levine) that some state court lawsuits against drug companies over warning labels are pre-empted by federal law if the FDA has made its opinion on labelling clear. While some cases might require guessing about FDA directions, in this case the FDA was asked to consider a specific warning and rejected it.

A Cancer ‘Moonshot’ Needs Big Data Analyzing vast genetic and clinical data from hospitals and doctors would lead to revolutionary advances. By Tom Coburn

Dr. Coburn is a physician and former Republican senator from Oklahoma. He serves as an adviser to Project FDA at the Manhattan Institute.

In his State of the Union address on Tuesday, President Obama called for America to become “the country that cures cancer once and for all.” As a three-time cancer survivor (metastatic colon, metastatic melanoma and metastatic prostate), I can tell you that this “moonshot,” as Vice President Joe Biden first called it, is a bold goal—but one within our grasp.

Last week’s report from the American Cancer Society shows that cancer mortality is down more than 20% over the past 20 years. Many patients are living longer thanks to better treatments and earlier detection. Science is tipping the odds of survival in favor of patients.
Ironically, we’re handicapping ourselves in the war on cancer, in part because of a web of privacy regulations like the Health Insurance Portability and Accountability Act. HIPAA makes it difficult for researchers to tap into large caches of clinical and genomic data shared across multiple institutions or firms, and then share their findings more broadly.

The law allows some research uses, but only if the uses (and informed patient consent) are specified in advance. As one analyst put it, “because obtaining [consent] from huge numbers of people or [institutional review board] waivers ranges from the impracticable to the impossible, important research has gone undone and important findings unshared.”

Harnessing that information—“big data”—would allow us to personalize prevention and treatment based on the genetic characteristics of a patient’s tumor, family history and personal preferences, while minimizing unwanted side effects. But today cancers are often fought “off the grid.” Patients whose cancers resist standard treatment, or whose tumors reappear years later, are medical puzzles. Their doctors cobble together treatments through intuition, experience and case studies scattered in the medical literature.

The clinical trials that pharmaceutical companies rely on for FDA approval and drug labeling capture too little of the information patients and physicians need. The trials only enroll 3% of cancer patients and can take years and tens of millions of dollars to finish. Many trials never enroll enough patients to get off the ground.

Obama’s Terror Sangfroid The threat isn’t ‘existential,’ unless you’re at Starbucks.

President Obama took pains in his State of the Union speech Tuesday to warn Americans not to exaggerate the threat from terrorists. “As we focus on destroying ISIL,” he said, using an alternative acronym for Islamic State (ISIS), “over-the-top claims that this is World War III just play into their hands.”

On Monday ISIS murdered 51 people in suicide attacks in Baghdad and other Iraqi cities. On Tuesday an ISIS suicide bomber in Istanbul killed 10 German and one Peruvian tourists. On Thursday two people were killed and 23 injured by an ISIS suicide bomber near a Starbucks coffee shop in Jakarta.

This bloody spate follows last month’s murder of 14 office workers in San Bernardino by an ISIS husband-and-wife team, November’s Paris massacre by ISIS of 130 people, the killing a day earlier of some 43 people in Beirut, and October’s downing by ISIS of a Russian jetliner over Egypt, in which 224 civilians perished. Last June’s attack at a Tunisian beach resort, in which 38 mainly British tourists were murdered, is already beginning to feel like a distant memory.

14 Politics Election 2016 A Republican Debate Divided: the Leaders and the Rest As Trump and Cruz face off, five others jockey to be an alternativeBy Gerald F. Seib

There wasn’t one Republican presidential debate going on Thursday night in South Carolina, but rather two. And in that sense, the debate neatly and succinctly summarized this year’s unusual race.

The first debate was between the two unlikely front-runners, Donald Trump and Ted Cruz. After months of dancing around each other—and in some cases essentially supporting each other—in crystallizing antiestablishment anger, the two now know they are fishing from the same pond with less than three weeks to go before voting begins. And they conducted themselves accordingly.

The night’s second, parallel debate involved the other five aspirants on the stage— Marco Rubio, Jeb Bush, Ben Carson, Chris Christie and John Kasich—who seemed uncertain whether their mission was to go after the two top dogs or emerge from the rest of the pack as the alternative to them. By and large, they chose the latter course.
So Mr. Trump repeated, volubly and at some length, his assertion that Mr. Cruz, a Texas senator, might not be eligible to be president because he was born in Canada. Mr. Cruz responded by saying that his status under the Constitution isn’t in doubt, and charging that the businessman Mr. Trump fully agreed until he felt threatened by a Cruz rise in the polls.

“The Constitution hasn’t changed,” Mr. Cruz said. “But the poll numbers have.”

For his part, Mr. Cruz embraced anew his assertion that Mr. Trump embodies “New York values,” which, he said, are “socially liberal or pro-abortion or pro-gay marriage.” To a conservative debate audience in the conservative state of South Carolina, he added: “Not a lot of conservatives come out of Manhattan.”

Attacks in Indonesia Mark Expansion for Islamic State Coordinated assault in Jakarta raises fears of return to violence in AsiaBy Ben Otto and Tom Wright

JAKARTA, Indonesia—Attackers tied to Islamic State marked a new battlefield in the extremist group’s global expansion, terrorizing the Indonesian capital and killing two people in a suicide assault.

The coordinated gunfire-and-bomb attack, in which all five assailants also died, raised fears of a return of Islamist-inspired violence in parts of Asia that had largely subdued an earlier generation of militants.

The rise of Islamic State has drawn hundreds of Southeast Asia militants to Syria and Iraq—some 600 from Indonesia and Malaysia alone, authorities estimate. Though the numbers are small compared with Western Europe, they are bigger than the cadre of Asian militants that was forged in Afghanistan in an earlier decade.

And extremist leaders from Indonesia to the Philippines have pledged loyalty to its self-declared caliphate.
Security officials fear Islamic State’s growth is inspiring local radicals to become more violent at home to draw attention and lay claim to Islamic State leadership in the region. “There has been clamor among the ISIS community in Indonesia…to do something to show ISIS central leadership that Indonesia is important also,” said Todd Elliott, a terrorism analyst from Concord Consulting, referring to Islamic State.

The Jakarta attackers came from a group in Solo, on Indonesia’s main island of Java, that had been in contact with Islamic State in Syria, Indonesian officials said. Deputy Police Chief Budi Gunawan said communications had been detected, but didn’t elaborate.

Islamic State claimed responsibility for the attacks on its social-media accounts, according to the SITE Intelligence Group, which monitors global jihadist activity. But it wasn’t clear whether the Jakarta attackers had actual training from the group.

Heavily Armed Islamic Extremists Attack Peacekeepers’ Base in Somalia Suicide car bomb followed by gunfire as militants stormed the compound, says military official

MOGADISHU, Somalia—Heavily armed fighters from the Islamic extremist group al-Shabaab attacked a base for African Union peacekeepers in southwestern Somalia on Friday, blasting their way into the compound and exchanging fire with peacekeepers, a Somali military official said.

Dozens of al-Shabaab fighters started a complex attack on the military base which is run by Kenyan troops who are part of the African Union force in the town of El-Ade, not far from the Kenyan border, Ahmed Hassan told The Associated Press by phone from Elwak, a town near the scene of the latest attack.

The attack started with a suicide car bomb, and then heavy gunfire was heard as militants stormed into the base, he said.

Fighting is still going on inside the base, he said. He had no details about any casualties.

France Moves to Better Coordinate Its Antiterrorism Efforts French intelligence agencies to share information and resources By Matthew Dalton

PARIS—France on Thursday said it is moving to increase cooperation between its domestic and overseas intelligence services, pushing to break down bureaucratic barriers that have hindered its efforts to prevent terrorist attacks.

The government has been seeking to bolster its antiterrorism infrastructure since Islamist militants killed 130 people in Paris in November and another 17 a year ago. A weak point, security analysts say, is the lack of coordination across the multitude of French intelligence agencies, including the police, the country’s foreign intelligence service, its counterespionage agency and a military intelligence directorate.

The French government decided “to deepen coordination between interior and exterior intelligence services in France as well as overseas…particularly from transit zones and sanctuaries where terrorists gather who want to commit acts on our territory,” President François Hollande’s office said after the government’s weekly cabinet meeting.

France, like other Western governments, is scrambling to gather information on Islamic State’s attack planning in Syria, where hundreds of French citizens are still fighting in the ranks of the militant group. France ramped up that effort even before Islamic State operatives from France and Belgium slipped into Europe to sow carnage on the streets of Paris on Nov. 13.

Israel Quietly Courts Sunni States Shared animosity toward Tehran fosters a new push for closer ties By Rory Jones

Growing tensions between Saudi Arabia and Iran have raised hopes in Israel that officials can build closer ties with the Gulf monarchies based on their shared animosity toward Tehran.

Led by Dore Gold, director-general of the foreign ministry, Israel has stepped up efforts to mend and improve ties in the region—all in a bid to counter Iranian influence and the threat of Islamic extremism.

A long-standing hawkish ally of Prime Minister Benjamin Netanyahu, Mr. Gold said Israel and Sunni Arab states face a shared threat in Iran.

“Clearly there’s been a convergence of interests between Israel and many Sunni Arab states given the fact that they both face identical challenges in the region,” Mr. Gold told The Wall Street Journal.

The recent torching of the Saudi Arabian Embassy in Tehran—and diplomatic fallout between the Persian nation and Arab Gulf states—have underlined how common ground appears to be growing.

Iran’s nuclear deal with the U.S. and other foreign powers in July helped spur Israeli efforts to further develop back-channel relations with Arab states, Israeli officials say.

Mr. Netanyahu fought the deal for fear it would encourage Iran to further support military proxies in Yemen and Syria, a concern shared by Sunni Arab states such as Saudi Arabia and its Gulf allies.

“What we have seen in the past six months is an intensification of the relationship [with Sunni Arab states],” a senior Israeli official said. “Israel is on the same side.”