RUTHFULLY YOURS

Flint, Mich., has been poisoning its residents.

The city, in an attempt to save money, planned to stop buying water from Detroit and sign up with a regional water system; in the interim, it was getting its municipal water from the Flint River, which is as much a garbage dump as it is a body of water. Residents complained that the water smells of chemicals, that it isn’t the right color, etc. Children’s lead levels are dangerously high, and an outbreak of Legionnaires’ disease may also be linked to city water. The city knew about this, and did approximately nothing in response until the problem was well advanced.

A word that is curiously scarce in coverage of this disaster: Democrat.

Flint, like big brother Detroit down the way, has a long history of political dominance by the Democratic party. Its current mayor is a Democrat; so was her predecessor; the mayor before him, Don Williamson, was a career criminal (he did time for various scams some years back) and a Democrat who resigned under threat of recall; his immediate predecessor, Democrat James W. Rutherford, is a longtime politico and was elected to finish out the term of Woodrow Stanley, who was recalled because of the financial state in which he left the city.

Stanley was in effect replaced by — Democrat — Darnell Earley, former director of the Democratic legislative caucus’s research-and-policy team, who became the city’s emergency manager. Earley is the Democrat the other Democrats blame for changing the city’s water supply, and the Michigan Democratic party has demanded his termination.

The Obama administration knew about this, too, and had known for a long time, since February of last year at least — but it chose to keep quiet on the matter.

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.

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.

Janet Levy,Los Angeles writes

“More Pakistanis and Afghans (including 4 know Islamic State operatives) on the terror watch carrying American passports entered the United States in October than in the prior 12 month period. These potential jihadists are being transported on remote farm roads instead of interstates and being stashed in Acala, Texas, a ghost town outside of El Paso within easy access of a state highway.Judicial Watch (JW) reports the existence of an ISIS camp within a few miles from El Paso and another camp within proximity of Deming and Columbus, New Mexico.Reportedly, Texas Congressman (Beto O’Rourke) contacted local FBI, Homeland Security Investigations and Border Patrol officers in an effort to identify and possibly intimidate sources that may have been used by JW to break the story of the nearby ISIS camps.There is growing cooperation at our southern border between organized crime and terrorist groups, including Hezbollah, to finance terrorism, launder money and smuggle people and drugs into the U.S.See the report below from New York Analysis of Policy and Government. ”

More Pakistanis and Afghans, including those of military age, carrying U.S. passports, and on the terror watch list illegally entered the United States in the first month of this fiscal year (October) than in all of FY2015 (September 2014 to October 2015), According to a San Diego Reader report.

Rep. Duncan Hunter (R-California) in a recent letter to Homeland Security Secretary Jeh Johnson, stated:
“It is routinely said that there is no ‘specific and credible information about an attack on the homeland.’ Despite this assertion, the Southern land border remains vulnerable to intrusion and exists as a point of vulnerability. And evidently there are criminal organizations and individuals with the networks and the knowhow to facilitate illegal entry into the United States without regard for one’s intentions or status on a terror watch list. The detention of two Pakistani nationals underscores the fact that any serious effort to secure our homeland must include effective border security and immigration enforcement.”
According to the San Diego Reader, “Muhammad Azeem and Muktar Ahmad, both in their 20s, surrendered to U.S. Border Patrol agents in September, according to Immigration and Customs Enforcement. One was listed on the Terrorist Screening Database for ‘associations with a known or suspected terrorist. The other was a positive match for derogatory information in an alternative database,’ according to Hunter’s letter. Azeem and Ahmad are among dozens of men – described by Border Patrol agents as “military age and carrying U.S. cash” who began entering the U.S. through a Tijuana-based human-smuggling pipeline in September.”

http://bigpeace.com/hfontova/2011/05/12/rapper-who-hails-stalinist-mass-murderer-invited-to-white-house/
For inviting the rapper-“poet” named “Common,” to the White House, our First Lady is currently taking some heat. Common’s lyric, it appears, are a trifle “racy,” plus in his “poetry,” he hails Black-Panther/Cop-killer Joanne “Assata Shakur” Chesimard.

Hip-hop artist Kendrick Lamar, whose latest album boasts a controversial cover and explicit lyrics, met with President Obama in the Oval Office on Monday.

The two reportedly discussed a variety of issues. The White House has not commented on the content of the meeting but Lamar said in a “Pay It Forward” PSA that they talked about topics related to the inner cities and the importance of youth -mentoring programs.

The PSA was created in support of the National Mentoring Partnership, which supports affiliate mentorship programs, and featured photos of Grammy-winner Lamar with Obama. The president declared January National Mentoring Month.

Obama has said the rapper’s “How Much a Dollar Cost” was his favorite song of 2015.

That was off Lamar’s “To Pimp A Butterfly” album, which shows a group of African-American men in front of the White House holding champagne bottles and hundred-dollar bills on top of the dead body of a white judge.

During an interview last year, Lamar commented on the meaning of the cover.

“You look at these individuals and you look at them as bad people or a menace to society, but they’re actually good people, just a product of their environment,” he said. “Only God can judge these individuals right here. Not no one with a gavel handing out football numbers of years and not giving these kids a chance at life. Every n**** is a star.”

There are currently 80 veterans serving in Congress. It is appalling that the VA continues with chicanery and there has been no serious challenge from the US Representatives. Go to the site http://www.openthebooks.com/openthebooks_oversight_report_-_us_department_of_veterans_affairs/ to see how this rogue bureaucracy spends its money and abandons the needs of veterans….rsk

During his Senate confirmation hearing in July 2014 to head the Department of Veterans Affairs, Robert McDonald pledged to “transform” the vast agency. After horrific reports of wait-time manipulation, coverups and even deaths at VA medical facilities across the country, veterans and the American people were calling for honest leadership to restore their trust in the department created to serve them.

Transformation wouldn’t be easy, Mr. McDonald said, but it was “essential.” And “those employees that have violated the trust of the nation and of veterans must be, and will be, held accountable.”

Sixteen months have passed but the VA’s culture of indifference persists, and the climate of accountability Mr. McDonald promised is nowhere in sight.

“Veterans still facing major medical delays at VA hospitals,” read an Oct. 20 CNN article; “VA execs demoted, but get to keep their jobs and fraud money,” reported a Nov. 23 Daily Caller piece. “VA’s own internal probe finds impunity of agency leaders at scandal-ridden hospital,” said a Dec. 16 Washington Post report.

It’s official: The Environmental Protection Agency has violated federal law by engaging in “covert propaganda” and “grassroots lobbying.” That is the finding of a Dec. 14 report by the Government Accountability Office—though EPA bureaucrats are unrepentant.

The investigation began in June, after Sen. Jim Inhofe (R., Okla.) requested that the GAO review the EPA’s online activities, including its aggressive promotion of the new “waters of the United States” regulatory rule.

Investigators concluded that the EPA illegally used Thunderclap, a social media site, “to correct what it viewed as misinformation.” Government use of social media is not unlawful in itself. But the agency crossed the line by asking supporters to share an EPA-written message on Facebook or Twitter without attributing it to the government. This failure to attribute caused the violation for “covert propaganda.” Simply put, citizens deserve to know when messages presented to them were created by their government.

The violation for “grassroots lobbying” stemmed from an EPA blog post that linked to websites encouraging readers to, for example, “urge your senators to defend Clean Water Act safeguards for critical streams and wetlands.” Federal law prohibits administrative agencies from lobbying the public to support or oppose pending legislation. As the GAO report notes, at least a dozen bills in Congress sought to prevent the EPA’s new waters rule from being implemented.

If you knew nothing about Barack Obama’s presidency and how he has conducted it, you could be forgiven for thinking this was a reasonable, albeit liberal, and even uplifting State of the Union Address. But after seven years of unrelenting presidential condescension, insults and cynicism, it’s very difficult to take his sermons against cynicism and incivility seriously. Cut through the rhetoric and the message was the same as ever: If you agree with me, you’re reasonable. It was all so tediously familiar and grating I couldn’t wait for it to end (much like Obama’s presidency).

I lost track of the straw-men and false-choices. I particularly enjoyed his “big question” of how to keep America secure “without either isolating ourselves or trying to nation-build everywhere there’s a problem.” Ah, yes, those are the only choices other than Barack Obama’s enlightened third way — a third way so enlightened he actually touted Syria policy as a success. I’m sure the quarter million dead Syrians and the Europeans awash in refugees agree that the Obama Way is so much more enlightened.

Probably the most interesting thing about the speech tonight was how it differed from his prepared remarks and what those differences said. Several times I heard him say things that sounded politically ill-advised and so I checked the prepared remarks thinking that maybe I misheard. But I didn’t.

Well, it’s that time of year again – the State of the Union! Here are my traditional thoughts on the occasion – after which we’ll deal with the peculiar circumstances of tonight’s festivities:

Strange how the monarchical urge persists even in a republic two-and-a-third centuries old. Many commentators have pointed out that the modern State of the Union is in fairly obvious mimicry of the Speech from the Throne that precedes a new legislative session in British Commonwealth countries and continental monarchies, but this is to miss the key difference. When the Queen or her viceroy reads a Throne Speech in Westminster, Ottawa, or Canberra, it’s usually the work of a government with a Parliamentary majority: In other words, the stuff she’s announcing is actually going to happen. That’s why, lest any enthusiasm for this or that legislative proposal be detected, the apolitical monarch overcompensates by reading everything in as flat and unexpressive a monotone as possible. Underneath the ancient rituals — the Gentleman Usher of the Black Rod getting the door of the House of Commons slammed in his face three times — it’s actually a very workmanlike affair.

The State of the Union is the opposite. The president gives a performance, extremely animatedly, head swiveling from left-side prompter to right-side prompter, continually urging action now: “Let’s start right away. We can get this done. . . . We can fix this. . . . Now is the time to do it. Now is the time to get it done.” And at the end of the speech, nothing gets done, and nothing gets fixed, and, after a few days’ shadowboxing between admirers and detractors willing to pretend it’s some sort of serious legislative agenda, every single word of it is forgotten until the next one.

I do not often watch Barack Obama’s speeches. No one at my daughter’s school is allowed to bring a peanut butter sandwich for lunch because some of the students have an aggravated allergy to nuts. So do I, just not to peanuts. So when my son asked if we could watch Obama’s recent, tearful speech about “gun violence in America,” it was with some reluctance, in addition to an assist from Mr. J. Daniels, over ice, that I agreed. But I am glad I did. It was a remarkable performance and it reminded me why Obama was elected in the first place. I find his rote face-this-way, then turn-and-face-that-way technique irritating, but boy is he good with a teleprompter (and, no, “boy” is not a racial slur). Obama is an attractive guy. He looks serious. He seems earnest, yes, but above all pragmatic. [Swivel.] He speaks slowly and in short sentences. [Swivel.] He is articulate. He is concerned. The atmosphere he creates, folks [Swivel], is one of simple reason battling dark forces. We’re against violence. We proposed reasonable solutions. Republicans in Congress made progress impossible.

Students of Quintilian should watch Obama. As a rhetor, he really is good. He even, as Mark Steyn noted admiringly, got off a little joke with perfect timing: The twin brother of Mark Gifford, the husband of Obama’s “dear friend and colleague” Gabby Gifford, is an astronaut and was in space when Mark came to see Obama. Obama asked Mark how often he spoke to his brother.

And he says, well, I usually talk to him every day, but the call was coming in right before the meeting so I think I may have not answered his call — (laughter) — which made me feel kind of bad. (Laughter.) That’s a long-distance call. (Laughter.)