RUTHFULLY YOURS

Again, unless there is real tort reform the FDA will have a permanent problem, and so will the pharmaceutical companies…..rsk
The Food and Drug Administration is the nation’s most ubiquitous regulatory agency, overseeing everything from syringes and CT scanners to drugs, vaccines and most foods. These products account for more than $1 trillion annually, or about a quarter of U.S. consumer spending. This slow, dysfunctional agency needs drastic reform of its requirements, procedures and attitudes.

One reform Scott Gottlieb, President Trump’s nominee to lead the agency, will likely embrace is “right to try”—that is, giving terminally ill patients access to unapproved medicines. He could remove the FDA from judgments about “compassionate use” of unapproved drugs. There is already a trend in this direction: Thirty-three states have passed laws aimed at providing easier access to experimental treatments that are still in the earliest stages of human testing.

The right to try unapproved drugs has the potential to be compassionate and sound public policy—but there are dangers. The concept must be implemented in a way that takes into consideration the realities of drug testing.

According to the libertarian Goldwater Institute, right-to-try legislation would allow “terminally ill Americans to try medicines that have passed Phase I of the FDA approval process and remain in clinical trials but are not yet on pharmacy shelves.” It would also expand usage of “potentially life-saving treatments years before patients would normally be able to access them.”

But here’s the rub: About three-quarters of drugs that pass Phase I will never be accessible. They ultimately won’t be approved, because of either safety concerns or lack of efficacy. Most legislative proposals, including the one recently introduced by Sen. Ron Johnson (R., Wis.), would enable patients to request the drugs after only the most meager safety testing.

Phase I testing, often the first time a new drug has been administered to humans, provides extremely limited information. These trials are performed on between 20 and 100 patients and last only a short time. They’re usually administered to paid, healthy volunteers, who may not provide a good representation of how the drug will affect terminal patients. Such trials essentially exist to determine what doses of the drug are tolerated without causing gross safety problems such as seizures, organ failure or death.

The determination of efficacy starts in Phase II, when the drug is administered to volunteers who suffer from the disease or symptom for which the drug is intended. If the results of Phase II are promising, the drug moves into still larger Phase III trials—the most extensive and expensive part of drug development.

A physician at a large health insurer, who spoke to me on the condition of anonymity, recently raised concerns about right to try. He wonders “where liability will ultimately lie when and if something goes wrong.” Even trickier: “Who is the deep pocket if and when the treatment fails and the patient’s family is looking for someone to blame?” He warns that the right to try could become an “unfunded mandate” and raises questions about who will pay for the drugs and how their prices will be determined. Medical insurance as we know it was never designed or intended to cover unproven treatments of last resort. CONTINUE AT SITE

America’s sheriffs have given President Trump a woefully inaccurate view of civil asset forfeiture—the process through which police seize, and prosecutors literally sue, cash, cars and real estate that they suspect may be connected to a crime. “People want to say we’re taking money and without due process. That’s not true,” a Kentucky sheriff told the president last month at a White House meeting. Critics of forfeiture, the sheriff added, simply “make up stories.”

In fact, thousands of Americans have had their assets taken without ever being charged with a crime, let alone convicted. Russ Caswell almost lost his Massachusetts motel, which had been run by his family for more than 50 years, because of 15 “drug-related incidents” there from 1994-2008, a period through which he rented out nearly 200,000 rooms.

Maryland dairy farmer Randy Sowers had his entire bank account—roughly $60,000—seized by the IRS, which accused him of running afoul of reporting requirements for cash deposits. Mandrel Stuart had $17,550 in receipts from his Virginia barbecue restaurant confiscated during a routine traffic stop. A manager of a Christian rock band had $53,000 in cash—profits from concerts and donations intended for an orphanage in Thailand—seized in Oklahoma after being stopped for a broken taillight. All of the property in these outrageous cases was eventually returned, but only after an arduous process.

Photo: istock getty

This kind of abuse has united reformers on all sides of the political debate: progressives, conservatives, independents, even a few former drug warriors. Since 2014 nearly 20 states and the District of Columbia have enacted laws limiting asset forfeiture or increasing transparency. Nearly 20 other states are considering similar legislation. Last week a reform bill passed the Indiana Senate 40-10. It would require a criminal conviction before a court can declare a person’s assets forfeited.

Another good step for state and federal legislators would be to bar agencies from keeping the money they seize. Today more than 40 states and the federal government permit law-enforcement agencies to retain anywhere from 45% to 100% of forfeiture proceeds. As a result, forfeiture has practically become an industry.

The Institute for Justice, where we work, has obtained data on asset forfeiture across 14 states, including California, Texas and New York. Between 2002 and 2013, the revenue from forfeiture more than doubled, from $107 million to $250 million. Federal confiscations have risen even faster. In 1986 the Justice Department’s Assets Forfeiture Fund collected $93.7 million. In 2014 the number was $4.5 billion.

Allowing police and prosecutors to keep part of what they confiscate gives them an incentive to target cash instead of criminals. In 2011 a Nashville TV news station investigated seizures on nearby interstate highways. Drugs usually came in on the eastbound lanes, while the money would flow out on the westbound lanes. The reporters found that police made “10 times as many stops on the money side.” They were less focused on stopping the drugs than on grabbing the cash.

On Capitol Hill last week, lawmakers began rolling up their sleeves to investigate the two components of the controversy that has embroiled Washington since Donald Trump was elected president on November 8: Russian interference in the election and what is now called FISAgate. The two components are interwoven . . . and antagonistic.

If, as Democrats suggest, the Russian interference was significant and there was evidence of Trump-campaign collusion in it, it would have been irresponsible for the Justice Department and the FBI not to investigate, including by monitoring communications under the Foreign Intelligence Surveillance Act (FISA). But if, as Republicans counter, Russian interference was immaterial (some say nonexistent), and there was no real proof of Trump-campaign collusion in anything nefarious, then the “hacking conspiracy” was just a pretext for the incumbent administration to investigate the opposition party’s political campaign, a stunning abuse of power.

Where does this all end up? I suspect it goes nowhere.

There is simply too much gray area of disagreement about what happened and what would have been an appropriate response to it. And our thinking is clouded by politics and its inevitable hypocrisy.

For example, during a campaign debate, Donald Trump vowed that if he were to win, he would have Hillary Clinton investigated. At the time, I thought (and said at NRO) that the torrent of condemnation — from the right as well as the left — was ridiculous. This was not, as overwrought critics said, tin-pot dictator stuff; nothing Trump said signaled an intention to use the executive’s awesome police powers to persecute political opponents. The critical fact was that there was patent evidence of felony misconduct on Clinton’s part — criminality that materially damaged national security and that had nothing to do with opposing Trump politically.

Now comes FISAgate, with its indications that while Trump was merely (and apparently emptily) threatening to investigate his Democratic rival, the incumbent Democratic president was actually investigating Trump, the Republican nominee.

Since some are now backpeddling from the assertions — matter-of-factly made over the last four months — that there really was an investigation, let’s be clear. This is not speculation. We know an investigation happened (and may still be ongoing). The only real questions concern the scope and the investigative tactics that have been used: Was there FISA wiretapping or, significantly, its functional equivalent in other forms of monitoring?

The deputy commandant for programs and resources of the Marine Corps, Lt. Gen. Gary Thomas, says that budget sequestration has cut into the Corps’ readiness for combat, with less than half of their aircraft ready to fly. General Thomas said that number should be 75 percent, meaning the Marines’ ability to meet challenges is severely restricted.

Washington Examiner:

The service’s goal is to have 75 percent of its aircraft on the flight line ready to go, a number he called “reasonable” since routine maintenance will always take some aircraft out of commission.

But the actual number now is just 45 percent, mostly due to aircraft exceeding their planned service life, Thomas said. The statistic seemed to shock Rep. Michael Turner, R-Ohio, chairman of the House Armed Services Tactical Air and Land Subcommittee.

“I’m sorry, can we go back for a second,” Turner said. “That’s pretty abysmal. To have that be closing the gap, we must have been in dire straits.”

Thomas also said the service has identified a capability gap when it comes to keeping forces safe in vehicles.

“If you look at some of our current vehicles, they no longer are adequate for the types of threats that they face in terms of protecting our Marines,” Thomas said.

Oshkosh Defense is building a new Joint Light Tactical Vehicle for the Marines that Thomas said will help better protect troops from current threats.

Other capability gaps include counting an emerging threat from drones, and coping with a fleet of amphibious vehicles that is 40 years old, Thomas said. CONTINUE AT SITE

The New York Times is again making hay of the fact that President Trump has not nominated any assistant secretaries of state, and Trump has been giving mixed signals on whether he thinks they are even necessary.

It turns out there are six undersecretaries of state and 22 assistant secretaries of state who report to them. If you factor in those with equivalent ranks, there are actually more like 33 assistant secretaries of state, each making an average of $155,000 a year, plus benefits!

Seven of the assistant secretaries cover different regions of the world, which makes some sense. You can’t have all ambassadors reporting directly to the secretary of state.

Assistant Secretary of State for African Affairs

Assistant Secretary of State for East Asian and Pacific Affairs

Assistant Secretary of State for European and Eurasian Affairs

Assistant Secretary of State for International Organization Affairs

Assistant Secretary of State for Near Eastern Affairs

Assistant Secretary of State for South and Central Asian Affairs

Assistant Secretary of State for Western Hemisphere Affairs

But after these posts it makes less and less sense. Let’s go over the rest of the list.

Assistant Secretary of State for Intelligence and Research

The State Department has an intelligence branch? I have never heard of it. Well, except maybe this guy (paragraph eight).

Assistant Secretary of State for Legislative Affairs

Why does a congressional liaison need to have the rank of assistant secretary?

Assistant Secretary of State for Administration

Assistant Secretary of State for Consular Affairs

Assistant Secretary of State for Diplomatic Security

The assistant secretary of state for administration deals with administering what? The consulates, I’ll bet! Why then do we need another secretary for consular affairs? And since diplomatic security is so integral to consulates, why can’t this all be wrapped into one job, rather than three?

cott Gottlieb may have landed the toughest job in Washington: President Trump has selected the physician and policy expert to run the Food and Drug Administration, where a culture of control strangles innovation. An iron triangle of interest groups, the bureaucracy and the press will resist change, but Dr. Gottlieb could save lives by renovating FDA’s drug-approval processes.

Mr. Trump deserves credit for picking a pragmatist who understands the agency: Dr. Gottlieb served as a deputy commissioner at FDA during the George W. Bush Administration, and he has also worked at the Centers for Medicare and Medicaid Services. He is a resident fellow at the American Enterprise Institute and his many contributions to The Wall Street Journal include insights on doctor autonomy, drug prices, antibiotic development and more.

One of Dr. Gottlieb’s priorities will be moving generic medicines to market, and competition is the best way to reduce the price of treatments like the now infamous EpiPen. About 10% of 1,300 branded drugs “have seen patents expire but still face zero generic competition,” Dr. Gottlieb wrote in the Journal last year. “New regulations have, in many cases, made it no longer economically viable for more than one generic firm to enter the market.” Now he can roll back such arbitrary directives.

Dr. Gottlieb has also suggested that the FDA should explain its reasoning when declining to approve a drug. FDA does not release a rejection notice known as a complete response letter. The rule ostensibly exists to protect manufacturers, but the silence allows the agency and a company to peddle divergent tales about what happened. The public is left with minimal information and FDA can operate without fear of accountability.

The press is overcome with relief that President Trump didn’t pick Jim O’Neill, a Peter Thiel pal who supports making drugs available to patients after testing for safety, though not for efficacy. But that idea is far from crazy, especially for drugs that treat rare diseases when no approved options exist. Why should desperate patients have to take a sugar pill so the FDA can satisfy its demand for 100% certainty that a drug works?

Laws in 2012 and 2016 directed FDA to include patient data in reviewing such orphan drugs, but the agency has refused to modernize or rely on anything but exhaustive placebo trials. Dr. Gottlieb should make the most of this legal flexibility, though he’ll be unfairly accused of lowering standards.

Most important is that Dr. Gottlieb understands that the fundamental problem at FDA is cultural: Staff reviewers think they are the “lone bulwark standing between truth and chaos when it comes to prescribing drugs,” as he put it in a 2012 piece for National Affairs. The agency delays approvals for therapies to search for remote risks, and the cost of this method is human lives lost from excessive delays in approving new medicines.

This culture has meant “that trials continue to get longer, larger, and harder to enroll,” he wrote. The average length of a clinical trial stretched to 780 days in 2005 from 460 in 1999, and median number of procedures (such as X-rays or blood draws) on patients in trials grew to 158 from 96. To speed approvals, Dr. Gottlieb has proposed that such decisions be made by a central committee of the agency’s most senior scientists, not the same reviewers who collect and analyze the data.

Dr. Gottlieb must win Senate confirmation, and some on the left are flogging that he has consulted for pharmaceutical companies and invested in health-care ventures, which they call a fatal conflict of interest. In other words, he’s disqualified because he’s qualified.

Dr. Gottlieb will have to adhere to government ethics rules, and the irony is that if he had never worked with the industry he’d be accused of inexperience. His understanding of entrepreneurship would be a valuable addition to an FDA that has for too long pretended its decisions have no influence on research or private investment.

One last credential: Dr. Gottlieb is a cancer survivor, which means he understands the urgency of helping treatments and cures reach the patients who need them. Dr. Gottlieb can expect relentless political and bureaucratic resistance, but he also has a tremendous opportunity to unleash medical progress in this era of rapid biological discovery.

Obama is a coward.

Trump will call someone a name while Obama will anonymously source a smear through three levels of staffers, political allies and reporters.

Trump called CNN “Fake News” on camera. Obama sourced Operation Rushbo, targeting Rush Limbaugh, through a variety of White House people and left-wing allies. Trump will boot reporters he doesn’t like. Obama authorized secretly hacking the emails of a FOX News reporter. Trump had an openly hostile conversation with the Prime Minister of Australia. When Obama wanted to call Netanyahu “chickens__t”, he did it by having one of his people anonymously plant it with a reliable media sycophant, The Atlantic’s Jeffrey Goldberg, before later having a spokesman disavow it.

Poultry ordure doesn’t smell any worse than that.

But Obama is very careful to launch dirty attacks without getting any on his hands. The insults are anonymously sourced. The retaliation comes out of the bowels of the bureaucracy. And he only finds out about it from the media. That allows him to retain what he cares about most: his popularity.

Obama and his people like to think that their dishonesty is a superpower. They pat themselves on the back for stabbing everyone else in theirs. Sometimes their smugness over how well they use the media to lie and smear gets out of control. Like the time Obama’s Goebbels, Ben Rhodes, boasted to the New York Times about how easy it was to fool everyone about the deal to protect Iran’s nuclear program.

After Trump won, it was business as usual.

Obama put on his best imitation of decency while his people went on preparing to undermine Trump at every turn by smearing him, wiretapping him and doing everything possible, legally and illegally, to bring him down. It was the same phony act that he had pulled for eight years, bemoaning the lack of bipartisanship while ruling unilaterally as a dictator, destroying the Constitution while hectoring us about our values, denouncing racism while organizing race riots, complaining about the echo chamber while constructing one and lecturing us on civility while smearing anyone who disagreed.

Trump’s killer instinct lies in understanding that hypocrisy conceals weakness. That is what powered him through the primaries and then through an election. His instinct is to grapple directly with a target. That is also the source of his popularity. Meanwhile the source of Obama’s popularity is his hollow likability. He’s likable only because he is almost always too cowardly to say what he really thinks.

Americans have seen the real Trump: because he is, in his own way, always real. Obama is always unreal. When Trump and Obama have appeared together, Obama seemed less real. He is a brand wrapped in all sorts of images that have nothing to do with who he really is.

Trump has always understood that Obama’s bravado was hollow. Obama boasted that he would have defeated Trump. Then he went on to try to do that with attacks from behind the scenes routed through government loyalists and media operatives while pretending that he had nothing to do with any of it.

But Obama and his people had learned nothing from how Trump had won the election. When Trump is attacked, his response is to go directly for the attacker, no matter what the argument is or how it’s sourced. Trump doesn’t get bogged down in debates or befuddled by media echo chambers that are so totally enveloping that they resemble reality. He just smashes past them to the source of the smear.

Attorney General Jeff Sessions has asked the 46 remaining Obama-appointed U.S. attorneys to tender their resignations, the Justice Department announced Friday.

The department described the request as part of an effort to ensure a “uniform transition.” About half of the country’s 93 U.S. attorneys have already left the department.

“Until the new U.S. Attorneys are confirmed, the dedicated career prosecutors in our U.S. Attorney’s Offices will continue the great work of the Department in investigating, prosecuting, and deterring the most violent offenders,” the statement added.

It is customary, though not automatic, for the country’s 93 U.S. attorneys to leave their positions once a new president is in office. Incoming administrations over the past several decades typically have replaced most U.S. attorneys during the first year or two.

The Obama administration allowed political appointees of President George W. Bush to serve until their replacement had been nominated and confirmed. One U.S. attorney appointed by Bush, Rod Rosenstein of Maryland, remained on the job for the entire Obama administration and is the current nominee for deputy attorney general.

The move comes amid increasing calls from conservatives to “drain the swamp,” especially as it applies to Obama holdovers in the Justice Department. Radio talk show host Hugh Hewitt pressed Counselor to the President Kellyanne Conway last month on why the attorney general hadn’t yet fired the lot of them.

“Why haven’t we fired the U.S. attorneys?” he asked. “They are all Obama appointees. They’re acting replacements, even if you haven’t got nominees lined up, would-be careerists. Why hasn’t he, a man of will, done that?”

Hewitt said that he wanted to see Obama’s “sleeper cells” “gone yesterday.” It may have taken a few weeks, but Sessions delivered.

Now, the status of Preet Bharara, U.S. Attorney for the Southern District of New York, is up in the air. Bharara was appointed by then-President Barack Obama in 2009, but as Fox News pointed out, he “met with Trump in November and said after the meeting that he had agreed to stay on.”

Bharara, the Daily Caller reported last year, was leading the New York-based probe of the Clinton Foundation.

Asked if the move by Sessions was unusual, former DOJ official Thomas Dupre told Fox News that the only thing unusual about it was that it took this long.

“This is something that all presidents do. The president is entitled to fill out his administration, including the top prosecutors in the Justice Department, with people of his own choosing,” he said.

This is hilarious but the best last year was in The New York Post cover with a picture of Hillary Clinton “Deleter of the Free World”….rsk

“…….Even better, it is factual. And almost inevitably, it’s about a “Florida man.”

Here it is, from NBC News:

Lawyer’s Pants Catch Fire During Florida Arson Trial

It seemed like a set up to a tired joke: A lawyer’s pants caught on fire in court.

But on Wednesday, it was Stephen Gutierrez’s reality when the Florida defense attorney’s pants began smoking during an arson trial, Eleventh Circuit Court Public Relations Director Eunice Sigler confirmed to NBC News Thursday.

Gutierrez, 28, was in the in the Miami-Dade county courtroom defending 49-year-old Claudy Charles, who was accused of setting his car alight.

But During his closing argument, Gutierrez began to feel heat coming from his pocket where he had several electric cigarette batteries, he told NBC News in an email.

As Gutierrez argued Charles’ car had merely spontaneously combusted, the lawyer’s pants seemed to do the same.

Witnesses in the courtroom told the Miami Herald the moment was “surreal,” as Gutierrez rushed out of the courtroom while smoke billowed from his pocket.

Gutierrez said as the heat intensified, he hurried into the bathroom where he tossed the battery in water. He was able to return to the courtroom with a singed pocket.

Because the defense argument was that the car spontaneously combusted, there is reason for suspicion among everyone but children that this was a set-up intended to make the point quite visibly to jurors. Lawyer Gutierez, of course, adamantly denies it.

I don’t really care. I just love the headline, probably because I write headlines on a daily basis and draw inspiration and amusement from the best of them.

In March 1993, Janet Reno began her tenure as President Bill Clinton’s attorney general by summarily firing United States attorneys for 93 of the 94 federal districts (one, Michael Chertoff, was retained in New Jersey, at the request of Democratic Senator Bill Bradley). That is more than twice as many as Trump attorney general Jeff Sessions fired on Friday.

Indeed, there were only 46 Obama-appointed U.S. attorneys left for Sessions to relieve because Obama appointees fully understood that this is the way things work. Many of them had already moved on, in the expectation that the president elected in November would replace them — an expectation that became a virtual certainty once it was clear that this change of administrations would be a change of parties, and visions.

It is frequently observed that, to be legitimate, law enforcement must operate independently of politics. It is an oversimplification, coupled with a misunderstanding of politics in its non-pejorative sense.

Of course the conduct of investigations, prosecutions, and their consequent judicial proceedings must be immune from partisanship. It would be intolerable for people to be targeted for, or insulated from, criminal law enforcement based on their political connections. Law enforcement, however, is about more than handling individual cases. It is about making overarching policy choices.

Resources are finite. Administrations must choose how many assets to dedicate to counterterrorism, immigration enforcement, health-care fraud, organized crime, and so on. Should the feds focus on the importation of illegal narcotics and their distribution by interstate criminal syndicates? Or should prosecutors and agents team up with state agencies to tackle street-level trafficking? Are the civil-rights laws an enforcement measure to protect fundamental liberties? Or are they a social-justice tool for transforming nationwide policing practices?

These policy choices are the stuff of politics. They often weigh heavily in presidential campaigns and elections. Law-and-order issues intimately affect people’s lives. When presidents make promises about them, they must expect to be held accountable.

U.S. attorneys are the instruments through which the president exercises his policy discretion. That is why they are political appointees. They do not have power of their own. Under our Constitution, all executive power is reposed in the president alone. Every officer of the executive branch is thus a delegate. The U.S. attorney exercises the president’s power and can be removed at the president’s will.