RUTHFULLY YOURS

https://www.wsj.com/articles/how-fda-rules-made-a-15-drug-cost-400-1491434230

The theory is that generic drugs should be less expensive than the original. By the time a generic hits the market, the drug’s patent has expired, allowing competition from companies that didn’t spend millions of dollars to develop it. As more options become available, prices are supposed to drop. But because of quirks in America’s regulatory system, it doesn’t always work out this way.

In 2009 the Food and Drug Administration approved a new version of colchicine, which treats symptoms of gout. Prices rose from 25 cents to $6 per pill. Two years later, the agency approved a new hydroxyprogesterone, which helps prevent premature births. It went from $15 to $400 an injection. In 2014 the FDA approved a generic of the man-made hormone vasopressin. Prices jumped from $11 to $138 for an injection.

What explains the counterintuitive price increases? All these prescription drugs fall under a category known as DESI drugs, named for their inclusion in an FDA program called Drug Efficacy Study Implementation. These drugs came to market before 1962, when getting FDA approval for a drug required proving its safety but not its efficacy. Such drugs, manufactured under expired patents, are used by millions of Americans today.

But once the FDA approves a new-drug application for a DESI drug, the existing drug can be pulled from the market. The “new” drug is treated as a material advance because it underwent testing for safety and efficacy—even though the DESI version was proved safe and effective over decades of actual use. The developer of the new drug may also get a new period of market exclusivity that lasts three years.

This makes little sense. Market exclusivity should let pharmaceutical companies recoup their often enormous investments in genuinely new drugs. Giving monopoly protection for what is essentially a generic version of a DESI drug merely enriches sharp-dealing companies while injuring patients.

Another reason generics often face no competition was described by Scott Gottlieb, President Trump’s nominee for FDA commissioner, in these pages last year. He noted that a generic-drug application can cost as much as $15 million. This high upfront cost is part of why would-be manufacturers of generics often pass on the opportunity to compete against branded drugs with smaller markets. This has allowed many pharmaceutical companies to raise prices with impunity. CONTINUE AT SITE

The Democrats and some Republican NeverTrump bitter-enders are still so addled by losing the election that they have lost themselves in a political Area 51. Like peddlers of space-alien autopsies and earthling abductions, they are spinning preposterous conspiracy theories straight out of Invasion of the Body Snatchers, while the real story––the illegal leaks of classified intelligence involving American citizens––is ignored.

We all know the lurid scenario: Vladimir Putin, filled with hatred of Hillary for criticizing and sanctioning him for his invasions of his neighbors’ territories, “hacked” the election in order to tilt the outcome to Donald Trump. Trump, after all, said some vaguely nice things about Vlad during the campaign, and most likely has secret dodgy business interests in Russia. Several of Trump’s friends probably do too, and so they cooperated with Russian intelligence, its WikiLeaks minions, and its propaganda rag Russia Today to smear Hillary and the Democrats. And, don’t forget, it’s likely Vlad has some embarrassing untoward info on Trump he can use to blackmail the president. QED.

This conspiracy theory is preposterous, and the media’s and Dems’ continued use of the phrase “hacked the election,” as if voting machines were meddled with, is rank propaganda and confirms the continuing absence of real evidence. Of course Russia tried to influence the election, as it has tried to influence every American election since the 1930s. And we have tried, and continue to try, to influence elections in other countries all over the world. Have the Dems forgotten how Obama in 2015 interfered in Israel’s elections by spending $350 on “campaign infrastructure” to be used against Benjamin Netanyahu? As for Americans colluding with Russia during an election, where was all this high dudgeon when in 1983 Ted Kennedy offered Soviet premier Yuri Andropov a quid pro quo? As Forbes reports of the deal, “Kennedy would lend Andropov a hand in dealing with President Reagan. In return, the Soviet leader would lend the Democratic Party a hand in challenging Reagan in the 1984 presidential election.” Kennedy also offered to visit Russia and help them with access to the American media.

This typical Trumpophobic hypocrisy is also evident in the amnesia about who was really getting chummy with Putin––Obama and Hillary. Taking missile-defense installations out of Poland and the Czech Republic; working on a “reset” of relations that had soured because of Russian territorial theft in Georgia and Moldova; Obama in 2012 asking Russian president Dmitri Medvedev to assure Vlad of his “flexibility” after the election––all comprise evidence of Obama’s appeasement more solid than the innuendo and rumor supposedly proving Trump colluded with Vlad.

Former President Barack Obama’s national security adviser Susan Rice is once again in the news, embroiled in a growing scandal. Bloomberg News has reported this week that Rice requested or directed the unmasking of the identities of U.S. persons in raw intelligence reports, who were involved with the Trump transition team. The communications of these individuals were apparently collected incidentally during the course of electronic monitoring of communications involving foreign officials of interest. Normally, Americans’ identities are masked, with generic references such as the title “U.S. Person One.”

According to Eli Lake’s Bloomberg report, “The intelligence reports were summaries of monitored conversations — primarily between foreign officials discussing the Trump transition, but also in some cases direct contact between members of the Trump team and monitored foreign officials. One U.S. official familiar with the reports said they contained valuable political information on the Trump transition such as whom the Trump team was meeting, the views of Trump associates on foreign policy matters and plans for the incoming administration.”

Daily Caller has reported that Rice “ordered U.S. spy agencies to produce ‘detailed spreadsheets’ of legal phone calls involving Donald Trump and his aides when he was running for president,” citing former U.S. Attorney Joseph diGenova as a source.

Circa has reported that Rice’s snooping actually preceded the election: “Susan Rice accessed numerous intelligence reports during Obama’s last seven months in office that contained National Security Agency intercepts involving Donald Trump and his associates.”

It also appears that the monitoring at issue had little if anything to do with the investigation of Russian interference in the presidential election.

These reports, and others along the same lines, raise serious questions about what Rice was doing with the unmasked identifiable information she obtained access to, even though nothing revealed so far indicates that Rice broke the law. She had the authority to request unmasking under certain circumstances where there was an intelligence need in the interest of national security for such information. But given Rice’s closeness to Obama and concern for preserving his legacy, politics, not national security, was more likely her primary motive.

Michael Doran, former National Security Council senior director, told the Daily Caller that “somebody blew a hole in the wall between national security secrets and partisan politics.” This “was a stream of information that was supposed to be hermetically sealed from politics and the Obama administration found a way to blow a hole in that wall,” he said.

It is a threat to our electoral democracy if a party in power is able to use the nation’s intelligence apparatus to do opposition research on the party out of power. This is what Rice appears to have done, perhaps to protect her boss’s legacy from being undermined by the new Trump administration. Rice denies all of this, of course.

The thing to bear in mind is that the White House does not do investigations. Not criminal investigations, not intelligence investigations.

Remember that.

Why is that so important in the context of explosive revelations that Susan Rice, President Obama’s national-security adviser, confidant, and chief dissembler, called for the “unmasking” of Trump campaign and transition officials whose identities and communications were captured in the collection of U.S. intelligence on foreign targets?

Because we’ve been told for weeks that any unmasking of people in Trump’s circle that may have occurred had two innocent explanations: (1) the FBI’s investigation of Russian meddling in the election and (2) the need to know, for purposes of understanding the communications of foreign intelligence targets, the identities of Americans incidentally intercepted or mentioned. The unmasking, Obama apologists insist, had nothing to do with targeting Trump or his people.

That won’t wash.

In general, it is the FBI that conducts investigations that bear on American citizens suspected of committing crimes or of acting as agents of foreign powers. In the matter of alleged Russian meddling, the investigative camp also includes the CIA and the NSA. All three agencies conducted a probe and issued a joint report in January. That was after Obama, despite having previously acknowledged that the Russian activity was inconsequential, suddenly made a great show of ordering an inquiry and issuing sanctions.

Consequently, if unmasking was relevant to the Russia investigation, it would have been done by those three agencies. And if it had been critical to know the identities of Americans caught up in other foreign intelligence efforts, the agencies that collect the information and conduct investigations would have unmasked it. Because they are the agencies that collect and refine intelligence “products” for the rest of the “intelligence community,” they are responsible for any unmasking; and they do it under “minimization” standards that FBI Director James Comey, in recent congressional testimony, described as “obsessive” in their determination to protect the identities and privacy of Americans.

Understand: There would have been no intelligence need for Susan Rice to ask for identities to be unmasked. If there had been a real need to reveal the identities — an intelligence need based on American interests — the unmasking would have been done by the investigating agencies.

The national-security adviser is not an investigator. She is a White House staffer. The president’s staff is a consumer of intelligence, not a generator or collector of it. If Susan Rice was unmasking Americans, it was not to fulfill an intelligence need based on American interests; it was to fulfill a political desire based on Democratic-party interests.

The FBI, CIA, and NSA generate or collect the intelligence in, essentially, three ways: conducting surveillance on suspected agents of foreign powers under the Foreign Intelligence Surveillance Act (FISA), and carrying out more-sweeping collections under two other authorities — a different provision of FISA, and a Reagan-era executive order that has been amended several times over the ensuing decades, EO 12,333.

As Director Comey explained, in answering questions posed by Representative Trey Gowdy (R., S.C.), those three agencies do collection, investigation, and analysis. In general, they handle any necessary unmasking — which, due to the aforementioned privacy obsessiveness, is extremely rare. Unlike Democratic-party operatives whose obsession is vanquishing Republicans, the three agencies have to be concerned about the privacy rights of Americans. If they’re not, their legal authority to collect the intelligence — a vital national-security power — could be severely curtailed when it periodically comes up for review by Congress, as it will later this year.