RUTHFULLY YOURS

https://www.wsj.com/articles/the-man-who-knows-too-much-1491434758

Politicians aren’t always as dumb or cynical as they sound, but you wouldn’t know that from Wednesday’s confirmation hearing for Scott Gottlieb. Democrats criticized the nominee to run the Food and Drug Administration for the “conflict of interest” of knowing too much about the industries he’d regulate.

Washington Senator Patty Murray and other Democrats devoted most of the morning to agitating about Dr. Gottlieb’s “unprecedented financial entanglements” because he has consulted for various companies and invested in health-care start-ups. Rhode Island’s Sheldon Whitehouse flopped in with a strange remark about “dark money operations,” which is an amusing way to describe financial disclosures available on the internet.

Bernie Sanders, never one to be hamstrung by knowledge, tweeted Wednesday that it was a “disgrace” to have an FDA commissioner who has taken money from drug companies. These are the same committee Democrats who pummeled Betsy DeVos for not having enough experience in public education.

Dr. Gottlieb disclosed his work in accordance with government rules and will liquidate his investments. He agreed to recuse himself for a year on decisions relevant to his past interests. He also promised Wednesday to follow directives from the Health and Human Services ethics office, and to be an “impartial and independent advocate for the public health.”

The irony of the claim that Dr. Gottlieb can be bought by the industry is that pharmaceutical companies won’t be thrilled by some of his priorities. One is increasing generic drug competition: On Wednesday he offered a tutorial in how companies exploit regulatory barriers to competition for their commercial advantage. Sounds like something ol’ Bernie should like.

Another ugly charge is that Dr. Gottlieb won’t address the opioid crisis because he has worked with companies that produce painkillers. Yup—he wants to take a pay cut and subject himself to bureaucratic hassles so he can peddle pills to addict more Americans. Who writes this stuff? In fact, Dr. Gottlieb called opioid abuse “a public emergency on the order of Ebola and Zika” and suggested an “all-of-the-above” strategy that would include inventing less addictive painkillers and better patient care.

Dr. Gottlieb has written lucidly about how FDA can unleash innovation without compromising public safety, which he rightly calls a “false dichotomy.” Democrats once believed in expertise, and if they cared about delivering cures for patients as much as they fret that someone is making a profit, they’d confirm Dr. Gottlieb in a millisecond.

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.