Since the election of Donald Trump, there’s been a lot of discussion in medical circles about bringing a Silicon Valley ethos to drug innovation in America.
This idea is embodied in Peter Thiel, the billionaire founder of PayPal, who has reportedly been helping the president vet a pool of candidates to lead the Food and Drug Administration.
Thiel, a libertarian iconoclast, has repeatedly made the case that the FDA gets in the way of drug innovation by making it too difficult for new medicines to get to the market. Some of the FDA candidates he’s identified — including Silicon Valley’s Jim O’Neill and Balaji Srinivasan — have similarly argued that the agency should dump its requirement that drugs be proven effective before reaching the market, and that we’d be better off if the FDA operated more like a “Yelp for drugs.” In other words, bringing the same speedy and disruptive approach to medical regulation that Silicon Valley brought to the taxi and hotel industries, for example, will unlock cures — fast.
But Thiel and his pals miss a very important point about developing new drugs: Manipulating biology isn’t the same as manipulating computer code. It’s much, much harder. Speeding up medical innovation will take a lot more than just stripping down the FDA — it’ll take huge leaps forward in our understanding of biochemistry and the body. Health care is also different from taxis and hotels in another key way: Consumers can’t really judge the safety and quality of medical products by themselves.
Trump to remove USDA animal welfare protections from cruelty for dogs. A reminder from 9/16: he's never HAD a dog pic.twitter.com/NykVqnG6Nj— Keith Olbermann (@KeithOlbermann) February 4, 2017
One of the key notions that undergirds the Peter Thiel view of the FDA is that if the agency just got rid of some of the pesky restrictions for drug approval, we’d usher in another golden age in drug development. (Thiel declined our interview request.)
To test this idea, I asked a longtime pharmaceutical scientist (and conservative), Derek Lowe, for his views. In his 28 years in the lab, Lowe has seen hundreds of thousands of compounds tested on a huge variety of drug targets, and never, not once, has he brought a drug to market.
The reason? “We don’t know how to find drugs that work,” he said.
For every 5,000 compounds discovered at this "preclinical" phase of drug development, only about five are promising enough to be tried in humans. That’s a success rate of 0.1 percent.
Drug innovation comes from painstaking tinkering and a dash of luck. “It’s very tempting for someone who has come out of IT to say, ‘DNA is code, and cells are the hardware; go in and debug it’,” Lowe said. “But this is wrong.”
On December 1, 1955, in Montgomery, Alabama, Parks refused to obey bus driver James F. Blake's order to give up her seat in the colored section to a white passenger, after the white section was filled. Parks was not the first person to resist bus segregation. Others had taken similar steps, including Bayard Rustin in 1942,[2] Irene Morgan in 1946, Sarah Louise Keys in 1952, and the members of the ultimately successful Browder v. Gayle 1956 lawsuit (Claudette Colvin, Aurelia Browder, Susie McDonald, and Mary Louise Smith) who were arrested in Montgomery for not giving up their bus seats months before Parks. NAACP organizers believed that Parks was the best candidate for seeing through a court challenge after her arrest for civil disobedience in violating Alabama segregation laws, although eventually her case became bogged down in the state courts while the Browder v. Gayle case succeeded.[3][4]
Parks' act of defiance and the Montgomery Bus Boycott became important symbols of the modern Civil Rights Movement. She became an international icon of resistance to racial segregation. She organized and collaborated with civil rights leaders, including Edgar Nixon, president of the local chapter of the NAACP; and Martin Luther King, Jr., a new minister in town who gained national prominence in the civil rights movement.
At the time, Parks was secretary of the Montgomery chapter of the NAACP. She had recently attended the Highlander Folk School, a Tennessee center for training activists for workers' rights and racial equality. She acted as a private citizen "tired of giving in". Although widely honored in later years, she also suffered for her act; she was fired from her job as a seamstress in a local department store, and received death threats for years afterwards. Her situation also opened doors.BTW - this is how you win:
Happy New Year to all, including to my many enemies and those who have fought me and lost so badly they just don't know what to do. Love!— Donald J. Trump (@realDonaldTrump) December 31, 2016
— Theater of SciFi (@theaterofscifi) February 3, 2017
ONE DAY after President Trump and Vladimir Putin held their first phone call, Russian-backed forces mounted their largest offensive in months in eastern Ukraine. Now, days later, one of Russia’s most prominent opposition activists is in a coma in a Moscow hospital, where he was rushed after suddenly taking ill on Thursday morning. Vladimir Kara-Murza, a writer and civil- society activist with many supporters in Washington, is believed by his family to be the victim of a poisoning attack — the second they believe he has suffered since 2015.
His agony most likely holds a message from Mr. Putin to the new Trump administration. Since 2014, the Kremlin has endured sanctions from the United States and the European Union for its aggression in Ukraine and for human rights violations, such as the killings of lawyer Sergei Magnitsky and opposition leader Boris Nemtsov. With the new assault on Ukraine and the felling of Mr. Kara-Murza, the Kremlin hopes to establish that such crimes will be tolerated by the new U.S. president as part of a refounded relationship with Moscow.
So far, Mr. Putin’s gambit is succeeding: Mr. Trump, while sparring with close U.S. ally Australia, has had nothing to say about the events in Ukraine and Moscow.
That Would Be Awesome. pic.twitter.com/hM1jHCxum8— Tomthunkit™ (@TomthunkitsMind) February 3, 2017
The key question after a mission like last week in Yemen: Are we creating terrorists faster than we're killing them? https://t.co/PcndhFLC7f— Maddow Blog (@MaddowBlog) February 3, 2017
