How Wallace Stevens, an introverted insurance executive, became one of the most powerful twentieth-century poets.
OH MY GOD! Well then fuck that guy, amirite? Probably best that he’s dead. A conservative…Christian…who opposed gay marriage…FIND MY SMELLING SALTS!
A third party already exists in America and Trump is leading it.
It’s April 2016 and President Shortbus is still confused over Putin’s intentions in Syria.
In which Jonah Goldberg explains the GOP convention to you like you’re a 5-year-old, so you can’t NOT get it.
Like every government agency, the FDA is horrible. This is fucking infuriating and inhumane:
No government agency controls the fate of more people than the Food and Drug Administration, which has the power to deny children a treatment that could help them walk. The FDA is reviewing an experimental drug for muscular dystrophy, and the outcome could determine the quality of life for thousands—and whether companies continue to invest in curing rare diseases.
On Monday an FDA advisory committee will consider eteplirsen, a drug by Boston-based Sarepta designed to treat a strain of Duchenne muscular dystrophy, which is a genetic disorder that weakens every muscle in the body. The condition usually affects boys, who by age 12 or so can no longer walk, and over time damages the heart and lungs. The fatality rate is 100%, and most do not live past 25.
Eteplirsen essentially pumps out the protein missing in patients with Duchenne, known as dystrophin, by skipping over faulty genetic code. Sarepta’s clinical trial started in 2011 and treated boys about 9-years-old whose abilities seemed to be deteriorating rapidly. After four years of treatment, 10 out of 12 children can still walk. In a comparable group of 11 boys who weren’t treated, only one could still walk. No side effects or safety concerns were reported.
Sarepta has gone back and forth with the FDA since 2013, and this is somehow considered the expedited track: A 2012 law allows the agency flexibility to accelerate approval in first-in-class drugs for lethal diseases, though the FDA seems to be flouting the spirit of this directive. The agency planned to assemble an advisory committee—which offers recommendations that the FDA typically follows—in January. But the meeting was postponed due to a blizzard in Washington, one that apparently snowed in the FDA for four months.
In January the agency issued a harsh report about eteplirsen, haggling over minutiae on the trial’s design and findings, and here’s why: The FDA is religious in trusting only large trials in which half of participants receive a placebo treatment. Yet such trials would prove near impossible since Duchenne patients are so rare.
And more important, unethical: What parent would sign up a child for years of weekly muscle injections and high-risk biopsies if the cocktail might be saline? FDA acknowledges these concerns and admitted in a Thursday report that the agency previously told Sarepta it would consider the type of study the company performed—only to change its mind. At the FDA, process trumps patients.
Adding more weight to the decision is that eteplirsen can only treat a certain mutation of Duchenne, and a no from the FDA would scuttle iterations in the drug-development pipeline that might help more patients. Biotech companies working on treatments for other rare conditions are also watching. If a drug with no safety risks, a four-year record of effectiveness, and a strong legal and ethical basis can’t win approval, what can?
Sarepta, with 200-odd employees, may not have the resources for several more rounds with an agency that seems to enjoy issuing ominous reports and watching the company’s stock crater; Sarepta tanked 44% on Thursday when the FDA issued another unfavorable briefing ahead of Monday’s meeting. The stock fell more than 50% when the January report emerged. The result of this political control is fewer companies taking the risks that result in cures.
On a happier note, here’s an awesome story that will restore some faith in humanity.
It’s not a conspiracy theory. He wrote an entire fucking book on it, FFS!
The Obama Administration is not only carrying water for Iran. It’s paying for it.
Devastating Alex Rowell rundown of Obama’s disgusting pro-autocrat, anti-human rights Middle East legacy.
No one hates millennials more than I do, but this is a vicious slander on them. NO ONE is doing this.
Idiot tries to initiate ‘peace talks’ with ISIS, they respond by sending him a photo of a beheaded body because duh.
Degas violently rejected the idea of painting outdoors. He said the sight of the sea was “too Monet” for his eyes.
“This is madness. The whole idea of acting has gone out of the window, if you follow the logic of that…To say it is offensive to transgendered people for non-trans people to play them is nonsense. Because you have to have been a murderer to play Macbeth, you have to be Jewish to play Shylock. It’s nonsense. The great point of acting is that it is an act of empathy about someone you don’t know or understand. I continue to defend Laurence Olivier’s performance as Othello.”