This is an excerpt from a story by CNN Fortune about long-term corruption inside Ranbaxy, a generic drugmaker. Ranbaxy makes, among other drugs, a generic form of Lipitor.
…Just three decades ago, generic drug companies in the U.S. were derided as patent breakers. They had no clear way to gain FDA approval, while brand-name-drug companies had a lock on the market. The 1984 Hatch-Waxman Act changed that. It created a pathway, the Abbreviated New Drug Application (ANDA), which allowed a generic drug company to simultaneously challenge a patent and demonstrate to the FDA that it could make a drug.
In the late 1980s several generic-drug companies were caught fabricating data and bribing FDA officials to gain approval. In the scandal’s wake, the FDA tightened regulations. It required that a company make three large “exhibit” batches to demonstrate that it could dramatically scale up its manufacturing, undergo inspection, and use an independent company to perform bioequivalence tests before an ANDA was approved. The purpose, says David Nelson, who exposed the 1980s scandal as a senior investigator for the House Energy and Commerce Committee, from which he retired in 2009, was to “prevent the systematic submission of false information” to get FDA approval.
The ANDA offered a lucrative reward for the company that risked almost certain litigation by first challenging a patent. If successful, the company got six months of exclusive sales after the patent lapsed, allowing the generics company to charge up to 80% of the brand-name price during that period. After that, other generics companies could jump in, and the price would drop to about 5% of the original price. Being first was the real jackpot. Consequently, first-to-file status became such an obsession that generic-drug company executives camped out in the FDA parking lot to file their paperwork first.
Ranbaxy learned how to game this system, according to former employees. To hasten the pace of its applications, Ranbaxy sometimes skipped a crucial intermediate step. Instead of making three medium-size exhibit batches and testing those for bioequivalence and stability, as required, Ranbaxy tested earlier and much smaller research-and-development batches that were easier to control and less costly to make. In some FDA applications, it represented these as much larger exhibit batches and presented the data as proof. And then there was the ultimate shortcut: using brand-name drugs as stand-ins for its own in bioequivalence studies.
These deceptions greatly accelerated the pace of the company’s FDA applications. They were also a grave public-health breach. Once Ranbaxy got FDA approval, it leaped straight into making commercial-size batches without any meaningful dry runs. The test results on file with the FDA were meaningless, and the drugs Ranbaxy was actually selling on the U.S. market were an unknown quantity, having never been comprehensively tested before.
At first we did not know the identity of the perpetrator. After a discussion about choosing a major, a Latino student quietly shared his anxiety: “God, I hope it’s not a Latino.” Then we heard that the first two victims had been an African-American man and a white woman. “I hope it isn’t a black person,” an African-American colleague told me in the mailroom. “If it is, we’re going to catch hell.”
At a luncheon to welcome prospective Asian and Asian-American students, the fact that the shooter was an Asian man had already entered the conversation. Many in attendance were on edge as they speculated about his ethnicity and immigration status. In an odd game of “guess the shooter,” they didn’t want it to be one of their own: “I hope he’s not Vietnamese,” “I hope he’s not Filipino.” The list went on. By the afternoon, the false rumor that he was a Chinese student from Shanghai took hold. A tiny part of me was relieved that he hadn’t been Korean.
Of course, it wasn’t to be. Seung-Hui Cho’s Korean identity became so firmly fixed that, for a time, it seemed to obviate all other parts of who he was. He was a Korean who battled depression; a Korean who wrote violent plays; a Korean who stalked women. He was, simply, the Korean shooter. The scenario unfolded in predictable ways: Korean and Korean-American students here said they were afraid for their safety, while from Los Angeles to New York, fears of a backlash gripped the Korean-American community. Newsweek reported online that chat rooms “throbbed with hate.”
I was bombarded with voice- and e-mail messages from the news media. Could I comment on the incident? It was as though Cho’s ethnicity itself held the key to his rage. At a faculty meeting, one of my white colleagues said, “I’m so sorry about what happened,” as if I had been in Blacksburg dodging the bullets. Being a Korean-American had become all-consuming.
It goes without saying that race and ethnicity still play a powerful role in American society. For racial and ethnic minorities, especially those of us who are marked by visible reminders of difference, minority status sets us apart as vulnerable. It is revealing that on the day of the shooting, everyone who played the “guess the shooter” game with any sense of personal investment was a member of a minority group. Given our past experiences, we knew that, if the shooter had been white, the responsibility, blame, and anger would have begun with the individual. But for us, the responsibility, blame, and anger also implicated our racial and ethnic identity.Edward J. W. Park on the 2007 Virginia Tech shooting.
But the 8-hour workday is too profitable for big business, not because of the amount of work people get done in eight hours (the average office worker gets less than three hours of actual work done in 8 hours) but because it makes for such a purchase-happy public. Keeping free time scarce means people pay a lot more for convenience, gratification, and any other relief they can buy. It keeps them watching television, and its commercials. It keeps them unambitious outside of work.
We’ve been led into a culture that has been engineered to leave us tired, hungry for indulgence, willing to pay a lot for convenience and entertainment, and most importantly, vaguely dissatisfied with our lives so that we continue wanting things we don’t have. We buy so much because it always seems like something is still missing.
I can’t watch this live because I have a lecture at the same time, but you should check it out—
Yale’s Institution for Social and Policy Studies presents The Future of Medicare: Policy Options and Political Realities. The discussion will be held on Tuesday, April 2, 2013, from 12:00-1:30 PM (E) and will be streamed live on YouTube.
Join us for a roundtable discussion that will address the fiscal realities of the Medicare program and examine the policy options and political challenges associated for making it sustainable.
David Brooks, Political and cultural commentator and Op-Ed columnist for The New York Times
Zack Cooper, Assistant Professor of Public Health and Economics, Yale University
Jacob Hacker, Stanley B. Resor Professor of Political Science and Director of ISPS, Yale University
Thomas Scully, Former Director of the Centers for Medicare and Medicaid Services (CMS) 2001-2003 under President George W. Bush
With Guest Moderator Sarah Kliff, Reporter for The Washington Post covering health policy
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“The Average Fourth Grader Is A Better Poet Than You, (And Me Too),” Hannah Gamble
While in graduate school at the University of Houston, I supplemented my income by working as a writer in residence for Writers in the Schools (WITS). I was with WITS for three years, during which I visited third, fourth, and fifth grade classrooms, and worked with groups of students visiting the Menil museum of art, the Houston Historical Society, and the Houston Arboretum.
When first hired by WITS, I expected that working to explain some of my favorite poems to fourth graders would result in me becoming a better teacher of poetry. What I wasn’t expecting was that (thanks to having my brain blown apart on a weekly basis as I browsed my students’ folders of barely legible poems) I would become a better poet.
Here are some lines written by students in grades 3rd-6th:
“The life of my heart is crimson.”
[Writing about a family member’s recent death:]
“My brother went down/ to the river
and put dirt on.”
“Peace be a song,
silver pool of sadness”
“Away went a dull winter wind
that rocked harshly, and bent you said,
[Writing about a terminal illness:]
“I am feeling burdened
and I taste milk……
I mumble, ‘Please,
please run away.’
But it lives where I live.”
“The owls of midnight hoot like me
shutting the door to nothing.”
[Writing about life as a movie:]
“The choir enters, and the director screams
‘Sing with more terror!!!’”
“I have provisions. Binary muffins.
It’s an in/out/in/out kind of universe.
We cannot help you,
this is a universe factory.
A sound of rolling symbols.
Disappearing rocks, screams of lizards.
Sanity must prevail. Save vs. Do Not.”
“I, the star god,
take bones from the
underworlds of past times
to create mankind.”
These young writers are addressing subjects that still obsess poets fifty years older: sadness, death, love, responsibility, aging, family, loneliness, and refuge…and they are addressing these subjects in language that is new, and thus has the power to emotionally effect a well-seasoned (/jaded) reader. The average fourth grader is able to do this because she hasn’t been alive long enough to know how to do it (and by “it” I mean talk about the world) any other way.
Story time: When I was a child I believed that one day I might be allowed to cross into an alternate dimension by walking through a quilt hanging on my living room wall. As I got older I stopped believing that this was a possibility—not because I grew to believe that the universe was not an extremely strange place where incomprehensible things could happen on a daily basis, but because I passed year after year after year not being able to enter the spirit realm through a wallhanging.
Anecdote that I hope you’ll find relevant: When Jean Piaget began studying the intellectual processes of children, he was not doing so because he had any special interest in children. Piaget was interested, rather, in the intellectual processes of (adult) humans and was seeking a control group. [His first thought was that the best control group would be comprised of martians but, as he did not have access to martians, he decided to use children since children possessed what is farthest from human consciousness.]
So let’s look at what happens to our young writers as they age [I took these lines from poems written by middle-school/ high school students (Italics, mine)]:
Snacking on this and that
my friends and I keep the party going
even when it is over”
“Whispers of a
secret crush being unraveled”
“I’m trapped in this hole that
I can’t break through”
“Barack Obama in the White House.
I can feel the inspiration
Can you feel it?”
“Now I feel secure with my head held high.
Sad times. By middle school/high school, the average student has learned how normal people talk. The resulting language is underwhelming and predictable—the safe regurgitations of a thoroughly socialized consciousness.
While the average older student’s poems are heavy with allegiance to a limited view of reality, the average younger writer’s vision of the world is nimble and surprising—bazaar, yet true.
Last year I spent every Saturday tutoring an extremely undersocialized kid in vocab. When I taught her the word blandishments (“to flatter, coax, sweet-talk, appeal to”) she wrote this sentence: “The blandishments of the sugar flowers made the cake so much more inviting.”
The sentence is interesting because the student understood that a blandishment is something that attracts favorable attention without fully realizing that people almost always use the word to refer to a human action.
The poet’s job is to forget how people do it.
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