Fantastic article about clinical trials and the balance between doing no harm and causing harm by doing nothing.
Deadly Caution: How our national obsession with drug safety is killing people -- and what we can do about it.
Fortune Magazine - February 9, 2006 - For six hours on Nov. 8, 2005, time moved so slowly for Frank Burroughs and Steve Walker that it seemed to stop altogether. The two had come to a dreary ballroom at a Holiday Inn in Gaithersburg, Md., for a meeting of the FDA's Oncologic Drugs Advisory Committee, or ODAC. Here, at three tables set up in a horseshoe and draped in burgundy cloth ruffles, sat some of the most important people in the cancer establishment. Their role was to review presentations about new-drug applications and make recommendations regarding their approval.
For Burroughs and Walker, fidgeting as other presenters went through their PowerPoint slides, this meeting was not about dispassionate science. The panel had the power to offer hope to cancer victims, or withhold it. Both men had lost loved ones to the disease--Burroughs had buried his college-age daughter, Abigail, 4 1/2 years earlier; Walker's wife had died after a two-year struggle with the disease. Both had tried and failed to get access to last-ditch experimental medicine. Both had become activists. And both felt an agonizing frustration with the FDA that, if anything, was growing.
Some in the room guessed what was coming when Burroughs stepped up to the mike. But even they were surprised when, after a few words of introduction, his cheerful face took on a look of fury. His voice began shaking, and soon he was invoking Thomas Jefferson's admonition on tyranny to those on the dais, reminding them that people of good conscience can't remain silent. He was particularly angry with the committee's lone patient advocate. Who did she represent? Burroughs wanted to know. Certainly not dying patients with nowhere to turn!
Moments later, Walker took the podium. He, too, tried to keep calm, but his voice began to crack. "We need to remember who this is all for," he said. "It's for the patients. It's not about P values; it's not about endpoints; it's not about policies; it's not about your careers. It's about the patients out there--the patients we have lost waiting for the process to run its laborious, tortoise-like course."
There was a hush as the awkwardness of the moment filtered through the room. And then the moment was gone. The chairwoman thanked Walker for his remarks, said they were "food for thought," and, after a five-minute bathroom break, moved to the next agenda item.
Burroughs and Walker are familiar names to people involved in the drug-approval process--Walker is the chief spokesman of the Abigail Alliance for Better Access to Developmental Drugs, an advocacy group Burroughs set up and named for his daughter. And judging from the scattered smirks around the room, there are plenty of people who think these guys are wackos.
It's easy to see why. The Abigail Alliance and other advocacy groups are pushing to get potentially toxic drugs released to patients in the earliest stages of testing and development, long before they've been proved to work. They want faster access right at a time when regulators are forcing the drug industry to slow down--often with good reason.
for the rest of the article: http://money.cnn.com/magazines/fortune/ ... /index.htm