http://www.pharmalot.com/2008/06/paxil-and-a-drugmaker-on-trial-alison-bass-explains/
From the article/interview:
"Drug companies know the side-effect profiles of their drugs and hide
something. In the case of antidepressants, these drugs do a lot of good
for a lot of people, but for a small population, doctors didn’t know
these drugs had (suicidal) side effects and, as a result, didn’t
monitor patients as closely as they should have. But they didn’t have
the information, because Glaxo didn’t publish its negative findings."
Not publishing negative side effects is not good.
The report is scathing. An expert panel has told the Food and Drug Administration that the organization is so understaffed and underfunded, it puts American lives at risk.
Gail Cassel, co-author of a 56-page report titled "FDA Science and Mission at Risk," said, "The wheels are coming off. In fact, I would say they're off. They're already off."
The report uncovered failures at every turn. The most glaring is that the FDA lost 600 inspectors in the past four years, making the agency unable to protect the country's food supply. And the FDA's responsibilities have grown, rendering the agency ineffecitve.
Bill Hubbard, a former FDA associate commissioner, said, "When I came to the FDA in the early 1970s, we were doing 35,000 food inspections a year. This year, the agency will be doing 6,000."
"Crisis management in FDA's two food safety centers ... has drawn attention and resources away from FDA's ability to develop the science base and infrastructure needed to efficiently support innovation in the food industry," the report said.
The report found the agency's computer system, which tracks hazardous foods and drugs, is so antiquated, it's constantly breaking down.
"Imagine having an e-mail system so old, they have to bring technicians out of retirement because current technicians have never seen equipment that old," said Hubbard.
Many front-line employees don't even have a computer. Inspectors must write urgent reports by hand, which often end up lost in huge warehouses.
The report does not blame the FDA but rather Congress, for continually cutting the agency's budget while asking it to assume more and more responsibility.
Overall, the FDA staff has shrunk 14 percent over the last 14 years.
A leading FDA critic in Congress, Rep. Rosa DeLauro, said, "The essence is, send me a plan, .ask for money, and we'll consider it. But they never ask for more money or authority."
While the squabbling in Washington continues, the agency charged with protecting our food and drug supplies is, tonight, according to the report, so broken, it cannot do the job.
I realize this article is 19 months old. I don't think much has changed at the FDA or if it has it's minimal. Washington doesn't move to quickly. LindyFor the FDA to be effective it needs to be restructured. My father used to work for the NTSB. The airline industry has the FAA to play a more friendly role with airlines, and the NTSB to investigate. Something similar would benefit the pharm industry.
[QUOTE=KatieG]For the FDA to be effective it needs to be restructured. My father used to work for the NTSB. The airline industry has the FAA to play a more friendly role with airlines, and the NTSB to investigate. Something similar would benefit the pharm industry.
[/QUOTE]