Understanding Government

Acting in concert with federal officials, authorities in Los Angeles raided a local natural foods buyers co-op and arrested three people for distributing raw milk and dairy products, reports Ian Lovett of The New York Times and Stuart Pfeifer and P.J. Huffstutter in the Los Angeles Times. Authorities also seized $70,000 worth of inventory from the Venice co-op, Rawsome, on the grounds that the shop was selling unsafe and unlicensed products to consumers and doing so without a business license. Operators of the co-op maintain that the products in question weren’t being sold to unknowing consumers, but distributed to members of a buyers’ club who specifically sought out unadulterated foods and were well aware of the risks. Because the operation wasn’t open to non-members and was run by volunteers, its trustees claim they aren’t required to have a business license. (more…)

Emily Tarsell thought she had enough information about Gardasil — a new vaccine marketed to young women to prevent certain types of cervical cancer — when she agreed to have her daughter receive the vaccine.  But after her third and last injection of Gardasil, in 2008, Christina Tarsell, a previously healthy 21-year old, was dead.

The depth of this family’s anguish at the death of their daughter can’t be conveyed.  But after some time (more…)

Peter Lurie

When Dr. Peter Lurie was working at Public Citizen, he was known as one of the FDA’s biggest public opponents.  He participated in congressional hearings, he fought Big Pharma, he spoke out on behalf of people who needed medicines or who had been hurt by the wrong medicine.  Now he’s working inside the FDA, and Rob Stein of the Washington Post decided to find out what it’s like for someone like Lurie on the inside.  The upshot?  Lurie has realized “the issues are more complex than people on the outside of government can fully appreciate.”  These may seem like wiggle words, but they’re certainly true.  Government officials have to look at more sides of an issue than issue advocates outside government, and they have to take into account more stakeholders — including, in the FDA’s case, the extremely influential pharmaceutical companies.  But in a way, working inside a large government agency and working with so many people, you end up being less exposed — certainly less exposed to some people’s anger than he was at Public Citizen.  (more…)

Here’s why industry self-policing doesn’t work when it comes to dangerous chemicals. Last month the Environmental Working Group found that those shiny grocery and gas station receipts contain high levels of the chemical, bisphenol A (“BPA”), which is absorbed into our skin.  The Food and Drug Administration is already considering whether to regulate BPA found in plastic food containers – including baby bottles – but only after a public outcry. (more…)

By Marci Greenstein

National Institutes of Health chief, Dr. Frances Collins was talking up his agency’s partnership with the Food and Drug Administration on NPR’s Diane Rehm Show last week.  The move is intended to speed up the process for getting drugs from laboratories to the marketplace.  What’s surprising is that this collaboration hasn’t happened sooner.  How often have we heard about patients desperate to get drugs that are successful in clinical trials but are moving at a snail’s pace through the FDA’s regulatory maze? (more…)