Posts Tagged: Food & Drug Administration

Natural foods co-op gets a raw deal

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…)

Preventive Journalism Alert: medicines go missing in America

Rob Stein brings an alarming situation to light in the Washington Post: sick people all over the country, including cancer patients, are encountering drug shortages and often are unable to get the most effective treatments available.  Medicines hit by shortages range from important cancer drugs like cytarabine (used against leukemia) to the most basic form of painkiller available to patients suffering serious pain: morphine.  In some cases, manufacturers have stopped making the drugs because higher profits are no longer available after patents run out, and generic manufacturers can’t meet the demand.  Some manufacturers are blaming the Food and Drug Administration, saying its overly stringent safety standards are preventing drugs from reaching the marketplace.  But Stein’s reporting makes it clear that manufacturing problems and supply chain mixups are the more likely culprit.  This is a clear case for urgent federal oversight.

Gardasil, the FDA, and VAERS: How Americans concerned about vaccines interact with government

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…)

Charles Peters: Regulators have egg on their faces

Even when there is an adequate number of inspectors at a government agency, they are conditioned not to make trouble for the inspected. When the Department of Agriculture inspected Wright County Egg in Iowa, later found to be a major source of salmonella, they discovered, according to the Wall Street Journal, “[d]rain clogged, full of shells,” “bugs everywhere,” “cooler floor was dirty, lots of trash,” and “the dry storage area had lots of trash, cartons on the floor everywhere.” These reports came from inspections that occurred from April 1 through August 17 of this year. But the DOA failed to tell the FDA, which is responsible for egg safety, about these problems. The salmonella outbreak occurred a few weeks later. Why didn’t the DOA say anything? “The conditions at the egg plant packing facility were routine.” In other words, the plant has always been a mess, so why speak up now?

Reprinted from The Washington Monthly by permission

FDA’s Peter Lurie on being out and being in

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…)

Charles Peters on FDA standards and why headlines matter

Charlie Peters has always said that to find the nugget of news inside the average news story, look to the last paragraph.  In this case, he recommends you at least make it to the fifth:

“Avandia Gets Equivocal Vote from FDA Panel. Fewer Than Half Want Diabetes Drug Pulled over Safety Concerns.” If this subhead from the Washington Post leads you to assume that more than half the panel approved of Avandia, it was significantly misleading. Here’s what you would have found if you had stuck it out through the story’s fifth paragraph: of the thirty-two members of the FDA panel who voted, only three favored allowing Avandia to continue its present sales practices unaltered. (more…)

Chemicals in our lives: Industry self-policing doesn’t work

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…)

FDA: fighting drugs in animals

Gardiner Harris reports in the New York Times that the Food and Drug Administration is pushing to limit the use of antibiotics in animal feeding “in hopes of slowing the growing scourge of killer bacteria.”  However, as Harris notes, “[i]n the battle between public health and agriculture, the guys with the cowboy hats generally win.” (more…)

True Fact: Government Agencies Cooperating

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…)