FDA
revere | December 9, 2008Old folks are dangerous enough. I should know. I am one. Bad enough you allow me to hurtle down the highway in semi-control of a couple of tons of steel while thinking about science (at least I'm not thinking about decking some young thing or even decking some young thing while hurtling down the highway in semi-control of a couple tons of steel). But put a weapon specially designed for my cold, arthritic hands? (OK, they're not arthritic, but they probably will be soon). This story (hat tip reader emc) is almost too bizarre:
A US company claims to have received federal approval to market a 9…
revere | December 5, 2008So what does heartburn have to do with diabetes? Funny you should ask. Big Pharma giant AstraZeneca is being sued by 15,000 people who claim that their atypical antipsychotic, Seroquel, causes diabetes. Seroquel is approved for bipolar disorder, but unless there are a lot more people with bipolar disorder than we know, it is clearly being use off label because it is AstraZeneca's second best selling drug. What's the best seller, at least for now? The heartburn/ulcer drug, Nexium:
Seroquel, used to treat bipolar disorder, brought in $4.03 billion last year, making it AstraZeneca's second-…
revere | November 18, 2008It's now two and half months since CDC and US FDA declared an end to the infamous tomatoes-no-it's-peppers salmonella outbreak of last summer. The outbreak itself was even longer: 3 months. There were some 1400 reported cases but probably many more that escaped detection. That's typical for foodborne disease outbreaks.
In case you've forgotten, here's a summary, courtesy Georgetown University's Produce Safety Project (PSP):
Although CDC and FDA initially pointed in early June to tomatoes as the cause of the outbreak based on epidemiological data, no contaminated tomato was ever found. In…
revere | November 17, 2008The team of investigative reporting team of Susanne Rust and Meg Kissinger at the Milwaukee Journal-Sentinel just keeps rolling along, this time with an amazing story about how microwave safe plastics are leaching bisphenol-A (BPA) at potentially unsafe levels. We are saying potentially unsafe because we really know little about the effects of hormone mimics like BPA except that at levels currently found in BPA containing plastics in contact with food and liquids produce biological effects in test systems and a recent analysis of a representative survey of US adults showed an association…
revere | November 7, 2008So we have more Salmonella contamination out and about. This one is in dry pet food. But it wasn't the pets that were getting the Salmonella:
Salmonella-contaminated dry pet food sickened at least 79 people, including many young children, and could still be dangerous, the U.S. Centers for Disease Control and Prevention reported on Thursday.
Even though the affected brands have been recalled and the factory in Pennsylvania closed, pet owners could still have the cat and dog kibble in their homes, the CDC said.
[snip]
"Dry pet food has a 1-year shelf life. Contaminated products identified in…
revere | November 4, 2008The tort system is the favorite whipping boy of the anti-regulation crowd. That's because once you remove regulation, something the Bush administration has championed and done effectively, the only recourse someone injured by the fraud or negligence of a product or drug manufacturer is through a lawsuit for damages. Since the anti-regulation crowd serves Big Pharma and their cronies, this is the perfect solution: no constraints. The propaganda machine, aided an abetter by a compliant congress and a business dominated media, has been extremely successful in promoting the idea that tort suits…
revere | November 1, 2008Blogging can vary in spontaneity. Some bloggers spend a lot of effort honing individual posts, while some do a lot of "one offs" in response to rapidly changing events. A limiting form of the latter is "live blogging," essentially reporting in real time during a meeting, demonstration or particular event. In this sense blogging isn't very different than print journalism. There are stories that are quickies, just reporting some facts or acting as a stenographer for the government, a political campaign or commercial press release. Then there are the more in-depth analytical and investigative…
revere | October 30, 2008We've been keeping an eye out for the FDA's expert task force review of their own draft report on bisphenol-A (BPA; for more posts see here, here, here, here, here for other BPA posts). We previously reported to you the concern that the (outside) chair of that expert panel had a risk assessment institute at the University of Michigan that was the recipient of a large gift from one of the most vociferous proponents of BPA's safety and an ardent anti-regulatory ideologue. Whether it was a result of "working the refs" or a straightforward judgment, the panel has returned its report, concurring…
revere | October 24, 2008Everyone knows newspapers are struggling, which means cutting back on everything, including investigative reporting. So it is nice to acknowledge that there is still some wonderful reporting going on. A particular standout has been Susanne Rust, Meg Kissinger and their colleagues at the Milwaukee Journal-Sentinel, whose investigation of FDA's handling of the bispheonal A (BPA) episode has been superlative. Yesterday they hit paydirt again. The FDA is currently considering an August draft report of a task force convened last April to re-examine the safety of BPA. The draft report says BPA is…
revere | October 14, 2008 I run a fairly large research program at my University. My NIH grant, which runs in the tens of millions, pays for a lot of things, including a portion of my salary. But as Director, my salary is (alas) only a tiny portion of this complex operation, which has many senior principal investigators and core facilities, labs, research groups, post docs, students, research staff, etc., etc. The whole operation has to fit together and work. We're big but not huge. So $5 million, while accounting noise in Wall Street bailout terms, is a pretty big deal and not because of the paltry half salary I…
revere | October 10, 2008The health concerns about bisphenol-A (BPA), a component of hard polycarbonate plastic, has been extended once again (see here, here, here for previous posts on BPA). BPA, a ubiquitous contaminant of human bodies, leaches from water and baby bottles, the lining of tin cans, dental sealants and many other sources. BPA also looks a lot like potent hormones, like estradiol and the synthetic estrogenic agent, diethylstilbesterol (DES), the cause of transplacental carcinogenesis in humans. So there have been plausible concerns that BPA might increase the risk of cancer in humans, especially in…
revere | September 27, 2008The Chinese food adulteration scandal is spreading. I'm calling it a food adulteration scandal because it's not just milk any more. Products with milk derived ingredients are also suspect:
Seven instant coffee and milk tea products made in China are being recalled in the U.S. because of possible contamination with melamine, as health fears increased worldwide over the safety of Chinese dairy exports.
The Mr. Brown brand mixes are being recalled by King Car Food Industrial Co., based in Taiwan, and were made by China's Shandong Duqing Inc., the U.S. Food and Drug Administration said today in a…
revere | September 17, 2008We've discussed the component of plastics bisphenol A (BPA) here before (here, here) but yesterday the Journal of the American Medical Association published a significant paper with an accompanying editorial that deserves mention. A panel of the FDA was scheduled to meet the same day to review FDA's draft assessment that BPA was not a safety problem in the US food supply and environment. As a result of the JAMA article, the ranking member of the Committee on Finance, Chuck Grassley (R-Iowa) has written to the Commissioner of the FDA asking for a clarification of the FDA's position on the…
revere | September 14, 2008Suppose you were a cattle dealer and the US Food and Drug Administration, one of the federal agencies tasked with keep the food supply safe issued you a court order, twice, prohibiting you from putting your product into the food supply until you complied with a legally required record keeping system. The agency had their eye on you because the meat you produced had been found repeatedly to have illegal levels of antibiotics making it unfit for human consumption. But you didn't care and you violated the court orders. So the FDA went after you and you were found in criminal and civil contempt…
revere | July 30, 2008The FDA is saying they still aren't sure how over 1200 Salmonella stpaul cases resulted from food chain contamination but they are saying its from jalapeno peppers grown in Mexico. This from a press release July 25:
The U.S. Food and Drug Administration is advising consumers that jalapeño and Serrano peppers grown in the United States are not connected with the current Salmonella Saintpaul outbreak.
However, the FDA continues to advise consumers to avoid raw jalapeño peppers--and the food that contains them--if they have been grown, harvested or packed in Mexico.
[snip]
The more narrow…
revere | July 26, 2008We've been saying this for a while. The produce industry has taken a big hit and their successful lobbying is one of the reasons. But it's not just their fault. It's also the fault of the Bush administration:
One of the worst outbreaks of foodborne illness in the U.S. is teaching the food industry the truth of the adage, "Be careful what you wish for because you might get it."
The industry pressured the Bush administration years ago to limit the paperwork companies would have to keep to help U.S. health investigators quickly trace produce that sickens consumers, according to interviews and…
revere | July 22, 2008The tomatoes-peppers-cilantro-? Salmonella story is starting to break, although which way is hard to say at this moment. Beginning about 3 pm yesterday afternoon newswire stories began to report that the FDA had found a single jalapeno pepper in a small distribution center in McAllen, Texas, contaminated with the same uncommon Salmonella serovar (S. stpaul) implicated in a large outbreak that has infected over 1200 people in 43 states. This is the first time any food item has turned up positive for this Salmonella strain in the 14 weeks federal and state authorities have been trying to nail…
revere | July 20, 2008The US FDA is lifting the warning on eating tomatoes it issued on June 7 because of the country's largest produce-associated foodborne Salmonella outbreak. The source of the Salmonella infections, all said to be "genetically identical" isolates of an uncommon serovar is still to be discovered, although epidemiological evidence associated it with salsa containing fresh tomatoes. Later the possibility that other salsa ingredients such as jalapeno peppers or cilantro might be the culprit has been raised. So far no one seems to know how that thousand plus cases became infected with the Salmonella…
revere | July 19, 2008About a year and half ago, in a post entitled "One donut, black", I noted the claim of a food company that it would soon be able to sell donuts spiked with caffeine. I wasn't sure I would ever see such a thing, but I was too skeptical. Not only is that company still on track with its product, but another company has now announced its intention to put caffeine into bakery goods. All for our benefit, of course:
After announcing the development of a proprietary way to encapsulate caffeine for foods using vegetable-derived lipids last year, the company has worked in collaboration with bakery…
revere | July 5, 2008Three food safety stories in the news this Fourth of July weekend. All three are worrisome but the third is the most worrisome of all. What are the first two?
You know them. The first is the largest produce associated multistate Salmonella outbreak on record (now over 900 cases in 40 states) rages on. Have they found the contaminated tomatoes? No. But now they think the tomatoes might be jalapeno peppers. Or maybe cilantro:
Investigators are seeing more signs that the salmonella outbreak blamed on tomatoes might have been caused by tainted jalapeno peppers and have begun collecting samples…