FDA

As the tomato Salmonella outbreak heads past the 800 case level, it's time to ask some questions about why we don't know the source of what is the largest produce associated disease outbreak on record. CDC has its own explanation, namely, that figuring out where tomatoes come from and where they go is much harder than they thought. Said another way, the experts in foodborne disease outbreaks at CDC and FDA didn't know much about the industry. Since tomatoes have been a frequent cause of Salmonella outbreaks, that seems odd, except that my experience with CDC in recent years is that it is full…
We've covered the FDA failure leading to their overlooking benzene in soda pretty often (at least if pretty often means here, here, here, here, here, here and here). It's like the guy who went to the doctor complaining of pain in his belly. "Ever have it before?" the doctor asked. "Yes, twice" the patient said. "Well, you have it again." In this installment we learn that the benzene, a known human carcinogen, doesn't really have to be there. Recall how it got there. Two preservatives commonly added to soft drinks, ascorbic acid (Vitamin C) and sodium benzoate, react to produce the benzene…
On a couple of occasions (here, here) we've taken note of the scientific controversy regarding the plasticizer, bisphenol-A (BPA). I shouldn't really put it this way, because as the leading BPA researcher, Fred vom Saal of the Univeristy of Missouri said in the Washington Post over the weekend, there is no meaningful controversy any longer. Now that NIH's National Toxicology Program has finally presented its draft report on BPA expressing concern over possible carcinogenic and developmental effects, vom Saal's statement seems pertinent: "The scientific community basically said, 'This argument…
Thanks to a local health officer in Colorado I get word that the US Food and Drug Administration (FDA) has begun an investigation of claims made by my favorite infomercial quacks, the Kinoki Foot Bad folks (see my howl of pain in the post The TV ad that DRIVES ME CRAZY). Here's some of the AP story: Late night television infomercials seem to have a cheap fix for anything: lose weight, banish cellulite or improve conditions like diabetes, arthritis and insomnia. Or, all of the above. Ads for Kinoki Foot Pads made exactly that bold claim, saying the pads use secrets of ancient Japanese medicine…
I haven't posted on the vaccine/autism question for several reasons. It is quite well covered by other science bloggers, it tends to generate more heat than light, and we didn't have anything new to say. I have on several occasions discussed it with two of the world's top experts on the health effects of mercury and one of the world's top autism experts. None of the three felt there was a vaccine-mercury connection to autism. But news that the US government was going to include vaccine critics in shaping national vaccine policy made me change my mind about posting. I won't be addressing the…
I'm away from home and I did something really, really bad to my back. I could hardly tie my boots this morning (boots needed; it is snowing like stink up here). One of my fellow scientists took one look at me and said, "I guess you need some Vioxx." Then he laughed. Since I hardly know this person I don't think he was trying to kill me -- he wouldn't have laughed, then, I'm guessing. But Vioxx has killed some other people before the FDA finally acknowledged it could do that. They were soundly (and appropriately) criticized for keeping too quiet. Now, it seems, some are complaining because…
The US Food and Drug Administration (FDA) doesn't want Americans to buy legal pharmaceutical products from Canada where the identical drug is considerably cheaper because the imported drug might not be safe. Those unreliable Canadians. Better to pay top dollar for heparin from the American subsidiary of a Big Pharma multinational, Baxter Healthcare. Except that the active ingredient in Baxter's intravenous heparin came from China. From an uninspected plant. And there was indeed a safety problem: More than 350 adverse reactions to the drug have been reported to the FDA since the end of 2007,…
I'm glad the FDA has gotten serious about people knowingly importing and selling tainted food from China. They have indicted two Chinese nationals living in the US and an executive of an American company. It would be nice if they did this for foods that threaten human beings, but for the next 347 days I guess I'll have to settle for crimes against pets. Several companies are involved, including Suzhou Textiles, Silk, Light Industrial Products, Arts and Crafts I/E Co. LTD. (SSC), a Chinese export broker that exports products from China to the United States; and ChemNutra, Inc., a Las Vegas,…
After our recent rant on the necessity of supporting the public health and social services infrastructure instead of cutting taxes, President Bush has replied. He is cutting the infrastructure: President Bush's $3 trillion budget for next year slashes mental health funding and rural health care and freezes spending on medical research, among the cuts outlined in budget documents obtained by The Associated Press. The budget for the Department of Health and Human Services would be reduced by almost 3 percent under the Bush budget plan to be released Monday. The $2 billion in HHS cuts are about…
Every year "flu season" comes during which there is a marked uptick in influenza-like illnesses (ILIs) in the community. An ILI is defined to be cough or sore throat together with a fever of over 100 degrees F. (37.8 degrees C.) or self-reported fever and chills as well as no other obvious cause (e.g., strep throat). But are all ILIs influenza? No. They are ILIs. In the absence of lab work (and since most are thought to be of viral origin, only non-specific symptomatic and supportive therapy is recommended and no diagnostic lab work is usually done), an ILI could be from influenza virus or…
There's a lot of stuff about tainted food in the news, whether it is toxins in imports or questionable additives in US products (e.g., bisphenol A in hard plastics). This stuff is not on any food label, of course, but there is a lot of detailed stuff that is on labels and increased concern about food seems to have made label reading more common. I've always wondered if the detail was encouraging or discouraging people from reading labels. How many people read labels really? Quite a few, it turns out, at least if you believe a new report, Label Reading from a Consumer Perspective, by the…
A couple of weeks ago, as I'm sure you heard, the FDA held an advisory committee meeting that concluded that there should be no use of cough/cold products for children under 6. There is a good amount of evidence that the drugs (including antitussive, expectorant, nasal decongestant, antihistamine and combination products) were not effective and are harmful in some cases. Now what happens? A couple of signs: Most manufacturers took all under 2 cough/cold medicines off the shelf. Many, like Wyeth who makes Dimetapp and Robitussin have recalled Children's Dimetapp and some Robitussin to replace…
Puffer fish are notorious. Considerable delicacy in Japan (a taste adopted by some non-Japanese Foodies), they come with a side of risk: some puffer fish have the potent lethal toxins tetrodotoxin and/or saxitoxin, neurotoxins more than 1000 times the lethal potency of cyanide: Symptoms start within 20 minutes to 2 hours after eating the toxic fish. Initial symptoms include tingling of the lips and mouth, followed by dizziness, tingling in the extremities, problems with speaking, balance, muscle weakness and paralysis, vomiting, and diarrhea. In severe intoxications, death can result from…
tags: researchblogging.org, treatment-emergent suicidal ideation, suicide, citalopram, celexa, SSRI, black box warning Despite what the news might have you believe, it is quite rare for a depressed person to exhibit increased suicidal thinking after they have begun treatment with an SSRI, such as citalopram (celexa). According to the statistics, so-called "treatment-emergent suicidal ideation" occurs only in approximately 4% of all people taking citalopram, whereas this same phenomenon also occurs in 2% of all placebo-treated cases. However, in those unusual cases where suicidal ideation does…
That's the hed for the Washington Post story on the study that found that doctors ignored or dismissed patients concerns about side effects and didn't report them to MedWatch (the FDA system for collecting side effects). The Post goes through some reasons for this but I think the end conclusion is that this is a very bad way of going about post-market safety. The data is extremely nosy, mainly due to the fact that not a lot of doctors use it (time, lazyness, or complexity of the forms?). Whatever the reason, events are under reported but I don't think it's the doctors' fault; and while punchy…
Dangerous drugs that got approved and are widely and intensively marketed; dangerous imports from China and elsewhere that are never examined; conflict of interest allegations; contaminated consume products from toothpaste to lens solutions; vaccine supplies that go from shortage to glut. Just business as usual at the broken US Food and Drug Administration (FDA). So it's an important problem and fixing it is a priority. It's always a dilemma when a really excellent piece appears and you just want your readers to go read it instead of what we are writing about it. That's the case with an Op Ed…