Sunlight Foundation

Similac recall: new FDA data on beetle-infested formula, other recalls too

A few days ago I received a plain white envelope in the mail from Abbott, the infant formula manufacturer. Inside was a form letter, telling me that the company was voluntarily recalling some of its cans of Similac powdered formula because they may contain beetle parts. The news was jarring; while I had just started my six-month-old son on solids, I wasn’t planning on including beetle bits on the menu.

The letter was dated September 27, five days after the company had announced the recall; while there were earlier news reports, somehow I’d missed them.

Coincidentally, I’d also just seen that that U.S. Food and Drug Administration (FDA), had launched a new data set on recalls, which we had called for earlier this year and which the agency later confirmed plans to do.  Sure enough, this new data set, which is available in programmer-friendly XML format, contains information about the Similac recall.

I also found the April report when McNeil Consumer Healthcare voluntarily recalled some batches of infant Tylenol and children’s Benadryl, among other drugs, which at the time  set me on a medicine cabinet emptying frenzy to find all the half empty bottles we used with my three kids.

The FDA’s release of these data in this format ultimately should be a boon to parents who would like to get this information in real time, once some enterprising programmers (hello Sunlight Labs!) start mashing it into some useful interfaces that makes it easier to search. It should also help public health, consumer advocates, journalists and others more easily analyze recall data to find out if there are patterns with particular companies or outbreaks. This can only help in a time that has seen recent massive recalls because of salmonella infestation in peanut butter and eggs.

But the FDA is the first to admit that the data are still lacking. The agency does not have the power to require companies doing recalls of drugs, medical devices, or food to provide a standard list of specific information. This includes such basics as an estimate of how many items are affected, the reason for the recall, and the geographic distribution of the product. (While some companies provide this information voluntarily, they’re not required to do so.) So last May, the agency issued a draft proposal--one of 21 transparency enhancing changes suggested by the agency--that it should seek such authority. Getting standardized information from companies would enhance the usefulness of this tool tremendously.

Last week the FDA also released another new data set, this one a database where the public can explore medical device inspections.However, the data only include 25 percent of inspections, and leaves out clinical trial inspections “because information about new medical device development is confidential.”

The trade journal Medical Device Daily (subscription required) calls the data “all bones and no meat,” because a user would still need to file a Freedom of Information Act (FOIA) request to get copies of actual inspection forms that give more detail.

For example, a search of St. Jude Medical, the company that we investigated in our award-winning “Heart of the Matter,” shows a list of five records; clicking on a record, however, shows us that the company was asked to take voluntary action to fix something, without saying why or what. These are data most useful to experts or investigative reporters with plenty of time and resources to dig in, not for ordinary consumers.

Incidentally, the new FDA recall databases appear to be available at Data.gov, the government’s data clearing house, but the medical device inspection data are not. All are now listed on the Sunlight Foundation’s National Data Catalog, here and here.

Next time there’s a recall of food or drugs affecting my kids I don’t want to wait to get an envelope in the mail. I want to get the scoop as soon as the government has it, with all the relevant details. I can’t act on what I don’t know.

The Feds Embrace Social Media

Last week Doug Belzer at Federal Computer Week has an encouraging article about how Twitter, blogs and other Web 2.0 tools are revolutionizing government business. Belzer writes how government managers and elected officials are using social media to network and collaborate online, quickly connecting with audiences like never before.

“If they’re looking for information about an obscure contract vehicle, they can post a message on a messaging service such as Twitter and see if someone can help them learn about it,” he writes. “Or if they run across a particularly useful piece of information on a community-created Web page, they can give it a high rating so others can find it easily in the future.”

Belzer gives five examples of how bureaucrats have used social media “to take care of business,” contrasting this new and effective strategy with how they would have approached the project or problem before Web 2.0 tools were available and in use, with less impressive results.

One of Belzer’s examples, as a un-recovered peanut butter fan, is near and dear to my heart. When salmonella-tainted peanut butter was found in a number of food products, it was the responsibility of the Centers for Disease Control and the Food and Drug Administration to get the word out about the recalls. In the past, the agencies would attempt to raise the alarm by employing press releases, posts on Web sites, toll-free telephone lines, but the agencies never knew how effective these efforts were at alerting the public. But with this emergency the agencies are using Web 2.0 tools, such as a widgets, blogs, Twitter feeds and other social networks, as well as other social media outreach efforts. The CDC first offered their peanut-butter widget in early February. And since then, Belzer reports, about 16,000 sites, including newspapers, health agencies and personal Web sites, posted the widget, resulting in more than 6.8 million views. “That viral effect is really pretty amazing,” he quotes a CDC information officer as saying. “The reach of the widget grows exponentially.”

The promise of Government 2.0 is just beginning to dawn.

Lobbying Blowback

The food industry's heavy lobbying over the past few years to reduce regulation and paperwork has turned into a "monkey's paw" of sorts. As the AP says, "Be careful what you wish for; lest it may happen," is certainly the lesson to be gleaned from the stupifying, and expected, blowback the food industry is receiving right now from their long lobbying effort. Here's the run-down:

The food industry pressured the Bush administration to reduce paperwork that would have aided health investigators "quickly trace produce that sickens consumers." The Bush administration also killed a plan to require electronic filing that would enable regulators and investigators to more rapidly search for the source of a food contamination outbreak in the case of an outbreak. The food industry spent millions on lobbying to stop these regulations, as evidenced in this chart from OpenSecrets.org:

The food companies worried about the costliness of these proposals and labeled them "burdensome," saying that they could disrupt the availability of consumers' favorite foods."

Now, according to the AP, during the current salmonella outbreak the food industry has lost $250 million, food supplies have been disrupted, and 1,300 people have gotten sick in 43 states and the District of Columbia. So, even without the regulations the food industry got their food disruption, consumers can't eat tomatoes or jalapenos (which are chief ingredients in salsa), and a lot of people got to get sick.

The AP calls these "unintended consequences." I'd say they are totally predictable and the public should take their scorn out on the food industry and their lobbyists for engaging in activities that have made eating more dangerous.

This whole episode reminds me of this scene from Kentucky Fried Movie, where a satirical science film posits a world without zinc oxide: