Regulations
revere | April 26, 2008We frequently observe here that almost everything in public health, from the societal level to the molecular level, is a balancing act. With most benefits comes a risk and with many risks a benefit. Of course there is a problem when the benefits and risks accrue to different parties as when the public runs the risks and the corporation gets the benefits. So that's one problem in making the trade-offs. Another is when the risks and benefits are completely different, essentially non-comparable. We often try to solve this by measuring them on a common scale like total number of lives saved or…
angrytoxicologist | April 24, 2008In today's New England Journal of Medicine there are two articles worth reading, especially for us critics of the FDA. Playing 'Kick the FDA' -- Risk Free to Players but Hazardous to Public Health is a good reminder of where the blame needs to go (See also Trying Times at the FDA -- The Challenge of Ensuring the Safety of Imported Pharmaceuticals) . My take on these is that while articles are correct about a lot of the blame going to Congress (and the Administration), the FDA needs to be more forthright about the problems they have. When you continue to say: "fine, fine, everything's" while…
angrytoxicologist | April 18, 2008I'm waiting around for a meeting (about animal testing!) and thought I'd share a few things that I've been thinking about.
1) While we're not going to stop using animals for testing in a long time it is a good idea to reduce them where we can and where industry and the public (at-large; I know industry is the public, too) can agree one should strike when the iron is hot - even when the reasons are really different.
2) Will the use of this alternative method increase the number of animals later? If refined models don't provide adequate information or aren't accurate enough, you'll end up…
revere | April 6, 2008About a month ago (March 1, 2008) we brought you the story of how a highly reputable and knowledgeable scientist, Dr. Deborah Rice of the Maine Department of Maine Department of Health and Human Services, was bonced off of an EPA scientific advisory committee because the chemical industry trade group, the American Chemistry Council (ACC), objected that she had a bias. How did they know? Dr. Rice, as part of her duties as toxicologist for the State of Maine, testified before its legislature that on the basis of a review of the scientific evidence she believed the deca congener of the…
revere | February 27, 2008I'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…
revere | February 22, 2008Recently we posted on the insanity of requiring informed consent for posting a hygiene checklist in the ICU. This week the New England Journal of Medicine weighed in.
Here's some background from the NEJM Commentary:
About 80,000 catheter-related bloodstream infections occur in U.S. intensive care units (ICUs) each year, causing as many as 28,000 deaths and costing the health care system as much as $2.3 billion. If there were procedures that could prevent these infections, wouldn't we encourage hospitals to introduce them? And wouldn't we encourage the development, testing, and dissemination…
revere | February 19, 2008Even in the world of giant beef recalls in the US this one stands out: 143 million pounds. This dwarfs (by a factor of four) the previous recall record of 35 million pounds, and as the AP report observes, amounts to two hamburgers for every man, woman and child in the United States. This one has an added twist: not just safety but animal cruelty:
The federal agency said the recall will affect beef products dating to February 1, 2006, that came from Chino [California]-based Westland/Hallmark Meat Co., which supplies meat to the federal school lunch program and to some major fast-food chains.…
angrytoxicologist | February 1, 2008There's something rotten in BethesdaPublic Citizen released, and the WaPo reported on, findings that the CPSC manytimes takes six months or more to alert the public of dangerous products. Never fear, says the National Association of Manufacturers, the CPSC only looked at the cases that were in the public record. Oh, well, okay then; I'm sure your secret files make you look great.
The CPSC itself says that 90% of recalls are done within 20 days. First, if something is truely harmful, why does it take 20 days? There doesn't seem to be a good reason for that (I can see a week so the company and…
revere | January 23, 2008This week sees the tenth anniversary of an important event in the American environmental movement, although few people know it (even some who were there had forgotten the date). In late January, 1998, a group of 32 environmental scientists, activists and scholars sat down together at the Wingspread Conference Center in Racine, Wisconsin to hash out a consensus statement on The Precautionary Principle. After a grueling three days, the statement was put into final form on January 25 (just in time to see my beloved Green Bay Packers lose the Superbowl. Is history repeating itself? Aargh!).
In…
revere | January 22, 2008Recently we posted on the EPA highly unusual (as in unprecedented) decision to reject Californian's new greenhouse gas regulations. Why did they do it? Good question and one the California Congressional delegation wanted an answer to. To whom did EPA talk about the regulations? Who advised them to reject it? Sorry. Mum's the word. Actually its words. Executive privilege:
Invoking executive privilege, the Environmental Protection Agency on Friday refused to provide lawmakers with a full explanation of why it rejected California's greenhouse gas regulations.
The EPA informed Sen. Barbara Boxer…
angrytoxicologist | January 16, 2008So the FDA says that cloned meat is safe and this is making big news. Well, this isn't much of a surprise, it's unlikely that a clone would be unsafe (it's a clone of a naturally healthy animal!). What sucks is the media's take on this (and the government's complicity in them getting it wrong). Almost all the outlets take the line: Gov't says no problems with cloned beef. What they actually said was cloned meat isn't any different from a safety and nutrition perspective. There's a big gap there.
For one, this is a long term mistake for the ag community. The already small gene pool for cattle…
revere | January 11, 2008The Consumer Product Safety Commission is supposed to make sure toys and other consumer products are safe. They recalled 472 products last year. That's a pretty good record for a Lilliputian agency that has a staff of only 400. This is George Bush's dream -- shrinking the size of the government. CPSC started out life with 800 staff. If Bush's budget recommendations had been adopted by Congress it would have had to cut another 19 positions -- 5%. For once Congress didn't go along. They increased CPSC budget from $63 million to $80 million. The agency's head, former industry lawyer Nancy Nord,…
revere | December 11, 2007One of the most effective environmental regulations that wasn't a command and control item was something called the Toxic Release Inventory (TRI) Program. Here's EPA's description:
The Toxics Release Inventory (TRI) is a publicly available EPA database that contains information on toxic chemical releases and other waste management activities reported annually by certain covered industry groups as well as federal facilities. This inventory was established under the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA) and expanded by the Pollution Prevention Act of 1990.
That…
revere | December 4, 2007
If you need the antibiotic ciprofloxacin ("cipro") (famous for its use as prophylactic agent for those potentially exposed to weaponized anthrax in 2001), I know where you can find a lot of it. In Patancheru, India, near Hyderabad, one of the world's centers for production of generic drugs. Most of the cipro made there is shipped out, but it turns out a lot of cipro stays behind, in the sewage of Patancheru. A paper by Larsson et al. (Journal of Hazardous Materials 148 (2007) 751-755; hat tip SusieF) found the highest levels in sewage effluent of pharmaceuticals of any yet reported. The…
revere | November 3, 2007I've been to plenty of scientific meetings sponsored by federal agencies in the last several years where we have either had to do weird back door stuff just to have coffee breaks as part of the program or if we are sponsoring it and inviting federal scientists and staff they have to go off and have lunch on their own nickel so they won't run afoul of conflict of interest regs. They would be taking a "gift" from us if they ate food we paid for. OK. I get the principle. Some of it is bureaucratic and dumb but where do you draw the line? Now I find out where the big guys draw the line:
The chief…
revere | October 15, 2007[Today is Blog Action Day, where bloggers of all political stripes and subject interest are encouraged to put up a post on an environmental topic. Here is the first of two.]
Maryland and its Chesapeake Bay have a water pollution problem. The size of the problem is not chickenshit, either. Or rather, it is chickenshit. 1 billion pounds of it. A billion. That's not chickenshit. Or rather, it is chickenshit. There's really a lot of chickenshit around in Maryland. Maryland regulators have been too chickenshit to regulate the source: the poultry business. Why? Guess:
Maryland requires [waste…
angrytoxicologist | September 28, 2007The NYTimes reports today on an upcoming HHS OIG (Health and Human Services Office of the Inspector General) report among other things audited less than 1% of clinical trial testing sites. When they did show up it was usually after the trial was finished. The worst part of it is, when the inspectors did find problems, they rarely followed up to make sure that the sites had complied with the information.
This reminds me of the inspectors on the food side. You may remember the story about them going to the peanut butter plant and asking for documents and when the company (ConAngra, I believe)…
angrytoxicologist | September 21, 2007I've been AWOL this week on SB; life, apparently, is not concerned with what is convienent for you. Anywho...
The House on thursday passed the FDA reform bill (H.R. 3580) by a huge margin (405-7) and the Senate passed it last night by a voice vote. As an aside, Sen Burr (R-NC) placed a hold on it but obiviously that didn't end up stopping the passage. Pres. Bush will probably sign it today. And it's a good thing, too. The FDA said it would have to send permanent layoff notices to about 20% of it's workforce if the legislation didn't pass by today.
So, you might ask, what does any of this mean…
revere | September 15, 2007I spend some of my time working with citizen groups from contaminated communities. There are a frightful number of them in the United States, as there are everywhere. The stories are frequently heartbreaking and the polluters heartless. So it's good to remind myself that things could be worse. A lot worse. In fact the US is much better off than most other countries in the world, including European countries when it comes to a polluted environment. The main reason government environmental protection regulations. I'm not saying they have done the job they need to do, and under the Bush…
angrytoxicologist | July 17, 2007Over at the Pump Handle, David Michaels has a post on how ineffectual the CPSC is. He makes the point that the CPSC is "toothless", wimpy and uses a NYTimes article that talks about the Magnetix case as an example of how the CPSC can't get the job done. Although David does acknowledge how much of the problem comes from the current administration (the last guy they tried to get to run it was the VP of a manufacturing lobbing group - the nomination was since withdrawn).
I generally agree with the post but I don't think that the CPSC is toothless. While they need much stronger regulatory tools…