Neglected Tropical Diseases and “The Other America”

The other day, I ran across this analysis of income distribution (posted here and here), which quantifies the class war that has been declared on most Americans. It shows 80 percent of Americans have been steadily losing ground financially over the past 25 years, with the people at the top 1% of the income distribution making out like bandits.

It’s interesting to lay that observation alongside a recent editorial in the Public Library of Science (PLOS) journal, Neglected Tropical Diseases, which suggests that large numbers of the poorest Americans suffer from the same diseases as low-income peoples in Africa, Asia and Central America.

The popular conception of parasitic tropical diseases consisted of hookworm infestations, which combined with pellagra and malaria, sapped the intellect and vitality of poor rural Southerners for generations until the New Deal “transformed the region from an economy based on subsistence agriculture into an urbanized one with higher wage earning and improved quality dwellings”. Hookworm is no longer considered endemic in the U.S., though this hasn’t been studied recently. Other parasitic diseases that have been recently studied include toxocariasis, which might be linked to the prevalence of asthma in poor black and Hispanic children, cysticercosis, which is emerging as the leading cause of epilepsy among Hispanics in Los Angeles County and toxoplasmosis, which poses risks of mental retardation, and hearing and vision losses to newborns of black and Hispanic mothers.

The closing sentence in the NTD editorial says it best, “There are no excuses for allowing such glaring health disparities to persist in one of the world's wealthiest countries.”

Environmental Health Tools – e.hormone

Wading through the bisphenol-a morass in an effort to tell a coherent story about this substance has taken me into endocrine hormone territory. Hormones are a fascinating but high complex topic, but in the course of my journey, I’ve rediscovered the e.hormone site hosted by the Center for Bioenvironmental Research at Tulane/Xavier Universities. The CBR conducts research on environmental signaling. On the “about” page, they say this about environmental signaling:

Environmental signaling encompasses the many ways plants and animals use chemical signals to communicate life-driving information, to respond to physical or biological stimuli, and to talk to each other. The internal and external signals police interactions within and between cells and organs as well as among individuals and species. Sometimes, certain natural compounds and synthetic chemicals incorrectly trigger signaling mechanisms – turning them on and off at the wrong times or changing signal intensity that may affect reproduction and health.

Endocrine disruption is one of the most studied areas of inadvertent environmental signaling. Endocrine disrupting chemicals (EDCs) – the pesticides, plasticizers, pharmaceuticals, and other pollutants that interfere with estrogen and other hormone system signals – can affect cells to ecosystems and invertebrates to vertebrates. Humans and animals are exposed to EDCs through food, water, and air and can experience health effects ranging from subtle changes in blood hormone levels to overt reproductive abnormalities, infertility, and cancer. Facing the most risk are women of childbearing age, due to increased exposure through lifestyle choices, and infants and children, due to their small size, higher exposure, and fast growth.

EDCs are something that we’re probably going to have to learn to live with, since I don’t see us moving very quickly with reducing exposure to the pesticides, plasticizers, and pharmaceuticals which might be responsible for inadvertent cell signaling. e.hormone (which is also on the blogroll now) is going to be a handy resource for me, and I hope for you too.

Quick Notes on Antibacterial Soaps

Antibacterial soaps with triclosan are coming under fire for being no more effective than plain soap as disinfectants, while at the same time promoting antibiotic resistance in bacteria. Now, recent findings from studies in laboratory animals suggest that triclosan is an endocrine disruptor.

This topic deserves a more detailed discussion, but since I’m getting on a plane this morning, that will have to wait for a later time.

Perhaps triclosan in soaps won’t turn out like bisphenol-a, TCE, perchlorate or dioxins, where we spend the better part of a generation wringing our hands about managing the human health risks.

Perhaps.

The Tangled Story of Bisphenol-a – The NTP’s Expert Report is Out

The Center for Evaluation of Risks to Human Reproduction (CERHR) has finalized its Expert Panel report assessing the reproductive and developmental toxicity of bisphenol-a (BPA). CERHR will be accepting public comments on the report through the end of January 2008. Once comments have been received, the NTP will prepare a NTP-CERHR Monograph for BPA. The Monograph contains the NTP Brief, the Expert Panel Report and the public comments on the Expert Panel Report. The NTP Brief is a summary for decision makers and presumably will represent a milestone in determining what steps are needed (if any) to reduce exposures to BPA.

What will happen after that is anyone’s guess. The NTP does not regulate chemicals – the EPA and FDA do that. It can be anticipated that the NTP’s report will churn slowly through the processes those agencies have for assessing health risks from chemicals; if the weight of evidence persuades regulators that BPA poses a significant human health risk, there will be rulemaking and negotiation with manufacturers. If you’re expecting regulations to be enacted banning BPA, be prepared to wait several years for them. Under that scenario, you can also anticipate manufacturers being given a few years after that to get BPA out of the production stream. Then, there will still be tens of millions of sports bottles and sippy cups in use for years to come after that.

Hopefully, there isn’t anything terribly bad associated with BPA exposure, because we’re all exposed to low levels of it, and probably will be for the better part of a generation.

The first draft of the Expert Panel report was prepared by an NTP contractor, Sciences International (SI). In March 2007, the Environmental Working Group reported that SI had working relationships with companies manufacturing chemicals being assessed by CERHR. CERHR apparently required contractors to make conflict of interest disclosures but didn't place any further restrictions on them. Officials at the National Toxicology Program terminated SI's contract with CERHR on April 13, 2007, but stood by the quality of the previous assessments conducted by the contractor. Representative Henry Waxman's Governmental Oversight Committee has looked further into the conflict of interest matter, but does not appear to have started an investigation as yet.

In March 2007, the National Institutes of Environmental Health Sciences (NIEHS) conducted an audit of two key activities carried out by SI as part of the bisphenol-a (BPA) review: (1) selection of literature relevant for review by the expert panel on bisphenol A (BPA) and (2) incorporation of input from expert panel members into draft reports. The NIEHS audit concluded that the draft BPA expert panel reports "include consideration of all relevant references and reliably include changes requested by the expert panel members. NTP concludes that the draft expert panel reports are useful for the CERHR evaluation of BPA". (Note: the expert panel members are selected by a CERHR Core Committee consisting of scientists in government service.) What this appears to mean that NIEHS was satisfied that the comments from the CERHR's expert panel, which issues the authoritative decision-makers' summary on a chemical, were incorporated into the report. Some of the public comments on the BPA report, for example from Fredrick Vom Saal, give a different perspective about how well the available scientific literature has been incorporated into the BPA review (particularly how his papers were incorporated into the review). The Pump Handle provides a summary by NRDC of the overall criticisms related to the BPA review process.

The NTP also convened a working group of the Board of Scientific Counselers to assess its contracts for conflicts of interest (COI). The methods and results as described in their report were described as follows:

In conducting their review, the WG analyzed each NTP contract and Statement of Work (SOW) as well as the extent of government oversight to determine the degree of risk for potential conflicts and/or impaired objectivity. Questions were sent to a crosssection of NTP contractors in an effort to assess the compliance of their COI policies with law and regulation, and to determine the existence of any COI. The WG relied on the contractor’s self-certifications regarding conflicts with current clients as the HHS Office of the General Counsel (OGC) has indicated that this is normal, reasonable business practice in the absence of specific factual allegations of impropriety. To gain a better understanding of the contracts and how they operate and interrelate, the WG also held discussions with NTP project officers responsible for various contracts including the NTP contract for pathology support. Based on the data provided, the WG did not find any evidence of actual or apparent COI in any of the cross-section of contracts reviewed.

The WG identified a number of best practices and specific areas where improvements could be made by NTP/NIEHS, as well as by the entire NIH, that could result in identifying COI as early in the acquisition process as possible in order to avoid, neutralize or mitigate those COI.

Representative Waxman's committee criticized those methods, stating that the contractors's processes for identifying and disclosing COIs were not adequate.

The working group's reliance on contractor reports is a questionable way to assess conflicts of interest. Most of the contractors do not appear to have adequate systems for tracking such conflicts. According to the report, although "most" of the ten contractors that completed questionnaires had a designated official to solicit and review financial dislosure statements from their investigators, "[f]ewer" contractors collected disclosure statements listing significant financial interests from their investigators. "Even fewer" contractors updated these disclosure statements during the life of their NTP contracts. And "very few" conractors kept the disclosure statements for the mandatory three-year period following the completion of their NTP contracts. In other words, many of the contractors that provided self-certifications to the working group did not collect or retain the information necessary to determine whether individual conflicts of interest existed under their NTP contracts.

I'm immune to the censorious tone of the NRDC and Representative Waxman ("I'm shocked, shocked to find that gambling is going on in here!"). It's hard to find a party, institution or organization that is free of conflict of interest (didja hear that, Congress?). For myself, there seem to be sufficient checks and balances with the BSC review alerting us that the BPA assessment might contain uncertainties that understate the developmental toxicity risk, the public comments from academic scientists which critically review the CERHR's scientific report, and supplemental reviews such as the Chapel Hill Consensus. Perhaps out of this event will come better contracting procedures and business practices for disclosing and managing conflicts of interest. In the long run, consulting firms who wish to keep their client lists confidential might have to forgo the pleasures of performing work for government agencies. In the meantime, there are enough points of view available that the BPA story needs to be brought up to date. For the moment, what's been done is to point out that some care may need to be taken in using the information developed from the government's review process.

And, if you're not willing to wait for a definitive, authoritative statement about BPA risks to emerge (not like that's going to happen anyway), you can start doing the precautionary thing now.

Explain to Me Again Why Ethanol from Corn for Driving Cars Makes Sense

Perhaps it’s time to start paying attention when the AEI-Brookings Joint Institute, that bastion of conventional Beltway thinking, starts bad-mouthing producing ethanol from corn as a replacement for gasoline. However, as I got further into this, I found that AEI/Brookings is still very much part of the problem. Hat tip to Environmental Valuation and Cost Benefit News for the link.

The results from a study just released by the Joint Institute (link not up yet) “strongly suggests that the case for ethanol is lacking”. Their analysis is based on data from “a recent Environmental Protection Agency report on the economics of mandating the production of alternative fuels”. The AEI-Brookings press release doesn’t say which EPA report they are talking about, but I suspect it’s this one. Under the Energy Policy Act of 2005, the EPA is responsible for developing regulations to ensure that gasoline sold in the United States contains a minimum volume of renewable fuel. The Renewable Fuel Standard program will increase the volume of renewable fuel required to be blended into gasoline to 7.5 billion gallons by 2012. The Renewable Fuel Standards program was developed in collaboration with refiners, renewable fuel producers, and many other stakeholders (with the refiners and renewable fuel producers around, one wonders how prominent the “other stakeholders” were in the rulemaking).

The AEI/Brookings report cites the statistic that using all of the corn grown in the U.S. for distilling ethanol would offset about 12% of the gasoline demand, based on the 2005 demand level. That statistic comes from a life cycle analysis of biofuel production from corn and soybeans, published last year by researchers at the University of Minnesota. In addition, while there may be modest reductions in greenhouse gas emissions from biofuels production (soybean biodiesel is the better alternative than corn-produced ethanol in this regard), any biofuel production has other impacts, including degradation of soil quality, ecological impacts from fertilizer and pesticide runoff, and depletion of nonrenewable water resources. The UMN study identified many of these impacts, but did not appear to incorporate them quantitatively into the life cycle analysis – a difficulty with LCA is aggregating dissimilar impacts into an overall metric. The other issue arising is the rise in food prices, both from converting corn production to ethanol and from the overall rise in energy prices.

The AEI/Brookings press release offers some helpful suggestions, such as discontinuing the tax credit for domestically-produced ethanol and removing the tariff on imported ethanol (if fermenting ethanol from corn is such a great idea, the market will validate it, right?). It suggests putting research emphasis into other endeavors to increase energy security and influence climate change. The examples for these other endeavors that it offers are a bit weak – geoengineering the atmosphere and biomass for electrical generation. What about upgrading urban mass transit? Read down a ways to Charles Pierce’s item about an intercity rail concept which makes entirely too much sense.

But the following statement by AEI/Brookings was just too much for me:

Congress might never have bet so much of the taxpayers' money on corn-based ethanol if an unbiased accounting of the consequences had been available early on.

. . . [momentary pause in blogging]. . .

. . . sorry about that, I’m back now. I was laughing so hard that I think I pulled a muscle. It goes beyond sheer naïveté to suggest that facts would get in the way of a splendid way of making money, with today’s Congress.

And, as for the AEI/Brookings closing recommendation. . .

We could use a separate agency, shielded in part from political considerations, whose sole mission would be to analyze the costs and benefits of regulations and government programs. Without such an agency, interest-group logrolling will continue to trump science and economics in major policy choices.

. . . words fail me. It sounds like something a policy wonk would say after a couple of bong hits. There’s no recognition in such a statement that the “political considerations” are a major part of the “ethanol problem”, and that campaign finance and lobbying reforms, along with a rejuvenated mainstream media that gave a shit about journalism, might also be helpful here. I think we're doomed.

If I had to speculate as to what the game here really is, the AEI/Brookings Joint Institute is attempting to establish its bi-partisan cred, by wagging its finger at Congress, the big growers and the renewable fuels industry, while at the same time offering up a completely toothless solution. As I said earlier, part of the problem.