September 2009 Archives

• 2nd Hand Smoke Bans Reduce Heart Attacks: According to two analyses of combined study data on second hand cigarette smoke, town or community enforced smoking bans reduce heart attacks by 17% after one year, and after three years the number of heart attacks decreases by at least 26%. The Journal of the American College of Cardiology published one analysis. UCSF researchers analyzed the same data and also found a 17% decrease after on year, which after three years became a 36% decrease in heart attacks. The journal Circulation published the UCSF results.

  While states and communities have increasingly enacted smoking bans, the tobacco industry generally rejects regulation. As John Singleton, spokesman for Reynolds American told the Wall Street Journal: "Our current position is to let the market take care of the issue". (09/21/09 "The Case for Bans on Smoking") On this argument however, the tobacco industry's reasoning might be losing sway. Smoking bans are catching on the world over, even in hard to imagine places like the country of Turkey's bars and restaurants.

• AIDS Trial: New Results, No Answers

  Scientists stopped the last clinical trial of an AIDS vaccine in 2007 when results showed the vaccine increased the HIV infection. They vowed to reconsider their strategy toward AIDS, especially with regards to clinical trials. Scientists postulated that the flush funding environment and political pressures pushed trials forward too quickly. Now the sometimes exasperating path of scientific research has taken a new turn in AIDS research and scientists have a new quandary.

  A recent HIV clinical trial in Thailand testing a combination of two drugs that had previously failed in clinical trials showed tenuously positive results. The US Army, National Institutes of Health, Thai Health Ministry, and Sanofi Aventis collaborated on the trial, giving vaccines to 16,400 volunteers who were not considered high risk. The new project combined AidsVax, an HIV derived protein, with Alvac HIV, a genetically engineered canarypox virus that contains HIV genes. 51 of the vaccinated individuals contracted HIV and 74 of the unvaccinated individuals became HIV positive, which translated to about a 30% prevention efficacy rate. Though this vaccine is a long way from being considered successful, scientists are buoyed by any news that's positive. The trial suggests that this vaccine could be effective if it were improved.

  The quandaries: First, scientists don't understand how two failed drugs add up to something that looks better or vaguely successful. Second, how and why does the combination vaccine prevent the symptoms of AIDS, if it does, without lowering the viral load -- the amount of HIV measured in the bloodstream of infected individuals? Perplexing. More research needed.

  Treatment is expanding but without prevention of HIV transmission, AIDS will remain a losing battle. So for now, "ABC", abstinence, "be faithful" (limit numbers of partners), and condoms, remain the best HIV infection prevention techniques. The good news for researchers maybe is that perhaps AIDS vaccine research has been kept alive.

  Acronym Required wrote previously about AIDS in Preventing HIV/AIDS: Back to the 1980's, New Directions for AIDS Research Funding", Mbeki's AIDS Legacy and Ours, Public Health, AIDS, Mbeki and the Media, Zimbabwe: Hopeful News for HIV/AIDS Prevention?, Burma and AIDS - Politics Rules", South Africa: Peddling Beetroot, Courting AIDS, and others.

  October UPDATE: Further statistical analysis of this trial showed that the results weren't statistically significant.

• Flavored Tobacco Banned: This week the FDA enacted the law banning flavored cigarettes. The ban does not include menthol cigarettes. Altria Group, formerly Phillip Morris, favors the ban, and not coincidently, is marching ahead with acquisitions to solidify its market leader status in smoke-free tobacco products and also expanding its international tobacco holdings. We previously wrote about the cigarette regulation in The FDA and Cigarettes.

• FISA in the Obama Administration: With part of the USA Patriot Act up for renewal, the House is debating intrusive pieces of the legislations that allow privacy intrusion by wiretap, allow the government by access to business records, and allow surveillance of "lone wolf" suspects who have no known links to terrorists.

  One of the more controversial features gave the FBI authority to deliver National Security Letters to businesses and demand information about individual customers. The Letter recipients are ordered to be completely mum about receiving the Letters, meaning they can't tell their spouses, never mind their customers. Critics charge the National Security Letters provision of the Patriot Act violates the First Amendment. According to the Washington Independent's coverage of yesterday's House Judiciary Committee Hearing, this provision has been widely used and abused by government officials.

• Network Neutrality The FCC upheld the principle of network neutrality this week. FCC chairmain Julius Genachowski's "open internet" is now online, along information, public outreach and requests for comments on broadband and the internet. The FCC site is one of the better ones, sharing and soliciting information on broadband and networking as the agency looks to deploy technology more widely and efficiently across the US for uses like healthcare and "telework".

  Of course, in opposition to network neutrality, a coalition of conservative legislators called the American Legislative Exchange Council (ALEC), criticized the principle. Not surprisingly, the group opined that "the market" should be allowed to assure openness unfettered by government.

• PG&E Leaves US Chamber of Commerce: The Northwest energy company PG&E has left the business association, citing the group's refusal to reconcile its rhetoric with the facts of global warming.

• Born Free: "Nature Communications" will begin accepting submissions to their new open-access "born digital publication" in October 2009. The first issue will be published in 2010. According to the press release from Nature Publishing Group (NPG) "authors will be able to publish their work either via the traditional subscription route, or as open access through payment of an article processing charge (APC)."

  "New Scientist points to a "puzzling passage" in the press release, where NPG explains that the new journal will publish papers from all science disciplines "of the highest quality, without necessarily having the scientific reach of papers published in Nature and the Nature research journals." To understand, New Scientist followed up with Ruth Francis, NPG spokesperson, who said that Nature Communications will, as New Scientist put it, "feature research that is more focused and less generally applicable than work that typically appears in Nature" from "fields that aren't covered by the [Nature] research journals".

  The journal will be peer reviewed, NPG stresses in its press release. It will employ a "rapid, yet rigorous, peer-review process", meaning "efficient peer review with fast publication", that is "rapid and fair publication decisions based on peer review, with all the rigour expected of a Nature-branded journal". So...Nature Communications, not to be confused with "bulk publishing of low-quality papers", which, as we noted, caused such a stir last year. Nature has long explored open-access publishing. We look forward to the new journal.

• In the Beginning...Mini-T: Before Homo sapiens, before meteors annihilated Tyrannosaurus rex, before that massive dinosaur bounded over the earth, a smaller, similar looking dinosaur existed. Raptorex kriegsteini had 1/90th the body mass of the ~2.5 ton T.rex and lived about 65 million years earlier. A raptorex fossil found in China had the same body features as T. rex and scientists think that the specialized predatory morphology -- large jaw, small front legs, powerful back legs -- grew larger in future generations, evolving to become T. rex. The photo is of a T. rex is from Wikipedia Commons.

New Science Journalism: Futurity formally launched September 15. Futurity, not to be confused with "Singularity", is a collective on-line publication effort by leading research universities. The universities will promote their science accomplishments and fill the gaps of dwindling newspaper science coverage. Articles will be submitted by members of the Association of American Universities (AAU), with Stanford, University of Rochester, and Duke leading the effort. Critics point out that aggregating news generated by University PR departments (20% fact, 80% big story?) won't provide readers the same unbiased perspective as proper journalism coverage. True, but we can't ignore the fact that a significant amount of science coverage consists of press releases anyway.

• Swine Flu Fallout: The H1N1 pandemic not only causes havoc for humans who fall ill, college campuses trying to manage the illnesses, and health workers. The pandemic effects society and economy in ways you don't necessarily think of. Consider, for instance:

  1.) Egypt can't keep up with its street garbage. As we wrote earlier this year, Egypt set out to kill all the pigs in the country, an unwarranted action. Many belonged to Christian herders whose pigs cleaned the streets of millions of tons of organic waste per year. Now parts of Cairo are knee deep in garbage.

  2.) Pork belly futures, which fell from 89 in April 2009 to 40 in August 2009, have now rebounded to their previous high.

• A Chance To Recalculate the Bush Ozone Ruling?: The Environmental Protection Agency (EPA) announced last week that it would reexamine the standard set by the Bush administration for ozone which had motivated states to sue the EPA. Ozone is a health hazard at certain levels, and in 2008, the agency set a new standard at 75 parts per billion (ppb), down from 84 ppm. The EPA heralded this as a life-saving improvement, but according to science advisors of the Clean Air Scientific Advisory Committee (CASAC), only 60-70 ppm will prevent deaths.

  Susan Dudley headed the Office of Information and Regulatory Affairs (OIRA) in 2008 when the Bush administration decision was made. OIRA influenced the outcome of Bush's ozone ruling by sending a series of memos to the EPA impeding the ozone ruling and killing a secondary standard which would have triggered certain safety measures in some weather conditions. We wrote last year how Susan Dudley had argued on behalf of industry prior to her tenure at OIRA, that "smog was beneficial because it protected individuals from ultraviolet radiation, and that since asthma rates were associated with poverty, a smog ruling would have the 'perverse effect' of costing communities money, which would in turn increase poverty and asthma." Her's was a twisted cost-benefit analysis.

  Now Cass Sunstein heads OIRA. According to the Environmental Defense Fund (EDF), the EPA has calculated the benefits to society from the now thriving environmental industry and determined that those monetary benefits outweigh the costs of the standard. So is cost-benefit ok when the outcome favors the politics you prefer?

• Team Players: Researchers at Oxford University published a paper in Biology Letters reporting that more elevated endorphin levels associated with team sports like rowing than single player activities.

• Justice Department On Proposed Google Books Settlement The Justice Department said Friday that the settlement needed changes to address copyright, class-action and antitrust issues, and urged the Federal Court to reject the settlement. However, the government added that current discussions between the parties were productive and should continue.

• EPA and NHTSA, Together At Last, Overlapping: The EPA also proposed new carbon dioxide emissions this week, in concert with the National Highway Traffic Safety Administration (NHTSA). The new rule would lower fleet standards to 35.5 mpg by 2016. As well, cars would be allowed to emit 250 grams of CO2/mile by 2012, as opposed to the current rule of 265 grams of CO2/mile. The Association of International Automobile Manufacturers, Inc. (AIAM), and Senator Markey praised the agencies for their collective effort.

  A coordinated effort from the two agencies that oversee automobile emissions and mileage efficiency has long been a goal of industry and policy makers, though a goal sometimes cynically pursued. We also wrote about EPA/NHTSA overlap here and here. The standards will cover model years 2012 through 2016, and as the Obama administration bills it: "the automobile manufacturers would be able to build a single, light-duty national fleet that satisfies all federal requirements as well as the standards of California and other states."

• Migraines: McCain's Bane: Cindy McCain is heading to Congress, reports the New Yorker, to lobby for money to study migraine headaches. And you thought perhaps you'd heard the last of McCain science research jokes? She told the American Headache Society (AHS):

  "For the first time in my life, I'm going to go to Congress, and I'm going to be tenacious and be forceful and be honest and tell them that it's time. If you can give five million dollars to study flatulence in cows and its effects on the ozone layer, you can give me some money for migraine research."

  Migraines are, of course, a debilitating problem -- that's no joke. As McCain details in her talks, migraine headaches are sometimes set off by "triggers" -- foods like chocolate, or particular odors or chemicals. McCain reports that her company's beer, Stella Artois, contains sulfites "out the wazoo" that trigger her headaches. Travel is full of trouble. Sometimes a perfume bottle breaks and the debilitating noxious fumes cause her to repack her bags and fly home. Foreign food smells prove treacherous too, she says: "...like...forgive me, but the scent of cooking dog"

  She didn't say which countries serve the offensive "dog", often a subject of nasty rumors, or how one can tell that it's not chicken, water buffalo, or frog. But fortunate she is then, that her role is the ambassador of headaches not the ambassador of smoothing international relations with her would-have-been President husband.

Everyone has an opinion on newspapers or the demise thereof -- us too (here, for instance. Sometimes the opinions are confusing. BoingBoing, for instance, generally writes that the news should be free, (along with music, movies, books) -- free, free, free. But then they publish "Free Parking Costs a Fortune", on the hidden costs of downtown suburban parking. Labor and resources for this free, costly, but not labor and resources for that free? Confusing.

Offering a different kind of confusing, Michael Moore harangues American newspapers (video, YouTube) for "slitting their own throats". He says that in the rest of the world newspapers support themselves with subscriptions: "they know that in order to keep circulation up they better put out a damn good newspaper".

Let's see, in the UK there's BBC -- scary public option, FT Group, part of Pearson and not dependent on the little pink paper, the Guardian and of course the Mirror, the Sun, Star...and others of their ilk. Are they thriving?

In the UK, publisher Archant had 61% drop in profits for 2009 through June. UK's Independent News and Media (INM)-- had a 3rd quarter 2008 drop of 99%, and News Corps -- with Australian, UK and US papers, a 97% drop in the same period. The Guardian profits have plummeted. Germany, France and the rest of Europe? All declining profits.

Moore's story for the demise of American newspapers but not any other country's is catchy and his voice rises to a booming crescendo as he unveils the familiar scapegoats: Republicans and capitalism. He says that newspapers supported Republicans who cut education therefore increasing illiteracy which decreased numbers of newspaper readers. But it's too pat. There are many factors contributing to the decline of newspapers but its not the fault of the Republicans. And is it any more than fantasy to think the rest of the world's wired that differently?

REACH in the EU: Model for TSCA?

Governments regulate chemicals to help keep citizens safe from toxicants that would otherwise pollute their food, drink, and air. But such regulations are difficult to pass because of course some parties will always claim that the regulation will cost taxpayers, will cost jobs, and will inflict mortal wounds to the economy. In this challenging environment, EU and US agencies are now working to strengthen historically weak chemical oversight. The popular press recently covered a Nature article that projected much higher costs for the EU's oversight plan and predicted the necessity of extraordinary numbers of lab animals for toxicity tests. Nature is a respected science journal, not predictably partisan venue like, say, the Wall Street Journal editorial page or the Socialist Worker. But critics including an EU agency and the Environmental Defense Fund point out flawed reasoning and familiar marks of bias in this Nature paper, flaws not highlighted in the popular press. ¹

As we wrote in our last post, efforts to regulate bisphenol A may be in process, but a larger issue persists in the number of chemicals with unknown safety profiles that citizens are subjected to. In the US, some chemicals can enter the market with minimal government testing and 60,000 chemicals were grandfathered in under the US Environmental Protection Agency's Toxic Substances Control Act (TSCA) of 1976. To be clear, not all of these grandfathered chemicals are on the market, and some are safe -- but some aren't -- which ones?

Toxicologists have long argued for an overhaul of TSCA, known in some circles as the "Toxic Substances Conversation Act" by those who think it serves the needs of the chemical industry all too well. Asbestos, for instance, remains on the market because the EPA can not use TSCA (.doc download) to ban most asbestos products, regardless of documented health risks.

On the European front, a newer regime for testing chemicals called REACH (registration, evaluation,authorization and restriction of chemical substances) promises more complete oversight of chemicals in the EU than TSCA in the US. But REACH has its own complex goals and challenges, as we described here and here. And like TSCA in the US, the European program has its foes.

REACH: Smelling A Rat in the EU?

REACH underwent significant changes in the face of the chemical industry pressure before its implementation. Companies continue to agitate about the costs of REACH and the European Chemical Agency (ECHA) and the European Commission continues to reassure the public by reiterating their cost estimates.

Recently, toxicologists introduced a new wrinkle. Thomas Hartung, from John Hopkins Bloomberg School of Public Health, and chemistry consultant Costanza Rovida caused a stir by estimating not only huge unpredicted costs for REACH, but for predicting that REACH regulations would require millions more lab animals than the EU had calculated. Their Nature article referred to their analysis in the less well known journal ALTEX. They claim most REACH overruns would stem from reproductive testing, and said the program would use:

"54 million vertebrate animals and cost 9.5 billion... This is 20 times more animals and 6 times the costs of the official estimates. By comparison, some 90,000 animals are currently used every year for testing new chemicals in Europe, costing the industry some 60 million per year."

You don't need to be an animal activist to recoil at costly regulations that might waste every last vertebrate lab animal in Europe and more -- a reaction that their study could provoke. But suppose the authors didn't calculate correctly?

The Environmental Defense Fund's Richard Denison et al. comb through the Nature and ALTEX calculations and dispute pretty much every the calculation Hartung and Rovida make, starting with the estimates of the number of chemicals in use, moving on to the numbers for chemicals pre-registered, likely to be registered, the numbers of rats needed, and the associated costs. Denison concludes:

"As noted at the start, this study has used numerous demonstrably false or highly questionable assumptions, one piled on another, to grossly inflate the number of chemicals requiring testing under REACH, and the number of animals involved."

ECHA comes to basically the same conclusion, and notes that "the real figures are more likely to be the ones assessed and published when the new chemicals legislation (REACH) was prepared and negotiated."

The Opportunities of Lax Oversight?

Given that Denison's estimates and the numbers originally estimated by ECHA were a fraction of Hartung's estimates, the reader may ask -- "Which is it? Are there hundreds of thousands of unknown chemicals that need to be tested? Tens of thousands? Thousands? Why don't scientists know?" Well exactly, that's the point. As REACH progresses EU citizens will get better grip on which chemicals they're being exposed to and in what quantities. The current level of public ambiguity indicates the extent to which the risks to citizens are now unknown. But ECHA estimates that about 16,000 chemicals will be be registered by the first two deadlines, and that less than 6,000 of these will need full testing. The picture will get clearer as the chemical registrations are assessed through REACH.

In the meantime, the years of lax oversight provide the authors the opportunity to shock everyone. 54 million animals, some might ask (gasping)? The Nature article prompts that loaded question -- to which organizations like ECHA and EDF, dedicated to protecting people from say, being blinded by eyelash dyes, must reply with the uncomfortable answer: "No, actually it's only 9 million animals, not 54 million".

In truth, REACH is already committed to alternative testing like cell-based assays, and cheaper toxicology testing methods such as high-throughput screening. Decreasing the number of animals used in testing is a goal shared by all -- by the EU, by EDF, the EPA, etc.

When Chemical Companies Ally with The Humane Society, It Means?

Based on their estimates, Hartung and Rovida conclude that REACH is unfeasible and recommend halting aspects of it. They also recommend increased funding, especially in the US, for non-animal testing methods. While it's impossible to discern any motive for their study other than science progress and animal welfare, it's nevertheless interesting to look at some background.

Hartung runs John Hopkin's Center for Alternatives to Animal Testing (CAAT), which aims to develop methods to replace animals testing. He left his position at the European Centre for the Validation of Alternative Methods (ECVAM) saying, among other things, that chemical companies weren't involved enough (via Alttox.com). He moved to John's Hopkins in 2008.

Chemical companies are involved now. EDF's Denison points out that although the ALTEX study claims to have been peer reviewed, 5 of the 6 "peers" were actually industry representatives. Also of note, ALTEX is a publication of John's Hopkins'. Co-author Hartung sits on the journal's board and was assigned the position of North American editor in February. ALTEX is not exactly a neutral publication venue for Hartung.³

Chemical companies have historically argued that chemicals are safe without testing, that REACH is unnecessary, and that TSCA is good as is. But their cooperation is important to the success of toxicology programs, so in this case we'd hope that they've come around, that their concern for animals is genuine, and that their commitment to REACH steadfast.

But Denison thinks otherwise. He points out that the chemicals targeted by REACH effect animals in the wild too. So why the huge concern for lab rats, but not for eagles? Denison also notes "a strongly shared interest between the chemical industry and animal welfare advocates in undercutting chemical testing programs".

EDF has a long history of working with companies to achieve market friendly environmental compromises. Denison himself has substantial history with chemical companies who have been less than cooperative (.pdf) in collaborations with the EPA. There may well be a need for increased funding of alternative toxicology testing methods. But given the background of EDF and Denison it's hard to ignore their criticism, despite Hartung's excellent credentials and expressed support for REACH.

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¹Nature 460, 1080-1081 (27 August 2009) | doi:10.1038/4601080a; Published online 26 August 2009, Chemical regulators have overreached, Thomas Hartung & Costanza Rovida

² Even the chemical, pharmaceutical and personal products industries are dedicated to reducing animal testing.Alttox, an on-line forum for alternatives to animal testing, is cosponsored by the Humane Society, Proctor and Gamble, and the American Chemical Council.

³ We previously criticized the journal "Risk Analysis" which we called vanity press for Sciences International Inc..