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  • Not So Fast: Fatally Flawed Research Asserts Alcohol Taxes Save Lives

    May 12, 2015 10:52 AM

    Last month, researchers at the University of Florida published a study in the American Journal of Public Health that concluded, “Increases in alcohol excise taxes, such as the 2009 Illinois act, could save thousands of lives yearly across the United States as part of a comprehensive strategy to reduce alcohol-impaired driving.” Their study presented the case that the 2009 tax increase resulted in a statistically significant reduction in alcohol-related deaths in Illinois. However, as I pointed out in a blog post, there only appears to be a reduction in fatalities because of the authors’ selective inclusion and exclusion of data. Rebecca Goldin, Director of STATS.org and Professor of Mathematical Sciences at George Mason University, found even more flaws in the research.

    In her post, Rebecca takes a bird’s eye view of the crash data in Illinois between 1999 and 2013. She finds a steady decline during this 10-year period with “hardly anything special at all going on at the end of 2009.” Looking closer at the data, she noted (as did I) the curious exclusion of data after 2011. “Results should be resilient to changes in choices, such as whether to use data published 2011-2013,” Goldin notes. When added to the evaluation, this 2011-2013 data shows a small decrease immediately after 2009, but then shows a steady increase in alcohol-related traffic deaths in Illinois. She also found that as a proportion of total traffic fatalities, alcohol-related fatalities on the road have been increasing since 2009 (though only by 2 percent—a statistically insignificant amount).

    Of course, the real story here is that breaking the data at year 2009 may not be an appropriate way of measuring the trends, and certainly it’s not appropriate to “blame” the excise tax for the proportionally increased alcohol deaths in the context of decreasing deaths associated to alcohol. But by the same logic neither is it appropriate to conclude that the excise tax has been saving lives.

    Finally, in addition to the “creative math” and error of conflating correlation with causation (bad scientists, bad!), there’s another potential problem with the study. The grant provided by the National Institutes of Health lists the purpose as “to develop a research program of HIV prevention focused on the intersection of event-level alcohol use… and sexual partner selection among adolescents.” There is no mention in the grant description about taxes or motor vehicle crashes. I say this is a “potential” problem because I have been unable to get answers from anyone at the NIH or the University of Florida researchers who worked on the project. My questions were simple: What was the rationale behind using an AIDS grant for alcohol tax research? And is this sort of change in scope common practice?

    It’s one thing to have public health advocates peddling flawed research in order to advance personal agendas, but it’s another entirely to use taxpayer money to do so.

  • Who Dares Question the Mighty Oz?

    April 24, 2015 11:41 AM

    Yesterday, Dr. Mehmet Oz launched his “counter attack” on several doctors who sent a letter last week to the dean of Columbia University’s medical department complaining about controversial positions and advice that Oz has offered on his show. Oz, who holds faculty and administrative positions at Columbia, exclaimed that he “will not be silenced” by his critics, casting the issue as an attack on his freedom of speech. In an article for Time magazine, Oz stated:

    The dean politely reinforced that the academic tradition of all institutions protects freedom of speech for their faculty, and I assumed the matter was over…. I know I have irritated some potential allies. No matter our disagreements, freedom of speech is the most fundamental right we have as Americans. We will not be silenced. We’re not going anywhere.

    Yet no one is trying to deprive Oz of his right to free speech. The doctors listed on the letter are simply exercising their own right to free speech—and that includes speaking truth to the powerful Oz. They shined a light on Oz’s often questionable, TV-publicized, health advice for good reasons, as many others have done so hereherehereherehereherehere… and the list could go on and on.

    And apparently, shining a light on Oz’s questionable approaches did some good. It prompted eight of Dr. Oz’s colleagues from Columbia University to speak out as well in a USA Today commentary. These doctors note:

    We are members of the Columbia faculty who recognize that the Dr. Oz Show performs a public service by bringing alternative therapies which are generally under-researched and under-regulated into the public forum. However, a 2014 report in The BMJ (formerly the British Medical Journal) reported that less than half of the recommendations on his show are based on at least somewhat believable evidence. This report raises concerns that Dr. Oz's presentations of anecdotal therapies as "miracle cures" occur in the absence of what we see as obligatory discussions of conflicts of interest, possible side-effects and evidence-based medicine (or lack thereof). Many of us are spending a significant amount of our clinical time debunking Ozisms regarding metabolism game changers. Irrespective of the underlying motives, this unsubstantiated medicine sullies the reputation of Columbia University and undermines the trust that is essential to physician-patient relationships.

    And last spring, members of Congress also attempted to rein in Oz when they invited him to testify on Capitol Hill about his claims related to “miracle” weight loss supplements. And apparently, it worked to some degree. On his show yesterday, Oz says that he’s backed away from making claims about miracle supplements. In addition, after the rebuke by his Columbia colleagues, he’s even said he regrets comments he has made about such supplements. That’s progress, but there’s more to do.

    While Oz thanked his colleagues at Columbia for speaking up, he attacked the doctors on the first letter because he says they have an “agenda.” And rather than address their arguments, he attacked them personally on his show. Apparently, it’s inconceivable to Oz and his crew that people can disagree with them based on informed, moral personal views.  

    In particular, he focused on the work of CEI friend and scholar Dr. Henry I. Miller of the Hoover Institution. Dr. Miller’s writings and research on the topic of genetically engineered food are among the most informed and scholarly in the world (he was also the founding director of the FDA’s Office of Biotechnology), and his positions are humanitarian. Rather than attack, it’s time for Oz to take a closer look at this issue and reconsider his position, as he has with supplements.

    Genetic engineering allows researchers to precisely modify plant genes in a process that is far more precise and safer than cross-breeding plants. Using GM, researchers have been able to add vitamin A to rice to reduce vitamin-A deficiency, a major cause of blindness and death, particularly among children, in parts of the world were rice is the staple of the diet, although anti-GM activists have fought this “golden rice.” Scientists also use genetic engineering to make food production easier and more affordable, which is essential to feeding a growing world population.

    Dr. Oz says he’s ambivalent about such foods, although his shows are laced with fear-generating suggestions about these technologies, and his “experts” are mostly anti-biotechnology activists. He did, however, allow one biotech apple farmer to appear on his show last week to offer a little balance in that one segment. 

  • TSCA Reform Debate Is Not about Public Safety

    April 1, 2015 1:59 PM

    At recent hearings on the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697), senators, environmental activists, and local government officials claimed that the Toxic Substances Control Act (TSCA) law is not sufficient protect public health. As I have argued before, that’s certainly not the case.

    There may be an economic reason to reform this law—to preempt a growing patchwork of nonsensical state-level consumer product regulations—but there’s no legitimate “safety” reason for reform.

    Still, activists and some members of Congress at the hearing complained that TSCA’s risk standard has prevented the EPA from banning “a known human carcinogen,” i.e., asbestos. Cosponsor of S. 697 Senator Tom Udall (D-N.M.) exclaimed at the hearing, “I think we all agree: TSCA is fatally flawed. It has failed to ban even asbestos.”

    Activists and members of Congress point out that EPA failed to address asbestos in part because TSCA requires EPA to pick the “least burdensome” regulation to achieve its goals. 

    But how can that be a bad thing? Shouldn’t we want to achieve our goals at the lowest costs? It doesn’t say EPA should pick a regulation that is less safe; rather, it says that EPA should simply pick a less expensive means to meet the safety goal.

    That requirement is part of TSCA’s robust risk standard that holds regulators accountable and prevents them from passing rules that do more harm than good. Under TSCA, EPA may regulate when the agency finds that a chemical may pose an “unreasonable risk of injury to health or the environment.” This standard requires weighing the risks of the chemical against the risks of the regulatory action.

    People who use the asbestos case to push TSCA reform are either grossly misinformed about the case or they are simply being disingenuous. It is true that the rule was thrown out by a federal court in part because EPA did not bother to find the “least burdensome” approach to meet its goals. In addition, the court pointed out that the rule might have produced more deaths than theoretical lives saved. Accordingly, this is not a TSCA failure, it’s a life-saving success!

  • Arsenic in Wine: Dangerous or Beneficial?

    March 26, 2015 2:23 PM

    Dan Nosowitz in Modern Farmer offers some insights on the recent class action lawsuit filed against California winemakers. The plaintiffs found that some inexpensive wines contained arsenic at levels exceeding the federal drinking water standard for this substance. Nosowitz rightly points out that the standard is for water, not wine and “people don’t, or shouldn’t, drink as much wine as water.”   

    Well, let’s not go that far… kidding of course! Moderation is surely a good idea when it comes to alcohol consumption. Yet even if you drank as much wine as you do water, there’s still no reason to be alarmed about arsenic. The levels in wine are still too low to have any significant adverse impacts, and ironically, such small amounts might even have health benefits. 

    Arsenic is an element that naturally occurs in the earth’s crust, so traces of arsenic inevitably appear in food and water. Certainly, high levels of arsenic are not healthy and concentrated exposures can be immediately deadly. But the trace levels found in water and food are rarely an issue. Problems have emerged primarily in developing nations like Bangladesh where poor people drink from untreated water sources with arsenic levels that range in the hundreds of parts per billion (ppb), and sometimes more than 1,000 ppb.

    It’s worth noting that the levels allegedly found in wine are reportedly just five times greater (or 500 percent higher as noted in the press) than the federal drinking water standard of 10 ppb. So, some number of samples—we don’t know how many—tested by the plaintiffs in this case had some level of arsenic near the 50 ppb level. But did you know that until 2006, that was the allowable level in drinking water in the United States and it had been for decades?

    The U.S. Environmental Protection Agency (EPA) changed the standard to 10 ppb in 2001 with full compliance not required until 2006. The 10 ppb standard for arsenic in drinking water is excessively overcautious. When EPA proposed it, it was very controversial because the cost to small drinking water systems was substantial and the benefits highly questionable. EPA’s Science Advisory Board highlighted lots of problems with EPA’s science and maintained that the change could actually undermine public health. The SAB explained that the costs might cause some small communities to disconnect their water systems, forcing people to use untreated well water, but EPA finalized the rule anyway. 

    If you look at the history, you can see that EPA did not change the standard for safety reasons; they did it for political ones. You may remember, environmental activists attacked the Bush administration for taking time to reconsider changing the standard, which the Clinton administration rushed out during the final hours of the Clinton presidency. Green groups made it sound like the Bush administration was adding arsenic to the water supply. And this bad press made a rational and scientific debate impossible.

  • Data Torturing at the CPSC

    March 19, 2015 1:57 PM

    James Mills of the National Institute of Child Health and Human Development lamented in an article in the New England Journal of Medicine back in 1993: “‘If you torture your data long enough, they will tell you whatever you want to hear’ has become a popular observation in our office. In plain English, this means that study data, if manipulated in enough different ways can prove whatever the investigator wants to prove.”

    Government regulators will resort to such data torture to justify an activist regulatory agendas if they can’t do it with good data and sound science. One approach includes selective use of data—excluding years or datasets that might change the conclusions of a risk assessment. The Consumer Product Safety Commission’s recent Chronic Hazard Advisory Panel (CHAP) report on the chemical class known as phthalates offers one new example of excluding inconvenient data.

    In short, the CHAP report is being used to justify a proposed rule that would essentially ban the use of certain chemicals for toys that children might mouth or chew. These chemicals make plastics soft and pliable, suited for such things as a plastic version of a “rubber duckie.” For background on this issue, see my other blog posts here and here

    In addition, in the absence of any compelling body of data that any individual phthalate is the cause of human health effects, the panel relied on the possibility that the cumulative effects of phthalates as a class pose risks. Accordingly, they needed data on human exposure from all sources.

    The panel developed a “cumulative risk assessment” that they maintained justified regulations. But pharmacologist Christopher J. Borgert, Ph.D., observes in a review of the CHAP report that the panel’s cumulative risk assessment: “failed to recognize obvious inconsistencies with human experience and clinical evidence”; “overstates the accuracy of its cumulative risk methods and conclusions”; and “appears to have grossly overestimated chemical potencies.” In other words, the panel failed to properly apply the available data and research.

    To make matters worse, they used old and irrelevant data for their human exposure assessments even though more accurate and recent data was available. Former and current CPSC commissioners have noted that had the panel used the most recent data, their risk assessment would have produced the opposite result. This issue raises the prospect that the panel members were intentionally “selective” in their use of data because they desired to generate a particular conclusion, as appears to be the case with their selection of studies that they also reviewed. 

  • CPSC's Scientific Shenanigans on Phthalates

    March 18, 2015 2:00 PM

    Many “stakeholders” have complained about the process through which the Consumer Product Safety Commission (CPSC) developed its proposed rule related to a class of chemicals called phthalates—and rightly so. In particular, the agency’s failure to allow public comment and open peer review of its Chronic Hazard Advisory Panel report (CHAP report) underscore the fact that bureaucrats want to avoid scrutiny that might hold them accountable for rash and unscientific decisions. 

    Designed to make plastics soft and pliable, these chemicals have many valuable uses for making a wide range of products from blood bags, to rain boots and swimming pool liners as well as children’s toys, which are the subject of this regulation. Safely used for decades, activists and regulators are poised to essentially throw away these valuable technologies based largely on junk science. 

    While this rule only affects toys that children might place in their mouths or chew, it sets a terrible precedent. I already detailed how this rule might harm consumers in a blog post last week. Now let’s look at the so-called “science” behind it.

    The justification for the proposed regulations are found within the CHAP report, which is a review and risk assessment that the agency released in July 2014. A key problem stems from the fact that the CHAP report relies on a selective review of limited studies that offer scant evidence that individual phthalates or cumulative exposure pose any significant risk to humans at current exposure levels. 

    Most of the CHAP-report-identified “evidence” that these chemicals pose health risks comes from lab tests that over-dose rodents to trigger health effects. Such tests are not particularly relevant to humans that better metabolize the substance and who are exposed to traces that are multitudes lower.

    The human research highlighted in the CHAP report is not particularly compelling either. Many of these human studies are noted to be “small,” which limits their value for drawing any conclusions. And many of them report associations between potential health effects in babies whose mothers’ phthalate exposure levels were measured in single “spot” urine samples during pregnancy. Given that humans metabolize phthalates relatively quickly, one time spot measurements may be misleading about actual exposures, raising important questions about the utility of such studies.

  • CPSC Proposal on Phthalates Likely to Do More Harm than Good

    March 13, 2015 8:58 AM

    On Monday, the Consumer Product Safety Commission will close the comment period for a proposed rule related to chemicals used to make soft and pliable plastics. While they claim to do this in the name of children’s health, it’s not clear that the rule will do more good than harm.

    The process and the “scientific” review that brings us to this proposed rule has been controversial, to say the least. I detail some of those issues in comments that I will submit on Monday and will post some of that here on Monday as well.

    Unfortunately, not enough attention has focused on the fact that the agency-commissioned study—referred to as the Chronic Hazard Advisory Panel (CHAP) report—failed to fully consider the potential implications of substitute products that will replace those they ban. 

    Before initiating a rulemaking that may remove chemical technologies from the marketplace that have been safely used for decades, CPSC should consider whether replacement products pose greater risks. The CHAP allegedly addresses replacement products by reviewing data on the potential environmental health effects of other chemical substitutes. But the CHAP did not address whether or not the substitutes that might actually win a place in the market would affect product performance in ways that help or harm public health and safety.  

    The rule should ensure net safety, considering all factors. It is incumbent that regulators don’t inadvertently increase risks with short-sighted decisions. Based on the CHAP, we lack reasonable assurance that regulatory action will increase net safety and, in fact, such actions might accidentally introduce new hazards and even greater public health and safety risks.

  • Victory for "Caveman" Blogger and Free Speech in North Carolina

    February 19, 2015 6:54 AM

    Many people associate professional licensing with consumer safety. For example, we wouldn’t want any schlub doing surgery. But where occupational licensing laws may have started out with the goal of protecting consumers, they have now become a means by which certain professionals restrict competition. States require licenses for hundreds of occupations including perilous professions like florist, funeral director, hair braider, and fortune teller.

    The case of the “Caveman” blogger who was bullied by the North Carolina Board of Dietetics/Nutrition for providing nutritional advice without a license illustrates how licensing threatens not just our economic freedom, but our other basic freedoms. Luckily for blogger Steve Cooksey, his right to express his opinion and give advice to fellow dieters won out over the need to protect licensed dieticians from competition.

    As the Institute for Justice, which has been fighting on Cooksey behalf, wrote yesterday:

    In December 2011, Steve Cooksey started an advice column on his blog to answer reader questions about his struggle with Type II diabetes. Cooksey had lost 78 pounds, freed himself of drugs and doctors, and normalized his blood sugar after adopting a low-carb “Paleo” diet, modeled on the diet of our Stone Age ancestors. He wanted to use his blog to share his experience with others.

    However, in January 2012, the North Carolina Board of Dietetics/Nutrition informed Cooksey that he could not give readers personalized advice on diet, whether for free or for compensation, because doing so constituted the unlicensed practice of dietetics. The board deemed Cooksey’s advice the unlicensed practice of nutritional counseling, sent him a 19-page print-up of his website indicating in red pen what he was and was not allowed to say, and threatened him with legal action if he did not comply.

  • New U.S. Dietary Recommendations to Correct Misunderstanding about Cholesterol, Not Fat

    February 12, 2015 1:34 PM

    Thomas Jefferson once said, “If people let the government decide what foods they eat and what medicines they take, their bodies will soon be in as sorry a state as are the souls of those who live under tyranny.” On this issue, TJ seems to have hit the nail on the head.

    Since Uncle Sam started telling us what to eat, Americans have steadily grown less healthy in many ways. In the 1970s, we were told to eat less meat and more grains. We listened, but it did little to curtail the oncoming obesity “epidemic” (some claim government recommendations may have actually caused this epidemic). And for decades, we have been told to restrict our consumption of cholesterol in order to reduce our risk of cardiovascular disease. That is, until now. The new dietary guidelines will no longer recommend restrictions on cholesterol consumption. This is a great first step, but the best advice is to stop listening to government nutritional advice.

    For many people, this will seem like an abrupt about-face after 50 years of lectures about cholesterol. But for those in the medical research field, the shift is long overdue. During the last decade, it has become increasingly clear that there is no real evidence linking dietary cholesterol and blood serum cholesterol (which is used as a stand-in for CVD risk). While many physicians are still wedded to the idea that their patients at risk for cardiovascular disease should limit their egg consumption, it sounds like the Dietary Guidelines Advisory Committee—a joint effort of HHS and USDA—has finally come to grips with the evidence. Unfortunately, the real lesson remains unlearned: the U.S. government shouldn’t be the authority on what is or isn’t a healthy diet.

    The DGAC, which consists of “nationally recognized experts,” meets every five years to review medical literature and hash out recommendations for what a healthy diet should look like. Their report to the secretaries ultimately becomes the official Dietary Guidelines for Americans, which is used by policy makers as a guideline in federally administered nutritional programs and assistance. Unfortunately, it sounds like they will still cling to their increasingly suspect beliefs about saturated fat.

  • Tainted Claims about "Agglomerated" Corks

    February 5, 2015 10:41 AM

    A recent article in Wine Industry Insight titled “Micro-Agglomerates: 350 Million Illegal Corks Per Year?” reports: “Agglomerated cork manufacturers and importers are facing scrutiny from two major federal agencies over health concerns about the plastic used to bind bits of cork glued together. The concern is that chemicals in the binding plastic can leach into wine.” 

    But a closer look at the issue indicates that these agencies are not focused on the corks, there’s nothing illegal about them, and safety concerns are unwarranted.

    The two agencies allegedly interested in the issue are the U.S. Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). The chemical in question, toluene diisocyanate or TDI, Wine Industry Insight notes, is “listed as a potential carcinogen” with the International Agency for Research on Cancer (IARC) and the National Toxicology Program (NTP).

    This sounds scary, but there are many reasons why no one should be alarmed about the closures or the chemical involved. But before going into that, we should be clear as to what the agencies are doing in regard to the corks.

    According to an EPA press release, the agency has proposed a rule that would require manufactures to notify the agency if a consumer product they are making will contain more than 0.1 percent of TDI by weight. The EPA does not mention scrutiny of corks that may contain TDI. It’s very possible that these corks don’t contain that much TDI and would not even be subject to this proposed rule.

    Nor is the FDA really scrutinizing the issue. Instead, the agency received letter from an outside party asking questions about related FDA law. Wine Industry Insight has posted a link to a letter from the FDA responding to that party, but the name of the party asking questions is either blanked out or never included. But Wine Industry Insight points out that it was an association that represents competitors of agglomerated cork producers—a synthetic cork association—who filed the petition. It notes:

    “Competition is fierce for the low-end market which is why a synthetic cork association blew the TDI whistle on agglomerates in a letter to the FDA.”

    Obviously, competitors have an interest in making this an issue, but FDA isn’t taking the bait. FDA has authority to regulate “food additives” that might pose a threat to public health and that includes chemicals that might migrate from packaging into food. In its cryptic, bureaucratically written letter, FDA is basically indicating that they have data showing there is no detectable migration of TDI into the wine for the closures currently on the market. Otherwise, they’d be regulating now, but they’re not.

    So much for “federal scrutiny.” There really isn’t much because there’s no good reason for it.

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