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.
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.
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.
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.
October 9, 2014 5:18 PM
The number of studies that have appeared in the news during recent years on the chemical bisphenol A (BPA) is staggering. Few substances undergo such scrutiny. So why BPA? Mattie Duppler of American’s for Tax Reform’s Cost of Government project answers that question in an article for The Hill’s Congress Blog: Congress has poured millions of dollars ($170 million since 2000) into BPA research for what amounts to little more than a witch hunt.
Follow the money and you may find a strong statistical association between government funding and the increased number of research studies that link BPA to various health ailments.
Money goes out to researchers motivated to produce studies that report positive associations that easily get published and that gain more funding. And the more money politicians spend for research studies, the more likely some portion of studies will come up with positive associations between BPA and various health aliments, which is likely to happen by mere accident. In addition, many positive findings appear to be attributable to activist agendas among some researchers who make creative interpretations of largely meaningless data. And the studies that come up negative usually don’t get published or end up in the news either because negative findings as simply not interesting.
Thus far, the allegedly most damning studies on BPA are extremely weak. Most don’t really find what the researchers claim they do, and they are often poorly designed. Consider the latest BPA study in the news. Published in the Journal of the American Medical Association Pediatrics (JAMA Pediatrics), it claims that BPA is associated with wheezing and reduced lung function in children.
October 6, 2014 10:14 AM
The New York Times reported Friday on the David-and-Goliath battle of businessman Shihan Qu, the last of the rare earth magnet renegades. Mr. Qu’s company, Zen Magnets, is the last U.S. company selling the popular sets of unusually strong magnets that first became popular when marketed under the name Buckyballs® (named after inventor and designer R. Buckminster Fuller). These sets allow scientifically-curious customers to creatively experiment with different geometric forms. When Craig Zucker and Jake Bronstein started selling Buckyballs® through their company Maxfield & Oberton in 2009, they were immediately successful.
Magnets this strong do have safety concerns, however, and some children have swallowed them and been injured as a result. This is why the companies selling them covered them in warning labels and didn’t supply the product to stores whose inventory is primarily targeted to children, like Toys R Us. Since the magnets require a fair amount of manual strength and dexterity to use, they were never marketed to children, gaining their following largely from popular science and geek-themed outlets.
September 29, 2014 4:43 PM
Today is the anniversary of one of the most significant food and drug related events in recent memory. Often discussed in college business classes these days, the 1982 Tylenol poisonings is usually heralded as the prime example of how companies should handle a consumer relations disaster. However, it is also a shining example of how the market itself—acting to protect its customers and thus its profits—can improve public safety. The actions that Johnson & Johnson took in the wake of this tragedy, without a doubt, improved the safety of consumers of all over-the-counter (OTC) drugs for the next 30 years.
Within three days, beginning on September 29, 1982, seven people in the Chicago area died after taking Extra-Strength Tylenol laced with cyanide. More than 30 years later, who committed this crime and why remains a mystery. After an investigation, it was determined that the cyanide was not introduced in the factory, which, according to Grey Hunter, author of True Crime Stories, “left only one other possibility. The Food and Drug Administration (FDA) and law enforcement agencies realized that someone had methodically taken the Tylenol bottles off the shelves at the stores where they were sold, filled the capsules with cyanide and returned them back to the shelves at a later period.”
The incident triggered nationwide panic and distrust of OTC medicine as well as numerous copycat attempts. Within the next month, the FDA counted 270 incidents of suspected product tampering. However, it was unlikely that any tampering following the Chicago deaths involved Johnson & Johnson products. That’s because the company immediately implemented a protocol to make sure that customers could rest assured that any OTC they purchased from Johnson & Johnson was tamper resistant.
While advertising genius Jerry Della Femina declared that Johnson & Johnson wouldn’t “ever sell another product under that name,” the company managed to turn the crises into a public relations campaign that would promote Johnson & Johnson products as safer than all others. Tylenol, which had been 37 percent of the analgesic market, plummeted to just 7 percent after the scare, but within a year it bounced back to a 30-percent market share. That is all thanks entirely to Johnson & Johnson’s robust campaign to prove to its customers that its top priority was their safety.
September 12, 2014 8:33 AM
It’s not exactly a blood-pressure raising headline, which is probably why the new report from the Centers for Disease Control and Prevention is actually bears the alarming titled, High Sodium Intake in Children and Adolescents: Cause for Concern. The study will no doubt be hailed by public health advocates as proof that something must be done to bring America’s sodium intake in line with the recommendations of the CDC and other health originations. However, the report’s findings, when put into context of 50 years’ worth of research on global salt consumption aren’t alarming at all.
High sodium intake is associated with all sorts of nasty health problems—as the CDC was careful to note in the opening paragraph of its report. As NBC News put it:
Studies clearly show that eating a lot of salt can raise blood pressure — not in every single person, but in a significant percentage of the population. The latest survey of what kids eat shows that more than 90 percent of them are eating far too much salt...
June 17, 2014 9:23 AM
A story in The New York Times is making the rounds about an Obama administration proposal to clarify the National Highway Traffic Safety Administration's (NHTSA) authority to regulate smartphone navigation apps: the administration supports giving NHTSA this clear authority.
The tech industry is obviously upset, as they should be. But the paranoia underlying the Obama administration's call for burdensome regulation deserves some examination.
As I have noted in the past, the administration has been obsessed with the supposed scourge of cellphones in automobiles, going so far to call on states to enact bans on texting while driving without examining actual crash data. Why? Because the data do not support cell-phone use bans, whether voice communications or texting. The Insurance Institute for Highway Safety found in 2010 that states which enacted texting bans did not see accident claims reductions, speculating that drivers became aware of the ban and associated fines and responded by moving their cell phones further from the windshield to prevent police offers from observing their behavior.
The lack of real-world evidence supporting their position has not dissuaded the Obama administration from pushing aggressive and likely counterproductive policies related to in-car technology and distraction risks.