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June 2009

Doing great science more than a century ago--proven by today's techniques

My latest Health News Digest piece is all about how a German anatomist was right about what we now call Merkel cells being the center of the sense of light touch.

Dr. Merkel proposed this 134 years ago, and it has only been proven quite recently.

Considering that it took some pretty sophisticated genetic engineering to pull this off, it makes Merkel's contention all the more astounding!

Read the complete article.

Another clueless journo weighs in on endocrine disruptors

NY Times columnist Nicholas Kristof, who usually writes about politics has now taken on science, but science is so politicized these days, there's not much difference anymore.

Not surprisingly, his June 28th article (registration may be required) "It's Time to Learn From Frogs," covers the oh-so-trendy and mostly junk science world of endocrine disruptors.

He mentions Louis Guillette's iconic work on phallus size in alligators (1995). Guillette compared the penis size of alligators from polluted Lake Apopka in Florida to those in supposedly pristine Lake Woodruff. The pop media takeaway from the study was that the Apopka alligators had smaller penises—certainly caused by the pollution—but the pop findings tended to ignore the many caveats in the study, as well as further points that can be raised.

For one thing, there is a possibility that some of the animals were not even sexed properly in the first place...

Due to the greatly reduced size of the penis in many males from Lake Apopka, and the fact that the cliteropenis of male and female alligators is similar in basic structure (see Allsteadt and Lang, 1995; Pickford, 1995), a source of error in sexing animals is possible. That is, the greatly reduced male phallus could appear similar to a slightly enlarged female clitoris.

The Apopka alligators showed other abnormalities, which tend to skew the findings touted by Guillette...

  • Penis length did not correlate with plasma testosterone concentrations in the Apopka alligators, as is customary
  • No relationship existed between penis size and body size in the Apopka alligators (in one area of the lake), as is also customary

The data does show considerable individual differences, with overlap between the alligators of the bad lake and the good lake. Guillette et al. take the trouble to add this qualifier:

However, it is important to note that a difference in the length of the penis tip and the diameter of the penis cuff occurred in all size classes of juveniles when the two lakes were compared.

In other words, individual differences exist, and since the purported effect of the polluted lake was not that great anyway, the findings here could just as easily melt away.

We also note that Tim Gross, an associate of Guillette on several papers, has said that Guillette's work is based on "weak data," in that Guillette did not know the age of the alligators, and whether their phalluses were still growing. Guillette's answer was that phallus size relates to body size, but how can that be reconciled with the opposite finding above? (second bullet point)

Kristof reports on the feminization of male smallmouth bass in the Potomac River watershed, widely blamed on estrogens in the water. The intersex fish finding is disturbing, and similar results have been reported in several other locations. However, it all depends on whose ox is gored.

There is little doubt that the source of the estrogens is human urine, fortified with the metabolites of birth control pills and patches, passing unchanged through sewage treatment.

One wonders how many Lefty Greens will tell women to stop practicing artificial birth control to save the bass. Heck, forget the bass. Numerous studies have found these estrogens in municipal drinking water, but the Greenies don't see this as an issue, because the source of the pollution is politically correct.

Just one more example of hypocritical Greenie nonsense.

Kristof then refers to the appearance of certain male urogenital abnormalities, although a recent study covering a large population in the state of New York has debunked this.

He discusses the synthetic estrogen DES—a powerful endocrine disruptor given to millions of women from the late 1930s to the early 1970s—for the prevention of miscarriages. Sadly, not only did DES not prevent miscarriages, but it caused certain abnormalities in the children of some of these women.

Kristof does not mention that these effects were only seen in women who took exceptionally high doses of DES, and that DES is a much more powerful disruptor than any of chemicals mentioned in his article. Moreover, when used in smaller doses, deleterious effects were essentially unknown.

According to renowned toxicologist Robert Golden: "Extrapolate from the DES record, and you can conclude that one endocrine modulator environmentalists most love to hate, the pesticide DDT, would cause no endocrine effect in a fetus exposed to more than a pound of DDT over the course of a pregnancy."

We have already commented on the shamelessly alarmist statement issued by the Endocrine Society—referenced by Kristof.

We conclude by reiterating the observations of Gail Charnley, former president of the Society for Risk Analysis: "The whole field of endocrine disruption is a conclusion in search of data."

Next time, Nicholas, read up on more than one side of an issue. Then again, don't change a thing. It's easier to mock you just the way you are.

Behind the scenes at the VA??

I have received a few interesting responses to recent postings on the VA colonoscopy situation. Note that the following information is credible, but has not been confirmed...

Fingers are pointing at Medivators—the company that has been fighting the more popular Steris System 1—for recommending the connector switch--at the core of the problem. Many had questioned the 510(k) approval on the System 1, and since May, 2008, the System 1 is the subject of an FDA warning letter.

The System 1 and Medivators unit are used to reprocess (disinfect) endoscopes, such as colonoscopes.

Strangely, there has been no concerted effort to remove the System 1 from active use, even if the company is not marketing the product anymore.

We now hear that some VA hospitals are going back to the System 1, despite the FDA's contention that it is an adulterated device, and the company's tacit admission that it had been an adulterated device for several years.

What about informed consent?

Since it is against federal law to use an adulterated device...

The Food, Drug and Cosmetic Act - SEC. 301. [21 USC §331] "Prohibited acts" - provides:

"The following acts and the causing thereof are hereby prohibited:

(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.

(b) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.

(c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise."

Check the regs.

...will the hospital have to get patient approval? Of course, by most theories, that would not matter, in that "consent to do something illegal" is an absurd concept on its face.

We know that the FDA is investigating this matter, and look forward to seeing the report.

More On The Veterans Affairs Colonoscopy Situation

The mess seems to be expanding, even as the VA's Office of Inspector General has released its report entitled "Healthcare Inspection: Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities."

While the report comes to some pretty harsh conclusions, including the finding that "The failure of medical facilities to comply on such a large scale with repeated alerts and directives suggests fundamental defects in organizational structure," it is silent as to just how the wrong connectors could have been used in the first place.

There is little doubt that the connector issue stems from the substitution of one without a one-way valve, to facilitate the scopes being reprocessed automatically. However, such an off-label use of an automated endoscope reprocessor (AER), if it were merely suggested by the manufacturer—without being validated by the FDA—would be a serious violation.

Complicating the matter is the widespread use of another AER, that itself has been branded an adulterated device by the FDA.

Read my latest HND article.

Bad doctors, terrible care, and a cover-up

As if the VA hospitals did not have enough bad publicity, the NY Times filed a story today detailing rotten cancer treatment in 92 of 116 cases over a span of six years.

There was a cover-up, and even in the midst of the investigation, a VA official could not bring himself to admit it. "I'm not going to look into this guy's soul."

Dr. Gary Kao, whom the Times cites as the bad doc in this story, boasts a prestigious medical background—but as many med students and residents will tell you, that can mean very little these days.

Read the story. Props to the Times on this one.

Dr. Phil Cole gives us the voice of reason on formaldehyde and cancer

In May, the Journal of the National Cancer Institute published a study concerning formaldehyde exposure and cancers of the blood and bone marrow. As is far too often the case these days, the authors overstated the results.

Listen to Betsy Natz, executive director of the Formaldehyde Council:

"Despite acknowledging that their findings are not definitive, the authors of the study took the step of asserting a possible link, rather than practice some prudent epidemiological restraint. For example, the authors of the study have conceded that the patterns found in the data could be due to chance, while JNCI’s own editors wrote that the study was based on 'limited measurement data' that would tend to compromise its conclusions."

An independent panel examined the study, and posted this video. In the video, Dr. Phil Cole gives an objective discussion on the findings, and mentions that the National Academy of Sciences should examine all existing research and produce its own report.

More info here.

The BPA Scare--Masterfully Debunked

If you've ever wondered what is behind the movement to effectively ban bisphenol A (BPA)—a widely used chemical—that has become a hot topic among Greens and their useful idiot political and media poodles, a comprehensive answer awaits you... The masterful report entitled "Science Suppressed:  How America became obsessed with BPA," released by STATS.

STATS is a nonprofit, nonpartisan research organization affiliated with the George Mason University. Its mission is to improve the quality of scientific and statistical information in public discourse and to act as a resource for journalists and policy makers on scientific issues and controversies.

Notably, neither nor the author received any payment from any industry or other source associated with the manufacture, use, or distribution of bisphenol A.

Here are a few highlights...

A handful of scientists and environmental activist groups claim that bisphenol A is the biological equivalent of global warming, and its presence in plastic bottles and can linings is endangering "millions of babies." Their message—and their accusation that the Food and Drug Administration has been swayed by industry-sponsored studies and has ignored vital scientific evidence—has led Congress to ask the agency to re-examine the safety of the chemical. A decision is expected by the end of the summer.

Missing in this debate is that it's not just "industry groups" that think BPA shouldn't be banned—or just industry-sponsored studies that say it's safe. Scientists, regulators, and politicians in Europe, Australia, and Japan have all rejected the evidence that the chemical is harmful as methodologically flawed, badly conducted or irrelevant—with some warning that banning it could actually endanger the public. Now that the National Institutes of Health has acknowledged it funded a lot of poorly-designed research on BPA—the very research that activists touted as evidence that the chemical is deadly—it's time to ask whether America has been spun by clever marketing rather than clever science.


Author Trevor Butterworth uses surgical precision in his takedown of BPA fear entrepreneur Fred vom Saal, and his media sycophants at the Milwaukee Journal Sentinel...

The cumulative effect of all this research and statistical analysis is that vom Saal, though highly vocal about the risks of BPA and the media’s go-to source for explaining the science, has found his research and his claims repeatedly rejected in regulatory assessments of the chemical’s risk in the past decade. When the Milwaukee Journal Sentinel claims he is considered a "leading authority" on the chemical, it is by virtue of the consideration of journalists and not his fellow toxicologists. His contention that BPA is highly toxic to humans has not been accepted by any major risk assessment conducted in the last decade. Indeed, EFSA [European equivalent of our FDA] went in the opposite direction, raising the reference dose for BPA by a factor of five, meaning that it considered the allowable daily intake for the chemical over the course of a lifetime to be significantly safer than had once been thought.

They [the Milwaukee Journal Sentinel] jumped straight to the conclusion that vom Saal must be right and everything else must be wrong. There was no puzzling out how such a flagrant dichotomy could come to be, there was no exploring of our [NTP’s Center for the Evaluation of Risks to Human Reproduction (CERHR) BPA panel] position, no digging around to try to understand what was happening. And important research WAS ignored.

I [Dr. Bill Durodié], felt vom Saal's presentation in London had every hall-mark of old-fashioned quackery. That is just my opinion after all. My reading of the literature indicated he was viewed by others in the field with a degree of circumspection to say the least. Gail Charnley, the then President of the Society for Risk Analysis, whilst not describing him specifically, suggested in an editorial that the whole field of endocrine disruption was a conclusion in search of data. Finally, the very fact that the detractors have to, again and again, refer to the work of a single investigator, or a limited number of his past collaborators, the results of whom others are unable to replicate, should alert them to a problem. In science at least, data does have to be independently verified.


Among other things, the anti-BPA crowd conflated oral ingestion with intravenous and subcutaneous injection, skewing results. But the Journal Sentinel tries to skate around this...

Animals tested were fed BPA through pumps under the skin that regularly administered the chemical. Some critics say that method exaggerates the chemical's effects. But others say it is an acceptable method because newborns are constantly feeding.

Butterworth asks...

How would readers understand this passage if they knew that "some critics" included the World Health Organization, the Environmental Protection Agency, and the European Food Safety Authority? What editor would allow such a characterization to make it to print if they were truly aware of the degree of opposition within toxicology and pharmacology to assessing the risks of oral ingestion through subcutaneous injection?


Anyone familiar with the PC nature of awards in journalism would not be surprised that the Journal Sentinel was lauded for its biased hack work on BPA, but it took STATS to bring this to light.

I suggest you download the entire report.

Absolutely a bravura job by Trevor Butterworth and STATS.

The EPA's Protection Racket

That's how the Competitive Enterprise Institute's Angela Logomasini views the agency's unprecedented 37 percent budget increase for fiscal 2010. She wonders what concrete public benefits the agency can realistically claim to have achieved.

A few highlights:

The EPA's public-health mission is misleading, because it is charged with addressing risks that are too small to measure or be regulated away. The agency's current risk-assessment practices compound the problem, harming both public health and our economic well-being. The agency issues extremely high benefit estimates for its regulations. But these estimates are out of touch with reality.

The EPA's mission involves spending considerable amounts of tax dollars to regulate risks that are in most cases too insignificant to be scientifically demonstrated. The agency has compounded this problem by employing highly questionable scientific assumptions when assessing risks—such as emphasizing high-dose rodent studies.

The environmentalists like animal tests and the uncertainty of their results. These studies give the EPA an excuse to rely on the precautionary principle—the notion that, without full knowledge of the risks, it is "better to be safe than sorry," and thus better to regulate even more tightly.

Read her entire article.

If the Feds are robbing you blind in the name of "saving the children," does that make it any less painful, less of a rip-off, or more than junk science?

Disrupting the "endocrine disruptor" hypothesis

That's the title of my latest HND piece, which speculates on how the "endocrine disruptor" mission got started. Along the way, we look at the consequences of overzealous regulators, and mention two articles (one already covered in this blog), which espouse rather different views of the situation.

The second article was written by a true believer—Stephanie Engel—who posits that "Any level higher than zero (of phthalates) is to some degree abnormal," and even objects to calling phthalates "trace chemicals." The article attempts to relate findings in an infant behavior test (BNBAS) to phthalate exposure, although the results—to be kind—are inconclusive.

I promise you that ten or fifteen years ago, this paper would not have been published.

I posed a few questions to Engel, which to her credit she did answer quickly...

Shaw Question 1.    Since sex-specific effects were hypothesized a priori, what specific hormones do you think are involved? How do these hormones relate to such factors as can be measured with BNBAS?

Engel's answer:  Research has shown that phthalates can be anti-androgenic (i.e. interfere with testosterone), anti-estrogentic, and/or estrogenic. They are known reproductive toxicants that have been shown to be related to reduced anogenital distance in both animal and human studies. Previous studies have shown that boys and girls perform slightly differently on the BNBAS overall, which may be related to differences in sex hormones/ brain development. We therefore hypothesized that phthalates may impact BNBAS differently in boys and girls.

Shaw comment:  She did not mention any specific hormones, referring only to speculations derived from earlier research. Normally, if a biological effect is proposed, some mechanism should be suggested.

Shaw Question 2.    You state that the median phthalate biomarker concentrations are within the range reported on another survey. Does this mean that most of the subjects were in a normal range?

Engel's answer:  I am not comfortable with referring to phthalate biomarker concentrations as "normal" or their range as "normal". Normal implies endogenous levels, and phthalates are exogenous environmental toxicants. Any level higher than zero is to some degree abnormal. However, the levels that we measured in these women were in the range of what has been reported in the large, population-based NHANES study. This implies that the women in our cohort were no more highly exposed than the general population is (i.e. we are not describing an unusually highly exposed population).

Shaw comment:  Normally, if one suspects an effect from a particular environmental chemical, tests are run on a normal as well as an occupationally-exposed cohort (or at least a cohort that has a higher exposure) to allow for a classic control. Since nearly everyone is exposed to phthalates, the researcher should have tried to find a cohort (possibly Amish people, who might not use modern personal care products??) with a much lower exposure.

Shaw Question 3.    Did you determine if lifestyle factors could explain the differing levels of phthalate metabolites in the women, or, again, did you simply see a normal range of titers?

Engel's answer:  We performed multivariate analyses that considered lifestyle factors that may be both associated with biomarker concentrations and BNBAS domains. In general everyone is exposed to phthalates. Women tend to have higher exposure to lower molecular weight phthalates than men do because they tend to use more personal care products that contain these chemicals. The purpose of this analysis was not to explain variation in phthalate levels (this has already been done), but to determine whether prenatal phthalate biomarker concentrations associate with neonatal behavior, after accounting for factors that might be associated with both phthalates and neonatal behavior. We found that phthalates were associated with neonatal behavior, particularly for girls, and particularly for the domains of orientation and quality of alertness.

Shaw Question 4.    Since you are trying to look at effects of a trace chemical, how wise is it to rely on a questionnaire to determine smoking, alcohol consumption, and illegal drug use--especially if CDC was running the urine tests--and presumably could have tested for such activities?

Engel's answer:I think characterizing phthalates as a "trace chemical" is inaccurate. Phthalate exposure in the general population is orders of magnitude higher than most other known environmental toxicants (PCBs, lead, methylmercury, organophosphate pesticides, bisphenol A). However, your question as to whether self-report is adequate to measure smoking, alcohol consumption and illegal drug use has also been addressed in methodological studies. Smoking is variable during pregnancy as women tend to repeatedly try to quit or cut-back, so biomarker measuring of cotonine in urine during pregnancy has almost as many problems as questionnaire based assessments (a spot cotinine level only addresses 2 week exposure). Methodological studies has found maternal self-reported smoking to be more accurate. Alcohol consumption cannot be assessed through biomarkers, and is probably under-reported. Illegal drug use can be measured through biomarkers, and is probably under-reported by questionnaire. However, these two factors would have to strongly associate with phthalate exposure to represent a substantial bias in our study. Neither do.

Shaw comment:  Sorry, not good enough. Since all the women are exposed to phthalates, how this associates with illegal drug use is irrelevant. Certainly, illegal drug use could affect the BNBAS, and to not check for it is simply ignoring a huge confounding factor. My take is that the women only agreed to the urine tests on the promise that illegal drug use was not going to be examined, although this is obviously not mentioned in the paper.

I am still waiting for an unequivocal study showing real health effects in real humans from these endocrine disruptors, but I'm not holding my breath.