Shaw's Eco-Logic

BPA "health effects": Reductio ad absurdum?

While the previous post describes excellent work that pretty much sets the record straight on human exposure to BPA—at actual real-world levels—we note that the University of Illinois is touting an unpublished fear-mongering study, by the very aptly named Dr. Jodi Flaws.

Under the rather sensational headline "Plastics chemical retards growth, function of adult reproductive cells," the press release from the university goes onto say that "Their study is the first to show that chronic exposure to low doses of BPA can impair the growth and function of adult reproductive cells."

You have to get deeper into the article to find that Flaws really WAS testing the effect of BPA on cells. She used cell cultures, not whole animals!

Cell cultures cannot metabolize and eliminate BPA, and the BPA concentration used—10 micrograms per milliliter—is hardly a "low dose." In fact, such levels are orders of magnitude higher than normal human exposure.

The press release begins with the bogus contention that "Bisphenol A, a chemical widely used in plastics and known to cause reproductive problems in the offspring of pregnant mice exposed to it." We would remind the good Dr. Flaws that numerous studies on lab animals (not just their cells) have failed to show evidence of fertility issues even at doses one million times higher than typical human exposures.

Of course, I don't know exactly what she means by "reproductive problems," and she doesn't define what she means, either.

Let's see, normal human exposure to BPA causes no problems. Let's try mice at extremely high levels, and get dubious results. I've got it! Let's try mouse cells—separate from the animal—at even higher levels.

For those of you who forgot their Latin, reductio ad absurdum is the disproof of a proposition by showing that it leads to absurd or untenable conclusions. In this case the reductio ad absurdum refers to the lab work, itself.

Thank you Dr. Flaws, and maybe you'll get some hard questions when you present this work at your poster session on July 19th in Pittsburgh.

More good news on BPA

Leave it to Health Canada to finally put a stake through the heart of the BPA fear-mongering nonsense. Those of you who have been following this issue have often read that Canada protects the health of its citizens ever so much better than our own FDA. Since EWG and NRDC are fond of promoting this idea, let's see what the good scientists at Health Canada discovered...

They tested the following classes of products for BPA:

• Baby food prepackaged in glass jars
• Canned powdered infant formula
• Bottled water

In all cases, dozens of products and different brands were tested, and in all cases, levels were exceedingly low. This new data confirms Health Canada's previous conclusion that exposure to BPA through food packaging uses is not expected to pose a health risk to the general population, including newborns and young children.

In fact, Health Canada stated that an adult would have to drink approximately 1,000 liters (264 US gallons) of water from polycarbonate water cooler bottles every day to approach the science-based safe intake limit for BPA recently established in Canada.

While all of the glass water bottles showed BPA concentrations below the minimum detectable level, so did many of the plastic bottles and the one water can brand tested (Perrier).

No BPA was detected in any of the canned powdered infant formula samples tested. The level of BPA found in baby food packaged in jars clearly indicates that exposure to BPA through consumption of these products is extremely low.

Health Canada's new data provides further support for recent assessments from eleven regulatory bodies around the world that determined BPA is safe for use in food contact products. These regulatory bodies include: the European Food Safety Authority, German Federal Institute for Risk Assessment, Danish Environmental Protection Agency, French Food Safety Authority, Swiss Office for Public Health, and Food Standards Australia-New Zealand.

I hope that this latest round of data will convince the public, but as long as grants are given out to the likes of Freddie vom Saal, Shanna Swan, and the rest of the endocrine disruptor gang, this trumped-up issue—based almost entirely on over-interpretation of data in rodents—will be with us.

Why not reach out to the gang, and ask them what they think of these new findings?

Here's the contact information:

Fred vom Saal      vomsaalf@missouri.edu      (573) 882-4367

Shanna Swan      shanna_swans@urcm.rochester.edu      (585) 273-3521

And, while you're at it, drop a quick e-mail to the feckless journos at the Milwaukee Journal Sentinel who did a big story on how bad BPA is, basing nearly the entire 30,000 word series on input from...Freddie vom Saal.

Susanne Rust      srust@journalsentinel.com

Meg Kissinger      mkissinger@journalsentinel.com

If you think I'm being too hard on old Freddie, check out this direct quote:

"The science is clear and the findings are not just scary, they are horrific," vom Saal said. "When you feed a baby out of a clear, hard plastic bottle, it's like giving the baby a birth control pill."

That's just the kind of level-headed thinking that should be driving this issue, don't you think?

Remember CPSIA?

You know, the awful, awful Consumer Product Safety Improvement Act, of which we have written about in the past.

Good guy Rick Woldenberg comes up with an absolutely devastating piece on his blog. For fun, check out this posting on another blog by a true-believing Leftie, who is starting to wonder about big government--at last.

I guess it depends on whose ox is gored, right?

The National Fisheries Institute takes aim at lazy and biased journos

Yesterday, the gauntlet was thrown down by Mary Anne Hansan, Vice President of The National Fisheries Institute, a non-profit organization dedicated to education about seafood safety, sustainability, and nutrition.

Hansan admonishes the news media to apply "strict scrutiny" to activist claims about fish consumption, nutrition and sustainability. She cites numerous examples of journos going way wrong, including these...

In November 2007, USA Today's Larry Wheeler wrote: "As many as 600,000 babies may be born in the USA each year with irreversible brain damage because pregnant mothers ate mercury-contaminated fish, the U.S. Environmental Protection Agency (EPA) says." What Wheeler failed to mention was that EPA never made that claim, but that it was simply an extrapolation made by an agency employee whose questionable methodology and conclusions have been challenged by other scientists. A correction soon followed. Further, Wheeler made the above assertion despite the fact that science shows mothers who eat the most fish have babies with the highest cognitive outcomes.

In January 2008, New York Times reporter Marian Burros conducted her own analysis of mercury in sushi that included remarkably similar methodology and conclusions to a report from environmental activist group Oceana that was released on the very same day her story was printed. Burros' story contained multiple errors, distortions and omissions; most critically, misinterpretations of the EPA "reference dose" and the U.S. Food and Drug Administration's (FDA) "action level" for mercury, ignoring the fact that both standards contain a ten-fold cushion of safety. The paper's public editor was forced to admit that the story "required careful judgment...and missed." He added: "I thought the package was less balanced than it should have been, given the state of existing research. James Gorman, an editor in the science department who reviewed the article before publication, said he had raised several specific questions but that in retrospect, 'I should have raised more questions about the general presentation.'"

In January 2009, an Associated Press article on tuna and mercury included the erroneous claim that the EPA and FDA advise women who are pregnant or may become pregnant, nursing mothers and young children to avoid eating tuna because of its "high levels of mercury that can cause brain damage in babies," --- a demonstrable falsehood. In the very first paragraph of the federal seafood consumption advice it is clearly stated, "women and young children in particular should include fish or shellfish in their diets due to the many nutritional benefits." The advice then urges this sensitive subpopulation to avoid just four fish during pregnancy: shark, tilefish, swordfish, and king mackerel. Tuna is not included on the list of 4 species to avoid. The advice clearly states that it is safe and healthful for women and children to eat 12 ounces of light tuna per week or 6 ounces of white albacore per week. When confronted with the error, the AP was forced to issue a correction.

Hansan notes that "In many cases, reporters will uncritically pass along charges from activists, yet at the same time apply great skepticism to experts, including independent scientists, who take a pro-seafood stance."

"At times," she says, "It can be hard to tell the difference between a press release from an environmental activist and what passes as mainstream reporting."

There's much more. Check out the complete letter.

Hansan and the Institute are to be commended for issuing one of the most comprehensive rebuttals of rotten journalism that I have ever seen coming from a trade association.

Would that more trade groups follow their example.

More bad news for the endocrine disruptor gang

Virtually all of the "scary" work on endocrine disruptors has been based on overblown findings in rodent studies. Although many of us think we know some human rats, the fact is that:

Rodents are not good models for human fetal germ cell development and, in view of the contrasting effects of phthalates on certain fetal characteristics in rats and mice, it is unclear whether the rat is a suitable model for the human.      {Mitchell R, Cowan G, Morris KD, Anderson RA, Fraser HM, Mckenzie KJ, Wallace WHB, Kelnar CJH, Saunders PTK, Sharpe RM. Germ cell differentiation in the marmoset (Callithrix jacchus) during fetal and neonatal life closely parallels that in the human. Hum Reprod 2008; 23:2755-2765.}

As such, the marmoset, a non-human primate, was used in a recent study to investigate if phthalate exposure can affect testis development.       { McKinnell C, Mitchell RT, Walker M, Morris K, Kelnar CJ, Wallace WH, Sharpe RM. Effect of fetal or neonatal exposure to monobutyl phthalate (MBP) on testicular development and function in the marmoset. Hum Reprod 2009 Jun 2. [Epub ahead of print] }

This study comprised two portions, one in which pregnant marmosets were dosed with monobutyl phthalate (MBP), and another in which newborn males were dosed with the same amount of MBP per body weight.

No measurable effects were observed in either portion of the study.

That's right: Despite doses of 500 mg/kg of body weight per day, nothing happened.

I wonder what Freddie vom Saal, Shanna Swan, and the Mount Sinai School of Medicine crew (all charter members of the endocrine disruptor gang) have to say about this?

Listen to Chris Bryant, managing director of the American Chemistry Council:

"This new research adds significantly to earlier work, and increases the overall weight of scientific evidence that suggests primates, which include humans, are more resistant to the effects of phthalates than are lab rodents. Japanese research published in 2006 by Tomonari et al showed that huge doses of a phthalate that can affect rodents showed no testicular effects in developing infant marmosets. It is worth noting that there are significant differences even between rats and mice in the way they react to phthalates. So it is not at all surprising that there would be significant differences between rodents and primates."

Rodents, of course, have long been favored by researchers since they are cheap, don't take up too much space, and are easy to care for—and kill, for that matter. The problem is that rodents are not humans.

Sad to say, non-applicable rodent endocrine disruptor results are only the tip of the iceberg. Untold billions have been spent on cancer therapies that cure mice, but not humans.

It's long past time that we leave the rats and mice on the sinking ship of useless rodent results.

We honor July 4th by attacking EWG's sunscreen scares

Declare your independence from fear-mongering Greenie fund-raising groups!

In my latest HND piece, entitled "Sunscreen Smokescreen," I take a critical look at the Environmental Working Group's annual sunscreen investigation. EWG just loves going after evil chemicals and scaring the public into sending in more donations. You might remember them from the absurd and discredited Alar scare of 1989.

Never mind if there is no science behind this latest sunscreen screed. Well, actually there is something behind it, but that would be the carefully undocumented standards set up by...EWG itself.

EWG especially goes after the chemical oxybenzone, proven safe by the FDA, and many other regulatory organizations in Europe and elsewhere. As "proof" of the dangers of oxybenzone, EWG trots out a truly awful study on pregnant women and their offspring done by the endocrine disruptors witch hunt group at Mount Sinai School of Medicine (courtesy of your tax dollars). Using methods that could charitably be called "questionable," about all that Mount Sinai can come up with on oxybenzone is that it could cause lower birth weights in girls and higher birth rates in boys.

Yes, I realize that this is a paradoxical finding, but they make no attempt to explain it, besides referring to a few other papers that posit similar effects, that are also unexplained. Science used to mean proposing a hypothesis, testing it, and publishing your results. The Mount Sinai gang seems content to take a single urine sample during pregnancy, test for a chemical, and then use statistics to eke out a finding.

This is high school science fair stuff, and not top tier academic research. But, since you can get grants for this sort of thing these days, that's all that matters, right?

Bear in mind, though, that the birth weight effect is well within normal variations, and corrections for such confounding factors as smoking, drinking, and drug use in pregnancy are weak at best.

Notwithstanding the vast resources of EWG, this is as good as it gets, which is not very good.

Enjoy the sun, use your sunscreen, and forget about the fear entrepreneurs.

Memo to NIH, partial sponsor of this work:  Why not take some of the money you're spending on this half-baked chemophobic research and put it into an area far more deserving, such as expanding clinical trials for generics like low-dose naltrexone?

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.

Blaming the chemicals proven wrong

Good guy Eric McErlain turned me onto this latest finding:

Missing, deformed and extra limbs in frogs are caused by natural predators, not pollution.

Check it out for yourselves, in the far from anti-Greenie BBC.

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.