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June 2008

Talk to a real person--you just might learn something

If you still need to be convinced that the modern environmental movement has deteriorated into little more than masturbatory feel good for elites, on the backs of the poor and the third world, I suggest you speak to some NON-elite, living in northern New England.

He will then explain to you how middle class life is rapidly becoming impossible--all because of high energy prices.  The direct hit, of course, is the skyrocketing price of heating oil, but then there's the secondary effect on food and just about everything else.

The pathetic thing about a clown and poseur like NASA's James Hansen, is even if he is right about what he says--and he most assuredly is NOT--the biggest threat to our way of life is overblown and over-publicized fear entrepreneurs such as himself.  Aided and abetted by a moronic media, weak "leaders,"  and ignorant tastemakers, these miscreants have changed the greatest country in the world into a sorry gaggle of victims.

Thanks, James.   

More great news about vitamin D

For decades, we were taught that vitamin D is important for building strong bones and teeth.  Many of us remember textbook pictures of poor kids with rickets--a condition whereby bones get weak and soft due to a lack of this vitamin.

In recent years, though, studies of the vitamin have shown promise in such diverse areas as cancer prevention, tuberculosis, multiple sclerosis, rheumatoid arthritis, and juvenile (Type 1) diabetes.

Now comes word that it's also good for your heart!

Check out my HND piece, and stock up on this inexpensive health aid.

Thimerosal does not cause autism--the proof is in

There was never enough evidence for the true believers, and maybe there never will be.  But, if science is still part of the debate, the party is most definitely over for the Thimerosal causes autism nutters.

The state of California finally ran the gold standard epidemiological study:  An agent supposedly linked with a disease is removed, and they look at before and after data.  The study shows--without any shadow of a doubt--that when Thimerosal was removed from vaccines, the rate of autism was unaffected.

The only comeback for the nutters is that Thimerosal is still used in flu vaccines, but a single vaccine could not make up for the absence of Thimerosal in all the others.

Case closed.  Read all about it in my HND article, mirrored here.

Are the chickens finally coming home to roost for the Steris System 1?

Regular readers of this blog know that I am big on improving infection control in hospitals.  Beyond the fact that hospital-acquired infections produce about 100,000 mostly preventable deaths every year in this country, the whole notion of this goes along with one precept of my basic philosophy.

That is, take care of the big problems first--especially the big problems that have relatively simple solutions!

What good does it do a patient to have the highest-tech medical care, if he is only to die of the same sort of infection he could have received in the hospitals of ancient Rome?

Classical, time-proven methods of sterilization include steam and ethylene oxide (a low-temperature process, perfect for the flexible scopes used in many of today's less-invasive surgical techniques).  However, ethylene oxide (EtO) is toxic (it kills germs, after all) and the sterilization cycle can take up to 16 hours.

Since the very most important consideration in health care these days is cost, sterile processing departments of hospitals have long been searching for alternatives to EtO.  And, sure enough, in the late 1980s-early 1990s two techniques did come on the market.  As it happens, their names are quite similar:  Steris System 1, and Sterrad.

In an earlier post, we detailed some of the issues with the Sterrad,  Now, Steris is on the hot seat.

On May 15, 2008, The FDA issued a Warning Letter to Steris, citing multiple violations of their 510(k) premarket approval.  The 510(k) provision is much sought-after by medical device manufacturers, since it streamlines the approval process by likening the product in question to a similar device (predicate device) that has already been approved.

Several authorities, including Lawrence Muscarella, have raised questions about the Steris System 1 since its introduction, asking how tap water can be rendered sterile simply by its passage through a filter.  In addition, the device has been implicated in patient deaths.

You will note that the Warning Letter claims that the System 1 is "adulterated" and "misbranded."  Thus, it can no longer be considered safe and effective without further agency review.  These claims usually prompt swift draconian action, but so far, we have not seen this.  Granted, with 16,000 plus units in the field, a full-blown recall could be messy, but then again, so are dead patients.

At this point, the silence is deafening from the company, the agency, and numerous non-governmental organizations (NGOs) that should be far more involved.

Muscarella is hopping mad now, and is seriously questioning the labeling of the device from the get-go, but he is most upset at the silence of the NGOs, and posits a conflict of interest--inasmuch as the NGOs rely on funding from device manufacturers.

Finally, there are even those who suggest that this Warning Letter might be the first blow in a death of a thousand cuts strategy, intended to remedy an errant 510(k) approval, dating back to 1989.

In the meantime, exactly what are sterile processing departments supposed to do?

First, they came for the PVC

Greepeace founder Patrick Moore finally quit his organization, based on their absurd attacks against several essential chemicals, including chlorine and phthalates.

Chlorine, of course made it possible to provide safe drinking water, and in fact, the chlorination of water is still considered to be the greatest scientific achievement for the benefit of mankind.  Quick:  would you rather have safe drinking water or a computer?

Phthalates, of course, are less familiar.  Their primary use is to make plastics, well, more plastic--and softer.  While they are used in sex toys, they are also featured in vinyl blood bags, and thousands of other applications.

The attack on phthalates started when Greenpeace and other enviro-loonies knew that they had to give up on PVC, since that plastic was so essential in its medical applications alone, that no one would ban it.  But then, they came up with a stratagem:  Attack phthalates, an essential component of PVC.  Most people haven't heard of it, and most people can't even spell it or pronounce the word.

They even got an ally in one Dr. Shanna Swan, of the University of Rochester, whose shrill work has not exactly gotten a great reception from her peers.  For one thing, an NIH panel was unable to validate key findings in her June, 2005 phthalate baby study. 

More than that, at least one independent statistician took great exception to her article, and wanted to submit a letter or even a full article to the journal that published her in the first place.  In the old days, this would have been no sweat, as this it what we used to call "scientific inquiry."

My spies tell me that all efforts to publish contradictory analysis, even in light of the NIH scoffing at her work, was rejected on the rather novel grounds that they were "picking on her."

The real reason is that the so-called peer reviewed journals have their own agendas, and science is not always part of it.

No matter, though, since there are many other places to obtain information, including my HND piece.

Formaldehyde phobia

Thanks to the FEMA trailers, everyone is clued into--or thinks they're clued into--the dangers of this chemical.

Naturally, the plaintiff's lawyers are all over this, as are the Feds, trying to solve this problem with even more regulation.  Actually, regs have been in place for a long time regarding formaldehyde emissions coming from manufactured wood products (from HUD). Of course, having these in place didn't prevent some errant trailers from being deployed.

It turns our that only a very small number of units even had a problem, based on rational and current regulatory levels.  BUT--this won't stop the regulatory geniuses and the fear entrepreneurs, who are now talking about regulatory levels that approach the amount of formaldehyde in human breath.

Check out my Health News Digest piece

Speaking of Supreme Court cases...

I received a few e-mails questioning the relevance of this posting, when it first appeared.  Let me explain...

The lion's share of actions affecting environmental or health care policy is under the purview of the government--and most of the time that comes down to the federal government.  The previous post alluded to the fact that the regulators are immunized from the catastrophes caused by their actions, because of a horrible Supreme Court case (Dalehite v. US). 

Thus, those who scandalously banned DDT--possibly the single worst regulatory policy in the nation's history--are free from any accountability.   Tell that to a kid who gets busted with a few ounces of pot.

While the Framers would be shocked at the imperial power of today's Supreme Court, and certainly did not intend it to be such, the Court has become a default legislative body for virtually any cause that "escapes" the attention of Congress.  Moreover, the civics curriculum is largely hagiographic in its coverage of the Court.

Like it or not, if you have an interest in government policy, you'd better get clued into the REAL Supreme Court.

The original posting follows...

Over the last few weeks, I have had occasion to study a number of so-called "landmark" cases, and when you come right down to it, most of them are essentially crapola.

In Roe v. Wade, for example, no matter what side of the abortion debate you're on, you have to be struck by one very stupid thing:  If Norma McCorvey (Roe) wanted an abortion so badly, why didn't she just go to another state to get one?  It was even part of the dissent that by the time the case reached the Supremes it was moot, since the baby was already born.  Normally, test cases are not moot, and normally test cases do not occur because someone volunteers to purposely create one against their own interest!

In Dalehite v. US (the case cited in the previous posting) an entire law was invalidated on absurd grounds, mostly so that the government would not have to accept culpability.  In dissent, Robert Jackson, a justice whom I do not particularly like, was brilliant.

[Most of the reason I don't like Jackson is that he quite self-importantly ran the Nuremberg trials, which viewed objectively were nothing more than victor's justice, completely perverted by having the Russians sitting in judgment--whose atrocities were more than a match for those of the Nazis.]

Brown v. Board of Education certainly de-segregated some schools, but there was no legal theory involved, as when the same issue had come up before (Plessy v. Ferguson) the Court went the other way.  Thus, it was purely political and a function of the popular culture.  That's what is so pointless and funny about con law:  Precedent is all important except when it isn't.

AND--Marbury v Madison, the case that started the entire business of judicial review actually did so by stating that the Court had no such authority!

Of course, no one seems to mind that the greatest constitutional question of all time--whether or not states could secede--was completely ignored until after the Civil War.  But, in 1869 in yet another crummy case (Texas v. White) that relied on very shaky theory, and even then was a vigorously contested 5-3 decision, the ruling was that a state could not secede (although some exceptions were made).  As you might expect, there was nothing high-minded in the details of the case.  The Reconstruction state government of Texas was trying to get $10 million from certain individuals who had held some bonds on behalf of the Confederacy era state government.

In my experience, few lawyers--including constitutional lawyers--really know the story behind any of these cases, and simply learn their names and memorize the capsule precedent.

A few weeks ago, I wrote about the case that broke FDR's National Recovery Administration:  A. L. A. Schechter Poultry Corp. v. United States (1935).  The plaintiffs really suffered, and the Feds, aided and abetted by much of the media, were pure scoundrels--not to mention that the laws they were trying to enforce were insanely stupid.

But, talk about drinking the Kool-Aid...

The Schechters, having their business and lives ruined by dear Franklin D., voted for him every time he ran.

Bottom line:  A "good" Supreme Court decision is one in which you agree with the political results.  There are seldom "higher principles" at work.

"Risk-free" is plenty risky

One way—maybe the best way—to grow political power is for the politicos to promise to "fix" or "reform" something.  Within this category is the notion of piling on regulations to virtually eliminate risk from our lives.

The only problem here is that there is lots of risk in trying to do this!

Banning DDT killed millions of Africans, with absolutely no measurable benefit to the environment is one example.  Recently, the geniuses promoted ethanol as the wonder fuel caused both food and fuel prices to skyrocket.  As a matter of fact, we were all over that one.

And of course, not allowing a refinery to be built since 1976, and severely restricting drilling didn't help, either.

In my recent Health News Digest piece, I cite a few more examples of the so-called "unintended consequences" of bad policies, and how a horrible Supreme Court decision protects the Feds even if they totally screw up and it's all their fault.  Check it out.