And we say it again

The fact that it is snowing like coke at an Aerosmith concert doesn’t mean that global warming isn’t real. Indeed, huge extremes in weather patterns – both hot and cold – are indicative of global destabilization of air masses. It isn’t even funny to say things like “looks like Al Gore was wrong.” Well, it would be funny if Bill Clinton said it. Or Bill Murray. Everything he says is funny. But outside of that, not funny.

Or any old Italian-American man. It would be funny just because of the accent. “Looks-a like…”. Classic.

But to the point: this is serious.

What is Broken?

This is question we should have addressed a long time ago. Broken is a very important thing to understand. And very tricky. Broken is more than a physical state of something. See, before Man, nothing was broken. Everything was as it should be. It might have been busted, or different than before, or all messed up, but it wasn’t broken until Man was there to deem it so.

Let me apologize for using the chauvinistic “Man” here. Nevermind. I’m not apologizing at all. I’m just recognizing that I’m doing it. It’s a useful enough term. Human, person… very cumbersome. And I don’t think that Man is chauvinistic anyway. But I’ve been wrong before. Give me a better word and I’ll use it.

Anyway, broken is a philosophical state. Things can still be busted, of course. I can bust my bicycle. That means, though, that I just throw it away and buy a new one. Then again, I can render my bicycle broken, then, I can try to fix it. And that is the difference.

Anything that can be broken can be fixed. Fixing it, though, never restores the exact same thing to a state where we could be convinced that it was never broken in the first place. It has changed. It had more effort put into it. It fills the same functional role, probably, but it does so in a little different way.

Let’s get right to the heart of it. The Republicans are right when they say that healthcare is broken. And it can be fixed. The same is true for everything. Everything, depending on how you look at it, is broken. It all needs fixing. Fixing is how we improve things. And everything can be better. So why not?

The Curse of Information

I know that I’m not the only one saying this, but one more outlet won’t hurt, just in case. First, let me be clear, that I am in no way saying that we should ignore facts when making decisions. Maybe an example would help: if I was to experience an earthquake, I would run into a doorjamb, which is on the face of things, the most safe place. But if, to get to that doorjamb, I had to run 100 feet through a glass-domed room when, alternately, I could just walk outside, that tiny fact would sway me to turn around and go into the yard. That one is clear. Now, what if we had something difficult, like balancing the national budget…what then? If we were to take a page out of the popular Washington publication “How to Stop All Progress”, we would shout, “what about the local municipality that can’t afford to lose ten thousand dollars of funding for jails” or “why are we budgeting extra money for snow removal for NYC but not for my district in Miami” or something else like that. In short, we’d answer with questions and offer no solutions.

And this is the curse of information. We can always run another simulation on snowfall and we can always trend early release from jail numbers one more time until the next election cycle comes around. This is why health reform isn’t inevitable anymore. Nothing is. We can stalemate until the end of days. That end of days will be hastened by our inactivity, of course, but so what?

Wait. So what? Well that isn’t very palatable, is it? How is it that our elected government can let that come to pass? Simply, because we let them. And we let them do it by our inability to stand behind something for more than a few weeks tops. Without saying that Pres. Obama should enact all of the change he promised or not, at least he had a plan! And we, as a Nation, totally abandoned him because we got nervous and wanted the numbers to be run again.

I don’t believe people could actually have let this happened in America. Sure unemployment is high, but almost everyone has had a job at least once. And for that reason, I know that all of those people must have at least an inkling that organizations require us to move forward once in awhile just to keep it alive. Could a business survive if it was run like the U.S. Government? And I’m not just talking about deficits. I’m talking about having a plan. Or at least having a set of principles that we try to balance this Nation on top of.

I wouldn’t mind if the U.S. lost its vaulted position atop the world scene if we did so doing the right thing. And if we did the right thing, I sincerely doubt we would fall in the eyes of the world. Indeed, it is our inactivity itself that threatens our democracy.

I wish I knew what to say next.

Losing the War of Gonzo Language

Sticks and stones will break my bones, but words will doom me forever. Yes, it isn’t just semantics, as the colloquialism flows. Take this: in 2008, the Republicans were the party of big spending. That last clause doesn’t mean anything. Why? Well, because the words mean nothing. What is a Republican? One that believes in small government, of course. But that doesn’t mean anything either. When you define yourself, you beliefs, or the size of your member on relative terms, you’re really saying that all you want out of life is to differ in some way from someone else. And I call you a jellyfish. Or a dead possum. Or a Republican. Or one of any Congresspersons, for that matter.

See, everyone can make themselves look better than someone else for a little while. This is why guys bring acrostic guitars to parties in college. You will, without doubt, get laid that night. But what happens at breakfast?

What I’m getting at is this: words matter. But few believe that we have to define them anymore. They have a “feel” to them that matters. Big Government is bad. Spending is bad. But reality has a bitter edge that keeps folks from sleeping at night. So a pregnant illegal immigrant will get a doctor’s full attention to give a child a chance at life. But Christ! Give her health insurance before that moment makes you a socialist swine that gives and gives until our Beautiful Nation is bankrupt! Silly.

But let’s be fair. I’m not out to destroy Republicans here. I couldn’t, since they don’t exist. It isn’t their words only that are meaningless. So are those of the Democrats. I say that because they were swept into power and did little. They did some very great things, but their failures are greater. Where do we go?

We go here. Define what matters. If you use a relevant term, you should lose. Know what you believe and fight for it. Only then will we be able to be a creative nation yet again. Because right now, all the media talks about is sex-hungry golfers and war. Neither of those things will make a better mousetrap.

The 20th of February

Five years ago today, one of the great fires of our society extinguished itself. Today is dedicated to Dr. Hunter S. Thompson. Enjoy life like it's the only one you get.

The Land of Pharma – This Old Facility

The Industry has been busy. Engineers all over the world in Pharma, in other industries, and in the Regulatory bodies have been refining old methods of production and have been creating new technologies that can see into processes to help show that everything is happening as it should. This is wonderful. But…

At our company, WMC, we have the new facility we’re creating, of which we’ve discussed at length, and we have a number of older facilities. Some of these are as ancient as 1995. Yes, dear reader, fifteen years is ancient in the Land of Pharma. Poor fella can’t even have a beer yet and already he’s past his prime. Anyway, for some time, our production processes will be grandfathered in, so to speak, because the 15 years of use has shown them to be reliable. Regulators won’t question the design because it is of an older era. For awhile… But the old factories don’t have the latest technologies – each one with the potential to take processing closer to the edge of perfection: complete process understanding.

Process understanding is, simply, knowing everything about the process. Thinking on gross terms won’t work here. This is more than knowing the inputs and outputs. We are speaking of knowing how passing material through a one foot long tube impacts the material relative to using a tube only eleven inches long. Or knowing that a 90 degree bend in a pipe increases the destruction of cells in solution by 1% more than a bend of 110 degrees. This knowledge is perfection in the Industry. And it should be, for knowing these details enables the Company to make a vaccine that is incrementally more effective and safer. And cheaper, ultimately…er, eventually, since knowledge enables decisions that can make yields go up. Would anyone argue with that progress?

But at what cost? To implement this latest technological innovation, a vaccine that is said to have saved billions of dollars in hospital costs (you don’t go to the hospital if you’re not sick in the first place) must be taken off line for three months. Is incremental understanding worth starving the market of this illness preventing vaccine? And there is one other issue: the vaccine is only available, per Regulation, to children under 12. If the vaccine isn’t available for three months, what of those children that have yet to get the vaccine but will turn 12 before the vaccine is available again?

The solution is apparent. Production must be increased to stockpile the material to cover the downtime. Running at full capacity already doesn’t make this easy. The process must be expanded first in order to increase production, then the entire thing taken down to implement the new technology, at a cost of US$33 million, all told. This is very good news for the suppliers of the machines needed and for the new workers that get good paying jobs with good benefits so the machines will run. It is also another instance of the Company needing to have many millions of dollars on hand to pay for advancements that won’t produce returns for a very long time. At the end of this, realize, that you only have more information. It will take many years for talented scientists to understand what this information really means and how to use it.

Ahhh, the sweet taste of progress.

All this, of course, while we’re still investing in our new novel vaccine plant to produce Menengvax. We’ll return to that next time.

To the Ladies...

Happy Valentine's Day.

It occurs to me that I am America

The West – and America, in particular – is in the same boat as late 1940s Japan. We are in such deep debt that we cannot capitalize out way out of this financial nightmare. We, too, need a revolution in the way we operate. Let’s do it, then. Let’s do it at the ultimate government level.

We’ll begin now. So what are our basic principles? Any solution should be adaptable and able to evolve. Nothing too specific, like “we pay one million dollars to every county to implement computer tracking in prisons” can be listed, as that isn’t a principle. Our only principle will be this: The business of the Federal Government is to ensure a fully functioning infrastructure to support growth of a creative and innovative society.” In effect, that surmises the Declaration of Independence and the preamble to the U.S. Constitution in one sentence. But we have to deal with a word in that sentence: infrastructure.

I think it is safe to say that we all will agree that roads are infrastructure. Having a system of roads allows for people to move to where they are needed to work and to where they want to live and find happiness. I’ll say the same for sidewalks. Look! We’re well on our way.

Early in the history of electricity, the electric grid was viewed in this same way. The same is true for potable water distribution and sewage collection. Though maybe more controversial than roads (maybe because we’re just not used to it), I claim that these things are also infrastructure.

The military, police, prison systems, and executive cabinet positions, such as environmental protection and public health are also infrastructure, in my book, but in a more specific way than they are practiced today. The fact that we need these things in order to ensure protection of the fundamental principle and resources makes them infrastructure, maybe, but that doesn’t give any of them a blank check to inject themselves into any and all parts of our life. It doesn’t give them unlimited funding, either. Public health can run the FDA and regulate the production of medicine and cigarettes, but it shouldn’t be able to say that it is illegal for us to smoke pot. It can only present the real data that is known about any of these substances and study what is not yet known. The military is charged to protect the country, but having a standing army at full-war readiness levels all the time isn’t a foregone conclusion. We have to play within the system, after all, and nobody is smart enough to micromanage every earthling on the cheap. This leads into another – and the most vital – part of infrastructure: education.

When was Civics taken out of your high school? When were you last expected to understand the full breadth of risks associated with something you ingested, instead of relying on a seal of approval from a governmental watch dog group? And how would have you been able to research the structure of mortgage investments to determine whether you wanted to risk the funds in your 401k in those securities or not, should have you wanted to? Do you realize that everyone gets a cold sometimes, or do you go to the emergency room when you cough? No governmental reform will succeed in providing the bedrock for a happy and innovative society if the people under that government are ignorant of what is out there and why. Having the knowledge (or access to it) to assess the outcomes of our decisions is the way society has grown over the millennia and it is no less important now. Education, then, is infrastructure for us, going forward. Without it, nothing else really matters.

What can help to support a good education infrastructure? Some of the basics are ensuring full access to everyone, that students are not hungry, and that they can see the board and the books in order to read what is being taught. Thus, equality and some basic form of health assistance is infrastructure for an innovative society.

Without any detail, these are only the first level definitions of the word “infrastructure,” which is vital to our basic principle. We don’t need to worry about funding, implications, existing social or business roadblocks or anything else yet. We only need to agree on two things: 1) what is the point of having a country and 2) what principle guides that country’s government. Still, I feel that these claims are being less accepted by the “right” as I move along. But I don’t understand why. This all seems perfectly obvious to me.

This is not meant to be a full list of what should be in infrastructure. Perhaps you, my dear readers, can offer opinions.

The Land of Pharma: The Toyota Production System

A lot has been made of Toyota being a benchmark of Quality lately. This is due, of course, to the incredible lack of quality that has popped up in their vehicles designed and produced during their march to the top of the world automotive industry. There has been little detail around the reasons for this failure save the normal weak explanations like “they grew too fast” and “they got greedy.” What a horrible shame this is and what a freakishly perfect example of the ineptitude of major media, as well. Please, dear reader, allow me to do my best to fill in the back story. I will keep it concise.

In 1945, the US blew up Japan and then took it over (concise enough?). We had a reconstruction policy that was, in a word, perfect. We did everything we could to instill what we believed to be right (after all, if Western Society didn’t believe it to be right, we wouldn’t be doing it) and set up Japan to be even better at it than we were. Years go by and in the latter part of the century, while the US was producing the Chevy Luv and other such nonsense, Japan had put their shoulder to the wheel. Toyota, the largest car company there, knew that the only way they could ever compete was to make superior product. Still on the outs from having had nuclear weapons dropped on them, they couldn’t ever invest capital in the same way GM or Ford could. Enter, the Toyota Production System (TPS).

The TPS espoused that if one never wasted anything (no rejected parts, no downtime for workers or machines, no scrap that could be used elsewhere) then they would have a “lean” system that produced only Quality products. This is to say, if you never have to reject anything, you never made anything that had to be rejected in the first place. Brilliant, huh?

So as everyone else in manufacturing realized that Toyota cars lasted forever, that their margins were fat, and that their manufacturing never went down, everyone began to adopt the same principles.

Let me say that you are probably saying to yourself “this TPS thing is just common sense like ‘waste not, want not’ and a dozen other old-timey sayings” and you are right. Don’t let that fact distract you.

Anyway, to get to the point, the culprit here in the takedown of Toyota is greed. And not necessarily bad greed where they just want cash, but the kind of greed that is tunnel-vision and just turns the eye away from the foundational principles that made something great in the first place. For the people that developed the TPS, the overall goal was always Quality. Being “lean” didn’t equal profits directly. Lean equaled quality products, which equaled a good reputation, which equaled sustainability, which equaled profits. But all of those equal signs got confusing, and something was identified as “waste” which was actually one of those intangibles that must exist in human culture: measure twice and cut once because well-meaning people get it wrong sometime. Here, it was the process engineers that thought “That should get it” and they didn’t measure again. And that culture of peer review seems to have been lost overall, as a lot of little issues keep popping up for Toyota now.

Don’t get me wrong: I believe in “waste not, want not” and the principles of the TPS get you there in a lot of ways. But like any tool, it is only as good as the folks using it. So up here in the Land of Pharma, we measure a dozen times and then talk about cutting, because medicine isn’t a car.

Land of Pharma - Good News, no matter how long...

It has been quite awhile since we revisited the Land of Pharma. This time, I am only putting forth some good information published in the Wall Street Journal on 03 Feb 2010:

Lancet Retracts Study Tying Vaccine to Autism
By Shirley S. Wang
The study that first suggested a link between vaccines and autism and spurred a long-running, acrimonious debate over the safety of vaccines has been retracted by the British medical journal that published it. The withdrawal supports the scientific evidence that vaccinations don't cause autism, but isn't likely to persuade advocacy groups that believe in a link.
A new autism study shows clusters of high autism rates in parts of California. WSJ's health columnist Melinda Beck joins Simon Constable on the News Hub with more.
The 1998 study of 12 children triggered worry among British parents that the measles-mumps-rubella vaccine caused autism, and many decided not to immunize their children against measles, according to Richard Horton, editor in chief of the Lancet, which issued the retraction Tuesday. He called the study the "starting pistol," though not the only cause, of the controversy.
Concern about the safety of vaccines, particularly regarding the preservative often used, thimerosal, which contains mercury, spread to the U.S. as well. Research has shown that as many as 2.1% of U.S. children weren't immunized with the MMR vaccine in 2000, up from 0.77% of children in 1995, according to a 2008 study published in Pediatrics.
"This retraction by the Lancet came far too late," said Paul Offit, chief of infectious diseases at Children's Hospital of Philadelphia and a coinventor of a vaccination for babies against a gastrointestinal virus, Rotateq, that is marketed by Merck & Co. "It's very easy to scare people; it's very hard to unscare them."
A widely cited 2004 statistical review of existing studies by nonprofit health-information provider the Institute of Medicine, which traced the vaccine theory back to the Lancet study, concluded there was no causal link between the MMR vaccine and autism. Some autism activist groups, however, continue to advocate against vaccinations for children, despite the lack of scientific evidence for such a link.
"Certainly the retraction of this paper doesn't mean that MMR doesn't cause autism and it's all a farce," said Wendy Fournier, president of the National Autism Association. It is "possible" that the MMR vaccine causes autism, she said, but "the science is not there in terms of the mechanism." The concern is that measles virus has been found in children's intestines after vaccination, said Ms. Fournier.
"No one is anti-vaccine," she said. "It's a matter of having vaccines be as safe as they can."
A study published in 2008 by researchers from several universities and the Centers for Disease Control and Prevention examined children with gastrointestinal problems who had autism compared with those who didn't have autism. They concluded there wasn't any evidence that the vaccine was responsible for autism.
Ten of the 13 authors of the original paper, all of whom were researchers at the Royal Free Hospital and School of Medicine in London, partially retracted the paper in 2004. However, the first author, Andrew Wakefield, didn't. Dr. Wakefield, who is now at the Thoughtful House Center for Children in Austin, Texas, didn't immediately return phone calls seeking comment.
"Many consumer groups have spent 10 years waging a campaign against vaccines even in the face of scientific evidence," said Dr. Horton of the Lancet. "We didn't have the evidence back in 2004 to fully retract the paper but we did have enough concern to persuade the authors to partly retract the paper."
The Lancet decided to issue a complete retraction after an independent regulator for doctors in the U.K. concluded last week that the study was flawed. The General Medical Council's report on three of the researchers, including Dr. Wakefield, found evidence that some of their actions were conducted for experimental purposes, not clinical care, and without ethics approval. The report also found that Dr. Wakefield drew blood for research purposes from children at his son's birthday party, paying each child £5 (about $8).
The Lancet's Dr. Horton said the journal was particularly concerned about the ethical treatment of the children in the study, and that the children had been "cherry-picked" by the study's authors rather than just showing up in the hospital, as described in the paper.
The authors "did suggest these children arrived one after another and this syndrome was apparent, which does lead you to think this is something serious," said Dr. Horton.
"I hope this brings closure to this controversy," said Fred Volkmar, an autism researcher and professor of psychiatry at the Yale Child Study Center who wasn't involved in the Lancet study. "My fear, unfortunately, is that this won't totally allay the fear of all parents."
In the 1998 paper, Dr. Wakefield and his colleagues described 12 children with gastrointestinal problems. Eight experienced symptoms that were thought to be related to the MMR vaccine, according to their parents or a doctor, and nine of the 12 children exhibited autistic behaviors.
Dr. Wakefield has been outspoken about his concern about the measles vaccine. He has continually pushed the view that the vaccine caused autism, said Greg Poland, professor of medicine and infectious diseases at the Mayo Clinic and director of the vaccine research group in Rochester, Minn.
"With the retraction, the hypothesis that he put forward has been debunked," said Dr. Poland.