Archive for November, 2008

Be careful what you wish for…

November 21, 2008

Recently, the Supreme Court heard arguments in Wyeth Vs. Levine.  This case has some import to the general public, but it has incredible impact on FDA regulated companies.  And that impact is just about exactly opposite of what Wyeth (the drug manufacturer defendant) expects.  In this case, to win is to lose.  Big. I work in the Medical Device industry, regulated by the FDA, audited by the FDA, and I understand how the system works today.  If Wyeth wins their case, it may grind the drug and device industries to a halt.

Basically, Wyeth is claiming that since the FDA approved their label, they are absolved of any further responsibility in making sure that label was effective.  Some background: A woman (Levine) lost her arm due to infection caused by side effects from how the doctors delivered Wyeth’s medication.  She claims the warnings on delivery methods were insufficient.  Rather than simply argue that they actually were sufficient, Wyeth claims that since the label was judged “effective” and “accurate” by the FDA, Levine has no grounds to sue.  (This is an oversimplification, but it highlights the key issue. And lest you think “but no one could fit all those warnings on an itty-bitty label, “Labeling” to the FDA means all documentation provided with the drug or device.)

If Wyeth wins, it will be a Pyrrhic victory for this reason: right now the FDA relies heavily on industry to evaluate the safety and efficacy of its own products (and this is a ‘good thing’ as I think will become apparent below).  To a large extent, what the FDA does is make sure you have an adequate process to evaluate and mitigate risk, and make sure you followed it.  Again, I’m oversimplifying but that’s the crux – if you demonstrate good process and accept responsibility, the FDA starts out assuming that your declarations are good, and only checks to see if there is evidence that they are not. If Wyeth wins, the burden of responsibility shifts – the FDA must assume that your declarations are inadequate and must dictate corrections.  This will devastate the industry.  It will cripple American medical innovation, and the American drug and device approval system, long considered the gold standard throughout the world, will grind to a halt.  The European equivalent will become dominant, because only it will be able to move drugs and devices through the process.

I hate to be over dramatic in these writings, but re-reading the above, I can’t find fault with what I wrote.  The FDA simply does not have the number of people, nor the type of people to analyze every specific claim.  The people who can do that the best are the drug and device manufacturers and the trust between industry and FDA is one of the most valuable assets those manufacturers hold.  For the sake of winning a single lawsuit, Wyeth is throwing this away, not just for themselves, but for every other manufacturer.  They have been given tragically wrong advice from their legal departments. After working Congress for years to pressure the FDA to speed up the approval process, resulting in real gains, gains that translate into helping people NOW rather than several years after they die, a Wyeth win will single handedly roll back back those gains.  Because if the FDA granting approval absolves manufacturers of liability, then the FDA is obligated to make sure it understands and approves all the data.  That it keeps current with all the complaints and incident reports and checks them against labeling.  That it has the expertise and cognizence to be the primary checker of safety rather than the ‘guardians of the guardians’.  It’s not even possible.  There are thousands of drug and device manufactures, millions of people working on these issues, and an FDA that ensures those manufacturers and people are doing everything they can to ensure safety, is the best FDA we can imagine. To shift this to “if we can get it past the FDA we absolve ourselves of responsibility” puts such an adversarial role on the government that we may never get another life saving drug or technology out into the market.

Imagine you are that FDA employee.  The Supreme Court states that once you approve something the FDA is responsible, which means that YOU are responsible.  Your signature takes upon your conscience the woman who lost an arm, the family that lost a mother, the straight A son who becomes a vegetable.  You are not a doctor, a surgeon, a specialist in drug reactions.  How long will it take you to sign on the dotted line?

Andrew Sullivan trying too hard

November 20, 2008

In this post Andrew Sullivan basically states that since Califronia voters decided to take away rights from homosexuals, he has to go along with it.  Methinks Andrew is overcompensating for his Obama support and trying too hard to be the good conservative – state’s rights and all that.  Much as I like Andrew, he’s wrong on this one.  One of the important reasons we have a constitutional democracy as opposed to a pure democracy is that the minority is protected from the will of the majority.  The courts can overturn laws that violate this. If this wasn’t true, I think there would be a pretty strong case for taking away the rights of Mormons, or perhaps members of the Knights of Columbus, two groups who gave more to the Pro-8 cause than anyone else.  I guess that’s a good question for Andrew: if it’s OK for the majority to vote away rights from a minority, is it OK if someone starts a campaign to strip marriage rights from Mormons?  I’ll sign the petition…

GM Again…

November 17, 2008

The auto bailout plan is for GM, Chrysler and Ford.  Chrysler has made some efforts, and Ford actually has a viable business plan.  But GM is truly headed by a bunch of nitwits, with the chief nitwit being a global warming denier.  The Volt may sound interesting, but it exactly follows another GM fiasco of 20 years ago – the “Factory of the Future”  And no one is talking about helping out Tesla, a real innovator, a company that has seen the way technology is heading and has decided to jump ahead of it.  I’m not saying the Big Three could be Tesla, they are different animals, but to throw a lifeline to GM management while throwing an anchor to Tesla is moronic.

So what does the Volt have in common with the Factory of the Future? Someone in management at GM latches on to a “savior” technology and starts riding it.  The other management don’t want to hear it, because they believe what they are doing is just fine and surround themselves with blowhards who tell them what they want to hear.  The Cassandra who is championing the new technology ratchets up the hype, trying to convince everyone else.  They get money for studies and senior management sees that it brings good press and attention from the board.  A real crisis hits and they hastily bet the farm on this new technology.  Rather than a sensible, steady work, steady rewards plan (think Toyota, Honda, or NASA during the moon launch), they go for the masterwork in one giant leap.  Costs mount, technological difficulties become overwhelming, and expectations are ratcheted down in proportion to the amount of delay.  It “launches” as a shell of what was promised, a few executives get pushed into early retirement, and everyone else starts waving and pointing at the new shiny thing.”

With Volt, we are at the “launching as a shell of what was promised” – it will cost $50-60K rather than $25K as orginally planned.  The prototype styling was incredible, the delivered version looks like another GM blob-0-matic.  And executives are downplaying the acceleration and handling.

GM Forever

November 15, 2008

A little more on the auto bailout.

  1. Yglesias is spot on in this post
  2. The argument is not about saving a huge job creation engine, aka GM.  That horse is already dead.  The bailout just keeps it from hitting the ground.
  3. Bailing it out keeps resources flowing to a brain dead company that hasn’t had a serious original idea in decades, rather than to one (or many) that can seriously innovate.  By serious I mean things like hybrids, quality in small cars, safety frames, i.e. things that other companies were created or resurrected by.  I don’t mean phony hail mary passes like the hydrogen car (where did that go by the way?  Didn’t GM Management swear just a few years ago that they were really really serious about investing in the hydrogen powered car as their future.  Remember, that was the reason we didn’t legislate increased fuel economy – it would only distract them from that “bet the company” endeavor), or the Chevy Volt ($50K plus for something that looks like a Cobalt, accelerates like a Vega and probably drives like Grandma’s Buick?).  And I don’t mean stupid moves like the “Factory of the Future” (We’re not going to learn how to use the technology first, we’re just going to throw billions of dollars into doing it all at once.  It’s like the guy who thinks he’ll try a little home handyman stuff for the first time in his life and immediately sets out to re-wire, re-plumb, redo the kitchen and bathrooms, and move all the load bearing walls, and by the way, he’s never so much as painted a wall before.

The pro-bailout faction keeps coming back to the idea that it’s too big to let fail, but hey, GM HAS ALREADY FAILED. What you’re proposing isn’t a bailout, it’s a 40 billion dollar remake of “Weekend at Bernies”.

Liberal/Conservative/Hammer…

November 12, 2008

For many years, if really pressed, I’ve self identified as a liberal. Lately, I’ve called myself a progressive but say I supported liberal policies. In reality though, I think the whole liberal/conservative thing is meaningless. I’ve never found anyone who can describe to me what fundamental principles (not policies, but principles) a liberal or a conservative should harken too, and then could successfully map those on to people “everyone knows” is liberal or conservative. Free Speech? Whose? When? Where? Burning the flag? Publishing a column in a university paper decrying the Jewish conspiracy?

So long ago I came up with my own definition of liberal and conservative.  A liberal position is one where change from the status quo or historical behaviors is pushed in order to realize a  better outcome.  A conservative position is one where more strict adherence to the status quo or historical behaviors is pushed.  I worked with that for a number of years and then modified the conservative one to include imagined status quo.  Because a lot of time what is considered “the way things have always been” is not really the way things have always been, but I understand the intent.

So when someone asks me if I am liberal or conservative, I’ll often ask “about what?” Because “what” matters.  Under my definition asking if you are a liberal or conservative is equivalent to asking a handyman if he will use a hammer or a screwdriver before telling them what you need fixed.  We have a name for someone who always uses a hammer on every problem: “idiot”.

This definition makes me feel good, but unfortunately, no one else seems to hold it, so it really doesn’t do me

Auto bailout

November 8, 2008

I couldn’t tell you if the coming auto bailout is a good or bad thing for the rest of the country. But I know this: if we bail out the automobile industry but leave in place the screw-ups who have been running Detroit for the past two generations, we would be better off burning the money for fuel.

As long as I can remember Detroit management has provided best-in-field innovation. Unfortunately it hasn’t been in automobile engineering. Instead they have led the world in whining. In the 70’s and 80’s they built junk, garbage cars that fell apart in a few years. Rather than see this as a problem, they continued to engineer in “planned obsolescence” but were wildly successful in getting the US government to impose “voluntary” import quotas on Japanese auto makers. In other words, the American people wanted fuel efficient, reliable, good looking and maneuverable cars, and rather than attempt to provide them, the Big Three convinced the US government to shaft its citizens and make it harder to buy them from the companies willing to make them.

The list of US Automanufacturers whining and special pleading is a mile long, but here’s a few notable episodes:

– The “It Can’t Be Done” response to government mandated fuel efficiency and pollution control in the 70’s. Hysteria, outrage, fear mongering – Detroit generated these in mega-doses as they spelled out the consequences to the American Way of LIFE! ™ if these foolhardy laws weren’t repealed. Honda, on the other hand, came out of nowhere and simply met and then exceeded all the mandates. You remember Honda? The car company that has done very well in the past decade and is still doing well now that the economy is down and fuel prices are doubled what they were before? Oh, and by the way: Honda Accords are built in the USA by UAW workers.

– The “Health Care Costs Are Killing Us” mantra. They endlessly trumpet a $1500 per vehicle penalty they have because of benefit costs as compared to other makers. Of course a big part of this is health care costs, both for current and retired workers. So obviously Detroit is using some of it’s lobbying army to persuade Congress to get serious about universal coverage, right? Take the burden off companies and put it on government/private citizens as is done in every other country with a per capita income north of $5000? Nah, if they lobbied for that the execs might get kicked out of the “Serious Businessman’s Club”, so instead they move production to Mexico. There is one huge flaw with their argument though. If they could be profitable with another $1500 per car, why don’t they simply build cars people are willing to pay $1500 more for? Simplistic and naive? Just remember, there isn’t a category of car that US citizens aren’t willing to pay a $1500 premium for, if it is made by Honda or Toyota. From the smallest econobox to the fanciest luxury vehicle, people are willing to pay $1500, $2000, $5000, or even more for the corresponding Toyota or Honda as compared to the equivalent car from GM or Ford.

– And last but not least, the old “But No One Could Have Predicted This” moan. I guess when Global Warning skeptics occupy your top leadership positions, the idea that oil might one day reach a production peak sounds farcical. But the rest of the world was asking “when?” and planning for it.

So when GM, Ford and Chrysler come with their hands out, the Administration should make it clear nothing comes out until the board acts to solve the fundamental problem: idiots in charge.

Why Barack Obama really broke the mold

November 7, 2008

Barack Obama is our first black president, and the mold for that has been middle aged to elderly white guy since George Washington. But somebody was eventually going to become the first, and I thought they would fit a mold of their own.

When a country elects its first woman president or prime minister, it is often someone who totally breaks the “woman” mold. Tough, stern, decisive and ruthless. Think Maggie Thatcher, Indira Ghandi, Golda Meir. So I expected the first black president to break the “black” mold. Someone like Colin Powell – Republican, quiet, kind of boring.

So how did a progressive democrat, young and charismatic become the first black president? I imagine it was because the total incompetence of the previous administration became the only mold he needed to break. In the end, a majority of people really didn’t care that much about his party affiliation, his youth, his charisma/celebrity. In the end, they just cared that he seemed competent.

Another Palin Prediction…

November 6, 2008

OK, so I got one right.  Here’s another, but it has a big “if” in it.

Newsweek is reporting that Sarah Palin’s $150K shopping spree was a) a lot bigger, and b) actually orchestrated by her, despite her denials.  She had aides do the shopping on their credit cards and only now are the receipts being submitted.  Additional charges like $40K for her husbands outfits.

If these charges are true (the big “if”), then Sarah Palin is washed up nationally.  These clothes will be to her what shoes are to Imelda Marcos.

At least Marcos didn’t lie about the shoes when she got found out.

– Romulus

Geek Porn – Sony Roly

November 1, 2008

Check out this new gadget from Sony Rolly

http://www.youtube.com/watch?v=HTxdKi77G20&feature=rec-fresh
Remus

Defense Budget and Obama

November 1, 2008

Obama will inherit an out-of-control defense budget because of the wars, all the new systems and equipment, and the corruption of the contractor system.  If he attacks this head on, he will be accused of being weak on defense.  To avoid this he should first start investigating waste, fraud and abuse.  This should be done with no fanfare until there is a sufficient number of successful cases.  This will help prime public opinion as well as make DOD officials more cautious in going after him.

Remus