AdvaMed: Hey if we reeeally want to scare them away we need to throw around the word "innovation"

Here is the article link:

http://online.wsj.com/article/BT-CO-20090415-716238.html?mod=dist_smartbrief

Nothing outside this statement can be farther from the truth about pre-emption:

""Nothing chases away advanced medical device innovation like uncertainty" about whether a company is going to get sued for its product, said Stephen J. Ubl, AdvaMed's president."

What is innovation?

For one, it has nothing to do with the fear of being sued. That would be "AdvaMed-artifically-generated-phobia".

Here is what the paragon of truthisms, Wikipedia has to say on innovation:

"The term innovation means a new way of doing something. It may refer to incremental, radical, and revolutionary changes in thinking, products ..."

Reference: en.wikipedia.org/wiki/Innovation

Innovation would be saying, "Let's not start another drug eluting stent company, only to lay off 111 out of 121 folks after a few years. Let's either prove that drug eluting stents work or let's find a new way to cure disease."

Innovation could also be innovation in cost restructuring, outside of keeping the devilishly under-performing CEO, handing him out bonuses and laying off 20% of your workforce (amounts to 4,300 employees. Very hard to find out which "innovative" company I am talking about).

Innovation could be steps taken in shorter time to establish Design Validation, better designs, better manufacturing, Design for Manufacturability and so on.

What else could innovation be?

Surprisingly, it could be some of this:

1. When patients die because of your device, report them, promptly! No "the dog ate my adverse reaction reports".

2. When patients' hips start squeaking and their ICD batteries die out, start investigating.

3. When your product is the result of some bad "fitting round pegs into square holes", apologize - no medical device company has done that before. It would count as one heck of an innovation!

4. Do post-market follow up, not because the FDA weakly grunts about it, but because it is something you ought to do!

5. Stop subscribing to AdvaMed and it's opinion pieces.

Are innovation and torts related?

Absolutely not. Here is how a typical medical device gets to market:

1. Doctor and couple of engineers get together in a garage. They sit on the device for a while, think of and do all kinds of crazy things. They then double mortgage their house and go present in West this conference and East that conference.

2. After several failures and crazy ideas, some random thing works. Then a couple of years down the line they get funding and muck about sleeplessly for a few more.

3. They start selling the first generation, possibly first-in-class device. They are about to hit the IPO.

4. Really fat company rolls (lumbers and sometimes huffs and puffs) in and purchases them. Wants to impose it's "culture". Brings strange looking aliens (managers, change agents, transfer managers and such are their taxonomic guises) who want to change everything from the coffee machine to the CAD program.

5. All the "good" folks leave or are kicked out. The people who are left are still well meaning people staring at designs they don't understand. New people replace yet another layer of skimmed off people. Eventually, no one knows what's going on where.

6. The second in class device based on "marketing driven product development" and other wonders of nature gets to market.

7. Hips squeak, leads break, stents fail, meters dole out improper readings and patients, of course, die or become otherwise greviously injured!

In this whole mess innovation can only possibly happen from step 1 to 3. Torts happen after step 7. The FDA is a thematic black comedy that spans all these steps, but really doesn't affect anything, at least positively.

So, are torts and innovation related? No!

But don't we still need pre-emption?

Nope.

First of all, the Supreme Court Judges are acting like a bunch of txting teenagers. On the one hand they say that devices are subjected to pre-emption but on the other hand they say that the same iconic government agency (I mean the F, D and A) is ill-equipped to regulate drugs pre-emptively.

What gives?

Secondly, "the fear of lawsuits is the mother of many things". If these companies walked off on a permanent basis from responsibility (helped by the likes of the Federal Judge "Kyle" from Minnesota), then consumers, in this case patients, dead, dying or a loved one, have absolutely no respite.

A parting word for AdvaMed

So, let's not abuse the word innovation please. Let's start with listing your "donors" and "Corporate Members" somewhere easily accessible on the home page. That would make it so much easy for us to separate reality from Kool Aid and find out who really is going to be chased away from innovation and if that indeed is an ironic oxymoron...

Congratulations old people of the Supreme Court - your "get out of jail free card" called preemption is live and kicking....

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...patients where it really hurts!!!

We now have a perfect system to circumvent any need for accountability or justice. We can watch patients die or be put through unnecessary morbidity by firms without any need for worry, whatsoever.

I am not talking only of Medtronic mind you - this article refers to their cases that were dismissed. Very recently, Stryker also walked away from any responsibility from similar cases filed in Colorado.

The FDA is dead and useless for all practical purposes, and the only lawmaker who even seems to know anything about all this is of course, Grassley, but that is almost plain hypocrisy since it is the Republicans who appointed the Supreme Court Justices and cheered the industry on to weaken regulation on any and every kind.

We do have only God (who created us 6,000 years ago alongside the dinosaurs by the way) to thank for the continued existence of the FDA - given President Bush's propensity to allow "free" markets and deregulation even when everything fails.

However, I do not trust the Democrats to stand up for, against or with anything. Even with 39 senators, Republicans can hold the Senate to ransom because Democrats are chronically weak, aimless and never in charge. Moreover, their focus is to bring in their grandchildren to inaugural ceremonies of every sort, and Obama is focused on "diversities of opinion" at the expense of the people who voted for him and stood by him.

Meanwhile, in other parts of the galaxy - companies do recalls, fail to sell products of any remarkable quality and are now well protected!!!

Apparently, the FDA is thrilled that there were "fewer" clinical trial rule violations in 2007 (that may be because they are all waiting 6 months to a few years before feigning knowledge of breaking the law!)

Read about it here:
http://www.smartbrief.com/news/advamed/storyDetails.jsp?issueid=7AAC37B8-F2E5-438D-82C6-FCA5A7DF75F9©id=F24E6520-7502-4050-9A02-DDC0053774B5

Sigh! Watch this space for continue sad and bleak revelations on the fruits that preemption will bear.

Meanwhile, an infamous stent manufacturing "power house" medical device company whose stock is worth less than fodder, just acquired a company in Ireland - this after laying off hundreds of well meaning employees and unloading assets over the last month.

Irresponsibility, seems to be the backbone of 21st century medical device manufacturing...

Oh, happy new year, by the way.

Well, Joe the plumber, I mean stent maker, I mean emancipated plumber, listen up...

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The Premise
The link up here refers to an article from The Canadian Press telling a grim tale of Angiotech's bleak future stemming from its inability to raise much needed funds.

And no, it has nothing to do with the "financial crisis" caused by banks that tried to make "something out of nothing". This has something to do with "drug eluting stents" which I also believe has a lot to do with the words something and nothing...

I have long lamented the lack of definitive proof that drug eluting stents, or for that matter if stents really work at all. The same question and lament goes to the "pioneers" of "balloon, bell and whistle angioplasty" who are labeling themselves experts and innovators quite generously.

Well, let's comeback to the stents beeswax anyway..

Not only have stents not performed in the market, they have also failed to perform inside the human body. Angiotech is just another proof of organizations that overtly stressed and counted on an unproven "technology", in this case Taxus.

What intrigues me is that the FDA has failed to question any of the drug eluting stents and their effectiveness. Our darling, the beautiful baby called "preemption" that the lovely Supreme Court handed us, allows us to theoretically assume that an FDA approval precludes "high levels of performance strictly in accordance with product labeling and marketing for which the device has been approved", how come reality seems to differ?

(Well, we all know accepting preemption is like stepping on horse do and continuing to stand on it, pretending the odor will just go away...well, if the device was put inside you and someone claimed preemption, how will you feel? Ever thought of that amigos?)

This is the last call for passengers of the "reality express" to dismount from the plumbing, er, stenting train.

Here are somethings to think about:

1. A nexus proof, large scale study on drug eluting stents. NIH should be dumping money on this, if at all to stop the money bleeding and waste on health care costs.

2. Companies, especially startups, (you know the ones that don't have too much money to throw away on full page ads, sponsorship of TCT and so on...) should really, really ask themselves if they want to go down the elusive, I mean eluting stent business?

3. VCs should really question further investment in stent companies. Let's see - where did Taxus get BSC and now Angiotech? What has Endavor done to Medtronic? And Xience, well its just Taxus (in case you don't know the whole Guidant story - which means a large portion of this rant makes no sense to you).

And no, I am not buying the bio-resorbable theory either..till I see scientific proof.

4. There seem to be so many companies with the -stent suffix, ThisStent, ThatStent and the NewNewStent..that soon we won't have "-stent" name combinations left...at least somebody stop it for that sake please!

5. Somebody should ask the FDA if it remembers what "post market followup" means. And they should also ask the FDA if they remember having something to do with enforcing something called "post market approvals and follow up".

People who advocate drug eluting stents to me right now look like people propounding all those "weight loss" drugs on TV.

Don't believe me? - I will give you a list of companies. Go look at their current status with reference to stents - BSC, Medtronic, Xtent, Angiotech...

A few random FEA runs on stent designs do not make for fundamental, analytical, scientific proof, without which we should rather be advocating healthier lifestyles and medical treatment.