Friday, November 21, 2008

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

[Click on Post Title for Link to External Article]

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 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.

Thursday, November 06, 2008

So, is there one thing that is not wrong with the FDA? Maybe Grassley should start checking off things that are right...

[Click on Post Title for Link to External Article]

Okay, so the FDA cannot get one thing right:

1. They have a very, very poor record on approvals - Avandia, Celebrex, Vioxx, Drug Eluting Stents (being continually approved despite the fact that EVERY single one of them has performance issues, fatalities and demonstrated weakness compared to medical treatment)

2. They have been so ineffective that companies openly disrespect them - before warning Bayer, the FDA did indicate to them that there was trouble brewing. Bayer didn't care. Take a look at the DTC ads by "Dr." Jarvik and how much pain even Congress had to go through to take him off air (yes, I was one of the folks duped by the ads with him as well, and I am still smarting!).

3. The website that the FDA put together on DTC ads to "inform" consumers was designed by a "non-profit" (which of course helps put all the good non-profits to shame) that is a front for the mob, er, pharmaceutical companies. This just makes me sound like one of those Area 51 conspiracy freaks, but this is real! :

And oh well, now this!

4. The FDA mismanaged and harassed its own employees - overpaying them and then threatening them with collection letters and such...

It makes you wonder if the FDA is deliberately harassing its employees to make sure it helps filter any possible talent that may even accidentally enter the FDA so that it can, in the words of someone we are all trying to forget "pall around with the pharma and medical device companies"!

This at a time when the FDA has brazenly sought more money to hire 1,300 hapless souls so that they can underpay them or overpay them only to shower them with collection letters and insult and humiliate them as much as possible.

In times of steeped economic strife, they must be getting special kicks out of this.

It makes one wonder, how "change" can be brought to the FDA!

Will it be Grassley who effects this? Or will we be just adding more bullets to describe the miracle that the FDA is as years pass....