[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 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.
Showing posts with label problems with drug eluting stents. Show all posts
Showing posts with label problems with drug eluting stents. Show all posts
Friday, November 21, 2008
Saturday, December 15, 2007
Update: Stent Startup facing difficulty with IPO..
[Click on Post Title for Link to External Article]
Here is my post from yesterday:
http://chaaraka.blogspot.com/2007/12/drug-eluting-stents-what-very-proactive.html
So, I talked about the FDA and their much delayed, yet knee-jerk reaction on DES. I also talked about how stent companies do keep popping up, regardless of several issues with perception. To sum it up, I defined how the major stent players are more worried about litigation on defective products than in actually trying to understand (I am pretty sure - no one has a clue) if stents are actually effective and proving it medically and scientifically.
Referring back to the article on VentureBeat, it is a little bothersome to me that they didn't react quickly. What is it that they were doing from May all the way through December? Yes, and what is with all the secrecy?
Well, it maybe that Devax has other issues to deal with. But they are venture funded. So aren't their investors interested in making sure Devax doesn't raise unwanted suspicions?
Maybe we will hear from them soon....
It is interesting though that Venture Capitalists do continue to fund stent companies. Only time will tell if these "new" stent companies will revive the market or if the whole thing will unravel. One thing we would not expect to see as much is the kind of mania that surrounded DES when they were first introduced.
Add to Onlywire
Here is my post from yesterday:
http://chaaraka.blogspot.com/2007/12/drug-eluting-stents-what-very-proactive.html
So, I talked about the FDA and their much delayed, yet knee-jerk reaction on DES. I also talked about how stent companies do keep popping up, regardless of several issues with perception. To sum it up, I defined how the major stent players are more worried about litigation on defective products than in actually trying to understand (I am pretty sure - no one has a clue) if stents are actually effective and proving it medically and scientifically.
Referring back to the article on VentureBeat, it is a little bothersome to me that they didn't react quickly. What is it that they were doing from May all the way through December? Yes, and what is with all the secrecy?
Well, it maybe that Devax has other issues to deal with. But they are venture funded. So aren't their investors interested in making sure Devax doesn't raise unwanted suspicions?
Maybe we will hear from them soon....
It is interesting though that Venture Capitalists do continue to fund stent companies. Only time will tell if these "new" stent companies will revive the market or if the whole thing will unravel. One thing we would not expect to see as much is the kind of mania that surrounded DES when they were first introduced.
Add to Onlywire
Friday, December 14, 2007
Drug Eluting Stents - what a very proactive, caring FDA has decided to do
[Click on Post Title for Link to External Article]
It seems like dinosaurs were converted to fuel faster. How long drawn out is the drug eluting stent story going to be? Are DES actually effective? If they are, what is happening with all those deaths and increases in mortality risk?
Is the problem with the drugs? Because stents work don't they? Or do stents work either?
While you may think these don't fall under the gamut of the FDA....they do have a responsibility to patients, companies and stock holders of publicly traded medical device companies.
The essential problem is that the device industry has not always paid a lot of attention to thorough analysis. To date, effective analysis has not been performed on what stents actually do.
Wasn't it one hell of a shocker to find out that angioplasty for all the hue and cry it created and made rich folks out of a handful few is actually not that effective when you compare it to drugs?
So, expert one day, lucky guy another....no one is an expert anymore.
Our only way to find out whether or not something works is to build it, build a hype around it, bring the FDA into the hype-building exercise and then when patients die...overreact!
Indeed, it is the stone ages of medical devices today. We hit something over the head and if it survives..it works!
Trying out unproven treatments on a whole lot of people based on a slim history to pass judgements is veritably not the right way to device use.
Where lies the solution? Definitely not with the FDA. The FDA has proven itself quite ineffective and gullible to industry pressure.
The solution lies in smart companies and in University laboratories. Instead of "teaching" people how to make devices, some of these schools would benefit from spending research effort and energy on building appropriate models of the human body, with respect to both anatomy and physiology and then study the interaction of the device with the body, and the long term effects of the device. The NIH will also benefit the industry by jumping in with grants..
Of course, data generated from devices should still not be ignored. It is a very critical source for further analysis wherever the models would become inaccurate.
Will it slow down product development? Not really. The current model for developing devices and bringing them to the market is fairly successful. No one is asking for an "overhaul" of the very basics of the industry. (Imagine suggesting that - boy would the bubble burst!)
A sound analytical background should be built around the device development process. That is already being done by the really good companies that spare no expense to ensure that they are actually building effective devices. But two things have to happen:
1. Extend the analysis, way into the post-market process without any slow down.
2. Bring more companies in-line with these efforts and make long-term device and device-body interaction studies an industry standard. After all, this is one heck of an industry where rituals and ritualistic folks make constant hay....
Will it be expensive? I ask you to spend a few seconds imagining your company, the company you built with your very hands on a stock market free fall....now does it sound expensive?
As to the FDA? Instead of restating the obvious, the organization would benefit from learning to act responsibly and instilling a sense of responsibility in device companies.
Didn't we all know that stricter guidelines and more studies were needed for drug eluting stents? Did we ever hear of any efforts by the companies involved to design appropriate research projects to understand drug eluting stents and their effect on the body?
No, instead they are merrily carrying on over a patent tussle on a product that doesn't work!
And more stent companies are popping up...everywhere!
Who do you think is responsible for all this?
Add to Onlywire
It seems like dinosaurs were converted to fuel faster. How long drawn out is the drug eluting stent story going to be? Are DES actually effective? If they are, what is happening with all those deaths and increases in mortality risk?
Is the problem with the drugs? Because stents work don't they? Or do stents work either?
While you may think these don't fall under the gamut of the FDA....they do have a responsibility to patients, companies and stock holders of publicly traded medical device companies.
The essential problem is that the device industry has not always paid a lot of attention to thorough analysis. To date, effective analysis has not been performed on what stents actually do.
Wasn't it one hell of a shocker to find out that angioplasty for all the hue and cry it created and made rich folks out of a handful few is actually not that effective when you compare it to drugs?
So, expert one day, lucky guy another....no one is an expert anymore.
Our only way to find out whether or not something works is to build it, build a hype around it, bring the FDA into the hype-building exercise and then when patients die...overreact!
Indeed, it is the stone ages of medical devices today. We hit something over the head and if it survives..it works!
Trying out unproven treatments on a whole lot of people based on a slim history to pass judgements is veritably not the right way to device use.
Where lies the solution? Definitely not with the FDA. The FDA has proven itself quite ineffective and gullible to industry pressure.
The solution lies in smart companies and in University laboratories. Instead of "teaching" people how to make devices, some of these schools would benefit from spending research effort and energy on building appropriate models of the human body, with respect to both anatomy and physiology and then study the interaction of the device with the body, and the long term effects of the device. The NIH will also benefit the industry by jumping in with grants..
Of course, data generated from devices should still not be ignored. It is a very critical source for further analysis wherever the models would become inaccurate.
Will it slow down product development? Not really. The current model for developing devices and bringing them to the market is fairly successful. No one is asking for an "overhaul" of the very basics of the industry. (Imagine suggesting that - boy would the bubble burst!)
A sound analytical background should be built around the device development process. That is already being done by the really good companies that spare no expense to ensure that they are actually building effective devices. But two things have to happen:
1. Extend the analysis, way into the post-market process without any slow down.
2. Bring more companies in-line with these efforts and make long-term device and device-body interaction studies an industry standard. After all, this is one heck of an industry where rituals and ritualistic folks make constant hay....
Will it be expensive? I ask you to spend a few seconds imagining your company, the company you built with your very hands on a stock market free fall....now does it sound expensive?
As to the FDA? Instead of restating the obvious, the organization would benefit from learning to act responsibly and instilling a sense of responsibility in device companies.
Didn't we all know that stricter guidelines and more studies were needed for drug eluting stents? Did we ever hear of any efforts by the companies involved to design appropriate research projects to understand drug eluting stents and their effect on the body?
No, instead they are merrily carrying on over a patent tussle on a product that doesn't work!
And more stent companies are popping up...everywhere!
Who do you think is responsible for all this?
Add to Onlywire
Subscribe to:
Posts (Atom)