It is like a scene from a bad cowboy movie. Or, a Chuck Norris episode, with GMC trucks and everything. Scott Brown was probably "coached" by his friends at some of the Biotech companies which have impressed on how they have to "train" FDA officials who are regulating them.
Equipped with this, he went and stood in front of a whole bunch of his Biotech friends in some dog and pony show in Massachusetts in his probably inimitable style, that gives no credence to facts or reality.
Here is a dose of what he is purported to have set. "Whether it’s the FDA, EPA or the “ABCDEFG, you name it — there’s so much overregulation right now,” he said. “When you go overseas, the processes are down, they’re set.”".
Too bad, entry into the U.S. Senate is not even under-regulated you say?
Well, according to Scott Brown's constituents, you have to drive certain vehicles, and take money from donors and recite what they ask you to say. See, the process are down, they're set!
Fighting with facts!
You may not like how the FDA regulates things. And if you choose to do so, you can fight in a way that doesn't make you look like a special-plastic smelling aficionado! Just don't do what Scotty here has done - ranting so poorly that one of the FDA spokespeople who he might deem "lacking in mental capability" was able to come out and say that Scott Brown is mostly, if not completely wrong - without having to try hard! As to mental capabilities, what do they say about it taking one to knowing...
Given that more devices and drugs have been approved over the past decade than ever before, and given that the US is still one of the safest bets as far as medical standards go, Scott Brown's statements make him look very eligible to hire himself out to children's parties for some quality entertainment, which some cynical people might deem all politicians to be eligible for...
Cacophony
Armed with the unfortunate ability that renders any ill-minded person to register "non-profits" in the US, a couple of them have engaged in all kinds of cacophony about "over regulation", "loss of competitiveness" and other terms that they can express without developing even a superfluous understanding for.
While the people of a state should observe and regulate their regulatory agencies, it has to be done without rants and forged reports. Bring up the facts, and urge patient-oriented action, not profit or donor oriented action.
Consulting "Experts" - the wrong way
On the other hand, Senator Franken got too excited and has asked the FDA to consult "experts" in the device industry before making changes to device approval processes. Er., should the cop stop you on the freeway and consult you on whether you were speeding or how much the ticket should cost you?
The right way
Health advocacy agencies that don't take money from biotech and device firms; consumer non-profits and other members of the public who have an understanding that goes beyond the sound-bites handed to US senators should be the ones most actively engaged in discussing any industry's state of regulations.
Senators, biotech companies and others have a right to fight regulations too, if they plan to do it with facts, sanity and coherence. That day, pigs plan to fly...
References:
1. http://www.bostonherald.com/business/technology/general/view/2011_0622fda_fends_off_browns_attacks/srvc=home&position=also
2. http://www.fiercebiotech.com/story/sen-brown-accuses-arbitrary-fda-crushing-biotechs/2011-06-22?utm_medium=nl&utm_source=internal
3. http://www.medcitynews.com/2011/06/sen-franken-to-shuren-get-industry-input-before-changing-510k-system/
A blog on medical devices, biotechnology, bioengineering, healthcare, etc. Join me on discussions about devices, regulations, the FDA, policies, law, and what not! Chaaraka is take on Charaka, an ancient Indian Physician of lore...
Showing posts with label FDA Approval process. Show all posts
Showing posts with label FDA Approval process. Show all posts
Saturday, June 25, 2011
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 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.
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.
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