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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?
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