On www. msnbc.com there is an entry for how the FDA does not set success criteria for "devices" - including PMs, stents etc. Here si the link:
http://www.msnbc.msn.com/id/34623228/ns/health-heart_health/
Any thoughts? I am not freaking out but it is concern ...
Thx all
Putnam

 

 

I have just read the information at the website and It certainly has my attention as well. I think I will ask my EP a question.... Just how much/long was the study for the particular model? We'll see what he says... ha ha
Take care,
Pacergirl

 

It's not food or drug, so I've wondered why they set any criteria. That's the rationalization they use for not controlling vitamins and supplements.

 

There is a big difference between devices like pacemakers and drugs. An electronic device like a pacemaker is actually doing some fairly simple actions to pace the heart. The results are obvious on an ECG or checkup data. Doing a double blind statistical study on it would be like requiring a 5 year study on the steering wheel of your car if they changed its color. The only thing they need to do with pacers is monitor failures and keep the manufacturers honest.

Drugs are another story. The results and side effects often aren't obvious for long periods of time.

By the way, Tracey, I agree with you on the vitamins and supplements.

frank

 

Thanks for bringing our attention to this article. People who need these devices need to be assured of quality standards and they also need, as frank says, to keep the manufacturers honest but also to ensure regulations are in place to ensure that happens.

 

I work for a medical device manufacturer. Many of our new products have been held up by the FDA. We just released a new product that was supposed to be released in August. The FDA wanted to do additional audits before it's release. In our business they have been very thorough and hold us to the highest quality standard. I had a friend who has getting a new hip. He is also in the medical field. He wanted a new replacement that was only released in Europe. He did some research and found this was the best replacement made. Plenty of research was done on this device and it had a history of success. He told me in order for it to be released in the US it would have to go through new testing. Any previous testing and history in Europe would not be taken into consideration with its' US release.
I hope the FDA is doing it's job. I know they make it difficult for us and I'm not complaining. Anything that goes into our bodies cannot be scrutinized enough.
Bob

 

After my son and about 800 other children almost died from a commonly prescribed, FDA-approved drug, I do not trust the FDA for anything. That said, I cannot believe I didn't question the testing procedures for my pacemaker safety. Here is an article from a Syracuse blog that discusses the issue at hand. The blog provides a link to the original article in the New York Times. According to the scientist quoted, the FDA does not test drugs and devices the same way. This is what the ruckus is about - a watchdog group wants them tested the same. The doctors say it's very difficult to run double-blind or controlled device studies. Understandably so - who would volunteer for a pacemaker? Who could?
http://blog.syracuse.com/healthfitness/2009/12/fdas_approval_process_question.html
:) Tracie

 

The whole double blind thing is a joke these days. While a study itself may do a very good job of following the double blind protocol, The drug manufacturer isn't required to disclose the results to the FDA unless they want to use them for approval. So if a drug company doesn't get the results they like, the study if filed away and a new one run that is tailored to get the results they want.

The drug company has spent millions in developing a med and isn't going to give up without a fight to make a profit on it. They are anything but disinterested bystanders doing research.

frank

 

Between
1) Global warming
2) Conspiracy Theories
3) Worldwide famine
4) Economic Hit Men
5) Federal/State/Local Politics
6) Corporate corruption and greed
7) Education by rote rather than creative thinking
8) Health Care Vertical Market
9) Financial Vertical Market
10) etc., etc., and so forth

My head hurts !!! But I am soooooo grateful for my PM.
:-)

 

Double-blinding is easy for drugs: you give some folks the drug, others a sugar pill, and you let doctors monitor them without knowing who got which pill. It's "double" blind because neither docs nor patients know who is in which group.

But with a pacemaker study, doctors cannot monitor pacemakers without knowing who has them! And even if you implanted a pacemaker in every person in the study (and left some turned on and some turned off), the doctors would still have to monitor them ... and that means the study can't be double-blinded.

Device studies are a bit different to set up than drug studies, but there have been lots of major clinical trials of devices.

Here's a link to an article on the subject: http://pacemakerpeople.com/.