Stents Can Kill

Originally posted by Mirthful Me

If stents are not for you, so be it... To condemn them is nothing short of irresponsible. Thousands upon thousands of lives are saved each year through these procedures.

...and other lives are lost.

The issues here are:

1. The need for transparency, accountability and independent analysis of trial data for medical devices which does NOT currently occur;

2. The fact that medical decisions often are NOT made to benefit the patient, but rather for other considerations; and

3. Drugs and medical devices are NOT one-size-fits-all treatments - each individual patient has different needs and tolerances - and under the circumstances, marketing practices for drugs and medical devices are arguably fraudulent.


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Of course there is no "one treatment fits all". But more people are helped by stents than are hurt by them. I was put on Zoloft, and heard from several people how much it helped them and how great it was. It did terrible things to me and I had to get off it, in less than 3 weeks. A stent might not work for you, but work great for me. There is no blanket cure, and condemming something because some people had bad reactions to it, is not good. Unless we can come up with something that helps EVERYONE the same way (which just isn't possible right now), then we're going to have to go with the traditional "Works great for Patient A, not so great for Patient B, and terrible for Patient C" method.

Originally posted by Zaphod58

. There is no blanket cure, and condemming something because some people had bad reactions to it, is not good.

Excuse me?

Did you read my posts? Or any of the links?

The main issue here is that no one besides the manufacturers has access to trial data. There is NO independent analysis of data.

The reason this issue is getting airplay is because the EU is looking to implement controls on medical devices in November of 2006, and a group of responsible cardiologists in North America want oversight and better trials.

Unless we can come up with something that helps EVERYONE the same way (which just isn't possible right now), then we're going to have to go with the traditional "Works great for Patient A, not so great for Patient B, and terrible for Patient C" method.

Wrong. We DO have "something" - it's called Personalized Medicine - but patients are used as guinea pigs just to protect the industrial status quo.



[edit on 15-9-2006 by soficrow]

And there are times when, even in personalized medicine, you aren't going to know what affects one person and not another unless you try. Until I had my knee surgery I never knew that an anesthetic/sedative would knock me out longer than other people, and make it hard to wake up from it. I knew it was POSSIBLE because of family history, but that doesn't automatically make it happen to me. So how is a dr going to know that if I've never been under anesthesia? How is he going to know that I'm more likely to get a bloodclot from a stent or not? You HAVE to have SOME testing of things like that if for nothing else than to find out how people will react.

Originally posted by Zaphod58
And there are times when, even in personalized medicine, you aren't going to know what affects one person and not another unless you try.

You're kidding right?!?

Until I had my knee surgery I never knew that an anesthetic/sedative would knock me out longer than other people, and make it hard to wake up from it.

...So how is a dr going to know that if I've never been under anesthesia? How is he going to know that I'm more likely to get a bloodclot from a stent or not? You HAVE to have SOME testing of things like that if for nothing else than to find out how people will react.

Again - please read the links provided.

Using a patient as a guinea pig is NOT "testing" to see what happens.

A range of tests including pharmacogenomics, proteomics, and immunology (at least) can provide the basic information required to predict individual patient response to drugs - or medical devices.
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[edit on 16-9-2006 by soficrow]

Unfortunately for you, Soficrow, Zaphod is right. There are are some people whose biochemistry is different, hence the reason for deviance in medical studies. There will always be the person who drops dead from a normal dose of morphine, and there will always be people who are super-receptive to atropine. There is no way currently to determine these effects prior to administering the medication.

Perhaps you should actually gain first hand experience in the medical field before declaring yourself an expert, no?

Mariella

Originally posted by bsl4doc

There are are some people whose biochemistry is different, hence the reason for deviance in medical studies. There will always be the person who drops dead from a normal dose of morphine, and there will always be people who are super-receptive to atropine.

True. Which is why personalized medicine - and individual testing - is needed.

There is no way currently to determine these effects prior to administering the medication.

!?!

NOT true.

Perhaps you should actually gain first hand experience in the medical field before declaring yourself an expert, no?

Sorry hon - I won't defer to your self-proclaimed superiority as a medical student.

NO ONE needs first hand experience in the medical field to use their own mind - or to know that the boyz who pay the bills call the shots, and serve their own agendas.

And remember the study showing that patients are NOT told about tests, drugs and procedures that they cannot afford?


BACK to the topic:

Transparency, accountability and independent assessment of trial data are urgently needed for medical devices.

Why? Because people lie when their cash on the line. ...They also deflect, distract, misdirect and attempt to intimidate.




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[edit on 16-9-2006 by soficrow]

Then maybe you can explain to us how they're going to know that Morphine will work great for me before they try it. How are you supposed to know that I'm allergic to certain antibiotics if I've never taken them in my life?

Originally posted by soficrow
True. Which is why personalized medicine - and individual testing - is needed.

Oh! Great! So maybe you can tell me which test I need to run to determine the response my patient will have to a Atripla? I mean, HIV medications are notoriously unpredicatble, but according to you, there's a simply test we can run. So, which is it? Oh wait, you're WRONG.

Sorry hon - I won't defer to your self-proclaimed superiority as a medical student.

Sorry "hon" (a horribly demeaning term, didn't know you like to disrepect women), but I'm not a medical student anymore. Graduated last summer =) .

NO ONE needs first hand experience in the medical field to use their own mind

Wow, you are an arrogant jerk. If you are so sure you don't need medical experience to "use your own mind", maybe you can answer a few questions for me that have been stumping me lately:

1) Patient presents with classic signs of shingles - red pustules and scabs along the fifth facial nerve, bilaterally symmeterical. However, upon further testing, the patient is negative for all signs of herpes zoster or other varicella virus, latent or otherwise. What is causing this outbreak of shingles?

2) Patient is known to be HIV+, responsive to Atripla. However, whenever taking the medication, the patients blood pressure drops almost to a dangerous level. The patient is unresponsive/hyperallergenic to all other available HIV medications. What do you do?

Again, please don't assume that because you have the internet and a big ego that you can do what we doctors do on a daily basis. I don't assume I can do a lawyers work, an engineer, a construction worker, etc. because I simply couldn't, it's not in my sphere of knowledge. Medical science, apparently, is not in yours.
- or to know that the boyz who pay the bills call the shots, and serve their own agendas.

And remember the study showing that patients are NOT told about tests, drugs and procedures that they cannot afford?

And? When you go to a car dealer with $5000, do you want him to show you all the new Mercedes-Benzs he just got in? I'm not saying I agree with the statement, I'm just saying I can see the reasoning.

Transparency, accountability and independent assessment of trial data are urgently needed for medical devices.

Why? Because people lie when their cash on the line. ...They also deflect, distract, misdirect and attempt to intimidate.

There will always be people who do this, regardless of your so called "transparency". No system will ever be transparent. And if you think "independent assessment" is the answer, you're an idiot. These assessors can be bribed just like the scientists, they're only human. The only possible way to accurately and reliably know a medication works is to go by the suggested uses of the study. You alert the patient to the fact that it's a new medication/procedure, and that they can receive the older method just as easily. If the patient chooses the new one, they accept the risks that come with it. If this didn't happen, we wouldn't have such things as heart transplants, neurosurgery, pacemakers, etc.



[edit on 9/16/2006 by bsl4doc]

Can we stop the personal bickering and get back to the topic in a civil manner.

Thank you.

Originally posted by sanctum
Can we stop the personal bickering and get back to the topic in a civil manner.

Thank you.

This is civil. Soficrow said that he can do just as well as a doctor without any kind o medical experience, so I'm asking him, civilly, to aid me in a few questions.

This is my civil face

Originally posted by Zaphod58

How are you supposed to know that I'm allergic to certain antibiotics if I've never taken them in my life?

There are allergy tests. But insurance providers have determined that it's cheaper to use patients as guinea pigs. They get away with it by focusing on numbers.


BACK TO THE TOPIC

A standard treatment for heart artery blockages has now been shown to increase the risk of fatal blood clots. ...Drug coated stents, which are little mesh tubes used to prop open clogged heart arteries, are used in more than 90 percent of stent procedures. (BUT)... The evidence suggests drug-eluting stents may be beneficial in only a third of patients. Some experts believe they should be used primarily in small blood vessels, where the risk of restenosis is greatest.

"We sort of can't just stent everyone with a drug eluting stent with impunity like we thought," Dr. Finkielstein said, "that being said, there is going to be a high risk patient who will benefit from drug eluting stents, certainly the technology is good and we just need to find which patients would benefit."

The stent market is worth more than $5 billion a year. Coated stents cost around three times more than bare metal ones.

***

The FDA said today it will hold a special meeting of a device advisory committee to assess new data about "small but significant" increases in the rates of death and myocardial infarction among patients treated with drug-eluting coronary stents.

...the FDA said that for "thousands of patients each year, these devices have resulted in a significant reduction in the need of second procedures to treat restenosis." An estimated one million drug-eluting stents have been implanted in patients in the United States.

More on the background studies presented in Barcelona::

The safety of drug-eluting stents in patients with coronary artery disease has been called into question following the presentation of 2 independent meta-analyses here at the European Society of Cardiology World Congress of Cardiology (WCC). ... The studies, which were reported at a Hotline session on September 3rd, sparked alarm and controversy by suggesting that drug-eluting stents carry a higher risk of death and myocardial infarction (MI) than traditional bare-metal stents. ...the new studies, which pooled data from randomized controlled trials involving first-generation sirolimus- or paclitaxel-coated stents, revealed increased rates of stent thrombosis leading to death or Q-wave MI, as well as increased rates of non-cardiac death.

Edoardo Camenzind, MD, cardiologist, University Hospital, Geneva, Switzerland, and colleagues found that rates of death or MI during extended follow-up were 30% to 40% higher in patients who received the Cypher sirolimus-coated stent than in those with bare-metal stents. ...Dr. Camenzind's analysis evaluated data from the Randomized Study with the Sirolimus-eluting Velocity Balloon-Expandable Stent, Sirolimus-Eluting Stent in De Novo Native Coronary Lesions (SIRIUS), European-SIRIUS, and Canadian-SIRIUS studies. Data were analyzed at 4 different time points for each type of stent.

In a second study, Alain Nordmann, MD, clinical epidemiologist, Basel Institute for Clinical Epidemiology, University Hospital, Basel, Switzerland, and colleagues combined data from 17 trials of drug-eluting stents with follow-up periods of 1 to 4 years. ...Dr. Nordmann's analysis found a greater than 2-fold increase in the rate of non-cardiac death in patients who received sirolimus-coated stents versus controls. Causes of death included cancer, stroke, and lung disease.

Studies Link Drug-Eluting Stents With Death, Myocardial Infarction: Presented at WCC

Also see: Studies linking drug-eluting stents to increased mortality/MI spark impassioned pleas for reason and calls for calm

Originally posted by bsl4doc

soficrow - I won't defer to your self-proclaimed superiority as a medical student.

I'm not a medical student anymore. Graduated last summer =) .

soficrow - NO ONE needs first hand experience in the medical field to use their own mind

Wow, you are an arrogant jerk.

bsdoc - I have quoted and linked extensively to world-reknowned experts.

Please feel free to provide links to your own published work.







ed to add response to bsdoc

[edit on 16-9-2006 by soficrow]

For those who are interested, here's a good overview of personalized medicine, the kinds of tests available, goals, etc.

Personalized Medicine: The End of Blockbuster Drugs?

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bsdoc - You have insisted that your credentials are superior to mine, and to others posting on medical topics. You have belittled my contributions, calling me an "arrogant jerk," and claim I have no legitimate base for commenting on medical-political-economic events because I am not a doctor like you.

I invited you to post your own published work to refute the work of experts I quoted and linked, for example:

A standard treatment for heart artery blockages has now been shown to increase the risk of fatal blood clots. ...Drug coated stents, which are little mesh tubes used to prop open clogged heart arteries, are used in more than 90 percent of stent procedures. (BUT)... The evidence suggests drug-eluting stents may be beneficial in only a third of patients. Some experts believe they should be used primarily in small blood vessels, where the risk of restenosis is greatest.

"We sort of can't just stent everyone with a drug eluting stent with impunity like we thought," Dr. Finkielstein said, "that being said, there is going to be a high risk patient who will benefit from drug eluting stents, certainly the technology is good and we just need to find which patients would benefit."

The stent market is worth more than $5 billion a year. Coated stents cost around three times more than bare metal ones.

***

The FDA said today it will hold a special meeting of a device advisory committee to assess new data about "small but significant" increases in the rates of death and myocardial infarction among patients treated with drug-eluting coronary stents.

...the FDA said that for "thousands of patients each year, these devices have resulted in a significant reduction in the need of second procedures to treat restenosis." An estimated one million drug-eluting stents have been implanted in patients in the United States.

***

The safety of drug-eluting stents in patients with coronary artery disease has been called into question following the presentation of 2 independent meta-analyses here at the European Society of Cardiology World Congress of Cardiology (WCC). ... The studies, which were reported at a Hotline session on September 3rd, sparked alarm and controversy by suggesting that drug-eluting stents carry a higher risk of death and myocardial infarction (MI) than traditional bare-metal stents. ...the new studies, which pooled data from randomized controlled trials involving first-generation sirolimus- or paclitaxel-coated stents, revealed increased rates of stent thrombosis leading to death or Q-wave MI, as well as increased rates of non-cardiac death.

Edoardo Camenzind, MD, cardiologist, University Hospital, Geneva, Switzerland, and colleagues found that rates of death or MI during extended follow-up were 30% to 40% higher in patients who received the Cypher sirolimus-coated stent than in those with bare-metal stents. ...Dr. Camenzind's analysis evaluated data from the Randomized Study with the Sirolimus-eluting Velocity Balloon-Expandable Stent, Sirolimus-Eluting Stent in De Novo Native Coronary Lesions (SIRIUS), European-SIRIUS, and Canadian-SIRIUS studies. Data were analyzed at 4 different time points for each type of stent.

In a second study, Alain Nordmann, MD, clinical epidemiologist, Basel Institute for Clinical Epidemiology, University Hospital, Basel, Switzerland, and colleagues combined data from 17 trials of drug-eluting stents with follow-up periods of 1 to 4 years. ...Dr. Nordmann's analysis found a greater than 2-fold increase in the rate of non-cardiac death in patients who received sirolimus-coated stents versus controls. Causes of death included cancer, stroke, and lung disease.

Studies Link Drug-Eluting Stents With Death, Myocardial Infarction: Presented at WCC

***

Studies linking drug-eluting stents to increased mortality/MI spark impassioned pleas for reason and calls for calm

So? Bring it.


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Doctors Rethink Widespread Use of Heart Stents

The medical community is having second thoughts about stents. ...Tiny metal sleeves placed in arteries to keep blood flowing, stents have become such a popular quick fix for clogged coronary vessels that Americans will receive more than 1.5 million of them this year.

And stents are a big business, generating $6 billion a year in sales for their makers and thousands of dollars in fees for each procedure performed by the specialists implanting them. ...But now stent sales are falling and some doctors are rethinking their faith in the devices, driven by emerging evidence that the newest and most common type — drug-coated stents — can sometimes cause potentially fatal blood clots months or even years after they are implanted.

The Food and Drug Administration said yesterday that it would hold hearings in early December to consider whether to issue new stent safety guidelines. ...The evidence indicates that overuse of stents may be leading to thousands of heart attacks and deaths each year, whether because stents are being used in relatively mild cases where drugs should be prescribed instead, or because patients are receiving drug-coated versions where simpler, cheaper bare-metal devices might work just as well.

And the evidence accumulates.

Angioplasty and Stenting Useless, Possibly Dangerous, 12 Hours After Heart Attack

Opening a blocked artery with balloons and stents can be lifesaving in the early hours after a heart attack, but a new study concludes that it often does no good if the heart attack occurred three or more days before. ...The new study “should change practice, and I believe it will,” said Dr. Judith S. Hochman, director of the cardiovascular clinical research center at New York University medical school, and leader of the study, which included 2,166 patients at 217 hospitals in the United States and other countries. ...Dr. Hochman presented the results yesterday at a meeting of the American Heart Association in Chicago. The study was also published online yesterday by The New England Journal of Medicine and will appear in the Dec. 7 issue.

Her report is the latest warning from researchers who suspect that stents are being overused and may even be causing heart attacks and deaths. Manufacturers sell $6 billion in stents a year, and cardiologists charge $10,000 to $15,000 each to implant them. ...The devices, which came into widespread use in the 1990s, are made of either bare metal or metal coated with a drug meant to help keep the artery from closing again. Recent studies have found that drug-coated stents can increase the risk of blood clots, even years after they are implanted. ...Use of the drug-coated stents has fallen since last spring, but they still account for more than 80 percent of stents implanted in the United States.

Stents have been increasingly used in people with clogged arteries who are not having heart attacks, but some studies suggest that those patients would be better off taking drugs to reduce cholesterol, inflammation and clotting. The reasoning is that artery disease tends to be systemic and extensive, but stents can treat it only in tiny spots. ...Opening a clogged artery in the early stages of a heart attack - “early angioplasty” - can restore blood flow and reduce damage to the heart muscle. It can sometimes save the muscle after 12 hours... After a few days have passed, though, there is little or no chance of preventing heart damage. But many doctors open the artery anyway, thinking it may still have long-term benefits and prolong the patients’ lives. In that situation, the procedure is called late angioplasty. ...The study showed there was no need for the procedure.

When Blind Faith in a Medical Fix Is Broken

A blocked artery is not a good thing. Public health campaigns have drilled that message into the national psyche. Surely, then, whenever doctors find a closed artery, especially in the heart, they should open it.

Maybe not. A major study, presented Tuesday at a medical conference in Chicago, challenged the widespread use of tiny balloons and metal stents in people who had suffered heart attacks days or weeks before.

Although such treatment can be lifesaving in the early stages of a heart attack, the study found that opening the artery later did no good at all. It merely exposed patients to the discomfort, risk and $10,000 expense of an invasive procedure. ...The new report is the latest example of a rigorous experiment turning medical practice on its head by proving that a widely accepted treatment is not the great boon it was thought to be (except maybe to the bank accounts of doctors, drug companies and makers of medical devices).

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Stem Cell Experiment Yields Heart Valves

Scientists for the first time have grown human heart valves using stem cells from the fluid that cushions babies in the womb, offering an approach that may be used to repair defective hearts.

The idea is to create new valves in the laboratory while a pregnancy progresses and have them ready to implant in a baby with heart defects after it is born.

The Swiss experiment follows recent successes at growing bladders and blood vessels and suggests that people may one day be able to grow their own replacement heart parts, in some cases, even before they are born.

Stents save far far more lives than they take.

Blood clots can and do happen at any time, in any place, to any body... The fact that its the stent (an implanted device) that causes it is sad, but, just how many days life did they have without the stent?

Your thread is alarmist and irresponsible - If you are a M.D / Cardiac specialist, then i might of listend a bit longer, but your not, so i won't.

I see day in day out people who's lives are saved by stents here in the UK, and have great respect for the surgeons who implant them.

Every patient is made aware of the risks involved. Every patient goes through pre admission screening, every patient knows whats involved.

Its summed up like this by those who have the stents.

No stent, dead in weeks.

Stent, years of extra life.

Its as simple as that.

An alarmist thread, and one I hope no one who is considering a stent takes with any credibilty at all.

Originally posted by D4rk Kn1ght
Stents save far far more lives than they take.

Your thread is alarmist and irresponsible -

No stent, dead in weeks. ...Stent, years of extra life.

Its as simple as that.

An alarmist thread, and one I hope no one who is considering a stent takes with any credibilty at all.

Another opinion, without references - based on a spurious personal attack, without grounds.

Review the literature and the links above for studies on the dangers of using stents inappropriately.

There are specific, limited times when stent use is appropriate. Otherwise, stenting is a waste of often limited personal resources better spent elsewhere - and sometimes, downright dangerous.


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