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HYPOTHETICAL SCENARIO (put yourself into a scientist/doctor's shoes):

You (Dr. X the MS researcher) read the Zamboni papers. As a scientist, you know that if ccsvi ends up being "the answer", and if YOU are one of the first few publications on the topic:

(1) Your work would be published in the best journals (most important currency in research), AND (2) cited by thousands(?) for years to come (2nd most important), AND (3) YOUR work would be known as one of the contributors to this "revolutionary" approach to MS...etc. <-- a true lifetime achievement!

So you start running a bunch of studies, hoping you'll be one of the first scientists (after zamboni) to confirm a new treatment for MS.

You design, lead and fund and follow patients clinically ... these tasks consume all ur time; others do everything else (recruiting, imaging, interpreting, data analysis, surgery) based on their expertise.

Then the stats guy calls in with the results ... to your dismay, the original Zamboni results were NOT replicated (in your study, prevalence of ccsvi in MS was lower than predicted; some of the non-MSers in your study had ccsvi (weakens the relationship more); and after treating ccsvi in 1/2 of patients, your randomized controlled studies showed minimal benefits) <-- all hypothetical

What to do then?

Can't make all MS subjects in your study "get ccsvi" to boost the proportion just because you WANT it to be higher. Can't "encourage" those who got the treatment to improve more (not allowed! and it's a blinded study, you don't know who got the treatment). Can't tell the radiologist to "re-interpret" making sure to say more MS patients have CCSVI (no allowed!)

In fact, none of your "hopes" and "predictions" will ever change the results you ended up getting. So you have to publish the "negative" results (= no significant difference between treated and non-treated).

But just imagine, knowing you have no control on what results the patients end up getting and being disappointed nontheless, you now hear of comments on facebook and forums attacking you PERSONALLY! From the comments, it's clear that some folks have never even read your years of hard work, nor are they giving valid criticism of your design or analysis!

"Dr. x is just against ccsvi; he's paid by pharma to publish fake results; he's trying to make sure MS never gets cured so he keeps his job; his study is flawed cause only zamboni can ever publish results on this; study is useless because it doesn't prove what I believe/want" <-- ALL of these I have actually heard!

Why aren't patients in your study blamed for not having the "right" venous anatomy to confirm ccsvi as a cause? why aren't ur patients blamed for not having better treatment response? cause that would be absurd! but you the researcher with no control over people's anatomies and treatment responses, are at "fault"?

You realize that some people actually think that journal articles are based on the author's "opinions" rather than being based on the patients in the study.

So you go on record and remind everyone that more research is needed (which you truly believe as a scientist) and that these conclusions are based the results that you got. <-- but this only intensifies the criticisms: "Dr. x is a MURDERER that does't want patients liberated from MS; he should be ashamed of himself for "saying those things" (!)...etc."

Your years of dedication to finding a cure for MS, your enthusiasm when you believed that this is finally the answer, all summarized into one legacy: DR. X THE MS PATIENT KILLER!

Now this is a hypothetical scenario (modified from real events!) based on the current ccsvi debate. But if it's not this, it'll be something else! Same story, different variables. In a field where if you end up getting results some others don't "agree with", you may very well become their nemesis, you will always be defending things that aren't yours to defend (other people's anatomy, their treatment responses). Could I live with that?

Let me ask you, Cece and others: What would you do if you were in his shoes? And if you were on the path of selecting a career (as I am), would you want to be Dr. X, the unlucky scientist/doc who got results no one wanted?

P.S. above story modified (a lot) from stuff that really happened (being called a killer part is true!) This happens all the time!

"Dr. x is just against ccsvi; he's paid by pharma to publish fake results; he's trying to make sure MS never gets cured so he keeps his job; his study is flawed cause only zamboni can ever publish results on this; study is useless because it doesn't prove what I believe/want" <-- ALL of these I have actually heard!

It's the internet....do the doctors care what patients say in a CCSVI subforum on the internet? Have you ever read the comments after a CNN article? There will be a story about a death and the comments will be about Darwin's awards and random things and then people chiding the people making jokes...there is a freedom to say anything that does not much exist outside of the internet.

Maybe in the doctor's rush to be first and get the rewards you mentioned, he failed to properly design the trial or to do all the 'tweaking' of the procedure necessary before trialing.

And if you were on the path of selecting a career (as I am), would you want to be Dr. X, the unlucky scientist/doc who got results no one wanted?

The pharmaceutical companies benefit from those unwanted results....

But I think we should all choose our career paths based on our interests and aptitudes and not let the opinions of strangers on the internet influence that choice! Particularly during these 'interesting' times! ("May you live in interesting times....")

I don't think researchers or IRs are used to having quite so many people following everything they do. We are invested.

I also think that, from a clinician's perspective, you cannot expect patients to be rational. Some will be, some won't. Some will be desperate, some will still believe in CCSVI two decades after it's disproven if that were to come to pass, and they'll have cognitive fogginess and mistrust in authority and they might make fun of your uselessness as a distraction from the misery of the disease with its useless treatments....then again even Dr. Freedman got a hug from a former patient (anyone remember that one?!) so it can't all be the ugly stuff.

It's an interesting discussion, willowford.
Perhaps if you really want to help MS patients, you ought to be an interventional radiologist. ;)

In your hypothetical scenario the problem is that you think that something needs to be done about results that are different than you imagined they would be. You publish the research without tweaking and without jumping to unsupported conclusions because that is science, or what science is supposed to be. Hopes and predictions don't always work out, but that doesn't mean the research was in vain. Someone else could look at your data and find some other useful association.

The bar for efficacy on MS treatments has been set pretty low. Even if people can't replicate the Zamboni 100%, the numbers of people helped or at least not harmed by angioplasty are a much higher percentage then those helped by other MS treatments. And the risk of death seems quite low compared to other avenues that have shown some success, but I know, we need more research

There is a parable about a man walking down the shore picking up starfish and throwing them back in. Someone comes along and asks why he is bothering, he can't possibly help them all so it doesn't really make a difference. He picks one up, throws it in and says, it made a difference to that one.

I think in all of your ramblings (I don't mean that word to be mean) this is the point you are missing. You come across as trying to tell us that we are naive and there is no evidence, wait for the science etc. But if you had MS and there was something that could potentially relieve some of your symptoms, even if it was temporary, I think you would look at it differently.

Oh, for heaven's sake. If you're afraid, if you can't stand the heat... These studies seem to find their way to publication in no time flat when they are negative, and I think there are many who are very interested in hearing them. If you don't find what think you want to publish, that's simple. Drug companies do it all the time. Don't publish. See? No backlash. No facebook posse. Don't spill any of your martini.

The other weird thing I've been thinking is about blinding. Why all the emphasis on blinding? If this were a drug remedy with a potential to competitively wipe out a whole segment of the drug industry, I could see that. This is a prevalence investigation. The answer should be pretty easy. Is this not the 21st century? I think the burden of proof should be on the medical profession to show that angioplasty does not relieve symptoms.

But that's just me, right?

1eye wrote:Oh, for heaven's sake. If you're afraid, if you can't stand the heat... These studies seem to find their way to publication in no time flat when they are negative, and I think there are many who are very interested in hearing them. If you don't find what think you want to publish, that's simple. Drug companies do it all the time. Don't publish. See? No backlash. No facebook posse. Don't spill any of your martini.

My point was actually not that people should be "afraid" of publishing things people don't want to hear. It was precisely that they should not have to be afraid to publish true results. But these days... that isn't the case.

Big pharma is criticized heavily among professionals over their failing to publish "negative" results - The solution is NOT for the rest of scientists to engage in what some would consider withholding pertinent information. Two wrongs don't make a right. If the pharmas do it , so should we argument doesn't fly with those of us that find some pharma practices questionable.

The other weird thing I've been thinking is about blinding. Why all the emphasis on blinding? If this were a drug remedy with a potential to competitively wipe out a whole segment of the drug industry, I could see that. This is a prevalence investigation. The answer should be pretty easy. Is this not the 21st century? I think the burden of proof should be on the medical profession to show that angioplasty does not relieve symptoms.

But that's just me, right?

Burden of proof is and in the foreseeable future will be to provide evidence for BOTH the efficacy and lack of efficacy of things we use - can't just ignore evidence of either. There is no division.

An objective scientist would never choose the end result (umm, I'm gonna report treatment blah to be beneficial in my next study) before actually conducting the study. That would make the whole study useless, wouldn't it? Similarly, they can't study efficacy without incidentally finding the opposite.

Remember, every argument you use about angioplasty, should be applied to everything else in medicine too!

So by the argument that potential treatments should be used ad libitum until someone provides evidence to the contrary, then we'd have to bring back in purging and bloodletting of less "scientific" times into medicine.

By your argument that science should be only focusing on disproving things, the next time you go into the doc's office with a throat infection, you may then have to experience bloodletting because no one has conducted a study to show that it does not relieve symptoms!

Fortunately for the rest of us who don't want our blood drained, the goal of studies is to find out what they find out - the good, the bad, and the unexpected.

debp wrote:
I think in all of your ramblings (I don't mean that word to be mean) this is the point you are missing. You come across as trying to tell us that we are naive and there is no evidence, wait for the science etc. But if you had MS and there was something that could potentially relieve some of your symptoms, even if it was temporary, I think you would look at it differently.

I absolutely agree that all research can be useful - even if the results are unexpected - in fact, especially when the results are totally unexpected. Withholding negative findings does not do anyone any favours and impedes our search for facts. Problem is all the issues that can (and do) arise with findings results noone wants to hear (all the things I mentioned above).

If we're trying to find out if a particular vitamin improves health outcomes, then failing to publish studies that find no effect will skew the overall conclusions we can make (we'll only end up with positive results, not know that the bulk of studies found no effect, and conclude incorrectly that it is effective, when in fact it's not). This is why failing to publish negative results, especially in treatment studies, is entirely unethical (although still common unfortunately).

I should note: I HAVE NEVER EVER ASKED OR SUGGESTED THAT ANY PATIENT WITH ANY DISEASE WAIT FOR MORE EVIDENCE BEFORE PROCEEDING WITH A TREATMENT. EVER IN MY LIFE. I DON'T GIVE OTHER PEOPLE ADVICE UNLESS IT IS MY DUTY (JOB). EVER!

On this forum, perhaps people interpret what I write that way. But it could't be farther from the truth! I have never once told anyone on this website to WAIT to get any treatment. AT ALL. (If any of my posts appear that way, please let me know so I can re-word or delete them because I personally consider giving others personal medical advice without being their doctor as unethical).

I have mentioned before, I have no interest nor any opinions about what others should/should not do with their bodies. In fact, I have never even advised my best friend to quit smoking. She's an adult. Knows the effects. Tons of data on all that. It's her body, her choice. (not making comparison with any treatments of course, but point is everyone has a right to their own body).

My discussion is PURELY on the need for research in any treatment (and that need doesn't stop even after the treatment is approved!) and how studies are sometimes misinterpreted by some people in the general public. My emphasis here was on the lack of control researchers have over their findings (e.g., how many of their patients are +ve for CCSVI as an example). And yet, their patients' results (anatomies) are used to discredit the researcher.

How is everyone so certain that I myself have never chosen to try an unapproved or experimental treatment???

you'll need the phlebotomy thread for blood-letting:
www.thisisms.com/ftopic-9480-705-days0-orderasc-.html

Cece wrote:

"Dr. x is just against ccsvi; he's paid by pharma to publish fake results; he's trying to make sure MS never gets cured so he keeps his job; his study is flawed cause only zamboni can ever publish results on this; study is useless because it doesn't prove what I believe/want" <-- ALL of these I have actually heard!

It's the internet....do the doctors care what patients say in a CCSVI subforum on the internet? Have you ever read the comments after a CNN article? There will be a story about a death and the comments will be about Darwin's awards and random things and then people chiding the people making jokes...there is a freedom to say anything that does not much exist outside of the internet.

I wish I was the type. Now that you mention it, I think that neurologists and other docs have much tougher skin. They have to, otherwise their sense of self would be shattered.

But in all honesty, the majority of people I know that went into medicine say that the best part of their job is being able to help someone, even if only once in a while, having a patient say they feel a little better (in any field not just MS).

If in this field, it is unlikely to get that satisfaction, then the best part of the job, the helping people part, is going to be missing. That really makes it a crappy career in my view.

Maybe in the doctor's rush to be first and get the rewards you mentioned, he failed to properly design the trial or to do all the 'tweaking' of the procedure necessary before trialing.

Entirely possible. Anything is possible. But the same argument can go for positive studies. (that's why we need more than a few to verify).

Nonetheless, despite best efforts to properly conduct a study, and to make sure the conclusions are related to the findings that not exaggerated, there's really not much I can think of to avoid getting results that others don't like and will blame you for... even if those findings end up being true.

The pharmaceutical companies benefit from those unwanted results....

But I think we should all choose our career paths based on our interests and aptitudes and not let the opinions of strangers on the internet influence that choice! Particularly during these 'interesting' times! ("May you live in interesting times....")

I don't think researchers or IRs are used to having quite so many people following everything they do. We are invested.

I also think that, from a clinician's perspective, you cannot expect patients to be rational. Some will be, some won't. Some will be desperate, some will still believe in CCSVI two decades after it's disproven if that were to come to pass, and they'll have cognitive fogginess and mistrust in authority and they might make fun of your uselessness as a distraction from the misery of the disease with its useless treatments....then again even Dr. Freedman got a hug from a former patient (anyone remember that one?!) so it can't all be the ugly stuff.

True. All patients may not be completely rational 100% of the time just as doctors are not empathetic and understanding of patients' plight at all times.

But it's tough to deal with this if it's so frequent. Which field has the LEAST mistrust (I'm considering dermatology or ophthalmology now... i have zero interest in either, but who can spread rumors about a guy that just fixes your vision in 15 mins... no mess, no fuss, no controversy).

It's an interesting discussion, willowford.
Perhaps if you really want to help MS patients, you ought to be an interventional radiologist. ;)

IR? Sounds great. Wouldn't there be the same controversies there too? (some others argue that these money hungry docs are just taking advantage of patients in desperate situations when they actually have no evidence that their treatment will improve the patients' lives!) LOL There's just no winning in this field, no matter what you do!

Cece wrote:you'll need the phlebotomy thread for blood-letting:
www.thisisms.com/ftopic-9480-705-days0-orderasc-.html

wow! I'm not surprised there's a whole thread on that. But I honestly didn't think people were still doing that. And I thought some of the things I've tried were unconventional!

Nonetheless, despite best efforts to properly conduct a study, and to make sure the conclusions are related to the findings that not exaggerated, there's really not much I can think of to avoid getting results that others don't like and will blame you for... even if those findings end up being true.

You can't please everyone, willowford. To thine own self be true...let the haters hate...etc

Cece wrote: It's the internet....do the doctors care what patients say in a CCSVI subforum on the internet? Have you ever read the comments after a CNN article?

One more note. I HAVE. It's devastating the level of misinterpretation going on.

Do most doctors initially start off as caring about patients' opinions and then realize that half of it is way off base? Wouldn't they then become less sensitive towards all patients because of these experiences? It would be a bad trade-off: sanity and self of self vs caring for others.

.

I'm not going to start from first principles and argue anything. I am saying, with *this* treatment with *this* history in *these* places all over the world, and the knowledge about it that exists, and the many strong proponents and supporters of many varieties, with all that is known today, the burden of proof should be on those who would obstruct and prevent this procedure from happening, that there is a good reason to do so. The burden of proof of a crime should presume innocence. These people are not scam-artists. This is not snake oil. This is not junk science. This is not criminal enterprise. This is not quackery. This is not unfair treatment of the disadvantaged or the sick or the desperate. It reminds me of a rape victim who must prove she didn't lead her victim on. It is almost as if the victim must show just cause why they should be allowed to pursue their own health!

Doctors are not criminals. They are not fraudsters. They are not con-artists. Let them practice medicine.

Brainteaser wrote:Willowford,

Researchers are not alone in having their worlds turned upside down by a combination of the internet and economic change. Society is changing rapidly and the old way of doing things is gone. Researchers will need to adapt like everyone else. No one with a condition like MS has the patience to wait for the medical community to catch up. The reality is that no-one trusts anyone these days and especially not authority figures and experts. The GFC has made people distrusting of individuals and organizations which are the pillars of society. Who trusts banks, politicians and large companies any more? The internet has empowered individuals to communicate, assess and take action themselves. Who would have predicted the internet-led revolutions of North Africa?

Your arguments regarding research protocol etc are OK for a by-gone era, but don't mean much today, to the people who count, namely the patients. And it is only going to get worse for you...... although the one good thing you have done is to join this site! Maybe you could find ways to harness the energy from this site/the internet to formulate new research protocols - vis-a-vis Drs Sclafarni, Cumming etc. I'm sure the imperfections of consumer-oriented research that you are on about, will be sorted out soon. Maybe you could position yourself at the forefront of the new age of doing things?

Interesting points. How do you envision the new approach though?

It would be the end of proper health care if we all only said things that other people already agree with. And patients can't be expected to run all their own research.

The consumer-driven approach is similar to how things work in the business world. It works there because there are no real "answers" or "facts" to be found. They make whatever we buy. We drive demand. Also amazingly used in revolutionary movements as you noted. Also works because the current view is that countries need to be run the way the public desires. There is no real right or wrong there as long as the majority agree.

The problem is that in medicine, it's not just about what people want or demand. It's also about the results of things we provide.

Like the docs that see kids with confirmed viral infections, but prescribe antibiotics anyway just because the parent is insisting. They do this, to the detriment of their real patient, the child, just because they can't convince the well-meaning but concerned parent to try to understand that viruses are not affected at all by antibiotics. What can we do... the parent is convinced that their kid won't get better without it... despite the facts saying otherwise. I'm sure we can all agree this is not helpful to the patient - but it's health care driven solely by the consumer.

Whether it's use of a vitamin or procedure in MS, antibiotic use, or chemo for cancer; what would be a way to maintain scientific integrity (reporting what was found exactly as it was found with no sugar coating) without upsetting people who have convinced themselves or each other of the contrary? (like Dr. X; what could he have done, short of falsifying data or hiding it to avoid being considered a villain?)

If this deals with the Zivadinov case, I think people is upset with the conclusion they made, not with the published data.