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#1 of 14 Old 11-16-2012, 11:25 AM - Thread Starter
 
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Let's define informed consent as it pertains to vaccination.

 

Here is a basic list, courtesy of AMA:

 

http://www.ama-assn.org/ama/pub/physician-resources/legal-topics/patient-physician-relationship-topics/informed-consent.page

 

 

  • The nature and purpose of a proposed treatment or procedure;
  • The risks and benefits of a proposed treatment or procedure;
  • Alternatives (regardless of their cost or the extent to which the treatment options are covered by health insurance);
  • The risks and benefits of the alternative treatment or procedure; and
  • The risks and benefits of not receiving or undergoing a treatment or procedure.

Patients also have the right to ask questions.  

 

I am going to work on the assumption everyone thinks informed consent is a good thing.  

 

Does informed consent mean all risks and benefits have to be explained?  Is that possible and should that be the goal?  

 

I read a Canadian article (really good read, for those interested in such thingshttp://www.cmpa-acpm.ca/cmpapd04/docs/resource_files/ml_guides/consent_guide/com_cg_informedconsent-e.cfm)  that said doctors had to disclose risks that reasonable people in that position would want to know.  Who gets to define what is reasonable?  I might think it is reasonable to know a one/10 000 risk; others may not.  I may think current prevalence rates of diseases are important, but the CDC informations sheets (at least this one:http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-mmr.pdf) does not list it.

 

What about the fact that many of the studies we base our vaccine decisions on are funded by pharmaceutical companies - do people need to know that for informed consent to take place?

 

What do you think?

 

 

 

 

 


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#2 of 14 Old 11-16-2012, 12:21 PM
 
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Originally Posted by kathymuggle View Post

Let's define informed consent as it pertains to vaccination.

 

Here is a basic list, courtesy of AMA:

 

http://www.ama-assn.org/ama/pub/physician-resources/legal-topics/patient-physician-relationship-topics/informed-consent.page

 

 

  • The nature and purpose of a proposed treatment or procedure;
  • The risks and benefits of a proposed treatment or procedure;
  • Alternatives (regardless of their cost or the extent to which the treatment options are covered by health insurance);
  • The risks and benefits of the alternative treatment or procedure; and
  • The risks and benefits of not receiving or undergoing a treatment or procedure.

Patients also have the right to ask questions.  

 

I am going to work on the assumption everyone thinks informed consent is a good thing.  

 

Does informed consent mean all risks and benefits have to be explained?  Is that possible and should that be the goal?  

Yes.  Otherwise, by definition, it is not informed consent. 

I read a Canadian article (really good read, for those interested in such thingshttp://www.cmpa-acpm.ca/cmpapd04/docs/resource_files/ml_guides/consent_guide/com_cg_informedconsent-e.cfm)  that said doctors had to disclose risks that reasonable people in that position would want to know.  Who gets to define what is reasonable?  I might think it is reasonable to know a one/10 000 risk; others may not.  I may think current prevalence rates of diseases are important, but the CDC informations sheets (at least this one:http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-mmr.pdf) does not list it.

Currently, the people profiting from the sale of vaccines get to decide what "reasonable" people would want to know, and they seem to think it's just fine to disclose only part of the truth, while hiding the most important part.

What about the fact that many of the studies we base our vaccine decisions on are funded by pharmaceutical companies - do people need to know that for informed consent to take place?

Yes.  If the information is from a biased source, who just so happens to be the profit-maker in this game, that should be made clear.

What do you think?

Honestly?  We already know that pharmaceutical companies pay employees to troll blogs and websites in order to try to convince people of the safety of their products. We also know that certain pro-vaccine blogs have comments from posters who implore others to not only troll, but to pretend to be concerned parents; they even include instructions on how to create an untraceable email address.

I think these are actions of an industry desperate to protect profits, not an industry devoted to saving lives.  And that industry exerts an enormous amount of control over the AMA.  For all practical purposes, it IS the AMA.

 

 

 

 

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#3 of 14 Old 11-16-2012, 12:28 PM
 
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On the subject of risk and what a reasonable person would want to know, this is the hallmark case is Australia on that subject http://www.bioethics.org.au/Resources/Online%20Articles/Opinion%20Pieces/0503%20Rogers%20v%20Whitaker%20duty%20of%20disclosure.pdf

Basically the risk of the pt developing sympathetic blindness from the surgery was estimated at 1:14000. Surgeon considered that a low enough risk not to mention it, pt developed sympathetic blindness. The basis of her case, which she won, was that even though the risk was low it was life-altering and therefore would have influenced her decision.

Since then Australian informed consent law requires that pts be informed of life-altering complications even if the risk is low.

Who decides is trickier. For common surgeries there is often a standardised consent form and pt information package which is usually developed by the relevant College or sometimes by the health service.

I guess it's only truely tested in court though, by which time it's too late for someone :-(

For things like vaccinations there is also usually a standard information sheet but all the ones I've seen take a very mainstream view. I've never seen one which acknowledges significant gaps in the available research.

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#4 of 14 Old 11-16-2012, 11:55 PM
 
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For me informed consent has to include making sure everyone understands that some of the safety information on vaccines found online (and in sime books) can be misleading and/or includes scare tactics. I think this "information" is spread by (mostly) well meaning parents and other self proclaimed experts who genuinely are concerned about vaccine safety, but it is still misleading a lot of people.

So for me informed consent would involve actually having a face-face conversation with a medical professional about the issues, not just making up your mind after reading around the issue online (or in one of the books published by members of the anti-vaccination movement).

Mother of two living in UK. Daughter (2007) born in USA, son (2010) born here. I'm pro natural birth, midwife care, breastfeeding, co-sleeping, baby wearing and a keen advocate of cloth diapering. I'm a full time working research scientist (physical sciences) and I'm pro-vaccine.

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#5 of 14 Old 11-17-2012, 06:39 AM
 
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For me informed consent has to include making sure everyone understands that some of the safety information on vaccines found online (and in sime books) can be misleading and/or includes scare tactics. I think this "information" is spread by (mostly) well meaning parents and other self proclaimed experts who genuinely are concerned about vaccine safety, but it is still misleading a lot of people.
So for me informed consent would involve actually having a face-face conversation with a medical professional about the issues, not just making up your mind after reading around the issue online (or in one of the books published by members of the anti-vaccination movement).

What about making sure that everyone understands that much of the official CDC information concerning safety/efficacy of  various vaccines is misleading,includes scare tactics, and completely ignores known adverse reactions to those vaccines?

 

What about making sure that everyone understands that the "official," mainstream-medicine information about the rate of flu deaths is not only misleading and full of scare tactics, but is downright INCORRECT?

 

Apparently, nowadays, the term "pro-science" is now starting to mean,  "steer the focus away from anything threatening pharm profits."

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#6 of 14 Old 11-17-2012, 07:53 AM - Thread Starter
 
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For me informed consent has to include making sure everyone understands that some of the safety information on vaccines found online (and in sime books) can be misleading and/or includes scare tactics.
Caveat:  I think the words "making sure everyone understands" are tricky.  In the Canadian link I talked about up thread, they spoke of how a Scottish court overturned a rule around duty to make sure people understand.  You cannot make people understand (nor, for that matter is it always easy to judge understanding). That being said, whether they "understand" or not, if they are generally competent, have the opportunity to ask questions...that is enough for them to make their decision. 
That being said, I do think a good message to deliver is that some of the information online can be misleading or have scare tactics.  In an ideal world examples could include scare tactics from both a pro and non-vax perspective, but if the doctor will not do that, then just a statement will suffice.

So for me informed consent would involve actually having a face-face conversation with a medical professional about the issues, not just making up your mind after reading around the issue online (or in one of the books published by members of the anti-vaccination movement).

 

Is informed choice something we should force on people?  The answer, I think, is a soft "no."  People have procedures and take drugs regularly that they have chosen not to become fully informed about.  Usually it is because they trust what the doctor is advising, and cannot be bothered with the ins and outs.  Should they be forced to listen to a doctor talk on the subject for a long time when their mind is made up (and it is their body and their choice, after all)? I do think a doctor can turn around and say, yes, but I have a duty to inform them of the risks and benefits before doing a procedure.....in which case forms to sign or paperwork to give out should suffice.  Just as you cannot make someone understand something, you cannot make someone really read or listen, either. 

 

As per vaccines, there really is no need for a conversation (or even a pamphlet mailout - although I have no issues with a pamphlet mail out) if someone refuses vaccines or does not bring their baby in for vaccination.  Informed consent is around procedures undertaken - nothing is being undertaken if someone is not being vaccinated.   Are all parents  mandated to have discussion on circumcision, nursing, etc with a hcp? NO.  It might be a good idea, but it is not,  nor should it be,  mandated.  Medical care, period, is not mandated...If your child is ill, you will be charged with neglect for not seeking medical care - but there are no rules that well people must have medical care throughout their lives.


There is a battle of two wolves inside us.  One is good and the other is evil.  The wolf that wins is the one you feed.

 

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#7 of 14 Old 11-17-2012, 11:54 AM
 
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You both make some good points actually. Thanks for making me think about it more as its interesting.

I think I was mixing up my ideas about informed consent, and informed rejection of medicine. I think in the case of the latter, where the medical professional genuinely believe something is a good idea for a patients health (current or future) they (the medical profession) have a much great burden of duty to make sure those refusing their recommendation understand fully the issues surrounding their choice. In fact I think it would fall somewhere in the Hippocratic oath. I suspect that's why those of you who refuse to vaccinate sometimes face a hard time at the doctor. They just want to make damn sure they've done all they can to make sure you understand the choice.

And as for simplify issues, or "sweeping complications under the rug", then taxi poses a good question (although I might have phrased it differently). I actually think about that quite a lot (although in a different field of science than we're discussing here). As experts trying to communicate science with the "public" we often debate where you are justified simplifying issues to make it easier to understand. After all experts spend years studying this stuff - its not reasonable to think other people can grasp absolutely everything. But it's quite common to have things in science which really have met a standard of proof, but there will be little niggling things (studies, pieces of evidence or even physical caveats) which don't write quite fit.

There has to be a balance between presenting everything, all doubts, and presenting what's geniunely thought to be the best idea or practice. But what that is I really don't know, and I can't see that we'll find the answer in an internet forum when science communicators around the world continue to debate it.

Mother of two living in UK. Daughter (2007) born in USA, son (2010) born here. I'm pro natural birth, midwife care, breastfeeding, co-sleeping, baby wearing and a keen advocate of cloth diapering. I'm a full time working research scientist (physical sciences) and I'm pro-vaccine.

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#8 of 14 Old 11-17-2012, 11:57 AM
 
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Actually makes me glad I don't work in a field related to medicine. I think I like my science communication worries to have slightly lower stakes than potentially affecting people's choices about their health!

Mother of two living in UK. Daughter (2007) born in USA, son (2010) born here. I'm pro natural birth, midwife care, breastfeeding, co-sleeping, baby wearing and a keen advocate of cloth diapering. I'm a full time working research scientist (physical sciences) and I'm pro-vaccine.

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#9 of 14 Old 11-18-2012, 07:40 AM
 
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Originally Posted by katelove View Post

On the subject of risk and what a reasonable person would want to know, this is the hallmark case is Australia on that subject http://www.bioethics.org.au/Resources/Online%20Articles/Opinion%20Pieces/0503%20Rogers%20v%20Whitaker%20duty%20of%20disclosure.pdf
Basically the risk of the pt developing sympathetic blindness from the surgery was estimated at 1:14000. Surgeon considered that a low enough risk not to mention it, pt developed sympathetic blindness. The basis of her case, which she won, was that even though the risk was low it was life-altering and therefore would have influenced her decision.
Since then Australian informed consent law requires that pts be informed of life-altering complications even if the risk is low.
Who decides is trickier. For common surgeries there is often a standardised consent form and pt information package which is usually developed by the relevant College or sometimes by the health service.
I guess it's only truely tested in court though, by which time it's too late for someone :-(
For things like vaccinations there is also usually a standard information sheet but all the ones I've seen take a very mainstream view. I've never seen one which acknowledges significant gaps in the available research.

Out of curiosity, are vaccine manufacturers shielded from liability in Australia? They are here in the U.S. So I would say that part of the informed consent process should include this information--I.e. that neither the doctor nor the drug companies can be sued for adverse events--as well as info on how and where to file a report on adverse reactions.

I am, however, going to give this some more thought. It's a fascinating topic.

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#10 of 14 Old 11-18-2012, 08:13 AM
 
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My beef with "informed consent" is that everyone with an agenda wants a say in what constitutes said "information."  I therefore believe that the informed consent process is incomplete until you detail to clients information that may make them say no...ie. go against what you'd prefer to see them do. (Or, in the words of a doula that I know, "It is not informed consent if you make me afraid to say no.") Because the practice of medicine isn't black and white, a genuine informed consent process should challenge everyone's biases.

 

ETA: KathyMuggle's link is mostly about CYA and encourages that doctors document the informed consent process.  The Vaccine Information Sheets from the Centers for Disease Control largely take care of this, and federal law requires that every patient receives one for each vaccine in question. I know from both personal anecdote and stories posted here that that doesn't always happen.  I would think that a smart doctor would give out the VIS and document that fact in the patient's chart.

 

Also, I like that the VIS quantifies your chances for different adverse reactions.  I would like to see them quantify your chance of catching--as well as catching and then spreading--the various vaccine-avoidable diseases.


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#11 of 14 Old 11-18-2012, 08:44 AM - Thread Starter
 
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Also, I like that the VIS quantifies your chances for different adverse reactions.  I would like to see them quantify your chance of catching--as well as catching and then spreading--the various vaccine-avoidable diseases.

I would like to see two figures quoted - current figures and a possible  scenario (based on historic figures) of what would happen if there were no vaccine.  

 

Something like this:

 

"Since the approval of a mumps vaccine in Canada in 1969, the number of reported mumps cases has decreased from an average of 34,000 cases reported per year in the early 1950s to fewer than 300 cases per year in the early 1990s."

 

http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/07vol33/acs-08/index-eng.php

 

We are told the average current rate, as well as what the rate was before vaccination.  

 

Some disease, of course, declined due to a number of factors.  Diptheria is one.  We do not want to give the false impression that a vaccine is the only factor responsible for disease decline - so listing other factors and their weight is appropriate. 

 

I also think information on who catches disease is important.  It needs to be worded carefully - but not everyone has the same risks from disease.  Something like:  "breastfeeding offers some protections against rotovirus - and when the breastfed infant gets rotovirus, it is likely to be milder" 


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#12 of 14 Old 11-19-2012, 08:23 AM
 
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I'm with you on all of that, Kathy, but you and I are definitely talking in the pie-in-the-sky realm. It will never happen because providing such data would force promoters of the vaccine schedule to admit that not all diseases bear equal weight. Nothing can get these promoters to stammer more quickly than to ask if certain vaccines or diseases have a higher priority than others. (Remember the Starting Fresh thread? Wasn't that your question?) That's one reason why when it comes to informed consent outside of the doctors office, The Vaccine Book is truly the most solid source. (I promise I'm not paid to say that!)

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#13 of 14 Old 11-19-2012, 06:37 PM
 
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I think they should have to tell you there are risks to every medical intervention.  Doctors should also have to disclose they have zero liability for damage/reactions due to vaccines.   The Supreme Court ruled that vaccines are "unavoidably unsafe"

Then parents could make an informed decision.  

 

We all know there are risks to driving a car and yet auto-makers do not have full immunity from lawsuits.  What is the incentive to make a safer shot if there is no liability.  

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#14 of 14 Old 12-10-2012, 01:35 AM
 
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dont vaccinate!!!!!

 

alternative medicine can cure all disease (herbs, yoga, spiritual, urine therapy, bowen, accapuncture)

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