As I am aware those joining clinical trials for myeloma treatments are more regularly closely monitored for biochemical, cellular and drug related changes / problems. I assume that those joining these trials in the US do not have a health insurance requirement to do so to access a drug.
What happens when a patient develops health problems, either from the trial regime or other causes, where I assume they would come off the trial and the health insurance would be needed to monitor and treat where possible with the health issue e.g. heart function changes?
My question is trying to tease out where the responsibility of the clinical trial investigators stops and that of the general physician/ other doctors begins when a patient develops problems due to the trial regime.
In many cancers people tend to go on trials at an advanced stage of disease when there are no other treatment options. In myeloma many trials tend to recruit newly diagnosed patients to test out two regimes for treatment against each other, or a new drug. Although now more are looking at relapse/ refractory stages.
If you have been on a trial or care for someone who has your experience of 'care' would be helpful.
Forums
Re: Responsibilities during clinical trials in USA?
Good day Edna! I think that you may be referring to 'medical tourism' in a way. If one changes countries in order to be on a clinical trial, then one's medical travel insurance might be needed in order to cover health issues beyond anything covered by the clinical trial. One policy I have had specifically stated that travelling outside Canada for medical treatment would not be covered on my plan. I think it is really important to read any 'fine print', both on one's own policy, and also in the details provided by a clinical trial. Hope that helps...I haven't been on a clinical trial myself though.
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Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
Re: Responsibilities during clinical trials in USA?
Hello Nancy
No I did not mean medical tourism. I wanted to understand what is and is not covered in terms of clinical trials and how what is not covered might be dealt with. Medical tourism implies you have travelled knowing you cannot pay in your own country to have a necessary treatment in a country where it is either free or more easily accessed.
In a clinical trial situation you are taking a risk as you have no choice as to the arm or dosages you will be on. The patient is doing the drug company and researchers a favour by taking this risk, they hope they benefit too, especially if they are short of treatment options etc.
I am well aware most insurance companies are unlikely to insure medical treatment for travel of myeloma patients unless in full remission from recent treatment.Although I do not understand why they cannot just fund the flight back immediately one starts to feel one is becoming ill if they will not fund treatment.
Mark 11 brought up that very small number of multiple myeloma patients enter clinical trials, perhaps without offering back care to deal with any problems they develop from the trial they would not risk a trial until no other option exists I suspect. That makes going to another country to enter a trial unlikely.
Edna
To encourage people to go on these trials the drug companies need
No I did not mean medical tourism. I wanted to understand what is and is not covered in terms of clinical trials and how what is not covered might be dealt with. Medical tourism implies you have travelled knowing you cannot pay in your own country to have a necessary treatment in a country where it is either free or more easily accessed.
In a clinical trial situation you are taking a risk as you have no choice as to the arm or dosages you will be on. The patient is doing the drug company and researchers a favour by taking this risk, they hope they benefit too, especially if they are short of treatment options etc.
I am well aware most insurance companies are unlikely to insure medical treatment for travel of myeloma patients unless in full remission from recent treatment.Although I do not understand why they cannot just fund the flight back immediately one starts to feel one is becoming ill if they will not fund treatment.
Mark 11 brought up that very small number of multiple myeloma patients enter clinical trials, perhaps without offering back care to deal with any problems they develop from the trial they would not risk a trial until no other option exists I suspect. That makes going to another country to enter a trial unlikely.
Edna
To encourage people to go on these trials the drug companies need
Re: Responsibilities during clinical trials in USA?
I'm sorry, but there are a couple bits of either explicit or implicit misinformation floating around here that really need to be addressed.
First of all, outside of perhaps the UK, most clinical trials for multiple myeloma are now, and traditionally have been, focused on patients with relapsed multiple myeloma, not newly diagnosed myeloma. Drugs being tested as potential new therapies for multiple myeloma usually start out, in fact, being tested in patients who have experienced multiple relapses. Later, you may see the drugs being tested in patients who have had 1-3 prior therapies.
It's just patently wrong to suggest myeloma trials have just recently become more common for for relapsed patients.
Second, medical tourism is any sort of travel aimed at seeking health care services outside of one's own country, regardless if the travel is motivated by cost saving. As Wikipedia, for example, explains: "Medical tourism is a form of health tourism commonly referring to the travel of people to another country for the purpose of obtaining medical treatment in that country" ([url=(https://en.wikipedia.org/wiki/Medical_tourismWikipedia article on "medical tourism"[/url]). Wikipedia's definition, by the way, is mirrored by most of the other definitions you'll find if you do an Internet search for "medical tourism definition".
Separate from those two points, I have to say that it's really not clear to me what the question is that is being asked here. Is it whether a patient who goes to the U.S. to participate in a trial is responsible for costs other than the drug and routine testing required for the trial? That's what I thought it was, but then I see statements like:
I mean, if something happens to a patient, doctors aren't going to be quibbling about who is going to help the patient. They are all going to try to figure out how to help. So why bring that into the picture if the real issue is who is responsible for the costs?
First of all, outside of perhaps the UK, most clinical trials for multiple myeloma are now, and traditionally have been, focused on patients with relapsed multiple myeloma, not newly diagnosed myeloma. Drugs being tested as potential new therapies for multiple myeloma usually start out, in fact, being tested in patients who have experienced multiple relapses. Later, you may see the drugs being tested in patients who have had 1-3 prior therapies.
It's just patently wrong to suggest myeloma trials have just recently become more common for for relapsed patients.
Second, medical tourism is any sort of travel aimed at seeking health care services outside of one's own country, regardless if the travel is motivated by cost saving. As Wikipedia, for example, explains: "Medical tourism is a form of health tourism commonly referring to the travel of people to another country for the purpose of obtaining medical treatment in that country" ([url=(https://en.wikipedia.org/wiki/Medical_tourismWikipedia article on "medical tourism"[/url]). Wikipedia's definition, by the way, is mirrored by most of the other definitions you'll find if you do an Internet search for "medical tourism definition".
Separate from those two points, I have to say that it's really not clear to me what the question is that is being asked here. Is it whether a patient who goes to the U.S. to participate in a trial is responsible for costs other than the drug and routine testing required for the trial? That's what I thought it was, but then I see statements like:
My question is trying to tease out where the responsibility of the clinical trial investigators stops and that of the general physician/ other doctors begins when a patient develops problems due to the trial regime.
I mean, if something happens to a patient, doctors aren't going to be quibbling about who is going to help the patient. They are all going to try to figure out how to help. So why bring that into the picture if the real issue is who is responsible for the costs?
Re: Responsibilities during clinical trials in USA?
Hi Again!
What I meant by 'medical tourism' was to travel to get treatments not available in one's country. That is different than going to another country to get procedures done cheaper or more quickly than would be available at home.
I just coined the phrase actually, and what I meant was that if one had health problems due to being on a clinical trial, such as a heart attack, or other serious health issues, one would want to know who would cover that financially. It would either have to be covered by the drug company offering the clinical trial, or by one's own insurance. So I would want to know about that before trying any trial in a different country than my own.
What I meant by 'medical tourism' was to travel to get treatments not available in one's country. That is different than going to another country to get procedures done cheaper or more quickly than would be available at home.
I just coined the phrase actually, and what I meant was that if one had health problems due to being on a clinical trial, such as a heart attack, or other serious health issues, one would want to know who would cover that financially. It would either have to be covered by the drug company offering the clinical trial, or by one's own insurance. So I would want to know about that before trying any trial in a different country than my own.
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Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
Re: Responsibilities during clinical trials in USA?
Hi Terry H
Usually medical tourism occurs because someone feels travel to another country for treatment has some personal benefit, usually because the desired treatment is unavailable / or a low standard in ones own country or because it is cheaper / easier to get that treatment outside of your own country. Normally someone who is ill and needs a treatment will not seek to travel to another country for treatment if they can get the treatment at a good standard, within their means, in their own country.
I think in Europe in general most trial have targeted the newly diagnosed patient with myeloma, It is good that the USA trials are for relapsed patients, possibly because a lot more newer types of therapies are being assessed there through trials. I doubt the UK will be able to offer such expensive therapies through a nationally funded system. The clinician in the US seems to have more flexibility with health insurance regimes, if the latter can be persuaded to fund an approved new treatment.
To clarify the question I was asking. Someone coming to the US to participate in a clinical trial is not likely to have insurance to cover any serious health problem that arises from trial involvement as the costs would be prohibitive I feel. I assume they would be treated and 'billed' for the costs if the trial only pays for the drugs and testing that goes with the trial. I was not suggesting if the trial participant developed serious problems that the physicians would not take appropriate action. But I am trying to tease out the cost of participating in a US clinical trial, should you have an adverse reaction which needs addressing promptly. In your own country these things are less of an issue and possibly for UK citizens in EU countries.
Edna
Usually medical tourism occurs because someone feels travel to another country for treatment has some personal benefit, usually because the desired treatment is unavailable / or a low standard in ones own country or because it is cheaper / easier to get that treatment outside of your own country. Normally someone who is ill and needs a treatment will not seek to travel to another country for treatment if they can get the treatment at a good standard, within their means, in their own country.
I think in Europe in general most trial have targeted the newly diagnosed patient with myeloma, It is good that the USA trials are for relapsed patients, possibly because a lot more newer types of therapies are being assessed there through trials. I doubt the UK will be able to offer such expensive therapies through a nationally funded system. The clinician in the US seems to have more flexibility with health insurance regimes, if the latter can be persuaded to fund an approved new treatment.
To clarify the question I was asking. Someone coming to the US to participate in a clinical trial is not likely to have insurance to cover any serious health problem that arises from trial involvement as the costs would be prohibitive I feel. I assume they would be treated and 'billed' for the costs if the trial only pays for the drugs and testing that goes with the trial. I was not suggesting if the trial participant developed serious problems that the physicians would not take appropriate action. But I am trying to tease out the cost of participating in a US clinical trial, should you have an adverse reaction which needs addressing promptly. In your own country these things are less of an issue and possibly for UK citizens in EU countries.
Edna
Re: Responsibilities during clinical trials in USA?
Edna, I am not sure that I can answer your question fully. I can only tell you from my own experience (and hope I am answering the question you are posing).
One of the big questions for me before agreeing to participate in a clinical trial at Johns Hopkins in Baltimore was what would happen if I developed some serious condition directly attributable to the trial. Who would be financially responsible for the treatments and / or hospitalizations required? Would Medicare, my primary insurer, and Blue Cross/Blue Shield, my secondary insurer, cover conditions which were created by my own voluntary risk taking?
Common sense told me that even fewer people than already do would participate in clinical trials if there was a chance that they would not receive full coverage for any adverse consequences. Who would want such a result? Certainly, it would not be in the public interest. But when it comes to our insurance companies, one never knows. So, I persisted.
It was not so easy getting a satisfactory answer, but in the end I researched the issue and learned that there are actually laws that were enacted by Congress (and not so long ago) specifically to cover clinical trial insurance issues. Our leaders, it seems, also thought it important not to set up onerous obstacles to participation in clinical trials. I participated in my clinical trial with the understanding that any adverse consequences attributable to a clinical trial would be treated like any other diseases by my insurance companies. Coverage would be provided. If anything went wrong, Johns Hopkins, or any other medical facility of my choice, would treat me, but they would bill my insurance providers for their services as in the ordinary course of business.
Perhaps this is of some help. I got all concerned about the assumption of the risk aspect of the clinical trial vis-a-vis insurance coverage, but maybe this has nothing to do with your inquiry. In which case, sorry.
One of the big questions for me before agreeing to participate in a clinical trial at Johns Hopkins in Baltimore was what would happen if I developed some serious condition directly attributable to the trial. Who would be financially responsible for the treatments and / or hospitalizations required? Would Medicare, my primary insurer, and Blue Cross/Blue Shield, my secondary insurer, cover conditions which were created by my own voluntary risk taking?
Common sense told me that even fewer people than already do would participate in clinical trials if there was a chance that they would not receive full coverage for any adverse consequences. Who would want such a result? Certainly, it would not be in the public interest. But when it comes to our insurance companies, one never knows. So, I persisted.
It was not so easy getting a satisfactory answer, but in the end I researched the issue and learned that there are actually laws that were enacted by Congress (and not so long ago) specifically to cover clinical trial insurance issues. Our leaders, it seems, also thought it important not to set up onerous obstacles to participation in clinical trials. I participated in my clinical trial with the understanding that any adverse consequences attributable to a clinical trial would be treated like any other diseases by my insurance companies. Coverage would be provided. If anything went wrong, Johns Hopkins, or any other medical facility of my choice, would treat me, but they would bill my insurance providers for their services as in the ordinary course of business.
Perhaps this is of some help. I got all concerned about the assumption of the risk aspect of the clinical trial vis-a-vis insurance coverage, but maybe this has nothing to do with your inquiry. In which case, sorry.
Re: Responsibilities during clinical trials in USA?
A few months ago I just went through the process of applying for a clinical trial but was not selected, my plasma cells level in my bone marrow biopsy were too low.
After going through this experience I will add in my two bits on my thoughts about the discussion and the medical tourism for clinical trials.
During the process of screening for the trial it was made very clear to me what the trial covers and what the trail does not cover as far as expenses go. There was lots of paper work to review and sign so this was clearly understood. It was also made clear to me I could drop out of the trial at any time if I chose to do so. The question of if treatment and heath care cost resulting from side effects and complications of the trial are covered by the trial once one leave the trial either voluntary or involuntary is a good one. If I recall correctly as long as I was on the trial the trail would cover those cost but if I was not in the trail I do not remember what the cost would continue to be covered by the trail. I do remember it was not an issue that was raised and my HMO never said anything about not covering any cost related to being on the trail once I left the trail. If one does not have insurance though I can see this a big issue that needs to be well understood. My thinking is though that most trials do not seem to have much difficultly recruiting patients so if someone does not have insurance and there is any issue raised about what cost are covered or not they simply would not admit them to the trail, there are usually plenty of other applicants that have insurance. I could be wrong about this, I do not have any data but just my experience.
Same goes for medical tourism. There is a lot of medical tourism but I do not know that means that someone on medical tourism will find it easy to get into a clinical trial in the US at least. Not that there is any laws against it but from the trial organizers perspective they want to select people that are most likely to be able to stay in and finish the trail. There is no right to be admitted to a trial. Why take the risk of admitting someone from out of the country in the US for medical tourism? And who may have insurance issues? Or Visa issues? I remember the trial wanted to continue to follow up with me for several years after the trail was over to monitor how I was doing. It seems they might be the ones most likely drop out for personal and none medical reasons. I remember the trial I applied to wanted to follow up with me for several years after the trail was over, much more challenging to do for someone who was in the trial as medical tourist. There are likely plenty of other applicants that do not have such issues. I would think only for the very wealthy such as a Saudi prince or something like that this may not be an issue.
Eric
After going through this experience I will add in my two bits on my thoughts about the discussion and the medical tourism for clinical trials.
During the process of screening for the trial it was made very clear to me what the trial covers and what the trail does not cover as far as expenses go. There was lots of paper work to review and sign so this was clearly understood. It was also made clear to me I could drop out of the trial at any time if I chose to do so. The question of if treatment and heath care cost resulting from side effects and complications of the trial are covered by the trial once one leave the trial either voluntary or involuntary is a good one. If I recall correctly as long as I was on the trial the trail would cover those cost but if I was not in the trail I do not remember what the cost would continue to be covered by the trail. I do remember it was not an issue that was raised and my HMO never said anything about not covering any cost related to being on the trail once I left the trail. If one does not have insurance though I can see this a big issue that needs to be well understood. My thinking is though that most trials do not seem to have much difficultly recruiting patients so if someone does not have insurance and there is any issue raised about what cost are covered or not they simply would not admit them to the trail, there are usually plenty of other applicants that have insurance. I could be wrong about this, I do not have any data but just my experience.
Same goes for medical tourism. There is a lot of medical tourism but I do not know that means that someone on medical tourism will find it easy to get into a clinical trial in the US at least. Not that there is any laws against it but from the trial organizers perspective they want to select people that are most likely to be able to stay in and finish the trail. There is no right to be admitted to a trial. Why take the risk of admitting someone from out of the country in the US for medical tourism? And who may have insurance issues? Or Visa issues? I remember the trial wanted to continue to follow up with me for several years after the trail was over to monitor how I was doing. It seems they might be the ones most likely drop out for personal and none medical reasons. I remember the trial I applied to wanted to follow up with me for several years after the trail was over, much more challenging to do for someone who was in the trial as medical tourist. There are likely plenty of other applicants that do not have such issues. I would think only for the very wealthy such as a Saudi prince or something like that this may not be an issue.
Eric
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Eric Hofacket - Name: Eric H
- When were you/they diagnosed?: 01 April 2011
- Age at diagnosis: 44
Re: Responsibilities during clinical trials in USA?
Hi Eric
You raise some very valid points, but I have come across trials abandoned due to lack of numbers recruited. Maybe that is not a US problem with the number of people with myeloma (or any cancer) there and maybe that is why big pharma companies focus on the US too for trials, there is a big market there.
From what you write there would not be much point in anyone coming to be in a US myeloma treatment trial, although I do not think you necessarily need to be a Saudi prince to do this. Long term followup may not be feasible.
I find the inequalities in access to medical care immoral from the perspective of humanity, because it means accepting someone in the same country is given a worse deal than oneself, and as a human being that does not make me feel good. But I would think it foolhardy for people to travel to another country for treatment if they do not have the means to cover their living and unfunded treatment costs and for the medical system in that country to accept this.
Edna
You raise some very valid points, but I have come across trials abandoned due to lack of numbers recruited. Maybe that is not a US problem with the number of people with myeloma (or any cancer) there and maybe that is why big pharma companies focus on the US too for trials, there is a big market there.
From what you write there would not be much point in anyone coming to be in a US myeloma treatment trial, although I do not think you necessarily need to be a Saudi prince to do this. Long term followup may not be feasible.
I find the inequalities in access to medical care immoral from the perspective of humanity, because it means accepting someone in the same country is given a worse deal than oneself, and as a human being that does not make me feel good. But I would think it foolhardy for people to travel to another country for treatment if they do not have the means to cover their living and unfunded treatment costs and for the medical system in that country to accept this.
Edna
Re: Responsibilities during clinical trials in USA?
This is definitely one of the areas where issues that are very important in one country is not at all considered an issue in other countries.
There are a lot of Danish and other European myeloma patients who attend clinical trials. But since all treatment in the Nordic countries and in many other European countries is free, the treatment of side effects is also free.
There are a lot of important questions to consider before joining a trial, money should not be one of them.
Most of the trials I hear about and the one I joined are the same as those available in the US and in other regions. There are to few multiple myeloma patients, if I may put it like this, to run the trials in one country.
There are a lot of Danish and other European myeloma patients who attend clinical trials. But since all treatment in the Nordic countries and in many other European countries is free, the treatment of side effects is also free.
There are a lot of important questions to consider before joining a trial, money should not be one of them.
Most of the trials I hear about and the one I joined are the same as those available in the US and in other regions. There are to few multiple myeloma patients, if I may put it like this, to run the trials in one country.
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Lev - Name: Lev
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: June 2014
- Age at diagnosis: 57
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