Interesting report about myeloma trials at UAMS (University of Arkansas for Medical Sciences). Goes into detail about the number of deaths attributed to "unknown" or "other" causes. Relates to all of us as we do not know what the long term side effects of the drugs are and the main myeloma therapies used by patients here in the US (Revlimid, Velcade, and carfilzomib) are relatively new drugs.
The concern
The proportion of deaths attributed to “unknown” causes in TT studies is 25-37%. This is dramatically higher than that reported in other published studies. Figure 1 shows the proportion of deaths from “other” or “unknown” causes in several published myeloma studies, and depicts the extraordinarily high proportion of patients on TT studies who have apparently died of “unknown” or “other” causes (details in Appendix 1). The terms “other” and “unknown” have been used interchangeably by MIRT investigators in different publications to describe causes of death. Most of these non-TT myeloma studies are multi-center studies. With multi-center studies, the likelihood of unknown or missing information is usually higher than with single-center studies such as the TT studies from MIRT. Yet, the opposite is seen here.
The high rate of deaths from “other” or “unknown” causes in TT studies is even more striking when compared to published studies in other cancers such as leukemia, lymphoma, melanoma, and stomach cancer (Figure 2 and Appendix 2). Most of the non-myeloma studies shown are multi-center studies. The extremely high proportion of deaths from “unknown” causes amongst TT patients raises concerns about misclassification of deaths due to disease or treatment as “unknown” or “other”.
Why classification of deaths as “unknown” should be a concern
The majority of deaths in cancer studies are the result of the underlying cancer or of toxicity of the treatment. A small proportion of deaths occur from unrelated causes – usually natural causes. Sometimes, the cause of death may remain unknown. However, in a carefully conducted and monitored study, this is usually a small proportion. If a death occurring as a result of cancer is misclassified as being from “unknown” causes, it makes the treatment seem more effective by making the failure rate of the treatment appear lower than it is. If a death occurring as a result of adverse effects of the treatment is misclassified as being from “unknown” causes, it makes the treatment seem safer by making the serious toxicity rate of the treatment to be small. There was controversy over deaths attributed to “unknown” causes in clinical trials of the drug Vioxx: http://www.nytimes.com/2005/04/24/business/24drug.html. As the Vioxx episode shows, attributing a death to “unknown” causes can be an attempt to deflect attention and scrutiny from problems related to the drug or treatment in question.
http://www.science-fraud.org/wp-content/uploads/2012/09/Deaths-on-Total-Therapy-trials-at-MIRT-2012.pdf
Forums
Re: Report on Myeloma Trials at UAMS
Thanks for posting this. It is an interesting argument being presented.
Do you know who wrote the document, and who funded it?
One possible reason the "unknown" category is relatively high is where patients are from. I have been going to both UAMS and the Univ of Arizona for the last two years. The other patients I see in Arizona are all local. But at UAMS many or most (I dont know the %) patients arent from Arkansas. So a significant portion of UAMS patients enrolled in TT may return home after their stem-cell transplant and dont come back to AR. When they die, after being gone from AR for a long time, their cause of death may be harder for UAMS to know with certainty.
I dont know the facts myself. But to be meaningful the report needs to present UAMS's perspective as well.
Do you know who wrote the document, and who funded it?
One possible reason the "unknown" category is relatively high is where patients are from. I have been going to both UAMS and the Univ of Arizona for the last two years. The other patients I see in Arizona are all local. But at UAMS many or most (I dont know the %) patients arent from Arkansas. So a significant portion of UAMS patients enrolled in TT may return home after their stem-cell transplant and dont come back to AR. When they die, after being gone from AR for a long time, their cause of death may be harder for UAMS to know with certainty.
I dont know the facts myself. But to be meaningful the report needs to present UAMS's perspective as well.
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Arizonan - Name: Arizonan
- Who do you know with myeloma?: Self
- When were you/they diagnosed?: April 2010
- Age at diagnosis: 54
Re: Report on Myeloma Trials at UAMS
Hi Mark,
While there are many who sing praises for TT and love Barlogie...I have always had a deep distrust of his methods and therapies. They have always seemed to be extreme conceptually and therapeutically without outcomes/success to warrant the grueling nature of the procedures and lethal toxicity of tandem high dose chemo in combination with the most toxic drugs available in oncology.
Which I suspect is the core reason for the high number of fatalities. Even salvage stem cells could not bring many patients back from the fatal toxicity of that dosing, is my guess. And is a big reason why we need not be too anxious about long-term effects of RVD. Barlogie used the most toxic drugs in the highest doses that in the end were not tolerable as the high fatality rates attest to. Further there is lots of data already that shows those toxic agents and doses have a high second cancer rate, typically a form of leukemia.
I think it is so sad that he is allowed to experiment on oncology patients the way he does. I recognize that many are desperate and it is not illegal but the theories and concepts Barlogie uses are just radical to the extreme.
Because, he held on to the data, no one was able to see that the fatalities were so disproportionate to any therapeutic benefits he touted. Plus, the revenue stream from tandem hi-dose chemotherapy is exceptional and likely a driver of the methods he used. When I first read about back to back high lethal dose chemo I was shocked that anyone would submit to it and then I was even more appalled that MIRT was deemed a premier center for myeloma therapy. I simply did not buy it on clinical basis alone. And once it was clear that Barlogie would not do randomized trials with other arms or investigators..I was convinced that something was rotten in Arkansas and would not have let my dog be under his care for myeloma. Barlogie's 'cure' was worse than the disease.
However, there are many patients who can't praise him long or hard enough.
Succes, though, was an exception and no one speaks for the dead.
What is the source of the data, was it culled from Medicare rolls?
ETA:
Ahhh, I see the author used the data from published clinical trials on TT vs other published myeloma therapy trials.
While there are many who sing praises for TT and love Barlogie...I have always had a deep distrust of his methods and therapies. They have always seemed to be extreme conceptually and therapeutically without outcomes/success to warrant the grueling nature of the procedures and lethal toxicity of tandem high dose chemo in combination with the most toxic drugs available in oncology.
Which I suspect is the core reason for the high number of fatalities. Even salvage stem cells could not bring many patients back from the fatal toxicity of that dosing, is my guess. And is a big reason why we need not be too anxious about long-term effects of RVD. Barlogie used the most toxic drugs in the highest doses that in the end were not tolerable as the high fatality rates attest to. Further there is lots of data already that shows those toxic agents and doses have a high second cancer rate, typically a form of leukemia.
I think it is so sad that he is allowed to experiment on oncology patients the way he does. I recognize that many are desperate and it is not illegal but the theories and concepts Barlogie uses are just radical to the extreme.
Because, he held on to the data, no one was able to see that the fatalities were so disproportionate to any therapeutic benefits he touted. Plus, the revenue stream from tandem hi-dose chemotherapy is exceptional and likely a driver of the methods he used. When I first read about back to back high lethal dose chemo I was shocked that anyone would submit to it and then I was even more appalled that MIRT was deemed a premier center for myeloma therapy. I simply did not buy it on clinical basis alone. And once it was clear that Barlogie would not do randomized trials with other arms or investigators..I was convinced that something was rotten in Arkansas and would not have let my dog be under his care for myeloma. Barlogie's 'cure' was worse than the disease.
However, there are many patients who can't praise him long or hard enough.
Succes, though, was an exception and no one speaks for the dead.
What is the source of the data, was it culled from Medicare rolls?
ETA:
Ahhh, I see the author used the data from published clinical trials on TT vs other published myeloma therapy trials.
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suzierose - Name: suzierose
- When were you/they diagnosed?: 2 sept 2011
Re: Report on Myeloma Trials at UAMS
I am on the fence.
My basic problem with the UAMS approach -- deaths and questionable data management issues aside - is that it seems to be doing nothing new. It identifies low-risk patients through a gene profiling approach and then touts great success after TT.
I say this because low risk patients with the right genetics are already predicted to have expected median life expectancies of 8-10 years in the first place. And this pool includes all patients, meaning those who receive conventional treatment.
That said, results from other myeloma centers, such as the Huntsman Cancer Institute in Salt Lake City, are in accord with UAMAS. See this FAQ, for example from the Huntsman website:
Q: What is your treatment approach, and what are the survival rates with your treatment?
A: We believe treating multiple myeloma aggressively on the front end is the key to long periods of remission, a longer life, and a better quality of life for multiple myeloma patients.
If you hit the myeloma cells hard at the beginning when they have not been exposed to treatment before, you will catch them off guard. Whereas, if you take the approach of starting off with less aggressive treatment and only moving to more aggressive treatment if a patient relapses, the myeloma cells have grown smarter in the meantime . The myeloma cells sense the effort to get rid of them, and they have time to grow resistant to treatment. Treatment will therefore ultimately be less effective.
We typically treat multiple myeloma with a regimen involving tandem (two) autologous stem cell transplants and maintenance therapy thereafter. This treatment method has been proven to result in median survival rates of 10+ years. No other treatment method for multiple myeloma has proven more effective in research studies.
.
My basic problem with the UAMS approach -- deaths and questionable data management issues aside - is that it seems to be doing nothing new. It identifies low-risk patients through a gene profiling approach and then touts great success after TT.
I say this because low risk patients with the right genetics are already predicted to have expected median life expectancies of 8-10 years in the first place. And this pool includes all patients, meaning those who receive conventional treatment.
That said, results from other myeloma centers, such as the Huntsman Cancer Institute in Salt Lake City, are in accord with UAMAS. See this FAQ, for example from the Huntsman website:
Q: What is your treatment approach, and what are the survival rates with your treatment?
A: We believe treating multiple myeloma aggressively on the front end is the key to long periods of remission, a longer life, and a better quality of life for multiple myeloma patients.
If you hit the myeloma cells hard at the beginning when they have not been exposed to treatment before, you will catch them off guard. Whereas, if you take the approach of starting off with less aggressive treatment and only moving to more aggressive treatment if a patient relapses, the myeloma cells have grown smarter in the meantime . The myeloma cells sense the effort to get rid of them, and they have time to grow resistant to treatment. Treatment will therefore ultimately be less effective.
We typically treat multiple myeloma with a regimen involving tandem (two) autologous stem cell transplants and maintenance therapy thereafter. This treatment method has been proven to result in median survival rates of 10+ years. No other treatment method for multiple myeloma has proven more effective in research studies.
.
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Joey
Re: Report on Myeloma Trials at UAMS
Hi Arizonian,
I hope all is well with you. I believe the author of the paper was Dr. Jayesh Mehta. Dr. Mehta used to practice at UAMS in the myeloma group. He currently practices at Northwestern. The reason I say that is there is a line in the paper above that says:
"As a coauthor on this paper, I have sought clarification from MIRT investigators on
these points, and have not received an answer."
The paper this line refers to lists the following authors:
Bart Barlogie1, Guido J. Tricot1, Frits Van Rhee1, Edguardo Angtuaco1, Ron Walker1,
Joshua Epstein1, John D. Shaughnessy1, Sundar Jagannath2, Vanessa Bolejack3,
Jennifer Gurley1, Antje Hoering3, David Vesole2, Raman Desikan4, David Siegel5,
Jayesh Mehta6, Seema Singhal6, Nikhil C. Munshi7, Madhav Dhodapkar8, Bonnie Jenkins1,
Michel Attal9, Jean-Luc Harousseau10, John Crowley3
http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2006.06271.x/full
Dr. Mehta recently wrote this letter to the journal Blood . It brings up the same points listed in the article.
"Patients enrolled on studies in Arkansas have an unusually high propensity to die of unknown" or "indeterminate" or "other" causes. This happened to 13% of all participants corresponding to 29% of all deaths) in the Total Therapy 2 study [1] and to 8% of all participants (corresponding to 30% of all deaths) in the Total Therapy 3 study [2]. Indeed, 13% of all patients with smoldering myeloma (corresponding to 56% of all deaths) who received thalidomide died of "unrelated" causes [3] that remain unclear [4]!
These mystery deaths are oddly out of keeping with the statement in their latest work looking at second malignancies [5]: "This uniform stringency in therapy and subsequent patient follow-up is a hallmark of the TT trials program and has afforded the investigators to make many clinically meaningful and novel observations.""
"I am also curious to know if all these unusual occurrences have been reported to the local IRB and the FDA (since the studies were conducted under INDs) - and would like to know what their suggestions were to reduce "unknown" deaths."
http://bloodjournal.hematologylibrary.org/content/early/2012/06/06/blood-2012-04-421883/reply#bloodjournal_el_7088
Hopefully they will respond to Dr. Mehta's letter in Blood. I have also seen another letter by Dr. Mehta being critical of UAMS reporting of data.
http://jco.ascopubs.org/content/29/5/e124.full
Mark
I hope all is well with you. I believe the author of the paper was Dr. Jayesh Mehta. Dr. Mehta used to practice at UAMS in the myeloma group. He currently practices at Northwestern. The reason I say that is there is a line in the paper above that says:
"As a coauthor on this paper, I have sought clarification from MIRT investigators on
these points, and have not received an answer."
The paper this line refers to lists the following authors:
Bart Barlogie1, Guido J. Tricot1, Frits Van Rhee1, Edguardo Angtuaco1, Ron Walker1,
Joshua Epstein1, John D. Shaughnessy1, Sundar Jagannath2, Vanessa Bolejack3,
Jennifer Gurley1, Antje Hoering3, David Vesole2, Raman Desikan4, David Siegel5,
Jayesh Mehta6, Seema Singhal6, Nikhil C. Munshi7, Madhav Dhodapkar8, Bonnie Jenkins1,
Michel Attal9, Jean-Luc Harousseau10, John Crowley3
http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2006.06271.x/full
Dr. Mehta recently wrote this letter to the journal Blood . It brings up the same points listed in the article.
"Patients enrolled on studies in Arkansas have an unusually high propensity to die of unknown" or "indeterminate" or "other" causes. This happened to 13% of all participants corresponding to 29% of all deaths) in the Total Therapy 2 study [1] and to 8% of all participants (corresponding to 30% of all deaths) in the Total Therapy 3 study [2]. Indeed, 13% of all patients with smoldering myeloma (corresponding to 56% of all deaths) who received thalidomide died of "unrelated" causes [3] that remain unclear [4]!
These mystery deaths are oddly out of keeping with the statement in their latest work looking at second malignancies [5]: "This uniform stringency in therapy and subsequent patient follow-up is a hallmark of the TT trials program and has afforded the investigators to make many clinically meaningful and novel observations.""
"I am also curious to know if all these unusual occurrences have been reported to the local IRB and the FDA (since the studies were conducted under INDs) - and would like to know what their suggestions were to reduce "unknown" deaths."
http://bloodjournal.hematologylibrary.org/content/early/2012/06/06/blood-2012-04-421883/reply#bloodjournal_el_7088
Hopefully they will respond to Dr. Mehta's letter in Blood. I have also seen another letter by Dr. Mehta being critical of UAMS reporting of data.
http://jco.ascopubs.org/content/29/5/e124.full
Mark
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Mark
Re: Report on Myeloma Trials at UAMS
Suzierose, Joey,
It is tough to be a myeloma patient, that is for sure. It would be great if a patient could have certainty that the data they are basing therapy decisions on was 100% trustworthy. We also have to remember that the different treatment centers are businesses. I often times think that if I was starting a business I would want to hire UAMS marketing department. They have done a great job of doing what Joey points out - they are using the same drugs everyone else is using but have gotten people to believe they need to travel to UAMS to get it. Here is an older article about the business of running a treatment center. Note what happens when a patient advocate points out problems with a Doctor that brings in a lot of business to a treatment center:
"For that reason, since 1987, the federal government has required that all institutions that conduct testing on humans maintain independent oversight groups called institutional review boards, or IRBs. Members of an IRB stand on the side of the human participants: They must assess, approve and review the protocols — the plans for a patient’s medical treatment and for the scientific experiment — to assure that the research is safe, or that where risks do exist, subjects are fully informed of those risks before they consent to participate."
"All IRB meetings and materials are supposed to be confidential. Members, as Valentine put it, pledge to maintain “graveyard silence.”
But by early 2005, frustration with Barlogie’s conduct — and what was seen by some IRB members as a failure of UAMS administrators to hold him accountable — prompted some members to break that silence.
Members who spoke to the Arkansas Times on a condition of anonymity said they and others complained for at least two years that Barlogie was not adhering to UAMS and federal standards.
Specifically, they charged that Barlogie was changing the treatment plans, or protocols of some patients enrolled in his studies, and that he was doing this on his own, without obtaining proper approval.
One source reported that Valentine’s immediate predecessor, former IRB chair Dr. Marisue Cody, a Ph.D. nurse, had fought a vigorous but losing battle to have Barlogie comply with IRB demands. The source said that Cody not only failed to win the backing of UAMS administrators, but that she was ultimately “canned” as IRB chair by Dr. Larry A. Milne, the university’s vice chancellor for academic affairs and research administration."
http://www.arktimes.com/arkansas/impatient-treatment/Content?oid=867965
Mark
It is tough to be a myeloma patient, that is for sure. It would be great if a patient could have certainty that the data they are basing therapy decisions on was 100% trustworthy. We also have to remember that the different treatment centers are businesses. I often times think that if I was starting a business I would want to hire UAMS marketing department. They have done a great job of doing what Joey points out - they are using the same drugs everyone else is using but have gotten people to believe they need to travel to UAMS to get it. Here is an older article about the business of running a treatment center. Note what happens when a patient advocate points out problems with a Doctor that brings in a lot of business to a treatment center:
"For that reason, since 1987, the federal government has required that all institutions that conduct testing on humans maintain independent oversight groups called institutional review boards, or IRBs. Members of an IRB stand on the side of the human participants: They must assess, approve and review the protocols — the plans for a patient’s medical treatment and for the scientific experiment — to assure that the research is safe, or that where risks do exist, subjects are fully informed of those risks before they consent to participate."
"All IRB meetings and materials are supposed to be confidential. Members, as Valentine put it, pledge to maintain “graveyard silence.”
But by early 2005, frustration with Barlogie’s conduct — and what was seen by some IRB members as a failure of UAMS administrators to hold him accountable — prompted some members to break that silence.
Members who spoke to the Arkansas Times on a condition of anonymity said they and others complained for at least two years that Barlogie was not adhering to UAMS and federal standards.
Specifically, they charged that Barlogie was changing the treatment plans, or protocols of some patients enrolled in his studies, and that he was doing this on his own, without obtaining proper approval.
One source reported that Valentine’s immediate predecessor, former IRB chair Dr. Marisue Cody, a Ph.D. nurse, had fought a vigorous but losing battle to have Barlogie comply with IRB demands. The source said that Cody not only failed to win the backing of UAMS administrators, but that she was ultimately “canned” as IRB chair by Dr. Larry A. Milne, the university’s vice chancellor for academic affairs and research administration."
http://www.arktimes.com/arkansas/impatient-treatment/Content?oid=867965
Mark
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Mark
Re: Report on Myeloma Trials at UAMS
Mark,
Thanks for bringing this report to everyone's attention.
I don't think this will account for the high "unknown" or "other" causes of death in the TT studies, but I'll ask about the issue anyway. Is it possible that the very long follow-up times involved with the UAMS studies are contributing to what seem to be unusually high rates of death due to other/unknown causes? Most other myeloma studies don't report data for such extended periods of times as the UAMS group does.
Also, it is worth bringing up that the UAMS group did publish a reply to the concerns Dr. Mehta raised in the letter you linked to about gene expression profiling and treatment related mortality in the UAMS TT studies. Here is a link to the reply:
http://jco.ascopubs.org/content/29/5/e125.full.pdf
One interesting statistic from that reply is the following: In the Total Therapy 2 trial, "Only
51 of 668 patients, or 7.6%, died as a result of treatment-related causes."
Those are the sorts of treatment-related mortality rates that get people worried about doing allo transplants.
I will say that data quality concerns such as those being raised in this thread have always made me reluctant to rely on self-reported treatment center survival rates .
Thanks for bringing this report to everyone's attention.
I don't think this will account for the high "unknown" or "other" causes of death in the TT studies, but I'll ask about the issue anyway. Is it possible that the very long follow-up times involved with the UAMS studies are contributing to what seem to be unusually high rates of death due to other/unknown causes? Most other myeloma studies don't report data for such extended periods of times as the UAMS group does.
Also, it is worth bringing up that the UAMS group did publish a reply to the concerns Dr. Mehta raised in the letter you linked to about gene expression profiling and treatment related mortality in the UAMS TT studies. Here is a link to the reply:
http://jco.ascopubs.org/content/29/5/e125.full.pdf
One interesting statistic from that reply is the following: In the Total Therapy 2 trial, "Only
51 of 668 patients, or 7.6%, died as a result of treatment-related causes."
Those are the sorts of treatment-related mortality rates that get people worried about doing allo transplants.
I will say that data quality concerns such as those being raised in this thread have always made me reluctant to rely on self-reported treatment center survival rates .
Re: Report on Myeloma Trials at UAMS
Hi Ricardo,
I hope all is well with you. Even those replies show a problem with reporting statistics. Allo studies usually report the non relapse mortality which includes TRM and "other" causes. 8% is right in line with allo transplants. Reporting these things properly is important because it makes information available so Doctors can improve the therapies. As I have mentioned my allo went very smoothly. That was possible due to patients that were willing to do the procedure when it was a risky procedure and Doctors being honest about what the TRM and causes of death were. It allowed the Doctors to improve the procedure to the point that we saw in the recent Beacon article where Dr. Kroger had a 6% TRM in relapses patients - that was unheard of until recently and lower than newly diagnosed patients in "Total Therapy II".
Mark
I hope all is well with you. Even those replies show a problem with reporting statistics. Allo studies usually report the non relapse mortality which includes TRM and "other" causes. 8% is right in line with allo transplants. Reporting these things properly is important because it makes information available so Doctors can improve the therapies. As I have mentioned my allo went very smoothly. That was possible due to patients that were willing to do the procedure when it was a risky procedure and Doctors being honest about what the TRM and causes of death were. It allowed the Doctors to improve the procedure to the point that we saw in the recent Beacon article where Dr. Kroger had a 6% TRM in relapses patients - that was unheard of until recently and lower than newly diagnosed patients in "Total Therapy II".
Mark
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Mark
Re: Report on Myeloma Trials at UAMS
We'll have to see how this plays out. For one, the percent of "unknown" deaths may be high relative to others -- but the percentage of deaths may be low at the same time. In other words, if 10 people out of 100 die at one place, and 3 die of unknown causes, that's 33% unknown. But at another center, if 30 people die, and 3 die of unknown causes, that's 10% unknown. Same number of unknown deaths. And where would you prefer to be treated?
Barlogie and team saved my life. Full stop. Any doubters that haven't gone to UAMS are entitled to their opinions but they should be taken with a grain of salt compared to those of us who went through Total Therapy and have seen its positives and negatives.
There is no "experimentation" on UAMS subjects and I found that post offensive, frankly, given the tireless dedication that the UAMS team has given to its patients for 20+ years. You want experiments? Go somewhere that doesn't share data and won't tell you the outcomes because they don't know what their treatment will do.
Also, for those who say that these tests favor low risks patients that would have had good outcomes regardless, "low risk" at UAMS is 85% of newly diagnosed patients, and good outcomes for them represent 60%+ operational cures for those group. Good luck getting anybody else to speak in terms of those numbers.
As for Bart not doing double-blind tests, it raises an interesting ethical question: if you have a treatment A that you believe cures people and treatment B that you know doesn't, is it ethical to randomize patients into a trial where they could get A or B?
When I began treatment, Velcade wasn't used in newly diagnosed patients -- except by Bart. Now it is standard. Revlimid wasn't used in newly diagnosed patients -- except by Bart. Now it is standard. Maintenance wasn't used, except by Bart. Now it is standard. The last domino to fall is tandem transplants, and I suspect that Bart will once again be proven right.
Bart, me, and everybody else at MIRT (whether patients or physicians) will be glad when transplants are no longer necessary and a simple pill like Gleevec can reduce this disease to a chronic condition. Until that time, thank God for these people.
I hope they defend themselves rapidly and decisively against these calumnies.
Barlogie and team saved my life. Full stop. Any doubters that haven't gone to UAMS are entitled to their opinions but they should be taken with a grain of salt compared to those of us who went through Total Therapy and have seen its positives and negatives.
There is no "experimentation" on UAMS subjects and I found that post offensive, frankly, given the tireless dedication that the UAMS team has given to its patients for 20+ years. You want experiments? Go somewhere that doesn't share data and won't tell you the outcomes because they don't know what their treatment will do.
Also, for those who say that these tests favor low risks patients that would have had good outcomes regardless, "low risk" at UAMS is 85% of newly diagnosed patients, and good outcomes for them represent 60%+ operational cures for those group. Good luck getting anybody else to speak in terms of those numbers.
As for Bart not doing double-blind tests, it raises an interesting ethical question: if you have a treatment A that you believe cures people and treatment B that you know doesn't, is it ethical to randomize patients into a trial where they could get A or B?
When I began treatment, Velcade wasn't used in newly diagnosed patients -- except by Bart. Now it is standard. Revlimid wasn't used in newly diagnosed patients -- except by Bart. Now it is standard. Maintenance wasn't used, except by Bart. Now it is standard. The last domino to fall is tandem transplants, and I suspect that Bart will once again be proven right.
Bart, me, and everybody else at MIRT (whether patients or physicians) will be glad when transplants are no longer necessary and a simple pill like Gleevec can reduce this disease to a chronic condition. Until that time, thank God for these people.
I hope they defend themselves rapidly and decisively against these calumnies.
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nvandyk
Re: Report on Myeloma Trials at UAMS
Myeloma is a disease where patients have to make a lot of difficult choices typically based on a lot more emotion than scientifically validated data. Ignorance is often a reason for offense. The entire team at MIRT is experimenting precisely because it does not have data that is scientifically and clinically validated nor have TT outcomes been replicated at other centers. That is what it means to experiment. It is not a lay person 'frankenstein' concept when the word experiment is used. It means the trials are not medically nor clinically validated anywhere. It's a crap shoot for the patient.
As far as I know, MIRT refuses to allow other investigative arms from other clinical centers and scientists to compare the efficacy and fatality rates of his TT. Presenting a patient with data from their own trials is the very definition of lack of full disclosure, as there is only a single source for the information the patients are propagandized with and often times lack the expertise for a comparative assessment.
There is no such thing as operational cure, it is nothing but a made-up term to hype TT. IOW's either it's a cure or it's not. The most likely reason no one has numbers comparable to MIRT is because they also do not have a lot of fatalities from unknown causes that inflate the efficacy outcomes. If the therapy is so fantastically superior why is no one else able to do it?
Using any oncology drug off-label is not some pioneering trailblazing concept, the vast majority of chemotherapy is off-label use and this has been true for over 40 years. Ergo.. UAMS is a maverick, alrright, but not in terms of using therapeutic drugs not indicated for myeloma.
It could be argued that the continued use of such brutal and toxic therapy is sheer malevolence with the sole purpose to promote stem cell salvage as therapy in order to deliver the most toxic doses of chemotherapy to uninformed myeloma patients who believe those stem cells are transformative therapy, while making obscene profits. Given that failure is often due to the lethal toxic doses MIRT has standardized.
But rather than argue the point...let the facts suffice as it appears we now have the mortality statistics to demonstrate the cruel hoax that MIRT has been allowed to perpetrate.
Those who leave MIRT with their lives are damn lucky.
** Moderator's Note: This posting has been edited to remove language that could be viewed as defamatory. The Beacon's Terms of Service do not permit postings which are "unlawful, offensive, defamatory, vulgar, pornographic, sexually explicit, abusive, threatening, or invasive of privacy rights ..."
As far as I know, MIRT refuses to allow other investigative arms from other clinical centers and scientists to compare the efficacy and fatality rates of his TT. Presenting a patient with data from their own trials is the very definition of lack of full disclosure, as there is only a single source for the information the patients are propagandized with and often times lack the expertise for a comparative assessment.
There is no such thing as operational cure, it is nothing but a made-up term to hype TT. IOW's either it's a cure or it's not. The most likely reason no one has numbers comparable to MIRT is because they also do not have a lot of fatalities from unknown causes that inflate the efficacy outcomes. If the therapy is so fantastically superior why is no one else able to do it?
Using any oncology drug off-label is not some pioneering trailblazing concept, the vast majority of chemotherapy is off-label use and this has been true for over 40 years. Ergo.. UAMS is a maverick, alrright, but not in terms of using therapeutic drugs not indicated for myeloma.
It could be argued that the continued use of such brutal and toxic therapy is sheer malevolence with the sole purpose to promote stem cell salvage as therapy in order to deliver the most toxic doses of chemotherapy to uninformed myeloma patients who believe those stem cells are transformative therapy, while making obscene profits. Given that failure is often due to the lethal toxic doses MIRT has standardized.
But rather than argue the point...let the facts suffice as it appears we now have the mortality statistics to demonstrate the cruel hoax that MIRT has been allowed to perpetrate.
Those who leave MIRT with their lives are damn lucky.
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suzierose - Name: suzierose
- When were you/they diagnosed?: 2 sept 2011
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