Shame on you BMS and all of Big Pharma!!!

If he is still on a trial, BMS has their hands tied.  There are criteria for staying on a trial DEFINED BY THE FDA and if those criteria aren't met, the patient is dropped.  These criteria are setup PRIOR to the clinical trial starting and only people who fit this criteria can be used in the final drug approval.  The only thing you can do is ask if he could be treated "off protocol" – basically someone who doesn't fit the criteria needed for approval.  The reason you signed so many papers is to protect you and the company, and those papers clearly define the protocol for staying on the trial.  FDA requires this and it is the nature of clinical trials.

If he is still on a trial, BMS has their hands tied.  There are criteria for staying on a trial DEFINED BY THE FDA and if those criteria aren't met, the patient is dropped.  These criteria are setup PRIOR to the clinical trial starting and only people who fit this criteria can be used in the final drug approval.  The only thing you can do is ask if he could be treated "off protocol" – basically someone who doesn't fit the criteria needed for approval.  The reason you signed so many papers is to protect you and the company, and those papers clearly define the protocol for staying on the trial.  FDA requires this and it is the nature of clinical trials.

If he is still on a trial, BMS has their hands tied.  There are criteria for staying on a trial DEFINED BY THE FDA and if those criteria aren't met, the patient is dropped.  These criteria are setup PRIOR to the clinical trial starting and only people who fit this criteria can be used in the final drug approval.  The only thing you can do is ask if he could be treated "off protocol" – basically someone who doesn't fit the criteria needed for approval.  The reason you signed so many papers is to protect you and the company, and those papers clearly define the protocol for staying on the trial.  FDA requires this and it is the nature of clinical trials.

Wow. I hope everything turns out for the best for him.

Artie

Wow. I hope everything turns out for the best for him.

Artie

Wow. I hope everything turns out for the best for him.

Artie

Hey Maureen,

So sorry about your latest.  I know it can be so frustrating.  I understand on one hand why BMS needs to remove your husband from the trial.  With the needed surgery it becomes difficult to quantify how much the drug is helping and how much the surgery is helping.  Having said that it would be nice if they could partition off patients like your husband who are obviously getting benefit and study them outside the confines of the trial.

I think the word on the street is Keytruda is still showing slightly more efficacy than nivolumab so I think that could bode well for your husband.

You guys have been through so much.  Prayers coming your way for a successful surgery.  This may not seem like it now but I can see this may be setting you up for a great 2015.

Brian

Hey Maureen,

So sorry about your latest.  I know it can be so frustrating.  I understand on one hand why BMS needs to remove your husband from the trial.  With the needed surgery it becomes difficult to quantify how much the drug is helping and how much the surgery is helping.  Having said that it would be nice if they could partition off patients like your husband who are obviously getting benefit and study them outside the confines of the trial.

I think the word on the street is Keytruda is still showing slightly more efficacy than nivolumab so I think that could bode well for your husband.

You guys have been through so much.  Prayers coming your way for a successful surgery.  This may not seem like it now but I can see this may be setting you up for a great 2015.

Brian

Hey Maureen,

So sorry about your latest.  I know it can be so frustrating.  I understand on one hand why BMS needs to remove your husband from the trial.  With the needed surgery it becomes difficult to quantify how much the drug is helping and how much the surgery is helping.  Having said that it would be nice if they could partition off patients like your husband who are obviously getting benefit and study them outside the confines of the trial.

I think the word on the street is Keytruda is still showing slightly more efficacy than nivolumab so I think that could bode well for your husband.

You guys have been through so much.  Prayers coming your way for a successful surgery.  This may not seem like it now but I can see this may be setting you up for a great 2015.

Brian

Stephanie

Stephanie

Stephanie

Oh, Maureen!  Sorry you are having to deal with all this.  When I was a little girl Marie Curie was my hero.  She still is.  Her work in radioactivity paved the way for the radiographic treatments and diagnostics that exist today.  But perhaps something she contributed apart from her work made an even greater difference.  She refused to patent her processes!!!!  Thus, allowing many other researchers to work on radiation and her ideas simultaneously…moving science forward exponentially….rather than waiting for only those researchers and institutions who could afford it to participate; to build on something that, in her view, belonged to humanity.  Marie Curie's today are few and far between.  Certainly BMS, Merck, et al operate in a manner that seems to be lacking such a creed.

To Janner's point. Yes, that assessment is pretty accurate regarding clinical trial protocols.  However, it is not so clear cut and easy as all that.  Additionally, the protocol is not as much in favor of the patient as is implied.  I have signed many such documents.  They all basically say:  "You will be getting this, for this long.  Here's how you qualify.  Here's how you get kicked out. If you live, die, grow three purple heads…so be it.  The company, researcher and the research institution will bear no responsibility….ethically or financially.  Costs will be paid by you for this, this and this….and for all expenses related to any side effects that may develop."

Now, as a patient…of course…I agreed.  I signed…my life and my rights away.  Patients are desperate.  No one signs up for a clinical trial when there are better options available.  And while various protocols are more fair to the patient than others, they are a legal document designed much more to protect the providers than the rights of those on the receiving end.  The best we can hope for as patients is that we will be giving "informed" consent.  Additionally, researchers, institutions and Pharma change the protocol ALL THE TIME!!!!  I have signed innumerable iterations of my ONE trial!!!  Never once has a patient been able to exact a change in such a document!

Additionally, for those who like to tout the lack of control Pharma, the FDA, and researchers have – I beg to differ.  Exceptions can be made any time they choose to make them.  They just don't often choose to do so.  For instance:  Take the case of Ralph M. Steinman.  Don't know Ralph?  Well, he was an amazing researcher in the area of the immune system and cancer….very smart….was awarded the Nobel Prize just three days after his death in 2011…and apparently, a really great guy.  Well.  Ralph got pancreatic cancer.  Perhaps the only cancer along with renal cell carcinoma that gives melanoma a good name.  So what happened?  His research buddies, folks at the FDA and various review boards pulled every string in the book.  "In addition to standard treatment, Steinman ended up enrolled – under a special patent provision – in four ongoing clinical trials of various dendritic cell-based cancer treatments, most of which were not even being tested for pancreatic cancer, along with several other experimental immunotherapy and chemo treatments.  Schlesinger, a member of the Rockefeller Institutional Review Board, steered his treatment through all the necessary IRB and FDA channels…"  [The Patient Scientist, Scientific American,  Harmon, Jan 2012]  Hmmm….  So, did Ralph deserve that special treatment?  Treatment that kept him alive years longer than most folks with his disease…and without said special treatment?  Sure!!!  I think so!  But!  Don't we all????  Must we all be brilliant, well connected scientists in order to be granted such care?

Finally, while it is obvious that patients cannot continue to take meds/treatments that result in life threatening side effects like hemolytic anemia….I think perhaps Maureen's ultimate point was this….  If Big Pharma is really, truly interested in saving lives…not just making money….wouldn't they want to know not just what makes their med work, but what makes it fail?  What in those two last sucky little tumors in Maureen's husband protected them while his other tumors responded to his treatment?  Wouldn't you want to know that?  Now, Pharma defenders will say, "Well, the FDA and pharmaceutical industry is not set up to do things like that when they run a trial."  And, those folks are right.  BUT….WHY NOT???????   Why aren't those in the drug industry REALLY set up to do REAL research?  Not just keep a tally of those who rise and fall? Achieve something more than a count of what side effects?  Why ISN'T a research team set up to evaluate tissue samples and patients, de rigueur? 

Maureen, I wish you and your husband my best…with his upcoming surgery and whatever treatment path you seek next.  While there is much that is good in our system of clinical trials, there is much that is broken.  For what it's worth, this is one rattie who does not plan to stop squeaking anytime soon.

Yours, Celeste

Oh, Maureen!  Sorry you are having to deal with all this.  When I was a little girl Marie Curie was my hero.  She still is.  Her work in radioactivity paved the way for the radiographic treatments and diagnostics that exist today.  But perhaps something she contributed apart from her work made an even greater difference.  She refused to patent her processes!!!!  Thus, allowing many other researchers to work on radiation and her ideas simultaneously…moving science forward exponentially….rather than waiting for only those researchers and institutions who could afford it to participate; to build on something that, in her view, belonged to humanity.  Marie Curie's today are few and far between.  Certainly BMS, Merck, et al operate in a manner that seems to be lacking such a creed.

To Janner's point. Yes, that assessment is pretty accurate regarding clinical trial protocols.  However, it is not so clear cut and easy as all that.  Additionally, the protocol is not as much in favor of the patient as is implied.  I have signed many such documents.  They all basically say:  "You will be getting this, for this long.  Here's how you qualify.  Here's how you get kicked out. If you live, die, grow three purple heads…so be it.  The company, researcher and the research institution will bear no responsibility….ethically or financially.  Costs will be paid by you for this, this and this….and for all expenses related to any side effects that may develop."

Now, as a patient…of course…I agreed.  I signed…my life and my rights away.  Patients are desperate.  No one signs up for a clinical trial when there are better options available.  And while various protocols are more fair to the patient than others, they are a legal document designed much more to protect the providers than the rights of those on the receiving end.  The best we can hope for as patients is that we will be giving "informed" consent.  Additionally, researchers, institutions and Pharma change the protocol ALL THE TIME!!!!  I have signed innumerable iterations of my ONE trial!!!  Never once has a patient been able to exact a change in such a document!

Additionally, for those who like to tout the lack of control Pharma, the FDA, and researchers have – I beg to differ.  Exceptions can be made any time they choose to make them.  They just don't often choose to do so.  For instance:  Take the case of Ralph M. Steinman.  Don't know Ralph?  Well, he was an amazing researcher in the area of the immune system and cancer….very smart….was awarded the Nobel Prize just three days after his death in 2011…and apparently, a really great guy.  Well.  Ralph got pancreatic cancer.  Perhaps the only cancer along with renal cell carcinoma that gives melanoma a good name.  So what happened?  His research buddies, folks at the FDA and various review boards pulled every string in the book.  "In addition to standard treatment, Steinman ended up enrolled – under a special patent provision – in four ongoing clinical trials of various dendritic cell-based cancer treatments, most of which were not even being tested for pancreatic cancer, along with several other experimental immunotherapy and chemo treatments.  Schlesinger, a member of the Rockefeller Institutional Review Board, steered his treatment through all the necessary IRB and FDA channels…"  [The Patient Scientist, Scientific American,  Harmon, Jan 2012]  Hmmm….  So, did Ralph deserve that special treatment?  Treatment that kept him alive years longer than most folks with his disease…and without said special treatment?  Sure!!!  I think so!  But!  Don't we all????  Must we all be brilliant, well connected scientists in order to be granted such care?

Finally, while it is obvious that patients cannot continue to take meds/treatments that result in life threatening side effects like hemolytic anemia….I think perhaps Maureen's ultimate point was this….  If Big Pharma is really, truly interested in saving lives…not just making money….wouldn't they want to know not just what makes their med work, but what makes it fail?  What in those two last sucky little tumors in Maureen's husband protected them while his other tumors responded to his treatment?  Wouldn't you want to know that?  Now, Pharma defenders will say, "Well, the FDA and pharmaceutical industry is not set up to do things like that when they run a trial."  And, those folks are right.  BUT….WHY NOT???????   Why aren't those in the drug industry REALLY set up to do REAL research?  Not just keep a tally of those who rise and fall? Achieve something more than a count of what side effects?  Why ISN'T a research team set up to evaluate tissue samples and patients, de rigueur? 

Maureen, I wish you and your husband my best…with his upcoming surgery and whatever treatment path you seek next.  While there is much that is good in our system of clinical trials, there is much that is broken.  For what it's worth, this is one rattie who does not plan to stop squeaking anytime soon.

Yours, Celeste

Oh, Maureen!  Sorry you are having to deal with all this.  When I was a little girl Marie Curie was my hero.  She still is.  Her work in radioactivity paved the way for the radiographic treatments and diagnostics that exist today.  But perhaps something she contributed apart from her work made an even greater difference.  She refused to patent her processes!!!!  Thus, allowing many other researchers to work on radiation and her ideas simultaneously…moving science forward exponentially….rather than waiting for only those researchers and institutions who could afford it to participate; to build on something that, in her view, belonged to humanity.  Marie Curie's today are few and far between.  Certainly BMS, Merck, et al operate in a manner that seems to be lacking such a creed.

To Janner's point. Yes, that assessment is pretty accurate regarding clinical trial protocols.  However, it is not so clear cut and easy as all that.  Additionally, the protocol is not as much in favor of the patient as is implied.  I have signed many such documents.  They all basically say:  "You will be getting this, for this long.  Here's how you qualify.  Here's how you get kicked out. If you live, die, grow three purple heads…so be it.  The company, researcher and the research institution will bear no responsibility….ethically or financially.  Costs will be paid by you for this, this and this….and for all expenses related to any side effects that may develop."

Now, as a patient…of course…I agreed.  I signed…my life and my rights away.  Patients are desperate.  No one signs up for a clinical trial when there are better options available.  And while various protocols are more fair to the patient than others, they are a legal document designed much more to protect the providers than the rights of those on the receiving end.  The best we can hope for as patients is that we will be giving "informed" consent.  Additionally, researchers, institutions and Pharma change the protocol ALL THE TIME!!!!  I have signed innumerable iterations of my ONE trial!!!  Never once has a patient been able to exact a change in such a document!

Additionally, for those who like to tout the lack of control Pharma, the FDA, and researchers have – I beg to differ.  Exceptions can be made any time they choose to make them.  They just don't often choose to do so.  For instance:  Take the case of Ralph M. Steinman.  Don't know Ralph?  Well, he was an amazing researcher in the area of the immune system and cancer….very smart….was awarded the Nobel Prize just three days after his death in 2011…and apparently, a really great guy.  Well.  Ralph got pancreatic cancer.  Perhaps the only cancer along with renal cell carcinoma that gives melanoma a good name.  So what happened?  His research buddies, folks at the FDA and various review boards pulled every string in the book.  "In addition to standard treatment, Steinman ended up enrolled – under a special patent provision – in four ongoing clinical trials of various dendritic cell-based cancer treatments, most of which were not even being tested for pancreatic cancer, along with several other experimental immunotherapy and chemo treatments.  Schlesinger, a member of the Rockefeller Institutional Review Board, steered his treatment through all the necessary IRB and FDA channels…"  [The Patient Scientist, Scientific American,  Harmon, Jan 2012]  Hmmm….  So, did Ralph deserve that special treatment?  Treatment that kept him alive years longer than most folks with his disease…and without said special treatment?  Sure!!!  I think so!  But!  Don't we all????  Must we all be brilliant, well connected scientists in order to be granted such care?

Finally, while it is obvious that patients cannot continue to take meds/treatments that result in life threatening side effects like hemolytic anemia….I think perhaps Maureen's ultimate point was this….  If Big Pharma is really, truly interested in saving lives…not just making money….wouldn't they want to know not just what makes their med work, but what makes it fail?  What in those two last sucky little tumors in Maureen's husband protected them while his other tumors responded to his treatment?  Wouldn't you want to know that?  Now, Pharma defenders will say, "Well, the FDA and pharmaceutical industry is not set up to do things like that when they run a trial."  And, those folks are right.  BUT….WHY NOT???????   Why aren't those in the drug industry REALLY set up to do REAL research?  Not just keep a tally of those who rise and fall? Achieve something more than a count of what side effects?  Why ISN'T a research team set up to evaluate tissue samples and patients, de rigueur? 

Maureen, I wish you and your husband my best…with his upcoming surgery and whatever treatment path you seek next.  While there is much that is good in our system of clinical trials, there is much that is broken.  For what it's worth, this is one rattie who does not plan to stop squeaking anytime soon.

Yours, Celeste

Hi  Maureen, I get how frustrating Melanoma is to the family and I feel you could use a hug from Canada! Reading the post from Celeste made me think of how Marie Curie papers are still too radioactive to work with and have to be kept in a special container. I think of that fact every time I get a Ct scan which is every 6 weeks in the BMS study that I am in. I am pretty sure that I glow just a little bit in the dark!  There will always be things that we can find that are negative about big pharma but I feel that without them I would not be writing a response to you tonight. I was also looking at my farourites bar, where I have many that are related to Melanoma. You had wrote Nick Auden's (save lockysDad) name which always hits close to home. I went through the same early steps as he did, with brain mets and not knowing if I would qualify for the BMS study. I often think " how did I get in and not others."  Wishing you the best Maureen!  Ed

Hi  Maureen, I get how frustrating Melanoma is to the family and I feel you could use a hug from Canada! Reading the post from Celeste made me think of how Marie Curie papers are still too radioactive to work with and have to be kept in a special container. I think of that fact every time I get a Ct scan which is every 6 weeks in the BMS study that I am in. I am pretty sure that I glow just a little bit in the dark!  There will always be things that we can find that are negative about big pharma but I feel that without them I would not be writing a response to you tonight. I was also looking at my farourites bar, where I have many that are related to Melanoma. You had wrote Nick Auden's (save lockysDad) name which always hits close to home. I went through the same early steps as he did, with brain mets and not knowing if I would qualify for the BMS study. I often think " how did I get in and not others."  Wishing you the best Maureen!  Ed

Hi  Maureen, I get how frustrating Melanoma is to the family and I feel you could use a hug from Canada! Reading the post from Celeste made me think of how Marie Curie papers are still too radioactive to work with and have to be kept in a special container. I think of that fact every time I get a Ct scan which is every 6 weeks in the BMS study that I am in. I am pretty sure that I glow just a little bit in the dark!  There will always be things that we can find that are negative about big pharma but I feel that without them I would not be writing a response to you tonight. I was also looking at my farourites bar, where I have many that are related to Melanoma. You had wrote Nick Auden's (save lockysDad) name which always hits close to home. I went through the same early steps as he did, with brain mets and not knowing if I would qualify for the BMS study. I often think " how did I get in and not others."  Wishing you the best Maureen!  Ed