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Tasigna Lawsuit


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#1 r06ue1

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Posted 10 November 2017 - 08:01 AM

Saw an advertisement on TV the other day, guess Novartis is getting sued.  

 

https://www.google.c...1.0.tJOT0AzUKJ4


08/2015 Initial PCR: 66.392%

12/2015 PCR: 1.573%

03/2016 PCR: 0.153%

06/2016 PCR: 0.070%

09/2016 PCR: 0.052%

12/2016 PCR: 0.036%

03/2017 PCR: 0.029%

06/2017 PCR: 0.028%

09/2017 PCR: 0.025%

12/2017 PCR: 0.018%

 

 

Taking Imatinib 400 mg


#2 kat73

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Posted 10 November 2017 - 11:23 AM

Wow.  And what else will we learn, over time?


Dx July 2009 on routine physical.  WBC 94.  Started Gleevec 400 mg Sept 2009.  MMR at 2yrs.  Side effects (malaise, depression/anxiety, fatigue, nausea, periorbital edema) never improved.  Kidney issues developed because of Gleevec.  Switched to Sprycel 70 mg in Aug 2011.  Above side effects disappeared or improved.  Have been MR3.5 - 4.5 ever since.  Two untreated pleural effusions followed by one treated by stopping Sprycel Jan 2017.  After 9 weeks, PCR showed loss of MMR; re-started Sprycel at 50 mg and in 3 months was back to <0.01% IS.  Pleural effusion returned within a couple of months, same as before (moderate, left side only).  Stopped Sprycel 50 mg for 12 weeks; pleural effusion resolved.  At about a monthoff the drug, PCR was 0.03; at 11 weeks it was 2.06 - lost CCyR? Have returned to 50 mg Sprycel for 3 weeks, intending to reduce to 20 mg going forward.


#3 rcase13

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Posted 10 November 2017 - 01:20 PM

Nice I am on full dose Tasigna. I get yearly echos and EKGs every visit. So far all have been normal and no trends. Do these tests detect Arteriosclerosis? If not what test should we be doing to detect it?

 

Should we switch to Bosutinib?


10/01/2014 100% Diagnosis (WBC 278k, Blasts 6%, Spleen extended 20cm)

01/02/2015 0.06% Tasigna 600mg
04/08/2015 0.01% Tasigna 600mg
07/01/2015 0.01% Tasigna 600mg
10/05/2015 0.02% Tasigna 600mg
01/04/2016 0.01% Tasigna 600mg
04/04/2016 PCRU Tasigna 600mg
07/18/2016 PCRU Tasigna 600mg
10/12/2016 PCRU Tasigna 600mg
01/09/2017 PCRU Tasigna 600mg
04/12/2017 PCRU Tasigna 600mg
10/16/2017 PCRU Tasigna 600mg
01/15/2018 PCRU Tasigna 600mg

 

Cancer Sucks!


#4 Jan0080

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Posted 10 November 2017 - 08:33 PM

I had a physician friend of mine who had serious complications from baby aspirin. Every drug has risk. We need our TKI's. These type of lawsuits is part of the reason that our meds cost so much. I cannot comment on the relative safety of Gleevec versus Sprycel versus Tasigna. These lawsuits tend to enrich the attorneys with little other public policy benefit.
Diagnosed Dec 27, 2016 started Sprycel 100 mg Jan 7, 2017. Initial PCR 77.9 after 30 days 28.4, day 79 1.4 and day 115 0.1%. That is a 99.9% reduction! Sprycel 100 mg for 3 months, 80 mg for 1 month and now at 50 mg. Hooray for Sprycel!!! PCR June 5, 2017 0.04! Dose reduction to 40 mg 6/15/2017 due to shortness of breath. 20 mg as of June 29th. PCR .02 9/11/2017. PCR .015 IS as of 12/11/2017. Lungs substantially better. Low dose Sprycel works!

Adverse Effect - At about week 6 of Sprycel sharp muscle pain that would start at 2 AM and last for about 4 hours. This lasted about 4 weeks and went away, thank goodness.

#5 tiredblood

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Posted 10 November 2017 - 08:54 PM

I had a physician friend of mine who had serious complications from baby aspirin. Every drug has risk. We need our TKI's. These type of lawsuits is part of the reason that our meds cost so much. I cannot comment on the relative safety of Gleevec versus Sprycel versus Tasigna. These lawsuits tend to enrich the attorneys with little other public policy benefit.


Yeah, the fact that many of us would already be dead without Tasigna should prompt us not to jump too quickly onto the legal bandwagon.

#6 thatguy

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Posted 11 November 2017 - 12:51 AM

Tiredblood nailed it. The only things that will come from this are A: a useful drug being pulled, or B: price further inflating. My pills always had the "black box" info...
3/25/2015- Dx'ed by FISH : 85% of cells dual-fusion signals, 7% with tri-fusion signals, WBC 212,000. Started Gleevec 400mg.... Calculated .93 SOKAL

08/17/2015- 14.793 % I.S P210 (quest)
10/15/2015- 3.313 % I.S (quest)
12/23/2015- 1.891 % I.S (quest)
1/07/2016- Tasigna 300mg 2x daily
1/14/2016- 4.414 % I.S P210- City Of Hope lab, mutation negative.
1/26/2016- 1.589 % I.S (quest)
2/22/2016- 1.719 % I.S (quest)
2/29/2016- 1.133 % I.S (quest)
3/03/2016- Tasigna 400mg 2x daily.
3/29/2016- 0.663 % I.S (quest)
4/27/2016- 0.781 % I.S (quest)
5/04/2016- 0.652 % I.S.(quest)
5/24/2016- 0.501 % I.S (quest)
6/28/2016-0.534 % I.S (quest)
7/15/2016-0.881 % I.S (quest)
7/22/2016- Bosulif 500mg
7/28/2016- t315i test- Negative
8/22/2016-0.432 % I.S (quest )
11/15/2016-0.325 % I.S (quest)
2/1/2017- .0445% i.s (genoptix)
5/6/2017- .0968% i.s (genoptix)
5/12/2017- .12 % i.s (quest).
6/4/2017- .083% i.s (quest)
6/11/2017- .0295% i.s (genoptix)
8/5/2017- .0501% i.s (genoptix)
11/6/2017- .0270% i.s (genoptix)

#7 r06ue1

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Posted 13 November 2017 - 07:19 AM

The lawsuit is over Novartis' failure to warn users over the atherosclerosis which they knew about (for at least 5 years) but decided to not inform the public of the danger.  The legal system is in place to punish individual or corporation that put people in danger without warning.  

 

And yes, lawyers are in business to make money, just as the big pharmaceuticals are in business to sell their product to as many consumers as possible.  We are all part of the system (to make money), most just don't want to admit to it.


08/2015 Initial PCR: 66.392%

12/2015 PCR: 1.573%

03/2016 PCR: 0.153%

06/2016 PCR: 0.070%

09/2016 PCR: 0.052%

12/2016 PCR: 0.036%

03/2017 PCR: 0.029%

06/2017 PCR: 0.028%

09/2017 PCR: 0.025%

12/2017 PCR: 0.018%

 

 

Taking Imatinib 400 mg


#8 chevyflame

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Posted 13 November 2017 - 10:28 AM

Good point ro6ue1. 

 

I'm new to Tasigna ( hopefully to resolve a severe pleural effusion) and will have a CBC and CMP every two weeks for two months, and an  EKG repeated every 12 weeks.  Because I have a carotid artery blockage that my vascular surgeon is monitoring, I've questioned if I need an ultrasound more often than twice a year to rule out the possibility that my blockage is getting worse.

 

I would much rather know all the risks associated with our TKI's to be able to have meaningful conversations with my oncologist. There are so many moving parts to treatment so up to date information is vital.



#9 carrie

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Posted 13 November 2017 - 05:06 PM

I just started taking Tasigna.

 

This lawsuit does concern me.

 

If it does cause several different  diseases then I want to know more about this.

 

I had 2 EKG's and I have only been on Tasigna for 3 months.I am on 600 mgs.(Started on 800).

 

This Atherosclerosis may also lead to other diseases including Coronary Heart Disease, Carotid Artery Disease, Peripheral Artery Disease, and Chronic Kidney Disease,...then I want to know what tests I should be receiving to find out if I am being affected by this drug.

 

I don't think 2 EKGs (1 before treatment and 1 after) is going to analyze the diseases listed.

 

I know people can have reactions to all sorts of things like baby aspirin...where freak reactions happen, but if this drug is causing these serious problems and they are just now discovering it then I would like to know more about it. 

 

I know lawyers and pharmaceutical companies make money, and that is their main concern,...but my main concern is- COULD TASIGNA CAUSE THESE PROBLEMS AND GO UNDETECTED BECAUSE THERE ISN'T A TEST TO DETERMINE THESE PROBLEMS.

 

 

In quoting RC13...." Do these tests detect Arteriosclerosis? If not what test should we be doing to detect it?"

 

If anyone has any serious information about these problems, or tests that could be run, please share.


Diagnosed   2007

On Gleevec for 10 years

Results from 2007-2012 not shown below

International Scale from 2012 until now

Never went to 0

0.166

0.038

1.155

0.789

0.104

0.099

0.701

1.986

1.063

1.799

2.817

1.832

3.449

1.050

1.438

3.376

3.370

3.370

2.580

8.990

4.250

6.176

14.109   Changing to Tasigna 7/7/17

 

7/28/17  800 mgs Tasigna

10/5/17  600 mgs Tasigna (Lots of bad side effects)

10/16/2017    PCR down to 0.141  

1/15/18          PCR down to  0.066   Dose reduction again. Now 400 mgs daily.


#10 kat73

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Posted 13 November 2017 - 05:39 PM

carrie - see Dr. Mauro's recent slide presentation, pp 11-12, particularly.


Dx July 2009 on routine physical.  WBC 94.  Started Gleevec 400 mg Sept 2009.  MMR at 2yrs.  Side effects (malaise, depression/anxiety, fatigue, nausea, periorbital edema) never improved.  Kidney issues developed because of Gleevec.  Switched to Sprycel 70 mg in Aug 2011.  Above side effects disappeared or improved.  Have been MR3.5 - 4.5 ever since.  Two untreated pleural effusions followed by one treated by stopping Sprycel Jan 2017.  After 9 weeks, PCR showed loss of MMR; re-started Sprycel at 50 mg and in 3 months was back to <0.01% IS.  Pleural effusion returned within a couple of months, same as before (moderate, left side only).  Stopped Sprycel 50 mg for 12 weeks; pleural effusion resolved.  At about a monthoff the drug, PCR was 0.03; at 11 weeks it was 2.06 - lost CCyR? Have returned to 50 mg Sprycel for 3 weeks, intending to reduce to 20 mg going forward.


#11 ROMO

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Posted 13 November 2017 - 08:17 PM

Bristol Myer just got FDA approval for Dasatinib for  Pediatric use for  CML.
 
ph-chronic-phase-cml
 
Bristol Meyer will now try and "Evergreen," Sprycel for Patent protection for
another 15 years...
 
"Evergreening",  is a clever trick that drug companies use to keep prices high.
Googel it!
 
If they are successful Sprycel will be expensive until the end of our time.
 
And it makes me mad. And, And And!
 
I have no answers.
 
Romo

DX August 2016. WBC ~160K
PH+ Cells 36%
No Spleen enlargement
No Symptoms. Other counts ~Normal
BCR-ABL p210 (Detected)
BCR-ABL p190 (Not Detected)
 
Sprycel 100mg.
PCR   02/01/2017    0.146 IS
PCR   08/07/2017    0.022 IS
Next PCR:           12/XX/2017
 

#12 carrie

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Posted 20 November 2017 - 04:44 PM

kat73, Where do I find  Dr. Mauro's recent slide presentation, pp 11-12, particularly?


Diagnosed   2007

On Gleevec for 10 years

Results from 2007-2012 not shown below

International Scale from 2012 until now

Never went to 0

0.166

0.038

1.155

0.789

0.104

0.099

0.701

1.986

1.063

1.799

2.817

1.832

3.449

1.050

1.438

3.376

3.370

3.370

2.580

8.990

4.250

6.176

14.109   Changing to Tasigna 7/7/17

 

7/28/17  800 mgs Tasigna

10/5/17  600 mgs Tasigna (Lots of bad side effects)

10/16/2017    PCR down to 0.141  

1/15/18          PCR down to  0.066   Dose reduction again. Now 400 mgs daily.


#13 kat73

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Posted 20 November 2017 - 05:38 PM

Agh, I was afraid you'd ask that, and I had forgotten the magic way I had found it!  So, I Googled it just now - I put in: what's on the horizon for chronic myeloid leukemia michael mauro september 2017.  Then, after it came up, I scrolled down to "Program Materials" and clicked on "CML Program Slides.pdf".  Let me know here if that works or not.


Dx July 2009 on routine physical.  WBC 94.  Started Gleevec 400 mg Sept 2009.  MMR at 2yrs.  Side effects (malaise, depression/anxiety, fatigue, nausea, periorbital edema) never improved.  Kidney issues developed because of Gleevec.  Switched to Sprycel 70 mg in Aug 2011.  Above side effects disappeared or improved.  Have been MR3.5 - 4.5 ever since.  Two untreated pleural effusions followed by one treated by stopping Sprycel Jan 2017.  After 9 weeks, PCR showed loss of MMR; re-started Sprycel at 50 mg and in 3 months was back to <0.01% IS.  Pleural effusion returned within a couple of months, same as before (moderate, left side only).  Stopped Sprycel 50 mg for 12 weeks; pleural effusion resolved.  At about a monthoff the drug, PCR was 0.03; at 11 weeks it was 2.06 - lost CCyR? Have returned to 50 mg Sprycel for 3 weeks, intending to reduce to 20 mg going forward.


#14 scuba

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Posted 20 November 2017 - 08:21 PM

https://cardiooncolo...0959-015-0008-5

 

Note table 1:


Diagnosed 11 May 2011 (100% FiSH, 155% PCR)

with b2a2 BCR-ABL fusion transcript coding for the 210kDa BCR-ABL protein

 

Sprycel: 20 mg per day - taken at lights out with Quercetin and/or Magnesium Taurate

6-8 grams Curcumin C3 complex.

 

2015 PCR: < 0.01% (M.D. Anderson scale)

2016 PCR: < 0.01% (M.D. Anderson scale) 

March        2017 PCR:     0.01% (M.D. Anderson scale)

June          2017 PCR:     "undetected"

September 2017 PCR:     "undetected"


#15 rcase13

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Posted 20 November 2017 - 09:50 PM

They all seem to have something scary. CML is even scarier. Hopefully they can either perfect these drugs so they don't eventually kill us or cure CML.

10/01/2014 100% Diagnosis (WBC 278k, Blasts 6%, Spleen extended 20cm)

01/02/2015 0.06% Tasigna 600mg
04/08/2015 0.01% Tasigna 600mg
07/01/2015 0.01% Tasigna 600mg
10/05/2015 0.02% Tasigna 600mg
01/04/2016 0.01% Tasigna 600mg
04/04/2016 PCRU Tasigna 600mg
07/18/2016 PCRU Tasigna 600mg
10/12/2016 PCRU Tasigna 600mg
01/09/2017 PCRU Tasigna 600mg
04/12/2017 PCRU Tasigna 600mg
10/16/2017 PCRU Tasigna 600mg
01/15/2018 PCRU Tasigna 600mg

 

Cancer Sucks!


#16 kat73

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Posted 21 November 2017 - 10:48 AM

Scuba, thanks.  Printed it out for my cardiologist, who I see twice a year to follow PAF (unrelated).  Talk about Scylla and Charybdis!


Dx July 2009 on routine physical.  WBC 94.  Started Gleevec 400 mg Sept 2009.  MMR at 2yrs.  Side effects (malaise, depression/anxiety, fatigue, nausea, periorbital edema) never improved.  Kidney issues developed because of Gleevec.  Switched to Sprycel 70 mg in Aug 2011.  Above side effects disappeared or improved.  Have been MR3.5 - 4.5 ever since.  Two untreated pleural effusions followed by one treated by stopping Sprycel Jan 2017.  After 9 weeks, PCR showed loss of MMR; re-started Sprycel at 50 mg and in 3 months was back to <0.01% IS.  Pleural effusion returned within a couple of months, same as before (moderate, left side only).  Stopped Sprycel 50 mg for 12 weeks; pleural effusion resolved.  At about a monthoff the drug, PCR was 0.03; at 11 weeks it was 2.06 - lost CCyR? Have returned to 50 mg Sprycel for 3 weeks, intending to reduce to 20 mg going forward.


#17 ROMO

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Posted 21 November 2017 - 06:12 PM

The lawsuit will need to prove that Tasigna caused the atherosclerosis.
Or accelerated this condition commonly found in people of middle age and older.
 
People of middle age and older most common get CML.
It's a chicken or the egg lawsuit. Or maybe not.
 
Apparently  Novartis didn't tell their collection of practicing Oncologist on the
payroll for Gleevec distribution  that the new and improved Gleevec called
Tasigna had this question about this one side effect.
 
If the Oncologist join the suite Tasigna will be pulled.
Gleevec will lose it's generic umbrella (distribution), and be massed produced.
 
You see  Novartis will want to distance itself from Gleevec because Gleevec
might have the same atherosclerosis tag. It's the same drug as Tasigna with
slight modifications. It was so new that nobody cared about hardening of the
arteries when they got cured of CML back in the day of Gleevec.
 
Let's suppose Novartis looses this lawsuit and Bristol Meyer the makers of
Sprycel get cold feet about pleural effusions and Arterial hypertensen.
And the other makers of TKI's like, Bosutinib with their own skeletons in there
closets. all release there grip on patent exclusivity. And liability.
 
The only way to make this drug cheaper is to make it not such a miracle
 
Think of it...TKI's cheep as Pez candy!
 
Another free association from:
 
Romo

DX August 2016. WBC ~160K
PH+ Cells 36%
No Spleen enlargement
No Symptoms. Other counts ~Normal
BCR-ABL p210 (Detected)
BCR-ABL p190 (Not Detected)
 
Sprycel 100mg.
PCR   02/01/2017    0.146 IS
PCR   08/07/2017    0.022 IS
Next PCR:           12/XX/2017
 

#18 scuba

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Posted 22 November 2017 - 06:21 AM

For those taking Tasigna ... consider vitamin K2 (menanquinone) as a way to help minimize calcification:

 

https://www.naturalp...cification.aspx

 

Another way to get vitamin K2 from your diet is to eat Japanese Natto (which I do most days now). It is an acquired taste like Scotch. Once you get used to it, you can't be without it.


Diagnosed 11 May 2011 (100% FiSH, 155% PCR)

with b2a2 BCR-ABL fusion transcript coding for the 210kDa BCR-ABL protein

 

Sprycel: 20 mg per day - taken at lights out with Quercetin and/or Magnesium Taurate

6-8 grams Curcumin C3 complex.

 

2015 PCR: < 0.01% (M.D. Anderson scale)

2016 PCR: < 0.01% (M.D. Anderson scale) 

March        2017 PCR:     0.01% (M.D. Anderson scale)

June          2017 PCR:     "undetected"

September 2017 PCR:     "undetected"


#19 carrie

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Posted 27 November 2017 - 05:15 PM

Thanks Kat73---I found the CML Program Slides (great directions). Scuba thanks for the links. I will finish reading those tomorrow.

I really appreciate the helpful information.


Diagnosed   2007

On Gleevec for 10 years

Results from 2007-2012 not shown below

International Scale from 2012 until now

Never went to 0

0.166

0.038

1.155

0.789

0.104

0.099

0.701

1.986

1.063

1.799

2.817

1.832

3.449

1.050

1.438

3.376

3.370

3.370

2.580

8.990

4.250

6.176

14.109   Changing to Tasigna 7/7/17

 

7/28/17  800 mgs Tasigna

10/5/17  600 mgs Tasigna (Lots of bad side effects)

10/16/2017    PCR down to 0.141  

1/15/18          PCR down to  0.066   Dose reduction again. Now 400 mgs daily.


#20 tiredblood

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Posted 29 November 2017 - 05:12 PM

For those taking Tasigna ... consider vitamin K2 (menanquinone) as a way to help minimize calcification:

https://www.naturalp...cification.aspx

Another way to get vitamin K2 from your diet is to eat Japanese Natto (which I do most days now). It is an acquired taste like Scotch. Once you get used to it, you can't be without it.

If we can't acquire the taste for the Japanese Natto, does a scotch chaser help?




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