$6.5 M Jury Verdict in California Actos Bladder Cancer Trial

It shouldn't be a surprise to anyone that a jury based out of California ruled against an employer. NONE OF THESE PEOPLE WORK! They're all either on disability or on the government cheese. No one wants to bring up that insulin also has significantly increased cancer risks. Doctors would then have nothing to prescribe for diabetics after the DD4's get pulled (for increasing pancreatic cancer risk). The real reason patients on insulin, TZD's and DPP4's are getting cancer is obesity and smoking. That's it. A jury is intended to be the biggest collection of morons that lawyers can find. Anyone with a brain is cut out. Look at the OJ jury. They completely ignored DNA odds of 4 billion to one! The whole reason medical care is so much more expensive in this country ties directly to trial lawyers. There is no interest in providing tort reform so everyone in health care gets sued and costs go up and up. We'll go bankrupt soon enough, which should help bring down the cancer rates in this country because people won't be able to afford to eat or smoke. Problem solved-brilliant!

The sooner a slimey,no-integrity company like Takeda goes bankrupt,the better.Payback is a bitch!
 




One of the reasons why they lost is because they didnt have a bladder cancer warning when Mr. Cooper started taking Actos in 2006. The Bladder Cancer Warning Was added on 2011 a little to late for him. Also Takeda try to downplay the risk of bladder cancer. Telling their sale Reps to not talk about bladder cancer to doctors unless they brought it up. In other words they weren't giving ADEQUATE information. They also delay Test results and gave them to the FDA much later. They didn't want their Product to be harm since itstheir most important drug. People have the right to know what they are taking and companys have to give an Adequate Warning and put Patient Safety First.

Takeda has proven that it doesn't give a rat's ass about patient safety.It's ALL about the money!Now they have to pay that blood money back!Tough sh##!
 




Yet the FDA approved the alo/actos combo, doesn't sound like the FDA is concerned about BC with Actos use. People want the magic pill but when the majic doesn't fix all their problems they sue. Chances are they would have died of BC, lost limbs or something else if they didn't take actos...but hey free money is where it's at!

You are a sick fu##,and a smart one too,you can't even spell MAGIC correctly.Go back under the rock you crawled out from.
 




Takedahas proven that it doesn't give a rat's ass about patient safety.It's ALL about the money!Now they have to pay that blood money back!Tough sh##!

I agree. Company Profit was 1st to them. The sad part is that even with those $6.5 million Mr. Cooper is still going to die in about 7 months. I was One of the 12 Jurors in this case and im checking everyday to see what happens since I've heard Takeda filed Motions and want to appeal if motion is decline. If they do I would feel those 2 months we spend were for nothing.
 




The reason why the warning was placed in 2011 and not 2003 was due to insufficient data. What "proof" did the company withhold that Actos causes BC? The warning came as a result of an ongoing study and the only reason why the FDA reported this was due to transparency. The FDA no longer waits for a study to be complete before they update the medical community.

The company never told reps to do anything. Not sure what initiative Takeda took to stop reps from speaking about BC or even downplay it.

To the juror (which I know is BS) what was the proof that was presented to you that showed Takeda withheld information and what is the reasoning the FDA just approved a new medication with Actos in it?
 




Any honest Takeda Legacy Rep/DM/RSD/VP will tell you that this has ALWAYS been in the Actos PI and has been brought up by providers for years..... Of course, we were told to downplay it as it was one study and above the maximum dose in rats....

A two-year carcinogenicity study was conducted in male and female rats at oral doses up to 63 mg/kg (approximately 14 times the maximum recommended human oral dose of 45 mg based on mg/m2). Drug-induced tumors were not observed in any organ EXCEPT for the URINARY BLADDER

hmmmm..... makes you wonder what if Takeda really wanted to look into what exactly was causing the "Drug-Induced Tumors in the Urinary Bladder?..... oh thats right, that would had been ethical and cost billions in profits.
 




You want proof that Takeda knew Actos caused "Drug Induced Tumors in the Urinary Bladder."...

Here you go.....

A two-year carcinogenicity study was conducted in male and female rats at oral doses up to 63 mg/kg (approximately 14 times the maximum recommended human oral dose of 45 mg based on mg/m2). Drug-induced tumors were not observed in any organ except for the urinary bladder.

Straight from the Actos Package Insert..... When reps asked about it, they were told it was in rats and above the maximum dose.

Regards,

M. Booth
 




Since rats treated with these agents at doses that produce bladder tumors have blood levels that frequently are similar to the blood levels achieved in patients treated with these drugs, bladder tumors in rats have become a significant issue for the potential approval of these agents by regulatory agencies for clinical use.

Two modes of action have been hypothesized for the possible induction of bladder tumors in rats by PPAR agonists, with very different implications for potential human cancer risk. Since PPARγ receptors are plentiful in the urothelium, one hypothesis is based on the direct interaction of the agonist with the receptor, producing an effect that ultimately leads to the induction of cancer.

Pioglitazone is the only thiazolidinedione so far reported, which actually produced bladder tumors by itself in a 2-year bioassay (El-Hage, 2005).

Bottom line anyway you look it it. If the rats were not given pioglitazone, they would NOT have developed Urinary drug-induced tumors...
 




The reason why the warning was placed in 2011 and not 2003 was due to insufficient data. What "proof" did the company withhold that Actos causes BC? The warning came as a result of an ongoing study and the only reason why the FDA reported this was due to transparency. The FDA no longer waits for a study to be complete before they update the medical community.

The company never told reps to do anything. Not sure what initiative Takeda took to stop reps from speaking about BC or even downplay it.

To the juror (which I know is BS) what was the proof that was presented to you that showed Takeda withheld information and what is the reasoning the FDA just approved a new medication with Actos in it?
-------------------------------------------
The situation that this company placed this patient and his family in deeply saddens me. I will never forget when we (Field Sales) first received notice of the BC concern. I was sitting in a Managers Meeting on the strip in beautiful Las Vegas back in late 2010 or early 2011. During one of Robin and Chris's "Build Trust and Commitment to the company" speeches all the DMs were busy on their iPhone's or BB. We received notice from the Home Office via an e-mail that their was a BIG concern with Actos and BC in the EU. The next day at the meeting we began brainstorming and role-playing of how to reassure our reps in the security of their jobs and answer questions from key accounts in a way that would protect the company's business. My interpretation of the training is we were verbally instructed by our RSDs of how to present the statistics and downplay the risk of bladder cancer. I cannot say if this was accurate or not, but I was surprised that we were not more aggressively educating patients on the risk.

Are you kidding me! They were aware since 2004! In my opinion, the company waited until the very last minute to instruct Field Sales how to handle concerned patients and physicians. Again, in my humble opinion, the lack of direction from Home Office on handling Actos BC in the Field with patients and physicians was done to avoid e-mail or any hardcopy communication. I do not recall receiving any hardcopy training or notification for HCP for several months into the situation.

After reading about the case in Los Angeles and learning that the makers of Actos were aware of the relationship between Actos and BC since 2004, I'm appalled. The additional 1,200 cases in Louisiana will greatly benefit from the CA verdict.

Disgusted,


:-(
 




You want proof that Takeda knew Actos caused "Drug Induced Tumors in the Urinary Bladder."...

Here you go.....

A two-year carcinogenicity study was conducted in male and female rats at oral doses up to 63 mg/kg (approximately 14 times the maximum recommended human oral dose of 45 mg based on mg/m2). Drug-induced tumors were not observed in any organ except for the urinary bladder.

Straight from the Actos Package Insert..... When reps asked about it, they were told it was in rats and above the maximum dose.

Regards,

M. Booth



Amen!
 




You want proof that Takeda knew Actos caused "Drug Induced Tumors in the Urinary Bladder."...

Here you go.....

A two-year carcinogenicity study was conducted in male and female rats at oral doses up to 63 mg/kg (approximately 14 times the maximum recommended human oral dose of 45 mg based on mg/m2). Drug-induced tumors were not observed in any organ except for the urinary bladder.

Straight from the Actos Package Insert..... When reps asked about it, they were told it was in rats and above the maximum dose.

Regards,

M. Booth

What were the reps supposed to say??? Something off label???? That's why there a 10 year study. If you want to say Takeda convinced the FDA to hold off or something like that, fine but I don't see where it was withheld.
 




You want proof that Takeda knew Actos caused "Drug Induced Tumors in the Urinary Bladder."...

Here you go.....

A two-year carcinogenicity study was conducted in male and female rats at oral doses up to 63 mg/kg (approximately 14 times the maximum recommended human oral dose of 45 mg based on mg/m2). Drug-induced tumors were not observed in any organ except for the urinary bladder.

Straight from the Actos Package Insert..... When reps asked about it, they were told it was in rats and above the maximum dose.

Regards,

M. Booth

Ask a Takeda rep what happens when you give Linzess to mice. Only then do they openly discuss rodent studies. What a shame.
 




-------------------------------------------
The situation that this company placed this patient and his family in deeply saddens me. I will never forget when we (Field Sales) first received notice of the BC concern. I was sitting in a Managers Meeting on the strip in beautiful Las Vegas back in late 2010 or early 2011. During one of Robin and Chris's "Build Trust and Commitment to the company" speeches all the DMs were busy on their iPhone's or BB. We received notice from the Home Office via an e-mail that their was a BIG concern with Actos and BC in the EU. The next day at the meeting we began brainstorming and role-playing of how to reassure our reps in the security of their jobs and answer questions from key accounts in a way that would protect the company's business. My interpretation of the training is we were verbally instructed by our RSDs of how to present the statistics and downplay the risk of bladder cancer. I cannot say if this was accurate or not, but I was surprised that we were not more aggressively educating patients on the risk.

Are you kidding me! They were aware since 2004! In my opinion, the company waited until the very last minute to instruct Field Sales how to handle concerned patients and physicians. Again, in my humble opinion, the lack of direction from Home Office on handling Actos BC in the Field with patients and physicians was done to avoid e-mail or any hardcopy communication. I do not recall receiving any hardcopy training or notification for HCP for several months into the situation.

After reading about the case in Los Angeles and learning that the makers of Actos were aware of the relationship between Actos and BC since 2004, I'm appalled. The additional 1,200 cases in Louisiana will greatly benefit from the CA verdict.

Disgusted,


:-(


Lots of attorneys popping champagne corks in Louisiana right now:):):)
 




Ask a Takeda rep what happens when you give Linzess to mice. Only then do they openly discuss rodent studies. What a shame.

AP

You're missing the point! The point is, ONLY when the rats, not mice, were given pioglitazone they developed "Drug-Induced Tumors in the bladder".....

That is the END of the discussion...
 




AP

You're missing the point! The point is, ONLY when the rats, not mice, were given pioglitazone they developed "Drug-Induced Tumors in the bladder".....

That is the END of the discussion...

Bladder cancer is not fatal. There is no Black Box warning for Actos and BC. Actos is not indicated for CIC or IBS. Dick.
 












I'm concerned about the good reps remaining at the company, but man does it feel great to see the unethical members of management (Director level and up) squirm. It was always odd the way the company did not want anything in writting or e-mail.

Folks should look into the continued push for speaker programs. Who are you educating on the benefits of a PPI? Really! How many programs have you done with the same docs until the budget is exhausted? Always entertaining the same HCPs is illegal and obvious quid pro quo.
 




I'm concerned about the good reps remaining at the company, but man does it feel great to see the unethical members of management (Director level and up) squirm. It was always odd the way the company did not want anything in writting or e-mail.

Folks should look into the continued push for speaker programs. Who are you educating on the benefits of a PPI? Really! How many programs have you done with the same docs until the budget is exhausted? Always entertaining the same HCPs is illegal and obvious quid pro quo.

There is no integrity left at Takeda.It all left in 2010 when Takeda lost its cultural identity,only to become the pond scrum that it is now.
 




You're all morons! What other company out there would have handled this differently than Takeda? (Silence). Oh, that's right, NONE.

The almighty dollar rules the world. Why is that so hard to understand? It always has, and it always will. Yes, I'll say it - the dollar is more important than human life. Sucks. That's just the way this world works, but I love all the posts about being ethical and doing the right thing. Give me a break, are you people that naïve?

Shut your mouth, wake up, go to work, collect your check, and make the world go 'round.

Januvia is next.