Merck found guilty re: Vioxx

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Merck found guilty re: Vioxx

Postby HarryZ » Fri Aug 19, 2005 8:36 pm

Saw on the tv today that Merck was found guilty of not advising patients about the dangers of Vioxx. Believe it was the family of a patient who died from Vioxx that launched the suit. The jury awarded a penalty of $ 229 million with another $ 24 million for pain an suffering because of the death.

There are a couple of suits against Biogen/Elan for the very same reason re: Tysabri. Interesting to see what will happen in these cases.

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Re: Merck found guilty re: Vioxx

Postby Daunted » Fri Aug 19, 2005 11:53 pm

It will be interesting. I believe the critical difference will be, it is pretty obvious Merck knew of these problems, I don't believe anyone this is the case with Tysabri.
On Vanderbilt Antibiotic Protocol since January
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Postby OddDuck » Sat Aug 20, 2005 4:44 am

Yes, they did. How I ended up knowing about the risks beforehand (which I wrote to the FDA about) was from Biogen's own previous research that they neglected to adequately inform the public/patients about. It'll be a slam-dunk case.

PLUS, other neuros had contacted Biogen regarding the same concerns. Remember, in a court of law, you don't have to prove that Biogen absolutely DID know, you only have to prove that they "should have known" about it. If others knew (such as myself and other neuros), then Biogen "should have known". And that is at the very least and is a slam-dunk case.

Plus, if they bring into court the same physical evidence that I found and posted previously here (which was Biogen's OWN research that they ignored), it will only make the case that much stronger.

How/why does anyone think I came to the conclusions and made the predictions I did about Tysabri? Just out of the air? Why was I doubley concerned once I found out that Biogen ITSELF did know about it? I came to my concerns about Tysabri partially based on Biogen's own research!! Which they then "conveniently" ignored when it came to testing and marketing Tysabri.

IF they had put the warnings out in complete detail (both within their clinical trial waivers and with their marketing statements) that I had noticed were NOT included with Tysabri, they would have had no worries now. Even with the deaths that occurred. Then when Tysabri's packaging came out, and there were NOT the same warnings with it that it should have had, (similar to the ones that Novantrone comes with), that pretty much sealed the case.

This is all very easy to prove in court.

And remember, Biogen did not have to know that Tysabri might cause PML to go haywire specifically; it only has to be shown that Biogen knew or should have known that Tysabri could or was very likely to allow/contribute to infection "running rampant". PML is a viral infection.

What Biogen knew (I got this from their own research) was that Tysabri stops T-cells (ALL T-cells) from crossing the BBB, but does NOT stop macrophages from crossing the BBB. Macrophages carry infection. It is the T-cells that keep infection in check. Therefore, if macrophages crossing the BBB carries and/or contributes to infection and it's the T-cells (as we know) that are the ones that fight infection, and since Tysabri prevents T-cells from crossing the BBB, then it is only simple common sense that tells you what is likely to happen. An infection will run unchecked. Are people saying that Biogen didn't have common sense? And that is going to be their defense in court? And that they are likely to WIN with that baloney?

As I said, if I knew it based on novice research BEFORE Biogen was approved, Biogen (with their so-called expertise) "should have known".

They better get their wallets out............

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Postby OddDuck » Sat Aug 20, 2005 5:34 am

And if anyone doesn't believe my last post above, then revisit this thread:

<shortened url>

Please allow me to explain something in further detail. Since the infection issue was simply "common sense" to me, I didn't dwell on that aspect particularly. The other side of Tysabri that has not yet come to light at all, was the concerns regarding fertility, conception and birth defects (along with many other intriguing questions that Biogen might want to make clear now, before this hits the market again). All that can be left for another day.

Let me prove what I am saying above (as far as what I myself, as a novice, could ascertain from the research, which remember, was Biogen's legal responsibility to fully and completely explain in layman's terms to patients and the public). I will also highlight portions of what I explained back in November, 2004, when "John" asked me to explain something further:


Posted: Sat Nov 06, 2004 11:36 pm Post subject:


Yea, that's the thing. And that statement is just a general one. Actually, it's a good thing for the rats for THAT disease, but could be a bad thing for MS in many ways.

The thing is, a VLA-4 antagonist stops T-cell migration, but does NOT stop macrophage migration into the brain and/or CNS. For some conditions, that can be a good thing, but in MS, that is NOT always a good thing.

So.....basically, a VLA-4 antagonist can stop the immune system T-cells from entering the brain, but will not stop APCs from entering the brain. So, the probability is that IF any types of MS pathogenesis is from antigens sneaking in and isn't solely an immune system dysfunction, then in the long run, that is a bad thing. (Hence, that may be where and why we are hearing the rumors about Antegren not working for long. Even the findings from Biogen that I posted above indicate the same thing.)

The thing with a VLA-4 antagonist, though, is that when it is used in connection with stem cell research, the very fact that it is so potent and does manipulate what crosses the blood-brain barrier and blocks "certain" other things from crossing COULD be helpful. If you want stem cells to cross over the BBB without interruption from other bodily processes trying to stop them, then it could be great. (Again, though, all this research is in its infancy and a VLA-4 antagonist is nothing to just play around with.)

The other possible problem, though, is the fact that it doesn't allow ANY T-cells to cross. Hence why it says that over time, the body switches to a mainly TH1 immune response. In MS, you want to keep your immune system predominantly TH2. Plus, this allows a HUGE margin for infection, etc. to run rampant should you ever pick something up.

My question also then is...........you DO want the "good" interleukines to do its work in MS (i.e. such as IL10, and other anti-inflammatory cytokines), so if you take Antegren as a monotherapy, how long WILL it take before it stops working? And especially since Antegren only works via ONE mechanism of action, where are the balancing mechanisms that you need to balance out what it's doing?
I think the advice that person got (that I posted above - no wait, maybe it was in another thread - but I won't name names) from her neuro was a good one. Antegren MAY need to be used in combination with something else.

Biogen's OWN research points out many possible difficulties, doesn't it? That's what I found a little disturbing, shall we say. What changed in under a year with their research? Or is getting Antegren on the market more for the goal of supplementing stem cell research in the future?

It's going to get interesting, I'd say.

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Postby OddDuck » Sat Aug 20, 2005 5:57 am

Ok.......last post.

Think about this, too. A very simple easy way to prove that Biogen "should have known" comes back to this very website itself.

We all know "Art". Art participates in this forum. Through Art's non-profit agency, he is in direct contact with Biogen itself. Question: How easy was it for Art himself to inform Biogen of the public's concerns and direct them to read our posts here on this website? What are the possibilities/probabilities even outside of communication with Art, that Biogen could have very well read our concerns? Therefore, indicating AGAIN that Biogen "should have known".

Plus, allegedly, someone from Biogen DID contact Aaron (the administrator of this website) offering to answer questions regarding Tysabri. At one point in time, (I'm sure many others will remember.....right, Harry?), there was a posting by Aaron which told us that very thing. Once again, does this indicate that Biogen "should have known", if from no other avenue then by reading this very website itself??

Let's get Biogen on the stand. Let's show them past printouts of the discussions here on thisisms regarding Tysabri. Let's ask Aaron if he was contacted by a Biogen [correction below - "Elan"] Rep offering to answer questions (thereby indicating that they WERE fully aware of this website). Now........let's ask Biogen on the stand to say AGAIN that they didn't "know" or had no way of knowing about the possible risks of Tysabri.

Frankly, I gotta hear their explanations for THAT one!

Deb

CORRECTION: Aaron was contacted by "Elan". http://www.thisisms.com/modules.php?nam ... opic&t=620 Still, that again makes no difference, as Biogen/Elan are in alliance, therefor Biogen will still be on the spot in trying to say they had no way of knowing. Yep, the postings on this website alone is good evidence in court.
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Postby OddDuck » Sat Aug 20, 2005 6:28 am

And before anyone goes on the rampage against me in the defense of Biogen, let me say this much:

Even if Biogen CEOs may indeed be "ignorant" of all this; how in the heck can they explain that their very own ATTORNEYS were pretty doggoned dumb not to advise them adequately up front to help them to avoid all this trouble in the first place?

Any attorney worth a dime would know UP FRONT and should advise their clients to fully and adequately INFORM patients of ALL possible risks of taking any drug, during a clinical trial or otherwise. A "general" overly-broad clinical trial waiver form that does NOT contain specifics does not legally "fully inform" patients of the risks involved. Any attorney with "common sense" knows that.

Biogen............fire your attorneys!!! Bring THEM in as a third-party defendant! HAH!

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Postby HarryZ » Sat Aug 20, 2005 6:41 am

Deb,

Reading your posts certainly reminded me of the numerous messages that were posted about Tysabri last year and the concern that some of us had about its long term use. If I can recall, we took a lot of flack from some readers because we were accused of being negative, were Biogen bashers, had hidden agendas etc. etc....and that we should drop off the face of the earth!

I could understand the positive anticipation that MS patients had about Tysabri because Biogen/Elan engaged in a very successful marketing program that had people lining up by the thousands to start on the drug. But in the background, as you have pointed out, there were a number of concerns about the possible dangers of this drug and Biogen/Elan swept them under the carpet. Dr. Lawrence Steinman (albeit working for a competitor) had stated a number of times the dangers of Tysabri but Biogen's answer to his comments was to ask him to stop making such statements.

I know little about the legal system but after reading this morning about how Merck was found guilty of cover-up with Vioxx on which legal experts said was a weak case against them, I feel that the suits against Biogen/Elan could very well be successful for the plaintiffs. And I've said it before, many times.....had Biogen/Elan simply followed their original plan and waited for all the two-year Phase III trials to end, they wouldn't be in the mess they are in today. And more importantly, thousands of MS patients wouldn't have had to go through the stress they are currently experiencing over Tysabri.

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Postby OddDuck » Sat Aug 20, 2005 6:47 am

Well said, Harry.

Oh..........and as you just now so aptly pointed out, NOW there is also recent precedent (the Merck case) for the Plaintiffs to use against Biogen, which only bolsters their case.

Frankly, I do wish Biogen luck, because that's what it's going to take to get them out of this one. Pure and simple dumb luck.
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Postby OddDuck » Sat Aug 20, 2005 7:11 am

I'm reading up a little on the Merck case.

Here is what I see is one of the differences between the Merck case and at least the one case against Biogen. The Merck case apparently alleged (and won - of course Defendants are taking it to appeal) that Vioxx itself caused the wrongful death of a patient. They went for the whole shabang - direct causal relationship..........win or lose. Pretty risky, but they won in District Court. (That is why you will read about such "elation" over this verdict. It was because of the extreme strategic risk and the approach the Plaintiff's attorneys took in Court.)

What the case against Biogen is alleging is that the patient was not legally "fully informed" of the possible risks. And that Biogen "knew or should have known" about the possible risks. Slight difference word-wise, but big difference in burden of proof on the Plaintiff. That particular allegation in this case should be easy to prove (as I previously mentioned). Very subtle difference, but very smart (strategically speaking) on behalf of the Plaintiff's attorneys. Moving up from there to proving their particular wrongful death claim is easier, then. They are not saying that Tysabri ITSELF caused the patient's death; they are saying that the patient was not legally fully informed, therefore the patient had no way to properly weigh the risks and make a fully informed decision about whether or not she wanted to take the risk (which apparently, as is now evident, included even the risk of death) before she agreed to take the drug. That allegation, if proven in court, also strongly supports a wrongful death claim against a Defendant.

As far as damages awards go, that will be dictated quite a bit by the laws that exist in the State where Biogen's lawsuit is filed (i.e. Massachusetts).
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Postby jaycee » Sat Aug 20, 2005 10:58 am

Merck is in soooooo much trouble. This is amazing.

http://www.fortune.com/fortune/articles ... ml?cnn=yes
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Postby OddDuck » Sat Aug 20, 2005 11:05 am

Please don't kill me, folks, but did I not just say in another thread not only some time ago, but also just the other day that the Unions were gearing up for their attack against the pharmaceuticals? And against PBMs? :wink: (referring to jaycee's post above).

Yep.........here it is. Posted August 5th. I was talking to Harry:

....Hey, Harry.........don't waste your breath on him, either. The pharmaceutical world is about to be investigated and hit by the largest industrial unions in the United States and Canada (with 850,000 members). They'll turn their little profitable monopoly upside down. HAH! I can't wait!


Of course, I guess I had some "hidden agenda" for saying that. Right, Harry? Not that it was ever going to actually happen, huh?

I rest my case. (Sorry for sounding sarcastic, but it's hard not to once your integrity and honesty have been attacked in the past like mine and Harry's have been.)

Oh, yeah..............and believe me, Biogen is one of the first ones already on the Unions' radar screen. www.biogenexposed.com
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Postby HarryZ » Sat Aug 20, 2005 1:01 pm

jaycee wrote:Merck is in soooooo much trouble. This is amazing.


After reading your link, your quote is an understatement!! I had read a number of months ago that Merck would likely cease to exist if all the upcoming litigation against them was successful. I can now see why!!

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Merck

Postby Cathy » Wed Sep 07, 2005 7:04 am

Just so you know, the client will never collect what was awarded in the Vioxx lawsuit, as in many others. Even though that is what was awarded, what will be collected will be determined by that states tort reform laws. There are caps on non-economic's and pain and suffering. The actual recovery will be enormously less than what was awarded.

My understanding of the Merck issues is that Merck knew, or should have known, that the products could lead to clotting problems resulting in strokes or heart attacks, deep vein thrombosis and pulmonary embolism. They did not tell anyone-not even the people who were prescribing.

I recently looked up copaxone again, as there are many post-marketing side effects listed now. You should all look up the drugs you take, new drugs, as they learn more and more as time goes on. Still, even with the potential for terrible side effects, I inject myself every day.

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Re: Merck

Postby HarryZ » Wed Sep 07, 2005 8:30 am

Cathy,

The ruling against Merck has certainly made other drug companies begin to think that they should indeed be telling their potential customers about all of the possible side effects. We've known for years that the CRAB drug makers have minimized the possible problems you can get with their drugs for MS and often don't tell the docs nor the patients about them.

I've read countless times about patients who use Copaxone not being told about the possibility of lipoatrohphy. They don't look for it, don't take steps to try and minimize it and then are totally surprised when their injection sites end up in terrible condition. The University of Ottawa did a study of Copaxone users and came up with a 45% incident situation of lipoatrohphy!

Like you said, tell us about the possible side effects and we'll make the decision on using the medication along with consultation from our doc. But don't hide anything...unfortunately Merck found out the consequences of doing just that!!

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drugs

Postby Cathy » Wed Sep 07, 2005 8:49 am

I totally agree Harry, and the thing with Merck is just beginning. I agree they should be punished for not imforming the public about the risks of taking the NSAID's. But I have to say, even my neuro who I respect, never once mentioned the bad side effects I could get from copaxone, not even the one that causes chest pain, flushing, shortness of breath. If I had not read this on my own, I would not know. The only reason I know about lipoatrophy is from reading somewhere, but not my Doc. I am lucky I am a nurse and know that anytime you really want to know something, you have to figure it out yourself, but I do feel for those who rely on Doctors, drug companies, or product companies for information.

My last visit with rheumatologist (I have osteoarthritis) he suggested celebrex or bextra (even though I told him Motrin working just fine) I had to remind him that everyone in my family has died of heart disease or stroke, and remind him of my risk factors for both. I am exactly the kind of person who should NEVER take these drugs. He was embarressed to say the least.



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