Efficiency of Antegren

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Postby OddDuck » Wed Nov 10, 2004 10:27 am

My sole "point", Meadow, is that how can people make a FULLY "informed" decision if they don't know ALL of the possible complications, no matter how small someone may think they might be.

Something small to YOU, may be something someone else may want to know. Do any of us have the right to make that assumption for others, and therefore to withhold ANY tidbit of information from them?

This IS a democracy, correct?

Deb

EDIT: I know.....let's hand out a pair of "rose colored glasses" with each Antegren prescription, shall we? (I know that's a petty statement, and I have probably just lowered myself somewhat, but I couldn't resist.) :wink:
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Postby OddDuck » Wed Nov 10, 2004 10:40 am

Let me quote from the FDA (with whom I may not always agree with, either, but in this case, they said it very eloquently):

...."Modern drugs provide unmistakable and significant health benefits, but experience has shown that the full magnitude of some potential risks have not always emerged during the mandatory clinical trials conducted before approval that evaluate these products for safety and effectiveness. Occasionally, serious adverse effects are identified after approval either in post-marketing clinical trials or through spontaneous reporting of adverse events.....

...Detecting, assessing, managing and communicating the risks and benefits of prescription and over-the-counter drugs is a highly complex and demanding task. FDA is determined to meet this challenge by employing cutting-edge science, transparent policy, and sound decisions based on the advice of the best experts in and out of the agency." ....

It is also encouraged that the public submit their concerns to them regarding drug safety.

Who are any of us to attempt to deprive or sway anyone from the right to do so?

If we don't learn from past mistakes, what/how can/do we learn anything? And what is the benefit of ignoring past mistakes?

Deb
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Postby OddDuck » Wed Nov 10, 2004 10:55 am

Sorry, I keep posting here, but I was just chuckling to myself........

I know what you were trying to ask me, Meadow.

Before I approach someone DIRECTLY, I research the "people" involved and their integrity, past performance, etc. I strategize completely. Then I put myself in THEIR shoes and ask myself how I would respond if I were them.

Based on all of the facts that can be obtained regarding all of the above factors I just mentioned, not to mention how/what their legal counsel would advise them, do you REALLY think they would answer me at all?

Hey.........I MYSELF wouldn't advise them to say a word! Again, that's just another side of "risk assessment". :wink:

I never said these guys at Biogen weren't smart. As a matter of fact, I said they were.

Deb
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Deb - regarding antegren

Postby MeadowStream » Wed Nov 10, 2004 3:49 pm

Deb,

Many companies are focused on anti-VLA4. Merck, Biogen, Elan, GSK, and others. By contrast, only Celgene was willing to dip their toes into the thalidomide waters again in the 90's. anti-VLA4 is not considered a particularly dangerous compound and you are the only one I have seen really banging this drum. That is OK, of course, and certainly doesn't require my approval anyway.

I think you are painting a picture of conspiracy surround Antegren. I still don't understand why. I have never known a company as straightforward about its therapies as Biogen is about their drugs. No non-sense. When there have been safety or soluability issues, Biogen has acted quickly to end a program.

In the mid-late 1990's Biogen had an anti-VLA4 program that they ended due to safety concerns - a soluability issue. They soon discovered that Elan had a molecule that solved that issue. They partnered. Half of big pharma is now trying to duplicate their joint approach to that pathway and, in my opinion, if there were legitimate safety concerns then they would not waste their money on development just to incur liabilities.

How do address the serious renal problems that rebif and avonex sometimes engender? Or the myriad serious side effects of all ABCR drugs? I just don't understand why you choose to focus on the "potential" side effects of a drug versus the very real side effects of other treatments - especially when data (the only data available for THIS molecule) shows it to be an order of magnitude safer AND more efficacious.

I do understand that you have the right to do so, and even appreciate that you are putting those concerns out there, but you seem to have reserved a special venom for antegren versus other treatments despite the fact that FOR MS PATIENTS the drug is superior to all other treatments.

If you are in Boston or Philly then we could meet for a cup of coffee sometime to discuss in person.

MS
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Postby OddDuck » Thu Nov 11, 2004 5:00 am

I'm just waiting to see if these "particular" safety precautions are identified. The CRABs DO inform people of the safety precautions for their drugs, and there is research you can find that investigated those side effects.

You can't find a thing where the full side effects have been fully "investigated" yet regarding Antegren, when there is indication (very much like the liver toxicity issue with the CRABs) that it should be.

That's the difference. I can find where liver toxicity has been researched with the CRABs and you can locate what the safety precautions may be before taking the CRABs, so you can be fully informed if you want to take the risk.

If I could find the same research having been done regarding the integrins (which I found enough, though, to indicate it SHOULD be done, but hasn't yet), then I wouldn't be concerned that this particular issue would be missed or that people may go on uninformed.

Where's the research that they have looked into it in depth....the same way the CRAB side effects were looked into? See the difference? That's the exact same circumstance that happened to Vioxx. IF they had simply UP FRONT told people that chronic use of Vioxx MAY cause cardio problems, and provided the research that indicated same, they wouldn't be in the spot they are in now. It was a simple issue made huge because they just plain either didn't want to believe it might cause a real problem or they didn't want to take the time to inform people up front.

Like I said, we'll see what the FDA thinks.

I'm in law..........I become "passionate" about the "rights" of people to know. I'm not as "passionate" about whether Antegren is harmful or not. It's the "right" of people to be fully informed that I'm "beating a drum about". If it doesn't cause any harm to block VLA-4, then simply show where and/or how they came to that conclusion.

That's all my question is. Will blocking VLA-4 be harmful long-term? And if the answer is "no", then show me how they reached that conclusion. Where is the research? If YOU can point me to it or give me data that shows the risk level(s), then great!! This subject would then be closed. But........hmmmmmmmmm.....nobody can, it seems.

Why is asking a simple question so difficult or referred to as trying to create a conspiracy? And believe me, I didn't charge them with RICO charges, nor any of the other unlawful allegations against them. They apparently have caused their own problems in the past. That's simply
relaying fact, not conspiracy at all.

And I wasn't the one who published research data that shows unequivocally the possible issues regarding VLA-4 blocking. If someone else hadn't found the possible problem, and/or I had seen where Biogen addressed that very issue, also, and provided reassurance and data about it, then hey! No problemo!

But.......they can't.........or won't. (Yet.) Why not?

I could see if they didn't provide any reassurance if there wasn't any research that clearly indicated there COULD be a problem, but there is. Plain and simple.

Deb

P.S. You buying the coffee? ROFL By the way, who are YOU? Or no, what I mean is WHERE are you? Fess up! You must be somewhere in between Boston and Philly?

EDIT: Oh, by the way........my feeling, also, based solely on the personalities of the neuros around here whom I know.........if a neuro or doctor is worth his salt, as they say, when being "sold" Antegren (either for MS or for Crohn's) he'll ask those same two questions also. Right away. If you were a sales rep for Biogen and Antegren, what would your answer be? Oh...there's no need to look into that possible side effect because of its remoteness? Then their next question would be "show me the data where YOU came to the conclusion that it IS that "remote". It all boils down to providing the data or substantive evidence upon which you came to your conclusion.

(Sorry, I'm editing for typos, not substance.)
Last edited by OddDuck on Thu Nov 11, 2004 5:49 am, edited 3 times in total.
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Postby OddDuck » Thu Nov 11, 2004 5:35 am

You know, I think it's the "specificity" of my question that is causing the "chagrin", isn't it?

Will blocking VLA-4 be harmful long term and/or what are its effects on male and female fertility, miscarriage, conception, and birth defects?

Again, simple question, Meadow. Why am I asking? Does it matter why? It's a simple question. Don't read anything more into it. You can BET there will be some patients who WILL ask that very same thing of their neuros. And will their neuros give them some double-talk? Or just say "I don't know". WHY don't they know? Because Biogen couldn't provide data at the time of sale?

Deb
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Deb - we need to wait for the label

Postby MeadowStream » Thu Nov 11, 2004 11:43 am

Deb,

We need to wait for the label in order to see whether your concerns are addressed to your satisfaction. The label should be known to we citizens sometime late this month, after approval.

I live in the Boston area but travel to Philly frequently, and I will be happy to buy the coffee. :D

Anyhoo, if you main concern is the possibility of birth defects then that is pretty focused and I would think the several companies researching the VLA4 pathway might have something to say and the differences between what they say could be interesting.

MS
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Postby OddDuck » Thu Nov 11, 2004 12:21 pm

:lol: Care to spring for lunch? (Hey....give an inch, I might take a mile.........hehehe...)

Deb
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Postby OddDuck » Thu Nov 11, 2004 12:58 pm

By the way, be careful what you offer, Meadow. *personal info edited out*. The *edit* is in Philly..........it's not totally impossible. :wink:

Deb
Last edited by OddDuck on Sat Nov 20, 2004 9:35 pm, edited 3 times in total.
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Philly and USWA?

Postby ElanMike » Thu Nov 11, 2004 1:40 pm

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Postby OddDuck » Thu Nov 11, 2004 1:57 pm

LOL................I stand corrected!

Well, Pennsylvania, anyway. :oops:

Geography was never my best subject........... (I'm cracking up.)

Deb
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Postby OddDuck » Thu Nov 11, 2004 1:59 pm

(I'm still cracking up over the geographical oops.)

Deb

*Personal information edited out*
Last edited by OddDuck on Sat Nov 20, 2004 9:34 pm, edited 3 times in total.
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Postby OddDuck » Thu Nov 11, 2004 2:10 pm

Hey, Meadow!!! Looks like you better just pick me up at the airport! ROFL I better fly right into Boston! :lol:

(Sorry to get off track, folks.....this just got funny, is all.)

Deb
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Coffee and geography

Postby MeadowStream » Thu Nov 11, 2004 4:07 pm

Deb,

Just let me know if you are game and we can set something up. Don't worry, am married with a great wife and sons and daughter so arguing about anti-VLA4 is not my way to meet women! <g>

Am pretty excited to see label for Antegren and expect it will foster some exchanges here.

Best,

MS
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Postby OddDuck » Thu Nov 11, 2004 7:11 pm

Meadow,

Truthfully and sincerely, thanks so much for your gracious offer. Hey, you never know! And it sounds like you have a wonderful family!

"Argue"? Naw.......we've only been having an intellectual exchange of ideas! :) And I always view those as learning experiences. Nothing like 'em! Speculation and honest respectful debate gets the creative juices flowing. :wink: Not to mention, you get to meet some very interesting people that way, also.

Yea, I'm anxious to see what else comes to light (if anything), at the end of the month from the FDA.

Bottom line, aside from my personal "caution" (which in reality is neither here nor there - everyone should make their own decisions based on individual factors known only to them), I truly do hope any and all of the new pharmaceuticals coming out in the near future to help treat MS prove effective! I've said before, and I'll just take a moment to say again.........I hate this crappy disease with a passion. Sometimes I feel so doggoned helpless, and I wish I could do more.

And with that..........(and not to get mushy here), but I truly hope everyone is doing well and "keep up the good fight"!

Best,

Deb
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