TNX-901 trials (AP reporter inquiry)

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Greetings all, I made a similar post on another board. My name is Paul Elias and I'm a reporter with The Associated Press. I'm working on story that explores the corporate infighting between Tanox/Genentech/Novartis and its impact on the development of a peanut allergy treatment. I'm hoping to talk to anyone who may have participated in the TNX-901 trials or anyone who has any views on the development of this drug and/or Xolair. You can email or call me at 415-495-1196. Thanks for your time and I apologize for the intrusion.

On Jun 12, 2003

I would definitely be interested in reading what you report! Will the article be on-line? Please post a link here if so. Thanks for covering this!

On Jun 12, 2003

I think you will this thread very informative: [url="http://uumor.pair.com/nutalle2/peanutallergy/Forum16/HTML/000116.html"]http://uumor.pair.com/nutalle2/peanutallergy/Forum16/HTML/000116.html[/url]

The author of the above thread has an e-mail address posted in her profile, if you would like to contact her off these boards. I don't recall seeing her posting here recently.

Good luck and please post a link to your finished article in our Media forum - thank you!

Carolyn

On Jun 22, 2003

Paul Elias' article appears this morning in the St. Louis Post Dispatch (page E2). It's called, "Corporate infighting halts development of peanut allergy drug". I'm sure it apprears in other newspapers this morning and I hope someone will post the link. Excellent article. Thank you Mr. Elias.

On Jun 22, 2003

Here's one link: [url="http://www.bayarea.com/mld/cctimes/news/6139681.htm"]http://www.bayarea.com/mld/cctimes/news/6139681.htm[/url] (If you want to see if it's printed in a local paper, you can try [url="http://www.google.com"]www.google.com[/url] - click on the news tab above the search field and search for peanut allergy elias )

On Jun 26, 2003

Thanks for the link. Interesting article. Before this, I never understood the relationship between Tanox, Genentech, and Novartis.

On Jun 27, 2003

No actually it's NOT an excellent article in my opinion.

It is just another jumble of words which would have more marketing type results than education and information.

It tells me nothing concrete about what exactly it did for this Allison Smith. How did it change her life? Did she start eating cross-contaminated food without worry? Is she taking greater chances with what she consumes? Are there side effects? How serious are they?

So what is the down side of this drug? Nobody seems to have any incentive to touch that one.

The stock may go up with this article but it certainly doesn't do much for my confidence in this drug.

On Jun 27, 2003

In response to River, I

On Jun 27, 2003

Are you the Allison mentioned in the article?

I'm a little confused because you talk about peanut butter on a desk but the Allison in the article is an adult woman who works as a nurse.

If you are, wow that was quick. There are certainly some well connected people hanging around this board.

Thank you for being very frank and honest about the side effects. This is something we haven't heard much about in the various press releases.

Since it has only been 2 years for you I guess there's not much you can say about the long term effects.

I'm not sure exactly how you can be certain the next bite won't cause anaphylaxis as the drug does not eliminate your sensitivity. You can't be. You never can be. Maybe you can feel a little more relaxed about trying new foods, but you'd always have to be prepared. It doesn't take much to slurp down over 8 grams of hidden peanut without realizing it.

Does this drug also take away the possible life saving defensive reaction many PA people have when they smell or taste peanut?

What this drug might do is allow PA people to be around peanuts thereby eliminating the need for peanut bans, which means higher peanut sales. Not safer conditions for the PA individual though.

I know that there would be pressure especially in the U.S. for parents to put their children on these drugs regardless of whether or not they feel confident about this medication.

My son is very healthy beautiful little boy. As long as he stays away from peanut he has as good a chance as any to live a long and happy life. I wouldn't want to put him on an unnecessary medication and find out 5 or 10 years down the road that I had caused him serious health concerns for little or no payback.

Thank you again for your honesty.

On Jun 27, 2003

River, I worry about this too. I worry that the people around DS (and more importantly, DS himself) will stop being careful enough to avoid a reaction in the first place or will be too slow to treat a reaction if one occurs.

And I agree with you about the pressure that will come. Every time there's an article about this it seems like everyone I know emails me about the great "cure" that will "take away all our PA worries".

Of course, I'm one of the laggards that won't consider laser eye surgery because I'm afraid my eyeballs would explode sometime in the next 50 years before I did of old age. ;-)

T.

On Jun 27, 2003

Quote:

Originally posted by river: [b]My son is very healthy beautiful little boy. As long as he stays away from peanut he has as good a chance as any to live a long and happy life. I wouldn't want to put him on an unnecessary medication and find out 5 or 10 years down the road that I had caused him serious health concerns for little or no payback.[/b]

Hi River,

I totally agree. I have been managing this allergy my entire life and feel comfortable managing it now, and I would not want to risk my health by taking some treatment that could have possible adverse affects in the future... anyone remember thalidomide?

I don't mind taking occasional Reactines (Zyrtec) for my seasonal allergy, but I do try to avoid any unnecessary medications.

On Jun 28, 2003

Quote:

Originally posted by river: [b]I'm a little confused because you talk about peanut butter on a desk but the Allison in the article is an adult woman who works as a nurse.[/b]

I think you may have misread this, river. "The nurse called Allison Smith..." means "The nurse telephoned Allison Smith..."

Allison Smith is the "teen", not the nurse.

On Jun 28, 2003

In response to Rivers questions, yes I am the Allison from the article and Gail is correct- the nurse called me to tell me that the study was being canceled.

[quote]Originally posted by river: [B] I'm not sure exactly how you can be certain the next bite won't cause anaphylaxis as the drug does not eliminate your sensitivity. You can't be. You never can be. Maybe you can feel a little more relaxed about trying new foods, but you'd always have to be prepared. It doesn't take much to slurp down over 8 grams of hidden peanut without realizing it.

You are correct I am not certain the next bite of food will not cause anaphylaxis; however I do know that I have a MUCH higher threshold to peanut then I did prior to the getting the drug. The purpose of the drug is not to allow people with food allergy to eat the culprit food but to prevent anaphylactic reactions to cross contaminations or other small accidental ingestions. I am still as careful as I was prior to getting the drug. I still tell everyone about my food allergies and still carry my epi pens everywhere.

[quote]Originally posted by river: [C] Does this drug also take away the possible life saving defensive reaction many PA people have when they smell or taste peanut?

I still have my peanut instinct- I smell it the second I walk into a room that contains peanut and I still worry about it even though I am fairly confident I won

On Jun 28, 2003

Well, I know I shouldn't speed read but...sorry Allison for confusing you with a nurse...unless of course this is your aspiration, then perhaps you don't mind.

Thank you for taking the time to answer my questions, and as I said in a post on one of the other boards, perhaps this is a good drug for people like you who suffer from such a number of ailments that something is needed. I however, still believe that this is in NO WAY A PEANUT ALLERGY DRUG, and can only wonder if it is being labelled such for political reasons.

Are you employed as a spokesperson for these trials? I believe they usually do that, don't they? That's not to say that you would ever distort the truth,(and I do believe you are being totally honest), but this is also a big part of a larger truth.

I wish everyone on these boards was honest about who they represent or who they are associated with.

On Jun 28, 2003

Quote:

Originally posted by river: [b]Are you employed as a spokesperson for these trials? I believe they usually do that, don't they? That's not to say that you would ever distort the truth,(and I do believe you are being totally honest), but this is also a big part of a larger truth.

I wish everyone on these boards was honest about who they represent or who they are associated with. [/b]

For the record: I am not associated with any organization, nor do I represent anyone other than myself.

I do not think the goal of this article was to evaluate the value (or not) of this drug. The focus, instead, was on the [i]process [/i]~ the infighting, the legal rangling, etc. between Novartis/Tanox/Genentech which lead to the trials ending.

How can we judge the pros and cons of this drug until the trials are completed and evaluated?

On Jun 28, 2003

Quote:

Originally posted by river: [b] Are you employed as a spokesperson for these trials? I believe they usually do that, don't they? That's not to say that you would ever distort the truth,(and I do believe you are being totally honest), but this is also a big part of a larger truth.

I wish everyone on these boards was honest about who they represent or who they are associated with. [/b]

Can't speak for Allison's experience with clinical trials, but I can share our (my family) own, or lack thereof.

A couple of years ago, a prominent physician (pediatric) requested our son (ASTHMA/PA/Nuts/excema/EA/Atopic in general/Rhinitis) be part of a study involving Phase 2 (I believe) of clinical trials for an injectible drug to reduce IGE levels. We would not know if he recieved a placebo or not. Aside from the study being free, the only monetary compensation was some [i]insignificant[/i] amount (approx 20 dollars a month) to cover travelling expenses). This is what we were told. Although money was not an influence in any way to our decision, we did ask out of curiosity (and amazement) if any harm experienced by participation in the study would be compensated (if that is possible). We were told no. (If I remember correctly, any medical care would be covered but not damages)I do believe there was a waiver to sign, if I remember correctly.

Being a healthcare professional, I can see the ethical conflict of interest in offering the possibility of financial gain to individuals in exchange for possibly risking their safety. Much similiar to (at least in the US) making it illegal to offer money in exchange for human organs.

You may begin to understand what I'm trying to relate. I truly believe (personally) that individuals who participate in such studies are either desperately seeking medical solutions for themselves, acting out of pure altruism, or a combination of both.

I would never, never, never classify their actions as suspect, personally, in light of my own experience in the healthcare professions. However, I did question the motivation of those asking us to participate in the study, for a variety of reasons (Who knows, maybe they were acting out of genuine concern and altruism. Who knows? I can think of only one [i]Person[/i] who does.

I personally believe the risks can be greater for the test subjects rather than those who orchestrate the studies.

BTW, We refused to allow our child to participate. And no, no amount of money would have changed our minds.

PS, I was asked to participate in a shingles pain study recently, but refused. This study did not even offer gas money. LOL. And, no, it was not an influencing factor. I just wasn't crazy about taking drugs to reduce the particular pain, personally.

Disclaimer: I am not offering advice in any manner or form.

MommaBear

On Jun 28, 2003

I am not a spokesperson for TNX-901. I am just simply trying to answer questions about my experiences in the trials because I know so many of you are very interested in TNX-901. I joined the study because I have basically reached the end of current medical treatments for my asthma/ allergies. Before agreeing to join the study I did a lot of research about anti-IGE (there were several published articles about Xolair). At the time there were very few documented negative effects of Xolair and since I knew both drugs were very similar on the molecular level, I decided it was worth the risk. Furthermore, I was on oral steroids a good portion of my life and the side effects of steroids are very debilitating. I really felt this was my best option and am very happy I decided to participate.

On Jun 28, 2003

Thank you for sharing your information with us, Allison.

On Jun 28, 2003

I'd like to add my thanks as well, Allison. You are a very well-spoken young lady and I wish you the best of luck. Thanks for sharing your experiences. I'm glad to hear of your general satisfaction with the drug so far and hope that you will check in with us on the boards to share any new experiences with us. -Cindia

On Jun 29, 2003

Allison, You spoke very well for yourself and should be proud of making a decision to participate in something that might save my son's life some day. I add my congratulations and praise. Peggy

On Jun 30, 2003

Allison, thank you for answering my question. Like I said before, I always assumed you were being open and honest about your experience, and I accept your answer in this light. I'll also add that you impress me as a very intelligent and articlulate young woman, especially when you are just barely out of high school. You are headed for some big things in life!

I can see how such a drug could be so important to someone like you with mutiple life-threatening food allergies and asthma. I can also see your need to get off of those steriods to avoid long term damage.

If this drug was not funded by The National Peanut Board, and if this drug was not being proclaimed "The Peanut Allergy Drug", and if it was not being "fast-tracked"---I would have no discomfort with the study. These three factors leave me feeling more than a little uneasy.

On Jun 30, 2003

raising for Kurt

On Oct 12, 2003

raising for prayforacure

On Oct 13, 2003

Allison, One well-respected doctor in our area told me that he was concerned that the drug might negatively impact the immune system (that is, suppress it). You mention in a previous post that you notice that you get sick more.

This is my major concern with this drug. Right now, I know what I am dealing with. I am comfortable with the protection we have in place. However, if DD were to take it and then have immune system problems...well...that is another problem all together and a problem I can't help her with (that is, I cannot protect her from germs).

Any thoughts on this based on your experience?

On Oct 31, 2003

Raising for Connie and Laurensmom I will answer your question but i've been really busy so it will probably take me a few weeks

allison

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