PA Vaccine Update

Posted on: Mon, 03/10/2003 - 5:28am
anonymous's picture
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Joined: 05/28/2009 - 16:42

See new info about the vaccine at
[url="http://wcbs880.com/medicine/health_story_069142305.html"]http://wcbs880.com/medicine/health_story_069142305.html[/url]

It looks like it's getting closer to becoming a reality

Posted on: Mon, 03/10/2003 - 6:13am
choguy's picture
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Joined: 02/20/2003 - 09:00

I have downloaded the research articles from the website of the New England Journal of Medicine (my company has a subscription). I will begin reading through them and mention anything of interest to the board. The articles will be available in hardcopy when the Journal publishes them on March 13th. I would imagine most large librarys would have it. As one who works for a biopharmaceutical company, I know how data can get people a little too excited. Even if everything went perfectly, this treatment is at least 4-5 years away. But, it is definite progress!
Troy

Posted on: Mon, 03/10/2003 - 6:37am
Joanne's picture
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Joined: 02/22/1999 - 09:00

Links to articles published online today in the New England Journal of Medicine
Link for "Factors Associated with the Development of Peanut Allergy in Childhood" by Lack et al.
[url="http://content.nejm.org/cgi/content/abstract/NEJMoa013536v1"]http://content.nejm.org/cgi/content/abstract/NEJMoa013536v1[/url]
Link for "Effect of Anti-IgE Therapy in Patients with Peanut allergy" by Leung, Sampson et al
[url="http://content.nejm.org/cgi/content/abstract/NEJMoa022613v1"]http://content.nejm.org/cgi/content/abstract/NEJMoa022613v1[/url]
Link for "Studying Peanut Anaphylaxis" by Mertz
[url="http://content.nejm.org/cgi/content/abstract/NEJMp030008"]http://content.nejm.org/cgi/content/abstract/NEJMp030008[/url]
Link for an Editorial: "Two Approaches to Peanut Allergy"
[url="http://content.nejm.org/cgi/content/abstract/NEJMe030007v1"]http://content.nejm.org/cgi/content/abstract/NEJMe030007v1[/url]
[This message has been edited by Joanne (edited March 10, 2003).]

Posted on: Mon, 03/10/2003 - 7:02am
mchammond's picture
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Joined: 09/21/2000 - 09:00

Thank you for the articles. Maybe eczema and PA have more of a link then once thought.

Posted on: Mon, 03/10/2003 - 7:20am
JSaastad's picture
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Joined: 03/29/2002 - 09:00

Thank you Troy very much for reviewing the data and reporting back here, I really appreciate it!!
Jill

Posted on: Tue, 03/11/2003 - 2:00am
Beth's picture
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Joined: 03/06/1999 - 09:00

While I am very hopeful about this treatment, the statement about the possible cost of this medication ($10,000 per year) made my jaw drop. Imagine how horrible it would be to know there is such a drug, but not be able to use it due to the cost. You can bet the insurance companies won't be lining up to pay for this. I don't mean to be negative, but the price tag is definitely a huge disappointment. And of course, the fact that no actual release date is in sight.

Posted on: Tue, 03/11/2003 - 2:31am
choguy's picture
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Joined: 02/20/2003 - 09:00

I have read all of the associated articles from NEJM about the PA treatment. It is heartening, but one must keep it in perspective. I'm sure many here have read these articles and have your own thoughts, but I will mention a few things that I caught.
1) The study group did not include anybody younger than 12 years of age. In fact, only about 20% of the entire group was less than 17 years old. The immune systems of young children may respond completely differently to this treatment than adults. It may not work as well or there could be more side-effects. Younger children must be included in the next study especially since this is the group most likely to have an accidental exposure.
2)This was a phase II study designed to show efficacy and find a suitable dose. It concerns me that it took almost three years to enroll 82 patients in the study. It could mean people were afraid to go through the peanut challenge or the selection criteria were too stringent. Sometimes in order to get the best results in a study one can make the patient selection criteria very stringent. A phase III study must be done with probably greater than 500 paitients. How long will it take to enroll this many people? The results could be completely different.
3)Subjectivity was introduced in the study when dermining the baseline tolerance. Each study MD had to watch his/her patient during a food challenge and determine the amount of peanut protein that began an allergic reaction. Check the threshold sensitivity ranges: 1-2000 mg! This could skew the outcome quite a bit. A more objective system to determine threshold must be established.
4) As I have reminded several friends already, this is not a cure. This is a potental LIFE-LONG treatment to prevent anaphylaxis from accidental ingestion. As everyone knows, this means a shot every four weeks for life to maintain increased tolerance. It took three shots before most in the sudy reached steady-state levels of the drug. There still was significant protection 8 weeks after the last dose, but it had begun to decline. To be safe, you wouldn't be able to miss any shots. I am sure there are plans to find a better delivery system for the drug, but that could be 10+ years away from the market.
5)I would like to know what happens to the study group after a few years of shots and multiple low-level peanut challenges (cross-contamination levels). Would the dose have to be increased? Is there a dose plateau? Are there more serious side-effects after several years? These are the kinds of things usually answered by a phase III study.
I know it seems like I have thrown "water on the fire" but keep in mind that is what I am trained to do. My research gets torn apart too but that criticism only helps in the long-run. This really is good news: they have shown you can block a peanut-specific antibody by giving another anibody (anti-antibody). The mean tolerance in the study group increased more than 15-fold on average. No more cross contamination worries - maybe [img]http://uumor.pair.com/nutalle2/peanutallergy/wink.gif[/img].
As so often in my field, I am aware of some associated patent issues with this drug (I don't know the details). Every company wants to recoup its hard-earned R&D money from other companies using their technology. Costly court battles could hold-up development of this drug for several years [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img] I know that sounds terrible, but believe me, if you saw a competitor using technology you worked on for years (and spent millions on) you would want a piece of the pie too. Lets keep our fingers crossed and hope things work out. I will look forward to seeing the phase III data in a few years. Only then can we be sure on this.
Troy

Posted on: Tue, 03/11/2003 - 2:47am
choguy's picture
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Joined: 02/20/2003 - 09:00

I know the price sounds incredibly steep. You are correct - the insurance companies will balk at first. Without going into a lot of detail, $10,000/yr. for this sort of "specialty" product is reasonable. Manufacturing costs are enormous and the patient population is relatively small. Over several years the cost would come down. However, it would be up to all of us to push the insurance companies to pay for the treatment. You would be surprised how quickly things can change once you explain how many ER visits/year could be prevented. I believe some patients have tried lawsuits with some degree of success. If one child were to die (God forbid) that could have been saved if they had access to this drug, the blocking insurance company would probably move pretty quickly to pay for the drug. It has happened before. Also, the marketing drug company has quite a bit of power to sway the insurance companies. If the drug is approved, insurance will cover it - eventually.

Posted on: Tue, 03/11/2003 - 3:15am
McKenziesMom's picture
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Joined: 03/05/2001 - 09:00

Thumbs up, Choguy, for your insightful comments about this "cure". It's great to have people on this board that can provide knowledgeable insight on topics that are extremely complex for a layperson such as myself.
The efficacy of this treatment, the cost issues and the long-term effects are significant areas that I'm sure will take years more research.
I think the fact that this even made it to TV just shows that there is a lot more public awareness about peanut allergies and this in itself is a good thing.
Linda

Posted on: Tue, 03/11/2003 - 3:29am
Beth's picture
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Joined: 03/06/1999 - 09:00

Choguy, I also want to thank you for your comments. What you said about insurance makes sense. I see in your profile that you are a cell biologist. I comment on that because my PA daughter who is in 10th grade has a huge interest in biology and genetics. Hopefully some day she will help with a cure for PA. She is very interested in research, too, so she will be checking out the NEJM, as soon as we can get our hands on it at the library.

Posted on: Tue, 03/11/2003 - 5:26am
Love my C's picture
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Joined: 04/03/2002 - 09:00

Qoute from the article:
"Peanut allergies have been rising in recent decades. No one is sure why, but a new study found that baby creams or lotions containing peanut oil may lead to peanut allergies."
I was thinking that these (our) babies were already predisposed to allergies and that eczema was an early indicater of that allergic tendency, not that the creams caused the allergy. They were just bringing relief to our already allergic babies.
But if this theory has been looked into...give me names!!! What lotions and creams have the peanut oil in them?! Let us know so they can be avoided!

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