Meeting Up in San Antonio NEXT WEEK!

[Paula O]

I can hardly believe it's almost December and almost time for the San Antonio Conference! Wooohooo! :) Let's talk about a time we can all meet up.

These are the people that I am aware of that are attending the San Antonio symposium coming up:

Rhonda (Sassy)
StephN
AliceM
KarenZ
Melissa (Mel3)
Rhondalea
Debbie Laxague
Hosea63 (Amy)
Paula O

Debra D and Chris, I heard that you guys might possibly be attending too--are you guys able to come? Anybody else? Please do speak up if you are attending the conference. There's still time to register.

The schedule sure looks packed with great topics! The evening mentoring sessions also look good. I am attending as a Project Lead scholarship recipient through the Alamo Foundation. There are some extra meetings in connection with that I'll be attending the day before the symposium starts and during the conference. This will be my first time there. As part of the scholarship agreement, we are assigned a "Hot Topic" to attend and need to write up and submit a report. I requested one that is Her2 related if possible but that might not happen which is fine too. Assignments haven't been given out yet.

There is a lunch break from noon to 1:35 on Wednesday that looks free and probably the best time for me. The other possibility is for a quick dinner Tuesday night. There are meetings that day from 4PM to 5:30PM and then there is a Her2 session at 6PM . It might work to leave one meeting early at 4:30 or 5PM and get together till 5:45 and go to that Her2 session together. Any interest in meeting up then or does anyone want to propose another time? ****It's also fine with me to grab a piece of fruit and skip going out for a meal and just find a spot to chat (anybody know of a good place to do that?) . It might be less rushed. I imagine area restaurants will be very busy**** Debbie--you and I have the same itinerary--do you see any other open spots to propose a meetup--am I correct in my understanding that we have nothing else scheduled the times I suggested? There is so much going on I want to be sure I have it right and be where I'm supposed to be. :)

I imagine that for you guys that will be rotating overseeing the Her2 exhibit booth that that needs to be manned (womaned ;))continually. Would it be best to just connect there at the exhibit booth so no one is left out or can you all be gone from the booth at the same time? Or would that be inappropriate to have all of us gathered at that booth at the same time chatting when people are stopping by for info?

I'll be having most of my meals at the same time as additional meetings for advocates I'll be attending and have also accepted some invitations from Drug companies that have a meal included with the presentation I'll be attending so free time looks very limited---looks jam backed from breakfast til night. Debbie--are you going to the Drug Co invites too?

Let's talk and make a meetup with everybody coming happen! :)

I look forward to meeting you guys,

Paula
P.S. To those who have attended in previous years--is there anything you want to share that would be good for someone attending for the first time to know? Have you guys looked into best deal on transportation to your hotel? Please share the link if you have found a good arrangement.

[chrisy]

Don't worry about going hungry! There is food available at every poster session and every satellite session:). Go to the genentech advocate briefing, it is usually worthwhile, a good chance to hear what's going on and in turn meet some interesting people who work for the company. What has always impressed me is when you get with these folks one on one, you find out they all have a passion and personal agenda which is to defeat disease.

I don't think I will be able to make it this year and I'm heartbroken over it! my leg just isn't yet able to tolerate the walking. I haven't yet canceled my room or flight reservations, but I Know it's just a pipe dream!

[StephN]

PaulaO - I LOVE your enthusiasm. The energy at this conference is absolutely amazing. Just when you think your tank is out of gas for the day, you drag your self to the next session, and somehow you become fascinated and able to draw from the group to keep going! It is a phenomanon like no other I have experienced.

Chrisy - I am HEARTBROKEN for your heartbreak. Was SO looking forward to seeing you and limping around together! My leg has been touch and go, but I think I just will make it using cabs to get to the conference center and probably taking a cane. (My therapists are working overtime to help me along.) And my hubby is bringing our exercycle upstairs to I can start using that now that my knee is less stiff.

Paula - You have the exhibit schedule and it may be good to meet there at our booth at 5pm exhibit closing, as that has been our usual plan in the past years. Then we all go to the Hot Topics Mentor Sessions taking a detour through the poster area to pick up some good quality eats and check out a few posters (rubbing elbows with a few famous doctors) on the way downstairs to the Hot Topics. (It is all in the Convention Center.) There is also a buffet at Hot Topics, but the food at the Posters area is better in MHO.

As for transportation each day, our hotel is pretty close so is not on the shuttle route. We walk or take a cheap cab. From the airport to town, we try to have a couple of people coordinate their arrivals so they share a cab fare. Same goes for when we are departing. In the past our dear Brenda would drive some of us in her big car. ;-(


You mentioned Tuesday evening. But there is no HER2 session on my schedule at 6pm - it must be part of the Educational Talks; I will check that. Our group will be going to the other educational talks on Tuesday afternoon - and they usually run into the evening. Maybe dinner after that???

[rhondalea]

I'm so sorry to hear that, Chris. I was looking forward to meeting you.

I hope your leg stops plaguing you soon.

Rhonda

[sassy]

I nominate Steph to coordinate a meeting time for our group of six if she is willing. We should all be pretty much together and on the same schedule more or less. If we want to try meeting up near the booth, last year there was a good spot at some tables nearby that allowed us to meet and keep an eye on the table at the same time. We could step over if someone was coming by. Haven't checked our location that closely for this year, but hopefully that would be an option.

Steph I may be right with you on the cab idea. I'm now in my boot for stress fracture until at least the Thursday before we go to SA. Hoping he agrees to let me out then!! We can just be the hobble twins!

[Paula O]

Chris, I'm sorry you won't be joining us. I imagine that was not an easy decision. Any chance that a rented wheelchair is an option? I'm confident you'd find many willing "WC pushers" who would be delighted to do it (me whenever I can as well as all these Her2 sistas who care about ya) to all the places you want to go ...just a thought in case it's a viable option for you. Hope that leg heals ASAP and all insurance woes are behind you. How was your vacation?

Regarding transportation, I wasn't clear. I meant to ask if anyone has compared prices on shuttle services for getting from the SA airport to your motel. My motel is in easy walking distance to the conference.

I wish I had allowed some time before the conference to poke around SA. My flight is not switchable. Some of my friends from Project Lead are going early to sightsee ahead of time which would have been fun.

Is it cold there this time of year? We're still wearing shorts in FL but are having a refreshing cooler (for here) front so sweaters are in use. I'll have to check Weather.com to determine how warm a jacket to bring. Is there a place to leave those so they don't have to be lugged around all day?


Paula

[Debbie L.]

Hi Paula and all. You freaked me out with the "next week" subject title. NO! It's not quite that soon, phew. I'm so not ready, although very much looking forward to SABCS as usual. Over the years, I've become less starry-eyed about the promise but still it's hard not to get caught up in the energy of so many brilliant minds trying to figure out this very complex puzzle. Somewhat balancing my growing cynicism is the increasing enjoyment of gathering with old friends and making new ones each year.

It seems like there's just one shuttle from the airport, I don't remember having to choose. Just buy the ticket outside in the taxi area and board the shuttle.

We usually do not eat out except one evening. Between the food at poster sessions (most mornings and evenings), at the mentor sessions, and then at the satellite presentations, lunch is the only time there is not food served to all (but there's food available to buy).

Chris, I am sad to hear you won't be there. I keep pointing out to my mobility-limited friend that each year there are more people on those little scooters. I don't know if the convention center rents them or the people make private arrangements, but it seems like such a great way to cover all that ground.

Weather can be surprisingly cold, one year the freeway was closed for a bit because of ice! But typically it's not super cold, nor super wet. If it's windy, the walk from hotel and/or to events at other hotels can be chilly. Or maybe it will be one of those balmy years. There is a coat check place I think, although I've never used it.

I look forward to some time together as a HER2 group. I probably cannot make it to things that last past the regular mentor session in the evening, as I'm staying outside of downtown with friends and we're sharing a car. But anything we can squeeze in during the normal convention hours (including the satellites on Wed. and Thurs.) will work for me.

Debbie

[phil]

I can't be there, maybe next yr, if i send u some FDA ! Approve T DM-1 ! t shirts, would u wear them ?

[rhondalea]

If I wear your tee shirt, does it mean I can also wear jeans and sneakers instead of "office pants" and dress shoes? ;)

(I really hope my dress pants fit. Guess I'd better try on clothes now, in case I need to shop.)

[StephN]

Phil - QUICK - get those tee-shirts made up.

In my opinion we should NOT wear them at the booth, but if we are at a session and away on our own, why not?? However I think approval is coming pretty quickly.

Debra Druther may need to have the last word on that, as we are representing a group.

As for dress code, comfort is important. Joe never considered this a fashion event, but even wore his suit on occasion - alternating with his flowered print Carribean vacation shirts. Two pairs of COMFORTABLE SHOES are a must! The floor is concrete and most areas have thin carpets.

Most of us bring separates that we can mix and match and LAYER. The convention halls are HUGE and not really heated. So if it is cold out, it is cool inside. We don't normally have a problem with keeping our sweaters and jackets on all day (unless one is prone to hot flashes).

There is a Macy's right across the street from where we stay and most of us have had to pop in there for something (scarf, turtleneck, coat, gift shopping ...). One year Joe posted a picture of a bunch of us buying new coats in there.

[StephN]

Debbie - I had the SAME thought, and had a moment of panic knowing the time has been slipping away from me for almost 3 months while I have been housebound and on "pills."

Saw my neurosurgeon today who gave me the go-ahead to do most anything I am able now. YAY!!!

Now I have one of those disabled parking permits to hang on my car mirror. And I bought myself a really pretty CANE.

So, maybe my cane will dictate my colors when I pack for Texas.

I think we need to get a list of phone numbers going so we can coordinate meeting up. The convention center seems to have quite good cell service now. We just need to keep phones often on vibrate and then check for messages or missed calls.

[phil]

I think getting to wear comfortable jeans is one more fringe benefit of being a bc activist. i have some t shirts , maybe a dozen , pink and black. u cansee them at http://stageivsurvivor.webs.com. also flyers left over from our protests earlier this yr. we won't get to do another protest for quite awhile up here in Boston, too cold , no conventions that i know of. rather see them get used than go to waste. i'm serious , i'll ship them this week. PM me if u want some.
u should check w/ the her2support.org board about wearing them at the booth. its not w/o precedent thast a bc web support grp gets involved in activism. breastcancer.org and mylifeline.org both sent official reps to the Avastin hearings in 2011. testified to thier support for stage iv rights. it is about our rights beyond t dm-1. flexible tx, informed choice, more $ for research. get fda politics out of acc. appr., we want stageiv pts input at the FDA approval discussions. as far as appr for t dm-1 , if its not done by the Symposium , it highlights the disrespect , disregard, This FDA has for pts. patronize us. and even if its appr by then ( wouldn't that be great ! ), you still spek for We Stage Ivs at the Sympsium. if appr comes tomorrow , I will still be Protesting This FDA . 4 more yrs of this disrespect ? no way.

[karen z]

I think you have heard it all. Layering is good for clothes as Steph said and it can definitely be chilly, windy, rainy at times (OR sometimes- all the time)- seems like I have a coat on most of the time outside and possibly inside (and one can dress casually or not- I really do not have many dressy clothes). Lunch is the only time one really has to seek out food (usually, it is all around you - especially at the evening events- truly an unbelievable amount). Also, one has to learn the food rules. There is food at the Hot Topics Sessions but ....don't eat too much......because there is even better and more food (and wine/deserts) at some of the later evening events. Breakfasts are usually covered free at one's hotel. So lunch seems the biggest issue although it seems that (over time) we have all learned how to find decent food at lunchtime (I know this doesn't sound good but you have to be there once to "get it"). Sometimes I just skip lunch (as do others)- one can grab some extra stuff at breakfast like fruit, etc.. There are so many good presentations, posters, events that one has to understand that it is not possible to see/hear everything (I learned that the hard way my first year). One can always pick up posters handouts "after the fact' so I have learned to try and go to the major sessions during the day and then go the Mentor sessions (fabulous) and later events (also fabulous). I also like the "wrap up" of the year on the last day. I drink a LOT of coffee when I am there. And somehow, even with all going on, I can almost promise that everyone will find their way to the across the street Macy's at least once (really a tradition at this point) and right next to the River Walk. I don't think it is possible to go to the conference and not walk part of the River Walk at least once. A good way to unwind. There is SO MUCH information presented that it is almost unimaginable. Quite something. Can't wait .......but thank God it is not next week as I need to finish teaching my classes before I can get out of here !!! k

[karen z]

Actually (upon reflection) the cab to the convention center does not sound like a bad idea. If only the cab could continue on and take us to that big (main) hall at the end of the convention center. For new ones: the convention center is huge. You will not have trouble (under normal circumstances) racking up thousands of steps each day. However, not to worry. The mall that houses the Macy's (and is right next to the River Walk) has chair massages available for sore backs !!! Last year I indulged out of necessity.

[Paula O]

OOPS on getting my timing of the conference messed up! Sorry about that!!!! Kittyheaditis has struck again I guess. I'm happy to have another week before leaving-- I'll consider it a real bonus during this super busy time.
Whoever is interested, what do you think of connecting at the Her2support exhibit booth on Wednesday when there are no meetings during that lunch break? If folks want, they could pick up something to eat as they make their way over and we can move nearby if that's best. I might mosey over to the booth to join your group on the way to evening mentoring sessions sometimes as Steph suggested--I need to check my agenda better--sure is lots going on!
I appreciate all the tips and input. Thank you.
Have you guys planned out yet which presentations you want to go to? Wanna talk about what looks interesting?http://sabcs.org/ProgramSchedule/index.asp


NO PRESSURE WHATSOEVER but saw this below if anyone might possibly be interested in this service. :)

Henry B. Gonzalez Convention Center
200 E. Market Street, San Antonio, Texas 78205
Phone 210-207-8500
Fax 210-223-1495

The main entrance to the symposium is located on street level across Market St. from the Marriott Riverwalk.

Symposium events & services are located on three levels of the convention center.
Street (1st) level ( Bridge Hall, Exhibit Halls A, B, C & D, Ballrooms A & B)
Entrance:
Coat check, baggage check, Scooter Rental, First Aid station
Special Assistance
If you require special assistance, please contact the symposium office by phone at 210-450-1550 or email SABCS@uthscsa.edu


http://sabcs.org/Overview/Index.asp
-------------------------------
Transportation
The info below is from the Alamo website. Note the online roundtrip pre-paid route is least expensive. When my husband has time to check around, if we find any on-line discount coupons for GO Airport Shattle or if he sees another servicethat looks better, I will share that info here. A man of many wonderful tallents, one being an extraordinary husbamd :0), John is superb at finding bargains. http://sabcs.org/images/transpxl.gif

Transportation From Airport To Hotel
GO Airport Shuttle, San Antonio Airport’s official shuttle service, has shuttles departing to and from downtown approximately every 15 minutes from 7:00 AM – 1:30 AM daily. For 24 hour reservations and information, call 210-281-9900, or go online to www.goairportshuttle.com (http://www.goairportshuttle.com/).

Shuttle tickets are sold at the baggage claim area, at Terminal 1 and Terminal 2 for $19.00 per person to downtown hotels or $34.00 for a roundtrip ticket. Book online and receive an additional discount. Online rates are $17.00 to downtown hotels and $32.00 for a roundtrip ticket. Major credit cards are accepted.

Taxi fare is approximately $27.00. As many as 4 people may ride for the price of 1. SABCS does not provide transportation from the airport to the meeting.
Symposium Shuttle Buses

SABCS provides free shuttle bus transportation between symposium hotels and the convention center December 4-8, 2012.

Shuttle buses will travel frequently between symposium hotels and the convention center.
This service is free.
Buses will drop off and pick up at the Market Street Entrance of the Henry B. Gonzalez Convention Center.
Buses will only stop at the official symposium hotels. A wheelchair accessible bus will be available during the listed days and times. It is necessary to make reservations for this service by calling Circa Texas at 210-394-0607. Please call 24 hours in advance to make your reservation at your specific hotel.
Shuttle routes and times will be posted September 2012.
SABCS does not provide transportation from the airport to hotels.

-------------------------------------

Paula

“I hate the term ‘cancer victim’. It somehow implies cancer is the victor. It wins; we lose… While we can do little to choose whether we get cancer, we can do a lot to choose whether we are it’s victims. I don’t just mean whether we live or die. I mean how cancer affects us in the deepest parts of who we are. I believe cancer cannot conquer our spirit unless we choose to become victims .”
From the excellent book, “When God and Cancer Meet” by Lynn Eib

[rhondalea]

I was just about to post a link to that page, Paula. Well done for getting it done.

Phil, if you look at the pictures from prior meetings, you'll see that the HER2Support group is ready for the catwalk, so there's no hope of jeans and sneakers while on duty.

As for me, all that unpacking I didn't do when we moved (almost five years ago) is in my very near future. <wondering where I put all my shoes> I may just go shopping instead. It'll be easier.

I started out very well organized--I had a plan. What I didn't take into account was a bunch of medical appointments, a hurricane and <gak!> Thanksgiving.

Here's hoping that I still work really well under time-pressure, or I'll be wrapping myself in a bedsheet.

[karen z]

really- most of us seem to have on a pair of pants/top/sweater or jacket. i have been known to wear jeans (or jeans out of cord or black jeans). i have not worn sneakers i don't think but have worn very very comfortable shoes ONLY- i have long given up any sort of heel whatsoever. as steph said, Joe could go from wearing a suit to wearing some amazing colorful vacation shirts (with a baseball cap i might add). i think you will find that the dress is pretty eclectic. unlike psychology conferences which I am more used to (where there are tons of jeans) the jeans may be dressier (or people may wear just basic pants) but i think that you are safe as long as you are comfortable and warm. honestly, you may end up having a long sweater or a coat on most of the time so jeans or regular pants are o.k. again, i don't own anything very dressy and i have managed fine. and when people find they need something (a scarf/gloves/another pair of pants).........they walk across the street to Macy's- with huge sales going on.

[karen z]

Paula,
As far as "meeting up" you will always find some of us at the booth so remember that. We are hard to miss. And usually be the "day of" we know what we are going to at night or split up (depending on interests, etc.) to go to different things. But just about everyone always goes to the Mentor sessions- you will not want to miss any of those.

[StephN]

Thanks Paula. The conference organizer is good at putting out the info we need.

However, for those of us in the HER2 group, we can share a cab and it will be cheaper than that shuttle. I have the arrival times of everyone and will let you know who to look for to share with. You also get to come directly to our hotel instead of stopping all over town to let others out.

It looks like three of us can leave in the same cab together on Saturday.

Paula, you may see if you can find people in Project Lead to share cabs with, unless you are arriving on Monday and then could share a cab with us.

[Paty]

I am so sad I will miss you this year! All the excitment and great conferences!! Sniff, sniff. Please keep us posted of the new advances in BC. Love you all.

[karen z]

We will miss you Paty!!!
K

[sassy]

I don't know who will be able to put up with my snoring this year Paty!

We will miss you!!!

[Joan M]

I'm attending and will stop by the table. And perhaps see you at breakfast in the hotel!

Joan

[Paula O]

So glad you are coming too, Joan! That's great. :)


Paula

[Paula O]

Right now I'm slated to attend an optional Genomic Health Pt Advocate meeting that scholorship advocates were invited to Thursday night . I am looking over the itinerary of symposium events and came across this description below for "Her2: Applying the latest developments to clinical practice". I'm considering the possibility of perhaps switching to it although it looks totally geared to physican's reaching a consensus of the best treatment plan for Her2 patient cases in small discussion groups. Seating is limited and registration is ahead of time on-line. Have you guys ever attended one of these small group discussion formats? Are they suitable for non-physican's to just listen in on? While I'd find it interesting, it's not like I'm an oncologist with a lot to contribute to small group discussion.

Any of you guys going to this? The Hot Topic mentoring session will be at the Convention center right before this, finishing up at 7:30 PM and the other meetings beginning at either 7:30 or 8 PM at the Grand Hyatt and Marriot Rivercenter. I know there are shuttle buses running frequently between hotels. Are the hotels pretty close together and reasonable to get to one meeting to another at a different hotel pretty quickly?

http://clinicaloptions.com/Oncology/Live%20Events/Satellite%20Symposium/HER2-Positive%20Breast%20Cancer/Tabs/Agenda.aspx

Open Satellite Event Thursday 7:30 - 10 PM
Event Overview
Location:
Marriott Rivercenter
Salon E, Third Floor
101 Bowie Street
San Antonio, Texas
Join us in San Antonio for this important educational event.
Interactive Symposium Format
A leading expert will introduce each case to help kick off your small group discussion on the optimal clinical management of patients with HER2-positive breast cancer.
One iPad will be available at each table to use as a group (to view details of the case as well as other tools to augment your discussions).
Your table will be asked to reach a consensus on how to manage the case and then submit your vote via the iPad. You will have the opportunity to discuss your table’s approach to the case with the larger group.
A distinguished panel of breast cancer experts will then briefly discuss the case and the approach they would take.
Agenda
Didactic Presentation 1: HER2 Testing and Current Knowledge on the Biology of HER2-Positive Tumors (15 min)

•Small group and faculty panel case discussions on HER2 testing and interpretation (15 min)

Didactic Presentation 2: State of the Art in Treating Advanced and Metastatic HER2-Positive Breast Cancer (15 min)

•Small group and faculty panel case discussions; selecting therapy for HER2-positive breast cancer (30 min)

Didactic Presentation 3: Research Highlights: New Agents and Therapeutic Strategies for HER2-Positive Breast Cancer (20 min)

•Small group and faculty panel discussions (10 min)

Question and Answer Session (15 min)
Event Date Details
Thursday, December 6, 2012

7:30 PM - 8:00 PM Registration and Dinner
8:00 PM - 10:00 PM Symposium

[karen z]

I would say we go to these events when we can- they are good. I plan on going. Everything is close by so walking from one event to the next (possibly in a hurry) is very doable.
KZ

[Paula O]

I don't have a Smart Phone but am passing this along in case folks are interested but did not receive the info yet. It was emailed to me today.

Receive symposium updates, information in the palm of your hand
https://mail.google.com/mail/h/1c7fjy1jny639/?view=att&th=13b3fc20e590bef5&attid=0.4&disp=emb&zw&atsh=1 (http://www.google.com/url?q=http%3A%2F%2Fsabcs-2012.ctrc.ascendplatform365.com%2F&sa=D&sntz=1&usg=AFQjCNHZofaFiD0ZDsUpXPiSrRaa0ZA5vg)
https://mail.google.com/mail/h/1c7fjy1jny639/?view=att&th=13b3fc20e590bef5&attid=0.5&disp=emb&zw&atsh=1 (http://www.google.com/url?q=http%3A%2F%2Fads.ascendmedia.com%2Fwww%2Fdel ivery%2Fck.php%3Fzoneid%3D2930&sa=D&sntz=1&usg=AFQjCNGbU8iHbEkE5dt6837mq9mx5cUiag)

Discover your smartphone's hidden potential and stay connected to the San Antonio Breast Cancer Symposium (SABCS) on the go with this free official symposium application, developed by Ascend Integrated Media.

What to expect from the mobile app
Here & Now: The "Here" portion of the feature lets you enter your location and the system presents you with a list of exhibitors within a specific radius. The "Now" aspect of the feature provides a schedule of events taking place at that specific moment in time, so that you are always aware of the event itinerary.

Presentations: Presentation title names, presentation numbers, categories and dates

Exhibitor Listings: Search for companies at SABCS 2012

Wayfinding: Uses the interactive exhibit hall floor plan to help you map your time on the hall floor

Entertainment: San Antonio activities you can enjoy

Stay in touch using SABCS's texting program
Stay informed of important SABCS issues and not-to-be-missed presentations and events by opting in to the new mobile texting program.

These messages sent directly from SABCS organizers keep you abreast of key events, times and locations. You'll receive no more than five messages each day, from Dec. 4 to 8, 2012.

Opt in to the texting program
You may opt in to the program by texting "SABCS 12" to 80802. Text "SABCS Stop" to stop receiving texts from SABCS. Standard text message rates apply and are only available through US operators.

Download the free app now
Enter m.sabcs.ascendmedia.com (http://www.google.com/url?q=http%3A%2F%2Fm.sabcs.ascendmedia.com%2F&sa=D&sntz=1&usg=AFQjCNFuoHTVX7mHv1WBh6Ix2ExZPYKS7w) into your mobile browser to then start your download or text "SABCS App" to 80802. (This texting shortcode option is only available through US operators.)

[karen z]

WOW- Now we really are meeting up next week- in one week !!!!
o.k., back to grading.
kz

[StephN]

Thanks, Paula -
Anyone who is registered by today got that email blast about the smart phone app. They have had that the last 2 or 3 years anyway that I knew about. I think Chrisy used it.

My phone is only semi-smart ...

[Paula O]

Debbie, How's your talk, “Advocate Perspective on Trial Design and T-DM1” for NBCC's Project Lead's Advanced Topics coming along? That's really cool that you're doing that--good for you! You go, girl :) I am looking forward to hearing you and Dr Hurvitz' “Latest Trials and Evidence for T-DM1 in Metastatic Breast Cancer” right before you.

This is going to be such a wonderful learning experience! I like the looks of the Her2 small group discussions that I shared the link to above. I got a postcard in the mail yesterday about it as well as another session too which I guess you guys going to the Symposium probably did too. The info says that space is limited and people are supposed to register ahead so don't forget to sign up on line if you are going to that one. I still haven't decided if I'll be going to that meeting or the Genomic Health Advocate Program.

I'd love to hear about the her2support booth in the exhibit area. What literature do you give out? I bet you've had some interesting conversations with folks stopping by. Do you have business cards for Her2support.org?

IMHO It seems like a great idea for us to set a specific date, place, and time for us ALL to connect, meet each other and we can get a group picture. Let's make it happen--I imagine that if those of us not part of the exhibit booth team just randomly stop by we won't see everybody. Don't you guys rotate taking turns in the booth? What are the exhibit hours--the whole time during meetings or other set times? For those of us who have never gone before, we wont recognize each other in the crowds without an initial contact I don't suppose. Debbie L. and I were in the same break-off discussion group the whole time during Project Lead this summer and neither of us recognized that we were both part of this forum the entire week we were there.

I've mentioned the possibilities that'll work for me--they've got us hopping on a tight schedule pretty much attending most every session plus additional ones (On Wednesday breakfast is at 6:15 and last meeting ends at 10). Debbie mentioned that she is carpooling with others and an evening meet-up after the meetings isn't good for her.

I know you guys at the booth will have lots of time together but I'd like to propose getting everybody attending the symposium together briefly to meet each other sometime during the break on Wednesday 12 - 1;35 (How about 12:30?) The sessions before then are at Exhibit Hall D--shall we meet there?

There is a session on Her2 Positive Breast Cancer from 6 PM to 7:30 In Exhibit Hall D on Tuesday. Maybe we can all sit together and that is the one night I am free after 7:30PM. Would our group want to connect after the meeting? While we chat, if people like the idea I'd be glad to offer to give feet, hands neck, or back rubs to any of you guys who wants one while we all visit. I am not a Massage Therapist but I've been told that I do a good job so if anybody has sore feet from all the walking or has any neck kinks, or could use some pampering, I'll do my best. :0) Rubbing feet in a hotel lobby wouldn't exactly work--we could go to one of our motel rooms (mine is fine or elsewhere) to hang out, or go out for something to eat instead of a chat with massages included, or whatever. If this isn't good with you guys, not a problem. I'm just tossing around some ideas and hoping we can arrange a time or two for us all to meet up. It would seem a shame for us to be travelling from all over the country and not have at least a little time all together. I'd love to get to know you guys. :0)

HER2-Positive Breast Cancer – Exhibit Hall D
Moderator: Eric P. Winer, MD
Dana-Farber Cancer Institute
Boston, MA
Adjuvant therapy of HER2 positive breast cancer – the next installment
Karen Gelmon, MD
BC Cancer Agency
Vancouver, CANADA

Advances in HER2+ breast cancer
Nancy U. Lin, MD
Dana-Farber Cancer Institute
Boston, MA

Neoadjuvant approach in HER2 over-expressing breast
cancer: Therapeutic implications and biomarker discovery
Mothaffar Rimawi, MD
Baylor College of Medicine
Houston, TX
Paula

[phil]

Too bad NBCC leadership did NOTHING to help get T DM-1 approved any quicker. sad that they then talk about trial adesign , jumping on the bandwagon after EMILIA finally got nat'l attention. Why did they not step in when This FDA rejected tdm-1 on 2010. ? because NBCC top leadership is a biased fan of This FDA . They have no understanding of the reality of Stage IV Survival issues. They are more interested in competing w/ other top bc advocacy groups for headlines . Komen and ACS have no understanding either , but at least they dont blindly follow whatever This FDA says about " speeding up " cancer drug approvals " . heres hoping we get a natl bc advocacy organization to ' get it ' in 2013 !

[Paula O]

Here's a raised glass of the carrot baby kale juice I am drinking tonite: (It tastes better than it sounds ;) toasting real change, lots of progress, and significant headway in 2013.

Phil, I left you a question a while back in a thread and apologize if perhaps you already answered me and I just missed it. Here it is again: At the very end of the video you guys made, there was a list of proactive things people can do to work toward expediting approval of T DM-1. It scrolled through very quickly and I wondered if possibly you also have it in a format that is easy for you to copy and paste and share with us. Thanks for what you guys are doing. Your voices are being heard and you are making a difference.

Paula

[phil]

I will try to get that for you . basically , we need natl media attention. Starts w/ local media stories. direct them to our website, http://stageivsurvivor.webs.com . Thanks, Paula , for your understanding and encouragement.
I get real testy about T DM-1. To see NBCC speaking up about future trial design when it isnt EVEN APPROVED FOR STAGE IV NOW, ticks me off. Honestly, I consider This FDAs' bungling of it one of the greatest tragedies in the history of the War On Cancer so far, costs many lives every month that appr. is denied . And NBCC's blind FDA support only helps This Slow FDA slow down even more. . So, I called , sent e-mails to "The Big Three " bc advocacy groups over a yr ago. Only Komen responded then , and talked a lot , did nothing. They did give lukewarm , written support to the Avastin super-responders . I called . e-mailed NBCC several times - no answer. After all, I'm a nobody , not Bill Clinton ! I was at the FDA Avastin hearing when Christine Drucker from NBCC shocked the Avastin Survivors by testifying against them. ran into a NBCC Boston area rep last month, polite talk , but , of course , no acknowledgement of a pro - FDA bias . Talk of ' stopping overuse of bone marrow transplants ", back 10 + yrs ago . What does that have to do w helping stage iv get T DM-1 now ? NBCC did great work w/ original herc in 96, but the operative word is " DID " . Right now their top leadership is way off base w This FDA , no understanding of stage iv needs , and rights. I'm on my second attempt to get in touch w/ ACS New England, met a senior official at a bc walk in Oct. so far no response .
Ok , I'm done , on this thread , because I love it when stageiv fighters get together , support each other , you are my " Wounded Warriors ". Have a great Symposium , if u get to wear our shirts we will be honored . God Bless and Heal.

[Paula O]

Phil, I am new at all this and you know a whole lot more than I do. Would you possibly be able to sum up key facts about TDM-1's delay and help me formulate and articulate some intellegent, well thought-through questions about the current status/availability of: TDM-1/ any other key Her2 related issues BY SUNDAY? I fly out early Monday morning. Perhaps your input would also be helpful to the other ladies who will also be attending. Here is a discussion about this to add to if you like (I appreciate and have printed off the questions that are already posted there): http://her2support.org/vbulletin/showthread.php?t=56299

If it works out, (and I get brave enough) I would like to present some questions in a factual, respectful, totally non-accusatory way if there is opportunity in a related Q & A session and/or perhaps privately with individuals --perhaps I can do a small part in stimulating thinking and action. I'm thinking right now of that quote I posted awhile back "Speak the truth even if your voice shakes". :) I'm brand new to breast cancer patient advocacy but want to do my part to fight this disease.

There are many Her2 fighters who could be helped with TDM-1 and it's wrong that it is not available to them yet. I understand why you are frustrated and upset, Phil. I appreciate you and your wife working so hard to help others.

I'd like to do what I can but I am not at all comfortable "attacking" NBCC leadership or anybody else there. I am willing to speak up and ask questions/make comments in a polite, factual, respectful way. Right now I feel ignorant about the subject so am trying to think through who to talk to that would make a difference and what to say. I'd appreciate anything you can do to educate me on the issues if you can point me in the right direction and have time to write out questions you'd like answers to.



Here are some docs I see listed as coming in one meeting;
Dennis Slamon (Wanna give that guy a great big "thank you" for his part in Herceptin!
Michael Press
Kimberly Blackwell
Howard Burris

There is a Gennentec meeting and other Her2 sessions with other Drs/researchers like
Eric P. Winer, MD
Dana-Farber Cancer Institute

Karen Gelmon, MD
BC Cancer Agency
Vancouver, CANADA

Dana-Farber Cancer Institute
Boston, MA

Mothaffar Rimawi, MD

and others if you take a look at the on-line program.
Anybody know these people personally? Anybody in particular stand out as being good to direct questions to?

Any hints/ tips from your experience? What would you want to say to the Gennentec reps if you were coming, Phil?

Paula

P.S. People who are going to the symposium reading this: any feedback on the questions in my post yesterday morning?

[phil]

Alright Paula , here we go !! " Phils " First rule : W / all these BIG organizations , " its not personal, its impersonal ", helps me kee p my sanity . For ex., This FDA Oncology Drug Review Division ( whew ! ) is not against Lorraine personally getting life-saving tx . Second Rule : We are non-partisan, we are not anti govt, not anti -Big Business , nor anti - Big Research, nor anti - Big Advocacy. Any large organization can lose touch w/ those its designed to serve, merely , by getting too big. and how could they all really understand Stage IV issues , when they havent personally experienced it ? And when , until the past 10 -15 yrs , so few Stage IV pts lived long enough to SPEAK UP , even now too many die too fast, too young . But more and more are living longer, and speaking up . I admire the perseverance of the founders of NBCC , and Metavivor, who dealt w/ many founding mbrs dying . But they did not give up. ( Metavivor does seem to have some affibity for BC Action top leadership. I havent even mentioned BC Action top leaders writing to This FDA in April , 2010, asking them to NOT APPROVE T DM-1 ! ) .
I try not to attack people personally, but I tell it like it is . I had aretired Congressman tell me early on, " They don't talk like that down in DC " . he wanted me to be more " politically correct ', I agonized over that a while, but really feel called to speak truth . I know people don't like to admit mistakes, but we all make them. Peope's lives are at stake . I am more sad than angry w/ the top FDA folks.
hey. breaks over , back to work. Appreciate your willing ness to step out for Stage IV. i will post talking pts later today. God Bless .

[phil]

re above : We are not anti -govt., etc. We are Pro- Stage IV Survivor .
If I were at the Symposium , I would seek out media , and give them the following :
Reasons To Investigate This FDA's ( Mis ) Handling of T DM-1 ;
1. This FDA Rejected Accelerated Approval in 2010 for a drug that had a" 38 % COMPLETE or Significant Response " for 6 months or longer. Isn't this one of the strongest statistical responses ever seen for one of the deadliest cancers ?
2. Doesn't T DM-1 have some of the fewest side efects EVCER in achemo?
3. In 2010 This FDA stated that it rejected T DM-1 partly because " patients had not exhausted all options" . Lorraine and THOUSANDS of others had ! They never interviwewed a single patient !
4. This FDA then mandated that genetech complete a 2-3 year trial comparing T DM-1 to an inferior drug , Tykerb. Tykerb was given acc. approval in 2007-note the date - previous Admin. We want consistent policy involving Stage IV Lives from Admin. to Admin. !
5. After rejecting accelerated approval , This FDA twice rejected Genentechs' request for expanded access data to count towards appr. Why so rigid ?
6. This FDA already knew the breakthrough , revolutionary nature of this " Smart Bomb " drug , yet has made NO attempt to consider early review of EMILIA data the past TWO and a Half Years ! Again, why so slow ? They had the original data from 2012, preliminary EMILIA data since May, , now the Final Data since August !!
7. The Assoc. Press reported at ASCO in June that this " Dream Drug " " just missed the RIGID criteria for immediate approval " . This FDA couldn't bend arule for the best breast cancer drug in 15 years ? One where SIXTY-FIVE PERCENT of the EMILIA Pts getting T DM-1 have lived TWO YEARS SO FAR , and counting ??They coudn'yt think justa little " outside the box " in 2010 , or now ? Even appr. in June would have saved hundreds of lives .
8. Why does This FDA sneak out Press releases on Fridays ? They had a sham hearing in June 2011, revoking Avastin, but the Commissioner waited until the Friday before Thanksgiving to release her final decision . 5 months ! On Friday, June 8th of this year they sent out a Press Release at 8:30 PM EST ?? , giving only conditional appr . to Pertuzumab , denying it to Stage IV Survivors to this day ! Are they ashamed of their actions ? They sure act like it , and should be ! Investigate This FDA !

[schoonder]

Phil,
If FDA's excuse in rigid implementation of rules that applied to evaluation of t-dm1, a targeted cancer therapy, regulations, which later agreed by head of agency, were obsolete and ineffective for new, cutting edge therapeutics, then what is use of having this governmental FDA oversight (sub)committee, what are their responsibilities in expediently addressing and correcting shortcomings to assure that stage iv her2+ mBC patients didn't receive a death sentence as a result of this ruling?

[StephN]

Paula -
Responding to your idea:
" I'd like to propose getting everybody attending the symposium together briefly to meet each other sometime during the break on Wednesday 12 - 1;35 (How about 12:30?) The sessions before then are at Exhibit Hall D--shall we meet there?"

The exhibit times are from 11 am to 5 pm. Some of us have to be at our table during that whole time, so WE do not get the break you spoke of. However, our place in the exhibit hall will not be hard to find - T-8, and we are an end booth sticking out into the center area.

There are round tables nearby and we can eat our lunch there and take turns being behind our booth. When you check in and get your conference materials, you will get an orange book of the presentation details and a map of the exhibit hall will be in the back of that.

There is still the Tuesday night after the HER2 talks, at 7:30. We will need to find some place for a bite to eat.

Hope this helps.

[Paula O]

Thanks for the info, Phil. Yesterday was the first email within our group looking for cancer survivors for the media to interview after certain sessions. They recruited and got volunteers for someone on Tamoxifen, with diagnosis of Triple negative, and Her2 NEGATIVE. I wonder if they'll be looking for someone who is Her2 positive who wants to talk about TDM-1 and it's delayed availability . I guess that would be me if that opportunity arises after I ask God to help me be brave and bold to speak up and get over feeling chicken-hearted and nervous with a media person or doctor who knows way more than I do . I'm concerned that I don't know enough to represent the cause well enough and am happy to hear the key points and get help with coming up with good questions. Truthfully I feel ill-equipped and inadequate to get before the media and start questioning these doctors either. I can picture it, cameras rolling...my response after they ask me something I don't know or defend their position: "Excuse me please, while I look through my notes from Phil to find the answer to that question." Ha, ha;) On a serious note though, I'll bring your website address along http://stageivsurvivor.webs.com (http://stageivsurvivor.webs.com/) --even handing somebody that would be a good thing because "You da man, Phil and Lorraine is the gal" in doing a top notch job representing this important cause. It can be rather intimidating to rock boats and question experts but I know one can get over it, just do their best, and speak the truth as you say. What did you do to arrange the interviews you've done, Phil? Are the media mingling among the people afterwards or is this by invitation only ahead of time more typical? I'll bring along all the questions people have shared they'd like answered, and if the opportunities arise to get answers from some of these presnters, I'll try to do that.


I attempted to get Her2/TDM-1 as my "Hot Topic" to be responsible writing up an article in layman's terms which is part of the requirement in getting the scholarship. I volunteered ahead of time for it, asked if I could switch with somebody assigned to it but that didn't work out. That's OK. I'll be learning alot though covering the Mini-Symposium 2: Breast Density: Mechanisms and Clinical Implications.

My favorite nursing job I ever had was as a clinical research nurse working at the U of Az, long, long ago, conducting clinical trials in various phases of study , mostly investigational antihypertensive and cardiac drugs. One time I was asked to present one of our abstracts at an International Symposium in Geneva, Switzerland (a fine place to be invited to I must say--there for a week with enough time to do a bit of touring with the Dr --one of my bosses--and nurse I travelled with which was fun, fun, FUN!). However, I witnessed doctors raking each other's research over the coals, interrogating each other during that conference and others I attended during the Q & A times Honestly, some of those docs seemed downright hostile towards each other after the presenting was done.(Thankfully they were merciful on me after my presentation--Whew, was I ever glad to have the standing up in front of all those doctors from all over the world experience behind me!!!!) I understand the need to back up research and make sure it's good quality stuff and not messing with statistics though and understand the importance of people looking over each other's research and peer review can be a good thing. Is there a lot of grilling of the presenter like that at this conference--is that what these Q & As are like in this conference too ? Have you found any doctors and scientists that have really gotten behind the cause of stopping this crazy delay in getting TDM-1 out there for the patients who need it? What exactly is the concern that is causing the delay by the FDA?

OK, onto the next topic---everybody getting together. Thanks, Stephanie for responding.

Let's plan on this:


---It looks like the easiest time for everybody to meet and connect is right after the 6PM to 7:30 PM Her2 meeting on Tuesday in Exhibit Hall D. Let's remember to get a group photo then. I know Debbie mentioned she is carpooling with others and an evening meetup is difficult but hopefully it'll work out for a short visit anyway since it's right after a meeting. Then, let's everybody who wants to go out to eat together.

Tuesday night looks much better than trying to work something out during exhibit hours. Let's skip my proposal of trying to get everybody together Wednesday too. I'll see how things go for me that day--maybe I'll say hi to whoever is manning the booth during lunch time then. I'm sure we'll all drop by the booth sometime during the week and see whoever is manning it then and perhaps it'll work out to sit together during some of the meetings.

(Please note Stephanie's correction below of directions to Her2 booth--am copying from email so Joan, Debbie, Amy, and I all have it--it's also on the exhibit map of course)

"Our table top booth - T8 - is on the far right side of the plan and is not on the end (like it was last year!).

We were close to those round table over in the middle last year, so none of those close by this time.

Further to the right, and off this map, is the Great Hall where the main presentations will take place. So we are close to that.

Hope this helps give you a mental image of where we should meet."

Paula

P.S. What kind of freebie food is typically availalble during poster sessions, etc? Do you usually see any raw fruit and veggie trays by chance?

[phil]

Schoonder, are you referring to Congress' HELP Committee ? which " oversees " This FDA ? We met w/ them in 2011, Sen. Harkins' aides saw Lorraine, listened , but made only a half -hearted attempt to talk w/ FDA . Each pol. party covers up for their own. But we will be back. They wont be at San Antonio anyway.
This FDA was mad at Big Pharma for not finishing trials they had promised to finish after getting acc. appr in the early 2000's. and felt some drugs ( avstin ) had too much risk . They could have kept avastin appr for metastatic tnbc, but they dont listen to pts in-put , so they revoked it completely. This FDA, w/ a rookie Prez., cracked down , revoking Avastin . Gen, fought back and appealed , along w/ the Avastin super -responders. FDA was pissed, completely affected thier scientific judgement, and they blocked t dm-1. Plus Dr. Pazdur wants longer testing to prove overall survival stats, overriding time to progression, which was gold standard before new FDA commish gave Dr. Pazdur free reign over trial approvals.
Paula , I have some public speaking exp. but always nervous. We think of what we've been thru, all those who never got a chance , and go for it. Politely ask ? at forums , who knows maybe a media person will hear you. Do it for our friends Jay, Jennifer, Tracys mom , who never got the chance to try it. Maybe T DM-1 Miracles will be there as " Living Proof " to add thier input , like Lorraine has . Many T DM-1 ers honestly dont know how lucky they are to have gotten it. and counter This FDAs saying Lorraine is an " outlier ', unusual. Shes unusual only because they rejected appr.
Docs wont say much, but they all thought it should have been appr. in 2010. If they speak against This FDA or Pharma, they get blacklisted from future trials. maybe a famous doc, like Dr. Susan Love, who isnt doing trials ?, might speak. Dont count on it.
We focus on This FDA for reform , others involved later. To Genentech, and Pharma in general, we have already said, " If you think your drug is good enough to be considered for Acc. Approval, its good enough to give out as compassionate use. " Theres not enough comp use , and the mechanism is way too unwieldy.
So go , mingle , tell anyone interested to talk w/ Lorraine. say to anyone, , why wasnt it appr in 2010 ? shouldnt there be an expose' , investigation to prevent such a slowdown from happening again ? get their e-mails and send them to us. We are always ready to talk ! God Bless , have a great time !!

[phil]

P.S. , maybe they will approve it after 5 EST tonight. Duck Big Media Publicity, yet still be " the talk " of the Symposium ! If so, don't let em get away w/ it !

[Paula O]

Sorry, I don't understand the P.S. What does it mean?

For anybody whose going,

Here is a link to the 10 day weather forcast to help with packing: http://www.weather.com/weather/tenday/San+Antonio+TX+USTX1200:1:US

See ya soon,

Paula

[phil]

sorry for confusion. I meant that noone knows when This FDA will approve t dm-1. their hx since 2009 is to issue approval notices about " controversial " drugs late on Fridays. that way they keep it out of the news.
looks like it wont be appr by time of Symposium, so it will be bizarre ; people talking about trial design , the wonderful stats , etc. of a drug that almost noone can get ! Imagine how many " Lorraines could be saved between now and Christmas ...many...

[StephN]

Paula -
The HER2group is here near the convention center. We will be setting up the booth at 1pm then heading to the educational sessions. Maybe you can catch us at the booth, before joining a herd of people in the ballrooms for the presentations.
They may not let you in the exhibit area without an Exhibitor ribbon on your badge, but maybe you can find a way to the back of that area near where the sign says "Exhibitor Services."
We are next that area.

[Rolepaul]

Ask the Genentech folks about supporting the MD Anderson work for Intrathecal Herceptin for Leptomeningeal and spinal nerve involvement by HER+ disease. Also, can someone get contacts for the Poster5 session 16 and 18 posters so I can write for copies. Lastly, if anyone sits in on the session Winer is moderating and hears interesting news, please let me know. Bummer not be there, but I used all my vacation time to see Nina when she was in Houston and now to go to MRI scans and doctor visits. Maybe next year.

[StephN]

Hello Rolepaul -
Do you want ALL the posters from Session 5, groups 16 & 18?

Group 16 (Immunotherapy) has 6 posters.

Group 18 (HER2 targeted therapy) has 26 posters.

I can get some reprints for you if you can find which ones you specifically want.

[Soccermom]

Looing forward to updates y'all. Wish I were there with you :(

Marcia

[Rolepaul]

I was able to get abstracts through Nguyen and will be contacting the lead authors. These are really good seesions. I am jealous.

[phil]

Ask docs there , do they think T DM-1 will be approved for all who progress on original herceptin , or will folks have to go thru taxane / tyk /xel nasty s/e ?
T DM-1 could be a nice " Christmas present " from This FDA . About time .

[StephN]

I have heard mention of setting up trials for Adjuvent T-DM1, but nothing yet from Genentech.
Our group will be at the Gen. Advocates Briefing tomorrow night, and we will get all the scoop direct from them as well as asking questions if they do not address this.

[Paula O]

My brain is busting at the seams with information (not that I understand it all, that's for sure)! It was an excellent symposium.

Welp, Phil-- I spoke with some oncologists, breast cancer advocates, Gennentec reps, and sought out some media folks about the FDA's denial of TDM-1's accelerated approval. The two words I heard most often in response were "Due Diligence". Many people expect TDM-1 will be approved in early 2013, probably in February, and feel confident that it will be approved once the FDA has done it's job fully examining safety and efficacy. After a special meeting of breast cancer advocates with Debbie L and a research oncologist (Dr Sara--forget her last name? Horwitz? presenting on Tdm-1 (Project Lead Advanced Topics for advocates and those a part of the Alamo Breast Cancer Foundation ) I stood up and shared frustration over the delay while many Her2 positive patients were experiencing disease progression and death and not able to access a drug which has strong proof already that it is safe and effective. Honestly, it was rather embarrassing to me that I got choked up and started to cry at the end of delivering my passionate little speech to the group (a summation of what you shared here) about those in urgent need of early approval of TDM-1 but I guess people got the message that these are real women in tough straits right now waiting for approval, some of them dying without the drug after exhausting other available options.

Phil, I am going to PM you contact info for one of the media people I spoke with briefly (a Chief Honcho assistant director at the symposium ) if you want to tell him Lorraine's story.

Paula

[phil]

We so appreciate your Speaking Up ! You and the others who spoke up , wore the shirts sent a message : We are Speaking Up for Stage IV Rights !
I didn't expect you to get much response from the docs, pharma reps , or " Big Advocacy ' It was worth a small gamble , sending shirts, flyers . Hoping for an investigative type reporter to pick up the story . That may still come when approval comes. but maybe not , so we will have to Protest ! If i had been able to get to San Antonio , I would have been protesting outside, just like in Boston this past yr., protesting that these Big Entities ( FDA, Big Advocacy, Docs who wont speak ( will get black listed ) just don't get it , that this FDA\ Big Pharma - led cancer drug approval System actually exploits Stage IV Survivors . And is not keeping up w/ 21st century advances like t dm-1, pert., drugs w/ fewer s/e. So , again , thanks for speaking up , T DM-1 is so good ( not perfect ) , that it will lead the way in exposing the failures of This FDA System.

[StephN]

Phil - There is another piece from the treating side. LAW SUITS. Malpractice insurance is quite costly, and doctors carry it as anyone who has a bad reaction to just about any drug can go to a law firm (they advertise on TV all the time) who says they will represent a patient who got a Bad Drug.

Research and trials do not necessarily guarantee safety for every patient. I do not know the extent that the 'sue me - sue you back' society we live in influences the FDA decisions, but they have some very specific rules to follow.

Patient safety has notched up, as a concern. Also, there are dozens of drugs for other cancers and conditions that are on the FDA docket.

I did speak to someone who has worked with the FDA for many years, who is well aware of the need to get T-DM1 to market. This person told me that Genentech took a "long shot" in designing a Single Arm Trial and applying for approval on the basis of those results. You well know that the FDA kicked that application back and asked for data on a broader basis with comparative data on other standard of care drugs.

[phil]

Stephanie, thanks again for your efforts. I disagree , of course , with all the naysayers , most of whom dont know the drug. it is an exceptional drug, and the stats showed it in 2010, over 3 years of testing, completed Phase I, II trials for safety, dosing . and results . As I see it, only 3 groups really know the drug, 1.the patients who have seen Stage IV tumors melt away, 2. the top research docs , including Dr. Winer , who have stated that it should have been approved 2 yrs ago, and 3. the Genentech /Immunogen clinical teams , who developed and studied the drug. I have been to This FDA, they did have a pre-conceived bias; I have been to Capitol Hill, have seen one Party covering up for its own at the top of the FDA .
So take comments from rival pharma execs who dont know the drug, , docs who cant speak up for fear of FDA backlash ( same risk for Gen. execs ) , with a big grain of salt. And media who run from ' big name personalities " to personalities ", from fluffy story to fluffy story tonight at 6, . You see how they half-listen to you , who are you ? what degree comes after your name, who do you work for ? what have you done ? Are you a lobbyist , w/ connections ? No , " jst ' someone who SURVIVED Stage IV for YEARS, thats all !! , so the drug with " best ever so far survival statistics ' for her2 , the one that will " revolutionize ' tx of metastatic Her2 , should have taken nearly 7 years to approve ? I just can't accept a System like that , it wasnt " risk " , or " due diligence ", it was This FDA flexing its regulatory muscles with Big Pharma, punishing them for past ' errors ', Big Brother FDA pushing longer stats called Overall Survival ", deciding for you what risks/ benefits should apply , . There are now other tdm-1-like conjugates in Phase I trials, for other cancers , will they take 7 years to get to us ??

[StephN]

Phil -

Paula, that was a heartfelt and honest appeal. BRAVO!

I certainly agree that T-DM1 should have had approval. If someone in the FDA decided the agency made a mistake in approving the single arm trial, then THEY should live with that. But then other drugs will come to them with single arm trials, and some of those may not be as good as our special drug conjugate.

The person who I spoke with has a long and deep abiding interest in metastatic breast cancer. She was at the FIRST San Antonio symposium, and goes to other meetings as well. From what I could gather, patient advocacy IS our best route at this time, and you are right that we need more people to speak up.

I did hear several "thought leader" type doctors speak from various podiums during the conference on the "fog of trials" which they think should have better designs and clearer effective parameters. The frustration with slow acceleration in getting good drugs to human trials and beyond is spoken more freely each year I attend the conference.