BCA fighting to keep tdm1 off market

[runtolive]

http://bcaction.org/index.php?page=letter-to-fda-opposing-tdm-1-fast-tracking

why???

March 23, 2010 - Letter to FDA Opposing TDM-1 Fast-Tracking

March 23, 2010
Richard Pazdur, M.D., F.A.C.P.
Director
Office of Oncology Drug Products
U.S. Food and Drug Administration
richard.pazdur@fda.hhs.gov

RE: Opposition to TDM-1 Fast Track Application

Dear Dr. Pazdur:

As you are no doubt aware, Genentech intends to seek fast track approval of TDM-1 based on the results of a single-armed, Phase II trial.

It is our understanding from the sponsor that the FDA was asked two years ago about what would be required for fast track approval of TDM-1, and that the agency took the position then that a randomized trial would be necessary.

Despite this clear direction from the agency, the company has completed -- and will seek FDA approval based on the results of – one single-armed trial, TDM4374g.

Breast Cancer Action believes, as the FDA does, that only sufficiently large, randomized trials will give us the information we need about drug efficacy and safety. We urge you, in the strongest possible terms, to require the sponsor to submit Phase III data before you consider approval of TDM-1 for breast cancer.

We understand that there is an important unmet medical need for people with advanced breast cancer whose treatment options have run out. We desperately hope that TDM-1 proves to be a beneficial option for these people. But we oppose sacrificing drug approval standards on the altar of hasty access.

As you know, the FDA used to require the results from two Phase III trials before considering approval of a drug for the market. More recently, a single randomized trial has been found by the agency to be sufficient in some cases. We think this weakens standards for drug approval. Please do not weaken them further by allowing marketing based on a small, single-armed Phase II trial.


We are in conversation with the sponsor about an expanded access program for TDM-1. While we applaud the company’s desire to make sure that those who might benefit have access to the drug, we are very concerned that the company intends to use what they are calling the “Expanded Access Study” as a substitute for a Phase III trial.

The Expanded Access program will not provide Phase III data. The FDA must insist on sufficient randomized results before approving TDM-1 for the market,

Sincerely,

Barbara A. Brenner
Executive Director


Note: As a matter of policy, in order to avoid the fact or appearance of a conflict of interest, Breast Cancer Action does not accept funding from Genentech or from any other pharmaceutical or biotech company.

[StephN]

"But we oppose sacrificing drug approval standards on the altar of hasty access."

Tired cliche! Is this the best they can do?

I have to say that while at the San Antonio Breast Cancer Symposium just last December, I heard more than one "mover and shaker in the cancer research world" say that we have a system of approval that is too ponderous now. The top oncology brains in the world are, as we speak, meeting and looking for ways to incorporate trials and data at a more efficient rate.

This revised system can shake out in both directions - drugs that don't fulfill the promise from labs to humans and those that do better than expected.

It seems to me that BCA just wants to slow down the approval and not have any special dispensation for this drug.

[Rich66]

Should the phase II have been better designed? Is TDM-1 available via "compassionate use"?

[Jackie07]

Here's a list of the 'accomplishments' posted on the BCA website:

http://bcaction.org/index.php?page=recent-victories

I wonder how many of their members are breast cancer survivors... I'm going to dig into the Tamoxifen thing...

[Jackie07]

Found it!

http://www.bhg.com/health-family/conditions/cancer/tamoxifen-for-breast-cancer-risk-reduction/


"The FDA approved tamoxifen to be used for breast cancer risk reduction in women who are at high risk and not in average-risk women."

I guess BCA is more of a 'watch dog' type of organization that wants to make sure no unnecessary sufferings are forced upon us 'desperate' breast cancer patients. They seem to have a point. But to delay TDM-1 seems to be somewhat extreme...

[Lien]

Hmm. The point is, that if it becomes too easy, the big Pharma companies can just fast-track meds that are no better than the old meds at high prices.

If they really wanted to prove that TDM-1 works, they should have complied with the rules and should have organised a large double blind phase 3 trial. Lots of people who desperately needed the med would have had access to it. Ofcourse, that would mean that some would have gotten a placebo, and when you think you found the magic bullet, that's a hard thing to do. But we have thought we had the magic bullet before, and sometimes we were wrong. There have to be some safeguards in the system.

So I think if they want to market the new combo, they will have to invest in giving it to a lot of people, even as compassionate use. That way there will be enough data.

But who am I? U dont even live in the US.

Love

Jacqueline

(wishing everybody would get the right drug to keep them dancing with NED)

[Ellie F]

I understand what the arguments seem to be however I am yet again dismayed as even when drugs get approved in the States it takes ages for the UK to catch up. It both saddens and angers me that more sisters will be lost for whom T-DM1 may be their magic bullet.

Ellie

[Unregistered]

Torn between "oy!" and "wtf?????"

whose side are they on?
Chris

[Soccermom]

In my personal experience BCA is a rather "radical" organization that tends to sabotage the very disease its supposed to be fighting against by making outlandish comments and press releases for publicity sake...
Marcia

[Unregistered]

Jacqueline, and all
I don't think it's an issue of they "did not follow the rules". There are in fact Phase III studies underway. As well as multiple Phase II studies. With a totally new investigational therapy they first need to do Phase I (safety) then Phase II (continued safety and efficacy) studies. These are necessary prerequisites to a Phase III.

Consider the difficulty of recruiting patients before these steps are taken: Here, you can try the approved therapy which we know works for some people and might work for you or you can try this other therapy that we have no idea if it will be safe, or work at all.

True, to get really strong data you need to have valid, large trials. But you can't get to valid, large trials without some smaller steps first. And all these take many years. Plus the many many years it takes to develop the drug itself - TDM1 has been in development for over 10 years.

I do not see "big Pharma" as the villain - or at least if they are, there are many others complicit including the FDA. True, they are in it to make money, but not ONLY to make money and internally they struggle mightily to keep sight of their mission to save lives.

I think too often they all lose perspective - for example to me it is ludicrous to prevent access to not-yet-approved therapies to patients who's only other option is to die quickly from their disease, in the interest of "protecting the patient". Certain death from cancer is a pretty serious "adverse event".

Or, worst of all, lets say that someone actually does invent a "magic bullet" - even a less than 100% one such as TDM1 which has an extraordinary clinical benefit rate considering the heavily treated population that has been studied so far. How many people died or had metastatic recurrence waiting for Herceptin??? How many is too many?

What does BCA or the FDA have to say to the families of all the people who die waiting for "proof"? Oops, sorry about the wait but your mom/sister/daughter/father died for the greater good of validating the data?

Sorry, I'll climb down off my soapbox, but in my opinion BCA should have as part of their "strategic mission" supporting efforts to (as Steph notes) speed up the process by improving the applicability of the science.
c

[Rich66]

to me it is ludicrous to prevent access to not-yet-approved therapies to patients who's only other option is to die quickly from their disease, in the interest of "protecting the patient". Certain death from cancer is a pretty serious "adverse event".

Or, worst of all, lets say that someone actually does invent a "magic bullet" - even a less than 100% one such as TDM1 which has an extraordinary clinical benefit rate considering the heavily treated population that has been studied so far. How many people died or had metastatic recurrence waiting for Herceptin??? How many is too many?

What does BCA or the FDA have to say to the families of all the people who die waiting for "proof"? Oops, sorry about the wait but your mom/sister/daughter/father died for the greater good of validating the data?

Boom. Boom. Boom. outta da park. Someone post this at ASCO.

[Nancy L]

I don't support BCA. I strongly suggest you all get linked into Faster Cures, an organization that wants to bypass all the BS with the US government bureacracy. It was set up by Michael Milken after he was told he only had 18 months to live. He didn't accept that answer. Here is their website you may want to visit

http://www.fastercures.org/

I believe any metastatic cancer patient should be allowed to take any drug that has passed Phase I trials. It should be my choice, not the governments. If I sign the papers and understand the risks, then give me the drug and learn what happens to me. It can't possibly be worse than dying with no hope. I have already watched that happen to my sister.

[hutchibk]

Steph, Soccermom, Unreg/C, Rich and Nancy... bullseye.

[Pam P]

Bullseye from me too!!!

Like others I'm one of the people who are running out of options and desparately waiting to get access to t-dm1. I had hope it might be available by end of 2010 or beginning of 2011. Now that's shot and I'm hoping I'm not going to be one of the "oops"!

[Carolyns]

What a load of crap. As a heavily pretreated Stage IV Cancer Warrior I am more limited to Phase I studies... if I can find one. I have participated in 3 clinical trials and got the placebo once (cancer progressed). I am a lab rat and do what I must to live. If I am drowning in a river do you think it matters if you perform more tests on the life saving ropes while I sink below the surface of the water? Yeah, we found this rope better than no rope at all... where the heck did she go?... whoops I guess we lost her.

TDM1 just gave me 7 more months... Tykerb at least 6 months... the science is moving fast data travels slow. No one in my situation would slow the science to wait for the data.

If I was standing out on a ledge TV cameras filming no one would let me die. Everything would be done without regard to risk or cost.

Healthy folks with options don't want to enter trials. Stage IV patients (many of us) are getting more limited and NEED trials to keep going. Groups like this seem to want to prevent us from getting access. Expanded access is a joke so we can't go there. Trials that are further along don't want us because we are too heavily treated. We walk a tight rope that is difficult for anyone else to imagine.... until it is them or their loved one.

Give me a break.

[Sheila]

Maybe we should start a new campaign...our photo, with the caption



I'M DYING TO TRY THIS DRUG


which in fact is true for many

[Joe]

Great Idea Shelia,

I am sure that we have many prolific writers in our group who can also write to the FDA.
In case you missed it:
Richard Pazdur, M.D., F.A.C.P.
Director
Office of Oncology Drug Products
U.S. Food and Drug Administration
richard.pazdur@fda.hhs.gov (richard.pazdur@fda.hhs.gov)



Regards
Joe

[StephN]

This is the part of the above letter from Breast Cancer Action that I don't understand AT all:

"We are in conversation with the sponsor about an expanded access program for TDM-1. While we applaud the company’s desire to make sure that those who might benefit have access to the drug, we are very concerned that the company intends to use what they are calling the “Expanded Access Study” as a substitute for a Phase III trial.

The Expanded Access program will not provide Phase III data. The FDA must insist on sufficient randomized results before approving TDM-1 for the market,"

I have not heard that there even IS "expanded access" to this drug. Joe or anyone heard of the referred to "Expanded Access Study??"

And BCA is in "conversation with the sponsor" about expanded access??

[Joe]

Expanded access is another name for "Compassionate Use"

Christine and I have been meeting with Genentech since last June's ASCO meeting lobbying this issue.

Unfortunately because of liability issues, Genentech could not release the drug for this purpoise until they could provide data to the FDA based on the phase II study.

Here is a copy of their press release from the Symposium: T-DM1 Press Release (http://www.gene.com/gene/news/press-releases/display.do?id=12527&method=detail)

I think this excerpt from ther release sums it all up:

As assessed by independent review, T-DM1 shrank the tumors (also known as objective response) in 33 percent of women with advanced (metastatic) HER2-positive breast cancer that had worsened following previous treatment. Women in the study had already received an average of seven drugs for metastatic disease, including chemotherapy, trastuzumab and lapatinib, prior to receiving T-DM1.


Warmest Regards
Joe

[Carolyns]

Interesting. At last year's annual NBCC I was an attendee. I felt very much alone as a Stage IV warrior. My greatest concerns were different from the majority of attendees. I went to the NBCC Comparative Effectiveness Presentation hosted by Sean Tunis MD.

The concerns that I expressed were in two categories - A). Over half of the chemos that had worked on me to beat back breast cancer were not approved for Breast Cancer. What if there isn't any data that proves / confirms what is already working? B). Trials for heavily pretreated patients like me. How could I get into trials to stay alive when trials wouldn't accept me or were closed? He mentioned expanded access and compassionate care... He also said that groups could be formed to study and gather data so that people like me could get treatment (sounds like what Joe mentioned). This came up when I mentioned that over 100 women had applied and had not made it into a TDM1 trial that filled up quickly.

I was finally able to get into a TDM1 trial but found all of the other options to be straw man options. They sound comforting until you reach for them and find out that in each situation there is are very valid reasons one of the parties that needs to be involved in the solution can't. Everyone feels just awful about this... terrible... but only one dies waiting and hoping.

This is Sean's information and he seemed very informative and nice. As I said during my ramblings he was the featured speaker at the NBCC conference in DC last year so I am assuming that this organization might also be involved in these sorts of issues.

Sean Tunis MD, MSc
Director, Center for Medical Technology Policy
www.cmtpnet.org (http://www.cmtpnet.org)

This topic makes me ill and scared out of my mind. Carolyn

[Joe]

I do not feel that one letter from one breast cancer organization will sway Genentech from applying for approval of T-DM1 or the FDA from approving the application.

The application will probably cover just those stage IV patients who are still progressing after treatment with Herceptin, Tykerb and other drugs.

Genentech currently has a phase III trial underway since January 2009. The trial design calls for 580 patients. Considering the success of the Phase II trials, I would assume tha the trial will complete recruitment within the next few months. The final data has an estimated completion date of August 2013 and will probably use that data for their formal FDA application . There is no reason why patients that NEED the drug now should needlessly die. As someone else stated, the side effect of not having access to T-DM1 is certain death.

I cannot understand why BCA would take a stand on an application not yet submitted as no one has any idea what the application will cover.

If it only covers those patients who ran out of options...then I support it.

One only has to do a search on "Irene from Tampa" from September 1, 2009 to her death would understand why this approval is needed. I personally spent hours on the phone with Genentech and others advocating for her to receive T-DM1 to no avail due to FDA requirements.

Warmest Regards
Joe

[schoonder]

Joe, maybe time spend on the phone with Genentech, trying to get Irene back on t-dm1 medication wasn't all for naught. Roche, today during a conference call announced that they will file this year for t-dm1 3L approval based on strong data results seen from the phaseII trial.
The FDA, according to Pascal Soriot, head of the Basel, Switzerland -based company's drug unit: “They accepted the data and with great enthusiasm.”

[hutchibk]

http://her2support.org/vbulletin/showthread.php?t=44689

Joe's update today.

[Joan M]

I had the opposite experience with trying to get into a TDM1 trial: I hadn't taken any chemos for advanced bc and therefore was not eligible because Genentech kept ratcheting up the ante, pitting the drug against more and more proven agents. The trial was the only option I considered in place of having a lung radiofrequency ablation for the tumor recurrence. It was either the RFA or the trial.

The quicker the approval, the better. Top oncs at research hospitals can work on skipping steps and getting approval when a drug shows a lot of promise.

Joan

['lizbeth]

I think that stage IV cancer fighters should be exempted from the current system and with a legal waiver to the developing comany be allowed access to drugs that might improve and prolong their life.

Why do we allow others to die to "protect the data". Have a group that is exempt from the data and make compassionate use more accessible.

[Unregistered]

I am deeply dismayed by the recent denial of fast tracking, and wonder if your organization is a cover for insurance company interests that would rather we suffer and die on the old awful chemos that have access to promising new, targeted, more expensive drugs......

[ElaineM]

I think we have some good contacts if we want to start a petition/writing campaign. Maybe we should flood their inboxes with mail. Maybe they need to hear from a few hundred or a few thousand actual patients/consumers who are directly affected by their decisions.

[chrisy]

Unregistered:
That would be a question to ask them. Link to their website is
http://bcaction.org/index.php?page=about-bca
Check out their website and see what they are about.

My personal opinion, having met/heard representatives from this group on several occasions, is that they are very passionate about what they believe and have a strong activist and social justice orientation. They think cancer sucks (as do we) but have a very different agenda about how to deal with it. I especially have very different experiences and beliefs with respect to if the pharmaceutical industry is friend or foe.

I disagree with them on a lot of issues and priorities, but I do not see them as shills for the insurance company.

From their website description of "what we do"
1. Advocates for policy changes in three priority areas:
- Treatment by shifting the balance of power at the FDA away from the pharmaceutical industry and towards the public interest while advocating for more effective and less toxic treatments.
- Environment by decreasing involuntary environmental exposures that put people at risk for breast cancer.
- Inequities by creating awareness that it is not just genes, but social injustices - political, economic, and racial inequities - that lead to disparities in breast cancer outcomes.
2. Provides information to anyone who needs it via newsletters, Web sites, e-alerts, and a toll-free number.
3. Organizes people to do something besides worry.

Their world view confuses me. For example their actions and position re TDM1- in my view fast approval of TDM1 serves the public interest because it is a more effective and less toxic treatment. To have the FDA refuse to file accelerated approval because they felt that regardless of Her2 status, trial subjects should have had more failures of non-targeted chemos is not a victory under either of these "priorities".

What I would say in their favor and would like to learn from that organization and others is they how to mobilize people and effect change. I think they have things to teach us in that realm. Of course, the first political changes I would want to influence would be to push the FDA in the OTHER direction.

They have a formidable organization and website, and although Her2support has a different mission (and Joe and Christine have not wished to have political discussions "in their living room"), as individuals we could be better armed to handle those issues.

Here's a tip from their website on how to write letters to the editor:
http://bcaction.org/index.php?page=tips-letters-to-the-editor

[Unregistered]

As an FYI, I have never seen a double blind Phase III for a cancer drug. In general, the Phase III studies are "standard of care" or the drugs currently used in treatment compared to "standard of care" plus your drug. In Stage IV BC patients, a Phase III trial could be designed so that "standard of care" includes Tykerb/Herceptin plus a chemo, for example, vs TDM-1. It is unethical to run a placebo controlled trial in patients that would surely progress without some form of treatment. What becomes a problem is designing a trial that includes drugs that many patients have not already received in some combination vs the new drug. It's not as easy as it sounds since the combination you choose for comparison could go out of favor during the trial and the trial then needs to be amended. Meanwhile, you still need to show statistical significance and fulfill other FDA requirements or risk not getting your drug approved.

Another guest.

[chrisy]

Guest -
There can be a double blind phase III study for a cancer, or any drug but you are correct that there would not be a placebo-controlled trial in this setting - it would always be in comparison to "standard of care".

Double blind just means that neither the patient or people giving the drugs know which drug is being given, so this is supposed to eliminate the placebo effect - where belief a therapy works/won't work actually impacts the results.

You make an excellent point about the moving target on "standard of care", and the challenges of designing trials with the appropriate comparisons. To include Ixempra for as a "you have to have tried that first" doesn't make sense to me as it has only just recently been approved itself.

Conversely, requiring MBC patients to have had Taxol AND Anthracycline is archaic as the first line MBC combination of choice now is herceptin and a taxane, not anthracycline.

Agreed, you have to show statistical significance either way but with the variety of therapies and the velocity of new developments, the FDA and drug co's need to do a MUCH better job of assessing new therapies more quickly.

Just as the "standard of care" changes, the "standards of approval" need to keep up with the science. That doesn't mean lowering standards, but as the science and oncology community moves more to personalized therapy (based on the individual's cancer biology), the old system of testing everything on everyone just doesn't cut it.

Just my humble opinion since I'm neither a scientist or an oncologist. Just a dumb Stage IV lab rat hoping for a cure...soon.

[Soccermom]

Gotta wonder what BCA thinks of the ISPY trials????

MUST SEE THIS! very hopeful


please watch this piece,I was lucky enough to sit in on (via webcast) and be part of the Q & A for this press conference.

http://vimeo.com/10262851
http://vimeo.com/10262072
http://vimeo.com/10263498
http://vimeo.com/11878324
There are 10 separate videos which are numbered and I posted just a few URL's... I believe this is EXCELLENT news for all

[Unregistered]

Chrissy,

Thank you for your post, all very good points. I would like to comment that you are not at all a "stupid" Stage IV patient but obviously very knowledgeable and I am right there with you hoping that the companies and the FDA can figure out better ways to get drugs approved. Also, good point SoccerMom regarding the ISPY trials, a real breakthrough in trial design.

Guest again.

[Jackie07]

I went to the BCA site and read some of their 'actions' from the 'Timeline' section http://bcaction.org/index.php?page=timeline:

1993 BCA testifies before the FDA in opposition to resuming the Breast Cancer Prevention Trial, a study of the drug tamoxifen in healthy women, because of reports of deaths from uterine cancer in the trial.

1995 BCA calls for the drug tamoxifen to be added to the list of substances known to the State of California to cause cancer. Despite the objections of Zeneca (the drug’s manufacturer) and then-Governor Pete Wilson, BCA’s argument prevails in 1996

1997 Citing the absence of evidence that routine mammography screening reduces breast cancer deaths for women aged 40 to 49—and noting the risks of mammography screening, including radiation exposure and the risk of false positives and false negatives—BCA publicly opposes the call by the National Cancer Institute, the American Cancer Society, and others for routine screening among women in this age group.


1997 BCA revises its mission statement and becomes the first national breast cancer organization to adopt a policy explicitly prohibiting accepting financial support from corporations, such as pharmaceutical companies and corporate polluters, that profit from or contribute to the cancer epidemic.

1999 Over the objections of other breast cancer organizations and the American Cancer Society, BCA successfully calls for the National Cancer Institute to promptly release the results of clinical trials testing high-dose chemotherapy/autologous bone marrow transplants for breast cancer.

BCA leads the call to guarantee that poor and uninsured women screened for breast cancer at state expense receive prompt access to quality treatment at state expense.

2002 BCA’s web site wins the People’s Choice Webby Award for best health web site.
BCA jointly releases the first edition of the report “State of the Evidence: What is the Connection Between the Enivronment and Breast Cancer?”

2003 BCA presents testimony to the FDA opposing attempts to reintroduce silicone breast implants, citing numerous safety concerns.
BCA launches an online aromatase inhibitor survey to collect information on the side-effects of this new form of breast cancer treatment.

2007 Asserts a unique perspective, focusing on cost and effectiveness, in opposition to approval of Avastin as a treatment for breast cancer.
Successfully argues for cancellation of STELLAR Trial, maintaining that pills for prevention always results in disease substitution.
Publishes initial Aromatase Inhibitor Side-effects Survey results

2008 Successfully advocates for removal of phthalates in cosmetics made by Secret, Arrid and Christian Dior.
Think Before You Pink Critical Questions appear in promotional literature and media statements from Susan G. Komen For The Cure and the American Cancer Society.

2009 Launches Milking Cancer campaign demanding that Eli Lilly stop making rBGH, thus removing it from the world market. Thousands take action in the fist week.
Successfully testifies on behalf of patients at the FDA against the approval of Doxil for metastatic breast cancer.
Joins ACLU in lawsuit against Myriad Genetics for their patents on breast cancer genes BRCA1 and BRCA2.
Dannon follows suit to General Mills and announces plans to go rBGH-free.
In response to consumer demand and BCA’s Think Before You Pink campaign, General Mills announces plans to go rBGH-free.

2010 BCA wins lawsuit against Myriad Genetics by challenging the company’s patents on breast cancer genes, BRCA1 and BRCA2. Patents were ruled invalid by a United States Federal judge on March 29, 2010.
Breast Cancer Action celebrates its 20th anniversary year!
FDA is responsive to BCA's concerns about ESA's, as well as time of FDA informational conference calls
Working on legislation to prohibit patenting of genes, in particular on breast cancer genes BRCA1 and BRCA2
BCA's policy is hailed as a leader in the field of screening and mammography
BCA begins exploratory conversations with Eli Lilly

[Soccermom]

This is the link to the lawsuit as filed by the ACLA and MANY, MANY others. It was NOT "BCA's lawsuit".. multitudes of patient advocacy orgs,patients etc. filed the suit. Joanna Rudnick producer of the documentary,"In the Family" takes Myriad to task in the film..

Funny enough this is an organization (BCA) that has historically been extremely vocal and aggressively AGAINST genetic testing for many years.
Have to wonder EXACTLY what their agenda is ,"methinks thou doth protest too much" ??

(okay forgive me my rant, I'll get off my soapbox now)
http://www.aclu.org/files/pdfs/freespeech/brca_08262009_plaintiffs_memoinoppto_uspto.pdf

Hugs to you Jackie!

[Unregistered soccermom]

Spam above!

[StephN]

Took out the spammer.
The above is a good conversation and I wonder where BCA now stands?

[schoonder]

"wonder where BCA now stands"

Hope they're satisfied because Genentech pretty much provided what BCA was looking for. Such as two "large scale" phase III evaluations, one (Marianne) in 1st-line setting and the other (Emilia that's now ~70% enrolled) in 2nd-line setting. Roche also plans to conduct a third phase III trial (T-DM1 vs doctor's choice) and expects 1st patient in (FPI) during 3 Q 2011. Genentech's extension trial in a somewhat limited fashion is still ongoing.

[radiant]

There's no other way to say this: THIS infuriates me. It's wrong, wrong, wrong. There must be something we can do?

- Kim

[unregistered]

BCA says that poor and uninsured women are covered under the National Breast and Cervical Cancer screening program. WRONG! Only women who are 40-64 are eligible for the breast cancer screening program and between 40-50 it's up to the provider's discretion.

[hutchibk]

True, Soccermom. It was NOT BCA's lawsuit. It actually was initiated by my friend Genae Girard here in Austin who is a member of my local b/c support group. I was in support of it early on when she would come to me to talk about it, but I backed away to the sidelines big time when she started recruiting the ACLU and BCA as well as other activists to help move it forward. I know it helped her in the long run get the result she wanted, but it felt smarmy at the point that I saw who the others were that were jumping on the train. http://online.wsj.com/article/SB126041358100284931.html

[Catherine]

This post is a year old, but I found it very interesting.