Update: Grandma McCartin Can Finally Get T-DMI in Boston (What Will She Do with the 15,500 Frequent Flier Miles She’s Earned?)

UPDATE: Jan 20, 2012
Phil McCartin reports his wife Lorraine is FINALLY able to get TDM-1 in Boston.
Great news! Now use those frequent flyer miles to go some place that isn’t VA!
Here’s what Phil says:
Those of you following This FDA’S Blocking of herceptin T DM-1 know that we had to travel from Boston to Va. to get it in 2010. And it works wonders for those who are HER 2 +. After 16 trips, and many Bureaucratic Obstacles, Lorraine finally got her platelets up over 75,000. Genentechs hurdle. her plats have been slwly going up, lows after each tx. less than before. Then they jumped 19,000 in 9 days ! Even the researchers were surprised ! She got the ok for tx. in Boston today , the 19th ! Since she was young, her ” lucky ‘ no. has been 19 ! We think its a “God Thing “. She is aTestimony for Flexible, Informed Choice in clinical testing for Stage IV Fighters. See her story on youtube :
Watch her in part 4.
UPDATE: Sept. 27, 2011

Amid glowing press accounts from the EMCC about T-DM1, there’s just one problem.

Lorraine McCartin must STILL travel 950 miles from MA to VA. Ironically, when she’s home in MA, she could throw a rock and hit ImmunoGen, T-DMI’s Waltham, MA-based co-developer.

This story  is representative of most EMCC reports:

Data from a mid-stage clinical trial of the new combination drug, trastuzumab emtansine (T-DM1), in HER2-positive breast cancer found patients given T-DM1 had a 41 percent improvement in the time without their breast cancer worsening compared with those given trastuzumab, or Herceptin, plus chemotherapy.

Side effects were also significantly reduced in the T-DM1 group, a factor that was “particularly important and very clinically meaningful“, said the study’s lead investigator Sara Hurvitz, since far fewer T-DM1 patients opted to stop treatment during the phase II trial.

The results are a boost for the medicine, which the Swiss drugmaker Roche has been developing with ImmunoGen as a successor to its blockbuster Herceptin. Herceptin had sales of more than $5 billion in 2010.

“These provocative Phase II data illustrate that first-line treatment with T-DM1 provides a longer time for patients to live without cancer progression and with fewer side effects than standard chemotherapy plus trastuzumab,” said Hurvitz, director of the breast oncology programme at University of California, Los Angeles, who presented her findings at the European Multidisciplinary Cancer Congress (EMCC) in Stockholm.

In the trial, which involved 137 patients who had not previously had chemotherapy or HER2-targeted therapy, those on T-DM1 had an average 14.2 months without the disease worsening versus 9.2 months for those given Herceptin plus chemotherapy.

Via  Facebook, Phil McCartin writes:

We started hearing from MGH last week that we might not get t dm-1 in Boston, at least not for awhile. Genentech confirmed that today. Very disappointing. The co. promised , then went back on their word, putting another hurdle in Lorrraines’ way .

It seems that when we transfer to Boston , L. enters a” new ” study ( not a trial ), and has to meet the labs, etc. that she ALREADY MET to get in the access study a yr. ago ! Lorraine has low platelets, but they are stable, and the cancer continues to shrink. She got an exception for tx. w/ low plats , granted by Gen. months ago. But the new Gen. doc, in charge of the new study, wont grant an exception for the new study.

Our doc in Va. agrees with us. He says that Lorraines response is ” remarkable ‘, ” excellent “. She can stay in Va, as that study is closed to new pts, but still treating those in it, incl. Lorraine.

We are fighting it. First the FDA decides to deny approval, then the co. wanted to close all access , until we spoke up. Now the co. breaks its promise.

Todays Globe announces that Immunogens stock soars on an analysts’ report that the T DM-1 Trial data is ” Striking “, and has ” Great Commercial Potential “.

Immunogen makes the chemo part of the drug, right here in Waltham, Mass.
With these Global Corporations ultimately its all about the $, protecting the investment, before the patient.–Our HER2 Struggle FB page

This is the original May 2011 blog post:

Positive development for HER2+ T-DM1 travelers

Lorraine Heidke-McCartin, 54, has been dealing with HER2-positive metastatic breast cancer since 2006. In August 2010, her doctors at Dana-Farber (Boston) told her she was a good candidate for Genetech’s T-DM1, a drug that has given some early users dramatic results with few side effects.
Some observers have called T-DMI “Super Herceptin. T-DM1 combines Genentech’s  antibody with a cancer-killing agent made by a Waltham, MA-based biotechnology company, ImmunoGen.
As reported in the Boston Globe, in late August, shortly before the treatments were to start under an expanded access program, the drug’s maker, the Genentech division of Roche Holding AG, shut down the program in Boston after the FDA refused to speed the approval process.Heidke-McCartin and her husband, Phil, were determined to get the drug.
Every month, at their own expense, they travel to a hospital in Fairfax, VA.
According to the Globe:  The 950-mile round trips are exhausting, but Heidke-McCartin said she manages because of her faith, her husband,  and her growing family, including five grandchildren born since her diagnosis.
“I was ready to give up,” she said, describing side effects from other cancer drugs that ranged from nausea and hair loss to yellowed palms. “Then I would look at my grandchildren and get back on my feet again.”
Genentech is moving forward with the regulatory approval process for T-DM1, but based on the current FDA timetable, it won’t reach the market before 2013. For now, it’s available only to patients in trials and those eligible for treatment at 13 expanded access sites across the country – none within 450 miles of Boston.
Phil McCartin, who lost his first wife to breast cancer, has worked tirelessly to make T-DM1 accessible to those who need the drug today. He contacted other patients on Inspire.com and BreastCancer.org. He wrote to Boston and national media. He and Lorraine went to Washington to lobby the FDA. Phil started a Facebook group: Our HER2  Struggle.
Jeanne Sather,  aka The Assertive Cancer Patient, found herself at a similar crossroads in Seattle. Sather was first diagnosed with breast cancer in 1998. Since then she has been in nearly constant treatment because her disease metastasized to her bones, lungs and brain. She had been getting T-DM1 in a clinical trial and did so well her doctor referred to her as “a star patient.”Becasue Sather could not get T-DM1 in Seattle, every three weeks she had to fly to Highland, CA.
According to a friend of Sather’s: “The travel and the constant fundraising to cover her expenses (she lives on Social Security Disability and financial help from friends) were physically and emotionally exhausting for her. She could not sustain the trips, so she had to drop out of the trial a few weeks ago.”McCartin and Sather just got some  welcome news.
According to Phil’s Facebook post:  Genentech [says]  they are ‘amending the protocol’  to allow us to GET THE DRUG IN BOSTON ! W/IN 90 DAYS OR LESS !! Women in the access program, who have responded well to the drug, and have to travel, can ask to have thier doc give them the drug. This is so awesome for us, for women who have to travel all over the country.”Remeber those women who haven’t , or can’t, get access, need the FDA to approve this wonderful drug. Thanks for all your support , financial and otherwise, for your prayers, You know who you are ! And God knows.”Sather told her readers: “One thing [my doctor said] is that he thinks my asking to get T-DM1 on compassionate use was ‘the straw that broke the camel’s back,’ because Genentech has been hearing from so many women recently who are in my situation: they could be helped by T-DM1, but they can’t travel to the nearest clinical trial site.”

Who helped Sather and McCartin?

With the exception of The Abigail Alliance, no breast cancer association or patient advocacy group cared to involve itself. Phil McCartin tried them all. His particular situation didn’t fit their mission. Sorry.

Some Genetech stockholders picked over Phil and Jeanne’s online health-related reports as a rail bird might study a tout sheet. They cheered Sather and McCartin’s success with the “miracle” drug. None seemed particularly interested in providing any practical  help with travel expenses or drug approval hurdles. Oh well.

I stand in awe of Phil and Jeanne. When people say “Be your own advocate” to a cancer patient they usually don’t add: “And start a grassroots drug access effort, even if none of  the established cancer groups will help you and even if you are one person taking on massive corporate, medical and governmental entities and even if amateur investors see you not as human beings but as a barometer of potential profits.”

Speaking of which: Both McCartin and Sather must continue to travel for T-DM1 for the next two to three months. Sather estimates her expenses will be $4,000.  If you want to help, see this page.

Rock on, Phil and Jeanne!

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10 thoughts on “Update: Grandma McCartin Can Finally Get T-DMI in Boston (What Will She Do with the 15,500 Frequent Flier Miles She’s Earned?)

  1. Kathi, thanks SO much for sharing this! As part of the herceptin club, I am so grateful for this targeted therapy, and also aware that Her2 is a nasty beast. I have been NED for nearly four years and it is reassuring to know that there is another tool in the box if I ever have a recurrence. As an Inflammatory Breast Cancer survivor, I am all too aware that this is not unlikely! I’ll sleep better tonight.

    BTW, loved your care package!

    Yes, I am a MAAM!

    Love,
    Elizabeth

  2. nancyspoint says:

    Like you, I am in awe of these people for not giving up and achieving something so profound. I’m also a bit disgusted when I hear only one group cared to get involved because this didn’t fit their mission. Thanks for sharing this story.

  3. Great post Katherine. I’m late to the party on this one having been dealing with another crisis this last week. I was aware of this issue with TDM1, as it was offered to me the last time we changed courses, but would have entailed travel to Virginia to get it every 3 weeks. So horribly ironic that very sick women were being made to endure this kind of travel, and undoubtedly with compromised immune systems on top of everything else. What a great result that these people were able to achieve. But once again it’s a clear indicator of where actual human lives lie in the great big drug bureaucracy’s priorities. And that would be, at their mercy. And as you rightly ask, where were all those really useful and well funded breast cancer orgs? Reading their mission statements obviously.

  4. katherinembc says:

    FYI: Phil writes:

    Genentech contacted me to tell us that they are closing the Expanded Access Program as of Sept. 6 th. We will be grandfathered in. They are starting a new trial, comparing t dm-1 to ” other supportive treatments “. Apparently this FDA’s new requirement of ” Overall Survival ” is harder, takes longer to prove. Some women who progressed on tykerb/xeloda in the ” EMILIA ” trial were switching to the access program to get t dm-1. Trying to live, but messing up this FDA’s ” new ” Goal “, another hoop for Stage IV pts to jump through. This FDA Administration continues to mis-treat Stage IV Survivors. T DM-1 had some of the best stats ever coming out of Phase II trials, after 3 + yrs of human testing, 40 % complete , or greatly reduced tumors , 6 months and beyond. That was back in April , 2010 ! This FDA wants to take 7 yrs to get it to you ! We t dm-1 survivors, and the long-term Avastin Survivors , are Living Proof !
    We will continue to fight this w/ the help of media, public protests. Congress has been disappointingly slow. But evry call you make to your rep counts still, remind them that you vote.
    Any thoughts on advocacy groups ? , ACS, Komen have done nothing. NBCC sold out w/ Avastin. What about others ? Any suggestions ?

  5. Actually, I think Jeanne will be able to get the drug in Seattle but only because the trial there had not been “officially” closed. It’s a crazy story; she tells it best:

    http://assertivecancerpatient.com/2011/09/the-right-ending-t-dm1-drama.html

    Thanks for writing about this. This whole thing is completely unacceptable.
    I am in awe of Jeanne and her ongoing fight against corporate indifference.

  6. Phil mccartin says:

    This is Phil. Thanks KOB for helping us advocate. Its all true…I hate to see Lorraine with extra un-necessary stress. If Genentech truly cared about her stress ( they say they do ), they would stop the travel, give it to her in Boston, and make clinical decisions from there.

  7. Very good article post.Really thank you! Fantastic.

  8. jbaird says:

    Wonderful news. Now I need to get mine transferred to a locale close to home. Lorraine is a true inspiration to me. Thanks for the post!

  9. […] simulations. Lorraine’s wonderful news that she can now be treated locally is featured in a post by a fellow breast cancer blogger. Now we need to find a way for me and so many others to be […]

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