WORDS OF KINDNESS AS WE CLOSE THE BOOK ON 2014

I'm sharing this, not to draw attention to myself, but hopefully, as a reminder to me and to all.  The spirit of this season is love and light.

Drowning out the love and light..... we have this, too.  Feuding family nonsense and commotion and clutter and traffic and noise.  Chaos and confusion.  Spinning in a million directions.  Trying to keep twelve balls in the air.  Stressing because all are equally important and inevitably several are going to hit the ground.  And in my case, several more are going to retreat to the recesses of my chemobrain, likely surfacing moments before I promised (or more likely am required) to do something.

Always remember, especially during this time of year, many are carrying burdens which may not be obvious. Be kind to all. It matters.
— AnneMarie Ciccarella (@chemobrainfog) December 16, 2014

Those words flowed from my brain and I sent them into the magical land of twitter.  Admittedly, it was easy.  I am carrying a mess of stuff but I wanted to remind myself that there are others whose stuff is a whole lot worse than mine.  And then, I ran out the door, late for a doctor appointment after which I pointed my car in the direction of the shopping mall.  I was determined to finish all of the gift shopping on Tuesday and I'm happy to say, I accomplished my goal.

I did the gift wrapping on Wednesday.  I was a woman possessed.  This year, I will spend the entire week before Christmas clearing my mind of everything.  My life has been consumed by much since 2014 was ushered in with the drop of a ball in NYC, just miles from my home.  Yes, I feel like I've been a magnet for far more than I should have had to deal with.  Yes, there are times I want to feel sorry for myself.  And then, I remember.  It could be worse, it is worse for some.  I allow myself my moments but I can't, I won't wallow.

Back to my shopping day.  On the way home, I stopped to put gas in my car.  Up until about two years ago, fingers were constantly pointed in my direction over the fact that I do NOT pump my own gas.  Period.  When I got my license to drive, I lived in a township that did not allow self serve pumps.  Thus, my first eight driving years, I didn't pump gas.  Because I couldn't since I primarily stopped at a gas station close to home.  That set the tone.  Then, there were babies in car seats and the No Pumping Gas thing was simply a way of life.  Not because I was too good to get out of the car, just because that's the way the cookie crumbled for me and gas pumps.

My kids made fun of me.  There were times I almost ran out of gas.  I remember a time I was in Miami visiting my daughter at college.  There are NO attendants on US 1 and I'm almost embarrassed to say, at the time, I had no idea how to even open my damn gas cap.   Yes, I was in a panic.  I know I didn't run out of gas and I know I didn't pump gas, I just wonder how far out of the way I went to find a gas station with a full service island.  That same daughter insisted I learn how to pump my own gas on a lengthy trip.  "Out of the car, mom.  You're doing this."  Now I know.  No more freaking out if I'm running low on fuel and the only stations are self serve.

That rule still exists today in that township and it was that township where I went shopping last Tuesday.  On my way out of the mall, I stopped in Starbucks.  I needed something to drink.  The line was so damn long, I opted to get in my car and stop somewhere else.  Realizing the tank was getting low, I stopped at a gas station.  Two birds with one stone.  Obviously, I wouldn't be pumping my  own gasoline.  I ran into the market to grab a bottle of water as the attendant filled the tank.

I jumped back into my car, grabbing a few dollar bills from the change in my hand.  When the attendant handed me my receipt and my credit card, I thanked him and handed him four dollars.  Four. Dollars.  I thought nothing of it, truly expecting a reciprocal "thanks" in return.  He was an older gentleman and his thank you was filled with such gratitude it took me by surprise.  "Thank you. Thank you so much.  This will help, especially since I won't be working tomorrow."

I had my wallet in my hand and a lump in my throat.  I didn't do anything grand.  I simply wanted to let him know I appreciated the fact that he was outside in the cold fueling my car.  The passenger window was still open and he was already at the rear of my car.  I was so touched, I yelled out the window, "Wait, come back!" and when he came back, I handed him a $20.  "Thank you so much, you have no idea what this means," and then, "please take these back," as he attempted to hand me back the singles.  I told him I didn't want them back and that I hoped he had a happy holiday.

It's the little things.  The littlest things.  I pulled away with tears in my eyes.  I know what's happening in my life and yeah, some of this stuff is exceptionally difficult.  But I have a roof over my head, clothes on my back, food on the table and I'm not worried about how I'm going to stay warm while I'm working in the cold.  Or if there will be gifts under a Christmas tree.

Start a kindness tsunami.  Hold a door for someone.  Offer to help someone who my be struggling with a few too many packages.  Wear a smile.  If you are fortunate enough to have spare change, hand it to someone who helps you or pay for someone's coffee.

That man's pure and heartfelt gratitude was a gift to me.  He thinks I did something for him; In reality, he did more for me than he will ever know.

I wish each and every one of you joy and peace and a heart filled with love, throughout this holiday season and each and every day after.  And to those who may be struggling, whether it's health issues or just plain stuff, know that you are never far from my heart and my thoughts.

To those who are no longer here, to the many friends whose voices I will no longer hear, whose words I will no longer read, my world is a better place because I was graced by the gift of their friendship.  They are all sorely missed.  This year hit hard.  The losses have been enormous.

I hope 2015 starts off a little more calmly than 2014 did.  This year has flown by, but it has been one where I've been tested and challenged.  The sheer fact that this blog has seen a decline in posts tells a story.   In 2014, I wrote one quarter of what I'd managed to write in the the two and a half years prior. I see this space as a place to join friends and the other side of that? I always made my best effort to respond to every comment.  You read, you comment and I see every comment.  That I hadn't had the head or the time to reply, isn't my style either.

And, No mom, there's nothing else happening that you don't already know about...... sometimes it's best if your things are only read by strangers.  But my mom, as many of you already know is one of us.  One of us, twice over, at 20 year intervals and now living with, and thankfully, responding to treatment of metastatic disease.  It was close to two years ago that you all held me up as I walked around MSCKK in circles in the cruelest twist of irony, to learn that she had joined the ranks of the group of patients whose needs are most urgent.  And overlooked by most.

You held her up, too in the comments left specifically for her.  She was stunned.  I wasn't.  I always knew we are a group of friends.  We might not meet face to face but our lives are forever intertwined thanks to the magic of social media.  It made the world incredibly small and exponentially larger in the very same breath.  It made it possible for the cultivation of friendships that would not exist.

So yes, in 2014, I've fallen down many times but I've gotten up every time.  And, I'm still standing.  Still here.  You've been an integral part of that still standing thing.  And yes, beyond all of that, I am and forever will be, grateful for the joy you bring to my life.

Thank you, thank you..... thank you.  From the bottom of my heart and from deep within my soul, thank you.  

Much love,

AnneMarie


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DANNY'S SONG

Every life has a story and this life is no different.

Danny is someone who was very dear to me.  His ashes, as I understand it, have been spread over the graves of his mom and dad.  That was his wish.  He planned each detail.

Beyond being someone who was so very dear to me, going back many decades, Danny was a man whose smile could like a room.  His heart was huge.

Danny and I were inseparable after high school for a bunch of years.  We lost touch for many years at a time with an occasional phone call here and there.

Earlier this year, I found out he was diagnosed with lung cancer.  I called him to say hi, to let him know I was thinking about him.  He gave me the details.  He had shingles.  Bad.  For whatever reason, they did a CT and saw this thing on his lung.

When I spoke to him in March, he had completed chemo.  I recall him saying that it really knocked him on his ass.  He told me the oncologist pushed a very strong regimen because he was in great shape and in that oxymoronic fashion, he was very healthy.  Except for that cancer shit.

I spoke to him again in May.  This time, he called me just to say hi.  It was May 18th.  The date held sentimental value to us and he mentioned during that call how he never forgot that and how each year, he would remember our friendship and how each year, he would think about calling, but he never did.  This year, less than four months ago, he decided he was going to call.  We strolled down memory lane together.  He sounded great, he was feeling great.  Cancer was a blip, he fully rebounded from the chemo and life was good.

Except, apparently, it wasn't.  I have no reason to think he knew something was wrong when we spoke.  I can only surmise the cancer returned with a vengeance.  A couple of weeks ago, I got word that he wasn't well.  In fact, I learned, "it doesn't look good."  I had every intention of calling him but each day, every day brought new challenges in my own life.  I never made the call and now, it's too late.

Danny died on September 3rd in a hospice facility in Florida, near the town where he had been living for the past few years. His former wife, an MS patient, was at his side the entire day.  Five minutes after she left, he took his last breath.

This is the essence of who he was.  Danny was married for a short time.  Married life was not for him and although they divorced, they remained best friends.  When she was diagnosed with multiple sclerosis, well after their divorce, Danny made it his business to care for her.  When her condition deteriorated to the point where she would need care beyond what he could do in his home, when she was no longer able to live alone, he arranged for her to be moved to a nursing home.  When he relocated to Florida, he arranged for her to be moved from NY.

It wasn't near his home, but rather than settle on something less than, he had her put on a waiting list at a facility that was close to his home.   He would not accept anything short of the best possible care and he spent every weekend visiting with her, driving quite a distance but never missing even one weekend.  Until the shingles thing.... and then the cancer thing....

My heart is broken.  It has taken me more than three months to put my feelings and thoughts on paper.  I started writing this shortly after his death.  The hurt, the emotions, the anger over what I feel is senseless kept me from putting pen to paper, to fully capture the man, the friend and the gentle soul with the big heart.  I can't pick up the phone to check on him.  I won't hear his voice again.

Lung Cancer.  It kills and it kills and it kills some more.  My friends who work so diligently to promote awareness of this disease, the stigma attached to it and the lack of funding for research to improve outcomes, do so because this should not be happening. Even with earlier diagnoses, the outcomes are not nearly where they should be.  My beloved grandfather was 55 when he died.  I was ten years old.

Danny was in his 50's too.  He had a LOT of life left.

Instead, he was stolen from those who loved him.

Today, I cry.  And today, I remain aligned with my friends who advocate on behalf of that patient population.


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TRANSLATIONAL RESEARCH .... PATIENT STYLE

Translational research is, in very broad and simple terms, the ability to take science from the lab and make it useful to us, the patient.  This can take years.  And years.....

Translational research for the patient population is translating the research so that is actually means something to us.  Using language that is familiar to a lay population.  (OK, so that's not in any official definition of translational research, but from a patient point of view, I'm using literally terms, making it my own.  All me some leverage here.) Having had the honor of being an Alamo scholar in 2012 and a participant in the AACR scientist <-> survivor program in 2013, I listened closely to the research findings and quickly realized I had to learn a new language, too.

Statistical significance is an accomplishment for researchers.  In science, this means that the study achieved its goal. Research was able to prove that A was better than B because "A" was a certain percentage better than "B" at the end of the day.

What does that mean to the rest of us?  Unless it's put into real world context, not a whole lot.

Patients who took Fulvestrant 30% less likely to die of ER+ metastatic breast cancer compared w/those who took anastrozole #SABCS14
— Naoto Ueno, MD, PhD (@teamoncology) December 12, 2014

Let's look at this tweet reporting finding from the 2014 San Antonio Breast Cancer Symposium as an example.

For starters, to see 30% less likely to die, as a patient, I'm all over that.  And, for what it's worth, this particular study should force a change in first line treatment of metastatic disease.  Bottom line, until metastatic patients "fail" on arimidex, they are not switched to faslodex.  From that point of view, why should we wait to have the drug fail us before we are offered a better option.  That's something that must be addressed with the insurance companies that pay for this stuff.  Lives matter.

For the purpose of this discussion, however, I'm trying to make a different point.  Just want to be clear that this should be a game changer in clinical practice.  Basically, a no brainer.  But what exactly does that 30% mean?

Six months.  To be precise, 5.7 months.  When you are staring down a fatal diagnosis, to be given six additional months is a big deal.  However, when I read 30% "less likely to die," from a patient point of view, this is what I see:

"Seven people will die, three won't.  Maybe I'll be one of the lucky three."

And therein lies the rub.  That's inaccurate.  The study is clear.  Death is imminent.  The amount of time has been increased by 30%.  Out of context, even if I understood that concept, that it was time to death, we are still missing crucial information. What is the base from which we are working?  Without that information, 30% is no different from hearing blahblahblah.  If we are, for example, starting at ten years, we've just gained three more years.  Quite a difference from 5.7  months.

Then, there are treatments for prevention of recurrence and this is where shared decision making becomes so important. Using that same 30% as a measure of reducing risk of recurrence, the real information lies in this.  How many women must be treated to derive the benefit?  If, for example, 100 women would need to be treated to prevent 2 recurrences, THAT is the information that should be discussed between doctor and patient.  That is the only true way for us, as patients, to weigh the risk associated with any treatment against the potential benefit.  Some of us are risk takers, some of us are not.  Some of us who are risk averse but can't bear the side effects need to know that a decision to stop a particular treatment in favor of quality of life are not writing ourselves a prescription for disaster.

Without information, in context, presented in ways that the rest of us can understand, there can be no true shared-decision making that is determined using the evidence.  It's all relative, yes.  But some of us don't understand the theory of relativity. Speak to us in ways we can understand.

The era of patient centered care, of precision medicine, has made this a bit challenging.  Sometimes there are many different qualifiers (age, hormone status, genetic biomarkers).  While there is no cookie cutter answer that works for all, each of us deserves all of the available information so we can play a role in guiding our treatment.


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PREVENTION OF METS < SAVING LIVES

Someone needs to clarify this for the ignorant in the room.  I'm referring to me.  That symbol in the title is not meant to be an arrow pointing to prevention of mets but rather a mathematical symbol.  In other words:

Of the two, Saving Lives is a priority, is (>) of greater importance than preventing mets.  And yes, since I'm in the latter, I feel I have the "right" to be strong in my opinion.  Although, there are likely enough researchers to address all of this simultaneously. We just need to rearrange the funding and understand how to properly distribute and prioritize.  Easier said than done. Possibly impossible to achieve.

Breast cancer is front and center at the moment as the 2014 San Antonio Breast Cancer Symposium winds down.  I've tried to follow the twitter feed (#SABCS14) but there are few advocates who are tweeting from the event this year.  I hope that changes in future years.

Last year, I followed the feed and the presentations and the press releases and tweeted what I was seeing from my home in NY.  The year before, I tag teamed with Lori, tweeting live from the sessions.  It's not easy to live tweet with a chemobrain but it's easy with a partner.  Lori is an excellent partner.  This year, I have much on my plate and I couldn't follow the stream with the regularity necessary to do justice to remote tweeting.

Instead, I'm relying on articles being written in publications, press releases from the companies who stand to make a boatload of money from the sale of a particular drug or product should the study make it through peer review to publication and/or approval by the FDA prior to peer review.  Some are skewed and some are leaving out important pieces of information.

One example is a study called IBIS which examined the long term use of tamoxifen as a preventative in high risk women. Many of the women in my own family who've not been diagnosed with cancer fall into this group.  The results were reported in the Lancet but the best write up of the results, the most thorough reporting has come from my friend Elaine Schattner in Forbes.

Bottom line, prevention of disease was observed, reduction in death was not.  Statistically insignificant but highly significant to me? The incidence of endometrial cancer (and subsequent death from same) and non-melanoma skin cancer along with a trend toward ER negative breast cancers at the 16 year mark.  I didn't read this carefully but Elaine's article is something to read slowly and carefully.  I'd say the jury should still be out on the use of tamoxifen as a preventative method.  Anyone considering this approach, in my opinion, should be carefully weighing the actual benefit (not the statistically significant benefit) against those noted (statistically insignificant findings and trends) risks.

That's not my ignorance.  I just haven't had time to digest that fully but at quick glance, I have an opinion that I would share with my loved ones, if asked.  My ignorance is in another area.  I could be hypersensitive about this.  I could be missing an entire piece of the point.  Or maybe I'm just ignorant.

These are three blurbs taken out of context from another article.

"The real question, the question that demands a real answer, is how do we stop the women and men we love from dying from this disease?"

".... the only way to save lives is to focus collaborative research on two very important areas: primary prevention of breast cancer and prevention of metastasis--or the spread of the disease to other parts of the body."

"This year, worldwide 522,000 women will die from breast cancer--isn't that a strong enough motivator to change the way we approach breast cancer research?"

I'm completely befuddled by the whole thing and I do not wish to bite the hand that feeds.  It was an invitation from the author of this article that found me in the White House.  It was the tireless push by this author that found me as a reviewer on the DoD grant panels.  It was the people I met on one of those panels that opened doors for me to meet researchers who asked me to prepare a lay abstract as the patient advocate on a research grant that I later learned was funded for one million dollars.

I'm not biting the hand but I am challenging the questions and the proposed solution.  I have spoken to many in the research community for their opinions and for clarification in the hopes that I might understand.  I'm trying to address my lack of understanding or my complete ignorance.  Bottom line, yes, I believe in prevention **if** that is indeed an achievable goal. Everything I'm hearing seems to indicate, "No."  That the best we are going to be able to do in our lifetime is continue to reduce risk but prevention is not lurking around any corner.

Am I disgusted with the incremental gains?  You bet I am.  My mom's first primary was in 1987.  Likewise, the person whose hand I'm not biting was diagnosed in 1987.  My treatment in 2006 mirrored my moms.  I've often said there's been no meaningful progress when it comes to  my own circumstances.  My mom's second primary was in 2007, shortly after I completed my active treatment.  In 2013, my mom's cancer found its way into a rib.  Although not definitive, the doctors feel this was a 20 plus year dormancy, that the metastasis was from the first cancer in 1987.  And even if they are wrong, she still passed that magical, bullshit five year mark.

I'm about to morph into Mona Lisa Vito.  (For non-fans who really need a good laugh and if you are the one person on the planet who has NOT seen My Cousin Vinny, seriously, watch it)

"So what's your PRAAHHHBLUM?"

"Would you like me to explain??"

Here's my question, my problem and an explanation of my question and my problem.

I've asked some of the preeminent researchers in the breast cancer world how prevention of metastasis equates to prevention of death.  In other words, does prevention of metastasis help those already living with metastatic disease?  I've gotten a resounding, "NO" from every single one of these people.  They are people who are studying metastasis hoping to unlock ways to prevent death and prevent metastasis.  I'm not certain if their is an overlap in the research but it was clearly stated to me, "Two completely different animals......"  Might prevention of mets equate to stopping progression of mets, thereby saving lives?  It's a stretch in their eyes, but yes, there's an outside shot that could happen.

In The Meantime, statements that challenge us to think about what we are doing to stop the deaths of our loved ones followed by suggestions that prevention of metastasis will actually help those presently sitting on death row is misleading.  To follow that by saying that worldwide, more than half a million lives will be lost this year, I wonder how any of what is proposed is going to help those half million people.  Or the half million plus who will likely die next year and the year after that, too.

I've pushed back on this before and I'll do it again.  I have skin in every part of the game.  I need to know I'm protecting my family and myself and there is a three pronged approach necessary.

1. For my daughter, I need research on primary prevention.
2. For myself, I need research on prevention of metastasis.
3. FOR MY MOM (and so many of you who mean so much to me), I REALLY need dedicated research on stopping the progression of metastatic disease to SAVE LIVES while preserving a good quality of life.

Triaging those, my mom's needs are the most important of all.  Her life is the one hanging in the balance.  First we address those with the most urgent needs.  You can't fix death.  That's Game Over time and frankly, 2014 has been an awfully rough year for me.

I've watched far too many who were near and dear to me succumb to this disease over these past 12 months.  I stopped keeping a "scorecard" and I will likely remove the Gone But Not Forgotten list from the left of this blog margin and put it on a page.  The deaths came in waves this year and I couldn't keep up.  I just kept crying instead.  And then cursed and then screamed and then cried some more.

Prevent mets in me.  Please.  But first, save my mom and save my friends.

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NIH PROPOSES CHANGES FOR CLINICAL TRIAL REPORTING -- MAKE YOUR VOICE HEARD

Research saves lives.

Research ideas begin with a thought.

Beyond the thought, it becomes an idea, a concept, a design.  Tissue studies, animal studies and if the thought seems to hold up throughout the process, ultimately, the life saving research requires human clinical trials.

The process from the thought to the patient can be decades.  Since that's not the purpose of this post, I'm not going to seek out the necessary information to back that length of time statement.  I'll just say, "It takes a damn long time" and leave it there.

All Trials is an initiative I've supported since I learned about its existence.  It irks me in ways that I can't describe to know that study results are not always reported.  ClinicalTrials.gov is the repository for trial information.  It's cumbersome to use but it's there.  My aside comment:  Maybe the government should consider an overhaul of the site including some real, "normal" patients on a committee and I'd like to toss my name out for consideration.

And, as much as I'd love to be involved in a project like this, the unfortunate thing is that patients might be included as tokens or as unpaid consultants and frankly, my time and my efforts can't always be pro-bono.  The experts get paid and the patients, the real experts, should simply bask in the honor of being asked.  I'd rather bask in the glow of holding the hand of someone in need, in choosing small projects to help organizations whose efforts align with my beliefs.  I will gladly be first in line to volunteer my time in those capacities but frankly, when others are being paid for input, it's a tad insulting to be seated at the same table at my own expense.  HUGE digression that has nothing to do with this post either.  I think I just had to get that off my chest.

I need your help.  We need *all* study results to be reported.  Right now, the so-called negative findings are considered failures and are not reported in trial results.  From where I sit, there is no such thing as a failure when it comes to research.  A failure to meet a trial endpoint means we LEARNED something.  I don't see that as a negative anything.  We've ruled out one more needle in the proverbial haystack.  We've rid the haystack of one more "barking up the wrong tree" idea.  That's good.

These results are not reported.  Not only is that a disgrace to the taxpayers whose dollars fund this research, it is absolutely disgusting to the patient population that chose to enlist in one of these "failed" trials.  What?  Their enrollment meant nothing? They contributed to advance the science and their efforts are in a paper shredder.  That is the epitome of indifference by those who withhold evidence from those who put themselves out to participate in accumulating that evidence.

It's just wrong.

Currently, there are two complementary initiatives to change this paradigm and I support each of them.  Bear with me as I make a run at explaining why there is a need for two separate proposals and why it is imperative that each of us add our voices to support the changes.

The National Institute of Health aka The NIH, under the leadership of Francis Collins has a pending proposal that would require certain clinical trials to report ALL outcomes for which it has provided any source of funding.  Currently, according to the announcement, "scientists fulfill their obligation to contribute to the general body of knowledge through peer reviewed journal publications."

The entire peer review process can be a problem for a number of reasons.  Journals, customarily, are not available to the general public.  If a study is rejected for inclusion, it is a small number of people making the decision that the results of any given study are not important enough for their journal.  Not only is that an elitist stance, it removes the patient population from access to seeing the study information that is published unless we are willing to pay upwards of $35.00 to access.  Last I checked, there are no patients on the panels that determine what is considered publication worthy.  I believe there are studies that would be of tremendous interest to specific patient populations but without a patient voice on those review panels, that whole system reeks of paternalism.  Sorry... digression.  Huge but important digression as this all goes to patient centered, patient powered, patient whatever.....

Less than half of the clinical trials funded by the NIH were published within 30 months of trial completion according a recent study referenced in the announcement.  Concerns about "selective publication of the results of some trials and not others -- or publication of incomplete or partial findings...... can lead to inappropriate conclusions about the usefulness of particular therapies."  I do believe we refer to that as publication bias but don't quote me on that.

The new criteria would prevent duplication of efforts.  This is particularly useful when the duplication might involve something that was already studied and determined to be unsafe and unsuccessful.  That's not rocket science, that's simply common sense.  Then, there is the matter of those individuals who show up.  The volunteers who participate in a study assume risks. As previously mentioned, it is the epitome of "you don't matter, regardless of the risk you took," to withhold study results because they don't meet journal criteria or they are considered a failure.  The patient didn't fail anything.  The study didn't meet it's endpoint.  Or, particularly with phase I studies which determine safety, the intervention was found to be UNSAFE.

At the heart of this proposal is the need to find other ways for results to be shared with researchers, clinicians and patient communities.  It's not about the journals, it's not about presentations at a science meeting, it's about having the information, all of the information, in a place that is accessible to all, namely clinical trials.gov.  You can read the red tape version, NIH Request for Public Comments on the Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information here. Comments will be accepted through February 19, 2015 and may be submitted via email, snail mail or fax.

Email:   clinicaltrials.disseminationpolicy@mail.nih.gov
Fax:      301-496-9839
Snail:    Office of Clinical Research & Bioethics Policy, Office of Science Policy, NIH
             6705 Rockledge Drive, Suite 750, Bethesda, MD   20892

As for the second complimentary proposal, online comments will be accepted in an open forum on regulations.gov.  Clicking on the Comment Now button will open up a new page where you can submit your comments.  They may be viewed by others (although the name field is required, "Anonymous Anonymous" is acceptable field input).  You may read some of the previously submitted comments here.

The second proposal involves changes suggested to clinical trials reporting which expands upon a previous FDA amendment. The document is over 100 pages in length.  Again, bear with me as I make yet another run at an explanation the rest of us might understand....

The key changes are in the PDF which is available for download located here.  There are two pertinent elements that jump out at me from a patient perspective.  Determination of what constitutes an applicable clinical trial (ACT) would be removed from the hands of the submitting researcher.  Instead, the FDA will implement the use of an algorithm to determine which trials fall under the new reporting measures.  Presently, the application includes submission by a responsible party to indicate whether the trial is an ACT.  New data information would be required within the application to assist in making the determination via the algorithm.

Also, it appears there will be rules in place for evaluating the use of already approved drugs for other purposes.  What we know as "off-labeling" would be incorporated into the changes being sought by the FDA.  Adverse event reporting requirements will be expanded.  Whether anticipated or not, adverse events that occur in more than 5% of the study population would have to be included in a second table.  From the way this is written, it appears this is presently not required.

This second proposal is much more specific in its goals and as a result, seeks more detailed public commentary.  Specifically, they are looking for comments regarding the advantages and disadvantages of including technical and non-technical summaries in clinicaltrials.gov reporting.  Additionally, opinions and remarks regarding information that might assist in the understanding of adverse event information is being sought from those who are providing commentary.

Of note, this is not cancer specific.  This applies to all clinical trials funded by the NIH and all trials involving FDA regulated products.  Also noteworthy, comments are being accepted from anyone.  In other words, you do not have to be a US citizen to weigh in.

I encourage everyone interested in advancing research at a quicker pace to support these changes by raising their voice by the February 19, 2015 deadline.  If petitions are drafted or sample letters are proposed by any organizations that help add the patient voice to this discussion, I will be sure to update here.  The reporting part is one piece of the puzzle I am only superficially familiar with.  I can review a grant application, I can help write a lay abstract, I can decipher published study results and translate them into lay language.  The reporting process and journal inclusion is the big abyss and it would appear, for the moment, it's by design.  That design must change.

If my brain allows me to clear itself enough from the mountain of personal medical stuff that continues to swirl, I will take a stab at drafting something on my own.  Right now, I'm still trying to learn about hypertriglyceridemia (which apparently could well have been fatal, but while I was still in emergency mode fighting over proper patient care, I had no time to learn and wasn't being included in any medical discussions).  Throw in an attempt to navigate the mental illness maze when someone is too sick for some treatment programs and not sick enough for others.  Add a dash of being stuck in the middle of that mess leaving one feeling both helpless and hopeless and I know something MUST change.  Lives are being sacrificed.  Yes, there is much in front of me and despite the ACA's promise of mental health parity, it doesn't exist.  It's all about the haves v. the have nots, particularly as it applies to the treatment of those with mental illnesses and I defy anyone to show me differently.  In this country, at this point in time, that is simply not acceptable.

I have much to do.  But this clinical trial change is an opportunity with a ticking clock and it's one I could not afford to share, despite the fact, I have much to do.


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LET'S KEEP SHARING THOSE MOMENTS

Cross posting from ShareThoseMoments in case you are new to this blog or weren't aware of my pet project.......

The project continues.  It's not been forgotten, it's just been one of many balls I'm juggling at the moment.

I've done a quick analysis of the responses.  My friends at Breast Cancer Action invited me to participate in a webinar.  I will be presenting the unsexy side of breast cancer.  The most important aspect of advocacy, at least for me, is to remember that it's not all about me.  It's about the community and bringing the voices of many to the conversation.  That is precisely what I hope to achieve during this webinar. 

I missed most of October.  In fact, I missed the entire month.  For the first two weeks, I was recovering from the effects of a reclast infusion.  The first day I felt better, my husband found his way into an emergency room which was the beginning of a ten day stint in an ICU.  Severe acute pancreatitis caused by hypertriglyceridemia, which, in his case, appears to be a genetic thing.  He was discharged from the hospital on November 1st.  Since I started the month of October in bed with a fever hovering at 102 and spent the rest of the month raising hell in a hospital where they need a few lessons in patient centered care,  communication with family members and the concept of shared decision making, I missed the pink hype.

We did a run through of the presentation the other day.  The first half of the webinar will focus on the sexualization of a disease and the manner in which some of the awareness campaigns cross too many lines.  We are women, not objects.  We are more than our breasts.  In fact, there's a living, breathing person attached to those breasts.  The second half will, I hope, get people to think about the women attached to the breast, about what happens after a breast cancer diagnosis, about what goes on in our minds, about the effects on our bodies and what is, or more accurately, is not happening in the bedroom.  At least some bedrooms.

If you'd like to join the webinar, there will be two presentations next week:  one on Wednesday and one on Thursday. The information is on Breast Cancer Action's website if you'd like to join one of the live webinars.  There is no charge.  Next week is the San Antonio Breast Cancer Symposium, too.  I'll be following the twitter feed and it may not be possible for some to join the live presentation.  No worries.  BCA will provide a link so you can watch and listen at a more convenient time.

I hope to see you there.  The survey is still open.  If you want to weigh in, I'll be writing notes for my presentation right up until game time.  Add your voice.

In related news, I was interviewed for a publication of facingcancer.ca, Lives Affected By Cancer.  The article, "The Side Effect No One Talks About," is well written and I was happy to share a bit of my own story.  Shout out and thanks to Catherine Brunelle and Terri Wingham.  Each of them suggested the executive director, Sherry Abbott contact me for the article.

That's all for now.  Stay tuned for Wednesday and I'll be sure to get a link posted here.

~AnneMarie 

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