Moonshots All Around -- Part II, Data Sharing

. . . continued from Moonshots Part I found in my post previous post.

The White House Office of the Press Secretary released on January 28, 2016 a memorandum outlining the White House Cancer Moonshot Task Force Initiative here. One of the goals, support greater access to new research, data, and computational capabilities, offers hope to those who wish for data sharing between scientists and laboratories to occur more easily. 

Currently, federal law see here says data from most large human trials funded by grants from the National Institutes of Health (NIH) must be reported. Most small NIH grant contracts do not require reporting except for those that involve certain rare diseases. In my investigation of data sharing, I found that for private facilities there are avenues to access data involving an application process. For projects funded with grants at the $500,000 level and above from the National Institutes of Health, guidelines have been in place for data sharing all the way back to 2003.

From the President’s first mention of the Cancer Moonshot Initiative “dozens of new initiatives” have been created. Jo Cavallo, July 25, 2016, explains here and mentions one in particular, The National Cancer Institute (NCI) Genomic Data Commons, which aims “to facilitate access to genomic and clinical data among researchers.” Seems like a good plan, but I wonder . . .

For many of you reading, a discussion about data sharing will most certainly be boring. But you should consider that this will affect every one of you, from the federal taxes (US) you pay to the diagnosis you or a loved one might one day hear.

In my perfect world, data sharing makes logical sense. Progress in science will occur, patients will benefit, and money will be spent efficiently because everyone would have an idea of what the next step is in a particular research area. But my world—our world--is no utopia.

The idea of sharing takes me back to college where, as I worked toward my degree in K-6 education, Cooperative Learning was the buzz. The idea that if you bring different people with differing ideas and knowledge to a group, those ideas can be expanded and improved with input from everyone ultimately producing a better project as a result. Easy, right? But, no.

With any group sharing situation, the ones who work the hardest are not always recognized. A+ work by someone could become B - work or worse for the group. I am not anti-team. I want everyone to work for the same goal—cures for cancers that can be cured and better treatments for a longer better quality life for those that can’t. Team work is how progress is made; however, individual accomplishments not recognized can have the potential to de-incentivize people within the team. Why else do we see most valuable player or employee awards and salary bonuses? Recognition of individuals obviously works.

I agree with David Shaywitz who said in a Forbes article here, “Unfortunately (as one participant observed yesterday), until you can look at each individual researcher, or clinician, or data scientist, and credibly answer their question, “What’s in it for me?” (to share my data), progress is likely to remain slow–a result painfully at odds with the urgency demanded by Biden and deserved by patients.”

I think most humans want to help others despite social media portraying pharmaceutical companies as bad because they only care about profits. But those entities are made up of people, and as I said, I think most care. Please consider why such an assumption that certain companies are greedy and a plight on society might not be true; consider what a researcher might face when it comes to data sharing as they work to see the advancement of science.

As I explained with my example of Cooperative Learning, individuals can become less important than the group. People have an innate desire to be recognized especially when their well-being is tied to it. Although there are some protections in place to prevent theft of scientific information, there are still situations where the hard work of an individual or group can end up in the hands of another individual or group through data sharing especially if it becomes more easily accessed. Some researchers may claim it as their own, though it is not, thus possibly receiving grant money to continue the research leaving the original team with not enough money to continue what they started. Their research stops, the lab receives no public (NIH-National Institutes of Health) funding potentially causing salaries to remain stagnant, promotions stopped, company morale plummets, and profit margins suffer. When profits cease research cannot advance, new equipment cannot be bought, and new employees cannot be hired. The researchers’ well-being and personal satisfaction is jeopardized--or worse their jobs are lost. If everyone faces this same fear, new discoveries will be impacted. 

When the pressure is on to secure grants for research, to get a drug to market, or to protect a company’s investment, what I will call “the fudging effect” could and probably does occur. That is: in the reported data, details may be left out or inaccurate information provided. It is wrong, but as you can see in the above argument, people have a lot at stake that they do not want to lose.  

For me--as someone who wants the newest research as soon as possible--it would make me happy to have access to all research even at its earliest. But, then I think, no, I am wrong about that. Data in many publications is sometimes difficult to comprehend since I am not trained to interpret that data in those documents and it is long, complicated and I might add—boring at times. Plus misinterpretations of medical research already exist. Easier access to data could potentially make this situation worse. Our society has plenty of medical untruths that cause people to believe in preventive measures of diseases, cures and treatments for those diseases that will absolutely not help them. This could become more food for pseudo-science peddlers. I say, let the researchers do their jobs, repeat their research as many times as needed to ensure results are reproducible and accurate signifying a real scientific advancement. Perhaps the attention needs to be directed toward how to overcome mistakes and biases in research, in peer reviews and publications instead of the need for more access.

With the excitement generated about data sharing, I am having dollar signs spinning in my head. Those dollars aren’t going to research either. Data sharing and the computer programs to track and submit data that will be needed, new administrative guidelines, and everyone converting to a new system that will grow from this project will cost a lot of money. Instead of research, money will be used by pharmaceutical companies and researcher laboratories to make sure they are complying with the new rules.  Scientific advancement will be slowed as our government reorganizes and establishes new departments when what may really be needed is some tweaking of what already exist. 

Steven Lewis on Feb 15, 2016 in the Yale News reported here that “Robert Alpern, dean of the Yale School of Medicine, said: "We hear all the time from people outside of science that science is slowed down by the lack of data sharing. Data is shared in science and at just the right time."

And then Carolyn Johnson in her article here in the Washington Post in March of 2016 said this about data sharing: "Despite the considerable lip service that data sharing gets, the researchers behind the JAMA study determined there are relatively few people actually taking advantage of the data."

Perhaps, data sharing is not as much of a problem as the Cancer Moonshot is implying.

Finding money to fund research for all cancers is the real issue.

Maybe, we should all drink a couple of jiggers of a new liquor concoction and call them Moonshots. At least then we will feel good for a little while. The Cancer Moonshot is giving me a headache.

Sources:
https://www.whitehouse.gov/the-press-office/2016/01/28/memorandum-white-house-cancer-moonshot-task-force
https://www.statnews.com/2016/06/29/biden-clinical-trials-cancer/
http://www.ascopost.com/issues/july-25-2016/the-national-cancer-moonshot-lifts-off/ 
http://www.forbes.com/sites/davidshaywitz/2016/06/30/first-hand-account-the-biden-moonshot-summit/3/#74f622e079df,
http://yaledailynews.com/blog/2016/02/15/obama-announces-cancer-moonshot/ 

http://healthitanalytics.com/news/why-sharing-cancer-big-data-is-key-to-personalized-medicine

http://www.forbes.com/sites/arleneweintraub/2016/01/26/here-are-the-sticking-points-for-biden-big-data-and-cancer-moonshots/#3112c4ae2299
https://www.washingtonpost.com/news/wonk/wp/2016/03/29/pharma-companies-are-sharing-their-data-but-few-are-looking/
http://www.npr.org/sections/thetwo-way/2016/02/01/465153594/white-house-to-request-1-billion-for-cancer-moonshot
http://www.bna.com/moonshot-improve-trial-n57982066347/
https://grants.nih.gov/policy/sharing.htm

http://www.cancer.gov/grants-training/grants-management/nci-policies/genomic-data/about-policy

Moonshots All Around--Part I

When I first thought about writing this post, I imagined describing the Cancer Moonshot Initiative, giving my opinion and hoping after sharing what I had learned that someone else learned something too--this is the Cancer Classroom after all. Easy, right? Well, no, actually. The complexities of the Moonshot have made it a hard post to write, and my inability to quit asking questions about each new piece of information I found has made this a difficult post to keep short. But, here I go anyway. Luckily, for you, I have broken it into two parts. 

note: This post is not about Cancer Moonshot 2020 find here. It is about the Federal Government’s National Cancer Moonshot Initiative. 


Are you excited about the Cancer Moonshot Initiative? Or, are you like me?--a skeptic--always trying to figure out if the latest excitement of the day is really just another feel-good attempt in the political world to cause the American people to stop and say, “Yeah! This is exactly what is needed to stop the 2nd leading killer of our citizens."

The issue of curing cancer by our Federal Government is not new. On January 22, 1971 President Richard Nixon said in his State of the Union Address to congress, "I will also ask for an appropriation of an extra $100 million to launch an intensive campaign to find a cure for cancer, and I will ask later for whatever additional funds can effectively be used". The ‘War on Cancer” had begun—with high dollar federal funding. For me, the Cancer Moonshot Initiative is simply a repackaging of this former endeavor with government now playing an even bigger role.

Back in 2007, Barack Obama, before he became President, made a campaign promise to double the federal government’s cancer research spending in five years. It was a promise he couldn’t keep. The economy wouldn’t let him. Perhaps driven by the personal loss of his mom to cancer and in an effort to keep his campaign promise, he introduced the Cancer Moonshot Initiative in his last State of the Union Address in January 2016 later asking congress for 1 billion dollars for the National Institutes of Health for the effort of curing cancer(s). Some of that 1 billion would be made available this year with the rest available next year. Don’t let that number cause you to think no other money has been allocated for cancer research by our government. Vice President Biden already was involved in the handling of 264 million dollars for cancer research. The National Cancer Institute gets around 5 billion a year, plus there are other governmental programs contributing to the cancer research effort. The Department of Defense, the Department of Veteran Affairs, and the Food and Drug Administration are all involved. Heck, even the Department of Energy has a hand in it. Yes, government involvement in the health of our citizenry has grown a lot since the National Health Institute was formed in the 1930’s--information here.

I am not suggesting that good things haven’t or won’t come from our government being involved in cancer research, but before we get all excited about this additional billion dollar enterprise, maybe it would be a good idea to spend some time figuring out if tax payer dollars are already being used in the most efficient and effective way. I am not convinced that more government involvement is going to do a better job than the private industry does. It seems to me all the intricacies of forming this new project will take money away from actual cancer research.

When I learned through twitter that Vice President Joe Biden—who had been named by President Obama to lead the Cancer Moonshot Task Force--would be on The Nightly News with Lester Holt on NBC on June 29th I became a little excited hoping I would learn something new. Tom Brokaw, a famous news anchor from my youth, interviewed the Vice President. The two came together to discuss what likely is an important issue for both men. Vice President Biden’s son died of brain cancer last year, and Mr. Brokaw was diagnosed in 2014 with multiple myeloma, a cancer in the bone marrow’s plasma cells.

Pen in hand, paper underneath, I watched the interview attentively jotting down a few notes as they spoke. I wanted to hear information convincing me that this additional billion dollars for cancer research from our country’s tax payers was a good idea. I wanted to believe this initiative was different than the hype and promises of the past; that the money would not be wasted. Too soon the segment was coming to an end and no one had addressed what the Moonshot Task Force’s main objectives were instead highlighting Biden’s take on rising drug prices with his quip, “What the hell is that all about?” If he doesn’t know, why didn’t he say, "I intend to find out".

He is leading the task force and doesn’t know what that is all about? Hummm, Mr. Vice President let me see if I can help: lengthy expensive clinical trials, government regulations, patents on drugs keeping generics from being produced (although I support protection of intellectual property), better technology, new drug releases, and the involvement of insurance companies. Some might argue profit desires are the problem, perhaps there is an argument there, but have you ever thought that maybe a drug goes up in price rather quickly because the market place dictates the increase, or that insurance companies have a role in setting that increase? Maybe the company is trying to recoup any costs involved in helping people with little income have access to their drugs? Someone has to pay for it; nothing is free. Plus, nowhere have I seen lowering drug prices as part of the initiative, so why did he mention it--drama, attention?

His wife ended the segment saying something about hope. Hope is not what this initiative is about or is it?--hope that it will work, hope that tax dollars are being spent in the most appropriate way yielding the best possible results, and--above all—hope for cures?

Needless to say, but I will say it anyway, I didn’t learn anything new.

Biden also talked about high drug costs on that same day at the Moonshot Summit in Washington, DC. Maybe I missed it, but again I have not found cost cuts for drugs to be part of the Cancer Moonshot Initiative.

During the Vice President’s speech at Washington, DC’s Howard University, he talked about the difficulties of research facilities working together toward one goal and of patients’ inability to find affordable and better care. (Affordable: a word carelessly thrown around even though it means different things to different people.) He explained that the Moonshot will work to fix those problems.

Let me back-up and give some background for the Cancer Moonshot Initiative and its Blue Ribbon Task Force. The biggest goal will be to speed up the advancements in cancer research. What is done in ten years, the President and the Vice President want to see done in five. (This is different than his original promise of doubling the amount spent, but okay, that's fine.) Another piece of the plan is to tackle the sharing of data between research entities to help the first goal succeed. This is to be done with the cooperation of private and public entities. The key areas of research will include: pediatric cancer, prevention and cancer vaccine development, early cancer detection, cancer immunotherapy and combination therapy, genomic analysis of tumor and surrounding cells, enhanced data sharing, and the FDA is supposed to develop a virtual Oncology Center to evaluate products, support diagnostic tests and drug development for the prevention, screening, diagnosis, and treatment of cancer.  Find more information here.

I hope genomic analysis of tumor and surrounding cells is where metastatic disease will get some attention otherwise I don’t see the other pieces of the plan holding promise for me and others like me--unless metastatic cancer is included in the treatment portion of the initiative, but it is not stated that it does.

One billion dollars makes me say, wow! And then I remember that it takes a lot of money to find what is fueling the survival of a cancer cell. Finding a significant protein to attack, figuring out what chemicals can be put together that will target that protein and cease its function are costly. Consider, too, the clinical trials: years of funding are needed to go from ideas to petri dishes to mice and finally to humans. Once the testing begins in humans, specific candidates--who do not usually pay for their participation--must be selected, dosages determined, side-effects acknowledged, end points met. And of course we can’t leave out the costs involved paying researchers for their time and the purchasing of equipment necessary for the work to occur. Then, of course, patents must be obtained and the FDA must approve the drug for consumer use. Consider all the failures and restarts that do happen in order to finally reach something that may only give someone 6 more months of life. I will take the 6 months, but this shows how time-consuming and costly the process is. Condensing research time, fast-tracking drugs to the market place within 5 years may not yield what we are all hoping. None of this is easy and some—perhaps all--of it shouldn’t be rushed.

The other goal of the sharing of data quickly and easily between research institutions will be discussed in my next post Moonshots All Around--Part II.

One thing before I go. I learned this interesting information from Margot Sanger-Katz in her New York Times article in February of 2016 found here. She said:

"Moonshot . . . It's become a popular metaphor for national cancer cures. In 1971, President Richard Nixon announced his so-called War on Cancer in his own State of the Union speech. Here’s what he said: 'The time has come in America when the same kind of concentrated effort that split the atom and took man to the moon should be turned toward conquering this dread disease.' When George W. Bush was running for president in 2000, he, too, called for a “medical moonshot” to cure cancer".

With all kinds of information available to all of us, I think the bureaucrats involved should have picked a different name, don’t you. Where is their originality?

To be continued . . .

References:

http://www.politifact.com/truth-o-meter/promises/obameter/promise/84/double-federal-funding-for-cancer-research/ 

_{https://www.whitehouse.gov/the-press-office/2016/02/01/fact-sheet-investing-national-cancer-moonshot}  

http://www.nytimes.com/2016/02/14/upshot/moonshot-metaphor-on-cancer-is-a-failure-to-communicate.html

The Results Are In!

Scan Day also became infusion day #34 of TDM-1!

What a relief to see a smiling face come through the door to tell me my scan looked great. I believed I startled Ms. P (PA) when I embraced her maybe a little too enthusiastically--I was joyful and couldn't contain it. 
 
My next scan will be in October. In the meantime I will travel to Kentucky to see my sisters, visit Cleveland, Ohio where my daughter will be working and watch my other daughter leave (again) for Japan where she will work over the next year. I am looking forward to a busy summer.     

Oligometastatic Disease--A Chance to Live Longer

For a little over three years, I have lived knowing my existence is threatened by metastatic cancer. From the beginning I wanted nothing more than to live long enough to see each of my children become independent of me. I still want that. But, now there is an added dimension.

For an unknowable amount of time a thought has been entering my mind then fading as fast as it came. Recently, I noticed it lingering. Even more recently, it has decided not to leave at all. Why I noticed its presence, I am not sure. What I am sure about is it is not going away. I want to live for my children, no doubt about it. Additionally, I want to live for me, too!

I enjoy living. Not just living, but being an active participant in it. Of feeling the warmth on my skin from a summer sun, sensing the cool air gliding across my face as the temperature drops before a storm, witnessing flowers change a dull landscape to a beautiful one, engaging in thought-provoking conversations, revisiting experiences of yesterdays, dreaming of tomorrows, having my pets soak-up my blues and restoring some happiness within me, and experiencing the stories of others providing me the human connection that I cannot and do not want to live without.

My brain is on high alert right now about my wanting to live because my scan day is approaching. The date, time and machine locked in place just for me. This Monday I will pull myself out of bed, reluctantly. The firing squad will have their weapons pointing at me. Will the firing of their bullets begin?

As my days drift closer to this next scan, I replay the conversation I had with my radiation oncologist. His words held promise of a longer future for me. Now I live each day hopeful of many tomorrows. I am also cautious—fearful too--that he spoke too optimistically too soon. This is a wicked balancing act for me. Do I lean heavily on the hopeful side or lean more into the hopeless side, so if I fall the fall will hurt less. 

That day in October when hope became real, Dr. Z (my human life-preserver) used the term oligometastatic disease—a term I had read but had never heard spoken. Though I couldn’t find a lot of free information about it on the internet, I did find this--Oligometastatic disease is defined as:  

low-volume metastatic disease with limited number and size of metastatic lesions (up to 5, and not necessarily in the same organ), potentially amenable to local treatment, with the aim of achieving complete remission. Definition from Medscape article by Linda Brookes, MSc, April 28, 2016, Mastectomies: Local Approaches to Breast Cancer. www.medscape.com

From this same article Dr. E. Senkus-Konefka, MD (Medical University of Gadansk, Poland) at the 2016 European Breast Cancer conference said this: Oligometastatic disease is an intermediate biological state between localized and widely metastatic disease. Evidence suggests that OMBC is biologically distinct from polymetastatic disease.

With present day radiation methods, better drugs and surgery for certain candidates, it does seem possible that my situation is leaning in the direction of hopeful instead of hopeless. My fingers are crossed.

For those of you not familiar with oligometastatic (OMBC) disease or are new to learning about metastatic breast cancer, I will attempt to explain why oligometastatic disease could have a better outcome than widespread disease--at least in the way I understand it: Dr. Elaine Schattner wrote in a Forbes article--here--It takes about a billion cells for a tumor to reach the size of one centimeter, less than half an inch, in diameter.--a billion cells, imagine that for a moment. Though some may no longer be alive deep within the tumor, killing even a million cells individually is daunting, wouldn’t you agree? Each time a group of cells breaks-off and travels to a new site forming another tumor with billions and billions of cells means less of a chance of controlling or eliminating them.

In those billions of cancerous cells, many will look similar to each other, but others will not. The longer the cancer cells continue to survive, the more different they can become. For example, my cancer tested positive for the Her2neu receptor on the cancerous cells’ surfaces. That means the generations of cells before they became cancerous had the right amount of receptors to behave normally. Then something went wrong resulting in too many receptors receiving an onslaught of messages causing the cells to behave abnormally. The tissue taken from a lymph node in the middle of my chest for biopsy tested the same as my primary cancer—Her2neu+. Samples from the nodules in my lungs and all other affected lymph nodes were not taken for biopsy so really it was and is a hopeful endeavor that they have/had the same mutation. Since all but one disappeared it is likely that most of the cells resembled my primary tumor—at least enough to respond to treatment. The one nodule in my right lung that was recently radiated did not respond to therapy like the others. It stayed the same size for a long time, almost as if it wasn’t an active tumor. Some cells were killed and some grew until the growing ones outnumbered the ones responding to treatment. Those unresponsive cells to TDM-1 could have been negative for the Her2neu receptors, found a new pathway of proteins to use to get messages to the nucleus or could have been positive for the estrogen receptor fueling its growth—no way to know for sure. I say “could have been” hoping they have all been destroyed by Cyber Knife delivered radiation.

As I went through my stage 1 treatment and during the 3 years before I knew I had metastatic disease, I often inquired about scans for recurrent disease. My goal was to catch it early. I didn’t know then that doctors aren’t interested--at least don’t seem to be--in catching advanced disease in its earliest state. The ongoing belief seems to be once you pass into stage IV land, it is too late.

After chemotherapy and radiation ended, I was allowed two PET scans. Since I was a breast cancer repeater—stage 0 then stage 1--I assume it was approved by insurance to make sure I wasn't already stage IV. Once those scans were clear, my former oncologist saw no reason to undergo any more diagnostic tests. Is this because stage IV has such a bleak outcome so why bother? Is it because he knew my insurance company would not pay for additional testing? With my new knowledge--albeit limited and from a patient's perspective--of oligometastatic disease, I think my desire to catch this disease early before the tumor load was impossible to manage was reasonable. Catching advanced disease earlier and treating aggressively may give some patients long-term control and dare I say the possibility of a cure. I think having scans at year 3 and year 5 after early-stage disease should be considered. Maybe waiting for symptoms to occur will stop being the standard of care after early-stage disease.

The information I found about oligometastatic disease never indicated if remission was only attainable at initial diagnosis or if it could be attained after treatment reducing the disease to this state. The latter is the category in which I fall. I asked Dr. Z about this since my disease didn’t start out that way--my tumors were small but more than 5 were seen on a scan. He didn’t miss a beat as he continued filling the room with his energy and optimism of the success that radiation of this nodule could bring making me feel he was waving a golden ticket in front of me. All I had to do was grab it. But, I was afraid because if I grabbed it, it might be ripped from my hands. 

Three weeks later a Physician’s Assistant said when looking at my last scan, “Well, we know it is still there. We just can’t see it.” making my golden ticket appear farther away making it harder to grab, slapping me back to the reality of the hopelessness of my disease. Love her, but grrrrrrrr . . .

I want to pretend none of this has happened to me, but my brain is never quiet. I know too much about this disease. My anxiety increases as the winds of time keep pushing me to that great white machine again asking me to breathe in, breathe out.


What if . . .

What if it isn’t there any longer?

I want to believe in this possibility for me.