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#LCSM Chat topic 5/21: Living with and Beyond Lung Cancer

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This is a reblog of a 5/18/2015 post on the #LCSM Chat site (reposted with permission).

You mean I have to say something

Lung cancer patient advocates are beginning to make their voices heard and gain acceptance in the medical world.  For the first time ever, patient advocates will be speaking from the stage at the World Conference on Lung Cancer (WCLC), the largest meeting dedicated to lung cancer anywhere.  The meeting, which runs September 6-9 in Denver and is sponsored by the International Association for the Study of Lung Cancer (IASLC), will have sessions on research, treatment, biotech developments…and patient advocacy topics.

In the session titled “Advocacy in Practice,” #LCSM Comoderator Janet Freeman-Daily will be speaking about “Supporting Lung Cancer Survivors–Living with and Beyond Lung Cancer,” which will inform lung cancer healthcare providers … read more

The President’s Cancer Panel Wants … ME?

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When the Twitter icon indicated I had a new direct message last Tuesday, I took my time opening it. I was down with a bad case of the flu, including a fever and a cough that had stolen my voice, and I wasn’t at the top of my game.  When I finally clicked on the icon, I felt a jolt of adrenaline.

The message was from “@PresCancerPanel” and started “We’d like to invite you to …” …continue reading

 

Edit May 7, 2015:  list of March 2015 workshop participants

Call to Action: Proposed FDA Regulations Could Limit Cancer Patient Access to Life-Saving Therapies

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This article first appeared on my February 1, 2015, blog for Cure Today Magazine.  Reprinted here with permission.
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As posted in a recent CURE article, the US Food and Drug Administration (FDA) has proposed draft regulations titled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).”  The FDA should withdraw this proposed framework because it could limit cancer patient access to potentially life-saving therapies.

Metastatic cancer patients have waited years for the hope that targeted therapies and genomic testing are now giving us. Don’t let the FDA throttle our hope. Knowledge of cancer genomics and proteins is evolving faster than government regulation can move.

Of course, we all want LDTs to be as validated, accurate and clinically relevant as possible. However, we also want the laboratories where these clinical testing services are performed to be able to exercise the flexibility, innovation and medical judgment necessary for good outcomes in thousands of cancer patients.  This isn’t possible with the proposed FDA regulations.

Please sign the change.org petition at http://chn.ge/1uN2e2Z, and ask your friends and family to sign. If you or a loved one has benefited from molecular or genomic testing, please say so in the comments.  The petition and its comments will be submitted to the FDA as an official comment. The more signatures we have, the stronger our voice will be.

Here is a specific example of patient harm these proposed regulations might cause, taken from my own journey with metastatic ROS1-positive non-small lung cancer (NSCLC).

I live near Seattle. Because I was able to send my slides to University of Colorado for ROS1 testing, and my slides tested positive for ROS1, I was able to take crizotinib and achieve two years (and counting) of No Evidence of Disease. LDTs for ROS1 have been validated by medical research and have given many patients months or years of extra time.

Under the proposed regulations, some patients might have to travel to a distant or out-of-network medical facility to get the existing ROS1 test and receive treatment for their ROS1 cancer. In addition, some labs might stop offering the test because of the lengthy and cost-prohibitive process to obtain FDA approval. A medically validated test that is currently saving lives may become inaccessible to future lung cancer patients. The proposed FDA regulations would have effectively interfered with the practice of medicine.

Getting the best diagnostic and treatment outcomes from available cancer specimens relies of the practice of medicine, particularly the judgment and skill of pathologists, molecular pathologists and other molecular laboratory professionals.  The use and safety of LDTs can’t be regulated in the same manner as self-contained medical devices such as stents, or commercial test kits that come with pre-defined instructions.  Yet that is how the proposed regulations treat LDTs.

All cancer patients should have access to clinically validated tests that can help decide the best course of treatment.  Please sign the petition to tell the FDA to withdraw its proposed regulations.

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A more detailed version of my ROS1 example:

ROS1-rearranged non-small cell lung cancer (NSCLC) testing and treatment with crizotinib are recommended in National Comprehensive Cancer Network guidelines because crizotinib, an FDA-approved drug for ALK-positive NSCLC, “showed marked antitumor activity” against ROS1 NSCLC, with a 72 percent  response rate in clinical trials—one of the highest response rates of any lung cancer drug—and a duration of response that exceeds 17.6 months.  Crizotinib is currently available off-label for ROS1 NSCLC through most insurance companies because of its strong clinical evidence of effectiveness.  Since most cancer treatment facilities do not offer an LDT for ROS1, they send slides to one of several CLIA-approved laboratories for testing, and treat ROS1-positive patients at home with crizotinib. Because no FDA-approved companion test exists for ROS1, any non-FDA approved LDT used to detect the ROS1 rearrangement would fall under the “LDT for Unmet Needs” exemption — IF the LDT is ONLY used for patients within the laboratory’s healthcare system. Therefore, any lung cancer patient whose home clinic does not offer ROS1 testing would have to either send specimens to a laboratory with an FDA-approved ROS1 LDT (none are available at present), or travel for diagnosis and treatment to a facility that offers a ROS1 LDT within its healthcare system–even if the patient’s insurance doesn’t cover that system.  Many patients may not be able to travel to another healthcare facility for ROS1 testing and treatment because they might be too sick, or face work, family, or financial constraints (insurance doesn’t cover travel expenses).  Thus, under the proposed regulations, some future ROS1 patients would not be able to get crizotinib treatment, even though that treatment is available today at their home cancer clinic.

Another example from lung cancer:

Under the proposed regulations, when using an FDA-approved companion test kit (currently available for EGFR and ALK NSCLC), any change in equipment, reagents, or patient specimen type must be submitted to the FDA and obtain the FDA’s approval before it can be offered to patients. Currently patients who have little tumor tissue (a common problem in lung cancer) can sometimes be tested for ALK based on cells obtained from pleural fluid or lymph nodes. Under the proposed regulations, only tumor tissue could be tested for ALK (that’s what the FDA-approved test kit requires) unless laboratories submit their modified ALK LDT for FDA approval. Also, published medical research has demonstrated that sometimes patients test negative for ALK using the FDA-approved test, but those patients may test positive using alternative, validated testing methods (such as genomic sequencing) and respond well to crizotinib. Under the new regulations, those alternative testing methods won’t be allowed unless they obtain FDA approval.  Lung cancer patients who don’t have enough tumor tissue would either go without testing, or undergo risky biopsies in hopes of obtaining enough tumor tissue.

Image credit:  “Researcher looks through microscope (2)” by Rhoda Baer. Licensed under Public Domain via Wikimedia Commons.

#LCSM Chat Topic 1/15 at 8PM ET: “Should the FDA Regulate Which Cancer Tests You Can Have?”

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The US Food and Drug Administration (FDA) announced its intention to regulate laboratory developed tests.  Under the FDA’s proposed Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) — which treats LDTs as medical devices and healthcare providers as manufacturers — laboratories would have to submit applications for expensive premarket review for thousands of LDTs if they wish to continue offering them to patients.  This could limit access to life-saving genomic testing for patients who have cancer and other conditions treatable with targeted drugs.

This Thursday, January 15, 2015, at 8 PM Eastern, the subject for #LCSM Chat will be “Should the FDA regulate which cancer tests you can have?”  We invite patients, caregivers, doctors, researchers, professional societies, advocates, and regulators in all cancer communities to participate in this discussion.  Your moderator will be Janet Freeman-Daily.

Our discussion topics:

  • T1: What info about an LDT would give you confidence that it accurately identifies cancer or treatable mutations?
  • T2: Does FDA approval ensure accuracy and usefulness of LDTs? What other info/oversight could do this?
  • T3: Would FDA regulation of LDTs interfere with the practice of medicine?
  • T4: Should only FDA-approved LDTs be used to guide treatment of cancer patients?  Why or why not?

Background information about subject is below.

We look forward to seeing you Thursday 1/15 at 8 PM.  Please be sure to include #LCSM in your tweets to participate in the chat.  For more about how to participate, see our #LCSM Chat Primer.

 

BACKGROUND

Laboratory developed tests (LDTs) are developed, validated, performed and interpreted by trained professionals in hospital, academic, and commercial laboratories.  Examples of important LDTs for lung cancer patients include blood tests (blood count, liver function, cancer biomarkers), identification of biopsied cell types (e.g., adenocarcinoma, small cell lung cancer), molecular tests (EGFR, ALK, ROS1), and genomic panels (which can test for over 200 cancer-causing gene mutations and rearrangements from one set of tissue samples).  While some tests are automated, the results of these tests often depend on the judgment and skills of medical professionals such as MD pathologists or PhD scientists.  Cancer-related LDTs are often developed at the request of (and in consultation with) oncologists to allow physicians to tailor treatments for their patients.

LDTs that are performed in your hospital’s lab or commercial labs (like Foundation Medicine) typically are not regulated by the FDA.  However, labs are regulated and certified by the Centers for Medicare and Medicaid Services through Clinical Laboratory Improvement Amendments (CLIA), state health agencies, and organizations such as the College of American Pathologists.  They also participate in programs such as proficiency testing to ensure accuracy.

Unlike LDTs, tests that are boxed and shipped to other labs and professionals contain all of the components and information necessary to perform the test outside of the laboratory in which it was designed and manufactured.  Because they are manufactured by a company and not developed and validated by health professionals as part of a medical service, test kits are regulated by the FDA. The BRAF test manufactured by Roche is an example of an FDA-regulated kit.

Under the proposed framework for regulation of LDTs, the FDA would regulate LDTs just as they would medical devices such as stents, blood glucose monitors or hip replacements.  Regulations would vary depending on risk categories, with tests that determine patient treatments considered as “high risk.”  If this proposal were finalized, in many cases laboratories would have to pull their LDTs from their list of patient services or submit them for review by the FDA.

At first glance, FDA regulation of LDTs might seem like a good idea.  The number of commercially available LDTs to detect mutations in cancer tissue has exploded from a handful in 2011 to dozens today.  Some people argue we need regulations to protect vulnerable patients, citing as one example the Ovasure LDT for early detection of ovarian cancer, which the FDA forced off the market in 2008.  The test aimed to detect specific proteins in the blood that, when analyzed via a mathematical algorithm, could determine whether the patient had ovarian cancer.  However, the LDT was marketed before its accuracy was validated in a large group of patients.  As a result, Ovasure false positives caused some women to have their ovaries removed when they did not actually have ovarian cancer.  We need to prevent such things from happening, right?

Yes, we want LDTs to be as accurate and clinically useful as possible.  But FDA regulation will not change the fact that ALL tests, whether an LDT or test kit, occasionally have false readings.  Early in my cancer journey, a blood test said my blood glucose was 30-something (normal range is 70-120).  The doctor called me late at night, concerned that I was seriously ill (if not dead).  I was fine.  The test result was incorrect.

The FDA held a workshop on the proposed regulations on January 8-9, 2015 (see agenda day 1 and day 2 videos).  During the two days of presentations, several issues were raised :

  • PACE of scientific discovery: Our knowledge of cancer-causing genes, how they affect the body, and ways of detecting them is evolving rapidly. FDA regulations move slowly; approvals usually takes years.
  • VARIETY of labs producing LDTs: Some large for-profit labs that offer genomic tests might be able to afford the cost of additional personnel and fees to comply with proposed FDA regulations. Smaller labs such as those associated with hospitals might not be able to absorb the additional costs and might be forced to close.
  • SCOPE of tests: Determining which LDTs to perform, validating results, and applying the results to treatment is the practice of medicine, which the FDA is prohibited from regulating. Also, the FDA seeks to regulate LDTs as medical devices, but laboratory professionals claim LDTs are not medical devices because they involve medical judgment.

Our understanding of existing oncogenes (ALK, EGFR, BRAF, etc.) and their associated targeted therapies continues to evolve even after the FDA approves companion tests to detect targetable mutations.  It’s not unusual for an LDT to be developed that detects a new variation of an oncogene not detected by the FDA-approved test.  Must cancer patients wait years until the FDA approves the new LDT before they can receive an effective targeted therapy?  Most stage IV cancer patients can’t afford to wait that long.

Here’s an example of how pace, variety, and scope can make a difference for patients.  In a presentation to the FDA on January 8, University of Colorado pathologist Dara Aisner, MD, PhD, shared the following:

“This Kaplan-Meier Curve demonstrates survival benefit for patients with metastatic melanoma treated with vemurafinib [vs dacarbazine] when they have an ‘atypical’ mutation – V600K.  Of note, 34% of the V600K mutation positive patients in this cohort were classified as NEGATIVE by an FDA approved assay and were only detected using a non-FDA approved assay. … This is an example of the clinical validity that evolves rapidly with time.  Determining clinical validity is the physician’s job.”

 Survival Analysis of patients with BRAF V600K mutation

As you can see from this example, restricting the targeted therapy vemurafinib only to patients identified by the FDA-approved test would have prevented many patients from receiving effective treatment.  The current FDA approval process takes years, is resource intensive, and could potentially interfere with the practice of medicine.  Dr. Aisner has stated that if the FDA’s proposed regulations are enacted, her lab at the University of Colorado might have to close or at least stop providing many of its tests.

Another example: the current FDA-approved test for detecting ALK rearrangements in lung cancer is only approved for testing biopsied tumor tissue.  If a patient doesn’t have sufficient biopsied tissue for testing, sometimes other sources of cells (such as fluid collected from a pleural effusion or a lymph node) can provide enough cells for ALK testing.  Many labs have independently validated the test on such specimens.  However, under the proposed FDA regulations, testing these alternative specimens would no longer be allowed unless a lab submits the test to the FDA and obtains its approval.  As a result, some lung cancer patients would have more limited options for testing, and might require additional, potentially dangerous biopsies in order to obtain tumor tissue.

Note that the proposed regulations include an exemption for LDTs for unmet needs that would allow the use of non-FDA reviewed LDTs when no approved LDT is available for the condition.  For instance, ROS1 NSCLC (my diagnosis) does not have an approved LDT, so patients could be tested with an unapproved LDT.

This proposed regulation has the potential to prevent targeted therapy treatment for thousands of patients with cancers and other diseases.  We hope you’ll join us for #LCSM Chat on Thursday January 15 at 8 PM.

Comment period for the proposed FDA Framework for Regulation of Laboratory Developed Tests (LDTs) closes on February 2, 2015. Please let the FDA know what you think by submitting your comments ASAP to http://www.regulations.gov (be sure to include the docket number FDA-2011-D-0360).  You can also submit comments electronically here.

REFERENCES

Overview Articles:

Opinions Divided on Proposed FDA LDT Regulations (Genetic Engineering and Biotechnology News)

To regulate or not: FDA hears arguments on medical tests (New England Center for Investigative Reporting)

 

Supporting the FDA’s Proposed Framework:

Advamed (medical device manufacturer’s trade association)

American Association of Cancer Research

American Cancer Society Cancer Action Network, American Heart Association, and Ovarian Cancer National Alliance

American Society of Clinical Oncology

Journal of American Medical Association (yes)

 

Opposing the FDA’s Proposed Framework:

American Clinical Laboratory Association

ARUP Laboratories

Association for Molecular Pathology (white paper)

Joint Letter to FDA (signed by 51 organizations, societies, and laboratory directors)

Journal of American Medical Association (no)

 

Joe Cocker Dies from Lung Cancer

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Although I’m saddened by his death, I’m glad Joe Cocker’s obituary stated lung cancer as the cause of death. Only when prominent people are brave enough to admit they have lung cancer (despite the stigma) will the public realize the prevalence of the biggest cancer killer. All you need to get lung cancer are lungs.

RIP, Joe.

Stanford Scope blog: Lung Cancer Social Media contributions to my Medicine X speech

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This is a reblog of my post that appeared in the on the Stanford Scope Blog on November 17, 2014. 

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Tackling the stigma of lung cancer — and showing the real faces of the disease

 

When I first learned I would be giving an ePatient Ignite! talk at Stanford’s Medicine X, I knew I wanted to speak about the stigma of lung cancer. I had frequently heard the first question typically asked of lung cancer patients – “Did you smoke?” – and I wanted to help change public perception of my disease.

I had plenty of material and preparation. I had actively blogged about my metastatic lung cancer journey for more than a year. I had researched statistics and funding disparities. I had gleaned patient perspectives via participation in online support forums and Lung Cancer Social Media (#LCSM) tweetchats. I also had years of public speaking experience, so I wasn’t anxious about getting up in front of an auditorium full of people.

What I didn’t have was knowledge of those who typically attended Medicine X, or how best to connect with them. I had never spoken publicly about lung-cancer stigma, certainly not to an auditorium full of people unfamiliar with my disease. After MedX ePatient adviser Hugo Campos helped brainstorm ideas, I wrote a speech – but it lacked something.

To figure out what was missing, I reach out to the online lung cancer community – patients, advocates and health-care providers I knew from support groups, Facebook, and Twitter. When Chris Draft of Team Draft reviewed my speech and slides over breakfast at Denny’s during one of his trips to Seattle, he smiled tolerantly when he saw my engineer’s fascination with graphs and pie charts. Then he made a point that changed the focus of my entire presentation.

Despite the dire statistics, the public will only care about the number one cancer killer when they can see that these patients could be people they love – a parent, sibling, child, friend – or even themselves. My speech needed to show the real faces of lung cancer, he explained.

So I rewrote the entire presentation and looked for graphics that could help people connect with the patients as well as the facts. I ditched the numbers-based charts for concept-based images. Online patients provided pictures of themselves living life and doing things they enjoyed. A dozen friends from across the online lung-cancer community reviewed the pitch via email or in person. It truly became a collaborative effort.

When I stepped out on the MedX stage that September day, I brought the hopes of many in the lung-cancer community with me. Chemobrain gave me a moment of terror (I lost my place while the slides continued to change every 15 seconds) but judging from the standing ovation the ePatients gave me, I made our point. My Twitter handle was in the top ten mentioned in the #medx stream that day. Tweets from health-care providers watching the speech online and in the audience said it changed their view of lung cancer.  Lung cancer patients -smokers, non-smokers, and never smokers alike – said it expressed everything they wanted others to know about our disease. And as of today, the YouTube video (above) has been viewed more than 1,100 times. But perhaps the most gratifying reaction was when someone friended me on Facebook just to say my speech helped her forgive her father, a life-long smoker who recently died of lung cancer.

This speech represents the best of what an online community can accomplish when they collaborate. The only thing I’d change next time is to avoid delivering it in San Francisco the day before my clinical trial visit in Denver: Evidently butterflies are aggravated by PET scans.

Lung Cancer Bloggers on WEGO Health Activist Twitter Chat (11/18 at 3PM EST)

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On Tuesday November 18, 2014, at 3 PM Eastern Time, the WEGO Health Activist Twitter Chat (#hachat) will focus on lung cancer in honor of Lung Cancer Awareness Month.  I will be the guest host along with three other guests, all lung cancer bloggers:  Linnea Duff (), Samantha Mixon (), and Tori Tomalia (). I’ll pose six questions to help our guests and chat participants discuss their lung cancer advocacy efforts on blogs and social media.

  • Q1: Why do you share your lung cancer journey online? What motivates you to write a post?
  • Q2: What kind of info do mbrs of online lung cancer community want? What messages do you try to convey?
  • Q3: On which social media sites do you share lung cancer info? How do you choose what info to share on different sites?
  • Q4: How/where do you find content about lung cancer that you want to share? What makes content you find share-worthy?
  • Q5: How has the lung cancer information you share changed over time?
  • Q6: What reactions do you get to your lung cancer blogs and social media posts? What content gets viewed or “liked” most?

Hope you will join us on Tuesday, whether you choose to actively participate in the chat or just watch.  Remember to include #hachat in your tweets. For more information about how to participate in a tweetchat, check out the tutorial at the #LCSM Chat website (remember to #hachat instead of #LCSM as the hashtag for this chat).

Read the Storify summary of this chat here.

Technology for Coordinating Care — #hcldr chat 10/28

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Lung cancer and other acute/chronic health conditions require care teams with more than one healthcare professional, sometimes located in more than one care facility.  To provide the best care for the patient, these teams often must coordinate with the patient as well as caregivers, family members, care facilities, and community services.  How can technology platforms (like smart phones and social media) help with this process?

#HCLDR Chat will tackle this topic, Platforms for Community-Wide Care Coordination, in their next chat on Tuesday, October 28, at 8:30 PM Eastern Time.

I hope you’ll join the #hcldr chat and share YOUR thoughts on this important subject.  We’ll be discussing the following topics:

  • T1: What are the most important challenges patients, family members & caregivers face in coordinating care?
  • T2: What challenges do care teams (clinicians, lay health workers, managers) face in coordinating care?
  • T3: What are examples of where social media and other technologies have supported care coordination?
  • T4: How can social media & other technologies help coordinate care for publicly insured, rural & other underserved communities?

I (@JFreemanDaily) will be participating as a guest in this chat, along with other members of a panel who will be presenting at the upcoming Workshop on Interactive Systems in Healthcare (WISH) 2014 which will be co-located with the American Medical Informatics Association (AMIA) Annual Symposium on November 15, 2014 in Washington, DC.   The responses gathered in the #hcldr chat will be included in our WISH panel discussion.  The other panelists participating in the chat are:

  • Katherine Kim, PhD, MPH, MBA (@kimkater): health informaticist, researcher and Assistant Professor at University of California, Davis
  • Charles Boicey, MS, RN-BC, CPHIMS (@N2InformaticsRN): Enterprise Analytics Architect for the State University of New York, Stony Brook Medicine
  • Susan Hull, MSN, RN (@SusanCHull): nursing executive , founder and CEO of WellSpring Consulting
  • Anna McCollister-Slipp (@annamcslipp): diabetes epatient, co-founder of Galileo Analytics

My Take on This

This is a topic of great interest to me.  I can see many care coordination needs that might be addressed with technology platforms.  Here are some snippets from my own experience as a lung cancer patient.

Having multiple care providers at different facilities is a common situation with lung cancer.  When I was undergoing my first line of treatment, I met regularly with seven healthcare providers in four different facilities:  a pulmonologist and infectious disease doctor in a major medical center, a medical oncologist and infusion nurse in a local clinic, a  radiation oncologist and nurse in a different local clinic, and a contractor that provided supplies for my PICC line.  Even though the doctors all belonged to the same medical center, each facility had different scheduling software and limited or no access to my electronic medical records at the other facilities.  Care coordination was mostly done by telephone and fax.  My husband and I tracked my daily appointments on a wall calendar at home.  If the infusion nurse giving me my chemo needed to ask a question of the radiation oncology nurse who has seen me when I received my radiation treatment 30 minutes earlier, they played phone tag in between patients.  Having a common platform accessible to all team members that showed my appointment schedule and treatment notes and allowed even brief instant messaging (e.g., “give Janet 1L IV fluids after her chemo today”) would have been very helpful.

Having a device that could display my current health conditions and meds, then connect an emergency medical tech or doctor to my oncologist (even when out of cell phone range) would be pretty nifty.  Currently I keep a two-page summary of my lung cancer treatment history and contact info with me on a USB Medic Alert bracelet when I travel.  This presumes whoever finds me unconscious has a PC with a USB port and a PDF reader handy. My epatient friend Casey Quinlan had her medical record access info tattooed as a QR code on her chest.

I have learned the value of keeping a complete set of my medical records at home in case I need them.  While I can access some of my medical records online at the two medical centers where I currently receive care, right now I can only see lab results, and (at one facility) scan reports.  When my tumor tissue underwent mutation testing at an NCCN facility, an oncologist’s office at the same facility couldn’t find the test results without my sleuthing to find a specific number on a faxed copy of the test report–fortunately I had requested one previously.  There’s GOT to be a better way to transmit current medical records rapidly between facilities than faxing or emailing scanned documents!

Metastatic lung cancer patients like me–especially those who are eligible for targeted therapies, aggressive treatment, or clinical trials–find second opinions can be life saving.  When a patient takes a turn for the worse or a clinical trial has limited openings, the second opinion may occur on short notice.  For me, pursuing a second opinion for my lung cancer today would mean going to a 3-foot-deep file cabinet drawer and gathering a stack of CDs containing relevant CT, PET, and MRI scans and other medical records (clinic notes, pathology reports, lab results, chemo summaries, radiation treatment summaries, etc).   If I were to include all the records I’ve generated in over three years of lung cancer treatment, the stack of CDs would be over 4 inches thick.  The radiology scan files are too big to be transmitted electronically and still preserve the ability to view the data, so I’d take those CDs with me.  All those other records provided by my care center exist as a few unsearchable pdf files containing hundreds of images of hardcopy documents.   For those records, I’d save the second opinion doc from having to read every single page of the huge file; instead, I’d ask which files they need to see, and print hardcopies to take instead (I keep the most important of these in a 3-ring binder).  If I had a week, I could request CDs of the specific files from the medical records department and wait to receive them via snailmail.

Some patients may use medical devices such as my CPAP machine that generate medical data useful to the care team.  However, it may be difficult or impossible to pass that data to a healthcare provider in a different location, or even access the data if the device employs proprietary designs.  My CPAP has a removable SD disk that can be read by most card readers in PCs.  However, I’d have to download the software to read it, and I can’t capture the data I read so I can transmit it to anyone.  “Interoperability” doesn’t really exist with medical devices yet.  I may be hallucinating from too much chocolate, but I’d love to see a platform that provides an interface to different medical devices and electronic medical records so they can network the way my Fitbit shares data with my LoseIt! diet app on my smartphone.

I’d also love to see care coordination solutions designed for those who do not have reliable access to the Internet.  Not all patients live in areas where broadband Internet or cell phone coverage is available, and not all patients can afford to pay for Internet service or devices that access it.  Yes, they could go to the library, but who wants to put sensitive personal medical info on a screen and unsecure computer for everyone to read?

Speaking as a system engineer, creating a secure technology platform that meets all the requirements and desirements without causing more complications in the already messy digital medicine world will require out-of-the-box creativity.  Maintaining data security and HIPPA privacy is essential.  Forcing already overloaded healthcare workers to use yet another interface, or forcing facilities to invest in a new standardized medical records system without providing the funds and training to implement it, are both non-starters.  The motivation for change will have to come from demonstrating that a new technology platform improves care quality and access, reduces cost and workload, and is readily adopted by patients and carers alike.

The first step in solving this problem is to capture the requirements; I hope the #hcldr chat on 10/28 will contribute to this effort.

Care Coordination Challenge graphic (UC Davis)
Image credit: UC Davis Betty Irene Moore School of Nursing

#LCSM Chat Topic 10/23: How can we help new stage IV #lungcancer patients consider 2nd opinions, mutation testing and clinical trials?

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The following post is reblogged with permission from today’s #LCSM Chat blog.

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Most patients experience a period of stunned disbelief or shock when they hear a diagnosis of “metastatic lung cancer.”  For those who are offered treatment options, the first few months revolve around medical appointments.  Others may only be told to go home and get their affairs in order.  Patients and family members may be in denial, or trying to process what all those dismal survival statistics mean for their future. It might be the first time the patient or a family member has had to confront the possibility of death for themselves or a loved one.

Some patients (or their caregivers) may be empowered, engaged and researching options, but many don’t have the physical or emotional energy to do so.  At this point, few patients are thinking about second opinions, mutation testing, or clinical trials.

The problem with waiting for metastatic lung cancer patients to become empowered and engaged is that the majority won’t live a year if they can’t access the newest treatment options. However, if they get educated about their options, consult with a knowledgeable oncologist, and are eligible for newer treatments or clinical trials, their lifespan may be years longer.

You might ask, how could this be true?

The landscape of personalized medicine and new lung cancer treatments is changing fast, and more stage IV lung cancer patients are living longer.  Unfortunately, due to the pace of that change, not all healthcare providers who treat lung cancer are current on the newest treatment options. Some oncologists do not test their patients’ adenocarcinoma lung cancer tumors for EGFR or ALK, even though NCCN and other respected guidelines recommend it.  Even research oncologists at NCCN facilities can’t track every new clinical trial for lung cancer.  And, sadly, some healthcare providers simply believe that because metastatic lung cancer is not curable, there’s no point in treating it.

The fact is, most metastatic lung cancer patients (or their trusted caregivers) will need to become engaged and empowered if the patients want a better chance at survival.  Many will need help to do this, either online or offline.

The #LCSM Chat on October 23 will explore how the lung cancer community might help metastatic lung cancer patients become interested in and knowledgeable about second opinions, mutation testing, and clinical trials. Your moderator Janet Freeman-Daily (@JFreemanDaily), a stage IV lung cancer patient who currently has No Evidence of Disease in a clinical trial, will offer the following topics for discussion:

T1:  How can we help a stage IV lung cancer patient understand the need for 2nd opinion when their doctor offers no treatment?

T2:  How can we help a stage IV adeno lung cancer patient consider EGFR & ALK mutation testing if their doctor has not done it?

T3:  How can we help a stage IV lung cancer patient consider targeted therapy clinical trials if they have a targetable mutation?

We look forward to seeing you in the chat! To participate in the chat, remember to include #LCSM in all your tweets, or use a tweetchat tool like tchat.io with that hashtag (more on that here).

A Fog of Feeling

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An onshore flow is washing over the Puget Sound this morning. The mocha-thick fog smells of shoreline and decaying leaves.  Fall is wafting in, and it soon will be dark when I get up at 7 AM.

If you detect a bit of melancholy in my words, you’re right. My emotions are foggy.  It’s been a week of highs and lows.

Yes, the highs outnumbered the lows. Friend and lung cancer advocate Tori Tomalia (who has the same type and stage of lung cancer as me) gave an inspiring and moving speech at a lung cancer event.  Someone found my blog by googling “wonderful late stage cancer blogs.”  A Facebook friend said my Stanford Medicine X speech on lung cancer stigma changed her life.  And a new lung cancer drug received Breakthrough designation by the FDA for those with ALK-positive non-small cell LC.

But the down came late, and hard: another stage IV lung cancer patient with my genomic mutation (ROS1) died yesterday.  Burton, a Harvard grad, was only 26.  He didn’t even have time to marry his fiancée, Emily (who’s been blogging about Burton’s lung cancer since April).

Being part of lung cancer community that includes advanced and late stage patients means the community, however educated and motivated, will lose members. I’m almost numb to it by now.  But I still feel something, even when the lost member is someone I’ve known only through Emily’s “ros1positive” blog.

For no logical reason, Burton’s death also makes me a bit anxious about my monthly blood work tomorrow. I’ve had so many blood draws over the past 3 years that I don’t really think about them.  But now, for the first time, I’m wondering if the blood draw will hurt, or if the nurse will even be able to draw my blood.  Last month my power port was seriously misbehaving, so I had to have the PET scan tracer and CT contrast injected into a vein on the flat inside of my left arm.  The tracer injection was fine, but the pressured injection of contrast HURT.  By the next day, I had a lumpy blood vessel at the injection site, and skin around the vein was angry red.  A month later, that section of vein is more black than blue.

My port is misbehaving on most scan days now, and the fibrin sheath I’ve grown over the tip of my power port’s catheter is getting tougher and tougher to remove. It may be time to have my port replaced.  Yes, it’s only minor surgery, but it means losing a day to the anesthetic  and accepting considerable discomfort around the surgery site for a week or so.

Being good at growing a fibrin sheath is not a useful skill. I wish I could grow something over my emotions when yet another friend who has lung cancer dies.