By Michelle Esser, Senior Program Manager, Research and Advocacy, Young Survival Coalition
A new law recently passed by Congress and signed by President Trump has been making headlines over the past few months. This “Right to Try” law allows terminally ill patients to request an investigational drug that has completed Phase I trials directly from a pharmaceutical company. A physician must support the request and forty states already had a similar law. At first glance, this sounds like a great idea and law. However, is it?
Let’s take a step back to what is called the Expanded Access or Compassionate Use program currently in place at the FDA. Compassionate Use also allows a patient to request usage of a medicine not yet FDA-approved, but in clinical trials. The request goes straight through the FDA, which, if it approves the request, provides guidance on how to administer the drug and what information it already knows about its safety and potential side effects. While the FDA has been criticized as being slow and not granting many requests, data has shown that the process typically only took 24 to 48 hours and that over 90% of requests were actually approved by the FDA. Once the request clears the FDA, it is up to the pharmaceutical company to make its decision.
So what is the difference under the Right to Try law? Under this new law, the FDA is out of the process. Patients, with their physician’s support, can request the drug directly from the pharmaceutical company. The FDA’s knowledge of other clinical trials using this drug, or safety and administering suggestions will not be shared.
The concern is that this process could ultimately hurt patients. Not only is FDA information not shared, but Right to Try could open the door to companies more concerned about selling or promoting their drug than with patient safety.
As it is not clear under this new law who will pay for the drug or the administration of that drug, images of the so-called “snake oil” salesman comes to mind. Could a company charge an exorbitant price for an unproven drug that could do more harm than good? It really isn’t clear.
Of course, as with the Compassionate Use program, under the Right to Try law pharmaceutical companies can say no to the request. There are a variety of reasons they may do so, including the concern that providing the drug outside the context of a clinical trial could impact the trial results. Ultimately, they can say no for any reason.
If you are a patient in need of a new drug, which appears promising in early clinical trials, what should you do? There is nothing preventing you from making your request under both the Right to Try law and the Compassionate Use program. Given the FDA guidance which can be provided under Compassionate Use, it may be worthwhile to start there. If you proceed under the Right to Try law, have some frank conversations with your doctor about what is known about the investigational drug. What are the potential side effects? What clinical trial data already exists? What costs may you incur?
Hopefully, these requests made under the Right to Try law are documented so we can see if concerns about patient safety are warranted, and craft regulations to implement the law in a way that keeps patient safety in mind.
For more information:
A recording of YSC’s Facebook Live “Right to Try” presentation with Holly Fernandez Lynch from the University of Pennsylvania is available here.
Information on Expanded Access (Compassionate Use) from the FDA is available here.
Disclaimer: The views expressed in this article are those of the authors and do not necessarily reflect those of Bay Area Cancer Connections. It is not considered comprehensive and is intended for informational purposes only. This information does not substitute for medical care, and should not be used for the purposes of diagnosis or treatment. As each medical condition is unique, we strongly advise you to consult your physician with questions about your own situation, or about any of the information provided as it may relate to your specific case.
When my life gets on overload (raise your hands with me on how many of you find yourself in that position), my brain seems to disappear. I have a thought, and in a blink, something else comes up, and I race to find the idea I had because it disappeared so quickly. Blink. Gone. It can be SO exhausting.
So I’ve found that using simple meditation techniques (much like the ones we offer for family caregivers) can help to pull me out of the stress, pull me back into the ‘present’ moment and out of the frustration. I use them in so many situations, and it helps me out a lot. What tends to happen if you forget something; you start getting riled up about why; “If only so much weren’t going on, if only I had time to myself…” …..etc….etc….etc….then you’re putting up a mental block. The techniques really can brush those away, and I find they help with peace of mind and clarity. And at times that idea pops right back in.
There are other ways to keep track of things that come up that I use as well. I tend to stay away from electronic devices as much as possible. My job is spent communicating, writing, talking, researching so I spend a lot of time on them. So even though I can make notes on my phone there is something clear and decisive about a list, on paper. You’re able to cross things off and can easily jot them down without getting pulled in another direction. So when I’m in the middle of something, and a thought pops up, I write it down quickly and go back to the task at hand.
It can be as simple as me writing this blog, I remember I need to pick up oranges (why my brain goes there in the middle of this is beyond me, but it happens) so I turn and write it down and poof! I’m not taken off track, and I’m still typing away. Quite happily.
Your life as a family caregiver is full, really full. Some days better than others. So it’s the little things you can do to help alleviate some of the stress and do believe an overall sense of calm help our bodies overall.
Step away…..pick up a pen…..and make notes.
*This blog was written by Cyndi Mariner of BACC partner Breathing Spaces. To learn more about the services Breathing Spaces offers, click here.
Eating seasonally is kind of my thing—you could say that it borders on obsession. You could also say that I’m a food and nutrition geek…you’d be right. Here are a few reasons why I’m a big proponent of eating seasonally:
1) Seasonal produce is often grown locally and is therefore fresher because it hasn’t traveled nearly as far as when it’s not in season. For example, imagine you are eating tomatoes in March. With some certainty, I would predict that those tomatoes are from either Florida or Mexico (as long as you’re in the States). It’s also possible that they’re grown in a greenhouse. Those Florida tomatoes are picked underripe and green and then shipped across the country (they look like apples according to Barry Estabrook, author of Tomatoland: How Modern Industrial Agriculture Destroyed Our Most Alluring Fruit). They are then gassed with ethylene to artificially ripen them. Eating tomatoes that are local and in season would avoid the CO2 gasses emitted due to those hundreds or maybe even thousands of miles traveled.
2) Seasonal produce, grown locally, tastes significantly better than when it’s picked unripe. The example that I provided about tomatoes above also applies to most fresh produce. They can look fresh and tasty but are almost always flavorless. Have you ever tasted a garden strawberry or freshly picked peach (or insert your favorite fruit or vegetable)? There is no comparison in taste.
3) Seasonal produce is fresher and fresher produce has more nutrients. For example, author Jo Robinson educates readers that a significant amount of nutrients in broccoli are lost within the first 24 hours after harvesting. Imagine if that broccoli was picked a week ago so that it could travel to you? It might look fresh, but it sure wouldn’t be providing you with the vitamins, minerals, and phytonutrients that you were hoping it did. (By the way, I highly recommend her fascinating book Eating on the Wild Side: The Missing Link to Optimum Health.)
4) Get your fill of in-season produce. In Barbara Kingsolver’s book, Animal, Vegetable, Miracle, she discusses eating tomatoes so much while they’re in season that you almost become sick of them. You don’t crave them as much during the off season and you’re not tempted to eat a tasteless, mealy tomato in January because your tomato craving has been satiated for the year. I love this way to view it and have really tried to adopt this mentality since reading her book in 2011.
5) Seasonal produce promotes local jobs and boosts our local economy. This one is pretty straightforward. I’d like to emphasize that it would be great to extend the “Shop Small” and “Made in America” movements to the food and produce that we consume each day.
I hope that you’re inspired to go to your local farmer’s market this weekend and get some local food! CSA (community supported agriculture) boxes are filled with farm fresh produce and are delivered straight to your door. If you’re interested in a CSA box you can check out www.localharvest.org to see what’s available in your area.
Here’s a fun, seasonal recipe for spring! Try it out and please share your pictures and thoughts with us! @bayareacancer @cleaneatingwithkatie
Strawberry Chia Seed Pudding
1 can full-fat coconut milk
2-4 tbsp. chia seeds (2 for a thinner pudding and 4 for a thicker pudding)
10-15 organic strawberries, rinsed and halved
1 tsp. vanilla
2 tbsp. raw honey
Place coconut milk, chia seeds, and strawberries in food processor (or high speed blender) and pulse until it becomes a smooth consistency.
Add the vanilla and honey. Pulse until just incorporated.
Place into small jars and store in refrigerator for 1-2 hours or overnight. Chia seeds become gelatinous and will thicken the pudding as it sits. It can also be eaten right away.
There are many other options for chia seed pudding. Try experimenting with other seasonal fruits like peaches, raspberries, pears, blueberries, and even pumpkin. Also consider adding nuts, other seeds, and spices. The possibilities are endless!
Katie is enthusiastic about helping people maintain health and vitality through whole-food based nutrition, customized supplementation, and wellness coaching. She received her certificate as a Nutrition Consultant through California state-certified Bauman College Holistic Nutrition and Culinary Arts. She is skilled in gluten-free and paleo-centered cuisines. Katie is also a Certified 21-Day Sugar Detox Coach and leads regular monthly detox groups. She has been following a paleo diet and has been gluten-free since 2012. She practices yoga, hikes, swims, runs, and cycles. She is also a breast cancer survivor. Katie and her husband, Jim, live in Santa Clara, California, with their dogs, Jax and Molly. You can reach Katie at www.cleaneatingwithkatie.com or firstname.lastname@example.org.
Cancer treatments create a massive physical struggle and a daily fight for survival. Constant medical scrutiny leads to insecurity. Treatments take away strength, both physical and mental. Then one day, my last treatment is done and it hits me: What comes next? Is the cancer gone? How will I know? Isn’t there anything else that can be done? Where do I go from here? The season after treatment is very difficult, filled with emotional instability, questions, fear, and uncertainty. Unfortunately, for many of us, once treatments are complete, we enter a season of feeling stuck in a post-treatment anxiety. There are many fears and unanswered questions. These thoughts fill us with a new type of need, but they are needs that cannot be easily revealed nor clearly communicated. How do I start again? Has everyone already forgotten that I had cancer? How will I pay for these past two years? How long before this all begins again? What is this pain in my side? On and on the questions roll, controlling our emotions and crushing our ability to thrive. In this emotional process of beginning again, the question “Who am I?” emerges. This question might seem trite, but in this season of significant change, it deserves proper attention before we are able to heal emotionally.
Before cancer, I would have described myself as a confident, centered person on the best path for my life. Then my life stopped. I was stripped of my confidence and my path. I was left with nothing but the question, “Who am I?”. All of the adjectives I would have used to answer the question before cancer, no longer apply. At the same time, I came face-to-face with new truths about myself. Before cancer I would have stated with confidence, “I am more than my circumstances,” yet when terrible circumstances came my way, I was left changed and shaken. Before cancer, I would never have thought, “I am defined by my physical appearance,” yet when my hair fell out and my eyebrows and eyelashes were gone, I truly struggled to find myself, in the mirror or otherwise. Cancer’s impact on my self-image showed me that I have a lot of room for growth. The truth is that I am more complex than I will ever know.
There are pieces of myself that I put on and bring forward daily for all to see. There are parts I do not even want to show myself. Upon honest examination, there are an unknown number of layers that make up who I am. Each significant story in my life created a layer. Some layers happen to fall on the surface and receive the spotlight while others lay hidden despite their significant value. One exercise for escaping a post-treatment anxiety, is to take time to find an honest answer to the question, “Who was I?” and the follow up question “Who do I want to be?”. These are not easy questions to resolve. I am fractured. I am different at work than I am at home. My ideal “me” is different than who I am every day. There are many versions and many visions of myself. Fortunately, this complexity provides opportunity for who I can become.
Cancer took at least one version of me. It disappeared and was left in my past. As treatments end, it is important for me to take time to mourn for that version of me. I have spoken to survivors who wrestle with picking up the pieces in order to put that old “self” back together, with minimal success. I feel we must be reminded that whatever picture of self that was lost during cancer is not the only version of you. Perhaps it is not even the best version of you. Cancer stripped me of both good and bad, but I have the ability to rebuild. I have the power to recreate myself not as who I was, but who I want to be. I have the opportunity to minimize the negative aspects in my life and replace it with what I want to define my future. Post-treatment is a unique moment of time to become whomever I want to be. It is a moment of vulnerability and rawness, and a moment when I am not healed, but I have moved beyond the sickness. There is stillness, as the routines of life have not swept in, but there is also churning within my thoughts. My old expectations are gone, along with many of my fears. So what do I want for myself now? Post-treatment is a season of freedom. Freedom is a gift that is both liberating and terrifying, and beginning again requires significant courage.
So let us fortify ourselves as we consider who we are. As cancer survivors, we have accomplished an impossible task. There was something in our life, in our body, trying to kill us. You made difficult decisions, that only you could make. Perhaps when you received the diagnosis, there was no question that you would proceed with treatment or perhaps you struggled with where to begin. Either way, it requires significant courage to willingly submit yourself to chemo, radiation, and surgery. Once treatment begins, it requires more and more courage to continue through the process. The night before a scheduled chemo is filled with choices: Can I handle another treatment? Do I want what tomorrow will bring? Then despite the knowledge of what is to come, you moved forward, pushing through treatments and in the end accomplishing impossible things. You pushed back a disease that wanted to kill you. You beat the odds. You are triumphant. You are fierce. You are strong. You may not feel it today, but it is there inside of you. If you choose to own this piece of your new self it can monumentally change how you answer, “Who do I want to be?”.
I am choosing to embrace the strengths cancer revealed and I have placed this strength on the surface of my new identity. I consider this a gift of cancer. Before cancer, I would never have described myself as fierce, but now, if I am honest, I know that inside of me is a strength that will rise against any challenge in my life. I can face any impossibility with confidence. I have done impossible things; I can do it again. I have pushed through crippling fear; I can do it again. I have submitted all that I am in order to accomplish a goal; I can do it again. I am driven by a deep unshakable confidence and courage that I never experienced before cancer. As I learn to walk in this new strength, I become more and more thankful for my cancer experience.
So, who am I? I was changed by cancer, that is true, but how I was changed plays an important role in my future. The presence of cancer in my life did not change me, there were months or possibly years when I had cancer in my body and I was unaware. My life began to change because of what I chose to believe about myself and others after I heard the words, “You have breast cancer.” Through treatments, did I believe I was all alone in my fight or that I was surrounded by a community? As a survivor, do I believe that I have overcome cancer or that I only have a few years before the fight begins again? It is what I choose to believe that changes me, not the cancer itself.
Cancer provides a platform for deep reflection. It showed me what was already inside of me. It revealed my insecurities and fears. I cannot blame cancer for the baggage that was already present in my life, just as I cannot blame cancer for who I am. Cancer taught me many things and helped me take an honest look into the layers of who I am. Now, what I choose to place on the surface, for all to see, is different than before. Now, the characteristics I simply did not acknowledge before, I choose to embrace. Who I am after cancer is not a puzzle needing to be put together in the correct way, but rather is one layer upon the next. Like the layers of the Earth, each layer tells a story. Each story cannot stand alone for they are all interconnected and require each other for a true understanding of all that I am. My cancer experience has become a layer in my life. A layer that tells a new story of who I am. Cancer is only one layer though, what I do with that part of my story, is up to me.
Lauren Huffmaster, aka Eden, was diagnosed with breast cancer in 2015 at the age of 35. Months after completing all recommended treatments, she was diagnosed with metastatic breast cancer in 2017. Lauren is a wife, and mother of three young girls. Since diagnosis, she has worked as a freelance writer and photographer. To read more of Lauren’s work, visit PursuitOfKindness.com.
When I was first diagnosed with breast cancer, I had already returned to knitting several years earlier after a break of many years. Knitting projects were great to bring along on business trips and I spent many hours knitting in hospital rooms as my father’s health declined. There was an exciting new social media platform for knitters and the recent resurgence in the craft meant that wonderful fibers and tools were easily available, both in brick and mortar shops and online. Socks were my main project of choice, although scarves, hats, cowls, baby blankets, and sweaters had also made their way onto my needles.
But suddenly I was faced with a scary diagnosis. Now, my little projects were worked on in waiting rooms—waiting for doctors, scans, blood work, and consultations. I couldn’t always fully concentrate on my project, but having one to pull out and knit a few stitches on moved my thoughts away from the fear and worry I was feeling.
So, I began a year of treatment. Surgery, chemo, more chemo, more surgery, and finally, radiation. Through it all, I kept knitting. There were difficulties, of course—restlessness during chemo sessions, post-surgical pain and recovery, and losing most of my fingernails—but I did my best to power through and pick up my needles as each issue resolved. I joined an amazing support group, Knitters with Breast Cancer, on Ravelry (an online community of knitters) and found my hand virtually held through every step of the way by the wonderful women there. Knitting is relaxing and can almost be meditative when I knit at home, listening to music. And once my treatment was over, I joined a few local knitting groups and connected with yet more wonderful women.
I also began to volunteer at Bay Area Cancer Connections, where I’ve worked on their Helpline for two years now. When discussions came up about starting a knitting group there, I was more than happy to help get it started and gather together some easy patterns people can work on. Now I lead this group and we meet twice monthly: the second Tuesday of the month from 2:00–4:00 p.m. and on the fourth Thursday from 6:00–8:00 p.m. Everyone is welcome to join! I can get beginners started on a washcloth or shawl, or you are welcome to bring your own project. There is little structure—just a group of women sitting in the BCC living room, knitting and chatting away. Our topics range from our own experiences with breast cancer to travel to how to tell the difference between a knit and a purl stitch.
I hope that you can join us!
This knitting circle, “Knit One, Purl Two”, is not a support group or group therapy.
Catherine first learned to knit during the six months she attended school in Ireland. Starting with a sock and using white wool was probably not the best introduction to knitting. She took it up again in earnest when she traveled for her job as an engineering director. She freely admits that she is a yarn addict, and her husband and three sons are well supplied with hand-knit socks. Catherine is a two-time breast cancer survivor and volunteers weekly for BCC’s Helpline.
There’s not much that can rock one’s world like a cancer diagnosis; diagnosed with breast cancer a few months after the birth of my daughter, what was the most joyful time in my life suddenly became the scariest. Instead of worrying about what type of dye-free, biodegradable diapers I should purchase, I was consumed with the fear that I would not live to see my beautiful baby girl, Penelope, whom I’d only just started to know, grow up.
Jessica is a breast cancer survivor, the author of Cancer Hates Kisses, and the National Field Leader for Literacy at Open Up Resources, an education not-for-profit. She was formerly an elementary school teacher, district literacy coach, and Chief Academic Officer at an award-winning literacy company.