Erik Messamore, MD, PHD wrote about the FDA’s recent approval of a very expensive version of ketamine in this article on KevinMD.com.
Articles that call bullshit on the way our medical industry is run have a special place on the Internet. With corporations having a lot of control in our society, it can be scary (and career-suicide) to put such information out there. Medicine is now very much a big business. It’s important that we continue to critically look at the way it is being practiced and handled in our country.
Esketamine, or Spravato, the “new” drug manufactured by Janssen Pharmaceuticals, is actually just one of the two isomers, or chemical molecules, that makes up ketamine. By filtering out the drug to have just one of the isomers, the company was then allowed to patent the drug. By patenting the drug, they were then able to move towards getting FDA approval for its use as a treatment for depression, knowing that no one else would be able to have access to selling this form of ketamine. It was pretty much a given, and thus a very safe business investment, that they would get FDA Approval since there is already years of evidence out there showing ketamine’s efficacy in treating depression.
Dr. Messamore points out that we could have been routinely using ketamine years ago to treat depression, but that insurance companies wouldn’t pay for it without “FDA Approval” for depression. Similarly, physicians shy away from using drugs without FDA approval, because liability insurance companies won’t support them doing so (it’s too risky). So, why doesn’t the FDA just approve a drug based on previous studies? Well, why would they?
Unfortunately, in order to get a drug approved by the FDA for a specific indication, someone (not the FDA) has to spend money to run FDA trials. The only companies that spend money for the the FDA to approve a drug are the companies that stand to gain a lot of money from that approval. No one wants to spend a lot of money on trials for an old, cheap drug, because they won’t make any of that money back. They will end up spending the money for the trials, then multiple pharmaceutical companies will make generic versions of the drug and sell it. Because multiple companies are making the drug, the cost to purchase that drug stays low. The only time companies want to spend the time and money getting FDA approval, is if they have a monopoly, or patent, on the drug.
Now, Janssen will be charging roughly $800 per dose for this “new” medication, esketamine, that actually costs a fraction of that to manufacture. Dr. Messamore concludes his article with expressing disappointment in the way that the government and medical industry function in making treatments available. I could not agree more.
By Sarah Rivers Deal, PhD, LPC With Perinatal Loss month in October, I wanted to introduce myself through this blog as well as cast a light in the often dark places that hold this kind of silent, disenfranchised grief. As a psychotherapist that specializes and has been trained in infertility counseling, I too experienced my own reproductive trauma. Five years of fertility and alternative medicine treatments yielded a roller coaster of emotions, existential crises, and ultimately, two small graves in our back yard. Allow me to share something I wrote after my first miscarriage. We read to know that we are not alone – and – you are not alone. If you’re like me, the struggle to create life took over my life. It was all I thought out, dreamt about, planned for, spoke about, made exceptions for, ate for, stopped drinking my favorite red wine for – you name it. Life became hinged on hypotheticals – What if we get pregnant after I accept this new position? What if I accept this invitation then can’t travel in a few months because I’m pregnant? Should we buy the house in the better school district or wait until little one is here? What if little one never gets here? As much as I tried to balance my life, infertility crept in at every turn. In her insightful memoir, The Art of Waiting, Belle Boggs describes this all-consuming experience, calling it the Take Over – “…the problem with infertility is that it is not a patient, serene kind of waiting, not a simple delay in your plans; it happens for many of us in the context of consuming struggle, staggering expense, devastating loss.” Deciding to pursue fertility treatments put my barrenness on the front burner, making it difficult to escape. After five years in fertility clinics, more people had seen my vagina than the inside of my home. What was supposed to be private and magical between my partner and I was now public and scientific. All around me, women were “blessed” with babies, flaunting them as little “miracles.” These terms are especially painful for those struggling to conceive, as it implies that certain people are chosen while others are not. As much as I tried to participate in the world, being around pregnant women or infants was hazardous to my mental health. I remember attending my first baby shower in several years, believing I was safe now because my partner and I were months away from our daughter (by way of adoption) being born. Hope had begun to blossom again in my heart, as I believed that soon I would be a mom too. While I was emotionally prepared for my friend Serena to be eight months pregnant (after years of trying and two miscarriages), I wasn’t informed that the shower host was visibly pregnant too, and to boot – after only one round of I.V.F. with the same doctor I used. As we munched on our blue painted cookies shaped like pacifiers, I learned that the champagne drinking host had a 9-year-old son already, and became recently engaged after finding out about the pregnancy. I wish I could say I genuinely celebrated her happy news, but on the inside, I was fuming. On the drive home, with no other car in sight, I blasted the radio and screamed bloody murder. Despite various challenging life experiences up to this point, I still somehow believed in the concept of justice – a philosophy of how fairness is administered. To put it simply, it seemed unfair to me that this host woman was pregnant and going to be a mom – for the second time – and all I had to show were memorial stones in my yard commemorating two pregnancy losses. Unfair that I had earned high marks for effort and still wasn’t getting to graduate. Unfair that I wasn’t stroking my own belly, marveling at the miracle of science and creation itself. Infertility or perinatal loss may be experienced as an existential crisis, planting seeds of doubt in life questions you thought you had basically addressed, figured out, or had plenty of time to answer. What legacy will I leave behind? Who will carry on my values? Who will remember me after I’m gone? Am I broken? Dr. Anne Malavé, mental health expert in the field of infertility, wrote – “Infertility is like trying to find your children. The child, the imagined and expected child whose presence is palpable yet missing, feels near. It feels like searching for a lost child–you keep looking and searching around every corner. To stop trying can feel like an abandonment of an actual baby, of “my/our own baby.” Pamela Mahoney Tsigdinos in her raw, genuine book Silent Sorority, poignantly captures this existential crisis – “One instant you are like everyone else. The next, you’re not. Your DNA now ends with you. You are infertile. Your branch of the family tree will forever be just a truncated twig. You’ve been denied a rite of passage, a biological imperative. You had no say in the matter. It wasn’t a conscious choice. The comfortable sense of continuity and legacy others take for granted disappears in an instant.” After experiencing perinatal loss in 1999, Amy Douglas poetically wrote: “A life inside me, a love so strong. She died inside me, but the love lives on. It broke my heart for her to go. I love her, I need her like she’ll never know.” If infertility and/or pregnancy loss have ever been downplayed as a less significant human loss, Tsigdinos, Malavé, and Douglas legitimize the profound aftershocks of devastation experienced by those affected. From my personal and professional experience, I want you to know that the takeover is part of the journey. Well- meaning partners and friends might advise you to find a hobby to try to get your mind off of it, to relax, but that probably won’t help. It IS where you are right now, and that’s okay. Most people will be uncomfortable with your discomfort, and you’ll likely receive your fair share of unsolicited and unhelpful advice. Being the recipient of said advice, I tried to remind myself to listen to their intentions, not words. Week after week, clients that struggled with infertility would say something like – “These next few weeks I want to focus on my work and getting back into exercise” or “I want to start hanging out with my friends again and expanding my social circle.” We would set vague or concrete goals, depending on the client, and vow to focus on balance and self-care. And then, week after week, these same clients would come in ashamed, embarrassingly admitting that even if they did go to the gym or see an old friend, the ghost of infertility haunted them. They wanted to be more present in the here-and-now, they really did. Although I truly believe the takeover must run its course, there may be some coping skills and strategies to help it along. And I’m certain that whatever I tell you won’t always work. Some days the takeover will allow some wiggle room to remember the other aspects of your life; other days – it won’t. If you’ve felt quite low more days than not, and for an extended period of time, please check it out with a doctor. I will share with you the most salient professional (and personal) guidance here, and hope that on a few days, it might help. But please, don’t beat yourself up if it doesn’t. Honor the takeover, but also look for windows where you can see the larger picture. 1. Do something that has direct, observable results. You likely have felt powerless for a while. I want to you to do something, no matter how simple, where you can see results. Start with something easy. Make your bed. If you feel relatively competent cooking, use a recipe to create something, then share it with someone. Plant something that you can watch grow. Start with a plant that’s native and more likely to survive; you do not need a failure right now. Rearrange furniture in your space; a new look often evokes new feelings. 2. Practice Self-Compassion Breaks. I adopted this idea from the lovely Dr. Kristin Neff, a self-compassion researcher and professor from my town in Austin, Texas. Here’s the step-by-step process: a) When you notice that the Take Over has happened, say to yourself: “This is a moment of suffering” or “This hurts.” (It may help to place one hand over your heart = self-soothing gesture) b) Then say, “Suffering is a part of life.” c) Then, “May I give myself the compassion or understanding that I need right now.” Then breathe in and out, consciously and with intention. 3. Mindfulness (paying attention on purpose) is an Eastern practice, but its application has hit Western shores, and I’m a firm believer that it’s a necessary healing tool in your toolbox. You can become a conscious consumer of your mind, observing with a curious and gentle sense what’s going on in there. None of us would believe that a face cream could make us look a certain way after a few applications. However, we often experience our thoughts as facts, then experience powerful emotions as a result. It’s important to get some space from our thoughts, and see them for what they are – potentially unhelpful narratives. Use the letters N-N-R to remember the steps: a) Notice. Your mind is an active, interesting narrator that tries to piece information together but often falls short. Become a neutral, curious observer of your mind. Think of it as a radio, always playing music (some songs on repeat). b) Name (thoughts, feelings, body sensations, urges). For example, you may be ruminating (circular thinking that goes nowhere except down) something like “It’s not fair Tamara is pregnant. She didn’t even want another baby” and so on. As soon as you notice you’re stuck on a loop, say to yourself – “That’s a thought” You may notice tightness in your chest. Ask yourself what your feeling. Then say, “I’m having a feeling of sadness.” Noticing and naming gives you critical space to honor what’s going on with you without letting it suck you in automatically. c) Re-engage: Get back to what you were doing before you got caught in the loop. Re-engage in the moment. 4. Make a playlist or soundtrack for various themes throughout your fertility/infertility journey. For example, weeks before my 2nd I.V.F. transfer, I made a compilation of uplifting songs, burned them on a CD that I titled “Hope,” and played it every chance I got. A week after my first miscarriage, I made another playlist, calling it “Coping.” These songs were instrumental in helping me process the often contradictory emotions I experienced. Your body’s limitations don’t define you. Focus on what your body CAN do for you right now. Can you walk, jog, skip, hop, swim, or hug someone? It’s easy and completely understandable to get caught on a failure-loop narrative. But you’re not a failure. This is your roadblock, your life challenge, your grief and sorrow, your call to action. Answer the call, my friends. Above all, be patient with yourself. You are not alone. (Originally written September 2017; Revised September 2020) Dr. Sarah Rivers Deal is an Austin-based licensed professional counselor that specializes in infertility and reproductive trauma. She’s a member of the American Society for Reproductive Medicine (ASRM) and has participated in numerous trainings on infertility counseling and perinatal loss.
Read Blog Post
Dr. Kristin Lasseter writes about common signs and symptoms of postpartum depression and anxiety.
Read Blog Post