The Clinical Trial Dilemma

by Guest Blogger Sandra Kanowitz

Yes, No, Maybe?

As patients with a chronic illness, we all might be invited at some time to join a clinical trial. Such an invitation can raise many questions, and requires some serious deliberation on our parts before making a commitment. Knowledge of the basic workings of clinical trials is a must to start with, but since trials come in a wide variety of styles, getting to know the particulars of a specific trial is crucial. There are lots of good reasons for joining a trial, and we must examine our own motive for doing so, and be realistic about our ability to carry through our commitment and obligations over time.

I recently finished participating in the Lupus Outcome Study sponsored by the University of California at San Francisco Rheumatology Department. It was designed to measure the impact of having lupus over a 20 year period on a patient’s physical, mental and social well-being. The trial consisted of a 45 minute telephone interview once yearly, answering many questions about symptoms, treatment, social interactions and mental health. I looked forward to my yearly interview (on the couch), reporting my current state of health. It was rewarding to know that my responses were part of a consortium of other patients’ responses about how lupus had affected them over a long time period. I felt proud of the principal investigator for taking on such a lengthy, monumental task, with concerns of lifestyle impact, not just medical management of lupus. I would imagine the results could be extrapolated to many other similar chronic illnesses as well. It felt good to provide information that may help others in the future.

With the focus on evidence-based medical management, research is the cornerstone for future treatment protocols of lupus and most other illnesses. Research must be disciplined, is demanding, and is very time consuming and expensive to conduct. The participants are critical team members, part of the scientific community trying to prove a hypothesis, answer a question, solve a serious problem. We must enter any commitment we make to a clinical trial with the utmost respect, good intentions, and follow the protocols judiciously. We cannot “fizzle out” and jeopardize the data. It is essential to know all that is expected before entering a trial, both the risks and benefits, costs, travel requirements, length of time involved, how results will be handled and published, etc. I would encourage anyone to participate in a clinical trial that might benefit you or others in a similar situation. Only you can decide if the terms of the trial are compatible with your lifestyle, time constraints and constitution.


For Most Lupus Patients, One Diagnosis May Not Cover it All

Lupus is a systemic disease, meaning it does not discriminate when looking for areas of your body to attack. But many people don’t know that people with lupus also suffer from a number of “overlap” diseases. In my case, a common “overlap” disease ended up being my primary diagnosis (meaning that I never quite met all the criteria for the lupus diagnosis; my symptoms and blood work over the last six years have revealed that I have primary Sjogren’s Syndrome rather than lupus).

Common Overlap DiseasesCarie Sherman

Sjogren’s Syndrome. It’s easy for me to start there because this is what I have. Sjogren’s makes your moisture-producing glands malfunction, causing dry eyes, dry mouth, and dry mucous membranes (yup, pretty much anyplace you need moisture is lacking, good times). The fun doesn’t stop here though, folks! Along with these fun symptoms comes joint/muscle pain, fevers, and fatigue. My taste buds have been impacted–the love of my life (FOOD) isn’t all that enjoyable as I can barely taste anything that isn’t super sweet. I have chronic sinus issues and lately I think it’s been affecting my hearing and my ability to stay hydrated. Like lupus, organ damage can also occur, which is why I’m monitored every three months. Learn more. 

Raynaud’s Disease. One-third of people with lupus get this, too. Raynaud’s affects the cardiovascular system, restricting the flow of blood to your feet and hands when you’re stressed or it’s cold. Typically, the tips of your fingers turn white, blue/purple, or red. I’ve heard it can be painful and cause tingling and numbness as well.

Scleroderma. Scleroderma causes the skin and body’s connective tissues (i.e., the tissues that connect, support, bind, and separate our other tissues and organs) to harden. Like lupus, it can range from mild to severe. For some, it only impacts the skin, but it can also impact your organs, blood vessels, and digestive system. 

Rheumatoid Arthritis (RA). Like lupus, RA causes the immune system to attack the body’s own tissues. In RA, the thin membrane that lines the joints, called the synovium, is attacked. It causes a build-up of fluid in the joints as well as inflammation throughout the body. Also like lupus, it’s systemic, which means it causes fatigue,fevers, and pain.

Antiphospholipid Syndrome (APS). Here’s another fun one. APS is a blood disorder. It causes blood clots. Many women discover they have APS only after experiencing miscarriages or stroke. I have antiphospholipid antibodies in my blood. Since I haven’t had any blood clots, my doctor has me take a baby aspirin every day to keep my blood thin. Those who have APS may require much stronger blood thinners, and those with APS who become pregnant must be heavily monitored.    

These are some of the most common diseases people with lupus ALSO have. Just for kicks and giggles, here are some more:

  • Autoimmune thyroid disease
  • Celiac disease
  • Myasthenia gravis
  • Polymyositis
  • Dermatomyositis
  • Vasculitis
  • Thrombocytopenia
  • Anemia
  • Mixed connective tissue disease
  • Peripheral neuropathy

And some other conditions a lot of people with lupus have:

  • Depression
  • Anxiety
  • Fibromyalgia

And some of the diseases a lupus patient might be incorrectly diagnosed with:

  • Rosacea/psoriasis and other skin diseases
  • Lyme disease
  • Fifth disease
  • Multiple sclerosis

So after six years of working closely with my rheumatologist, I’m only now starting to understand just how difficult it is to diagnose people with autoimmune disorders. In addition to so much overlap and misdiagnosis, no two lupus cases are the same–other than being chronic and often debilitating.

You can help Lupus Colorado support patients living with lupus on Saturday, September 16, 2017 from 4:00pm – 7:00pm at the 2017 Lupus Colorado Community Walk. Learn more!

 

 

 


Why Funding Basic Science is Important

The first World Sjogren’s Day was July 23, 2010, one day after I had my first (and only) daughter. Which, my doctor says, was the likely trigger for me developing primary Sjogren’s Syndrome myself (the causes of autoimmune disease are largely unknown but like lupus, it’s thought to be triggered by hormones, and is most often diagnosed in women of childbearing age). Sjogren’s is often co-current with other autoimmune diseases, including lupus. Carie Sherman

Sjogren’s (show-grins) attacks healthy cells and causes dry eyes and dry mouth. But whoa Nelly, it’s so much more: never-ending fatigue, chronic pain, extreme sensitivity to stress (+ or -). Best of all, it makes me feel hungover to varying degrees most days, sans the good time the night before.

It’s a life sentence. It’s partially managed by medications but most of my good days are due to major lifestyle changes. And it’s not all bad: I’m learning how to live a balanced life. I’m learning how to say no. I’m learning that beyond my daughter, family, and close friends, I don’t need much. I’m honing in on what adds joy to my life, and discovering all the things within me that block that joy. I’ve stopped being in a rush, stopped being busy just because being busy is what we do. I’ve found work I love that helps support my family without running my health into the ground.

But it’s hard. If you’re still reading, know that you likely accomplish more before 11 am than I will all day. So yes–feel good about that! Good health is a beautiful thing. I miss my old Energizer Bunny self–she did All The Things (and had oh-so-much fun!). New me still has big dreams. And hates how long these take to accomplish.

Everyday with Sjogren’s is different, and despite my best efforts, unpredictable. I’m lucky to have the love and support of so many. And I’m so lucky to have been forced to slow down, as I’m not exactly sure I’d have enjoyed being a mom nearly as much had my body not forced me to stop and smell the roses, so to speak.

My story isn’t unique. The truth is that we all have a disease that’s impacted our lives or the lives of those we love. I ask you to take another 5 minutes of your life and watch this video that demonstrates the importance of funding basic science. It starts with this question: It’s 1960, and you have $10 to donate: where’s your $ best spent? You might be surprised.

If you’re still with me, thx for letting me vent AND get on my soapbox.

https://youtu.be/GmhD-RWNL6c

 


How the Cost of Health Care Turns Patients into Triage Nurses

I took our family Jeep into the auto shop today. It’s served our family well, but it’s showing its age. The mechanic and I have an Carie Shermanunderstanding: He focuses on the problem then scans it for things that compromise safety. He inevitably calls with a lengthy list of everything that’s broken (thankfully the cassette tape deck still works!). Today I asked him to get us through the next three months. When he calls, we’ll agree to the cost of the parts and the labor. He will fix it and I will stop worrying about it breaking down and start saving for the next round of repairs.

I recently presented a webinar on the 7 “Sins” of Health Communication, in conjunction with Talance, Inc. (I earn a living helping health care organizations with their written communications.) I talked about my experiences as a patient and ways people in communication roles can help build trust and understanding while reducing the fear we patients have when our bodies break down.

The final “sin” I talked about surrounded money. At this time, cost of care is one of my biggest concern as a patient. I almost avoided the topic of money altogether—mostly because I feel angry and defeated by the amount of money I’ve paid in the last six years. And I feel ashamed by the amount of money I owe at this very moment.

This is my theory: the cost of health care turns patients like me into triage nurses. Like the triage nurse, we scan our bodies and decide on the “broken” things that take priority. Unlike the triage nurse, we are not trained professionals. 

There are a bunch of things I would love to fix on my body right now. I won’t bore you with details. But frankly I spend so much time in the rheumatology clinic that it’s easy to ignore the rest of my body. Plus I have a stack of bills from a procedure I had earlier this year. So for now I wait, hoping the issues resolve on their own. Though I’d love to feel better, the cost of health care has my bank account bleeding out.

Everyone knows the cost of care is a hugely debated topic. I find it interesting that people like me are finally starting to demand answers. Health care organizations need to be more upfront about costs. Like my mechanic, they need to start thinking about how they can help us “frequent fliers” spend our limited health care dollars. I get that I’m responsible for my portion of the cost of my care. But let’s face it: when you’re in pain, you’ll do anything to feel better. Including taking your doc up on the referrals, tests, and medications you’re offered. Cost is the last thing on your mind. And unless you’ve got Cadillac-level insurance, the costs quickly become overwhelming.

I don’t have a Cadillac health plan. But I’m still lucky to have insurance. After working in health care for nearly two decades, I’m fairly health literate. But I’m also human. I’m ashamed that my body fails me. I’m worried about the next time it fails. I’m scared that I’m wasting my health care dollars on the wrong stuff. I’m embarrassed that I can’t write a big check and clear all these bills. I’m terrified that people more vulnerable than me are going to lose their coverage. And as they become triage nurses for their own bodies, they’ll get sicker, and sicker, and sicker, eventually ending up in the emergency department for things that could have been improved had they not been forced into triage mode.