The Magic of Black – Part II

Jax CloseHappy Halloween! It’s an excellent time to celebrate the magical, mysterious black cat and this post is all about Jax, the man of the house. He will be mad at me later today when his roaming privileges no longer extend past the front or back door. I fear for his safety, even though almost everyone on the street knows Jax is mine, as is his sister, Sophie. Sure, we live on a cul-de-sac, but crazy knows no bounds when it comes to black cats on Halloween and I take no chances.

We get plenty of people of questionable intent flying up and down our street. Just last Friday a dude driving an Escalade came within inches of making me his hood ornament. Jax and I were walking back home after visiting our friend across the street when this guy came cruising along, looking every which way but in front of him.

“Dude!” I shouted. Continue reading The Magic of Black – Part II

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The Magic of Black – Part I

TJax up closeoday’s post has nothing to do with drugs, celiac disease, gluten, or my health.  It’s about a special creature both revered and reviled, especially this time of year: the black cat, the familiar of witches, plus the maker of mischief, bad luck, and all manner of ne’er do well.

I’m taking up for the black cat today because I know there are people out there who think it’s funny or even necessary to torture, abuse, or otherwise harm these majestic creatures. Such horrors are so common, many animal shelters won’t allow anyone to adopt a black cat (or even black dogs) during the month of October for fear the adopter has something other than a forever happy home in store for the ebony set. Continue reading The Magic of Black – Part I

The Serious Challenge of Getting Gluten Free at the Pharmacy

Gluten can hide anywhere, even in pills and syrups. Yes, gluten can contaminate the pills and the liquids we take for everything from sniffles to sinusitis, diabetes to depression, asthma to ankylosing spondylitis. I remember reading this early post-diagnosis and feeling overwhelmed. How on earth would I figure out if the manufacturer used wheat starch instead of corn starch as an excipient (bulking agent or ingredient needed to create a pill or capsule form) in yet another round of antibiotics for yet another respiratory infection? Continue reading The Serious Challenge of Getting Gluten Free at the Pharmacy

Well Not All Well

I’m still basking in the glow of the good news that my gut has healed so much. So golden was the glow I firmly believed I could turn persistent aches and pains into chalk dust and blow it from my fingers.

Alas, of course, mind only gets so far over the matter of pesky respiratory bugs. No matter how much positive thinking I rain upon feelings of infectious illness, the illness persists until I drag myself to the doctor and submit to another course of antibiotics. This applied as recently as Sunday, when I finally stopped telling myself my tonsils didn’t look THAT bad and my face didn’t hurt THAT much and I probably could kick this bad feeling because it, after all, probably just was allergies.

Probably. The probability that I could kick this malaise crouched in the tail end of the distribution at about 10%. I know the signs and the symptoms. I’ve had four to eight sinus infections every year for years. Continue reading Well Not All Well

The Making of a Birthday Party

Party TableI love to cook, bake, make and serve food. I love to plan events. When I get to combine food making with event planning with celebrating someone I love, well, it makes me very, very happy.  This week, I had the pleasure and joy of planning and making my sister’s birthday dinner. Yay!

I have become quite skilled at utilizing mixes and ready made condiments and food accessories to make meals and desserts people really like. When I ate and baked with gluten, I made all kinds of things from scratch and people scratched their heads wondering how I made it all taste so good: pizza dough and pizza, bread, cakes, muffins, appetizers, you name it. Continue reading The Making of a Birthday Party

This Is a Test: The Wellness of Failure

Test results change lives. They can define and redefine a person in a flash. Remember how you felt when you first passed the test for your driver’s license? In a matter of minutes you went from kid passenger to Grown Up Driver. How about the SAT or the GRE or the MCAT? Those scores sealed your academic fate: told you and whoever else accessed them what tier school you could or could not attend and how many degrees you could pursue. One minute you’re dreaming of climbing the steep hills of Ithaca in a Cornell red jacket and the next you’re standing in line with a mountain of textbooks, sporting the muddy colors of Whatsamatta U.

I still remember the moment the dermatologist came into the exam room to tell me the skin biopsies came back with a diagnosis of dermatitis herpetiformis. My face lost its color as I thought this meant I’d acquired some horrific contagious disease that would render me dateless for the rest of my life. Continue reading This Is a Test: The Wellness of Failure

The Failure of Wellness – Part 2

Last week I completed my last clinical visit for the trial. Maybe to prolong the experience, I lost my way in the office complex. For some reason I was sure the building was on the right, when, in fact, it was and remains on the left. How did I misremember that? I kept driving around and around the buildings on the right, believing number eight would pop up between numbers twelve and sixteen. It didn’t. I finally decided to drive to the other side of the complex and there, eight appeared suddenly between seven and nine. Imagine that!

Once inside the correct office, I was whisked into the exam room, which still registered as near-Arctic on the thermostat. Once again this proved problematic for drawing blood, though the coordinator only stuck me twice before hitting the vein. My blood trickled into the test tubes, Continue reading The Failure of Wellness – Part 2

The Failure of Wellness – Part 1

The bad news came by phone: “Bad news. You failed randomization. You measured 2.5 but needed to be no more than 2.”

“Oh,” I lamely replied, wondering what 2 and 2.5 meant. Millimeters, maybe? I didn’t ask, though. I knew it referred to the measurement of villi and how damaged they might be from exposure to gluten.

The coordinator sounded so dejected. “We’re really disappointed,” she continued, and I thought I heard her add “in you” under her breath, but that was my inner voice, not her outer one.

“I’m so sorry,” I said, feeling as if I really had failed her, failed all of celiacdom. Continue reading The Failure of Wellness – Part 1

Being Part of the Cost Calculation for New Drugs

Being a lab rate for this clinical research trial has spurred me to understand better the cost of medication, rather, the cost of testing a potential treatment in the quest to bring it to market. In this case, the sponsor needs 15,000 people to go all the way through the research protocol: fulfilling all the criteria to be randomized into the treatment phase; taking the investigational drug or placebo for several months; and then a second endoscopy, blood tests, and other measures of physical health.

They’ll have to enroll thousands of people in the pre-test phase to get 15,000 people who will complete the study. I’ve been reading on the message boards for celiac advocacy groups and GF blogs how many people have volunteered for the study but have not been able to complete the study because they “failed” the endoscopy and biopsy. Their guts were healed too much from following the gluten free diet to qualify for the treatment phase of the study.

Here are my back of the proverbial envelope calculations.

The Cost of Admission:

The endoscopy with biopsy, according to the handy website Newchoicehealth.com, costs between $2,500 and $3,600. The average for where I live is $2,300.

Participant incentives (AmEx gift cards) for completing each milestone in the process up to this point totals $500.

The cost to operate the telephone celiac symptom diary each subject has to call every day. I have no idea how to calculate the cost of that.

Two sets of blood tests probably are $200 in this preliminary phase, based on what they cost when billed to insurance.

And then there is the hourly rate of pay for the study coordinators who complete the intake and initial screening; the training to use the phone system; the scheduling of our procedures and appointments; the disbursement and recording of participant incentives; and the general management of the process. Let’s say they make $25 an hour and each subject in this phase requires 20 hours of work. That produces an additional cost of $500.

Now add in the physician’s fee for the two medical screenings we have, each taking about 30 minutes, plus 30 minutes reviewing test results. A generalist physician according to salary.com earns at least $100 an hour (this seems ridiculously low) so this results in a cost of $150.

So, that means I cost $2,300+500+200+500+150=$3,650 just to see if I might qualify to test the medication. If I don’t, that $5,000 doesn’t get them toward the result, but, rather, seems like a loss.

Now think of this: 15,000 people just going through this screening phase costs $3,650 x 15,000 = $54,750,000.

Of course, this is a rough estimate. The actual amount may be higher or lower, but, still, that’s a lot of money just to get to the point of being able to begin testing how well and how safely the medication works in human beings.

Completion Costs:

The cost to complete the trial for each person would be almost double, at least, or between $5,000-$7,000, given the length of time, the amount of medication needed to be distributed and consumed, the second endoscopic exam and another biopsy, and even more blood tests and another physical. Wow.

We also have to consider the number of people who “fail randomization” and don’t get to the next phase of the study, and add that to the cost of the 15,000 completing the study. We are well over $100,000,000.

I have a whole new view of pharmaceuticals now. Yes, I still believe we get gouged at the pharmacy for drugs that have been on the market a long time yet keep getting minor tweaks to their formula to qualify for a new patent and thus seven more years of protection from generics.

Cost-Benefit or Safety-Efficacy Dilemmas:

In this frightening time of Ebola and other deadly diseases, it’s important to remember how much it costs to develop and test new drugs and how difficult it is to balance expediency against safety. We want it now, but how much are we willing to risk or pay to get it now? Do we rush a drug to the front lines without having sufficient data that it’s at least no more deadly than what it’s trying to treat? How much less deadly does it have to be to allow it to come to market and what do you say to the loved ones of the people who take it and die from it, especially when not to have taken it likely (but not 100% certainly) would have resulted in death, too? Is it okay to give a patient infected with Ebola a promising drug that hasn’t gone through all phases of testing so you don’t know how well it will work or how high its mortality rate is, or is it better to withhold the drug until testing is completed, knowing that thousands certainly will die because they don’t have any effective treatment at all?

Who pays the $100 million for expedited testing?  And who determines what protocols can be relaxed and by how much to expedite testing with the hopes of more quickly bringing a drug to a global market?

Tough choices in the face of a frightening pandemic or epidemic (time will tell which it is).

Taste Test While Patience Tested Waiting for Test Results – Sweet Potato Popchips

Testing and tasting and waiting: describes the last several days to a t, or T!

While I wait to hear if I made it into the next phase of the clinical research trial or not, I’ve been reveling in the GF tastes of fall. For me, nothing says fall like sweet potatoes, pumpkins, and the spices that enhance them: ginger, cinnamon, coriander and traces of cloves.

I love Popchips in general. They deliver great crunch and potato flavor without all the fat found in regular chips. I think the potato flavor tastes better than baked Lays, which remind me of Pringles, a childhood delicacy that isn’t gluten free, at least that I can find. The basic Sea Salt variety tastes better with hummus than crackers or pita chips, I think.

Sweet Potato ChipsI discovered the sweet potato Popchips last year in the Halloween aisle at Target. They aren’t in that aisle this year, but they can be found at Kroger and Whole Foods, which I discovered when I went to the Popchips website and entered my zip code in the store locator. You can discover purveyors in your locale using the locator, too. We picked up six bags for us so we didn’t have to make frequent grocery shopping trips to a store that’s not our go-to food emporium (thank you, David!)

These chips taste great by themselves, I think, but they also are fabulous with light cream cheese dip or spread, and are crunchy companions to a steaming bowl of creamy fall soup. They taste lovely with Applegate Farms‘ GF roasted or herbed turkey breast lunch meat. I’ve put a sliver of meat onto the chip and then crowned it with a dab of homemade cranberry sauce for a protein and vitamin packed snack or fancy, no-cook appetizer for a game night party. I’m toying with the idea of crushing them to make crumb coating for chicken tenders. A cranberry barbecue or mustard dipping sauce would compliment them nicely, I think. I will let you know!