How Things Are Going

I finished my course of 10 radiation treatments on July 20 and returned home on the 21st, completely exhausted and troubled with pain in my right shoulder. I spent much of my time the remainder of the week asleep, as the exhaustion was completely debilitating. I did have a birthday, I think, but I mostly slept through it. My friend Swanknitter had made arrangements to visit from the 25th, so I was happy to be awake when she arrived. I was still absolutely flattened by the pain, which seemed not to be responding to anything. I had been switched from Dilaudid to an Oxycontin/Oxycodone combination and I was feeling quite ill from the diminishing effects of the radiation, the new painkillers, and other accumulated problems. I was finally feeling better from the radiation by the 28th, to the extent of having an appetite and getting some energy back.

Dr. G had asked that I come back for new scans on the 30th so we'd have a new baseline set. Swanknitter and I finished up our visit on the 29th and she returned to DC to head home to Australia from there, and we headed up to Cleveland that afternoon. The scan results weren't great but they weren't hopeless either: I'd been off all forms of treatment since end of April, so no surprise to see progression in the lungs. Test results also showed that I had high blood calcium levels, and that was probably to blame for the complete exhaustion and slight confusion I'd felt after getting home. I was given a two-hour, two-liter infusion of saline, and an infusion of my old friend Zometa.

Dr. G also made arrangements for me to meet with Dr. R of the Pain Management Clinic. Her recommendation was to continue on a reduced dose of the Oxycodone, the dose of Oxycontin that I was already on, and to add to this a prescription for Neurontin. Dr. R's nurse Brenda said, "As it is, nobody knows how it works or what it does, but it works and that's all that most people ask."

I was able to fill my first month's prescription for Afinitor before we headed home, and Saint H handed in my Neurontin prescription to fill at my local pharmacy after we got home.

I sat down last night and wrote out my pill schedule since so many things have changed: we start at 7:00 a.m. and can run continuously through 24 hours every 2 hours, if I'm awake, though the blessed Brenda says "we don't set alarm clocks to take pills, for heaven's sake!" I like that thinking. Also, last night having been the first complete cycle including the Neurontin, I'm thrilled to report that I have very little pain in my shoulder for the first time since November of last year. It's great to be witness to one of those little mysteries of medicine; I don't have to know why Neurontin works, either; just the fact that it does makes me happy. I look forward to improved conditions in the coming days. Wah-hoo!

On Treatments and Loss

The schedule questions finally got resolved with a couple of phone calls on Tuesday, 7/6. Julie, the Social Worker in radiation oncology, called me mid-morning to say that Hope Lodge had a room for me starting Wednesday, 7/7, and had Dr. V's office called me? If not she would call them, verify the starting date, and call me back. As they hadn't called yet, that sounded the best option to me. She called me back about half an hour later with the news that I was to undergo my dry run on Wednesday, immediately followed by the first treatment, and that I was confirmed at Hope Lodge through 7/21.

I called Saint H and we hustled to make arrangements for furry childcare, and all the usual "leaving-town-for-3-days-with-less-than-24-hours'-notice" tasks... It's wonderful to have a known address for the duration, as we can leave things in place when we head back home on weekends to replenish clothing.

I haven't figured out whether I'm going to see near-immediate benefit, but I do know that my back pain has diminished somewhat. I'll take that, I think.

We received word that the second founding member of the Renal Cell Networking Group, John Gillivan, had passed away this morning. His brain mets came back and he lasted only a few days in ICU at the James. John and his caregiver, wife Susan, were instrumental in my being here still. When I first joined the group, I was trying to figure out what next course of action should be (remember this was in 2004). I had almost settled on starting with a clinical trial when they pointed out that one had to try and fail at high dose IL-2 in order to be eligible for most clinical trials. If one chose to start with some other therapy, one would be disqualified for most drug trials and other medications. Luckily I listened to them, suffered through high-dose IL-2, and then when that failed me I moved onto trials and other drugs; "the rest is history" as they say. I'd have missed buying the farm, building the house, refocusing my life on what's important. This process of postponing a bad outcome has taught me what's precious. I'd not have missed these lessons for the world.

Keen-Eyed Man

I'm such a good, compliant patient! Much against my inclination I decided to go back on the full dose of Votrient after my stomach had stopped rebelling. I really wanted to cut back the dosage, but Dr. G overruled me. After I got over sniping about "Dr. God" I finally figured out that he was simply trying to remove the reaction to the sulfa drug from the equation, and his wishes actually made more sense than mine. And I'm happy to report that over a week has passed on the full dose and I have had no apparent side effects. If things go well I'll stay on it at least until the first set of scans next month. If, however, I develop the side effects again I'm sure he'll have no objection to cutting the dosage back somewhat.

I had some trouble sleeping earlier this week. One night I stayed awake until 5:00 a.m.; before I went off to bed I managed to drop my laptop edge-wise on my left big toe, leaving a big gash and a fabulous bruise. That was partway healed when, another morning, I had gotten up and settled on the couch to work on some documents. I stood up, my right foot buckled under me, and I fell, twisting my ankle. Thank goodness (in some ways) that I've much experience with that ankle - I've probably sprained it six times since I entered college, twice really badly, and I've broken it. I could tell that it wasn't broken, and I had all the goods to alleviate my situation - I just wrapped it and elevated it, put cold compresses on it, and clumped around in my airboot (from the break in 2001). It's still sore after 5 days but I can walk almost normally. I suspect that my balance has suffered over the years, or else I've become sensitive about falling after repeated episodes; I find that I'm just not as steady on my feet as I used to be. I guess I can live with it as long as the damage isn't too severe.

Last week my brother P got a big surprise - he found a downed weather balloon in a field across from the house. He called the number listed and received a visit from some very excited University of Illinois students who came to retrieve it. You may enjoy the pictures taken by the balloon's camera on its short flight. The boys refer to the "keen-eyed man in IN" who found the balloon. I think it's more the case that P, like Saint H, is so familiar with his environment that he notices things; he doesn't necessarily have to "see" things to register a difference in his mind. Since he refused a reward the boys brought him a "Chief Illini" statue as a thank-you; I'll look forward to seeing it when we go visit next month.

Mr. Yuk Is My Friend

Well, it's been an interesting lapse. I developed a salivary gland infection at the end of April (my second in a month) but fortunately was able to get in for an appointment with one of the ENT guys quickly. I'm choking down 500 mg of a sulfa drug twice daily along with Compazine to alleviate the nausea.

At this point I have virtually no appetite; I haven't really been interested in food for about a week. I don't believe it's the Votrient; I'd much rather blame the sulfa drug in hopes that it will stop eventually! You may wonder, "Why sulfa?" Well, as time went on and I developed more and more serious infections from surgery and the like, I was being pumped full of antibiotics. Unfortunately I got hit with side effects pretty hard. I have a list of about 10 allergens now, but at the moment none are sulfa-based. So I guess that's my "drug class of choice" for the time being! And, much as I hate to admit it, it does seem to be working and I'd rather not be sporting an infection.

We've had killer weather too, alternating between hot and dry, and cold and windy and rainy. It's the type of system train that guarantees uncomfortable nights and difficulty breathing. I'm back to sitting up on the couch and snoozing, rather than trying to breathe all night lying on my back. I know it could be worse; we could be flooded. Saint H led a hike in Myers Woods last Saturday. It was damp and chilly but doable.

Saturday night we trekked to Columbus and huddled in a tent venue with 175 other people for the spotlight concert of the Columbus Folk Music Society's annual Central Ohio Folk Festival. My musical hero, James Keelaghan performed for all his chilly friends and warmed the evening greatly. Keelaghan is from Winnipeg, his voice is pure, his poetry unmatched; all in all his music has over the years given me great hope and solace.

We lost a good friend and member of the Renal Cell Networking Group; Gale was diagnosed in 1995 and was always quick to prefer surgery over drug therapy. She was a great-hearted lady; Saint H knew her from their shared times in the 1980s with the Ohio Wildlife Center, and she loved all animals, particularly dogs and horses. Gale and I shared the same birthday, too.

Our local friend who has battled brain tumors for 25 years is nearing her end; she's at home under hospice care. I'm nearly finished with a baby sweater for the granddaughter she'll never see. I always feel that I'm doing something worthwhile when I'm knitting for little ones.

First Day

We went to Cleveland for appointments on Friday - benchmark scans and a general check on my health and well-being. And, because I was still dealing with edema in my lower legs and feet, I had ultrasound exams on both legs. Our results were good: scans were stable and lab results were generally in good shape, though my hemoglobin levels are down to 8.7 from 11.4 at the last set of labs. The ultrasounds were added to the mix late in the day, so we didn't have final results when we left. By the end of the day I had my first 30-day supply of Votrient with instructions to begin on Monday if all the test results were good.

I spent much of the weekend stewing about the possibilities: side effects, my body's weaknesses and strengths, warning signs, and the like. Even though I had come to a decision, that decision once made must still be lived with. Without data to fold into the equation, one's mind becomes the hamster, endlessly chasing the "what if"s through the night on the treadmill of the unknown.

I did query my friend Bruce who started on Votrient about 3 weeks ago; we've gone through Sutent and Nexavar together, with some of the same reactions to the same drugs. I was reassured to hear from him that it's gone well; I can't tell you how much that calmed my fears.

Monday I saw my primary care physician Dr. MC to reassess my current maintenance meds; we changed out one blood pressure med for another, and reconfirmed my use of a diuretic to continue fighting the edema. Then I called Dr. G's office; Nurse Shari and I traded phone calls for a while until we finally talked together in late afternoon. The ultrasounds showed no blood clots so I was given the go-ahead to start on Votrient today.

I took a full dose, 800 mg, at 10:30 this morning. The day passed relatively normally (a meeting, lunch, and a lecture tonight) and I'm feeling relieved. So far so good; no immediate negative response, no big red flags. I'll be watching things closely, monitoring my blood pressure and looking for signs of trouble. Keeping fingers crossed - would love to have a med without side effects! What a concept!

All-Nighters

I've had lots of near-sleepless nights since the gamma knife procedure. That's due in part to the steroids, I know, but I've had a lot to think about since the middle of February.

When we left Cleveland Clinic on March 1, we had information on 4 drugs, a rough idea of schedule needs, and an assignment: choose the next drug I wanted to use by the end of the week. You may be wondering what goes into making such a decision, and I can tell you it's not easy. The four drugs we were looking at were: Votrient, Torisel, Avastin, and Afinitor. Here are some of the factors we considered:

Schedule - How quickly can one begin a new therapy? What might influence the schedule?

Risks - All of the drugs involve varying types of risk, though certainly better odds than doing nothing. Of the four, which posed the most immediate threat to me based on my individual response to the drugs I've taken so far?

Efficacy - What's the drug's mechanism of action and track record to date? Is it similar to drugs I've already taken, or is it something new that we'll have to monitor closely?

Side effects - Are the side effects controllable with other medications? Is there evidence of any new or particularly threatening side effect that I haven't encountered with other drugs?

Costs - What is the drug's cost? How much will insurance pay? How much will I pay out-of-pocket?

Other considerations - Are there some inherent constraints that will control access, schedule or other points on the list?

Taking these factors, we came up with the following concerns:
Schedule - In this case, Dr. G wanted me to start as soon as I could, possibly by March 8. The problem: steroids would preclude concurrent use of two of the four drugs, and my late-night driving adventure spelled the need for continued steroid use; therefore all four drugs return to the list of possibles. My start date: on or about my next appointment, April 2

Risks - Risk assessment is the hardest part of the equation and is closely tied to the drug's efficacy and side effects. Each person's reaction to a drug is very individualized. So, while I know that VEGF-inhibitors may increase one's risk for internal bleeding, not all VEGF-inhibitors cause me to bleed (so far only Sutent holds that distinction). Newly approved drugs try another approach, with a new drug pathway to try, the mTor inhibitor. My leaning is to exhaust all the drugs of a single class before trying something new; hence my inclination to go with Votrient first. But the most serious side effect of Votrient is the potential for liver failure, and given the liver damage I already have, this gives me pause.

Costs - I'm very lucky; these drugs are horrendously expensive and all require a "pharmacy override". That is, I must use my drug plan's special pharmacy service so that the cost benefits are spread over the entire pool, or else I must pay a good portion out-of-pocket. Heck, yes, I'll let them mail the drug to me and pay my normal co-pay.

Other considerations - Oral drugs can be mailed directly to me; drugs requiring an infusion (in this case, Torisel and Avastin) would be administratively harder to deal with. With infusions, the hospital or facility administering the drug probably would have to receive the drug. Would it go to their pharmacy, in which case would I have to pay more for it? It's not a scenario I'd like to test out just now.

So, my choice became "an oral VEGF-inhibitor", which leaves me with Votrient. As we don't have any idea how my body will react to a new drug, I'll be "baby-sat" off and on while I adjust to the medication and dosage level. I'll probably be traveling to Columbus during the day, sitting and knitting at C2's house. That way should I develop any problems I'm 10 minutes away from the OSU Medical Center, as opposed to being 20 minutes from the nearest hospital here and over an hour from the OSU Medical Center.

There you have it - a breakdown of what is, in essence, a life-and-death decision. It's not something to be taken lightly, but we can certainly weigh all the factors as part of the whole. Given enough information, I can analyze just about anything, I believe, and come up with a decision that I'm happy with.

I'm happy to say that my diaper rash has finally cleared up. Now I've got pitting edema in my lower legs. What I've read isn't encouraging but at least we're doing what we can to combat it. Will be interested to see what Dr. G wants to do when we go up on Friday.

Going Forward

At long last we've gotten through 2009, a fairly miserable year for so many people that I hope we never see its equal. On the whole I feel I got through it with few scrapes, and I know I'm lucky.

We were in Cleveland for evaluations on December 30, and I'm stable still, so we are moving forward with Cycle 7 of the clinical trial. The worst side effect continues to be fatigue - I'm tempted to say "the only side effect" but I don't know that for certain. I do know that this drug seems to be tolerated well by participants, from the scanty reports I've heard. The company was able to get the full complement of trial patients for the study. That's a pretty good mark on its own; many trials run into trouble amassing the target study group, whether that's due to stringent prerequisites for participation, or adverse reactions leading to patient dropouts.

During December I started having pain between my right scapula and my spine - nothing drastic, but a fairly constant dull ache. The pain felt very much like pressure on a nerve, similar to what I'd experienced in 2004 while recovering from my liver resection. At that time I developed an abscess that extended from my liver to mid-back behind the right lung, and I was in constant pain from it. Only after we discovered and drained the abscess did I get relief.

For this round I jokingly suggested that it might be my cooking habits - maybe I was straining a muscle while chopping vegetables? I asked Dr. G to review my November C/T scans with me prior to my second treatment in the cycle; even though I'd joked about my cooking habits I had in fact altered my kitchen setup, but there was no change in the pain or its location. We moved through frame by frame and discovered that the tumor in my right lung is now pressing against one of my ribs, and that appears to be the cause of my discomfort.

So what does that mean? I feel better knowing what the problem is, and we're in no hurry to take me off the trial - Dr. G still refers to it as my "body vacation" from other treatments. We may reassess my pain medication, though for now my regular routine is enough to keep it at bay. We may look more closely down the road at some type of Gamma knife or Novalis procedure.

We continue to have options, even beyond available therapies. I'm so very glad to have such good teams to work with.

Kick In The Teeth

Well, crap. Last week, insurance paperwork, billings and all from the first of the year finally worked all the way through the mill and I sent off the usual $900+ check to Cleveland Clinic to settle my annual out-of-pocket requirements. Hooray, no more unknowns, just the usual copays, prescriptions and incidentals for the rest of the year.

But wait! Yesterday I went to the dentist for a regularly-scheduled cleaning, and we found yet another cracked tooth. The rear right lower molar has cracks in all four directions, plus a couple of chips, plus decay along the edge of a filling that went in about 3 years ago. That's 3 cracked teeth in the last 2 years, folks. Some of my other teeth are now developing chips on their cutting edges, too. And the remedy for a cracked tooth, of course, is another crown. Crap!!!

Vivian asked, "Do you grind your teeth?" "No, I don't think so ..." "Well, what about dry mouth from your medications?" Oh, yes, indeed - what about dry mouth?

Dr. K doesn't think that there have been any studies about the relation between dry mouth, cancer medications, and dental problems. I'm ready to believe it, though - I have always taken care of my teeth, and I'm stunned by the amount of dental work I've had to go through in the last 3 years. Saliva acts as a lubricant, and without it the teeth bang against each other - grinding without grinding, as it were.

My schedule stinks, as does my bank account; I'm going to put off getting the crown as long as I can. For now I've got a prescription toothpaste, Colgate PreviDent 5000 Dry Mouth, Biotene mouthwash samples, and strict instructions to brush and floss religiously, and chew carefully. We may look into some sort of mouthguard as well, in the meantime. And I think I'll start doing some reading up in the dental literature too. At least the toothpaste doesn't make me gag, so far.

Starting the Next Phase

I'm still not certain what I can and can't say here about the upcoming clinical trial, but I'd guess it's okay to say that we have a start date if all works out. I'll go in for screening on April 13, and if I pass the screening I'll start the trial on April 27.

I don't think I realized just how hard this had hit me, until we finally got the dates outlined. Such a relief! I'd been coasting along for over 3 years with only minor upheavals on Nexavar, knowing with some degree of certainty what each day would bring and what would factor into how I felt overall.

Imagine feeling terrible all the time without knowing why; that was the norm for me from 1998-2000. Being diagnosed with RCC was terrifying but it was also a relief - at least I knew what was wrong with me. Each step since then has had its own challenges. The biggest shock was the liver metastasis in 2003; and that probably comes closest to what I felt when Nexavar finally failed.

Yes, we all tell ourselves that we're being pragmatic and facing up to the fact that metastasis can and probably will happen, or that this or that drug can and probably will cease to be effective over time. Yes, we try to share information with other RCC patients and keep up our knowledge base. Yes, we do what we can to prepare ourselves for change and the next step. It's still not comfortable when the time comes.

I've been awfully depressed about having to face these changes. Maybe it's the equivalent of losing a job and being in limbo until finding another one. All that I know is that I'm glad to have something more definite in front of me now.

Tree swallows have returned as of last Sunday. Spring is offically back!

Lifetime Supply

Friend and sister C2 and I have kidded each other for years: She'll take my lifetime supply of coconut if I'll take her lifetime supply of lima beans. Or I'll take her share of pears for my share of red wine. All in good fun, of course. But what if it isn't?

The British National Health Service has attempted to come to grips with drug costs for treatment of chronic disease as well as catastrophic illness with a payment formula. NICE [National Institute for Health and Clinical Excellence, a government agency] establishes a protocol for maximum payouts. As outlined in this article, the outcome can be dismaying. The process is illustrated by Bruce Hardy, a kidney cancer patient whose disease has progressed alarmingly since he was refused coverage for Sutent based on projected costs under the formula. The reasoning behind the decision: Sutent and similar drugs extend life only by an average of six months, according to the NICE deliberations, and the drug costs are extravagant based on these results: "But at that price [$54,000], Mr. Hardy's life is not worth prolonging ..."

I guess I don't know how to respond to the question, what is a life worth? What cost is "justified"? Since August 2005 I've received treatments totalling over $75,000 in insurance benefits for Sutent and Nexavar alone, disregarding other attendant drugs and prescriptions that I've taken to ease and control side effects of the medications or the disease. And my needs have been relatively modest compared to those who must take the full dose of Nexavar; had I been prescribed the full dose for the past 3 years, those insurance benefits would have skyrocketed to nearly $250,000, again just for Sutent and Nexavar.

Can we truly say that these drugs are effective "only" for six months on average? The drugs are fairly new, their effectiveness (less and less likely to be questioned) is still being tested, and happily the end stage results for their use keeps being pushed further and further out on the timeframe. Biologics are expensive, and no doubt there could be ways to reduce their costs. We seem to operate under a "whatever the market will bear" mentality and that free-wheeling free-market approach may well be inappropriate when people's lives are at stake. If one's life is extended and one is reasonably self-sufficient because of the medications, as I am, is the cost "worth" it?

I don't dispute that extraordinary measures are extravagances when applied to someone whose prognosis is poor and likely to remain so. I certainly don't expect extraordinary measures to be taken for me when the time comes; quality of life is uppermost in my mind, and I don't want to linger, insensate, when my disease progresses faster than any drug can control it. But I can't help thinking about Mr. Hardy: I was in his position in August 2005, I was given Sutent and Nexavar, and I've benefitted greatly from it. What kind of shape would he be in now, had he had the same chance? One positive note: given public outcry, there have been some modifications proposed to the NICE standard, so it's not written in stone - yet.

Who will decide what's best: Bean-counters? Physicians? Patients? This is a lifetime supply of conundrum that I'll gladly trade for something else. I don't think I'll get any takers, though.

Pick-Up Lines

I guess I'm old-fashioned; I like going to the pharmacy to pick up my prescriptions. I use two local pharmacies; I have favorite clerks at each one. They know who I am, and I guess that's flattering - or it's reflective of the number of prescriptions I've had filled in the last 8 years. Having grown up in the country, where we generally only went to the grocery on Saturdays, I find it useful to have an occasional excuse to go into town when I might not otherwise be going. It doesn't hurt either that the pastry shop is on the same street as both pharmacies.

My Nexavar comes by mail through my insurance company. Every month I get a call reminding me that I need to refill it, and they carefully schedule the delivery. I find that rather amusing on two counts: I'm usually home during the day so I'm not likely to miss it; and FedEx doesn't come to the door to deliver it to me. At least they do drive down that long lane and drop it off at the house, rather than leaving it at the mailbox.

If I chose to go to another pharmacy I would pay full price for Nexavar, and that would empty the coffers pretty quickly. The drug is expensive, though not the most expensive one on the market these days. There's probably a price break (hmmm, Nexavar in bulk? - scary thought; I wonder how many of their customers need Nexavar) and, by requiring that I get it through their specialty pharmacy, the insurance company is able to realize that price break on all the absorbed costs. I certainly won't complain about getting this drug on a co-pay when it could brook total financial disaster otherwise.

My local pharmacies don't have Nexavar on their purchase lists, or at least they didn't when I started my prescription in 2006. It would be a hassle for them to get it just for me, aside from the cost that would be passed on. On the whole this arrangement works well.

We're hoping for rain but the weather isn't cooperating; maybe tonight, maybe sometime next week. I'd sure like to get another cutting of hay off but we need rain for that to happen. In the meantime we're planning to complete the hoop structure, cut brush in the woods, and squeeze in a picnic over the holiday weekend. Happy (and safe) Labor Day to all!

Same Old Same Old

(I hate to tempt the fates by using that for an entry title.) Yesterday we went to Cleveland Clinic for the usual scans, labwork and appointment. Dr G met us with his usual hugs and handshakes and a beaming smile. "Your scans show the same old thing - a little bit of growth in the lung, stable in the abdomen. No sign of ascites. We'll stay on the current medications, no changes."

We were stunned - how could this be? Suspicion now turns to my thyroid, and we'll look for test results on that either today or tomorrow. If thyroid, increase Levothyroxine. If not thyroid, then what? A fluke? A cosmic joke? Whatever, I'll take it. I'm keeping the remainder of the diuretic prescription just in case - it certainly seemed to relieve the symptoms regardless of what caused the problem.

We drove home, indulging in a rare squabble on the way - seems that we were both keyed up over the potential diagnosis, and sandbagged by the results, leaving us both feeling adrift. Emotions boil over quickly in such situations. I don't think either one of us was aware of how edgy we were until the pressure was relieved. Thank goodness we can both say "I'm sorry" and relish a hug and a good cry when it's all over.

Get Hep

I've been watching the unfolding drama: tainted drug supplies, multiple deaths, international fingerpointing, lax inspection. At the very least the furor over Heparin manufacture in the last few months has outlined a disturbing trend. Heparin is a life-saving drug that figures into treatments for dialysis (and, like me, for patients with Mediports) every day. If something is that vital to survival for people whose health is already compromised, why isn't more done to control its manufacture and its safety? I must say that finding out where Heparin comes from, pig intestines, isn't disturbing in any way to me; lots of valuable medicines come from animals. Finding out how Heparin is processed, again, might not be of concern; good for those enterprising Chinese families who make the effort to provide the raw material. Finding out that the supply chain is so limited gives one pause - why do we have only two manufacturers in this country? Finding out how few checks and balances are in place is frightening. Finding out how little the FDA can do to perform the necessary inspections is infuriating. I think it will be interesting to see what happens next.

Yesterday Saint H and I put up the martin gourds for this season; keep your fingers crossed that this will be the year for our colony to start. We have 16 tree swallow eggs and 4 bluebird eggs in the nest boxes here. We walked through the woods, finding blue and yellow violets, May apples, Solomon seal, and bellflowers (as well as poison ivy, Virginia creeper, and garlic mustard). Much to my surprise, about 50 trees have survived years of standing water in the south field - they're not big, but they look pretty robust. I wish I had the stamina and determination that plants show!

Got Dilaudid?

A couple of weeks ago I started having nightmares that I was addicted to Dilaudid, so I spent several days trying to resist taking it. I didn't get the shakes, I didn't get nauseous, I didn't get addled or demanding, I just felt like I was wallowing in pain. It wasn't sharp pain, it was constant, never-ending waves of discomfort. I lost sleep and felt miserable.

I talked with friend and sister M about it - she's eminently sensible, reasonable and easy to talk to. She seemed surprised that I was worried: "Your doctor trusts you to be sensible about your use, and of all the people I know you're about the least likely to be a substance abuser." She told me to get out there and educate myself, and for heaven's sake to use the drug when I needed it!

I started looking and came to the following conclusions:
If one takes opiates for pain and takes them as directed, one may develop a physical dependency, but medical experts recognize compliance as a key indicator that one is NOT an addict.
Physical dependency is different from addiction, but today's social climate can easily lead one to equate ANY use with abuse.
Patients are generally willing to label themselves abusers, and will stop taking their medications despite their doctors' assurances that they will come to no harm if following directions. By not taking their medications they suffer needlessly.

There are several excellent sites available on this topic:
American Pain Society's Advocacy statement, "The Use of Opioids for the Treatment of Chronic Pain" addresses the social and legal aspects
US Food and Drug Administration's Consumer magazine, "Managing Chronic Pain" gives a good overview of the overall discussion
WebMD "Pain medication addiction and tolerance" gives general guideines for discussion and action

I talked it over with Dr G in Cleveland and he's not concerned with my continued use of Dilaudid. I'm taking it when I need it and I never exceed the prescribed dosage. I guess I have to trust myself. All things must be taken on balance:

"Every form of addiction is bad, no matter whether the narcotic be alcohol or morphine or idealism." - Carl Jung (1875–1961)

Guaranteed Or Your Money Back?

My friend Richard often sends me articles from the New York Times - I subscribe to the email headline notices and skip through those regularly, he subscribes to the "TimesSelect" option and actually reads the entire paper daily. So he picks up a lot that I miss.

One of his recent mailings was "Pricing Pills by the Results", which outlines industry thoughts on pricing expensive drugs based on efficacy. The lead example is Johnson & Johnson's proposal that the national health service in Britain pay for Velcade, a cancer drug ($48,000 per patient), but only for those whose tumors actually shrink; monies for other patients would be refunded.

It's an interesting concept, but I wonder how the details would be worked out. What constitutes shrinkage, for example (thirty percent, ten percent, seventy percent, or "all or nothing"), and who determines the definition of success (the drug company, the patient/oncologist team, or the purchaser)?

Is shrinkage the only goal? As we move further and further toward redefining cancer as a chronic illness, managing the disease rather than "curing" it, shrinkage seems to be less dominant in the discussion. I haven't seen any shrinkage for over a year now, yet my disease is well managed and my quality of life is good. I'm more comfortable now than I've been since fall of 2003 when my metastases were discovered, and I appreciate the stability. Shrinkage is a wonderful thing when it happens, but it isn't the only measure of patient response. Having nearly died while taking a drug that was shrinking my lesions at a spectacular rate, I'll take maintenance as the best response.

I can see pharmas pushing for relaxed definitions of success, to ensure the greatest possible rate of payment, and purchasers pushing for stringent definitions of success, to limit the number of payouts required. At what point does the struggle to define the bottom line, also define when and how the drug will be administered? What happens if one elects to remain on a drug even though results might not be "guaranteed"?

I hope that patients have a voice in the decision.

Alphabet Soup: EPO/FDA, Part II

Well, the EPO/FDA story continues.

A New York Times article yesterday outlined the ties between physicians and pharmaceutical companies, using Dr. Allan Collins's relationship with Amgen as the lead example. Dr. Collins is highly influential, and is the president of the National Kidney Foundation. Amgen manufactures Aranesp. In 2004, Amgen granted $1.9 million to the Minneapolis Medical Research Foundation. Dr. Collins was the designated senior researcher on the grant. [NOTE: Dr. Collins did not receive these funds personally]

Couple that with an FDA announcement that its advisers will no longer be able to vote on product acceptance if an adviser has received more than $50,000 from the product's company, and my friend Richard's comment ("It's not a very encouraging article") pretty much sums up most people's reaction to the whole mess. Even if there's no impropriety or conflict of interest, it just doesn't look good.

See more on the whole conflict. It's very interesting to see mainstream media coverage on something I live with daily.

Both Dr. G and Dr. SC feel confident that if I need Aranesp, they can justify prescribing it and can clear it with my insurance company. But I'll be calling my insurance company anyway. Am I being too anal about this? Perhaps, but I'm also on a fixed income and I don't want to get surprised by an unexpected $4000 bill.

Results from Cleveland: I'm still stable (slight growth again in the right lung lesion, balanced by slight reduction in the largest liver lesion). My joint and back pains are probably another Nexavar side effect - it's not just that I'm getting old! - and my Dilaudid use (now averaging 2 doses per day) didn't raise anyone's hackles. And I discovered Lindi Soothing Creme at the pharmacy; it's an over-the-counter formulation for hand/foot syndrome that seems to be pretty effective.

Do I need to make a disclaimer here, that I have no relationship with Lindi?!

Alphabet Soup: EPO and FDA

This will be quick; we leave shortly for Cleveland and appointments tomorrow.

Aranesp and other EPO drugs (synthetic erythropoietin, a hormone produced by the kidney that stimulates red blood cell production) have been shown to lead to increased risk of heart problems in dialysis patients, when used to combat anemia. The risk is severe enough to prompt the FDA to require the dreaded "black box warning". The drugs were approved, in fact, to reduce the need for blood transfusions (maintaining the hemoglobin level at 10-11), not to prevent anemia (hemoglobin level at 12 and above), though they are effective at both results. Oncologists have prescribed EPO at higher dosages to alleviate anemia in cancer patients; certainly I took it for 2 years for that reason.

According to a NY Times article, the American Society of Clinical Oncologists (ASCO) has issued a directive to its members to cease prescribing, and Medicare will no longer cover the use of these drugs to combat anemia in cancer patients. How long will it be before insurance companies follow suit?

As one of my fellow RCC patients commented, "This is sad ... It seemed like these drugs were addressing the issue. What will people do now?" I'll be asking Dr G tomorrow - will there be any "slack" cut for patients with RCC, whose anemia may result equally from cancer and renal problems?

To quote the King of Siam, "It's a puzzlement!"

Man Injects Dog, Etc.

My friend Richard sent me this NY Times article on human cancer drug trials for dogs. I guess I've never really considered the crossover of human drugs into veterinary use, other than the over-use of antibiotics and growth hormones in industrial farming. But I wasn't surprised to find that this drug use is regulated by the federal government. Central to the government's focus is the American Medicinal Drug Use Clarification Act, or AMDUCA.

The US Food & Drug Administration has, in fact, a Center for Veterinary Medicine. And the US Department of Agriculture regulates "vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin" at its Center for Veterinary Biologics.

Stress is placed on the therapeutic use of human drugs in a standard veterinary/client relationship, where drugs are administered only under the care and advice of a vet. In a perfect world, the American Veterinary Medical Association guidelines for antimicrobials would be followed to the letter. But that's sometimes countermanded by our seemingly universal guideline, "If one is good, two is better" that governs such things as the application of home pesticides, or sharing Grandma's medicine because it works for her ...

The emphasis on regulating drugs entering the food chain is a good start. We often seem prone, however, to allowing a drive for profit or personal satisfaction to override both common sense and the law. I guess that's why the "duh" principle is seen at work, when the FDA must issue a guideline prohibiting the use of human anti-influenza drugs in poultry, in the face of avian flu epidemic scares.

Thanksgiving Comes Early

Yesterday, Saint H and I were in Cleveland for tests and appointments. The C/T scans were quite good - no appreciable growth, stable disease state. So far I've had 4 successive scans over 8 months showing stable disease. Given that I'm on a half dose of Nexavar, that's very encouraging. If I were on higher doses, would I see shrinkage? Perhaps, though there's no guarantee of that, and I can't imagine living with the side effects. No tradeoff of misery for longevity, please.

Dr G adjusted some of my medications (one less blood pressure med, hooray) and added a new prescription for an iron supplement. We're trying to fight the anemia and fatigue with this. So, that's minus 4 daily pills for the blood pressure, plus 2 daily pills for the supplement; net -2 pills. (Gosh, no, it doesn't take much to amuse me!)

And life goes on; Dr G and his wife have a baby girl, their first child. I found out they were expecting at my September appointment, and took this sweater along. I love making baby things - small projects, lots of scope for trying new stitches and techniques.

The Wandering Mind Falls Into Deep Waters

I don't know why my mind works this way. I take many prescriptions; I use the toilet; we have a septic system; the septic system leaches into an underground waterway. What happens to the drugs? Is this a thought process that normally occurs to people early on a Sunday morning??!

At least I know I'm not the only one wondering. Scientists in Germany have been studying this very question since the mid-90s at least, and there are research reports from the US as well. According to Science News, in some cases as much as 50% to 90% of a pharmaceutical substance can be excreted by the body. It appears that ozonation is effective against many pharmaceutical residues of the studied compounds and products, and that longer detention, denitrification, nanofiltration and reverse osmosis also produce beneficial results.

I don't know if there is ongoing research on this question; I suspect there is, but it takes a long time for research to get published. And is this question a priority for any of our national regulatory agencies? The FDA reduced manufacturer reporting requirements in July 1997, according to the Science News article cited above.

Instructions are posted for restroom use during chemotherapy, at the infusion center where I receive Aranesp and Zometa: sit down on the seat; stand up when finished, lower the lid; flush twice; continue this procedure for two days following chemo administration. What happens with chemotherapy residues? Is anyone researching the effluent life cycle of the new, targeted therapies such as Nexavar and Sutent?

According to the German study, the most difficult residues to treat are iodinated x-ray contrast media. Every time I have a C/T scan with contrast, the final word from the attending nurse is "be sure to drink more water than normal so you can flush that from your kidney." But what will flush it from our environment?