Alphabet Soup - the Conclusion?

Monday I went to Columbus for bloodwork. My hemoglobin was 10.9, so Aranesp was ordered. I spoke with the pharmacist at length before it was administered.

Basically, she and my oncologist both feel that the clinical study at basis for the negative reports on EPO drugs was flawed to begin with. The drugs were being administered to patients with "high normal" hemoglobin levels (in the 13-14 range), and at that level the drugs were, essentially, unnecessary. Certainly it is the practice of OSU and Cleveland Clinic to administer EPO drugs only when the patient's hemoglobin is below 12.

But the damage has already been done - once Medicare pulls out of funding use of this class of drugs for anemia, insurance companies are likely to follow suit. It will be up to oncologists individually to make the case for payment. As for those of us with renal cell carcinoma, the pharmacist assured me that the insurance report will be coded for "renal insufficiency" rather than for "renal cell carcinoma," so there should be no question but that it will be paid. Even knowing that it's probably paid for doesn't make the darned injection sting any less ...

Tree swallows are back! It must be spring at last!

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!"

The Years Fly By

Last night found us at the Wellness Community's Renal Cell Networking Group meeting. On the way home, I remembered that I missed last year's March meeting because I was in the hospital. I've gone over a year without being hospitalized!

That might not sound like much, but here's the summary for the last few years:
2004 - 4 stays (surgery and complications)
2005 - 8 stays (treatments, complications and drug reactions)
2006 - 2 stays (drug reactions)

Each stay was for a minimum of 3 days, and 5 lasted over a week. I was basically out of it for the first couple of days of each stay, surfacing gradually to full competence and boredom in the last days. I started keeping non-challenging, small knitting projects packed at the ready in anticipation of those last days.

I became expert at dancing my IV pole all the way to the hospital gift shop to pick up magazines and newspapers. I got to know some wonderful hospital employees. I spent a Fourth of July, a Christmas Eve, and my 15th wedding anniversary in the hospital. With all that practice, I got to be pretty good at coping with it. But, guess what - I haven't missed it at all!

Something to Sink My Teeth Into

Last week I finally made it to the dentist's office for a long-delayed session with the hygenist. I'd had x-rays done last month, and those showed nothing suspicious. I asked a couple of questions and learned things I didn't know before; maybe you didn't know them either:
Dry mouth is a common side effect of many of my medications. Is it a dental problem? Yes, because it can promote tooth decay and infection, aside from the discomfort. Remedies: drink lots of water; use Biotene gum, specifically formulated for dry mouth; use a non-alcohol mouthwash.
When you're cleaning my teeth, why blast air into my mouth? It helps clear the mouth of moisture and debris, and remaining plaque shows up frosty-white and is easier to see.

Dr SC told me at my last visit that, unfortunately, osteonecrosis of the jaw doesn't show up in x-rays until it's well advanced, so I guess I'll keep going to the dentist, eh?