Oral Cancer Drug Parity

Many of us have discovered that oral drugs that we take at home, like Revlimid or Thalidomide, can cost us much more than intravenous (IV) drugs, like Velcade, delivered in the doctor's office or a clinic. There are various reasons for the difference, including deductibles, co-pays, annual or lifetime maximums, and the "donut hole." The costs can be so staggering that many patients simply don't fill their prescriptions.

So why not just use IV chemotherapy instead of oral meds? (1) For some patients, oral meds may very well be the best medical treatment, especially with the newest oral meds; (2) It is SO much more convenient for the patient (us) to take a pill once a day instead of sitting in a clinic for an infusion. We can work, and travel, and live fuller lives, without being tied to a clinic; (3) For some patients, the nearest clinic may be many miles away; and (4) In some cases the oral drug may cost the health care system less, considering the much higher number of office visits required for IV therapy.

Fourteen states have now enacted laws requiring insurers to cover oral drugs on terms as favorable as they cover IV drugs. HR 2746, the Cancer Coverage Parity Act of 2011, is intended to fix the problem at the federal level, eliminating the need for the remaining states to enact their own legislation.

After running the Marine Corps Marathon yesterday, I stayed in Washington to help the International Myeloma Foundation (IMF) and the Leukemia and Lymphoma Society (LLS) bring this issue to the attention of a few congressmen and senators. Today we visited:

• John Martin, Legislative Director for Congressman Phil Roe, MD (R-TN);
• Paul N. Balzano, Legislative Director for Congressman K. Michael Conaway (R-TX);
• Caira Woods, Legislative Health Fellow for Congressman Frank Pallone, Jr. (D-NJ);
• Pat Pelletier, Legislative Correspondent for Congressman John Kline (R-MN); and
• Elizabeth Hoffman, Legislative Assistant for Congressman John R. Carter (R-TX)

I've never done anything like this before, and was actually more apprehensive about these meetings than I was about Sunday's marathon - I didn't sleep well last night. But I found that I liked it, especially after the first person was warm and affirming. Everyone was cordial, at the very least. In most cases, the issue was new to the staff person with whom we spoke. They were there to be educated and they learned something. I enjoyed it and will sleep well tonight!

Tomorrow we have six more meetings. I believe five are with congressional staff, and hopefully one with an actual senator. Can't wait.

Article in Minneapolis Star Tribune

Here's a nice article in the Minneapolis Star Tribune's East Metro Section about my marathons and Team Continuum, published yesterday.

Team Continuum helps families that are devastated by the costs and disruptions of cancer.

You can help, using someone else's money! If you have a Fecebook account and go to my E-Race Cancer Facebook Page and "like" it, a donation will be made to Team Continuum by a generous third party. We invite you to do that - there is no cost to you.

Of course you are certainly also welcome to go directly to my Team Continuum page and make a further contribution to the cause. It's deductible.

Thank you!

Not Good News Today

I've participated in a study of a new drug called pomalidomide (originally called CC-4047) for 47 cycles now, each 28 days long. It's been a wonderful ride so far, with the cancer held stable for more than 3 1/2 years. Eventually every treatment fails, however, and when that happens I will see the cancer markers starting to increase.

They increased today. The blood test results at Mayo Clinic showed a 28% rise in immunoglobulin G (IgG), from 1020 to 1310 mg/dL, which is the largest jump in IgG since I started in the study. The monoclonal (naughty) component of immunoglobulin G is called M-Spike, and it increased too, though more modestly, from 1.0 to 1.1 g/dL. The results do go up and down, of course, for perfectly natural reasons, and they most likely will go down again next month. Or, they could continue on upward. Meanwhile, I'll be on pins and needles.

What if they do keep going up? There are several other treatments that my myeloma hasn't yet had a chance to outgrow, and some of them will undoubtedly help.

Better news: Calcium, kidney function, hemoglobin, and white counts are all within normal limits. I think that means that the myeloma most likely isn't hurting me yet.

Some Current Test Results:

Test		Jul 28		Aug 25		Sep 22		Oct 19		Remarks
M-spike g/dL		1.0		1.1		1.0		1.1		\ Tumor marker up
IgG mg/dL		1030		1150		1020		1310		/ Tumor marker up
Lambda mg/dL		2.21		2.25		2.49		2.75		L Free light chains
Calcium mg/dL		9.8		10.5		10.0		10.0		OK
Creatinine mg/dL		1.3		1.1		0.9		1.1		Kidney, OK
HGB g/dL		15.1		14.7		14.9		14.6		Hemoglobin, OK
RBC M/uL		4.17		4.08		4.09		4.07		Red cells, low
WBC K/uL		5.1		3.8		6.2		4.8		White cells, normal
ANC K/uL		1.90		1.40		2.60		2.30		Neutrophils, normal

Related Links:

My Myeloma		A discussion of my myeloma, not very technical.
My Treatment History		Not technical.
My Test Charts		Graphic displays of several key test results over time.
My Test Result Table		Somewhat technical. Best with a wide browser window.
My Supplement Regimen		With links to where I buy them.

Prepared by Sunshine on the road between Hartford and St Paul: Applegate organic chicken/turkey fire-roasted red pepper sausage, organic mustard, tuna dish (organic peas, tuna, organic brown rice), veggie dish (organic squash, organic sweet potatoes, onions), avocado:

Stacy Died

Stacy was the wonderful young mother of two small girls and as warm, caring, and upbeat a person as I've ever known. She was struck down today by myeloma.

I feel so damn ANGRY at this disease. So helpless. I hate it! My own ride with myeloma has been easy by comparison, but now I've personally known thirteen people, shaken their hands and spoken face-to-face, people like Stacy, who have gone down before this merciless killer. All of them died too early, and Stacy's death is a particular tragedy.

Some people say that new treatments for myeloma might eventually turn it from a uniformly fatal disease into a chronic one. That's a great goal, but we're not there yet, not when a young wife and mother of two cannot be saved by the best medical care on earth. There is a lot of work to do.

Stacy, we love you and we commend you to the hands of God. We will most certainly miss you here.

Stacy, second from left, with her mother and two daughters:

Still Stable After Cycle 46

I'm a very fortunate myelomiac, I know that. My numbers go up slightly, and then they go down again. This time they're down a bit after the 46th 28-day cycle of the investigational drug pomalidomide. I've never been injured by the myeloma and I can still run, and in fact we just finished our 55th marathon since diagnosis. That's very lucky indeed, and I'm so grateful to the professionals at Mayo Clinic, and to Celgene, the makers of pomalidomide, and to my two sweeties who care for me, and all others who make the hope come true. Life is very good.

Serum Cancer Markers:

My myeloma is IgG Lambda, a very common type. So far, the tumor burden seems to be quantifiable by measuring its surrogates, the IgG protein level and the M-spike. IgG is down from 1150 mg/dL last month to 1020 this time. Accordingly, M-spike is down from 1.1 to 1.0 g/dL. Light chains are basically unchanged. Liver enzymes are up a bit, but that could be from running a marathon four days ago - they're still within the reference range.

Calcium:

Last month my calcium was 10.5 mg/dL, which is significantly above the top of the reference range. Doctor LH recommended that I cut my daily Vitamin D3 supplementation in half, to 2500 IU, and I did. This month calcium was 10.0 mg/dL, just below the top of the reference range. Calcium in the blood has varied quite a lot from month to month, so we can't say for sure that the Vitamin D3 reduction made any difference, but it might have. There is such a thing as too much Vitamin D, although 5000 IU/day is far below the levels generally thought to be harmful. That threshhold might change, however, when the supplement is taken for years, as I have done.

Too much calcium in the blood can be harmful in itself, playing a part in atherosclerosis, but for a myelomiac it can also be a signal of bone loss, indicating that the myeloma is active in the marrow of some bone or bones. I'm glad that it went down, and for now I'll stay on the reduced amount of Vitamin D3.

Even though the calcium level went down, though, it's still on the high side of normal. Considering that it's been 18 months since the last skeletal survey, Dr RH thought it would be reasonable to have one, and scheduled it as part of next month's tests. That's a proactive approach that I appreciate. I did have a clear PET scan six months ago, but myeloma can be very sneaky.

Some Current Test Results:

Test		Jun 30		Jul 28		Aug 25		Sep 22		Remarks
M-spike g/dL		1.0		1.0		1.1		1.0		\ Tumor marker
IgG mg/dL		1070		1030		1150		1020		/ Tumor marker
Lambda mg/dL		1.74		2.21		2.25		2.49		L Free light chains
Calcium mg/dL		10.0		9.8		10.5		10.0		OK
Creatinine mg/dL		1.3		1.3		1.1		0.9		Kidney, good
HGB g/dL		14.8		15.1		14.7		14.9		Hemoglobin, OK
RBC M/uL		4.28		4.17		4.08		4.09		Red cells, low
WBC K/uL		3.6		5.1		3.8		6.2		White cells, normal
ANC K/uL		1.17		1.90		1.40		2.60		Neutrophils, normal

Related Links:

My Myeloma		A discussion of my myeloma, not very technical.
My Treatment History		Not technical.
My Test Charts		Graphic displays of several key test results over time.
My Test Result Table		Somewhat technical. Best with a wide browser window.
My Supplement Regimen		With links to where I buy them.

Presque Isle State Park, September 18, 2011, a view of Lake Erie from along the marathon route:

Collaboration With Team Continuum

I'm now running on behalf of Team Continuum, raising money for people living with cancer, while I pursue my goal of running a marathon in each of the 50 states. We three have a full schedule of marathons for the rest of 2011, including the New York City Marathon, the Marine Corps Marathon, and several others.

You can help. If you go to my new E-Race Cancer Facebook Page and "like" it, a donation will be made to Team Continuum by a third party. We invite you to do that - there is no cost to you.

While you are there, you are certainly also welcome to click on the Team Continuum link and make a further contribution to the cause.

Thank you!

Vitamin D3 and High Serum Calcium

At my last Mayo Clinic visit, serum calcium tested at an all-time high, 10.5 mg/dL. The reference range is 8.9 to 10.1 mg/dL, so it's significantly above normal. Why is that? (1) It could be the myeloma attacking a bone somewhere; or (2) Dr LH noticed that I take a lot of Vitamin D3 and Vitamin K2 supplements, and decided to measure INR and Vitamin D levels. INR was OK.

Vitamin D levels came back the next day, and a couple of days after that Dr LH called to discuss them:

Test Name	Result		Units
25-Hydroxy D2	<4.0		ng/mL
25-Hydroxy D3	71		ng/mL
25-Hydroxy Total	71		ng/mL	Total (D2+D3) optimum level is 25-80 ng/mL

Dr LH pointed out that the Total Vitamin D is near the high end of the optimum range, and suggested that I cut my Vitamin D3 from 5000 units per day to 2500 per day, which is easy enough to do. Arguments for doing that (these are from my own research):

• Some authorities believe that it is possible for continuously-high levels of Vitamin D to cause high serum calcium.
• In some individuals, high levels of calcium can result in deposition of calcium in arteries, atherosclerosis.
• There is really not enough research to determine the safe amount of supplementation.

Arguments against reducing Vitamin D supplementation:

• According to the Vitamin D Council, toxicity begins at about 200 ng/mL and higher. They suggest an upper limit of 100. Other authorities seem to agree, though research on humans is lacking and individual responses could vary widely.
• The purpose of the high Vitamin D3 intake, along with Vitamin K2, is to combat bone loss. In a one-year test this seemed to be effective, with two density scans a year apart showing no measurable difference in density. It's just one short test, but I'm reluctant to make a change that might reduce the effectiveness of this treatment.

So what to do? My serum calcium levels have varied widely in recent months. Below is a chart of recent measurements.

Possibilities: cut the Vitamin D3 supplement in half or leave it the same for the current cycle, and, either way, the serum calcium might stay high or it might go down. But if I cut the D3 in half and calcium remains high, then we should worry about a myeloma hot spot in a bone somewhere. That's the worst case scenario here, so let's check for it.

High Calcium

It's not extremely high, just 10.5 mg/dL, where the reference range is 8.9 to 10.1. But it could be an indication that the myeloma is etching holes in some bones somewhere. I don't even like to think about that. On the other hand, my calcium level does seem to bounce around a lot these days. It was 9.4 in May, 10.4 in June, then 10.0, and finally 9.8 in late July. Doctor LH says watch and wait, and hydrate, which can affect the calcium level especially. It certainly could be a hydration issue this time - I felt thirsty last night and probably didn't drink enough.

That "watching and waiting" business is one of the hardest parts of myeloma, because I do know of people whose bones broke while they were waiting. Fortunately, though, I do get new tests every 28 days, so I'm watching pretty closely, and if calcium stays high Dr L will probably do something to get a closer look.

Pomalidomide Study:

Otherwise, at the end of the 45th 28-day cycle of the study drug pomalidomide, IgG is up about 12% from last month. This is not good, but it's been there before, several times. Likewise M-spike, which follows IgG, is up 10% to 1.1 g/dL. Light chains are unchanged, and creatinine (kidney marker) is down, which is good. Dr LH pronounced the myeloma "stable."

Bactrim:

The doctors have prescribed Bactrim, a sulfa-based antibiotic, to be taken prophylactically to ward off opportunistic pneumonias. I've been stalling, reluctant to take it, but decided to try it a few weeks ago. After about a week of it, I had constipation, pain in my abdomen (probably from the constipation), and fatigue. These symptoms are not highly unusual and could have appeared anyway, of course, but they resolved when I stopped the Bactrim. Our pharmacist said that Bactrim has produced these symptoms in other people too. So I stopped taking it again, and will discuss it with Dr L on the next visit.

Vitamin K2:

I take 30 mg of Vitamin K2 (menatetrenone) every day, along with 5000 mg of Vitamin D3, to help protect and rebuild bone. Dr LH seemed concerned about the amount of Vitamin K2, because too much Vitamin K can theoretically affect blood clotting. I may be misrepresenting her concern here, but she ordered two more tests: INR, and Vitamin D level.

INR was 1.1, where the reference range is 0.8 to 1.2. This is OK, and certainly my blood is not too apt to clot. I don't have the Vitamin D level yet, but expect it to be fine.

AAA Screening:

Once in a lifetime a man who has ever smoked should be screened for an Abdominal Aortic Aneurysm. I did smoke for a couple of years, almost 50 years ago. I got smarter later, but the USPSTF (who?) recommends one ultrasonic exam of the abdominal aorta in such stupid men, sometime between the ages of 65 and 75. It's a simple ultrasound between the bottom of the sternum and the navel.

When it was finished, I told the technician that I wouldn't ask for a result, but asked if it was safe to drive home. She grinned and said "well, I'm letting you go, let's leave it at that." So I'm sure I passed, because a ruptured aortic aneurism has a very low survival rate and she would have kept me if she had seen a risk.

Some Current Test Results:

Test		Jun 02		Jun 30		Jul 28		Aug 25		Remarks
M-spike g/dL		1.1		1.0		1.0		1.1		Best tumor measure?
IgG mg/dL		1110		1070		1030		1150		Best tumor measure?
Lambda mg/dL		2.52		1.74		2.21		2.25		L Free light chains
Calcium mg/dL		10.4		10.0		9.8		10.5		High
Creatinine mg/dL		1.2		1.3		1.3		1.1		Kidney, OK
HGB g/dL		15.2		14.8		15.1		14.7		Hemoglobin, OK
RBC M/uL		4.13		4.28		4.17		4.08		Red cells, low
WBC K/uL		4.9		3.6		5.1		3.8		White cells, low
ANC K/uL		2.40		1.17		1.90		1.40		Neutrophils, Low

Related Links:

My Myeloma		A discussion of my myeloma, not very technical.
My Treatment History		Not technical.
My Test Charts		Graphic displays of several key test results over time.
My Test Result Table		Somewhat technical. Best with a wide browser window.
My Supplement Regimen		With links to where I buy them.

Leftover turkey and other good stuff:

Carfilzomib Access

Carfilzomib is a new proteasome-inhibitor drug similar to Velcade, but with fewer side effects. In addition, some patients for whom Velcade no longer works have responded to Carfilzomib in trials.

Until now it has only been available in limited trials, but a new trial has been announced which will make it much more widely available. Here is the link: The MMRF.

To be eligible, patients must have progressive disease, had at least four prior therapies, and be refractory to at least one of those. Please check the website (MMRF link above) for a better definition of eligibility and exclusion criteria. 40 different clinical centers throughout the country are enrolling for the study, so that patients can have access locally.

The drug will be provided at no cost until it become commercially available, which could be as soon as the first half of 2012.

If you've tried everything else, here is one more good therapy.

Stacy Needs Your Stem Cells

Stacy is a young Minnesota mother who needs an allogeneic transplant, and the doctors have not yet found a match for her.

For more information, please visit Minnesota Myeloma

L-Arginine

July 28, 2011

Cycle 44 of the pomalidomide trial is complete and my myeloma is still stable. IgG is down a few percent, M-spike is unchanged, and Lambda free light chains are up, but only to where they usually sit. NOT ho-hum, though - I'm always a bit nervous, because we know that the lovely ride on pomalidomide will come to an end someday. Not today though. Yay!

L-Arginine:

I mentioned to Dr RH that L-Arginine made a significant improvement in a uniquely-male problem for me. He seemed pleased, but did caution that there is some anecdotal evidence that L-Arginine can increase the frequency of cold sores (herpes simplex). Perhaps it helps the herpes virus to replicate. In the same vein, a blog reader has commented that he developed shingles (herpes zoster) while taking 2000 mg L-Arginine daily. Ouch.

Consequently, an increased risk of cold sores and shingles outbreaks may be the price of improved erectile function through L-Arginine. Cold sores might not be such a high cost, but shingles can be very painful and, in rare cases, can even result in permanent injury. Further, we myelomiacs have an unusually high risk of shingles, because our immune systems are impaired.

Nevertheless, I'm not stopping the L-Arginine, at least not until I learn the lesson the hard way. I take a daily capsule containing 500 mg L-Arginine and 250 mg L-Ornithine. However, I also take a daily tablet of L-Lysine 500 mg, which is reputed to help suppress those viruses.

Some Current Test Results:

Test		May 05		Jun 02		Jun 30		Jul 28		Remarks
M-spike g/dL		1.0		1.1		1.0		1.0		Best tumor measure?
IgG mg/dL		1130		1110		1070		1030		Best tumor measure?
Lambda mg/dL		3.07		2.52		1.74		2.21		L Free light chains
Calcium mg/dL		9.4		10.4		10.0		9.8		Normal
Creatinine mg/dL		1.1		1.2		1.3		1.3		Kidney, High
HGB g/dL		14.7		15.2		14.8		15.1		Hemoglobin, good
RBC M/uL		4.11		4.13		4.28		4.17		Red cells, low
WBC K/uL		4.6		4.9		3.6		5.1		White cells, OK
ANC K/uL		1.90		2.40		1.17		1.90		Neutrophils, OK

Creatinine is a measure of the kidneys' ability to clear waste from the blood, and has been a little high (wrong direction) for several cycles now. I don't quite know what to think about that. Drink more water I guess ...

Related Links:

My Myeloma		A discussion of my myeloma, not very technical.
My Treatment History		Not technical.
My Test Charts		Graphic displays of several key test results over time.
My Test Result Table		Somewhat technical. Best with a wide browser window.
My Supplement Regimen		With links to where I buy them.

Leftovers atop greens, with sweet potatoes and beans. Mostly organic, especially the sweet spuds, greens, and beans. The red lines on the sweet potato slices are a tasty pepper sauce:

Excellent IMF Seminar in Minneapolis

Dr. Parameswaran Hari, MD, MS, and Teresa Miceli, RN, BSN, OCN spoke to a large group at the Minneapolis Sheraton. Dr. Hari is Section Head and Clinical Director, Bone Marrow Transplantation, University of Wisconsin in Milwaukee. Teresa Miceli is a bone marrow transplant coordinator and preseneter at Mayo Clinic in Rochester, MN.

Dr. Hari:

You would be well served with Dr. Hari as your myeloma doctor. He certainly seems as knowledgable as any doctor I've met. He cruised through a lot of information, on a lot of slides, in a fairly short time:

• My Favorite: During a coffee break, a patient asked Dr. Hari, "What can we patients do besides just following our doctor's orders?" Back on the podium, Dr. Hari departed from his prepared presentataion with with brief, unscripted lifestyle suggestions:
  
  
  1. Fitness: He recommended both weight training and aerobic exercise for people whose bones can take the stress.
  2. Nutrition: In addition, he recommended more vegetables and less red meat. Further, he mentioned that curcumin is a helpful myeloma treatment for some people and harmless otherwise, but green tea (or EGCG) should not be taken with Velcade because the green tea can rescue the myeloma cells that Velcade tries to kill.
  
  I've never heard such an enthusiastic endorsement of lifestyle changes from any doctor before. Every one of my doctors has wholeheartedly supported the choices that I have made, training for and running marathons, and eating the best diet we can find, but Dr. Hari proposed a similar lifestyle out of the blue.
  
  
• He also gave a quick review of what myeloma is;
• Some statistics about cases, including length of survival as treatments have improved;
• Some discussion of "high risk" versus normal risk myeloma;
• Spine repair;
• Current therapies, including the "novel" therapies: thalidomide, Revlimid, Velcade, and others in various ombinations;
• Transplants, including auto, allo, mini-allo, and combinations;
• Post-transplant consolidation and maintenance;
• Treatments which are in clinical trials including pomalidomide, catfilzomib, elotuzumab, and more;

More than once, Dr. Hari mentioned that the cure for myeloma is to hold it off long enough to die of something else, and he believes that should be the treating physician's first goal.

Nurse Miceli:

Teresa Miceli's presentation was titled "Managing Side Effects of Myeloma and Novel Agents:

• She discussed how myeloma itself impacts quality of life;
• Gastrointestinal side effects;
• Myelosuppression (low blood counts);
• DVT and other blood clots;
• Peripheral neuropathy;
• Renal function (drink, drink, drink);
• Bone health; and
• Sexual function and dysfunction.

What can we do in our battle with myeloma? Drink lots of water!

Thanks to the International Myeloma Foundation for hosting this seminar, free of charge to all.