Delayed in Dallas: Lesson for travel and CLL

Sometimes it seems being smart and having connections allows you to see the train wreck coming, but may not let you get off the train.

Still in Dallas trying to fly home from Orlando.

I was notified as we landed of the delay due to change of planes. That pushed back our departure just long enough to catch the start of the weather delay. Now we have been delayed three more times for mechanical issues. 10 or 15 minutes each time. I get test messages every 10 to 15 minutes with the latest update from American Airlines. But we all know that nothing on a plane takes 10 or 15 minutes, but they soften the blow with these mini delays until sometimes it's too late to do anything, to find another way home to the west coast.

I thought about taking a later flight out when I first heard of the trouble, but this flight was scheduled to leave two hours earlier so I gambled it was the better choice.

The joys of flying. I guessed wrong.

Sometimes CLL is like that. You might know that your FISH report is bad news, that the best option for a remission will whack your marrow, that infections are a significant risk, but what can you do?

You do your best is what you do.

Make a wise choice and hope for the good response without too much damage and keep moving forward. Sometimes you realize that maybe you didn't make the best choices, but you must forgive yourself and move on. How could you know, and even if you did know, it might not have made any difference.

The one advice I have for flying or tackling CLL is to keep your options open. Try to avoid the last plane home that night. Look at the departure schedule. Know your Plan B. Have your airline phone number on speed dial. And bring a few extra days of your meds just in case.

What about CLL?

Try not to close doors for future cancer treatments and try to walk through doors that open that might lead to a chance for a long healthy spell between decisions and delays. They may not stay open for long, so the timing of when to start therapy is always tricky. As I have said before, the best time to start therapy is a few weeks before you need to.

I will eventually get home. The mechanic is aboard. Maybe we can leave real soon? We were just ask to fasten seat belts so that's a very good sign.

I am off to Ohio State next week for my clinical trial assessment. No direct flights I am afraid between anywhere in southern California and Columbus. I chose to fly through Phoenix to avoid weather. I am optimistic that route was a wise choice.

But my real optimism is reserved for my banging the door open to Dr. Byrd's trial with PCI-32765 and ofatumumab, That I am betting will turn out to be a sea change of a wise choice.

I am finishing this post 30,000 feet up in the air nearing home, so all is well.

Why I am keen on PCI-32765

This very nice blog post deals with the business as much as the scientific aspects of the enthusiasm about Bruton's Tyrosine Kinase (BTK) Inhibitors, specifically PCI-32765 in CLL and other B cell lymphomas.

It is a nice simple introduction to how the BTK inhibitors work and outlines the little but promising data presented at ASH 2011. The blog does not mention the 89% progression free survival in CLL.

I suspect we still don't have the whole story. In fact, I am sure we don't.

What do you think?

Am I and many others over excited about this little pill when the evidence is still pretty sparse?

Probably, but there doesn't seems to be much downside, and the other options of doing nothing or using an established therapy sure have their own very real problems.

And I can always move onto those options later if PCI-32765 doesn't work out. Moving in the other direction is not a likely option.

I am not going there. I have every reason to believe that I will be part of the vast group of dramatic responders, especially since my disease is so concentrated in my nodes and my 11q deletion has pretty much done everything by the book so far, which means my clone should melt away in this trial.

Can't wait to get started.

I see Dr. Kipps in three days to go over my bone marrow biopsy and get his final blessing on my plans.

Getting closer

I am fully approved with my authorization numbers for the consult with Dr. Byrd at Ohio State to see if I qualify for the trial. Hard to imagine that if my insurance OK'd the consult to see if I was appropriate for the trial they would give me grief about enrolling in it if Dr. Byrd so recommends.

I am feeling pretty confident that Blue Shield, OSU, my docs here and I are all pulling our oars in the same direction now and it will all work out.

The reams of medical records as PDFs, photocopies, and on disc are slowly coming together.

Hotel is booked. Rental car will be done tomorrow.

My bone marrow biopsy FISH showed my 11q del in an estimated 11.5% of my cells. Surprisingly, this is the first time over the many years at UCSD at Kipps's lab or at City of Hope with all my blood tests, bone marrow biopsies and even the removal of the huge mass of CLL cells with my splenectomy that the FISH has confirmed my original finding of 11q deletion at time of diagnosis. That is a matter for a much longer post, but it will have to wait until a time I am more awake.

With the patient help of my son Ben, I have made good progress on getting the ASH videos online and they should be available by next week. I am very pleased with the project to educate primary care providers about CLL and transplants.

Watch here soon for more on a link to an audio file on handling the stress of CLL with hypnosis. Another project I am very proud of and one that I hope will not only certainly help those who listen to it, but will also raise a bit of money for CLL research. More later. I promise.

It's all getting closer.

BLUE SHIELD BLUES

I am being very nice, honest, though at times it is not easy, answering the same questions over and over again after waiting on hold to cheery recordings of all the same tips about how to save my insurance company money.

Today is my third day of hours on the phone with Blue Shield of California member services, prior authorization, appeals, case managers, and supervisors, and who knows what and who else trying to get authorization for the Ohio State University consultation with Dr. Byrd for my clinical trial with PCI-32765.

It seems that their right hand doesn't know what the right wrist and the right pinkie is doing.

It's an appeal. It's a prior authorization, It's wrapped in with the clinical trial. No, it's back to a prior authorization. It's Super-Conflated.

After hours on hold and multiple lateral passes yesterday, I thought that when I finally got a phone number and a reference number from a case manager for my local oncologist to use with clear instructions of what he needed to do, the path was clear to a yes or no.

Boy, was I naive. His nurse got the same polite run around that I did today.

But everyone (even me), is very sweet and tries to be oh so helpful.

Remember all I am trying for is authorization for the relatively cheap mandatory consult to assess whether I am a candidate for the trial, not for the pricey trial itself. I understand quite sensibly that once it is ascertained that I indeed qualify, OSU will then apply for the trial coverage, and that is the real critical action. I am quite confident that will work out. And I am very confident that I will be in the trial by February.

I suspect, again probably naively, that the authorization for the trial itself is a more traveled route and an easier path to navigate.

This is just a fun and informative diversion in learning how the other big blue (not IBM but Blue Shield or BS) works.

The trial is the goal. I can pay for the consult, but not the trial. This is the practice run. I am keeping detailed records. I am hoping that I don't need them.

I am keeping my eyes on that prize. For a chance for real durable disease control. The excitement of a healthy and lengthy old age, a new drug that offers a true truce with my leukemia: these joyful possibilities almost get lost in these side battles.

I remain realistically confident that 2012 will be the beginning of the end of CLL struggles.

And very polite and helpful.

Death and Renewal

Today is the winter solstice, the shortest, darkest, blackest day of the year.

Six months ago on June 21, the first day of summer, the brightest longest day of the year, I lost my father.

I have said Kaddish (the Jewish prayer for the dead) every Sabbath for him except thrice where a could not find a minion, the 10 Jews necessary to formally pray. It happened once in Cusco, Peru, once in a distant suburb of Dallas near the airport, and once on the road in Arizona. Other than that, I have enjoyed hospitality at all types of temples and synagogues all over the USA.

Though Kaddish is prayed ostensibly to guide his soul to a well deserved place of rest, it is more for me to remember what a son received and a father gave. We were good friends and honest counsel for each other, especially over the last part of out 60 years together. I miss him so much it still hurts .

I lost a sweet friend one year and one day ago. Another father but of three young children, not of one older son about to enter his seventh decade like my 84 year old father. Robert died of CLL too young, too soon, too unfairly, and with too much love left to give and receive.

Not much in life is guaranteed, but one thing for sure is that the days will grow longer and the nights shorter.

That must be enough for now.

The world of CLL is changing fast and it's good.

For the last week, I have wrestled long hours with many demons in the form of questions of insurance and chance and convenience and travel and risk and unknowns and timing and money.

I have had help from so many especially my family and a few dear friends, but also my insurance broker and my case manager and my local oncologist.

In CLL, there are three types of crises. The disease related ones, the treatment related ones, and the decision related one.

I have just slayed the last one- for now. I have made my next treatment decision.

I am gambling everything on getting into and doing great in the Ohio State University trials that include PCI-32765.

I am full of hope.

Tomorrow will be less dark than today for sure.

Fewer long shadows, more sunlight.

PS I have not forgotten my promise of a recounting of ASH. First I needed to heal myself. Or at least decide what was my my chance of getting to that place.

Insurance woes with Clinical Trial NCT01217749 at OSU using PCI 32765 and Ofatumumab

It looks like a tough decision I made to take the next step in my treatment path could be undermined by the big bad insurance company and the university teaching hospital with its inflated fees.

Here is what I wrote my online friends in the CLL community. This is aggravating stuff, but not the real bad stuff. Bad stuff is crashing or skyrocketing counts and worse. This is about money and a tilted system of health insurance. What could be bad, but I am not there yet is the removal of choice, the removal of a hope. I would hate that, but I am not there yet.

Soon I will post why this is my favored course of action today, but right now I am just trying to find a way to make it a realistic possibility. This is only the beginning. The door is not shut yet. I just need the pass code. Or the route to the backdoor. Or....

Hi,

My CLL needs treatment again, and after much thought and research, my first choice is Clinical Trial NCT01217749 at OSU using PCI 32765 and Ofatumumab, BUT my insurance, ANTHEM HMO covers nothing non emergent out of state.

What I understand about the trial is that the meds are free but everything else (usual standard of care is the coy term used) would be at my expense at the wrack rate- pricy for the individual payor (unlike the insurers who often pay pennies on the dollar). Labs, doctors' visits, BMB, CT scans all would be my responsibility. Maybe over a $100,000 for the whole deal.

Do I have this right?

Any advice?

Is it possible to negotiate to get a discount rate or a flat rate for the study?

Is it possible to get the bulk of the work-up done in my home state where my only cost is the co-pay?

Any other thoughts? Insights?

It is hard enough to make a treatment decision, even it is a preliminary and tentative one.

As the old joke goes: Besides bankruptcy, what other side effects does this treatment have?

Thanks as always. I bet there is a way to make this trial happen if it should. Just another challenge. Compared to CLL, this should be easy.

On a less challenging note, I am excited to be off to ASH next week as a accredited reporter (I keep picturing Jimmy Olson at the Daily Planet). Lots of good stuff on CLL especially PC! -32765 and CAL 101 and lenalidomide. In addition to trying to save my own skin by learning the latest on CLL and transplants and ITP, I am looking to help other family docs learn more about hematology and will be videotaping interviews with several experts.

Email if you have any burning questions or thoughts on what you or a good primary care provider should know about blood disorders. I will let you know when I post the videos.

We are all in this together (well maybe not the insurance companies).

Brian

I always have the rebbe to help me:

"Life is a very narrow bridge. The important thing is not to be afraid".- Rebbe Nachman of Bratslav

More from Brooklyn- Kinase Inhibitors for CLL

Except maybe for a transplant, a cure for CLL is still not around the corner and is not likely going to be a single magic bullet. Progress is rapid and exciting, but clinical application is slow and very very expensive.

What is more likely is that a series of lower toxicity, higher specificity, more personalized therapy will be coming our way.

If we choose wisely, and are on the happy side of the survival curves AND meet the strict entry criteria for a trial (set up to insure approval of the drug and not to help the patients in the study) or the very limited FDA indications for our therapy (established among other reasons to give insurance companies coverage to say no to our needs) AND can afford the possible calamitous expenses of these new approaches either through insurance or our savings, we may be able to keep going for a long long time.

Some of the options include the new generation of small molecules that inhibit pathways that are preferentially expressed in CLL cells. Often these drugs block the cross talk (BCR) with other supporting cells, making the cancer clone more vulnerable.

I didn't see any data in Brooklyn, but I heard reassurance that these oral drugs like PCI 32765 (as the manufacturer's web site says: "As a Btk inhibitor, PCI-32765 blocks BCR signaling in human B cells but does not affect T cell receptor (TCR) signaling") and CAL 101 (a selective PI3 kinase inhibitor) and others in the pipeline not only shrink the nodes, but that the rise in the white count when the clonal cancer cells are run out the nodes is only temporary and it too falls to normal, AND even the bone marrow gets cleaned up.

Few side effects, but the risk of infection is significant and seems to me is a bit underplayed.

These drugs are going to big part of the future of CLL management, but now they are only available in trials, and it seems that you need to stay on them very long term or the leukemia quickly flares up again. Nodes can flare up again almost overnight to bigger than they were before therapy But the argument on the other side, is that if they are so safe, no worries, why not stay on them forever. The drug companies love this logic, but that is true with a ton of other therapies from insulin to blood pressure meds.

To their credit, the drug companies are allowing patients to continue (for free) on the meds after the trials are closed.

Not close to a cure, still they are a big step forward.

For that I am grateful.