Secret Shoppers: Needing A Weatherman To Know Which Way The Wind's Blowing

Brian Klepper

June 28, 2011

Every now and then, a well-intentioned administration does something relatively harmless but so hare-brained and openly foolish that it takes our breath away. The Obama Administration’s primary care “secret shopper” plan fit this bill, and has already been shelved due to the withering criticism. My inbox a couple days ago was filled with rants by physicians of all political persuasions marveling at the lameness of the idea.

Here’s a short description from Robert Pear’s article in Sunday’s New York Times.

The administration says the survey will address a “critical public policy problem”: the increasing shortage of primary care doctors, including specialists in internal medicine and family practice. It will also try to discover whether doctors are accepting patients with private insurance while turning away those in government health programs that pay lower reimbursement rates.

Elaine Update 6/04/11

Friends,

A little more than a month ago, Elaine was in the kitchen, cooking and I was sitting at the counter, writing. She suddenly whirled around and said, “It’s a year today. It’s April 26th. The big surgery was a year ago today.” It was worth noting. It had been a difficult year, but we are both still here and happy together.

We’re in the flow of cancer now. It is a regular routine, as though everything’s alright, but with the nagging awareness that you’re under the Sword of Damocles. After her first round of conventional chemotherapy, Elaine entered remission, which means that most of the signs and symptoms had disappeared. But in all likelihood the cancer remains, with fewer cells present. For now.

Most women with primary peritoneal cancer have a similar experience. Their cancer is knocked back for 12-36 months and then it recurs, strengthened and more ferocious than ever. The problem is that, after the wrenching experience of chemotherapy - the hair loss, the intestinal roller-coaster, the bruising - nobody much wants to press on, and there’s the sense that you’re in a lull and can relax just a little.

That’s an illusion. Cancer is a stealthy, sneaky, relentless adversary, and it’s at it day and night. Or as my friend Tom Barr noted the other day, “the Emperor NEVER takes a day off.” This means that the ONLY path is vigilance, and pursuing every possible rational lead, independent of whether we feel like it or not. We’re after long term benefits for short term sacrifices, however difficult those may be.

With cancer, patients’ realistic options have been extremely limited in the past. But there’s one in front of us now that appears to be promising, and the very leading edge, not just of cancer care, but of medicine. A colleague at Harvard learned about Elaine, and put us in touch with a small Boston personalized medicine start-up. N-of-One (great name!) doesn’t provide care directly, but is really a personalized cancer treatment ombudsman service. It is based on the understanding that cancer most often occurs from mistakes in the genetic code, and that individuals with the same kinds of cancer can have dramatically different error signatures.

Here’s an excerpt of the explanation under the heading “Discovering the Molecular Signature of Cancer” on the N-of-One site.

...most cancers are associated with mistakes in the genetic code. Such mutations have been found in more than 120 genes. These genes control the synthesis of proteins that carry out the biochemical reactions (referred to as molecular signaling pathways) that regulate cell division, growth, and death. Mutations to one or more of these genes may cause a cell to produce too much or too little of a key protein or produce a defective protein that does not respond appropriately to the molecular signals. Carcinogenesis is initiated when these mutations are sufficiently severe to disrupt the molecular pathways that control cell division and other related cellular properties, resulting in the formation of a tumor, invasion of surrounding tissues, and metastasis. 

Each cancer has its own unique genetic and molecular signature. This explains why individuals with the same type and stage of cancer may experience dramatic differences in their responses to chemotherapy. Researchers now have the means to rapidly analyze the unique signature of a patient's tumor based on the expression of the genes involved in its carcinogenesis. This capability has opened the door to more accurately predicting the outcome of a patient's cancer and individualizing his or her treatment to match the molecular characteristics of the tumor.

Think for a moment what a breathtaking, sweeping advance this is! It is now possible to conduct assays on tissues to evaluate mechanisms at the level of the gene. Then we can try to match the particular configuration of problems with therapies that exist or, alternatively, build a new therapy that can target that individual’s issues. This approach, still very much in its infancy, of course, moves medicine to a much deeper, more individual level of biology than ever before, and has immense promise.

So, in this approach, the N-of-One team would coordinate assays at labs around the country, each of which provide high expertise in different tests. As the results come in, a genomic profile would be assembled that reflects the patient’s - in this case, Elaine’s - molecular characteristics.

Then a search would be conducted to match Elaine’s genomic signature to an available genomic therapy. At the moment, there are nearly a thousand of them, though most aren’t germane to Elaine’s condition. Still, it is probably safe to say that there are more than any busy practicing oncologist can keep track of on his or her own. (Actually, it’s worth noting thatElaine’s current treatment regimen, a one-year course of Avastin, falls into one of the four categories of currently established genomic treatments.)

This is important. This approach is credible, yet few physicians I’ve spoken with have more than a passing knowledge of what’s available. Which means that many patients with serious conditions who might benefit from it, don’t, because their doctor is too immersed in the day-to-day to really understand it.

We’re now seriously assessing going down this path. Steve Buckley, our wonderful gynecologic oncologist, sat in on our call with Jennifer Levin-Carter, MD, the Founder of N-of-One, and is thinking through this with us. If we proceed, Dr. Buckley would still manage Elaine’s case, but presumably he’d have access to a great deal of new, better information.

It’s important to keep this in perspective. When it’s all said and done, this approach, at this time, may provide no benefit for Elaine. But maybe it will. And that what makes it seem worth it.

In the meantime, Elaine is as beautiful, happy and busy now as I can remember. Our kitchen is doubling as a painting studio. There’s yoga and reading and some discussion of new ventures. Strange to say, but it’s a remarkable, productive time.

More as events unfold. Thanks again for going through this with us. 

B

An Anniversary (Elaine!)

Dear Friends,

I am celebrating an anniversary!

It has been one year since I began chemotherapy for stage 3c primary peritoneal (ovarian) cancer. Today I am in remission, enjoying life, and have learned to call myself a survivor.  There were less than cheery moments when the view from the bottom of the hill was overwhelming but never enough to shake my resolve.  Brian shared my journey on this blog with candor, humor, and always with love.  Because of him, I have been connected to a unique world of family, friends, clinicians, caregivers and scientists, many of whom I never met but who have sent me wonderful messages of affection and support.

I want to share my personal reflection of that long year. It has been an everlasting challenge to make peace with things over which I have no control.  I remind myself that I cannot be angry that this unthinkable thing happened to me or that it is a result of some failure on my part. I cannot resent the people who throw health caution to the wind and go about their business without getting cancer.  And I will always be subject to the capriciousness of a disease that may choose to pursue its spiteful path again. These are things I cannot change and fighting them will do nothing but steal precious energy.

I came to appreciate family and friends in a deep and different way.  This, of course, is the universal mantra of all who survive cancer although it is impossible to grasp its importance until we face a devastating event.  And so I am grateful for the times when they were there, especially the small moments that would likely puzzle them if they knew that the visit, the phone calls, the little gifts or the emails made me smile on the toughest of days.  I loved the jokes about my bald head and the cards with wisecracks.  And most of all, I loved those who did not treat me differently or define me by my illness. 

My view of the future has changed.  The future is not ten or twenty years down the road but rather it is tomorrow, next month or next year and it is still fraught with anxiety.  The odds that I will face this again in my lifetime are very strong but Brian and I are pragmatic about it.  I have had magnificent care from doctors and medical professionals who have given me the very best they have to offer.  I am indebted to them for their skill and more importantly for their honesty about the gravity of my illness and the frustrating limitations of medicine to deliver a cure. 

Finally, I give my greatest thanks to Brian.  He has never left my side, literally or figuratively, for a second of these past fourteen months.  It was less about bravery and more about the comfort of his presence that helped me through painful hours, fearful procedures, long nights and weary days.  He has been tireless and relentless, I might add, in seeking information about research, new science, and innovative treatments.  He has seen me at my worst, has never let me lose my sense of humor, and absolutely will not let me forget for a minute that I have a condition that must be managed and monitored every day. 

I retired in January and have enjoyed the guilty pleasures of reading endlessly, painting, Yoga and taking delicious naps in the afternoon.   I elected to continue with a maintenance treatment of Avastin every three weeks for a year which we hope will hold the tumors at bay.  We have also begun to explore the possibility of targeted therapies based on genomic research.  I shall leave it up to Brian to be my voice with regard to the clinical details and efficacy of those treatment plans.  But today, as I celebrate a year of survival, I am content with life, I have a grateful spirit, and I am hopeful of the future. 

Regards,

Elaine

Seeking What's Possible

Friends,

A little more than a month ago, Elaine was in the kitchen, cooking and I was sitting at the counter, writing. She suddenly whirled around and said, “It’s a year today. It’s April 26th. The big surgery was a year ago today.” It was worth noting. It had been a difficult year, but we are both still here and happy together.

We’re in the flow of cancer now. It is a regular routine, as though everything’s alright, but with the nagging awareness that you’re under the Sword of Damocles. After her first round of conventional chemotherapy, Elaine entered remission, which means that most of the signs and symptoms had disappeared. But in all likelihood the cancer remains, with fewer cells present. For now.

Most women with primary peritoneal cancer have a similar experience. Their cancer is knocked back for 12-36 months and then it recurs, strengthened and more ferocious than ever. The problem is that, after the wrenching experience of chemotherapy - the hair loss, the intestinal roller-coaster, the bruising - nobody much wants to press on, and there’s the sense that you’re in a lull and can relax just a little.

That’s an illusion. Cancer is a stealthy, sneaky, relentless adversary, and it’s at it day and night. Or as my friend Tom Barr noted the other day, “the Emperor NEVER takes a day off.” This means that the ONLY path is vigilance, and pursuing every possible rational lead, independent of whether we feel like it or not. We’re after long term benefits for short term sacrifices, however difficult those may be.

With cancer, patients’ realistic options have been extremely limited in the past. But there’s one in front of us now that appears to be promising, and the very leading edge, not just of cancer care, but of medicine. A colleague at Harvard learned about Elaine, and put us in touch with a small Boston personalized medicine start-up. N-of-One (great name!) doesn’t provide care directly, but is really a personalized, cancer treatment, concierge ombudsman service. It is based on the understanding that cancer most often occurs from mistakes in the genetic code, and that individuals with the same kinds of cancer can have dramatically different error signatures.”

Here’s an excerpt of the explanation under the heading “Discovering the Molecular Signature of Cancer” on the N-of-One site.

...most cancers are associated with mistakes in the genetic code. Such mutations have been found in more than 120 genes. These genes control the synthesis of proteins that carry out the biochemical reactions (referred to as molecular signaling pathways) that regulate cell division, growth, and death. Mutations to one or more of these genes may cause a cell to produce too much or too little of a key protein or produce a defective protein that does not respond appropriately to the molecular signals. Carcinogenesis is initiated when these mutations are sufficiently severe to disrupt the molecular pathways that control cell division and other related cellular properties, resulting in the formation of a tumor, invasion of surrounding tissues, and metastasis.

Each cancer has its own unique genetic and molecular signature. This explains why individuals with the same type and stage of cancer may experience dramatic differences in their responses to chemotherapy. Researchers now have the means to rapidly analyze the unique signature of a patient's tumor based on the expression of the genes involved in its carcinogenesis. This capability has opened the door to more accurately predicting the outcome of a patient's cancer and individualizing his or her treatment to match the molecular characteristics of the tumor.

Think for a moment what a breathtaking, sweeping advance this is! It is now possible to conduct assays on tissues to evaluate mechanisms at the level of the gene. Then we can try to match the particular configuration of problems with therapies that exist or, alternatively, build a new therapy that can target that individual’s issues. This approach, still very much in its infancy, of course, moves medicine to a much deeper, more individual level of biology than ever before, and has immense promise.

So, in this approach, the N-of-One team would coordinate assays at labs around the country, each of which provide high expertise in different tests. As the results come in, a genomic profile would be assembled that reflects the patient’s - in this case, Elaine’s - molecular characteristics.

Then a search would be conducted to match Elaine’s genomic signature to an available genomic therapy. At the moment, there are nearly a thousand of them, though most aren’t germane to Elaine’s condition. Still, it is probably safe to say that there are more than any busy practicing oncologist can keep track of on his or her own. (Actually, it’s worth noting that Elaine’s current treatment regimen, a one-year course of Avastin, falls into one of the four categories of currently established genomic treatments.)

This is important. This approach is credible, yet few physicians I’ve spoken with have more than a passing knowledge of what’s available. Which means that many patients with serious conditions who might benefit from it, don’t, because their doctor is too immersed in the day-to-day to really understand it.

We’re now seriously assessing going down this path. Steve Buckley, our wonderful gynecologic oncologist, sat in on our call with Jennifer Levin-Carter, MD, the Founder of N-of-One, and is thinking through this with us. If we proceed, Dr. Buckley would still manage Elaine’s case, but presumably he’d have access to a great deal of new, better information.

It’s important to keep this in perspective. When it’s all said and done, this approach, at this time, may provide no benefit for Elaine. But maybe it will. And that what makes it seem worth it.

In the meantime, Elaine is as beautiful, happy and busy now as I can remember. Our kitchen is doubling as a painting studio. There’s yoga and reading and some discussion of new ventures. Strange to say, but it’s a remarkable, productive time.

More as events unfold. Thanks again for going through this with us. Keep reading for Elaine’s take on where we are now.

B

The Breather

Elaine's 6-month long, first line chemo-therapy treatment finished 4 months ago, in October, and she's looking positively radiant. Now that she can taste again, she's put on a little much needed weight. Her hair has grown back into a very short but very attractive style, and people who don't know her or about the cancer spontaneously tell her how cute it is. (She's said, "My oncologist did it for me.") The bruising, the digestion problems, the numbness in her feet and hands, the relentless fatigue all have improved as we've entered the honeymoon period that is remission.