Sunday, April 20, 2008

Boston & Protocols

The Dana Farber Cancer Institute is an amazing complex. Tyler and I were there for two days to discuss treatment options for Tyler. The oncologist took the time to listen to our questions and provide honest answers. We found a willingness to discuss options to a degree we have not experienced in the process thus far.

The conversations at Boston were about protocol options. It has been an education learning about the extreme reliance most pediatric cancer facilities place on protocol. There are many advantages to the protocol process. Protocols are based on the collective data of hundreds of cases. That data is then reviewed and analyzed by experts throughout pediatric oncology. Therefore the doctors are making decisions based on collective knowledge that goes well beyond what they would ever be able to learn from their own experiences. There is also a significant benefit of a much more streamlined treatment, requiring fewer staff and more cost effective management.

However we are learning a negative side to the protocol process. Protocol treatments are based on a "statistical average" patient. All patients are treated as though they are identical to this "hypothetical statistical model". Protocol medicine is actually the opposite of individualized care. This becomes a real problem when you realize that children, especially teenagers, typically have rare cancers. Few of these rare cancers have their own protocols. The protocols are borrowed and modified from other cancer treatments. In fact, in the past 25 years, only one new drug has been developed for pediatric cancers. The chemo drugs Tyler is on were all developed in the 1960's.

I do not understand the approach. In business I guess I use protocols. I repeat things that have been successful in the past. I try to streamline things as much as possible. But I am always on the outlook for the deviations. After 20 years, I have a very successful system at selling homes. But I never assume anything. I have a standard process in place, but I watch closely for any deviation in the expected results. I do not understand a process of ignoring those deviations, while have an almost biblical faith in the protocol.

I have brought to the doctors attention 6 specific areas where Tyler is deviating from the "model" that they are treating. However they refuse to discuss the concerns. It is not because they believe the concerns are unwarranted. It is because there are no established protocols telling them what to do about the deviation. As a result they stay the course regardless of ANY deviation (other than those spelled out in the protocol). There is no discussion of Tyler's individual situation.

On a related issue, there are three specific drugs I believe Tyler needs. They are called "smart bomb" drugs, and are able to identify and destroy the specific cells carrying the cancer. They do far less damage, and have fewer side effects, than the chemo drugs he is on. The trials have shown very positive results with these drugs, however our doctors insist that the drugs can not be used on pediatric stage IV Burkitt's. Why not? Is it because it has been tried and doesn't work, or because it has never been tried? The question seemed to be irrelevant to our doctors. With a few hours of Internet research, and calls to the pharmaceutical manufacturers, I learned the trials relating to stage IV Burkitt's are underway, and showing promising results. But the results are not yet in the protocols. The reason? It takes 350 trial cases before it becomes protocol. Since Burkitt's is very rare, it will take several years before they have the necessary numbers. In the mean time these promising results will be ignored, waiting to become established protocol. It becomes even more troubling when you learn that these new procedures tend to be more expensive, and the insurance companies are actively involved in the protocol process.

A five year study at Children's Hospital of Philadelphia recently concluded that teenagers have declining survival rates from cancer. The study concluded that the problem was due largely to the lack of access teenagers have to clinic trials, requiring them to stick to older protocols. Those receiving the newer treatments available in clinical trials have vastly superior survival rates. But many childhood cancer trials have a maximum age of 13, while many adult trials often have a minimum age of 21. Is it a coincidence that 15-19 year olds have the lowest cancer survival rates? In our very first meeting with the doctors after Tyler's diagnosis, I tried to get Tyler into one of the trials, but through a mishap by Children's, he was disqualified for the trial. We were told nothing could be done, but have since found that there were other options.

I believe our doctors are very concerned about patient care. However, several books and articles have come out recently citing studies with concerns about the system many doctors must work within.

--Much of the medical training is about following protocol, not about decision analysis.

--The Doctors are required to take on more and more cases, and simply do not have the time for individual care. At Children's, each oncologist carries an average of 50-65 cases, many of which are critical. That is in addition to teaching, doing rounds, and clinic duty. The system is structured such that they do not have the time to focus more than a few minutes a day on each patient.

--Streamlined protocol care is much more cost effective, therefore the doctors often receive enormous pressure from both insurance companies and the hospital administration to stick within protocol.

--Staying within the established protocol "box" gives safer protection against potential lawsuits. This places further pressure on the doctors from the hospital legal departments.

I have heard about the benefits of a total adherence to protocol. But I still question the "one size fits all" approach. If it is so good, why do cancer patients in clinical trials do so much better? These kids are individuals. They are not products on an assembly line. I do understand the financial advantages of a more predictable and stream lined system. How much of the enthusiasm for protocol is motivated by financial rather than medical reasons?

As with every father, I want only one thing...the best treatment for my son. As with every father, I will stop at nothing to accomplish that. When our questions were ignored, I contacted the department head. When that was ineffective, I called the hospital CEO. When I felt the answers were incomplete and evasive, I called the research physicians that developed the protocols, then doctors participating in the trials, the CEO's of the companies that made the drugs, and every hospital associated with those activities. Would you do less for your child?

We have been speaking with other hospitals that seem to have a more balanced approach in the protocol vs individual care discussion. Boston prefers to stick to protocol, but is at least willing to discuss other options.

Our initial discussions with MD Anderson (we have has several), indicate a very open philosophy toward communication and the discussion of treatment options for your child. MD Anderson opened the very first speciality focusing on the unique characteristics of cancer in teenagers and young adults (ages 15-25). According to Dr. Eugenie Kleinerman of MD Anderson, “Cancers that develop in adolescents and young adults have a distribution and biology that is distinctly different from that of cancers in children or in adults, although it’s unclear exactly why.” They may not have all the answers, but at least they are willing to ask the questions. We go there tomorrow.


beth said...

We need to talk...the things that you are describing cross over to other areas... In our case spinal cord injury and traumatic brain injury. Alex has always been treated by the knowledge and protocols that are established for the very few that have ever survived an injury even close to his...THIS DOES NOT WORK!!!!!!! Each individual is individual. If the system cannot change as a whole right now, the question becomes...what can we do to make changes where we are at within the system on the individual levels. What about those that do not have the abilitiy to discern things for themselves? Squeaky wheels can make changes but it takes alot of patience, perserverance, courage, stamina... and guidance from a source that guides where human eyes cannot go on their own...I am with you Kyle!

Anonymous said...

AMAZING! We have experienced very similar attitudes with our sons treatment. Thank you for your posting this!

deyerles said...


I have a friend who has been going back and forth between here and M.D. Anderson's for the past eight years. She has been in several studies over the years and has been able to maintain very well. She was first diagnosed with stage 4 lung cancer eight years ago and given NO treatment options. I know M.D. Anderson has options that other don't. We are continually praying for you all and praying God gives you the answers you need.

Keep Fighting to Win Tyler!


Laura said...

Amen, Amen, Amen....When our daughter was having issues with care at Children's we were told by friends within the system to be very focused on being her advocate regardless of the brick walls that were being put in front of us.....You are exactly right - push forward. Challenge everything. Our children deserve nothing less!!!

My prayers are with you!!!!

Anonymous said...

You are correct. Our experience with our twins was that all was good as long as we did not questions the doctors. If we questioned them, we were shut out. That giant brick wall came up. The clear message was sit back and have total faith in the doctors. But these people are not gods. We must fight for out children.

Lori Brown said...

Best of luck with your trip to Texas. We continue to keep your family in our thoughts & prayers.

Anonymous said...

My cousin was treated for cancer at Children's in Columbus also, a few years back. I remember hearing those same frustrations and complaints that you mentioned. In all fairness though, my daughter was treated there for for GI problems, and all went extremely well, and the doctors didn't sound anything like the cancer doctors. The GI doctors were very helpful, answered questions, and we felt we were very informed. Maybe the cancer doctors could learn something from them! It's too bad that you are having to go through all of this, and you don't even have confidence in the doctors who are treating your son. Don't they know this is hard enough on all of you, without them making it more difficult? Good luck at MDAnderson.

Anonymous said...

Keeep being the best cheerleader your son will ever have. I admire your strength in fighting for what is best for Tyler. Gone are the days when we knelt in awe and praise of the health care professionals. NOT that we do not honor and respect them [I am in health care] but we know they are human and make mistakes and do not have ALL the answers!
Connie Lukacs

Jeremie Barr said...

It was nice to meet Kathy and Tyler today at clinic. Good luck in your continued battle. Just know that you are in our thoughts and prayers.
Jeremie Barr(Matthew's father)

Anonymous said...

We're still praying for you guys. I hope this trip to MD goes well.


Kyle said...

Just a responce to the comment above about the GI doctors at Children's. I would agree. Our experiences with GI and with Radiology have been great. It was the GI doctor who immediatly identified Tyler's cancer and sent us dirctly to Radiology. Between the folks from GI and Radiology, we had all of our information very quickly. We were given resources to go to find further information. Our questions were never treated as bothersome. It was 3 or 4 days later that Oncology finally came to us with all the same information. By that point we were well prepared with questions,but the docs were clearly unprepared to answer our questions. The attitude was very different.

Tammy C said...

My head was spinning after reading this entry.At Boy Scouts I asked a father who has a daughter in remission from brain cancer.Since he was very familiar with protocols he explained it more to me.

Thanks for the updates.

Anonymous said...


My prayers are with you daily.

Have a safe journey.

You are teaching us all so much about the cancer
protocol "game".

Thank you.