Tuesday, October 13, 2009

Healthcare Reform

Hey, there's an easy topic to breeze through. I was going to post something about the meaning of life or the existence of God, but I thought those topics would be too simple.

Actually I don't wish to get into a political debate on health care reform. This blog has one purpose: supporting a cure for childhood cancers. And on that topic, I am concerned that both sides in the political debate are ignoring the real issues.

Before you can reform anything, it probably helps to understand the problems you are attempting to fix. From our personal experience, here are the problems we found:

PROTOCOLS: Individualized treatment is extremely rare in pediatric cancer. Most hospitals follow a strict adherence to protocols, created as a result of cumulative data from clinical trials. The system works with common cancers (such as breast cancer, with 200,000 new patients each year). But there is a math problem with childhood cancers. Protocols require clinical trial data of 350-500 patients. Although there are 12,500 annual childhood cancer cases, they are divided into a lot of different cancers. Most childhood cancers have about 200 new cases per year. And only 10% of children are enrolled into the trials. With only a few dozen cases to work with, it is impossible to create a specialized protocol.

The solution has been to "bundle" similar types of cancer, creating several "one-size-fits-all" protocols. To fully appreciate the problem, understand the purpose of protocols: Cost-cutting. It is to allow the senior oncologists to take on more patients. This is done by reducing individualized decision making, and delegating more work to the 1st year residents and nurse practitioners. Individualized attention is greatly reduced, and often non-existent.

In his book "How Doctors Think", Dr. Groopman of Harvard Medical describes the intense pressure on doctors to follow protocols. He writes that doctors often ignore symptoms that do not fit neatly into the “assembly line systems”. He states that doctors who deviate from protocol are "ridiculed by their peers for being obsessed with the esoteric while ignoring the mainstream. They are said to be showoffs."

My son was put on the “Burkitt’s protocol”, but I soon learned there is no such thing. Burkitt’s is too rare to have a protocol, so he was placed on a generic protocol for all large B-cell lymphomas. I then profiled the most relevant factors effecting my son’s prognosis (advanced stage IV, grade C, leukemia and extensive bone marrow/cns involvement, 15-19 age bracket), and asked for specific data about kids matching that profile. No one knew.

My search lead me to Stanford University Hospital that got the protocol approved through the FDA, then to the Institut Gustave Roussy in France that developed the protocol, and finally the research statistician currently living in Germany. He did not know. The numbers were too small to have any statistical relevancy. Still, treatment decisions are made, and parents are being informed, as though all these generic treatments are custom tailored to their child.

SUTTONS LAW: This is the medical principle of quickly diagnosing the most likely disease, and immediately proceeding with treatment. The law is named for the bank robber Willy Sutton, who was asked why he robbed banks and replied "because that is where the money is".

The truth is that there is very little money in diagnosing cancer. The big money is in the treatments. The emphasis therefore is to immediately diagnose the most probable problem, assign a standardized protocol, and quickly move to the next patient. Dr Groopman states in his book that “once begun, a diagnostic momentum is created that is rarely questioned.”

Taylor Schrauger lost his let to cancer at 14. His father recounts their experience in his book “Walking Taylor Home”. Taylor finally went into remission. The most probable location for a relapse was Taylor's lungs so, following Sutton's Law, doctors scheduled regular lung scans. But Taylor’s dad found that, although very rare, a relapse in the other leg would be fatal if not caught immediately. He insisted on scans of the leg. But following Sutton's Law, the doctors refused. Finally, after reoccurring leg pain, the doctors reversed their decision. Unfortunately the results were devastating. The cancer had already relapsed in the leg, and spread aggressively. Sutton’s Law focuses on highest probability to achieve a speedy diagnosis. It ignores risk.

This is not an issue of bad doctors; rather it is a reality of good doctors being forced to handle more and more patients. This focus on cost control has created enormous pressure in all levels of the medical staff to "stick to the plan". Pressure comes from hospital administration, legal departments, and insurance companies to avoid any type of individualized treatment.

Dr. Croskerry of Dalhousie University in Nova Scotia, states that "Doctors are shying away from a rare diagnosis. Powerful forces in medicine discourage hunting for them. In an era of cost containment, when insurers and managed care plans scrutinize how much time physicians spend on any one patient, doctors have a strong disincentive to pursue the ideas that are out there".

CLINICAL TRIALS: Survival rates are much higher for children enrolled in clinical trials. However fewer than 10% of childhood cancer patients enroll in trials. Why is this? Another curious fact...many clinical trials are shut down because of lack of enrollment. These trials can save lives, but few will enroll. Why? The University of Arizona conducted a study earlier this year to find the answer. The number one reason: Doctors never informed the family of the existence of the trial. Why is this? With our son, we asked specifically about trials, and were given a lot of mis-information. Why? I have never received a straight answer, but did find a couple of possibilities.

1. Money: Clinical trials have a long list of very specific guidelines on the patient and their disease progression. This is to keep a "pure" data pool, avoiding the possibility of unrelated issues affecting the results. This is understandable. But this only applies to the data being added to the research data pool. Why can't a patient follow the treatments in the trial, without their data being added to the research pool? The reason is money. Research facilities will not pay the cost of the trial if they can not use the data. And few insurance companies will pay for trials, because they are outside of protocol. The burden then falls on the hospital. The response from the hospital, all too often, is to simply never mention the option.

2. Money: For those kids that do fall within the guidelines of the trial, there is another obstacle. On average, 75% of a pediatric cancer hospital profits are from markup and rebates on chemotherapy drugs. But in a clinical trial, the research facility funding the trial typically supplies the drugs, cutting the hospital out of their primary source of profit. The hospital is still paid for services rendered. But with all the cost controls, the elimination of the chemo profit center often results in a net loss to the hospital.

FUNDING: To understand the funding problem, it is important to understand the numbers. To bring a cancer drug from concept to market takes an average of 15 years, at an average cost of $750 million. Factoring the litigation cost of potential problems, many groups estimate the total cost to be $1.2 billion. That is for a single drug. Add to this the fact that less than 8% of cancer drugs researched ever receive FDA approval (15%-20% is the average for non-cancer drugs). Look at these numbers, and it is easy to understand why there has not been a single pediatric cancer drug brought to market in over 25 years. A study last year by the National Institute of Health concluded that there was simply no profitability in researching new pediatric cancer drugs. Bluntly stated, the market is too small to justify the cost if investment.

Many assume the government would step in to fund the research. But this also failed. Congresswoman Carolyn Price worked aggressively for funding after losing her daughter to leukemia. This past election year, after years of effort, both houses of congress unanimously approved her $30 million Cure Childhood Cancer Act. $30 million is low considering the numbers above, but something is better than nothing. Unfortunately, the same politician who approved the bill during the election, have now refused to approve the spending. In a compromise, supporters tried to get $10 million included in one of the spending bills (something is better than nothing). But this also failed to get the needed votes.

The current system is placing increasing pressure to streamline the diagnosis and treatment of pediatric cancer. Decisions are increasingly made by business managers working to increase profits. There is absolutely a need for reform. But the reform discussions never address these issues.

The reform discussions are all about lowering costs to get more people in the system. I appreciate the merits of the goal, but it does nothing for pediatric cancer. In fact, the emphasis on cost containment could create even more assembly line "on-size-fits-all" systems.

As stated above, this blog is not "pro" or "con" on any political views. This is just information. If you are opposed to the government’s health care reform, please understand the problems and help us improve the current system. If you are in favor of the health care reform, please understand the problems, and work to include viable solutions into the reform.

The simple truth is this: We desperately need more money. A lot of money. We need more money in research, and we need more individualized treatments (which cost more money).

I understand those who claim the problem are caused by a system run by business managers seeking higher corporate profits. There is truth in that statement. But please understand this as well: The problems will not automatically disappear when run by political appointees attempting to juggle mounting federal deficits.

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