Experimentation or "lucrative medicine for a handful of special interest groups"

[WhiskeyGirl]

I saw this story on Fox this morning.

Van Nocker Family Files Complaint Against HealthAmerica Insurance Company Seeking Coverage of Cancer Treatment for their Five-Year-Old Son

HealthAmerica has denied coverage of treatment doctors call "medically necessary" to save the life of Kyler Van Nocker.

What does this young man have?

Kyler was diagnosed with nueroblastoma, a rare and particularly lethal form of childhood cancer, in 2007, when he was about 2 ½ years old. He spent a year in and out of the hospital, and underwent various treatments including chemotherapy, radiation, and multiple bone marrow transplants. His treatment was successful, and his cancer was in remission by September 2008.

In September 2009, tests revealed that the cancer had returned. Kyler's physicians at the Children's Hospital of Pennsylvania (CHOP) recommended that he undergo MIBG therapy, the only known effective treatment option for child with relapsed refractory neuroblastoma.

In direct contradiction of the advice of medical professionals, the HealthAmerica insurance company denied the treatment, calling it "experimental" and "not medically necessary."

more here - http://www.24-7pressrelease.com/press-release/van-nocker-family-files-complaint-against-healthamerica-insurance-company-seeking-coverage-of-cancer-treatment-for-their-fiveyearold-son-136908.php

I could not find a hospital "Children's Hospital of Pennsylvania", I'm thinking they mean "Children's Hospital of Philadelphia".

When is someone experimental?  When is it standard treatment?

In the new piece, someone said a hospital built a treatment center.  One of the few in the nation.

Just because there is a 'treatment center' does it mean something is not experimental?

Perhaps there is a treatment center for experimentation?  Fund raising?

Should insurance companies be forced to pay for the experimental programs of hospitals?

iirc, the public or charity or nonprofit hospital model disappeared years ago.

[WhiskeyGirl]

Because only about 600 new cases of all forms of neuroblastoma occur
annually in the U.S., familial (inherited) neuroblastoma is a very rare
subset of a relatively uncommon disease. Scientists at Children's Hospital
have studied familial neuroblastoma for the past 15 years, and the current
study drew on family data collected from throughout the world.

    John M. Maris, M.D., senior author of the current study and director of
the Center for Childhood Cancer Research at Children's Hospital, leads a
laboratory with the world's largest collection of neuroblastoma tissue
samples, gathered through the multicenter Children's Oncology Group in the
U.S. and through multiple international collaborations. Maris said, "This
is a very important discovery, as it not only helps us understand the
genetic roots of this terrible disease, but also has led to dramatically
new ideas for curative therapy."

    The study team used high-speed, automated analytic equipment at the
Center for Applied Genomics at Children's Hospital. By employing
genome-wide scans to analyze DNA from the 10 most informative families with
a history of neuroblastoma, Mosse and her colleagues first discovered that
a region of chromosome 2 was associated with the disease. Further
sequencing of that region identified mutations in the anaplastic lymphoma
kinase (ALK) gene in eight families with familial neuroblastoma.

more here - http://www2.prnewswire.com/cgi-bin/micro_stories.pl?ACCT=159681&TICK=CHOP&STORY=/www/story/08-25-2008/0004872713&EDATE=Aug+25,+2008

With only 600 new cases a year, what are the chances that there are multiple hospitals/research centers or places of treatment?

Are the experiments the only treatment?  Recommend the treatment you're studying?

Socialize the costs of experiments/studies?  Pass the cost research on to insurance companies?

Who decides when something at this center is no longer experimental?

[WhiskeyGirl]

Does CHOP have any studies that might be confusing the insurance company? 

I found three active studies with this hospital listed -
   

Phase I Study of Irinotecan Hydrochloride, Vincristine, and Iodine I 131 Metaiodobenzylguanidine in Young Patients With Resistant or Relapsed High-Risk Neuroblastoma

Last Modified: 8/19/2009     First Published: 7/24/2007 
Alternate Title

Irinotecan, Vincristine, and Iodine I 131 Metaiodobenzylguanidine in Treating Young Patients With Resistant or Relapsed High-Risk Neuroblastoma

Phase II Study of Iodine I 131 Metaiodobenzylguanidine and Autologous Stem Cell Transplantation in Young Patients With Relapsed or Refractory High-Risk Neuroblastoma

Last Modified: 2/11/2009     First Published: 4/15/2008 
Alternate Title

Iodine I 131 Metaiodobenzylguanidine and a Stem Cell Transplant in Treating Young Patients With Relapsed or Refractory High-Risk Neuroblastoma

   
Phase II Study of Iodine I 131 Metaiodobenzylguanidine and Combination Chemotherapy Comprising Carboplatin, Etoposide, and Melphalan Followed By Autologous Bone Marrow or Peripheral Blood Stem Cell Transplantation and Radiotherapy in Patients With Relapsed or Refractory Neuroblastoma

Last Modified: 12/10/2008     First Published: 11/4/2005 
Alternate Title

Iodine I 131 metaiodobenzylguanidine, Combination Chemotherapy, and Radiation Therapy in Treating Patients Who Are Undergoing an Autologous Peripheral Stem Cell or Bone Marrow Transplant for Relapsed or Refractory Neuroblastoma

You can research all kinds of studies here - http://www.cancer.gov/search/ResultsClinicalTrials.aspx?protocolsearchid=7357082

[WhiskeyGirl]

CHOP has a new building to support research.

Since its inception in 2007, the Center for Childhood Cancer Research (CCCR) has brought together a diverse group of researchers focused on pursuing cures through innovative approaches to treatment. The only thing lacking has been space to house the entire multidisciplinary team.

That changed in the fall of 2009, when the Center moved into the Colket Translational Research Building on the Hospital's South Campus. Approximately 30 CCCR investigators, spanning the spectrum from basic to translational research, now occupy clinical and lab space within the building.

Lab space has expanded from 14,000 square feet to 56,000. Maris also sees an enormous opportunity for recruitment: "We now have the space and the resources to attract even more top-level scientists." The very best scientific minds will be essential to realizing the Center's vision of personalized medicine. As Maris notes, "Cancer treatment today requires that we change the way we think about the disease, to be more proactive for each patient. Our Center is designed to bring people and tools together to deliver on that promise."

The Colket Translational Research Building is the result of the single largest gift to CHOP's recently concluded Hope Lives Here campaign. Longtime supporters and Hospital Trustees Ruth M. and Tristram C. Colket Jr. saw the potential in state-of-the-art laboratory space and generously provided funding to get the building started.

Who's going to continue funding the building?  Research?

http://www.research.chop.edu/programs/cccr/location.php

[WhiskeyGirl]

Gene Findings Unlocking Reasons for Neuroblastoma Risk
06/22/2009

Whole-Genome Searches Are Revealing Secrets of a Childhood Cancer

PHILADELPHIA, June 22 /PRNewswire-USNewswire/ -- Two new studies from The Children's Hospital of Philadelphia advance the search for genetic events that result in neuroblastoma, a puzzling, often-deadly type of childhood cancer.

Originating in the peripheral nervous system, neuroblastoma is the most common solid cancer of early childhood and causes 15 percent of all childhood cancer deaths.

"Only two years ago we had very little idea of what causes neuroblastoma," said study leader John M. Maris, M.D., chief of Oncology and director of the Cancer Center at The Children's Hospital of Philadelphia. "Now we have unlocked a lot of the mystery of why neuroblastoma arises in some children and not in others."

http://stokes.chop.edu/publications/press/?ID=477

How much research do they do at CHOP?

Is it possible to separate the research from the 'treatment'?

Or, to be objective about treatment options when it comes to billing insurance companies?

[WhiskeyGirl]

Insurer Denies Life-Prolonging Treatment To Five-Year-Old Boy With Cancer

...

Due to successful treatment in 2007, Van Nocker’s cancer went into remission, giving him 12 months of pain-free life. Unfortunately, in Sept. 2008, the cancer returned, and Van Nocker was once again in need of treatment. Unfortunately, his health insurer, HealthAmerica, refused to pay for one form of treatment doctors believe could save his life (MIBG treatment) because they consider it “investigational/experimental” since it has yet to be approved by the FDA.

Yet in April 2008, the insurer approved cheaper treatment for Van Nocker that was also “experimental,” prompting Philadelphia Daily News columnist Ronnie Polaneczky to ask, “So why, pray tell, is HealthAmerica playing the ‘experimental therapy’ card in the case of the MIBG treatment Kyler now needs? Gee, money couldn’t have anything to do with the decision, could it?”

How much are they charging for this 'new' treatment?

Who decides how much to charge?

How much does CHOP make on these treatments?

How much do they make in selling the treatment to others?

Who is really paying for the research?

[WhiskeyGirl]

Also from the article -

Van Nocker’s parents are suing HealthAmerica, citing the fact that the company has apparently been dishonest about its criteria for the types of treatment it will cover and is denying payment for treatment in this case because of the high cost of the procedure — $110,000  pays for only two rounds of MIBG treatment. “These companies have to be brought to the courthouse to get them to do the right thing,” says the VanNockers’s family attorney. “This child needs this treatment, or else.”

How can a hospital charge $110,000 for only two rounds of MIBG treatment?

[WhiskeyGirl]

What do others charge for this 'treatment'?

I googled, so hopefully this is a good comparison.

From the NIH, UK -

BACKGROUND: The standard treatment used to control the symptoms of carcinoid syndrome (CS) involves subcutaneous injections of the somatostatin analogue octreotide. This is expensive (US $8000--16,000 per year), and treatment may be for many years...

http://www.ncbi.nlm.nih.gov/pubmed/11417988

$110,000 for two rounds in the US, $8 - 16 thousand per year in the UK...

Why does CHOPS charge so much?

Who's taking the hospital to task for charging so much?

[WhiskeyGirl]

The United States is the only industrialized nation without cradle-to-the-grave, universal health care. In no other developed country would a child with cancer have to go without care because an insurance company decided it was not profitable enough to cover him.

read more here - http://blogs.alternet.org/speakeasy/2010/02/09/1219/

What about greedy hospitals?

We could cover a lot more people with the money if we paid fair prices for drugs and treatments like they do in other countries.

$110,000 for just two rounds in the US, vs $8-16 thousand a year in the UK?

Obamacare's gonna cover this, right?

 

[WhiskeyGirl]

Did the Van Nocker family sign up for experimental programs for their son?  Did they sign agreements for experimental therapy?

[WhiskeyGirl]

The Harrisburg-based company's denial of benefits to Kyler, the lawsuit claims, is the result of "a biased, self-serving misreading and misinterpretation" of everything from Kyler's medical records to the company's own internal documents.

read more here http://www.pharmacychoice.com/News/article.cfm?Article_ID=533470

What is in Kylers medical records?

Maybe he is a research participant?  Isn't receiving standard treatment?

[WhiskeyGirl]

When Kyler was 2-1/2 years old he was diagnosed with Neuroblastoma, a rare childhood cancer. He was in remission for roughly a year. Recently his parents learned that the cancer has returned with a vengeance. There's only one treatment option left for Kyler, but his insurance refuses to cover it, not because it's overly expensive, but because of a technicality-- it's in clinical trial. In fact, all the standard of care treatments for neuroblastoma are clinical trials. His insurance would rather let him die than pay for the only chance he has at survival.

The therapy is not approved by the Food and Drug Administration, another criterion that HealthAmerica requires.

"It's considered experimental because not enough kids with recurring neuroblastoma live long enough" to become candidates for MIBG, says Paul VanNocker, 44, a heavy-industrial-equipment salesman (Maria, 37, is a homemaker). "So, really, all treatment at this stage of Kyler's disease is considered experimental."

Only about 650 children in the United States are diagnosed each year with neuroblastoma. Half of them, including Kyler, have the most lethal form of the disease. So it's tough to study a large enough cohort of patients like Kyler to yield research results that HealthAmerica might consider valid.

HealthAmerica spokeswoman Kendall Marcocci told me that she was not permitted to divulge the amount of money the company has paid so far for Kyler's treatment, but Paul VanNocker says that the figure is between $1.6 million and $1.8 million. He was not sure what Kyler's MIBG therapy would cost, since it's unclear how many MIBG treatments Kyler might require, but Grupp says that the treatment is actually less expensive than other cancer therapies.

Hmmm...hospital wants $55,000 per round of treatment, others say $8 to 16 thousand per YEAR for treatment?

Why is the hospital CHARGING so much?

"If Kyler can't have MIBG, he will have to enter hospice care," says Paul. "He'll have a good month, and then he will lose the ability to walk. Then he will become bedridden. And then he will die a slow, agonizing death."

MIBG is the only option to postpone that terrible possibility for as long as possible.

Would Obamacare cover such expensive treatments at the end of life?

http://sweetnotalways.blogspot.com/2009/12/for-kyler.html

What is in Kyler's medical records?

Who profits @ $55,000 per round of therapy?  This drugs been around for years, so has the therapy.

How can the hospital charge this much?