Patient Navigator

Should I be concerned that my son’s pediatrician has never heard of the National Cancer Institute (the “NCI”)?

A few weeks ago, during my son’s routine 12-month check-up, his doctor and I were making small talk and it came up that I am a Cancer Information Specialist trained by the NCI.

My son’s doctor, a lovely woman whom we’ve seen before turned to me and said “The NCI?” to which I replied “The National Cancer Institute” and her reply was “What is that, some sort of Government agency?”

I was blown away.   My jaw practically dropped to the floor.   Maybe it’s naiveté, but I just assumed that all doctors, regardless of their chosen field of specialization, would have at least heard of the National Cancer Institute (www.cancer.gov)   Am I wrong?  I understand that doctors choose a special track or focus and that they cannot be expected to be fully familiar with each facet of the medical world, but aren’t all aspiring doctors introduced to each field of medicine while in medical school?

Even if aspiring doctors aren’t exposed to all fields of medicine in their education, wouldn’t someone in the medical world, particularly a doctor, know that the National Cancer Institute, created in 1937, at least existed?

I left the office a little perplexed.   If this doctor hadn’t heard of one of the largest medical institutions in the world, should I let her be in charge of my son’s health and well being?  Is this a big deal?   Am I making too much of this?   I would love to hear from others about this topic. Please comment and tell me your thoughts.

Guest Editor, Heather Matthews – Patient Navigator LLC Cancer Information Specialist

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Scientists have mapped specific genes that turn normal healthy cells into cancerous cells through The Cancer Genome Atlas Project (TCGA).

Through the TCGA, researchers have now developed a more reliable scientific method to identify these genes.   As this research is shared around the globe, more accessible and effective cancer treatment options are being discovered.  The ultimate goal of the TCGA is to create a catalogue of these “defective” genes, thereby offering increased detection, and ultimately, better prevention and treatment of cancer.     

As healthy cells grow and divide, they not only produce more healthy cells but also kill off cells that are no longer needed.  A cancer cell is produced when an otherwise healthy cell grows abnormally or does not die off when it should.  These cancerous cells then form a mass or tumor.

Through the TCGA, researchers are trying to pinpoint why these specific genes change and how that can lead a cell to become cancerous.  Once this information is gathered, cancer treatment will move to a more targeted form of treatment.  Doctors will target only the abnormal gene, as opposed to today’s standard treatment of chemotherapy, which affects the whole body.  Such a change in treatment will be beneficial because standard chemotherapy kills off cancerous cells but also some healthy cells in the process.  If researchers can instead identify the “defective” genes and target them directly, healthy cells will stay intact and be less affected by the cancer treatment.

For example, the National Institutes of Health recently announced that TCGA identified distinct subtypes of glioblastoma multiforme, the most common form of malignant brain cancer in adults.  In the past, doctors treated this type of brain tumor as a single disease, whereas now they know that glioblastoma multiforme is, in fact, four distinct molecular subtypes.

In addition, through the TCGA, researchers have also discovered that response to chemotherapy and radiation differed by gene subtype.  Although the current standard of treatment will not change overnight, these new discoveries will help doctors to tailor a cancer treatment plan using genetic information.  

Originally a pilot project, TCGA has turned out to be quite a success in demonstrating the value of cancer research.  In the fall of 2009, President Obama announced that the National Institutes of Health will spend $275 million to expand TCGA to other types of cancer, thus opening the door for more specific treatment options and hopefully more cures.

To learn more about the cancer cells we have in our body, please read our January 27 blog post at: http://patientnavigator.com/blog/2010/01/27/we-all-carry-cancer-cells/

For further information on The Cancer Genome Atlas Project, please visit:

http://cancergenome.nih.gov

http://www.nih.gov/news/health/jan2010/nci-19.htm

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Access to investigational therapies is a highly debated topic in the medical world.  Investigational therapy involves drugs that are being scientifically tested but not yet approved by the Food and Drug Administration (FDA). Often these drugs are offered through programs such as “compassionate use programs,” and “expanded access programs” to allow seriously ill patients access to new drugs before they have obtained FDA approval.

The processes of acquiring FDA approval can, in some instances, take up to ten years.  In the interim, because of where they are offered (typically in large cities), the associated costs (many insurance companies do not cover experimental treatments), and the strict eligibility requirements, most patients have limited access to these potentially life-saving therapies.

The FDA has realized the need for an overhaul.  In the past year, representatives from the FDA, the pharmaceutical industry and the medical profession have convened to re-interpret the rules and regulations of investigational therapies to form a new framework that allows greater access to more patients.

One such change centers on whether drug manufacturers can charge for the investigational trial drug.  Before, the regulations were unclear on what the manufacturer could charge and for what.  Under the new guidelines, the FDA has made it very clear that manufacturers can recover the cost of the product but can not make a profit.   The FDA hopes that with costs down, more people will seek out investigational therapies as a treatment option.

Additionally, the FDA is now requiring full-safety reporting for all patients in compassionate use programs, a requirement that exceeds the usual reporting protocol for serious adverse events.  While in theory this is good medical practice, companies could be resistant to this regulation since it would require more staff to follow up on patients, thereby raising a company’s bottom line, which could turn a company away from implementing compassionate use programs. 

While it is a positive development that the FDA has recognized the need for change, it is still a complicated process to gain access to investigational, but potentially life-saving therapies.  

To learn more about the new FDA guidelines and expanded access programs, please visit. http://www.medscape.com/viewarticle/711719.  You should also read the National Cancer Institute’s Fact Sheet on investigational drugs at:  http://tinyurl.com/ybmh4mk.

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