New Breast Cancer Guidelines

The St Gallen International Breast Cancer Guidelines were recently updated to include the Oncotype DX test for breast cancer as the only screening tool for women with early stage ER+/Her2- breast cancer to determine the benefit of chemotherapy.

On some levels this is great news but again it is not for all women. The criteria for the Oncotype DX test for breast cancer are:

"You may be a candidate for the Oncotype DX breast cancer test if you are medically eligible for chemotherapy and:

• You have been diagnosed with stage I,II or IIIa invasive breast cancer.*
• Your breast cancer is estrogen-receptor positive (ER+) and Human Epidermal growth factor Receptor -negative (HER2-) and you do not have lymph node involvement (also known as lymph-node-negative breast cancer).

        OR

• You are a post-menopausal woman recently diagnosed with node positive, hormone-receptor-positive, Human Epidermal growth factor Receptor -negative breast cancer"

The problem is that while most women have ER+, Her2- and node negative breast cancer, not all do. For example, I was not given this test because I had one tiny positive lymph node. Apparently they are starting to do some testing on women with node positive disease. The Oncotype DX test is also available for colon and prostate cancer as well.

I have digressed. I do like the fact that this test is available for some if not all. I do like the fact that it is covered by most insurance companies. I do like the fact that it helps determine if a patient will benefit from chemotherapy before they receive it. I do like the fact that it is part of standards for treatment.

I do not like the fact that it is still part of the conversation about treatment - do you remember the little analogy - an ounce of prevention is worth a pound of cure? Why can't we put that into the guidelines?

What would you pay?

Would you pay $4000 for something that is only should cost $99? Apparently women who get a BRCA test pay nearly $4000 for something that should cost around $99. This because of the monopoly Myriad Therapeutics has by patenting the genes. I know I have logged about this before so may you call me redundant.

We are still waiting for the Supreme Court's response to the argument that gene's can't be patented. But Myriad is so sure that there will not be a problem for them, they are planning further profits later this year.

"Without competition, Myriad can effectively charge whatever it wants. Later this year, the company said it would begin incorporating the BRCA test into a 25-gene cancer-risk evaluation and phase out the à la carte BRCA test by 2015. For that broader test, it projects a gross profit margin of 87 percent."

I wouldn't mind an 87% profit on my investments. Would you? I'm just awaiting the Supreme Court''s response.

Breast Cancer Patients Go to Washington

Today is a big day. Around here it is Patriots Day which means there are parades (mostly yesterday), Revolutionary re-enactments, pancake breakfasts, award ceremonies, a little road race called the Boston Marathon, and a minor hint of spring - its a tropical 32 degrees right now.

In Washington DC, its typical pomp and circumstance, the ego battles, and political denials, as well as oral arguments in the Supreme Court on the patent-ability of human genes and the genome. The ACLU, breast cancer patients, scientists, Biotech companies, and more are all meeting together to hear the oral arguments and then the Supreme Court will make some big decisions.

At the root of the matter is are human genes and the genome patentable? They have been awarded patents in prior years. For example, Myriad Genetics patented BRCA1 and BRCA2 genes using the grounds that they isolated them so they should be able to patent them. Then they developed the breast cancer BRCA tests which they sell for a paltry $3340 and have earned $2.1 billion on these tests. They want to retain their patent because it makes them rich. Some scientists say the gene patents allow them to earn money from their research.

On the other side,  people like the ACLU say they are naturally occurring and therefore should not be patented. And that the patents actually restrict research.

Personally I don't think naturally occurring things should be able to be patented. Does someone want to patent the crab grass in my lawn? Then they can pull it out because I'm not going to pay them for it (free weeding).

Maybe they can patent the tests that are done using the genes but not the genes themselves. Other people could then patent their own tests and there would be competition and someone wouldn't be $2.1 billion richer on a test that some insurance companies won't cover because of the cost. (Patients first please.)

Medical research often includes genetics and molecular level testing these days. Our legal system needs to catch up to current scientific research. If genes are patented, will we have to start tattooing their bodies to show where other people own bits and pieces? What if someone patented the human heart, would they get a fee every time someone had heart surgery. Let's think rationally here.

Angiogenesis

I only learned about angiogenesis last year. Not having recently gone to medical school, I turned to my friend, Mr. Google (as opposed to Dr. Google) for a definition. Wikipedia says:

"Angiogenesis is the physiological process involving the growth of new blood vessels from pre-existing vessels."

 It goes on to add:

"Angiogenesis may be a target for combating diseases characterized by either poor vascularisation or abnormal vasculature."

Now we have gotten through a LOT of big words this morning.I have found an article explaining how contrast MRI may predict how women would respond to chemotherapy and possibly allow them to avoid mastectomies. Another (as if we needed it) research study was done and found:

"... contrast-enhanced MRIs can work as an early predictor of the body’s response to neoadjuvant chemotherapy by measuring the blood vessel formation in tumors, a process known as angiogenesis.  Angiogenesis is considered an earlier and more accurate marker of tumor response."

"... MRIs can detect tumor changes as early as the first cycle of chemotherapy.  If the tumor appears smaller and less bright on the scan, it can be interpreted as a sign that the chemotherapy may be effective and eventually lead to tumor eradication."
However this is all new and exciting but the results will be published later this year and then we need to see if this is coming soon to a hospital near you (and me). So one big word I learned last year combined with a technology I have already experienced has created progress. We may have to wait but in this case progress is progress.

Predictive risk screening

We have all heard about genetic testing to see if you are more likely to get an ailment or not. I am not sure if I would do that or not simply because I am not sure I want to know. I can look at my family history without a genetic test to get an idea of what I might get. Oh, but there were no cases of breast or thyroid cancer in my family....

Actually the vast majority of breast and other cancers are not caused by genetic or family history. They just happen. There are risk factors that are known but the real reason of why someone gets it instead of someone else is not really known. But there is a fear among women regarding getting breast cancer. A lot of women are just scared of it.

So even though we do not have the cause ironed out, a company, BREVAGen, has developed a predictive risk screening test to see if women are more or less likely to get the disease. And they are selling it.

'"The vast majority of women who get breast cancer do not have familial history such as first degree relatives with cancer. For those patients, BREVAGen allows me to make informed decisions based on their individual risk indicators and genetics"... "Determining the appropriate level of surveillance is critical for patient compliance, early cancer detection, and controlling healthcare costs. BREVAGen helps me identify those patients that benefit from a more intensive surveillance. This proactive approach might include breast MRI and/or the use of anti-estrogen medications, coupled with patient lifestyle changes, all focused on the prevention or early detection of breast cancer." 

BREVAGen is a clinically validated predictive risk test that more accurately identifies a woman's unique risk of developing sporadic, estrogen-positive breast cancer. BREVAGen examines a woman's clinical risk factors, such as their lifetime exposure to estrogen, combined with scientifically validated markers to determine each patient's personalized five-year and lifetime risk of developing breast cancer.'

Hmmm... so they are analyzing exposure to risk factors. But that does not give us a cure.This is part of the role personalized medicine plays in helping treat patients. I am completely for personalized medicine but I am not sure what I think a company making money off analysis of risk factors as opposed to finding a cure. Yes this will help in getting the right women early screening and allow for early detection. But does it help prevent cancer?  Not really. Does it help determine the cause of cancer? No. Does it prey on the fears of women who are concerned about developing breast cancer? Possibly.