The Zen Koan of Cancer and Lab Testing

How do you study for a test where you are never asked a question?

Sounds like a zen koan.

Koans are a method of training the mind in order to achieve the state of Satori or enlightenment into the nature of reality.

That's great. But what if you are getting a cancer diagnosis?

The Wall Street Journal on January 4 had an article about how thousands of breast-cancer patients may be getting the wrong treatment because of lab test errors.

Sounds scary. Talk about the nature of reality.

The tests are used to determine if women with invasive breast cancer will receive Herceptin, Tykerb, Arimidex, Faslodex or generic tamoxifen.

Not exactly the kind of test you want to fail.

Insurers generally assume that every test is done right, and they pay accordingly. More critically for patients, many of them will also pay for second-opinion breast cancer tests.

But many doctors don’t order them.

In 2007, ~178,000 patients are expected to be diagnosed with invasive breast cancer in the US, according to the American cancer Society, and the tests that these patients will require are not straightforward lab procedures. These tests require pathologists to make judgment calls after looking at a tissue through a microscope. That ain’t a simple yes or no.

Oversight in this area is as demanding as one might think. While the FDA must approve every drug, it allows laboratories more freedom in the designing tests. Even when the FDA does approve a test, the lab can still tweak it.

If the pharmaceutical, government and clinical laboratory industries are going to get this right, then a greater emphasis on standardization and review is critical.

How much goes for naught if a pharmaceutical or a biotech spends $1 billion to design and test the drug, and then it doesn’t get into the right person.

Last week, I talked about the power of micro-trends. If more and more people ask questions and request second-opinions and more and more companies focus on improved testing protocols, we can have a very powerful trend that will only be for the better.

This is a move for enlightenment. This is how you study for a test where you are the question and you really want and you really need the right answer.