Leland Hartwell, the 2001 Nobel Prize laureate in Physiology or Medicine delivered a lecture recently at the Formosa Medical Association's conference in Taipei. Here is the link to the story and below are quotations from Dr. Hartwell (boldface emphasis mine):
Despite the enormous amount of knowledge we now have of the mechanisms through which cells become cancerous, there has been little progress in reducing the death rate from from cancer since the fifties. We all know that detecting cancer early is the way to save lives. Cancer patients often do not discover their cancers until the disease is well-advanced because the early stages of cancer are symptom-free. Early detection techniques such as colonoscopies are effective but expensive and invasive. DNA analysis has the disadvantage of needing an actual sample from the site of the cancer, while protein markers have the advantage of being detectable in bodily fluids. What we need now is more inexpensive, sensitive, quantitative assays for detecting the protein markers. The lack of economic incentives are a major roadblock to progress in the field of molecular epidemiology in the US. Pharmaceutical companies can charge whatever the market will bear. But diagnosticians are only compensated for the cost of doing the assay.
I agree with his ideas pertaining to the use of protein biomarkers and their efficacy in the early diagnosis of cancer, particularly when coordinated with medical and molecular imaging. Here are links to previous notes in this blog about these same topics (here and here). For this particular discussion, however, I would like to focus on his point that pharmaceutical companies can charge what the market will bear for a drug whereas diagnosticians (I will take this to mean the IVD companies and labs for this discussion) are compensated only for the cost of the test.
For unique chemotherapeutic drugs, pharmaceutical companies can and will charge whatever the market will bear for them. Although they maintain that they are only trying to recover their development costs, there are examples of companies raising the cost of such drugs by large amounts after coming to market and discovering that market demand is greater than anticipated. In part, I suspect that this latitude regarding drug prices, as opposed to the prices of lab tests, is based on the notion that there is greater value in treating a patient than diagnosing a patient's disease.
With regard to the pricing of lab tests, I recall a lecture I heard a couple of years ago about the Roche Diagnostics AmpliChip CYP450 Test that was co-developed by Affymetrix (links here and here). The test provides comprehensive coverage of gene variations for the CYP2D6 and CYP2C19 genes, which play a major role in the metabolism of an estimated 25% of all prescription drugs. The test is intended to be an aid in individualizing treatment selection and dosing for drugs metabolized through these genes. The rationale cited by the speaker for the relatively high cost of the chip was that it was less than the costs incurred for the non-tested patient who may be burdened by multiple unnecessary physician visits and the need for adjustment of initially incorrect drug doses. Using this same logic, a higher cost for some biomarker panels may be justified in the future on the basis that some medical imaging costs may be avoided by the greater specificity of such lab testing.
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