Tuesday, February 03, 2015

Not so precise

Michael Millenson is unusually prescient about health care matters, often anticipating by years issues that become major public policy concerns.  In a Forbes.com article, he riffs off of President Obama's recent call for "Precision Medicine."  Here are some excerpts :

Yes, President Obama’s new $215 million Precision Medicine Initiative supports important science, but it also bolsters biotech branding in a way the science doesn’t always support.

In [the] State of the Union address, which preceded the detailed proposals sent to Congress, he spoke of “the right treatment to the right patient at the right time.” But branding an industry as “precision medicine” doesn’t make it so. There’s still uncertainty in many test results, uncertainty by clinicians over proper clinical indications for using current tests and equivocal evidence for cost-effectiveness.

Michael uses the example of three different breast cancer tests meant to determine whether a certain type of breast cancer will recur, in the hope of helping to avoid the physical, emotional, and financial costs of unneeded chemotherapy.

An analysis by BiomarkerBase found that just 12 of the 125 biological targets used by these competing tests are shared, and no one gene is used by all three. More importantly, results of the three – Genomic Health’s Oncotype DX, Agendia’s Mammaprint and Prosigna from nanoString Technologies ­– often disagree.

As an article in the journal Tumor Biology put it, these assays
differ in the technological platforms used for assessment of gene expression, in the number of genes and in the specific genes that are being tested, in the patient populations used for their development and validation, and in their clinical utility.
Pay particular attention to “validation” and “clinical utility;” i.e., evidence the tests help patients. Breast cancer is a deadly serious problem, accounting for between a quarter and a third of all cancer cases, and it is the second-leading cause of cancer-related deaths. But like other cancers, it’s also complex, with the prognosis depending upon the mix of molecular subtypes and other patient-specific factors.

Precision, anyone?

Michael concludes:

Americans love the glittering prospects of new technology, and Congressional Republicans were quick to jump onto the president’s biotech bandwagon. However, a more accurate description of present reality comes at the end of a White House blog ballyhooing stories of how “precision medicine is already working to cure Americans.” It reads: “We’ve only begun to tap into [the] potential for precision medicine to improve care and produce new treatments.”

One might call that the precise truth.

This whole issue becomes more relevant as health insurance and Medicare start to pay for these kinds of tests more and more.


Anonymous said...

Of course, since the industry loves this initiative and the GOP loves what industry does, and the academics get their big bucks from the feds and the pharma companies, support is "bipartisan" and widespread.

Christopher Goodman ‏@drcwg said...

From Twitter:

Agree, just one more place for money to leak with only incremental if any benefit to population health

John Freedman MD said...

Dangerous ground when commercial interests and (not-fully-informed) public sentiment intersect. As Michael warns, we could well pour wasted time, money and hope into this. It is perfectly analogous to the robotic surgery craze Paul has been following.

Bob said...

Right. I, too, am critical of the Obama message. Sounds like he was sold something. It seems probable that this is a case of the government picking winners when it shouldn't.