Wednesday, August 12, 2009

IBD, Stephen Hawking and Nice

You have by now all read of the very funny folks at Investors Business Daily thought England's NHS was so awful that a poor soul like Stephen Hawking would be long dead had he to depend on those slugs in England for his care.

Just in case you missed it, here's the correction:

Editor's Note: This version corrects the original editorial which implied that physicist Stephen Hawking, a professor at the University of Cambridge, did not live in the UK.
But, enough hilarity. If you read the rest of IBD's editorial, you might notice their attack on England's National Institute for Health and Clinical Excellence (NICE), an arm of the NHS, for its ruthless analysis of the cost and effectiveness of drugs. The bastards!

Anyway, the editorial contains this sentence, "In March, NICE ruled against the use of two drugs, Lapatinib and Sutent, that prolong the life of those with certain forms of breast and stomach cancer." This is interestingly the exact same sentence that appeared in a WSJ op-ed on July 7th. But it's a beautiful sentence. Who can blame IBD?

IBD also has this gem: "The British are praised for spending half as much per capita on medical care. How they do it is another matter. The NICE people say that Britain cannot afford to spend $20,000 to extend a life by six months. So if care will cost $1 more, you get to curl up in a corner and die."

I can just see the clinicians and scientists at their final meeting, throwing patients under the bus for that dollar/pound. Bastards! The corollary to this, when you think about it, is the pharmaceutical company not lowering the price for the wonder drug by this apocryphal dollar. Bastards!

But what about these heartless beasts at NICE and these wonder drugs the British public is being denied.

From the NICE report on Lapatinab for breast cancer:

Clinical Benefit Rate
Using the independent assessment a greater proportion of subjects in the lapatinib + capecitabine group (29%) than in the capecitabine group (17%) achieved clinical benefit (odds ratio: 2.0, 95% CI: 1.2, 3.3, two-sided p-value: 0.008; cut-off date 3 April 2006). Using the investigator assessment of the clinical benefit response rate a greater proportion of subjects in the lapatinib+capecitabine group (37%) than in the capecitabine group (21%) achieved clinical benefit (two-sided p-value: 0.001).

Duration of Response
For subjects who responded to treatment, the median duration of response was 32.1 weeks in the lapatinib+capecitabine group and 30.6 weeks in the capecitabine group.



Get that? They are being denied a drug that increases the median duration of response by a staggering 1.5 weeks for the additional 12% who had some response to treatment!

The same paper included an analysis of a study on brain metastases that showed no significant difference in outcomes there, either.

Don't get me wrong. I am all for research and pushing the envelope. Continuing to study these drugs is fine, as long as all the appropriate ethical guidelines are followed, particularly with regards to real informed consent. But arguing on the basis of a study as described above that this should be placed into mainstream use is ridiculous.

My other pet peeve about these types of treatments is the cruel, false hope given to so many patients as they are offered "the next" chemotherapy regimen, intensive care, and so on.

I also have no objection to choosing to continue these treatments to the bitter end, as long as one understands the choice. I often get patients on "salvage" chemotherapy, palliative chemotherapy or palliative radiation treatments who don't understand what those terms mean. Maybe they were too rattled when the discussion took place and simply don't remember. But my experience with these patients and their families is that the discussion never took place in earnest.

Being told that the cancer has come back or spread to your brain or whatever and that here's what we can do next is far different than having a really hard conversation about your prognosis and all of your options.

Maybe your options are 2 or 4 or 6 months with "salvage" chemo if things go well (or a much more abrupt end if they don't!) versus 1 or 3 or 5 months without, but at home, having your symptoms aggressively managed by a palliative care specialist and working with hospice for a peaceful dignified end. And more than likely the 2 or 4 or 6 months with aggressive treatment means a lot of that time spent in the hospital, dying in an intensive care unit, hooked up to life support until someone finally tells you, too late, the hard truth.

Let's not kid ourselves about this disturbing side of American medicine: our often mindless devotion to doing "everything" up until the nails are being hammered into the coffin is, more often than not, in stark contrast to doing "the best things" for our patients.

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