Posts Tagged chemotherapy

Oncology Drugs — shortcuts and high cost

ShortcutSome shortcuts just don’t work out.  The US oncology drug industry has found ways to reduce the time from drug discovery to market by taking shortcuts called “surrogate endpoints”.

The two most important questions cancer patients have when thinking about cancer drugs are 1) how much life do I gain? (survival) and 2) will I feel OK while I survive? (quality of life).  The problem for drug makers is it is expensive and time consuming to answer those questions (to use endpoints of survival and quality of life).

Drug surrogates are measurements that show some effect of a cancer drug but are not absolutely related to those 2 primary questions.  An example of a surrogate endpoint is “event-free survival”.  This is a measure of time, like the time from when chemotherapy is given before something bad happens.  Clearly important, but not the same as survival or quality of life.

The Federal Drug Administration (FDA) has a list of surrogate endpoints it will accept in order to approve cancer drugs.  Drug companies have progressively moved research to those surrogate endpoints.  The graph below is based on the data of Martel.Cancer Treatment Endpoints

Many times this shortcut is helpful for patients but it is always helpful for drug makers.  It has decreased the costs associated with marketing a drug.  But, the cost of drugs has gone up at a faster rate than the prolongation of life the drugs impart.  And, that survival may not be a benefit in quality of life.  Now, virtually all new anticancer drugs exceed the $50,000 per quality life year many social researchers say is the amount our economy can afford.  It means insurance can’t include those drugs otherwise premiums would be so high the average citizen could not afford the insurance.  Here is a very disturbing graph from an article by Howard.chemo costs and life year

The vertical axis is that cost being paid for one year of life provided by a cancer drug.  The horizontal axis is the year in which that drug was approved.  Meaning it’s not a very good deal — the cost of one year of life gained by chemotherapy is rising and you likely can’t afford such drugs.  The economics are really depressing and the situation is absolutely not sustainable.  Rather than hoping a treatment will be invented we will be hoping the cost of that treatment is within reach.

There are signs the cancer drugs are overpriced, inflated by speculation and simple price gouging.  To the extent such unethical practices exist they need to be rooted out and stopped.  Given the past history of big pharma there is likely a lot that needs to be fixed.

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Dartmouth Atlas — Over-Treatment Revealed

Graph from The Dartmouth Atlas of Health Care 2003 – 2007
Percent of cancer patients receiving chemotherapy during the last 2 weeks of life.

The Dartmouth Atlas is a great quality tool for US health care.  The idea of small area analysis dates back about 20 years when researchers noticed a considerable geographic variation in care.   Now it has become an accepted technique to show how different regions adopt different practice patterns.   The patterns are almost always disturbing since they mean US health care is not consistent thus not reliable.  When such a map reflects billing for unnecessary care it is even more disturbing.  Such is the case in the map above:  some oncologists stop giving expensive chemotherapy when the situation is hopeless whereas other oncologists give chemotherapy until the patient is dead.   If the oncologists did not derive financial benefit from chemotherapy one might be able to believe they were just giving a heroic effort in the face of death.  But, given the financial incentive another interpretation would be prescribing something of no medical value for profit.   It seems unlikely market forces would change this practice except to make it more widespread.

Performance status is a measure of how the patient is doing generally.  If the patient is bedridden the performance status is very poor.  In that very poor condition no chemotherapy helps, and in fact may hasten death.  So, from a quality assurance standpoint close attention is needed to make sure oncologists are documenting performance status and acting accordingly.

The current thinking is when the performance status is bad it is time to stop chemotherapy and talk about hospice.

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