Posts Tagged cancer

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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Dangers for Removing Fibroids – the morcelator

morcelatorJennifer Levits reported in the Wall Street Journal 12/18/13 “Doctors Eye Cancer Risk in Uterine Procedure“.  She recounted the story of Dr. Amy Reed who had a hysterectomy.  The uterus contained fibroids and the fibroids contained cancer.  The procedure was done with an instrument, the morcelator.  In kitchen terms it is a combination blender and vacuum cleaner.  It is used during laproscopic surgery to chop up things (like a uterus with fibroids) and remove them through a small incision in the abdomen.

The problem is the morcelator does not remove all the tissue.  A few cells escape the vacuum and they are left behind in the abdomen.  If those cells contain cancer the cancer is then planted in the abdomen later to grow and likely kill the patient.  Dr. Reed developed the seeding of cancer and claims other procedures would be better.  Traditional surgery removes the uterus and fibroids intact with less chance of spreading any unsuspected cancer.

Here is what the package insert that comes with the morcelator says:

CAUTION: … use of the …  Morcellator may lead to dissemination of malignant tissue.

So what are the statistics?

  • 20% – 40% of women will develop fibroids
  • 1 in 1000 cases of fibroids contain cancer
  • intact removal of fibroids with malignancy failed to stop the malignancy 19% of the time
  • morcelator removal of fibroids with malignancy failed to stop the malignancy 44% of the time

The big question is:  should a morcelator be used if a woman has fibroids because it may double the risk of spreading an unsuspected cancer?

The simple answer is NO, because there are other surgical options.  But, will women accept that answer?  The laprosocopic procedure has less pain and quicker recovery, so the answer turns out not to be so simple.  There are many forces at work on the decision to continue to use the morcelator.   The analysis of these forces is called force-field analysis which was originally described by social scientist Kurt Lewin in the 1940’s.     The following is such an analysis (the rating of force vectors is by the author of this blog):

Morcelator Analysis

So, what will happen?  It seems at this point the morcelator will continue to be used.  But, the risk remains.  Law suits will continue.  Perhaps a safer device will be developed.  Perhaps a high risk of litigation will be perceived by gynecologists and the malpractice insurance companies as  being too great.  Such risk will lower the forces from doctors and perhaps tip the balance.  Time will tell.

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Update (8/1/14):  since the original post the FDA issued a warning about morcelators.  Yesterday, Johnson & Johnson, the major supplier, stopped selling morcelators.  Looks like the forces to abandon the morcelator have been joined by the FDA and the manufacturer.

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Update (2/27/15):  yesterday the Wall Street Journal reported United Health (insurance) requires surgeons to obtain permission for procedures that might use the morcelator — “another blow” to the device.  At this point any surgeon using the device must feel like they are walking a tightrope without a net.

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