Posts Tagged 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.
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.
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.