For a sick person, which is worse?
1. Getting better for the wrong reason.
2. Wasting a lot of money.
It sounds like a joke — #1 isn’t even harmful, whereas the cost of health care is a very serious problem. Yet the FDA and legislators with FDA oversight have been given this choice — and chosen #1. They have chosen to protect us against #1 but not #2.
If you get better from a placebo effect, that’s the wrong reason. How dare you! The requirement that drugs be better than placebo controls prevents this from happening. The requirement might have been — but isn’t — that a new drug be better than pre-existing alternatives. Many aren’t but they are always more expensive — not to mention more risky.
Seth, I think your post is a bit misguided.
1) The reason that drugs are required to perform better than a placebo is because the placebo effect tends to only occur in a small set of patients. That is that the mental makeup of a specific patient is the cause of a placebo response (irregardless of the treatment). It is also not clear whether a placebo respondee is “actually getting better”. It is just as likely that they were not actually sick in the first place (or as sick as they thought).
2) Those patients who are not predisposed toward exhibiting placebo responses need to be given an actual effective treatment to “get better” and therefore deserve medications that exhibit “better than placebo” characteristics.
3) There is a requirement from FDA (and regulatory agencies worldwide) that new drugs be as good or better than existing medications; or that they provide some sort of unique benefit (or reduced risk).
4) The expense of new medications is largely due to the high cost of research to make those medications (and fund future research). The low-hanging fruit is largely gone.
Best,
TJK
T.J. Kuhn, thanks for your thoughtful comments. I’ve never before heard the idea that “the placebo effect tends only to occur in a small set of patients.” It’s a surprising and puzzling idea because there are so many different placebo effects, i.e., so many different situations in which some sort of supposedly-impotent treatment has an effect. What is this idea based on?
I don’t grasp the reasoning behind #2. It doesn’t seem logical. If Person X doesn’t respond to placebos, why the need to study or use them?
The FDA requirement you mention is useless. Any drug can be claimed to have a “unique benefit.” There’s always something.
“The expense of new medications is largely due to the high cost of research.” Huh? Drug companies spend vast sums on advertising and marketing. This surely affects the price of drugs. See my recent posts on Charles “Disgraced” Nemeroff. The reason he’s disgraced is how much money he was given (and failed to report).
The important thing to remember about a placebo response is that the response is not due to the treatment. It occurs because of the expectations of the patient. In some studies, there has even been a negative placebo response (that is, the patients were expecting to get worse and did because of their expectations).
With regard to my second point: Placebo use in double-blind trials is not an attempt to study them. Rather, placebos are used to better study the actual investigational product independently of the subjects expectations of what taking medicine should do.
With regard to advertising and the cost of drugs: Kraft, Coca Cola, Toyota, Miller Beer spend vast sums advertising their products. Surely that has an effect on their prices as well. However, drug companies spend hundreds of millions of dollars researching new treatments. The best (although imperfect) analysis puts the cost of bringing a single medication to market at over 800 million US dollars. I’m pretty sure that Kraft doesn’t spend that much on their latest line of crackers.
Your point, however, is well taken; “should we allow advertisements for prescription drugs?” There are a lot of valid points on both sides of that debate. I see both benefits and drawbacks; so I think the jury is still out on drug advertising.
Have a good day,
TJK