Ask mj: "Clinically Proven"

An anonymous reader asks mj: "What does 'clinically proven' mean? It's in all the commercials for drugs and whatnot. Is there anything that isn't clinically proven?"

The answer to the second part is yes and no. But you'll never hear someone advertise whether something that wasn't clinically proven.

The process of getting FDA approval for a drug is long and difficult, most drugs that companies start to develop never make it through the entire process which involves clinical studies near the end.

The studies are usually paid for (and often conducted by) the pharmaceutical company that creates the drug. The real catch, however, is that the company get to choose which studies they submit to the FDA and which ones they do not.* Moreover they are under no obligation to make the study public (e.g., publish it anywhere). The study is actually considered proprietary information.*

This post has been in the making for awhile, I was going to use Lunesta as an example which of course advertised itself as clinically proven, but previously did not post actual results of any of the clinical trials. Since that time at least one study is available on their website although details of the study are not provided which is necessary to actually evaluate whether the study was "good" or not.

The final note is important, it is extremely easy to spin studies however one wants. Hence the multiple headlines in the media, "New study suggests that [noun] [increases/decreases] chance of [disease/heart attack/stroke/whatever]." While I am not going to bother to go into details, but it is extremely difficult to both design and carry a good study (this has applications beyond medication, sociological studies, economic studies, etc., [basically anything that isn't a hard science] suffer many of the same difficulties.)

Final word: unless an independently conducted and publicly reviewed study was conducted "clincically proven" doesn't mean much at all. And don't expect the media to accurately report on "studies." Unless the organization takes a hard look at the study (which is rare) the reporting is from the abstract, which also means little by itself.

*This was at least true three months ago when the post was started. As far as I know it is still true, but I no longer remember the sources I used other than to say they were reputable.