This Is MS Multiple Sclerosis Community: Knowledge & Support

I have had some doubts concerning the "Placebo Effect", my reasoning had to do with numbers, in most cases I have seen, the numbers used in the test group have not been a large number, and in many cases the logic was to test a controlled group, consisting of a specific number, of coarse divided evenly.

Although the purpose, as per disease, is common in some cases of tests, in many others it was not as specific as to the purpose of the test and it was to get a number for something that was generalized..

And with that in mind, if you take the number, lets say, 1000, and divide that in half, then you administer a test, and you use the outcome to determine the impact on the entire population of the planet, I doubt that would be a reliable outcome, why?, because when you deal with large numbers the variables are very unstable, just to take that a step further, if the numbers were actually taken to infinity, the results would be moot, you could take a group of people from the other side of the globe, and do the same test and get totally different results due to many many reasons.

So I still am not sure about the parameters set for "Placebos" and the results they give us.

Just some thoughts from beside the bay on a nice morning


The link below is an article on the Placebo Effect
http://skepdic.com/placebo.html

............ and your point is????? ROFL

Deb

People tell me if I wear a hat, noone will notice my point ..

I think you may be doing what a lot of people do, which is over-generalize what a particular study tells you. Each study has a specific set of inclusion and exclusion criteria that everyone has to meet, both controls and tested subjects. Of course the demographics of the population you use will have an impact, and you need to make sure both your control and tested groups are drawn from the same pool. The size of the study is determined using a bunch of hocus-pocus and some serious statistical analysis and represents a best guess of what is necessary to come up with reasonable conclusions - all bounded by the amount of money available of course.

In the end, you get a result that compares placebo to active drug in a specific population. Since the populations have similar characteristics you can decide if the drug had any real effect or not because that's the only difference (well it isn't really, but it's as close as we're going to get without having infinite resources). To then say the drug works in any other situation is leaving the realm of science and entering the world of marketing.

Then the over-generalization happens. After 3 phased trials and a review by the FDA, the drug is declared effective (or not) and put on the market. Of course the physicians who prescribe it don't make sure you fit the profile of those in the trial, they just give it to you, even though there is not necessarily any evidence that it works in people like you. But we've had some pretty good successes doing that, so we keep on doing it.

Hi Art and welcome to the forum, I think we kinda agree on the murky results, I think anytime with numbers and maybes and whatifs, the results can be kinda used as needed..

But as you say, some good comes out of it, so there is reason in the logic even if the outcome is illlogical..

Philip

Sorry, time to leave the board.

-finn

Finn, thank you for this link, "Sylvia Lawry center".

I will be adding that link to my website soon..

Thanks, Philip

Sorry, time to leave the board.

-finn

Finn,

Here is another interesting side note about the initial Avonex trials conducted by Biogen.

The first interferon drug to receive FDA approval was Betaseron . It also got orphan drug status classification as well from the FDA. Because there weren't any classifications for MS at that time, the MS patients used for those trials were randomly selected and included what we now know as RRMS, PPMS and SPMS.

Along comes Avonex. Biogen wants orphan drug status as well but the only way that you can get orphan drug status for a drug when there is already another drug with this status is to prove that your drug is more effective. So how is Biogen ever going to do this?

Along comes the NMSS. They decide that there should different classifications for MS patients and after sending out surveys to thousands of neurologists, they only get a small amount returned. The NMSS comes up with the four classifications and Biogen does their trial only with RRMS patients. Of course their results are going to look better because of the type of patient that they are using. And like you pointed out, they also skewed the results to a certain extent to add insurance. Voilà, the FDA grants approval of Avonex to Biogen and also orphan drug status.

Oh, BTW, each and every member of the NMSS Board of Directors at that time received some nice grants from Biogen for their research!

And some people think we make up these stories!


Harry

Harry,

that was an interesting anecdote, but I personally think that more important than to know that such things have happened is to make sure that they won't happen again. My answer to that problem is more transparency to all decision making, more patient activity, more valid and reliable unbiased information, and more financial support to industry independent nonprofits (if there are any).

-finn