Sunday, November 9, 2008

More about Abilify - and the makers Bristol-Myers Squibb






Let's take a look at the http://www.abilify.com/abilify/depression/index.jsp the official site brought to you by Bristol-Myers Squibb.


Now we have this conflicting data to decipher and make some sense of as a potential consumer? Those slick fancy commercials tell us this is the greatest thing to come along since sliced bread; but only a 11% success rate showed for some improvement as an add on to an Antidepressant for depressive symptoms. They don't even market the drug for what it is "Anti psychotic"; but as an add on treatment for depression.


ABILIFY IS AN ANTI PSYCHOTIC MEDICATION <~~~~~WARNING


The adverse side effects: "In the first study of Abilify, 362 patients were randomly assigned to Abilify or placebo for six weeks after a failed trial of antidepressants. There was a -8.8 v -5.8 change on the Montgomery Asberg Depression Rating Scale (MADRS), a difference of 11.5%. 23% of patients on Abilify versus 5% on placebo had akathisia, a potentially very disturbing side effect where you feel like you are jumping out of your skin or cannot sit still. Restlessness was seen in 14% v 3%. Fatigue was also more common.


"In the second study
of Abilify, 381 patients who had failed at least one antidepressant medication trial were treated for eight weeks with an antidepressant followed by the addition of Abilify or a placebo for six weeks. Abilify showed an -8.5 change on the 26 item Montgomery Asberg Depression Rating Scale (MADRS) versus -5.7 for placebo, a difference of 2.8 points, a difference of 11%. 26% of patients on Abilify versus 4% on placebo had akathisia, and 10% versus 1% had restlessness.


Now here comes the fun part of this whole clinical trial and data collection business for profit nightmare.


This is what they don't tell you!


Who are the people they are using as test subjects? I have seen over many years working and observing in various institutions, hospitals, and with varied populations that many of these so called "Test Subjects" used in many if not the majority of these so called scientific studies are actually people pulled off the streets; as in homeless, and/or indigent populations, starving students hurting for some extra or much needed income (we have all read about those horror stories and deaths in the news and elsewhere), or prisoners, some have institutionalized extremely mentally ill patients involved; most study subjects are paid cold hard cash to do these trials (some get other benefits as in institutional brownie points, and there is even a population of professional Ginny pigs that do these trials to make a living!).
They have built in incentives not to complain, and complete the studies no matter what the side effects are; (thus the low dropout rates reported in the data) since they are making money, being provided food, shelter, and other goodies such as cigarettes in many cases.


This is only one of the many reasons why these clinical trials and studies should be strictly regulated and overseen with standardized protocols with not only with the drug in question itself; but also factoring in the backgrounds and status of the test subjects involved by completely independent bodies with no stake in the outcome, or are part of the huge windfall pie so to speak.
This is why I personally consider these trials/studies voodoo medicine, invalid, bad science, as well as very skewed statistically.
Maybe you'll get lucky and be part of that 11%, but I must ask can that justify the FDA approval and advertising an anti psychotic to the general population with so much at stake in adverse results and consequences?
How does that make you feel about your friendly neighborhood Pharmaceutical Company?

3 comments:

susan said...

one more great thought provoking post Stan!

Stephany said...

It's imperative people know they are receiving an antipsychotic when being treated for depression; hell that's almost off-label use (like it used to be)by not disclosing this information it places innocent consumers at risk.

It's going to be the same way with Seroquel XR.

Antipsychotics are dangerous medications that should be reserved for psychosis and schizophrenia as they were originally "designed"; and then take a look at the stats and the people who have used them for that purpose and the less than efficacious results are right there.

IF Abilify worked so great for psychosis, my daughter would be well, fine and doing great. (for example, she has trialed ALL antipsychotics and like many readers here has had less than efficacious outcome with use)

This is reckless endangerment of lives of innocent people using antipsychotics as depression medication, and just as the placebo vs. antidepressant data comes in to wash out SSRI use, the new hot drugs come on the market to replace them....the problem is, these are not new drugs.

New marketing targets, that's all. (that's you)

I'd like to say I've witnessed dozens of people, on daily basis in hospitals and everywhere my daughter has been show the signs of a tough road lived on antipsychotics. The permanent tremors, the drugged looks on their faces, the loss of memory, the decline in body health, and the shortened life-span---and the FDA allows these DTC ads? where is the public safety commission?

Invega is repackaged generic Risperdal; Abilify is re--marketed schizophrenia drug...after one year on Abilify, my bet is the people who feel benefit from Abilify for depression will be singing a new tune, and hopefully it won't be that they have diabetes or permanent involuntary muscle movement of their face, tongue, legs or hands.

All of this is just my opinion, and it's based on seeing people suffer first hand on these drugs (including myself).

Dano MacNamarrah said...

Stan,

I have a link to Circare in my side-bar. I'm rehabbing a house of one of the staff there, Elizabeth Woerknek. One of her collegues busted the Doctor running tests on inmates at Holmesberg Prison years ago.

The doctor still has his license to practice. They fight on behalf of those used in drug tests: The mentally diminished, the ASL, the poor and people from countries who have no protection.

Pop her a line. Let her know you are interested. I just put up a link to a study she exposed, that the AP published.

A caveat: I am taking many meds that I believe have helped me live. I just don't want people to have to take them needlessly. My p-doc thinks I'll be med-free at some point. We are all working hard for that, sometimes it seems to no avail.

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