Maybe SOME Good News from the FDA

[Zeppelin795]

The FDA is right to insist that only proper clinical trials can make that case.

So the people that are already being helped don’t count?

Are all the people claiming to be helped by medical marijuana over the last decade just imaging their benefits?

[ActivitiesGuy]

We’re about to see if Zep can break the T-Nation record for saying the same exact thing the most times within one thread.

[Zeppelin795]

I think I’m 2nd behind you and your lame consumer protection excuse. While there are plenty of people already being helped by this treatment you support policies that deny them that choice in this country. I suppose your against medical marijuana because of the lack of clinical trials to prove it’s safety. So all the people that are finding relief from it, you would deny them the help they are receiving because it doesn’t fit into your little box because results don’t matter. Just your adherence to the FDA’s regulations supported by Big Pharma. But a criticism of a for profit medical system is synonymous with lizard people. You are small and stupid.

[SkyzykS]

Is this treatment free in Panama?

What if it became a legitimate treatment in the US, but they expected you to pay for it?

[Zeppelin795]

No. Does it matter? At least they have the choice provided it’s not so expensive that the majority of people can’t afford it. But at least they know it’s available and that it fairs better than the pharmaceutical solutions.

[anon50325502]

@Zeppelin795

I think I’m 2nd behind you and your lame consumer protection excuse. While there are plenty of people already being helped by this treatment you support policies that deny them that choice in this country. I suppose your against medical marijuana because of the lack of clinical trials to prove it’s safety. So all the people that are finding relief from it, you would deny them the help they are receiving because it doesn’t fit into your little box because results don’t matter. Just your adherence to the FDA’s regulations supported by Big Pharma. But a criticism of a for profit medical system is synonymous with lizard people. You are small and stupid.

Totally agree, we should treat the obesity epidemic with the human immunodeficiency virus. Fuck the FDA for keeping this from people!

[Zeppelin795]

Can you answer the reason why this treatment is being kept from people in this country despite the tremendous results already achieved in other countries, like Panama?

[Zeppelin795]

Episode 2 The Truth About Cancer: A Global Quest - Episode 2

[anon50325502]

@Zeppelin795

Can you answer the reason why this treatment is being kept from people in this country despite the tremendous results already achieved in other countries, like Panama?

Sure:

@anonym

Out of curiosity, do you know what the purpose of Phase II and Phase III trials are?

If you do, could you please explain your reasoning for supporting the marketing of pharmaceutical products backed by no efficacy data in humans, and with safety data limited to however well a handful (e.g., up to 100) of (typically) healthy individuals tolerated various dosages?

Do you know how many trials are dropped during either Phase II (hint: ~70%) or III (hint: ~50%) due to safety / efficacy concerns?

@EyeDentist

The FDA approval process can be maddeningly slow, and I’m sure there are ways it could/should be tweaked. But wholesale abandonment of the requirement that a treatment be demonstrated effective prior to being made available to the public is not the way to go about doing this.

@anonym

Because a few people break the rules (arguendo), we should abolish the rules altogether?

How many more people will die if we permit the 90%+ safety / efficacy failures market approval?

@Aragorn

If it were a drug we were talking about, you would be livid that they were releasing the treatment without more safety and better design. Mere thousands of times, if one of those has so much as a hangnail you would cry wolf.

@ActivitiesGuy

We have answered you dozens of times by now. Frankly, I just don’t have the desire to have the same conversation again.

@Aragorn

…and again, and again, and again…

and again, and again, and again, and again, and again, and again, and again, and again

@ActivitiesGuy

No matter how many times you’ve posted links to cellmedicine.com glorifying the “thousands of people who have had the treatment and are receiving the benefits” that is not a substitute for well-designed randomized controlled trials which evaluate safety and efficacy. And, despite your ongoing crusade about this, the United States is conducting tons of research in this area. For reasons we have been over 20 times before, proper evaluation of a therapy takes time and controlled studies to document the true magnitude of “benefit” as well as establish the incidence and severity of side effects.

There are several sad examples from the medical history books of therapies that were approved and put into use without adequate study to establish benefit and/or safety, only to be retracted later because they were ineffective and in some cases harmful.

If I gave you a pill yesterday, and you feel better today, does that mean the pill helped you? I don’t really know. Maybe you would have felt better today even without the pill. That’s why we need randomized, controlled trials - to wash out the placebo effect, the rebound effect, and determine the true benefit of a particular therapy. You’ll cite the “thousands of people have gotten this therapy…” line all you want, but we don’t know if the cell therapy actually did anything for them until it is tested in a randomized controlled trial (which many U.S. scientists have been / still are working on).

I hope that will suffice.

[Zeppelin795]

You’ll cite the “thousands of people have gotten this therapy…” line all you want, but we don’t know if the cell therapy actually did anything for them until it is tested in a randomized controlled trial (which many U.S. scientists have been / still are working on) So they are just imaging the benefits, thousands upon thousands of people? Just like the thousands of people who are claiming to get relief from medicinal marijuana. They are just imaging their benefits and should all have suffered until “science” catches up? Your medical philosophy not mine. A study is not a reason to deny people choice. Especially when it’s been shown to be helpful and safe in various other countries. If you had your choice you would deny people the choice to take medicinal marijuana because of the lack of studies. You would essentially be a catalyst in making people suffer. How many examples of people that are being made to suffer vs. those who suffered because a treatment has been made available too soon? Research that is not applicable to real world instances are almost useless. The Stem Cell Institute has been helping people for a decade now and publishes all of their work and works with American Universities.

There is a reason that this is being kept off the market and good results is one of them. This treatment has been shown more helpful than drugs and as Dr. Barth Green of Miami University says " The pharmaceutical Industry around the world are shaking in their boots" Because they know the writing is on the wall so they will try and circle the wagons as much as they can. Eventually the tidal wave will be too much for them to hold back much like medicinal marijuana they will take the stance of, if you can’t beat’em join’em.

[anon50325502]

I guess that didn’t suffice, shocker.

[Zeppelin795]

No, much like the bogus “safety” issue.

[anon50325502]

@Zeppelin795

No, much like the bogus “safety” issue.

Might want to tell that to this lady’s family.
http://blogs.discovermagazine.com/80beats/2010/06/18/danger-stem-cell-tourists-patient-in-thailand-dies-from-treatment/#.WK85kdIrKHs

[SkyzykS]

@Zeppelin795

A study is not a reason to deny people choice.

Nobody or thing is denying anybody a choice.

Go whip up your own batch of stem cells and snort them off of a strippers ass for all Bayer pharmaceutical cares.

You just aren’t gonna get it from them.

[ActivitiesGuy]

My brain is bleeding.

[anon50325502]

[SkyzykS]

@ActivitiesGuy

My brain is bleeding.

Sprinkle some stem cells on it!

[Zeppelin795]

I love how you just gloss over the many people that have been helped. The side effects from treatment done in Panama have been site injection soreness and a grade 1 flu symptoms from 1 person. Wow! How many people have died from “safe and approved” drugs from Big Pharma since you care so much?

[Zeppelin795]

So people can get their own stem cells multiplied to a therapeutic dose and injected back into them?

[Zeppelin795]

I’m sure there is a FDA “approved” drug for that ailment that has double-blind placebo studies done on it.