Ha ha ha. It would be funny if it were not so pathetically the case.

Jim, as for old information, I did make a mistake on the AAN announcement. We see what we want to see, and my eyes being the window to the soul, I saw 2013 leap out when it in actuality was last year 2012. I wanted it to be so, and my brain played right along. Funny, how the power of suggestion and cognitive decline do not mix so well. So sorry about the confusion. Had I not been to lazy to link a source, I would have avoided it.

That was really of less importance than Abbvie being the lead sponsor of the Unity Walk, but I feel bad for misinforming others. There is no way Abbvie would position themselves as a major presence supporting PWP if they have no treatment to offer us. As Bob stresses it would be weird for them to sponsor that but offer us nothing more than we plan to submit for FDA approval this month, but who knows all is possible in this vaudeville act put on by the FDA. Timing an announcement with the Unity Walk gets them name recognition and great press; is is crucial for them to market directly to us because doctors only want to talk brain surgery. Many PWP are not even aware of this stuff.

Well, Conductor 71, here is some 2013 news about the sponsor of this year’s Parkinson’s Unity Walk at the end of Parkinson’s Awareness monrth:

AbbVie Opposes Disclosure of Studies on its $9.3 Billion Humira
by Ed Silverman March 11, 2013

In a direct challenge to the proponents of disclosing clinical trial data, AbbVie has filed a request for an injunction to prevent the European Medicines Agency from releasing detailed patient-level data from studies concerning its top-selling Humira rheumatoid arthritis treatment, The Financial Times writes.

The filing comes after two Freedom of Information requests were made to the EM last year to release “raw data” on the safety and efficacy of the medication, a ten billion-dollar seller…

Also. ….Last year, Abbott Laboratories which has since spun off AbbVie, filed a citizen’s petition with the FDA to ask that the agency not approve any biosimilar for its Humira treatment for rheumatoid arthritis….

The latest move comes amid a heated controversy over data disclosure…. researchers who argue that results cannot be independently verified unless patient-level data and case-study reports are fully disclosed.
There are, however, cracks showing in the stance taken by the pharmaceutical industry. Last year, GlaxoSmithKline agreed to make patient-level data to independent researchers, a step that came after the drugmaker paid a $3 billion settlement to settle civil and criminal charges that included a failure to release trial data. However, the drugmaker has not yet launched its effort…

(TS Eliot on a downer):

APRIL is the cruellest month, breeding
Lilacs out of the dead land, mixing
Memory and desire, stirring
Dull roots with spring rain. . "
What are the roots that clutch, what branches grow
Out of this stony rubbish? …
You cannot say, or guess, for you know only
A heap of broken images, where the sun beats,
And the dead tree gives no shelter,…
And the dry stone no sound of water.

This doesn't at all surprise me, but no one seems to care save for a handful of people here. Amgen is at it again too with forcing pharmaceutical sales reps to promote dubious off label use of a drug. This is exactly what Dr. Friend is fighting...where did he go, btw?

Conductor71, no need to apologize. I was simply lost with where did this come from when I read your post. I'd like to think I'm up to speed (ha) with what is going on in the realm of parkinson's but maybe not. The statement that not many PWP are aware of this therapy is an understatement. In the past 6 months or so I have been hospitalized 3x for various reasons. They have always had a neurological consult done just to ensure that I am ok. NONE of these neurologists had any idea of what I was talking about and one even said "So what is the big deal, you have to have an operation to have a tube put in that has to be maintained. Why not just take the pills by mouth." I kid you not!

You heard it here first- all the news that fits.
W-SPAZ News at Six
All Parkie, All the Time.

Transcript; FDA decision on Duodopa; Feb. 6, 2012
Fast Track Governance Meeting

FDA 2: Hey boss, that sample of Duodopa arrived from Europe, for the clinical trial for Parkinson’s.

FDA 1: Block Duodopa until our guy gets his ducks lined up.

FDA 2: Block it? How can you do that?

FDA 1: Like taking candy from a baby. Just use the rule book and find some obscure precedent. There are thousands of pages of rules; you can always find something.

FDA 2: Aren’t these repeated pointless delays detrimental to the people the drug is intended for, the Parkinson’s People?

FDA1: Hahahaha. Do you see any of them in this conference room? Do you think we are going to call them up and ask how this would affect them? Do you really think we are going to inform them at all? What they don’t know won’t hurt them. Or at least they won’t know what is hurting them. “Ignorance is bliss.” That’s the motto above our front door.

FDA 2: Well, we have to tell them something.

FDA 1: Tell them we are Fast Tracking it and it will ready in six months.

FDA 2: But we have been telling them that every 6 months since 2004.

FDA 1: It’s part of the research. How many times can you fool them with the same promises, re-issuing the same press release each time? Every six months for 5 years? 10 years? Just the fact that they believe us again and again is proof that their cognition is severely damaged. There used to be institutions for that kind of people. Now they wander around in the streets demanding “to be part of the process”. Some of them don’t even know how to button a shirt. And you think they would understand medical science? Look, I didn’t spend 6 years in Grad School, followed by 20 years of brown-nosing, just to be told what to do by some twitchy spastics.

FDA 2: But we are supposed to help, not hinder.

FDA 3: Son, you’ve got a lot to learn. For one thing, always remember what side your bread is buttered on. You think maybe the Parkies are going to pay the mortgage on your house? That SUV you drive was on sale?

Now shut up and update the Duodopa file as follows:
FDA Import Refusal Report 336-6232878-4/5/1
Importer's Product Description: DUODOPA (LEVODOPA-CARBIDOPA) INTESTINAL GEL FOR CLINICAL TRIALS
Refusal Date 06-Feb-2012
FDA Sample Analysis: No
FDA Record of Private Lab Sample Analysis: No

Violation of Code:
DIRECTIVE 502(f)(1), MISBRANDING (supposed to be Duopa in America; Duodopa is the European name.) (But it doesn’t exist yet in America, so the Duopa brand exists only on paper.) (So for the clinical trials, Duodopa was flown in from Europe.) (But in America, it is going to be called Duopa, not Duodopa). Misbranding!

Violation of code:
DIRECTIVE 801(a)(3): The article appears to lack adequate directions for use. (“Put in water. Stir. Do not use in internal combustion engines or flame throwers. Insert in well-insured Parkies only. Payment required in advance.”)

(Shipment was put back on an airplane to Europe). Import Refusal.

FDA 2: But this is not a commercial shipment – this is for scientists to use in the clinical trials that we are going to repeat again, instead of relying on the experience in 38 countries. The treatment has been approved and is used daily by Germany, France, Sweden, Holland, Israel, Switzerland, Austria, Australia, and 30 more countries. Can we not trust their experience with it? Do we have to repeat from scratch clinical trials done 10 years ago for a treatment that you can see being used successfully in every country in Europe? Sham surgery for the control group, for a treatment that has already been in use for 10 years?

FDA 3: Have you ever been there?

FDAB 2: Where?

FDA 3: Europe. I went to Europe once, and it was FULL of foreigners and they were all talking strange words so you couldn’t understand a damn thing they said. Did you hear that they eat horses? Savages. No sirree, we have to test Duodopa all over again, right here in America, on local folks. You don’t want to find out your control group was a bunch of horse-eaters in Europe somewhere, swilling cheap wine straight from the bottle, and whistling at anyone in a skirt. You ever seen the strange toilets they got over there? And 3,000 kinds of cheese? And they still smoke in their offices? No sirree, boy, you better stay down on the farm rather than go trolling in Gay Paree. You expect the Italians and the Spanish to cure you? Maybe the Germans and the Swiss, but how do you tell them all apart? 38 countries using Duodopa? Why, that’s just 9 short of the number of states we have, if you forget about Hawaii and Alaska. And Puerto Rico. But Lichtenstein – you call that a country?

FDA 2: I don’t know what you are talking about.
You say there were no “adequate directions for use” on the package. It’s not going to the public, it is going to the Phase III trial. Surely the scientists who ordered it do not sit and read the label and wonder what it is for and how to use it.

FDA 3: Son, you changed the topic again. You had better start looking for a different line of work. We work as a team here, and you are not a team player.

FDA 2: You guys are crackpots.

FDA 3: Yes, we’re the FDA. None for all and all for none.

Parkinson's minute, about Duodopa:
http://youtu.be/GkKuJrmXU6Y

An idea whose time has come?

April is Parkinson's Awareness month.
It ends with the Parkinson's Unity Walk.
The premiere corporate sponsor is Abbott (Abbvie)
They have exclusive world-wide rights to market Duodopa
It is expected they will use the occasion of the Parkinson's Unity Walk to announce that Duodopa has finally been approved as a treatment for Parkinson's in the USA; ten years after being accepted in 38 countries.
It will compete against DBS.
Abbvie does not share research data.
In fact they are launching lawsuits in Europe to keep research data secret for any and all drugs.
The British Medical Journal will no longer publish the abstracts of research from any researcher that refuses to provide the evidence.
This is an industry-wide satori that is not only about Abbvie, but it includes Abbvie, and thus includes research into Parkinson's. British Medical Journal says give us complete research info, or none at all. Them is fightin' words.

But Abbvie will, apparently, become a major supplier of hope to Parkies. If suppliers of drugs to Parkies truly want to have a Unity Walk with us, I want them to be aware that Unity with Parkies is something they will have to earn.
So walk on, be united, but also, if you so agree, make it clear to Abbvie that they have won our attention, but for long-term Unity, there are divisions that are too concrete to be fluffed over by a corporate public relations gambit.
So for one thing, I want our premiere corporate sponsors to be aware that some Parkie Unity walkers are signing this petition, and it should be made available at events during Parkinson's Awareness Month, as the refusal of Abbvie and others to reveal research results is particularly damaging when the disease, such as Parkinson's, is an enigma wrapped in a mystery inside a secret.
This is a petition that some Parkies are signing:
http://www.alltrials.net/

From the petition:
… about half of all clinical trials have never been published, and trials with negative results about a treatment are much more likely to be brushed under the carpet.
… If you tossed a coin 50 times, but only shared the outcome when it came up heads and you didn’t tell people how many times you had tossed it, you could make it look as if your coin always came up heads. This is very similar to the absurd situation that we permit in medicine, a situation that distorts the evidence…
…. Governments around the world have spent billions on a drug called Tamiflu: the UK alone spent £500 million on this one drug in 2009, which is 5% of the total NHS drugs budget. But Roche, the drug’s manufacturer, published fewer than half of the clinical trials conducted on it, and continues to withhold important information about these trials from doctors and researchers. So we don’t know if Tamiflu is any better than paracetamol.
Initiatives have been introduced to try to fix this problem, but they have all failed. Since 2008 in the US the FDA has required results of all trials to be posted within a year of completion of the trial. However an audit published in 2012 has shown that 80% of trials failed to comply with this law…
… The AllTrials initiative is campaigning for the publication of the results (that is, full clinical study reports) from all clinical trials – past, present and future…
We are calling on governments, regulators and research bodies to implement measures to achieve this. And we are calling for all universities, ethics committees and medical bodies to enact a change of culture, recognise that underreporting of trials is misconduct, and police their own members to ensure compliance…

So Bob, if I understand correctly, these companies are not required to provide the results even to the regulatory agencies they are seeking approval from?
I wish that there was enough cohesiveness in the Parkie community that we would stand up and say that we are not going to accept your sponsorship or use your medication in light of this policy. I wonder what the MJFF's feelings on this issue are? Debi Brooks, any word on this?