“Here we go back down the rabbit hole,” Paula W. and her co-conspirators used to say on the NeuroTalk Parkinson’s Forum.

About Amgen in the GDNF debacle.

About Merck and the deliberate sinemet shortage.

About the system of triage that was obviously in place, but denied.

And the inexplicable 10 year delay in getting duodopa across the Atlantic, Abbvie and its predecessor repeatedly promising and not delivering; and explaining none of it.

The inexplicable refusal (industry-wide) to publish half of the medical studies – the studies that are negative are jettisoned –

About the inexplicable refusal to provide data even on the positive studies,

And at all times, the inexplicable silence of the lambs.


Back down the rabbit hole, into the mysterious Parkinson’s Nether World.
That’s where we stand today with Abbvie and duodopa. What happened in the past 10 years? What’s the narrative? What’s the frequency, Dave? The FDA got your tongue? And what comes next? Triage again? Better than nothing, but why are the patients the only ones kept in the dark about the multi-billion dollar industry that grew up around our disease?

Whether it be Amgen or Merck or Abbott or others, when we ask simple questions about the decisions being made, decisions that for us may mean life or death, the response is that it’s none of our business. It’s “proprietary information.”

It is no longer Parkinson’s, it is now Parkinson’s™.

It’s none of your business, you hear? Now take your pills, sit in the chair and stare at the wall. That’s all you need to know.

FOLLOW ALICE DOWN THE RABBIT HOLE: (as per Walt Disney)

http://youtu.be/tOyasacx9vQ

Abbott 1: We are in deep doo-doo both in Europe and the U.S.A. We need some good PR fast, because the Parkinson’s People are getting out of control. Especially when they are “On”. When frozen, they are much easier to handle.

Abbott 2: maybe we should do a reality show; have Parkies run up Mt. Kilimanjaro in Back-to-the-Future Nike shoes.

Abbott 3: What’s the point of that?

Abbott 2: it doesn’t have to have a point. It has to have credibility and pizazz. You know, sell the sizzle, not the steak? Run it up the flagpole and see who salutes? Use commercial marketing focus group to choose the best fashion accessories to go with your duodopa intestinal gel pump – hey, get Martha Stewart and have her come out with a spring line of color-matched intestinal pumps; and then if we could have some high-powered celebrity to actually be seen in public, wearing the Abbvie intestinal gel pump at some event like the President’s State of the Union address.. or the Oscars – get famous people to wear the pump to the Oscars and then have Billy Crystal joke about it on stage… it’s brand recognition we need, to take over the Deep Brain Stimulation market monopoly.

Abbott 1: Yeah, and with marketing focus groups, we don’t have to have a control group.

Abbott 1, 2, and 3: Hahahaha!

Abbott 1: Let’s get away from this serious stuff and have some agonist induced impulsive - compulsive reckless behaviour at that bar down the street. All work and no play makes Big Pharma a dull stock market chart. If you can’t have fun selling addictive drugs to cripples, then there’s no way to have fun at all.

(All exit, stage left; lights dim. Somewhere in the distance, two riders are approaching, and a wild coyote howls. Tumbleweed blows across the stage).

This is DIY. Do It Yourself editing. I am not going to arrange the information for you. We report, you decide. We infiltrate, you expel. We paste, you delete. Such is the proper order of all things: and as it turns out, you actually do need a weatherman to know which way the wind blows.

I cannot take charge of filling all the gaps in your culture, because I long ago shrivelled my ego down to the size of a pea, and cast it into the pool of perpetual self-denial. At least that’s what I told my (former) employer.

So, dear readers, I am casting you adrift once again, poor dears. You are on your own now. Be sure to put up the mosquito nets before the monsoon.

W-SPAZ News at Six - you heard it here first
All Parkie, All the time.

19th annual Parkinson’s Unity Walk, Central Park, New York City
To be held April 27, 2013

Premier Sponsor & Proud Partner: Abbott

Fee paid by Abbott to be premier sponsor and proud partner of Parkinson’s Unity Walk: $100,000

Infiltrated: what a hundred K buys you:

This is from the business contract between Abbott and the Parkinson’s Unity Walk:

visibility in Central Park in New York City

the booth location and size as agreed upon
honored stage seating for Abbott executives with speaking opportunity for Abbott during program
Abbott’s logo on all of PUW T-shirts, prominently placed
day of walk signage
Abbott’s logo on full-size banner placed on Margot Zobel Way
Abbott’s logo on full-size banner placed on stage
Abbott’s logo on sponsor signs, placed in two locations

brochures, direct mail, media

Abbott’s logo on brochure cover and on sponsor page
Abbott’s logo in PUW mailing, with option to include Abbott enclosure in each envelope
Abbott’s logo in press releases and media advisories

website

Abbott’s logo on PUW home page, with link to Abbott’s website
Abbott’s logo and two or three sentence highlights about Abbott on sponsor page
expanded highlight about Abbott – up to 300 words – on PUW website, with link to Abbott’s website
red carpet interviews with multiple Abbott representatives
Abbott featured as Premier Sponsor & Proud Partner in video highlights

electronic communication

Abbott created separate e-mail to send in April, (Parkinson’s Awareness Month) with link to expanded highlights about Abbott on PUW website, and linked in turn to Abbott’s website
Abbott’s logo on post-walk newsletter, with link to expanded highlights about Abbott on PUW website, and from there to Abbott’s website.

Through the generous support of its corporate sponsors, 100% of all donations made to the Parkinson's Unity Walk are distributed among the major U.S. Parkinson's disease foundations for Parkinson's disease research. The foundations include: (1) the American Parkinson Disease Association; (2) the National Parkinson Foundation; (3) the Parkinson's Action Network; (4) the Parkinson's Disease Foundation; (5) The Michael J. Fox Foundation for Parkinson's Research; (6) The Parkinson Alliance; and (7) The Parkinson's Institute and Clinical Center

Thanks to PUW supporters, over $1.8M was raised in 2012 for Parkinson’s disease research.

when the white knight is talking backwards:

The best planned product launch ever seen: the top Parkinson’s charities lined up on stage in support of a duodopa project delayed for ten years, endorsing as Parkinson’s Partner a company that right now is employing lawyers to get injunctions against the European Medicines Agency, to oppose a movement started by Parkinson’s U.K. and a hundred other British patient advocacy groups who are demanding release of thousands of covered-up medical studies. The most aggressive refusal is coming from the legal department of our Proud Partner.

Just ask Alice, when she is feeling very small.

We lost Cecil.

He was part of our buddy system, where every Person With Parkinson’s is called once a week, to check up on each other and chat. And make sure no one is completely alone, harbouring dark thoughts.

We lost Cecil, waiting for duodopa to cross the ocean. Waiting for Godot.
Cecil often asked, in the weekly telephone calls, if there was any hope, was there any treatment in sight that would make it worthwhile to continue being alive.

He qualified for Deep Brain Stimulation, but was horrified by the thought of having brain surgery while conscious. He kept asking us if there was any progress in research into GDNF and Duodopa. He talked about his fear that he would keep waiting for a cure, and then be physically and mentally too far gone to be able to kill himself, and live for years like a vegetable in pain, completely dysfunctional. We told him to hang in there; that a cure was surely on its way. The Abbott duodopa system was successful in Europe, and it would be coming to North America soon, and Amgen was loosening its death grip on GDNF. Cecil believed, for years, that an effective treatment was just around the corner. He clung to every shred of hope.

He lived alone. His wife had left him and took the children with her, when his pay cheques stopped coming, just when he needed constant help.

Winters were a nightmare for him. He usually could not shovel snow. The cold made him tremble violently and painfully. He closed off the upstairs and part of the downstairs with plastic sheets to conserve heat.
The only rooms he inhabited were the living room, the kitchen and the bathroom. He slept on a mattress on the floor of the living room. He was not a good housekeeper, to put it delicately.

One night, one spring, one of Cecil’s neighbors called me, saying he drove by Cecil’s farm and the lights were off. That was strange. Ever since he was diagnosed with Parkinson’s, Cecil always left all the lights on, day and night. All the lights. The porch light, the barn lights, the lights in every room of the house. The whole place was always lit up like an ocean liner crossing the hayfield.

Now, it was in complete darkness.

I got there as fast as I could. It’s about 30 miles, on gravel roads. I drove up Cecil’s long driveway; the house was utterly dark; and I had a dreadful, sickening sense of foreboding.

The kitchen door was not only unlocked, it was swinging in the wind. The dog was whining in a corner. The horses were out in the field; he normally put them in the barn at night.

His gun rack was empty. There was an ominous note in it, saying, "I buried my guns in the ground."

There was no one in the barn. No one answered from the darkness of the fields and forests when his name was called.

The search began with flashlights; from the back of the barn, across the field, and into the forest, following a fresh, rough trail. It was as if horses had gone back and forth, dragging something.
The trail seemed to go on forever, deeper and deeper into the forest. Those who have wandered the forests at night will know what it's like; rocks and swampy areas and fallen tree trunks, underbrush and uneven terrain; and impenetrable darkness on all sides.

The path led to a clearing beside the stream. Cecil had long talked about building a cabin there. He wanted to live and die there in peace. Without electricity or telephone; he would be happy hunting and fishing. And he could rent out the farmhouse and the pasture to get some income, as Parkinson’s had taken away his ability to earn a living.

But his land is in a green zone, so he could not get a building permit, even though he owned the property and had lived there all his life, as did his father before him. His application to the authorities to live and die the way he wanted on his own land was refused, without a hearing, without a right to appeal.

The trail led to that clearing by the stream. It appeared that he had dragged lumber from the barn, with harnesses on one or both horses, and the ends of the boards dragging on the ground.

In the clearing, he had built a wooden platform, several feet above the ground. Like a deck in a suburban backyard.

He was lying on top of the deck, in the middle of the clearing, facing the sky, and he was dead.

What a tragedy. And to think that were it not for purely capitalist reasons we don't have the one thing that would have given him hope. What a shame.

Bob, lately your posts have been ahead of their time with the Alice in Wonderland theme. If only it were'nt so darn true. I am convinced of the conspiracy to keep duodopa out of the US market. It's all the dollars, gotta be. Meanwhile these corporate "sponsors" dangle a carrot in the air. I for one don't expect that we'll hear anything on duodopa come April 27th. They have the patent on it so nothing else is coming onto the market to replace it. We are left with slow acting pills and years of more research with them not even close to where stem cell transplants are a viable option. Like I've said before would you want to be an oncologist only to wake up tommorrow morning and find out that they have cured cancer? Ah, here ya go-they'll tell you they've cured it!
Anyone reading this, will not see a significant treatment modality such as duodopa, stem cells in their lifetime. We just won't. Takes too long, and even now do you want to go through a procedure where they only published the good results?
I woke up from a nap today and felt depressed, I had slept through 2 doses of sinemet and was quite stiff. I got in my powerchair and went up the street to a small park. All along the way I was thinking about this issue, what if we for some reason (like the Amgen debacle) don't get duodopa over here? There are lots of treatments not available in the US. I for one recognize the huge potential to change my life if we were to get it. Then I started thinking how bad would I get or let myself get before I gave up. A friend with PD died when he rolled over and was pinned between the wall and the bed. He could not clear his airway-swallowing problems and was found by family members.
Today has been a very depressing day for me with these thoughts, along with the factor of the Easter holiday with which I have been having some personal struggles. Along with that I recently decided to end a relationship with a woman who is wonderful but she has a special needs daughter that requires 24/7 care and it is just too much for me see her taking care of her daughter then to have to worry about me. As it is it will be some three yrs ago now that my wife left me. Yup just up and packed a bag and moved back home. When I was signed in to a hospital for the depression from this she came down and took everything including the nails hanging the pictures on the wall. When a friend drove me home I turned the key in the door and the place was empty. I shot you not. Well to top it all off fellow PDers my power chair broke tonight something in the wiring harness so I am relegated to dancing with the walker (faller) is more like it. Well it is nighttime, so I can a few mg of clonopin and deny reality until the morning.

http://youtu.be/wnAIIefjhKg

Parkinsons UK made the following statement: “We believe that the results of every Parkinson’s trial should be made public regardless of the findings. That’s why we’ve signed up to support the All Trials Registered, All Results Reported campaign. (http://www.alltrials.net/) We’re also working closely with other research charities to make sure that new rules being developed to govern clinical trials across Europe – the EU Clinical Trials Regulation – make reporting results mandatory.

AND ON THIS ISSUE, PARKINSON’S U.K. IS A LEADER IN A UNITED FRONT WITH ALL OF THESE:

Medical Research Council

Wellcome Trust

NICE

Health Research Authority

German Institute for Quality and Efficiency in Health Care

GSK

British Medical Association

Royal Society of Medicine

Royal Statistical Society

Royal College of Pathologists

Royal College of Paediatrics and Child Health

Royal College of Physicians of Edinburgh

Faculty of Pharmaceutical Medicine

Faculty of Public Health

Cochrane Collaboration

COPE

World Association of Medical Editors

PLOS

British Library

Global Health Information Network

British Pharmacological Society

Royal Pharmaceutical Society

BioMed Central

Association of Medical Research Charities

Patients Involved in NICE

Drug and Therapeutics Bulletin

GIMBE Foundation

Open Knowledge Foundation

American Medical Student Association

Center for Information and Study on Clinical Research Participation

UK Research Integrity Office

Association of Research Ethics Committees

UK Clinical Pharmacy Association

Macmillan Cancer Support

Cancer Research UK

Teenage Cancer Trust

Marie Curie Cancer Care

Irish Cancer Society

Cancer52

British Heart Foundation

HealthWatch

European Federation of Clinical Chemistry and Laboratory Medicine

European Public Health Association

Swedish College of General Practice

NEPI Foundation

Netherlands Epidemiological Society

Asociación Española de Pediatría de Atención Primaria

Muscular Dystrophy Campaign

London School of Hygiene & Tropical Medicine

Leukaemia CARE

Norwegian Cancer Society

Parkinsons UK

Brain Tumour Charity

eLife

Stop AIDS Campaign

UK Sepsis Trust

Bone Cancer Research Trust

Stroke Association

SABRE Research UK

Evidence-Based Veterinary Medicine Association

British Society for Gene and Cell Therapy

Renal Association

Rett Syndrome Research Trust

Depression Alliance

Scientists for Labour

SAGE

PhUSE

Radical Statistics

DXY

MedSci

The Lupus Research Institute

SLE Lupus Foundation

Birth Trauma Association:

National Collaborating Centre for Mental Health

UK Cystic Fibrosis Gene Therapy Consortium

Autism Rights Group Highland

Beating Bowel Cancer

Research Autism

Throat Cancer Foundation

NOW THAT IS A PROUD PARTNERSHIP

And who is opposed? Oh, AbbVie, for one. Sent in lawyers to sue the European Medicines Agency, to block this movement.
And everybody is asking, which side are you on?
Compare.

If AbbVie honestly wants to be Proud Partner of Parkinson’s People in America, they must first respond to one of our allies, Parkinson’s U.K., who have united with patient advocates fighting many other diseases, demanding – not begging, demanding -- the release of all data from clinical trials, past, present, and future, And, the release of the data from clinical trials that were kept hidden, as if they had never happened.

Ben Goldacre, Time Magazine, Feb. 28, 2013 says:
Marketing, payments to doctors, all of that stuff, they’ll fight on it, but to hide the unflattering results in clinical trials, they will fight viciously, tooth and nail, because that is more important to them than anything else .…They will defend that harder than they defend anything else..
….You watch….

The intention of the pharmaceutical industry is simply to delay the public becoming aware of the problems and delay professionals and policymakers from addressing the problems...

Future generations will look back with amazement on this. They will say, ‘You’ve spent tens of millions of dollars, sometimes hundreds of millions of dollars on one trial, to make sure it was as free from bias as possible, to sometimes detect very, very modest differences between two treatments. You went to all of this effort to exclude bias, and then at the final stage, you were perfectly happy to just throw away half the data and not any old half, the biased half of the data. People will look back on this in the same way that we look back on the medieval leeches and bloodletting by doctors.
…If we had any sense, we wouldn’t just spend our money on doing individual clinical trials that cost huge amounts of money. The thing that we need to invest in is better information architecture for evidence-based medicine—infrastructure like what we have for sharing x-rays across town. We need infrastructure for drawing together all of the evidence that we already have, summarizing it, getting it to the right doctor, at the right time, to help inform their decisions and make sure that we optimize the use of the evidence that we already have. Now, that sounds really boring, right? But that is the single most important flaw I would say, in the whole of medicine…” - Ben Goldacre

The Journal of the American Medical Association March 18, 2013
The Wall Must Come Down
Joseph S. Ross, MD, MHS; Harlan M. Krumholz, MD, SM
…
Nearly 30 000 trials globally are recruiting patients, and results from 75 trials are published daily in biomedical journals. However, there is a crisis… A wall surrounds much clinical research data, sequestering knowledge, impeding the free flow of information, and obscuring a clear view of the totality of evidence relevant to many research questions and clinical decisions.

Nearly half of clinical research trials are never published. Moreover, publications are often incomplete, selectively reporting favorable outcomes and infrequently reporting relevant safety findings….whether intended or not, selective publication distorts the medical evidence …vital to decision making by patients and their clinicians.

To ensure that patients and clinicians are able to make fully informed decisions about pharmaceutical agents, biological products, and medical devices tested through clinical trial research, an era of open science through data sharing is necessary. This step to establish a more transparent scientific process has already been taken by other fields, including genetics, physics, molecular biology, and the social sciences. Sharing maximizes the value of collected data and promotes follow-up studies of secondary research questions using existing data. Sharing also minimizes duplicative data collection, which in turn reduces research costs and lowers the burden on human research participants while positioning clinical trial data as a public good. Sharing also respects the contributions of the patients who consented to participate. …If science is to be progressive and self-correcting, then data, not just summary conclusions, must be open to independent scrutiny. In addition, multiple examinations of clinical trial data are often necessary, particularly when pharmaceutical, biologic, and medical devices depend so substantially on the results of only a few large clinical trials.
http://jama.jamanetwork.com/article....irst03/18/2013

Health Care’s Trick Coin
By BEN GOLDACRE, February 1, 2013
.. half of all the clinical trials ever conducted and completed on the treatments in use today have never been published in academic journals.
Trials with positive or flattering results, unsurprisingly, are about twice as likely to be published — and this is true for both academic research and industry studies.
If I toss a coin, but hide the result every time it comes up tails, it looks as if I always throw heads. You wouldn’t tolerate that if we were choosing who should go first in a game of pocket billiards, but in medicine, it’s accepted as the norm. In the worst case, we can be misled into believing that ineffective treatments are worth using; more commonly we are misled about the relative merits of competing treatments, exposing patients to inferior ones.
This problem has been documented for three decades…
http://www.nytimes.com/2013/02/02/op...html?hpw&_r=1&
First thing, we want to know about all the clinical trials that have happened on all of the medicines that we use… Not just all the ones from now, because that won’t fix anything for another 25 years.
We need to know about past hidden trials because 80% to 85% of all the prescriptions issued this year were for treatments more than 10 years old….
We want to have the basic summary results and the full clinical study report. No individual patient data, but the full details of exactly what was done and what was measured. Now, that’s an entirely reasonable thing to ask for. But industry in some corners has been up in arms. (yeah! We noticed!.... “to hide the unflattering results in clinical trials, they will fight viciously, tooth and nail”.)

We have support from around 100 patient groups. (Including Parkinson’s U.K.)
….You watch…. marketing, payments to doctors, all of that stuff, they’ll fight on it, but to hide the unflattering results in clinical trials, they will fight viciously, tooth and nail, because that is more important to them than anything else. If you can poison the well of medical evidence, then you are made. -Ben Goldacre
http://healthland.time.com/2013/02/2...-ben-goldacre/


(…makes me ashamed to see the AbbVie logo on the Parkinson’s Unity T-shirt. Now, if AbbVie would explain to us why duodopa was constantly delayed for 10 years, and if they put duodopa on the American market NOW, and if they are not afraid to say out loud what people are whispering about the FDA’s epic foot-dragging that had all the characteristics of sabotage, and if AbbVie would call off its predator lawyers and stop trying to slap injunctions on anybody who knows more than they do, and if AbbVie agrees to release all data from all trials past, present and future, and if AbbVie re-inforces that by going to the office of Parkinson’s U.K. and signing the AllTrials petition… (GlaxoSmithKline signed up so why can’t you?)

…. If all of these things were made to happen, then it could become possible for AbbVie to become a Proud Partner with Parkinson’s communities in America and in Europe; but right now, to pretend that any such relationship exists, other than as a hollow and false advertising slogan, is risible, humiliating, and just plain wrong.

Meanwhile…. En attendant Godot:

You ain’t never caught a rabbit and you ain’t no partner of mine.

I in fact think this should be a platform issue for the NPF and MJFF!

Peg,
I volunteered for 3 clinical trials. NONE were published.

http://www.ted.com/talks/ben_goldacr....html?c=540521