It's mid-May, we have 55,000 signatures; just in case you didn't see this, Dr. Benn is the energy behind all this. Listen one more time:

watch Dr. Ben Goldacre here:
http://www.ted.com/talks/ben_goldacr....html?c=540521

Page not found??? You are a computer. FIND IT

Trouble in Row 7. Old man is not computer literate

It's mid-May, we have 55,000 signatures; just in case you didn't see this, Dr. Benn is the energy behind all this. Listen one more time



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

Update: All Trials movement: petition stalled as Abbvie wins legal victory in getting European courts to issue injunctions.

29th May 2013
AbbVie, Proud Parkinson’s Partner wins in European court
Medical researchers denied clinical trial information
European medicines’ regulator forced to withhold trial documents

Despite the best intentions of the European Medicines Agency, injunctions issued against it in two court cases have spilled over to chill other requests for clinical trial information. There are at least 100 pending requests seeking trial results. Over the past 24 hours researchers have received letters telling them the EMA cannot release documents it holds from clinical trials of medicines currently used in Europe.

The letter from the EMA states that “in the course of on-going legal proceedings before the General Court of the European Union, the Agency has been ordered to suspend the implementation of certain decisions granting access to documents submitted by marketing authorisation holders of medicinal products.”

The legal proceedings are the cases brought by two pharmaceutical companies, InterMune and AbbVie, who challenged the Agency’s decisions to grant access to clinical study reports from clinical trials of drugs from each of these companies. On 25th April the President of the European Court issued injunctions preventing the EMA from releasing this information.

The EMA says it has been forced to decide not to release further clinical study reports from clinical trials of other medicines as it has been advised that it would put itself at risk of additional legal action by other pharmaceutical companies. In a statement the EMA said it is committed to continue its work on clinical trial transparency and intends to publish its draft policy on release of clinical trial data at the end of June 2013.

Peter Doshi, Fellow in Comparative Effectiveness Research, Johns Hopkins University who received a letter from EMA: “The European Medicines Agency’s November 2010 policy on access to documents has revolutionized the ability of independent researchers to critically examine data. Nearly 2 million pages of Clinical Study Reports and other documents have been released by EMA, and only two companies–AbbVie and InterMune–have challenged EMA’s releases in court.
If AbbVie and InterMune win their cases, there is a real chance that EMA’s revolution in data transparency will come to an abrupt end, returning us to the old status quo of data secrecy. GSK, Roche, Pfizer, Merck, AstraZeneca, Johnson and Johnson, Eli Lilly and other pharmaceutical companies cannot silently stand on the sidelines and watch. They need to declare now where they stand: do they agree with European regulators that ‘clinical trial data should not be considered commercial confidential information’ –or not?

“I am not aware of any evidence that any harm to public health has ever resulted from the sharing of clinical trial data.”

Carl Heneghan, Director, Centre for Evidence Based Medicine who has a request for information pending: “We requested information relevant to a Cochrane review on ‘Direct thrombin inhibitors and factor Xa inhibitors for atrial fibrillation,’ that we are presently undertaking. An email from the EMA on the 19th April stated it would provide us ‘with sets of documents at regular intervals in response to this request.’ The Agency stated at the time that ‘the provision of information in an open and transparent manner is part of the mission of the Agency.’ But we now find that the provision of important information relevant to our review, and direct patient care, is in jeopardy. The effectiveness of interventions should be based on all the available evidence. However, this is now in doubt; it is clearly a bad day for openness and transparency. Regulators and manufacturers should consider, and declare, whether the current use of treatments based on partial information is an appropriate use of scarce healthcare resources.”

European Medicines Agency statement on the interim injunctions http://www.ema.europa.eu/ema/index.j...ail_001779.jsp

But it is not over.
It won’t be over as long as this embedded practice of fraudulent pseudo-science continues.

It should be against the law, to with- hold information pertaining to research and clinical trials. How can you make an informed choice, if no choice is given to you. I hope this sitatuion changes.

Keep sending that music through....ginnie

So do we have to do it one country at a time?

Canadian Government suddenly remembers to govern

http://hc-sc.gc.ca/ahc-asc/media/nr-...013-70-eng.php

….”Patients, healthcare professionals and the public will now be able to find information on Health Canada's website about drug clinical trials involving patients…. The database is mandatory for industry - it will be maintained and updated by Health Canada to include information about all phase I, II, and III clinical trials in patients that it has reviewed and authorized since April 1, 2013. Providing access to a central database of clinical trials is an initial step that will help fill an existing information gap as the government works to further increase transparency around clinical trials….”

…”Since research involving male subjects cannot always be relied on to show how women will respond to the same treatment, Health Canada is also updating guidance on sex differences in clinical trials. This will support the optimal use of therapeutic products in both women and men… These new documents, Considerations for Inclusion of Women in Clinical Trials and Analysis of Sex Differences and Guidance for Clinical Trial Sponsors are available by request from Health Canada's website.

Note: Good because mandatory for ALL clinical trials, and the general public have access to it.

Still weak, because it is for all trials after April 1, 2013; and it is not retroactive; it has to be made retroactive because 80% of prescriptions are for drugs that have been on the market for 10 years or more.

Good because recognizes the possibility that women and men react differently to treatment. Still weak in that there are many other differences among patients; that the one-pill-suits-all paradigm that worked so well for the mass production of Model T Fords may not work so well for medical health; assembly-line efficiency is thwarted by Parkies being wildly individualistic.

Given the industry-wide collusion in covering up the truth, what can we do to have experts go through the trials on all Parkinson’s drugs since sinemet? What do they know, and hide, about Mirapex? Selegilene? Levo-carbo Controlled Release? Generics? D.B.S.? And any other treatment for PD? Are we lucky and we dodged the bullet?

Are Parkinson’s medications caught up in the felony crimes of dishonest medical research?

We have the right to know.

Because our lives are at stake.

Hi Bob, are you aware of this? madelyn

VICTORIA — The B.C. government has officially denied claims that it quashed crucial drug testing programs in an effort to protect lucrative donations to the B.C. Liberal Party from pharmaceutical companies.

The government filed a document in Supreme Court Tuesday in response to a civil lawsuit from a former contract employee who made such allegations. It denied “each and every statement” in the suit, except for those of basic fact.

The lawsuit in question was filed earlier this month by William (Bill) Warburton, a labour and health economist who had a $1-per-year contract to “conduct complex data analyses at the Ministry of Health.”

Warburton was terminated in July 2012 as part of an investigation that saw seven employees lose their jobs.



Read more: http://www.vancouversun.com/news/gov...#ixzz2UsHSscnI

WASHINGTON (May 16, 2013) – Many clinical trials involving humans are still not registered in a publicly-accessible database and critical study results are not reported, putting people participating in the studies at risk due to lack of information sharing among studies. In order to protect study participants, close dangerous loopholes, and bring certainty and public transparency to life-saving research studies, Rep. Ed Markey (D-Mass.) introduced new legislation to take the errors out of clinical trial reporting.

The Trial and Experimental Studies Transparency (TEST) Act of 2013 updates and expands the clinical trial registry data bank – clinicaltrials.gov – with stronger reporting requirements, and requires that all foreign clinical studies meet the same registration and reporting requirements as domestic trials if they are used to support an application to market a product in the United States. Eighty percent of the drugs entering the U.S. market in 2008 were clinically tested overseas and a growing number of device trials are also moving abroad. Many of these trials are not required to be registered with the clinical trials database.

Clinicaltrials.gov was updated in 2007 to become a mandatory registry, directly addressing issues stemming from a lack of transparency of clinical trials. High-profile examples included Paxil®, Avandia®, and Vioxx® trials, in which safety concerns and negative results were suppressed by the drug companies, leading to injuries to patients and in some cases death.
“If we were issuing a grade on the clinical trials report card, it would be Incomplete,” said Rep. Markey. “Unreported results and missing registrations leave participants, doctors and researchers vulnerable.

The TEST Act will:
--Require all interventional biomedical studies on humans to be registered with the database before the first participant is enrolled in the trial.

--Strengthen reporting requirements so that results from all covered trials are posted on the database within one year of the completion of the trial.

--Provide for delayed submission of results (up to two years after trial completion) for trials on medical interventions that have never before been approved for any use.

-require foreign trials that are used to support an application for marketing in the U.S. to comply with the registration and reporting requirements of the database.

Take, for example, Lilly Fang. You remember, she won an award for research into predicting the progression of ALS (Lou Gehrig’s Disease). She is young to have won such a prize.

But it was not the fact that she is young that caused indignation among beneficiaries of the status quo. It was the fact that she is not a doctor. Nor is she a scientist. Nor has she studied any aspect of medicine. Nor did she even know, at the beginning, what ALS is.

We’ve got an unidentified intruder in Lab 4. Please call security.

Lilly Fang has not one, but two advanced university degrees, and not one, but two careers. She is a lawyer. And she is a mechanical engineer. So what is she doing in the science lab?

Well, Albert Einstein never set foot in a science lab, and neither did Lilly.
Lilly had 3 months off between university sessions. So she spent a lot of time at her computer.

And there is this website, you see, that gives the complete data of each patient, of the 8,500 ALS patients who have given themselves to clinical trials, posted on the internet in hopes that it would click with somebody out there. It clicked with Lilly. The lawyer and mechanical engineer saw things in the data. Things that no one had seen when the data was being kept hidden.

Remember when AMGEN decided to pull the plug on their Parkinson’s volunteers, and made no effort to determine why, for example, one of the patients had an improvement of symptoms estimated at 80% - for three years. AMGEN, trying to keep a straight face, said it was a placebo effect. Yeah, sure, a 3 year long placebo effect giving 80% improvement. They think we are stupid.

AMGEN made no effort to find out why one patient got so much healthier than others. As Andy Grove of Intel said at the time, in direct reference to the AMGEN GDNF scandal, the VCR was invented by accident, when one attempt came out very different from the others. That is when AMGEN ran away and hid the data and turned off the lights and pretended that they were not at home, at the exact point where real lovers of science jump in to find out why one is so different from the others. Researchers created the VCR by mistake. They jumped on the mistake, figured out what made it different, open-sourced it, and made digital history, along with billions of dollars. Typical socialists.

Task:
… to confront a basic puzzling question in ALS: most patients are like Lou Gehrig, with a rapidly progressing disease course, surviving for 2 or 3 years. Some patients, however, turn out to be more like Stephen Hawking, where the disease progression is delayed for decades. What separates the Lou Gehrigs from the Stephen Hawkings? … If you had ALS, you would find that to be an important question .

Hello? Mega-Pharma? Open source data? You say it can’t be done for data from clinical trials? You can’t post the patient data on that new-fangled electrical inter-nets; the earth is flat and the sun orbits around the earth. To believe otherwise is blasphemy.

You can’t change the way scientific research is done; it has to be done by the scientific method, which means promoting whatever your peer reviewers believed when they got their doctorate 30 years ago. It’s not possible to go open source, like they did in the computer and internet and video-game industries. (All open source, which is why there are thousands of apps from thousands of code-writers, which is why it all grew so fast).

Cast thy bread upon the waters and it will be returned to you tenfold.

But that’s not how they teach it at Harvard Business School, right? Genuflect and make it look sincere. And publish or perish.

Pharma says they can’t go open-source. We would steal their oh-so-brilliant ideas. We would all start producing agonists in our basements.

So your Apple will never be able to send a G-mail through Firefox to post a video on You Tube. Unless they open-source their code. Which of course they did.

Ha! Microsoft, Apple, Google, Intel, Facebook, Dell, and all the video game creators – all a bunch of socialists, if you ask me.

Hello? Parkinson’s research? There seem to be more citizen scientists with Parkinson’s than any other cohort. No one pays attention to them.

Your citizen scientists need access to the raw data. And you have no way of knowing who they are or where they are. They start to emerge from the shadows when you say, “Here is the day-by-day full information about every patient who ever volunteered for a clinical trial for ALS. Tell us what you see.”

If Lilly had been aiming at Parkinson’s she would not have had access to the data. Because the data behind Parkinson’s research is private property, and certainly not available on the internet for the likes of Lilly Fang, who had no experience whatsoever with any disease.

The Parkinson’s Archipelago has to realize at some point that research is not best expedited by keeping people in ignorance.

Lilly says:
… ALS causes progressive loss of motor function in patients and typically leads to death in about three years. Currently, there is no cure, and the causes are not well understood.

The task set out was to take patient data from the first three months of a clinical trial and use it to predict the rate of progression of the disease over the following nine months… the data was provided by the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database.

Lilly said:
One of our biggest challenges was the lack of information about what aspects of the available data would likely be predictive, as the academic literature had thus far only identified a few relevant variables. This lack of information, combined with our lack of medical expertise, led us to extract a broad spectrum of features from the data and to choose an algorithm that would be robust to irrelevant features. In the end, we hope to have identified some unexpected but useful features.

PRO-ACT contains thousands of fully de-identified unique clinical trial patient records, including demographic, lab, medical history, functional scores, and other data elements. The dataset includes both placebo and treatment-arm data from late stage ALS clinical trials, resulting in over eight million longitudinally collected data points.

"… the ALS community and researchers around the world have access to enough data to answer previously unanswerable basic questions, such as, how much does ALS differ between men and women," said Prize4Life's Chief Scientific Officer, Dr. Melanie Leitner. "PRO-ACT will also help to answer more complicated questions, such as, can we identify subgroups of people who may actually have responded to treatment in any of the completed trials."

Although the average life expectancy of an ALS patient is about three years, some people live for decades, while others succumb within months. This lack of predictability makes the design of clinical trials for potential new treatments a long, costly and complex process. One key to better predictability in the future lies in the past - ALS research will move forward when scientists are able to identify the patterns hiding in the millions of data points in PRO-ACT...

"As clinicians who see ALS patients every day, we recognize the huge potential impact of having access to vastly more patient data than anyone has ever had before. As just one example, being able to identify factors that determine the rate of progression in people with ALS will allow us to improve clinical trial design," said Dr. Merit Cudkowicz, Neurology Chief at Massachusetts General Hospital. "Because of PRO-ACT, ALS researchers will be better able to design trials that need fewer participants."

The PRO-ACT database is freely accessible to the global research community for analysis and downloads at www.ALSDatabase.org.

Prize4Life believes that solutions to some of the biggest challenges in medical research will require out-of-the-box thinking, and that some of the most critical discoveries may come from unlikely places.

Founded in 2006 by Avi Kremer, who was diagnosed with ALS at the age of 29, Prize4Life encourages and rewards creative approaches that will yield real results for ALS patients. For more information, visit www.prize4life.org.

Dr. Neta Zach, Scientific Director for Prize4Life, says;

Understanding the variability of the disease can mean a lot for ALS patients going through diagnosis and can lead to a substantial reduction in the cost of clinical trials for ALS treatments. Providing ALS “Big Data” to a global community of researchers speeds up the process while driving down the costs of discovery, which is good news for both the scientific and patient communities we serve.

We are currently assessing ways in which the algorithms could benefit day-to-day clinical practice as well as using them in a clinical trials context. We already know two important and immediate benefits: they will increase the likelihood of clinical trial success, and our experts estimate that these algorithms can reduce the number of patients in a clinical trial by 23%.

Bob says;
Hello? AbbVie? Pfizer? Sanofi? Parkinson’s charities? Doctors? You are either on the train or off the train, but the train is leaving the station. All aboard all who want to be aboard.

Some guy said the earth is not actually flat, it just looks that way.
They burned him at the stake. Now THAT was a peer review.

Thanks for your great post Bob.

There is some Parkinson data available to the citizen scientist. Probably the best source is the MJFF supported PPMI database. There are also indirect sources, e.g. mortality data from the CDC and prescription data from the NHS.

If we need any extra data, we can collect it ourselves. See, for instance, my web site:
www.parkinsonsmeasurement.org
All the data collected there is open to everyone. All the code is open source.

We need to run our own clinical trials. (I'm thinking of curcumin, not DBS.) For that we need an ethics committee.

Any volunteers?

John

[QUOTE=
Remember when AMGEN decided to pull the plug on their Parkinson’s volunteers, and made no effort to determine why, for example, one of the patients had an improvement of symptoms estimated at 80% - for three years. AMGEN, trying to keep a straight face, said it was a placebo effect. Yeah, sure, a 3 year long placebo effect giving 80% improvement. They think we are stupid. AMGEN made no effort to find out why one patient got so much healthier than others. .[/QUOTE]


Thanks, Bob, for the continued flow of information on this extremely important topic. It's extaordinary! Please keep the info coming.