I have been t hinking about this "one big trial" that you spoke of earlier. That doesn't leave a lot of room for confidentiality, does it? What if patients or trial participants don't want their information or trial results published? Wouldn't HIPAA have to honor that? Or do you sign away confidentiality when you participate in a trial?

I was just trying to make some sense out of all of this.

Thanks. I am going to the Unity Walk this weekend (April 27). Anybody in thar area come join me.
Peggy

You would never sign away confidentiality in a clinical trial, that is to say, no one should be able to name you or find you or trace you. It's that way now and has not changed - they publish (or hide) the medical results of one group compared to a control group; there is no way to detect who the individuals are.
As for the future in cyber-space, it's getting harder and harder to know where information ends up - Facebook is quite a horror for that, and soon there will be a camera and a computer in your eyeglasses, so everything you see can be instantly on the internet. But that problem, of confidentiality on the internet, is not just a problem for medical trials.... bank accounts, your past, your politics.... hackers get in. We may all have to live as avatars.
But as for clinical trials..... who you are is confidential.

Peg,
The "one big trial" I mentioned is massive data crunching with no personal contact at all.
Microsoft can tell you the prevalence of a disease in any city on any day just by measuring how many people use the name of the disease as a search term!
Apparently - and this I know little about, "data-mining" computer programs can follow the frequency of word use on the net, twitter, etc. and bring back amazing info and this is already happening; I know little about it.
Myself, I just assume that NOTHING about me is confidential, if it is accessible anywhere on the net.
But scientists doing trials are supposed to list you as a number, not a name, this has not changed. It's mostly a question of computer security - somewhere there is a list of names - can hackers get to it? Can they get to your bank account? It's not specifically an issue for medical records; hackers usually want something they can get cash from.
What Facebook is up to worries me more. They aggressively sell the information they collect.
We soon won't remember which is the avatar.

You did all you could, and wanted to protect your children. That is all that really matters. If the researchers fumbled and got no new knowledge out of it, that is their burden to carry, not yours. You did all you could, and somewhere the universe remembers that forever.
As for clinical studies, even the ones that get thrown out by irresponsible researchers, at least you filled that slot for their research -they were rolling the dice to see if it comes up all 7's. The researchers were going to gamble regardless.
But as for the studies you were part of - and heard no results - go find them and get the results! Hassle them about it !

I got some more e-mails about the confidentiality question.

In response to Parkinson’s U.K. and 80 other patient charity groups, Pharma is telling the select committee of the British House of Commons that they cannot let us see the hidden studies, because we would then have the volunteer’s name, address, hair colour, shoe size, DNA sample, name of pet cat, full body scan, VISA number, finger print, mother’s maiden name, what kind of car they first drove, favorite movie, sexual preferences and marital status.

I am saying we already have all of that; now we want to see the science.

Me: Gimmie all yer files.

Pharma: We cain’t do that Billy Bob. Y’all would use it as a dating service.

Me: Yeah, so?

Pharma: Where’s yer ethicality? S’all con-fee-dent-chial.

Me: All sudden like? You published half the studies; deleted all names and all ID. Now we want the other half and you no can do? Yes, we have no bananas?

Pharma: You is so nasty, Billy Bob. We ain’t gonna’ talk to you no more.

Me: Threat or promise?

Pharma: You is so nasty Billy Bob.

Me: Yeah, so?

(Pharma’s argument about confidentiality will not work. This was tested in Britain – it is no big deal to cut out identifiers; it’s routinely done every time a full study is released.)

Pharma in the U.S.A. plans to go to the Supreme Court to argue that clinical trial results are their private property, and under the Constitution, spastics and cripples have no right to take someone’s private property by unreasonable search and seizure while crossing a state line without an assault weapon, thereby violating the right of assembly, interstate commerce, public decency, and the Hoot-Tartly Act.

It will take 5 years to get to the Supreme Court, and Pharma will win; but in the meantime they will lose. We will shame them, from their board members and executives on down – but you will find substantial support for our position among their own researchers. There ARE ways to work together, and Pharma can keep their damn money, but they have to stop playing their sick games to the detriment of people in pain.

We don’t need more laws and more restrictions, we just need full disclosure of research, because – remember? – we are fighting disease. Just release the documents, that’s all.

IF patient orgs and doctors and non-Jurassic Park Pharma and the patients themselves all demand that the studies get released, it will happen. Without any government action at all.

IF patients and patient orgs and doctors do not bother to make this happen, we will have to wait 25 years for a new generation to stop science fraud from damaging and killing victims whose doctors make wrong decisions because Pharma has deliberately falsified the evidence by hyping the studies that make their product look good, and shredding the studies that show negative results. It is not a complicated issue.

AbbVie’s decision to immediately unleash their legal hounds to launch lawsuits against the European Medicine’s Agency, taking the debate to court, has got to rate as one of the stupidest corporate strategies of all time. There is serious discussion saying, if there is going to be a court case about this, it should be in criminal court, and AbbVie should be the defendant.

And we are supposed to be fighting disease – remember? Just release the studies. We already paid for them, in donations, taxes, blood, sweat and tears.

As some of you know I run a web site

www.parkinsonsmeasurement.org

which is there to collect and data mine Parkinson's data. This is how we deal with some of the issues raised by Bob.

1. All raw data, with the exception of security data, is open to anyone to download.

2. User names are hidden to all but the user him/herself, and are replaced by randomly generated numbers.

3. No personal details except those directly relevant to Parkinson's are collected.

There is a tension between privacy and the usefulness of the data. I will give two exmples.

Date of birth. Knowing when a person was born is clearly critical for research. But knowing this to the exact day of birth narrows the source of the data considerably. The policy at parkinsonsmeasurement is to store month and year of birth, but not day of birth.

Address. The policy at parkinsonsmeasurement is not to collect this information at all. Clearly, this limits the sort of questions that we can answer.

John

“This is the beginning of the end for a dark era in medical history.”
- Dr. Ben Goldacre

“If you put yourself in the position of a patient, or a relative of a patient, what would you want to know? Answer: Everything.’”
- Frank Rockhold, Sr. V.P. of Epidemiology, GlaxoSmithKline (GSK)

GlaxoSmithKline, (GSK) world’s 4th largest pharmaceutical company 100,000 employees; 2012 revenue $41 Billion; 2012 net income $8 Billion

Pharmaceutical giant GlaxoSmithKline has announced its support for the AllTrials campaign, which means that the company is committed to publishing all of its clinical trials. (H/T: Olivia Solon; Wired in the U.K.)

The results of clinical trials are often withheld when the results are not deemed favourable -- i.e. they conclude that a drug is not as effective as its competitors or has worse side effects. This leads to a phenomenon called publication bias, whereby trials with "positive" results are much more likely to be published. This, in turn, distorts the evidence base and can lead to healthcare professionals making decisions about drug prescriptions that would differ if they had access to all of the trial data. And this can harm patients.

The AllTrials initiative campaigns for the publication of the results from all clinical trials -- past, present and future -- on treatments currently in the market.

GSK's announcement comes a year after it was stung with a record $3 billion fine, which had been issued in part because the company withheld data about the damaging side effects of its diabetes drug Avanda. Eight out of ten of the largest Pharma’s have been fined for similar reasons.

However, from now on GSK has committed to making the Clinical Study Reports (CSRs) for all of its medicines available. These are formal reports that provide more details about the design, methods and results of clinical trials.

GSK will release the data for all trials dating back to the formation of the company in 2001.

Tracey Brown, Director at Sense About Science, said that the move was "very important" for a number of reasons: "This will hopefully put a stop to the ridiculous obfuscation and foot-dragging that have characterised reactions to AllTrials from some other parts of the medical industry."

She adds: "GSK say in their statement that they owe it to patients who have taken part in their trials. I think that is very, very true. Companies who have yet to take this seriously should ask themselves where they want to be a few years from now."

The business case benefits are twofold, according to GSK. First, full disclosure filters through into the way the company works, helping to make it more transparent at every level of business. Second, it begins to break down barriers with external audiences. The pharmaceutical industry has generally done a poor job of explaining the complexity, time and risks involved in bringing a drug to market. By being more open about its internal processes, it stands a better chance of gradually improving public trust.

Today is May 7, 2013. We have 50,770 signatures on the petition.
Lend your support; sign here: http://alltrials.net/
all trials registered; all results reported.

7th May 2013
GlaxoSmithKline (GSK) today announced progress on its commitment to share more detailed data from its clinical trials.
In response to the GSK announcement Dr. Ben Goldacre said:

“GSK have made some great promises, and I hope they will deliver. Perhaps most significant is the discussion of collaboration with other companies, to develop a shared platform for access to trial data. These are systemic issues, and first movers will have a huge advantage.”

“There is an outdated view in some corners of industry that transparency is somehow optional, and that this issue can be wished away. Those backward looking companies, organisations, and individuals are taking a huge reputational hit, for little or no gain. It’s time for them to accept that the world has changed around them, show clear leadership, and move towards greater transparency.”

“Doctors, researchers, and patients need access to all the results, for all trials, of all uses, of all currently prescribed treatments, to make safe and informed decisions about which is best. The only discussion to be had on individual patient data is best practice for greater transparency. As the EMA have said: we need to discuss how, not whether, this will happen.”

You can read more details on the GSK announcement here: http://www.gsk.com/media/press-relea...ial-data-.html

Although the trial I was in for over 9 years through Mayo clinic/Columbia University Medical Center, may have helped me, I have no way of knowing. I did sign away confindentiality when I agreed to participate. My results were shared with God knows who, but not me. ( Not for PD but for auto immune problems) I wish you all the best. ginnie

I am the avatar!

I am the walrus
goo-goo-goo-gook