Great article on alternet.org about one doctor who is battling big pharma

http://www.alternet.org/meet-doctor-...arma-cant-shut

The article talks about a non-profit website Dr. David Healy's started for patients to record drug side effects: https://www.rxisk.org/Default.aspx

Please forgive me if this has already been reported here!

The year is 1965.

Andy Grove and Gordon Moore are fascinated by transistors; computer chips. Moore writes a scholarly thesis that comes to be known as “Moore’s Law”: computer power doubles every two years, for the same cost, combining rapidly falling cost, increased power and proliferation.

The year is 1968

Andy Grove and Gordon Moore launch a company called “Intel”. Remember the sticker on your first computer, that said “Intel Inside”?

Strange thing is, they planned and governed the company to correspond to the “law” Moore had invented. Double the power of computer chips every two years. They hired hi-tech wizards by the tens of thousands, and they worked day and night, frantically, fanatically and frenzied…; innovative, risk-taking, fiercely dedicated; they energized the computer revolution; everything changed fast, so very, very fast. And they showed the power of going Open Access, Open Data. And they showed just how fast a dedicated team of researchers can find solutions.

As Moore had predicted, Intel doubled the capacity of computer chips every two years, from 1968, to today. The equivalent price of a new Boeing 747 dropped to the price of a medium-sized pizza.

If the trend continues, the equivalent price of $600 worth of silicon chips in the year 2013 would be $18.75 in 2020, $0.59 in 2030 and overall power improving 1,000,000 times by 2050.

Grove noted that if car manufacturers had something like this, cars would already get 100,000 miles to the gallon and it would be cheaper to buy a Rolls Royce than to park it. That is not a joke; it is an actual financial calculation.

During his time as CEO, Grove oversaw a 4,500% increase in Intel's market capitalization to $197 billion, making it the world's 7th most valuable company, with 64,000 employees. Most of the company's revenues were reinvested in research and development, along with building new facilities, in order to produce improved and faster microprocessors. Double every two years, for 40 years. Grove has been called the "guy who drove the growth phase" of Silicon Valley.

Grove's office was an 8-ft by 9-ft cubicle. Preferring this egalitarian atmosphere, he made his work area accessible to anyone who walked by. There were no reserved parking spaces at head office; Grove parked wherever there was a space. Just like everybody else.

Grove said:
“Methods have to change. Focus has to change. Values have to change. The sum total of those changes is transformation.”

Time Magazine made him man of the year. Steve Jobs called him “my idol”.

AND THEN ANDY GROVE WAS HIT BY PARKINSON’S.

As a scientist, as a man of action, he jumped right in to the world of Parkinson’s research, and he was shocked by what he found.
In healthcare research, he said, “1950s-era thinking still rules the day.”

Andy Grove said (in 2007):
“The health care industry plays a gigantic game of Blind Man’s Bluff, keeping patients in the dark while asking them to make life-and-death decisions. The odds that they will make the best choice are negligible and largely depend on chance.”

Mr. Grove funds causes that make him angry. Frustrated by the slow pace of medical research, and unnerved by his own diagnoses with Parkinson’s and cancer, he has committed tens of millions of dollars to translational research in cancer and neurodegenerative diseases.

“Philanthropists tend to be so pleased with themselves that they are prone to self-congratulation. Rather, they should be angry—and let their anger guide their giving.”

“Things will change when we are sufficiently irate, upset, devoted, passionate, and emotionally committed to the subject. And I don’t think that is what’s happening.”

“The large, established foundations are run by 20-plus-person boards. They are consensus-minded caretakers. Gray, low-profile, competent, not passionate—that is how they appear to me. This is a broad generalization, of course. But in my view, there are no causes to which these foundations are committed with a passion, in a way that I would describe as angry. They’re unlikely to go against the grain, they’re unlikely to go after orphan projects—they’re just not likely to do anything like that.”

Editor of Wired: “What do you wish for your foundation in the future?”
MR. GROVE: “I want the surviving management and board to be passionate, committed—and angry.”

When asked by the Editor of Wired Magazine where motivation for change in Parkinson’s research will come from, he simply replied: “From you and I being sufficiently p***** off.”

The year is 2007

Part 1
“What is needed is a cultural revolution… that puts forward the concept of data being public property… the technology that is available today that was not available a hundred years ago, when the peer review publish process was formed by our forefathers: the internet. I call it the Open Data Concept, the Open Data Initiative…”
NOW LISTEN HERE:
http://youtu.be/H39cYW0xgbM

Part 2
“hundreds of billions of dollars ….. are they willing to use this money as it is, in trust for the public? If not, why give it to them anymore?”
NOW LISTEN HERE:
http://youtu.be/vsTQXrCJLWk

The year is 2012

…”So what do you do? You shrug. It is that shrug than enables the continuation of the economic behaviour of this industry.”
NOW LISTEN HERE:
https://www.youtube.com/watch?v=p9VnKbRW9W4

Dear Reader, I know you are very busy, but I think we owe it to Andy Grove to listen to him. Below is the 20 minute version of the interview about the Shrug. Andy Grove is suffering and he does not have to do this. But he is doing it. For us. Let’s listen to him. He is one of the great spirits of the age.

NOW LISTEN HERE: (87 MB)
http://youtu.be/6_RgCsW6Xfw
Thank you, Andy.

RIAT initiative for publication of historical clinical trial findings

14th June 2013

The RIAT (Restoring Invisible and Abandoned Trials) initiative is launched by BMJ, (British Medical Journal), PLOS and researchers today. It is a call to action to companies and academic funders to publish, or update already published, findings from trials they sponsored. The initiators of RIAT say they will make public all the confidential information they hold about missing and abandoned trials in one year’s time if trial sponsors fail to publish it themselves.

Ben Goldacre, author and co-founder of AllTrials campaign: “We have known about the problem of trial results being routinely withheld since at least 1986, and yet we’ve consistently failed to fix it. This is a stain on the reputation of the medical and academic professions, as much as on industry. Even now, with the growing strength of the AllTrials campaign, there are shrinking huddles of people in companies and professional bodies, desperately trying to pretend that fixing this problem is somehow difficult, or impossible. The RIAT project shows that there are simple pragmatic steps we can take, to publish the trials which have been unethically hidden from doctors and researchers.

“For the sake of patients, we cannot drag our heels any longer. It’s time for the most senior figures in medicine, academia and industry to stand up and show positive leadership on this issue. We need all the results, of all the trials, on all the uses of all the treatments currently being prescribed, to practice medicine as safely and effectively as possible.”

Síle Lane, Sense About Science, co-founder of AllTrials campaign: “This is an important initiative. There have recently been legislative proposals in Europe and the US to increase clinical trial transparency in the future. But historical data are as important, arguably more important, than information from future trials. On the list of missing trials published in the BMJ today are trials for drugs used by millions of us every day. People who make decisions about medicines need to see what was found in those trials. This is what RIAT has been set up to help achieve. We hope clinical trial sponsors sign up to it.”

Richard Stephens, cancer patient and clinical trial participant: “I have entered five research studies as a participant. I did it for several reasons, but the one motive that runs through every one of them is my belief that by taking part in research, I will help other patients in future. For that to happen, the results of the research must be made available. Even if the research isn’t finished or the results aren’t as expected, the data and information are still of value and should be made available. I am very pleased to support this amnesty, and I would ask every researcher and every research funder out there to do all they can to make their results available. Patients become participants to add to knowledge and to eliminate uncertainties. Hiding results, no matter what the reason, isn’t in that spirit at all. This amnesty is the chance to do the right thing. Please do it.”

On the subject of trials and data, can I also remind folks that results can only be generated as we have willing volunteers to participate. As Michael J. Fox has often said, there is a time in the pursuit of cures that patients, and only patients can make the difference ... all the smarts, science, money etc bring critical ideas to a point and then, it is up to the patient community to participate so we can get the answers we all seek.

Recruitment in PD trials remains very slow (on average fewer than one patient per month per trial site) --- this adds up to years of unnecessary delay. Please learn more about trials (interventions but also "learning" /observational studies) that might need you.

Check out fox trial finder to register / find a study near you:
www.foxtrialfinder.org

Debi

Debi,

I think one of the key issues hindering research progress is that patients remain ignorant of both the importance of trial participation for the potential individual payoff and for advancing knowledge for all with PD. MJFF Trial FInder does a great job at making it easy to get involved but quite honestly I don't see any difference in the number of patients who feel it is important; this is nearly 500 people in YO online Facebook groups and the large group on the NPF patient forums. We also need to educate one another.

One of the key reasons, I think, once a patient is medicated, their doctors push for DBS. It is happening at an alarming rate in the YO community. I don't have specifics but every day someone is announcing their doctor says they need it; they are screening for it; having it done; having settings tweaked etc. People listen to their doctors. If they promote having DBS as soon as med fluctuations start, patients become set on that and do not explore trials as a means of potential treatment because it is not even remotely considered by their doctors. In my own experience, my neurologist, despite the interest I expressed in trials, has done nothing other that recommend DBS from day one, and he didn't see it necessary to inform me that DBS would preclude me from any trial participation. I suspect other patients are not being informed of this either.

This is really detrimental to patients as a whole because all I can foresee is a decline in the 1% participation we have now unless this changes. We talk of a disconnect between patient and research, but we need doctors to be a part of this too. Doctors need to become cheerleaders for patient participation in trials and to promote it early and often. I honestly do not think patients have a clue as to how their lives will be impacted once levodopa tolerance creeps iin and takes hold, so by that time, they are so frightened and/or fed up with pills they see DBS as their only option. Not only do we need doctors to get more patients on board with trials, but we need to recognize there is a critical window of opportunity for trial recruitment. Strike too early and there is denial; strike too late and there is only wanting immediate relief.

Has anyone on the patient council noticed the surge in DBS early on for YO patients? Maybe I am over estimating. Regardless, I still think it important for doctors to be vocal advocates for patient involvement in research.

Laura

Big shortage of volunteers for medical trials

More than half of respondents to a 2005 CISCRP survey on clinical trial registry users would have greater trust in clinical research information if the results were made available on a public website registry.

A 2007 Harris Interactive poll found that among 1,726 US adults, 27% of the public distrusts- 'somewhat' or 'very strongly'- the Food and Drug Administration. That same poll in 2007 found that 31% of Americans believe that the FDA is effective at ensuring safety, down from 56% who did so in 2004. (2004 - 2007 – Amgen GNDF scandal?)

Nearly half of those polled said that they distrusted Capital Hill officials who govern regulatory oversight and drug development processes.

Forty two percent of Americans distrust the pharmaceutical and biotechnology companies.

In January of 2008, 44% of Americans said they viewed pharmaceutical and biotechnology companies unfavorably, 27% said that they do not trust them to provide reliable information about drug side effects and safety, and 45% said they do not trust the research sponsors to inform the public quickly when safety concerns about a drug are discovered. (Kaiser Foundation, 2008)

One in four respondents to a 2007 survey believed that their doctors would expose them to unnecessary risk in clinical trials. (Braunstein, Medicine, 2008)

…less than five percent of Americans know where to find information about relevant clinical trials. (Getz, Philadelphia Survey)

The Top Five Reasons Doctors Don't Refer Patients Into Clinical Trials:

-31% Lack of information on treatments and new investigational drugs (Yeah, how would doctors know high-falutin’ stuff like that?)

-15% Trials are not appropriate for my particular practice (And what practise is that? You are a specialist in a disease that has no trials? What disease is that?)

-13% Not enough time to learn about a particular trial (Well yeah, especially in golf season )

-10% Lack of access to information (How can a doctor get information about a clinical trial? Is it in the Yellow Pages?)

-7% Fear of losing a patient (MacDonald, "The Psychology", CenterWatch 2006) (“Losing a patient” in what sense??? The patient goes looking for a new doctor after experiencing the professionalism of the trial doctors, and starts to realize that his original doctor has been feeding him B.S. for years.)

Industry data suggests that fewer than four percent of all U.S. physicians participate in clinical trials. (And we blame Parkinson’s patients for poor attendance.)

A new survey in May 2008, released by the Society for Women's Health Research indicates 94% of Americans have never been informed by their doctors of medical research studies in which they might participate. (Sun, "Sometimes Bumpy Road". 2008)

Seven percent of Americans say that their doctors have ever suggested that they participate in a clinical study. (Getz, Public Confidence)

A survey conducted on 717 US adults in 2007 found high levels of public distrust in clinical research staff. The break down showed that this level of distrust was significantly higher in minority adults, as 73% said they were 'very likely' or 'likely' to be treated as guinea pigs without their consent, whereas 49% of whites responded this way. (Braunstein, "Race Medical Researcher". 2008) (Hmm, did they hear about AMGEN GDNF and the monkeys in the middle?)

… 10% of volunteers did not look at the informed consent before signing it; 18% signed without input from their personal physicians, nurse, family member, or trusted individual; and 70% reported that, at the onset of the process, they did not know what questions to ask. (Applied Clinical Trials)


Big rise in volunteers for medical trials

Three brief videos:
Two say It’s okay to ask
Four questions you should ask when you volunteer

http://youtu.be/HblCtlS2rqI

http://youtu.be/yT9bzhNwhik

http://youtu.be/nReoI5CniAw

Big rise in volunteers for medical trials

The National Institute of Health Research (NIHR) is proud to announce that the number of patients taking part in clinical trials in England has trebled in five years, from 208,000 volunteers in 2008, to 638,000 volunteers in 2013.

A similar increase in volunteers has occurred elsewhere in the UK. (including Wales, Scotland, Northern Ireland).

Although many people associate medical trials with healthy volunteers, the vast majority who take part in research are NHS patients testing treatments for their condition.

The chief medical officer, Prof Dame Sally Davies, said she was delighted NHS patients realised the benefits of participation and said they played a vital role in developing treatments.

The increase follows the establishment of the NIHR in 2006. Its remit is to "improve the health and wealth of the nation through research". The organisation, funded by the Department of Health, has increased the amount of patient-focused health research.

Dame Sally said: "We put between 15-20% patients into trials in cancer compared to 2-3% in the United States, so clearly we've managed to get through to the public to explain the advantages of joining clinical research, and the altruistic side of what they are doing for the people that follow them.

While the number of people taking part has trebled in five years to nearly 650,000, the number of new NIHR trials has stayed broadly similar at between 1,000-1,500 per year, so the number of volunteers available for each trial is three times more than it was just 5 years ago.

"The doctors and patients have properly funded expert support in the clinic - to help patients understand the meaning of taking part in research, their right to opt out if they do consent - and to help them and hold their hands as they go through the research."

The U.K. leads the world in implanting open access and the publication of trial results that had been kept hidden. The U.K.’s largest Pharma – GSK – is releasing all its studies done since it became a company in 2000 – the first in the world to do so.

Exposing and defeating dishonesty in research does not scare away volunteers. It brings them in to volunteer more often, when they know that they are no longer being duped.

Debi,

Your comments on the lack of patient participation are very true, as are Laura's regarding the lack of doctors who are supporting the process. There will never be a large percentage of patient participation if doctors are not pushing their patients. This is particularly true when the doctors are not associated with large hospitals/universities or MDS centers. It's a major decision for any patient to participate in a clinical drug trial. There is a lack of knowledge as to what studies are currently recruiting (MJFF certainly helps this issue). There is a fear of unknown side effects. There is uncertainty as to the right trial to join, knowing you may be locked out of others. There is the risk of ending up as a control and taking a placebo for a year or more. There is the general distrust of the pharmaceutical industry, as stated by others. All of these reasons, and many more, are why doctors have to make more of an effort to educate their patients and handhold them through the process. As the data from Bob show, less than 4% of doctors participate in clinical trials. It's hard to expect the patient to join when their doctors aren't involved and have little knowledge of whats going on.

I would like to add another problem. It’s the lack of efficiency in the whole research process, particularly in long-term observational ("learning") studies. I have participated in several of them and it amazes me when seeing the overlap how inefficient the process is. In the course of one month, I had three UPDRS tests, two cognitive function tests, two smell tests, two MRIs, and three EEGs. All of these were done in the same metropolitan area. These end up taking a full day and many times more. For many PWP, the time and effort to do these tests are very difficult, especially if still employed. There has to be a way to allow for sharing of baseline data. For example, in NYC there are several large centers (e.g. Columbia, Beth Israel, NYU, etc) where different studies are currently taking place. Why can't an MRI, EEG or UPDRS taken at one center be shared with doctors at another location (with patient permission, of course). They do that in multi-center research, so they should be able to do it in single center studies also. Then, the PD patient would just have to participate with the test variable part of the study, or specific questionnaire, as the case may be, and not have to duplicate base items, like UPDRS. For all of those who will scream about proper research controls, I was trained as a statistician, have designed, conducted and analyzed numerous research studies and have taught it at graduate school level. Trust me, it can be done. Maybe places like MJFF have to help coordinate multi-center, multi-study research.

Get doctors more involved and make the process easier for the PWP and I think you will see some improvement in participation rates.

Just the thoughts of one frustrated PWP,

Gary

The first Lenny asked: “Is it rolling?”

The second Lenny asked: “The camera, or the avalanche?”

Everything.

Yes, it’s all rolling.

How did this come about?

We said we were the Underground.

Yes, and…?

They struck us by accident, when they were digging for their gold.

http://youtu.be/Nor7XPJmF3o

This cripple that they clothe and feed
Is neither starved, nor cold.

Non-publication of trials results is research misconduct
26th June 2013

The British Medical Association today voted:

The motion agreed in full:

i) Selective non-publication of unflattering trial data is research misconduct

ii) Medical practitioners who give grounds to believe they have been involved in such conduct will have their fitness to practice medicine re-assessed by the GMC.”

How y'a like them apples, Mister?

Laura, both you and Tupelo (Gary) make excellent points about the problems inherent in the clinical trials system. Making a match is only the first step, and that is problematic in itself.

The MJFF patient council has not had a discussion about DBS. I guess I never think about it because my doctor does not push it, and I don't want to consider it. But your comments about using DBS as a fall back remind me of how PD research languished for years because of the success of c/l.

I think the researchers are on the ball right now - looking to move forward quickly. But, the front line doctors and neurologists continue to be a challenge in PD care and research on all fronts. They don't take the time to care about clinical trials, and they don't take the time to care about new advancements in care.

There is a huge information dissemination problem. Those of us (patients on this board, orgs, researchers, etc) who are well informed are not doing a good enough job educating others, and the others don't often have the time to listen or know how to listen.

We can want to improve care and find new treatments, but it's not going to happen if we can't reach those who are actually seeing the patients on a regular basis.